SOLANA BEACH, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today congratulates its partner PTC Therapeutics on completion of its BLA submission to the U.S. Food and Drug Administration (FDA) for the approval of Upstaza™ (eladocagene exuparvovec), an investigational treatment for AADC Deficiency. If approved, Upstaza™ would become the first therapy to treat AADC Deficiency in the United States.
“AADC Deficiency is a devastating rare pediatric movement disorder that causes significant developmental delays and autonomic symptoms starting from birth. Patients with AADC deficiency are at a high risk of death in the first decade of life,” stated Jeremy Stigall, Chief Business Officer at ClearPoint Neuro. “The Upstaza™ BLA is the first filing for FDA approval of a treatment that addresses this devastating condition. Through our partnership with PTC, we are demonstrating our commitment to drive progress for the AADC Deficiency community.”
About aromatic L-amino acid decarboxylase (AADC) deficiency
AADC deficiency is a fatal, rare genetic disorder that typically causes severe disability and suffering from the first months of life, affecting every aspect of life – physical, mental and behavioral. The suffering of children with AADC deficiency may be exacerbated by episodes of distressing seizure-like oculogyric crises causing the eyes to roll up in the head, frequent vomiting, behavioral problems, and difficulty sleeping.
The lives of affected children are severely impacted and shortened. Ongoing physical, occupational and speech therapy, and interventions, including surgery, also are often required to manage potentially life-threatening complications such as infections, severe feeding and breathing problems.
About the SmartFlow® Cannula
With over 7,000 cannulas sold to date, SmartFlow is the only co-labeled device to gain approval by a regulatory agency for delivery of an approved gene therapy to the brain. The industry-leading cannula is used by many of ClearPoint Neuro’s 50+ pharmaceutical, academic, and biotech partners to bypass the blood brain barrier and deliver therapeutics to regions of interest using Convection Enhanced Delivery (CED) under direct image guidance. The SmartFlow Cannula has 510(k) clearance from the FDA for use in the United States for the aspiration of cerebrospinal fluid or injection of the chemotherapy drug Cytarabine into the ventricles. It has also been CE marked to deliver approved fluids into the brain and for aspiration of cerebrospinal fluid, and holds regulatory clearance for clinical use in Israel and Brazil. SmartFlow is utilized in approved clinical and preclinical studies for various research and drug trials.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which has been filed with the Securities and Exchange Commission. The Company does not assume any obligation to update these forward-looking statements.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d375ef5e-925f-4976-8bb2-63f3e90871a3
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (888) 287-9109 ext. 4 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its fourth quarter and full-year ended December 31, 2023.
2023 Full Year and Fourth Quarter Highlights
- Reported fourth quarter 2023 revenue of $6.8 million, a 32% year-over-year increase compared with the fourth quarter of 2022;
- Reported revenue of $24.0 million for the full year 2023, an increase of 17% over 2022 and representing the ninth consecutive year of growth;
- Increased biologics and drug delivery revenue to $13.6 million for the full year 2023, a 49% increase over 2022;
- Completed Certification of Carlsbad development and manufacturing facility and shut down of Irvine manufacturing facility; and
- Cash burn of $1.2 million in the fourth quarter, bringing cash and cash equivalents to $23.1 million as of December 31, 2023.
2024 Operational Highlights
- Six new hospital customers already added since the beginning of the year;
- Received 510(k) clearance for Smartframe OR™ Stereotactic System;
- First-in-Human cases performed using ClearPoint 2.2 Software and ClearPoint Array 1.2 Parallel Trajectory Software;
- First product approved under European MDR and products shipped to Europe from new Carlsbad development and manufacturing facility;
- Validation Papers for ClearPoint Maestro and ClearPoint PRISM products published in peer-reviewed journals;
- Completed a public offering of common stock, resulting in gross proceeds of approximately $15 million; and
- Reaffirming 2024 revenue guidance to be between $28.0 million and $32.0 million.
Business Outlook
“We are pleased to confirm our fourth quarter 2023 performance which included record revenue of $6.8 million, over 30% topline growth, and a reduction in our quarterly cash burn to only $1.2 million, our lowest since 2020,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “In just the first two months of 2024 we have already achieved some key strategic milestones including multiple FDA clearances and first-in-human procedures, first shipments to EU countries from our new Carlsbad facility and under EU-MDR certification, publication of key validation papers in peer-reviewed journals supporting both our navigation software and laser therapy system, and activation of more new clinical customers in the first quarter than in all of 2023.
“As a result,” continued Burnett, “we have been able to complete an important equity offering of approximately $15 million which solidifies our balance sheet for our pharma partners and will allow us to retire our entire outstanding debt in the next 12 months. It was very encouraging to perform this capital raise alongside many other biotech companies in the past few weeks, highlighting renewed investment into this important and exciting gene and cell therapy space. We continue to look with confidence at 2024 and reaffirm our 2024 revenue guidance to be in the range of $28.0 million - $32.0 million.”
Financial Results - Year Ended December 31, 2023
Total revenue was $24.0 million and $20.6 million for the years ended December 31, 2023 and 2022, respectively.
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 49% to $13.6 million for the year ended December 31, 2023, from $9.1 million for the same period in 2022. This increase is attributable to a $6.0 million increase in service revenue related to new preclinical studies and services entered into with our partners for the year ended December 31, 2023, compared to the same period in 2022, partially offset by a $1.5 million decrease in product revenue.
Functional neurosurgery navigation and therapy revenue which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, decreased 7% to $8.5 million during the year ended December 31, 2023, from $9.1 million for the same period in 2022. The decrease is driven by lower service revenue of $0.6 million as a result of pausing a co-development program with one of our Brain Computer Interface partners for the year ended December 31, 2023, compared to the same period in 2022.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, decreased 21% to $1.8 million for the year ended December 31, 2023, from $2.3 million for the same period in 2022, due primarily to a decrease in the placements of ClearPoint capital and software.
The Company achieved a gross margin of 57% on its sales for 2023, compared to a gross margin of 66% for 2022. This decrease in gross margin was primarily due to an increase in biologics and drug delivery preclinical services, which, to date, have had a lower margin than in prior years, as we launch new services and increase our presence in this space. Increased costs related to the transition to the new manufacturing facility also contributed to the decrease in gross margin compared to the prior year.
Operating expenses were $36.1 million for the full year 2023, compared with $29.9 million for 2022. The increase was mainly driven by an increase in personnel-related expenses, including share-based compensation, as we increased headcount to fund the expansion of the research and development, clinical, and support organizations, as well as an increase in the allowance for credit losses.
Financial Results – Quarter Ended December 31, 2023
Total revenue was $6.8 million for the three months ended December 31, 2023, and $5.2 million for the three months ended December 31, 2022, which represents an increase of $1.6 million, or 32%.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 76% to $4.1 million for the three months ended December 31, 2023, from $2.3 million for the same period in 2022. This increase is attributable to a $1.8 million increase in service revenue, partially offset by a slight decrease in product revenue.
Functional neurosurgery navigation and therapy revenue decreased 11% to $2.0 million for the three months ended December 31, 2023, from $2.3 million for the same period in 2022. The decrease was driven by lower service revenue.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased 23% to $0.7 million for the three months ended December 31, 2023, from $0.6 million for the same period in 2022.
Gross margin for the three months ended December 31, 2023, was 59%, as compared to a gross margin of 64% for the three months ended December 31, 2022. The decrease in gross margin was due primarily to an increase in biologics and drug delivery preclinical services, which, to date, have had a lower margin than in prior years, as we launch new services and increase our presence in this space.
Operating expenses for the fourth quarter of 2023 were $8.7 million, compared to $7.8 million for the fourth quarter of 2022. The increase was mainly driven by the increase in headcount across the organization and share-based compensation as well as an increase in the allowance for credit losses.
At December 31, 2023, the Company had cash and cash equivalents and short-term investments totaling $23.1 million compared to $37.5 million at December 31, 2022, with the decrease resulting primarily from the use of cash in operating activities of $13.7 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's fourth quarter and full year 2023 on Tuesday, March 12, 2024 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time), which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=198rn5GM. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until April 12, 2024, by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor Relations website at https://ir.clearpointneuro.com/.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
CLEARPOINT NEURO, INC. Consolidated Statements of Operations (Dollars in thousands, except for share and per share data) | |||||||
Years Ended December 31, | |||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 10,603 | $ | 12,789 | |||
Service and other revenue | 13,352 | 7,762 | |||||
Total revenue | 23,955 | 20,551 | |||||
Cost of revenue | 10,341 | 7,020 | |||||
Gross profit | 13,614 | 13,531 | |||||
Research and development costs | 11,709 | 10,894 | |||||
Sales and marketing expenses | 12,595 | 9,358 | |||||
General and administrative expenses | 11,756 | 9,611 | |||||
Operating loss | (22,446 | ) | (16,332 | ) | |||
Other income (expense): | |||||||
Other expense, net | (29 | ) | (22 | ) | |||
Interest income (expense), net | 386 | (81 | ) | ||||
Net loss | $ | (22,089 | ) | $ | (16,435 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.90 | ) | $ | (0.68 | ) | |
Weighted average shares outstanding: | |||||||
Basic and diluted | 24,605,212 | 24,181,854 | |||||
CLEARPOINT NEURO, INC. Consolidated Balance Sheets (Dollars in thousands, except for share and per share data) | |||||||
December 31, | |||||||
2023 | 2022 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 23,140 | $ | 27,615 | |||
Short-term investments | — | 9,874 | |||||
Accounts receivable, net | 3,211 | 2,665 | |||||
Inventory, net | 7,911 | 9,303 | |||||
Prepaid expenses and other current assets | 1,910 | 1,723 | |||||
Total current assets | 36,172 | 51,180 | |||||
Property and equipment, net | 1,389 | 806 | |||||
Operating lease rights of use | 3,564 | 1,895 | |||||
Software license inventory | 386 | 450 | |||||
Licensing rights | 1,041 | 1,028 | |||||
Other assets | 109 | 131 | |||||
Total assets | $ | 42,661 | $ | 55,490 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 393 | $ | 272 | |||
Accrued compensation | 2,947 | 2,824 | |||||
Other accrued liabilities | 1,053 | 2,065 | |||||
Operating lease liabilities, current portion | 424 | 561 | |||||
Deferred product and service revenue, current portion | 2,613 | 1,066 | |||||
Total current liabilities | 7,430 | 6,788 | |||||
Operating lease liabilities, net of current portion | 3,568 | 1,532 | |||||
Deferred product and service revenue, net of current portion | 541 | 390 | |||||
2020 senior secured convertible note payable, net | 9,949 | 9,893 | |||||
Total liabilities | 21,488 | 18,603 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.01 par value; 25,000,000 shares authorized at December 31, 2023 and 2022; none issued and outstanding at December 31, 2023 and 2022 | — | — | |||||
Common stock, $0.01 par value; 90,000,000 shares authorized at December 31, 2023 and 200,000,000 shares authorized at December 31, 2022; 24,652,729 and 24,578,983 shares issued and outstanding at December 31, 2023 and 2022, respectively | 247 | 246 | |||||
Additional paid-in capital | 193,382 | 187,008 | |||||
Accumulated deficit | (172,456 | ) | (150,367 | ) | |||
Total stockholders’ equity | 21,173 | 36,887 | |||||
Total liabilities and stockholders’ equity | $ | 42,661 | $ | 55,490 | |||
CLEARPOINT NEURO, INC. Consolidated Statements of Cash Flows (Dollars in thousands) | |||||||
Years Ended December 31, | |||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (22,089 | ) | $ | (16,435 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for credit losses (recoveries) | 1,258 | (117 | ) | ||||
Depreciation and amortization | 626 | 244 | |||||
Share-based compensation | 6,079 | 4,126 | |||||
Amortization of debt issuance costs and original issue discounts | 57 | 55 | |||||
Amortization of lease right of use assets, net of accretion in lease liabilities | 831 | 533 | |||||
Accretion of discounts on short-term investments | (126 | ) | (284 | ) | |||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (1,804 | ) | (211 | ) | |||
Inventory, net | 1,246 | (4,421 | ) | ||||
Prepaid expenses and other current assets | (113 | ) | (1,216 | ) | |||
Other assets | 22 | (6 | ) | ||||
Accounts payable and accrued expenses | (649 | ) | 1,591 | ||||
Lease liability | (755 | ) | (541 | ) | |||
Deferred revenue | 1,697 | 515 | |||||
Net cash flows from operating activities | (13,720 | ) | (16,167 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (717 | ) | (253 | ) | |||
Acquisition of licensing rights | (334 | ) | (893 | ) | |||
Purchase of short-term investments | — | (21,590 | ) | ||||
Proceeds from maturities of short-term investments | 10,000 | 12,000 | |||||
Net cash flows from investing activities | 8,949 | (10,736 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from stock option and warrant exercises | — | 268 | |||||
Proceeds from issuance of common stock under employee stock purchase plan | 506 | 477 | |||||
Payments for taxes related to net share settlement of equity awards | (210 | ) | (336 | ) | |||
Net cash flows from financing activities | 296 | 409 | |||||
Net change in cash and cash equivalents | (4,475 | ) | (26,494 | ) | |||
Cash and cash equivalents, beginning of year | 27,615 | 54,109 | |||||
Cash and cash equivalents, end of year | $ | 23,140 | $ | 27,615 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 743 | $ | 523 |
Contact: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that preclinical results of an in vivo validation study have been published in the Journal of Neurosurgery.1 These data demonstrate that the ClearPoint Prism Neuro Laser Therapy System provides accurate, near real-time temperature of the brain tissue with a mean absolute error of <1°C. Additionally, the morphology of the lesion, as visualized by Thermoguide™ MR-thermometry software, correlated well with histopathology.
The research was conducted by the Company and its Swedish partner, Clinical Laserthermia Systems AB (CLS), with Dr. John Rolston leading the study as Principal Investigator. The aim of the study was to evaluate the safety, accuracy, and efficacy of the Prism System. This was achieved by 1) demonstrating a predicted safety margin via survival histology; 2) determining the Thermal Damage Thresholds (TDTs) that best predict irreversible tissue damage based on said histology; and 3) evaluating the accuracy of temperature prediction compared to actual temperature changes in vivo.
“Our research presents a comprehensive and meticulously conducted open analysis of the ClearPoint Prism laser system. Prism offers a seamlessly integrated solution for precise and more efficient laser interstitial thermal therapy, advancing new treatment options for patients with intractable epilepsy, movement disorders, and brain tumors,” said John D. Rolston, MD, PhD, Associate Professor of Neurosurgery, Harvard Medical School.
“This robust, peer-reviewed validation clearly demonstrates that the advantages of Prism result in excellent predictability of targeted cell death. Our comparison of histopathology to damage estimation is arguably the most definitive test we could have performed and was part of the dataset that led to FDA clearance,” commented Chris Osswald, PhD, Director, Global Segment Leader for Laser Therapy at ClearPoint Neuro.
Additionally, the Prism System has been used together with the Company’s recently FDA cleared Array software version 1.2 to improve the practicality of neuro laser therapy. The SmartFrame Array Neuro Navigation System combines hardware and software designed to streamline neurosurgical procedures2 and enable more workflow options for both laser ablation and drug delivery procedures. Array’s new “Parallel Trajectory” feature allows for combination biopsy and laser therapy procedures, for example, to be performed in a single setting, through a single frame alignment, without the biopsy void interfering with the accuracy of thermometry.
The Prism System features the only non-cooled neurosurgical laser applicators on the market. ClearPoint’s next-generation laser applicator technology eliminates the need for external cooling, simplifying setup, reducing power and ablation time, lessening imaging artifact, and enabling more efficient workflows. Currently, Prism is in limited market release at select academic medical centers across the United States.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
1 Singh H, Osswald CR, Rossman A, et al. Preclinical assessment of a noncooled MR thermometry–based neurosurgical laser therapy system. Journal of Neurosurgery. Published online March 08, 2024. doi:10.3171/2023.12.JNS232154
2 Sterk B, Taha B, Osswald C, Bell R, Chen L, Chen CC. Initial Clinical Experience With ClearPoint SmartFrame Array-Aided Stereotactic Procedures. World Neurosurg. 2022;162:e120-e130. doi:10.1016/j.wneu.2022.02.095
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/5b6c1042-46f3-43c2-8dc5-7adb98300d25
https://www.globenewswire.com/NewsRoom/AttachmentNg/0118a9fa-7c2e-4aef-8e24-898dbe0f9a63
https://www.globenewswire.com/NewsRoom/AttachmentNg/a6686b2e-206d-4a18-aafe-5d90ec662726
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (888) 287-9109 ext. 4 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.com
Fig. 1
Representative temperature recordings from thermal probes (solid blue) and thermometry (green circles).
Fig. 2
A sharp border between the lesion and healthy brain tissue was achieved.
SmartFrame Array® Neuro Navigation Platform
The SmartFrame Array system offers stability and flexibility for neuro navigation, with a highly rigid frame and an 'array' of six offset channels to simplify multi-trajectory procedures and entry point adjustments. The Array software provides an intuitive user interface with options for performing entire procedures in the MRI or starting in the operating room.
Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 fourth quarter and full year results on Tuesday, March 12th, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until April 12, 2024, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (888) 287-9109 ext. 4 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
The Company intends to use the net proceeds from this offering for general corporate purposes, which may include research and development expenditures, potential acquisitions of or investments in business, products and technologies that complement the Company’s business, or repayment of the Company’s indebtedness.
Lake Street Capital Markets, LLC is acting as the sole book-running manager for the proposed offering.
A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission (the “SEC”) on November 20, 2023. Before you invest, you should read the prospectus in the registration statement and related prospectus supplement for more complete information about the Company and this offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering are available on the SEC website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by visiting the SEC’s website, or from Lake Street Capital Markets, LLC, Attn: Syndicate Department, 920 Second Avenue South, Suite 700, Minneapolis, MN 55402, by calling (612) 326-1305.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the completion, terms, size, and timing of the public offering, and with respect to granting the underwriters a 30-day option to purchase additional shares. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including risks and uncertainties related to completion of the public offering on the anticipated terms or at all, market conditions and the satisfaction of customary closing conditions related to the public offering, and those factors described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Reports on Form 10-Q for the three months ended March 31, 2023, June 30, 2023, and September 30, 2023, all of which have been filed with the SEC, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the SEC on or before March 31, 2024.
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
Lake Street Capital Markets, LLC is acting as the sole book-running manager for the proposed offering.
A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission (the “SEC”) on November 20, 2023. Before you invest, you should read the prospectus in the registration statement and related preliminary prospectus supplement that the Company filed with the SEC for more complete information about the Company and this offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering are available on the SEC website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained from Lake Street Capital Markets, LLC, Attn: Syndicate Department, 920 Second Avenue South, Suite 700, Minneapolis, MN 55402, by calling (612) 326-1305.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the completion, terms, size, and timing of the public offering, and with respect to granting the underwriters a 30-day option to purchase additional shares. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including risks and uncertainties related to completion of the public offering on the anticipated terms or at all, market conditions and the satisfaction of customary closing conditions related to the public offering, and those factors described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Reports on Form 10-Q for the three months ended March 31, 2023, June 30, 2023, and September 30, 2023, all of which have been filed with the SEC, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the SEC on or before March 31, 2024.
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced FDA Clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling, and also the publication of a key validation study for its ClearPoint Maestro® Brain Model in the peer-reviewed journal NeuroImage.1
“Leadership and innovation in any medical field requires not only practical product development to deliver value for clinicians, but also robust validation and peer review to show how and why those products work,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “The Maestro Brain Model, and its integration into the recently FDA cleared ClearPoint 2.2 navigation software, is our latest example of just that. The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation. At the same time, we are pleased to announce that one of many planned validation studies has been published online in the journal NeuroImage to give surgeons confidence in the performance and accuracy of the Maestro Tool. The first clinical cases using ClearPoint 2.2 were completed successfully this quarter, and we expect full market release in the second half of this year.”
MRI-guided neuro interventions require rapid, accurate, and reproducible segmentation of anatomical brain structures for identification of targets during surgical procedures. This manuscript introduces the methodology for shape-constrained deformable brain segmentation behind Maestro, describes the validation performed for its FDA clearance, and presents a comparison with manual expert segmentation and FreeSurfer, an open-source segmentation software. Quantitative analysis indicates superior performance compared to both manual expert segmentation and FreeSurfer. The shape-constrained methodology results in accurate and highly reproducible segmentation. Furthermore, inherent point based-correspondence provides consistent target identification ideal for MRI-guided neuro interventions. A link to the open source publication can be found here.
Reproducibility error of Maestro (green), FreeSurfer 7.2 (blue) and manual segmentation (red) for common brain structures (left), and average over all structures (right). Bars represent range of measured relative volume difference.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, which may include the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
_____________________
1 Zagorchev L, Hyde DE, Li C, et al. Shape-constrained deformable brain segmentation: Methods and quantitative validation. Neuroimage. Published online February 16, 2024. doi:10.1016/j.neuroimage.2024.120542
Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/088f3809-a329-47e4-bfc0-21655bb9e1b2
https://www.globenewswire.com/NewsRoom/AttachmentNg/312932db-1574-4a9c-9bc4-5218308a2cee
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.com
ClearPoint Maestro Brain Model
ClearPoint Maestro Brain Model
ClearPoint Neuro Maestro Brain Model Comparative Reproducibility Error Results
Reproducibility error of Maestro (green), FreeSurfer 7.2 (blue) and manual segmentation (red) for common brain structures (left), and average over all structures (right). Bars represent range of measured relative volume difference.
“We are ecstatic to have completed our first successful case with combined ClearPoint Neuro MRI targeting and laser ablation solutions,” stated Dr. Jonathan Riley, Assistant Professor of Neurosurgery at the University of Buffalo, and Medical Director of Functional Neurosurgery at Kaleida Health. “This is a world leading suite of technologies that allows us to offer selected minimally invasive neurosurgical procedures to patients in our region.”
“Our successful first case with Dr. Riley and the team at Kaleida Health is emblematic of the excellent collaboration we have both with our customers and within our organization,” said Chris Osswald, Segment Leader for Laser Therapy at ClearPoint Neuro. “Our limited market release has been such a positive experience, mainly because of our team’s dedication. We look forward to continued success together with the team at Kaleida Health and as we look to expand into full market release later this year.”
The ClearPoint Prism Neuro Laser Therapy System features the only non-cooled laser applicator on the market. ClearPoint’s next-generation laser applicator technology eliminates the need for external cooling, simplifying setup, reducing power and ablation time, lessening imaging artifact, and enabling more efficient workflows. The Prism laser is currently in limited market release at select academic medical centers across the United States. For more information about the ClearPoint Neuro Laser Therapy System please visit: https://www.clearpointneuro.com/clearpoint-prism-neuro-laser-system/
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/66f919ac-c17e-402e-a88e-1211e8044e7c
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
European Medical Device Regulation 2017/745 (EU MDR), the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive 93/42/EEC (MDD) regulation. With the introduction of EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access.
“EU MDR is much more rigorous than MDD, forcing many medical device companies in our space who wish to enter or continue commercialization in Europe to closely assess every product before committing the time and resources necessary to meet its requirements,” stated Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “Our team has risen to this challenge, especially given the importance of the EU to our pharmaceutical partners.”
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for the future market of its products and services, regulatory and development plans, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its SmartFrame OR™ Stereotactic System.
The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company plans to commence limited market release in the first half of 2024, with a planned full market release in the second half of 2024.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated Joe Burnett, President and CEO at ClearPoint Neuro. “More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, Laser Ablation, Biopsy, sEEG, and more. This product is the first in ClearPoint’s history that does not require the use of MRI during the procedure, allowing us to access more hospitals, and to support an order of magnitude more patients than our legacy portfolio. Importantly, the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms and should not require the approval by hospital capital committees for surgeons to try this new product.”
“SmartFrame OR embodies over a decade of accumulated expertise in MRI-guided navigation, now enhanced with the latest OR imaging technology,” said Rob Rubio, Segment Leader for Neuromodulation at ClearPoint Neuro. “It offers surgeons flexible workflows, including iCT forward projection, enabling precise image-based corrections to achieve submillimetric accuracy.”
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a2ebbab0-b838-4d64-b33f-d57fdb80a9a6
Contact: Media Contact: Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
Fourth Quarter 2023 Preliminary Unaudited Financial Highlights
- Preliminary unaudited revenue of approximately $6.8 million, a 32% year-over-year increase;
- Increased biologics and drug delivery revenue to approximately $4.1 million, a 76% year-over-year increase; and
- Cash burn of approximately $1.2 million in the fourth quarter. The Company had approximately $23.1 million in cash and cash equivalents at December 31, 2023.
Full Year 2023 Preliminary Unaudited Financial Highlights
- Achieved preliminary unaudited record revenue of approximately $24 million, a 17% year-over-year increase, versus most recent guidance of $23 - $25 million; and
- Increased biologics and drug delivery revenue to approximately $13.6 million, a 49% year-over-year increase.
Business Outlook and Planned Value Creating Milestones
- The Company estimates revenue in 2024 to be between $28 million and $32 million, representing growth between 17% and 33%;
- Achieve FDA clearance and launch SmartFrame OR for navigation and first revenue in the operating room;
- Launch full market release of the ClearPoint PRISM® Neuro Laser Therapy System;
- Launch and deploy ClearPoint 2.2 Software with embedded ClearPoint Maestro® and 1.2 Array Software with parallel trajectory tumor planning application to the installed base;
- Win first purchase orders for GLP ready pre-clinical services;
- Prototype demonstration of next generation software application for AI predictive modeling to pharma partners;
- Continue global expansion to achieve 100 ClearPoint sites by 2025; and
- Demonstrate operating leverage with expenses increasing less than revenue growth.
“We are thrilled with our fourth quarter performance delivering record revenue of $6.8 million, reflecting 32% growth, while meaningfully reducing our cash burn and gaining commitments for multiple new ClearPoint installations,” commented Joe Burnett, President and CEO at ClearPoint Neuro.
“In 2024, we look forward to several new product introductions reflecting success with the strategic investments we have made to expand our leadership position, including the SmartFrame OR for our entrance into the operating room; the full market release of the PRISM laser therapy system; the integration of ClearPoint Maestro into our navigation software; and the expansion of our pre-clinical biologics and drug delivery services including GLP readiness. These represent four new potential revenue streams that we plan to add to our base business throughout the year.”
Management will be available for meetings in San Francisco during the J.P. Morgan Healthcare Conference from January 8-11, 2024.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of its products and services, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2024. The Company does not assume any obligation to update these forward-looking statements.
Contact: Danilo D’Alessandro, Chief Financial Officer (888) 287-9109 ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its third quarter ended September 30, 2023.
Third Quarter Highlights
- Reported quarterly revenue of $5.8 million, a 12% year-over-year increase;
- Increased biologics and drug delivery revenue to $3.5 million, a 55% year-over-year increase;
- Operational cash burn of $1.8 million, the lowest quarterly burn since 2020;
- Entered into new strategic biologics and drug delivery agreements, including additional milestone-based agreement;
- Submitted three new stereotactic products to the FDA for 510(k) clearance;
- Submitted one 510(k) clearance to the FDA for updated software that allows the ClearPoint Navigation Software to incorporate the Maestro Brain Model;
- Completed the transition to the new manufacturing facility in Carlsbad, California, which is now producing and shipping sellable product to customers;
- Cash and cash equivalents totaled $24.3 million as of September 30, 2023.
Business Outlook
- With additional focus on near-term investments that drive profitable growth, the company now forecasts 2023 total revenue between $23.0 and $25.0 million representing growth between 11% and 18% for the year.
“The third quarter was productive for the team as we continued to grow double digits while meaningfully reducing our operational cash burn,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “We believe that our long-term vision and strategy remain unchanged, however we are committed to focusing our near-term activities on profitable growth as our third quarter demonstrated. Despite reducing our quarterly operational cash burn to the lowest level since 2020, we were still able to execute multiple new strategic biologics and drug delivery agreements, expand our PRISM laser therapy system to new centers, execute multiple new product FDA submissions, and complete the transition of manufacturing to our new facility in Carlsbad, California ahead of schedule, improving gross margin and eliminating redundant costs heading into 2024.”
Financial Results – Quarter Ended September 30, 2023
Total revenue was $5.8 million for the three months ended September 30, 2023, and $5.1 million for the three months ended September 30, 2022, which represents an increase of $0.6 million, or 12%.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials utilizing our products, increased 55% to $3.5 million for the three months ended September 30, 2023, from $2.2 million for the same period in 2022.
Functional neurosurgery navigation and therapy revenue, decreased 21% to $1.9 million for the three months ended September 30, 2023, from $2.4 million for the same period in 2022. The decrease is driven primarily by lower service revenue of $0.3 million as a result of pausing a co-development program with one of our Brain Computer Interface partners.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, decreased 26% to $0.4 million for the three months ended September 30, 2023, from $0.5 million for the same period in 2022.
Gross margin for the three months ended September 30, 2023, was 57%, as compared to a gross margin of 71% for the three months ended September 30, 2022. The decrease in gross margin was primarily due to an increase in biologics and drug delivery preclinical services, which, to date, have had a lower margin than prior year as we launch new services and increase our presence in this space. Increased costs related to the transition to the new manufacturing facility have also contributed to the decrease in gross margin compared to prior year.
Operating expenses for the third quarter of 2023 were $8.2 million, compared to $7.5 million for the third quarter of 2022. The increase was mainly driven by the increase in headcount across the organization and share-based compensation as well as an increase in the allowance for credit losses, offset slightly by lower research and development costs.
At September 30, 2023, the Company had cash and cash equivalents and short-term investments totaling $24.3 million as compared to $37.5 million at December 31, 2022, with the decrease resulting primarily from the use of cash in operating activities of $12.6 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company’s 2023 third quarter on Thursday, November 9, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=dhaAzhXA. Investors and analysts who would like to participate in the conference call via telephone may do so at (800) 715-9871, or at (646) 307-1963 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until December 9, 2023, by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com/.
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company’s future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management’s expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company’s actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of macroeconomic and inflationary conditions, global instability, supply chain disruptions, and labor shortages; future revenue from sales of the Company’s hardware and software products and biologics and drug delivery consulting services; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s hardware and software products and service offerings, including our biologics and drug delivery partners’ use of our products and services in their delivery of therapies; our biologics and drug delivery partners’ ability to fund their business activities, conduct further research and development, and achieve success in their studies and clinical trials; and risks inherent in the research and development and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, which the Company intends to file with the Securities and Exchange Commission on or before November 14, 2023.
CLEARPOINT NEURO, INC. | |||||||
Consolidated Statements of Operations | |||||||
(Unaudited) | |||||||
(Dollars in thousands, except for share and per share data) | |||||||
For The Three Months Ended September 30, |
|||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 2,410 | $ | 3,130 | |||
Service and other revenue | 3,352 | 2,016 | |||||
Total revenue | 5,762 | 5,146 | |||||
Cost of revenue | 2,489 | 1,467 | |||||
Gross profit | 3,273 | 3,679 | |||||
Research and development costs | 2,429 | 2,654 | |||||
Sales and marketing expenses | 2,841 | 2,422 | |||||
General and administrative expenses | 2,900 | 2,398 | |||||
Operating loss | (4,897 | ) | (3,795 | ) | |||
Other expense: | |||||||
Other expense, net | (12 | ) | (25 | ) | |||
Interest income, net | 100 | 32 | |||||
Net loss | $ | (4,809 | ) | $ | (3,788 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.20 | ) | $ | (0.15 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 24,630,181 | 24,497,636 |
For The Nine Months Ended September 30, |
|||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 7,377 | $ | 9,750 | |||
Service and other revenue | 9,768 | 5,627 | |||||
Total revenue | 17,145 | 15,377 | |||||
Cost of revenue | 7,544 | 5,212 | |||||
Gross profit | 9,601 | 10,165 | |||||
Research and development costs | 9,057 | 7,967 | |||||
Sales and marketing expenses | 9,248 | 6,826 | |||||
General and administrative expenses | 9,036 | 7,235 | |||||
Operating loss | (17,740 | ) | (11,863 | ) | |||
Other expense: | |||||||
Other expense, net | (25 | ) | (22 | ) | |||
Interest income (expense), net | 295 | (165 | ) | ||||
Net loss | $ | (17,470 | ) | $ | (12,050 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.71 | ) | $ | (0.50 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 24,599,191 | 24,058,205 | |||||
CLEARPOINT NEURO, INC. | |||||||
Consolidated Balance Sheets | |||||||
(Dollars in thousands, except for share and per share data) | |||||||
September 30, 2023 |
December 31, 2022 |
||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 24,342 | $ | 27,615 | |||
Short-term investments, at amortized cost | — | 9,874 | |||||
Accounts receivable, net | 2,424 | 2,665 | |||||
Inventory, net | 8,987 | 9,303 | |||||
Prepaid expenses and other current assets | 1,557 | 1,723 | |||||
Total current assets | 37,310 | 51,180 | |||||
Property and equipment, net | 1,355 | 806 | |||||
Operating lease, right-of-use assets | 3,689 | 1,895 | |||||
Software license inventory | 405 | 450 | |||||
Licensing rights | 969 | 1,028 | |||||
Other assets | 109 | 131 | |||||
Total assets | $ | 43,837 | $ | 55,490 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 789 | $ | 272 | |||
Accrued compensation | 2,288 | 2,824 | |||||
Other accrued liabilities | 953 | 2,065 | |||||
Operating lease liabilities, current portion | 384 | 561 | |||||
Deferred product and service revenue, current portion | 1,175 | 1,066 | |||||
Total current liabilities | 5,589 | 6,788 | |||||
Operating lease liabilities, net of current portion | 3,695 | 1,532 | |||||
Deferred product and service revenue, net of current portion | 524 | 390 | |||||
2020 senior secured convertible note payable, net | 9,935 | 9,893 | |||||
Total liabilities | 19,743 | 18,603 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at September 30, 2023 and December 31, 2022 | — | — | |||||
Common stock, $0.01 par value; 90,000,000 shares authorized at September 30, 2023 and 200,000,000 shares authorized at December 31, 2022; 24,625,670 shares issued and outstanding at September 30, 2023; and 24,578,983 issued and outstanding at December 31, 2022 | 246 | 246 | |||||
Additional paid-in capital | 191,685 | 187,008 | |||||
Accumulated deficit | (167,837 | ) | (150,367 | ) | |||
Total stockholders’ equity | 24,094 | 36,887 | |||||
Total liabilities and stockholders’ equity | $ | 43,837 | $ | 55,490 | |||
CLEARPOINT NEURO, INC. | |||||||
Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
(Dollars in thousands) | |||||||
For The Nine Months Ended September 30, |
|||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (17,470 | ) | $ | (12,050 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for credit losses (recoveries) | 903 | (92 | ) | ||||
Depreciation and amortization | 443 | 224 | |||||
Share-based compensation | 4,536 | 2,954 | |||||
Amortization of debt issuance costs and original issue discounts | 42 | 41 | |||||
Amortization of lease right-of-use, net of accretion in lease liabilities | 590 | 400 | |||||
Accretion of discounts on short-term investments | (126 | ) | (159 | ) | |||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (662 | ) | (982 | ) | |||
Inventory, net | 263 | (3,318 | ) | ||||
Prepaid expenses and other current assets | 241 | (1,150 | ) | ||||
Other assets | 22 | 31 | |||||
Accounts payable and accrued expenses | (1,023 | ) | 1,255 | ||||
Lease liabilities | (553 | ) | (400 | ) | |||
Deferred revenue | 243 | 144 | |||||
Net cash flows from operating activities | (12,551 | ) | (13,102 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (696 | ) | (214 | ) | |||
Acquisition of licensing rights | (167 | ) | (678 | ) | |||
Purchase of short-term investments | — | (21,590 | ) | ||||
Proceeds from maturities of short-term investments | 10,000 | — | |||||
Net cash flows from investing activities | 9,137 | (22,482 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from stock option and warrant exercises | — | 263 | |||||
Payments for taxes related to net share settlement of equity awards | (173 | ) | (336 | ) | |||
Proceeds from issuance of common stock under employee stock purchase plan | 314 | 260 | |||||
Net cash flows from financing activities | 141 | 187 | |||||
Net change in cash and cash equivalents | (3,273 | ) | (35,397 | ) | |||
Cash and cash equivalents, beginning of period | 27,615 | 54,109 | |||||
Cash and cash equivalents, end of period | $ | 24,342 | $ | 18,712 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 554 | $ | 351 |
Contact: Danilo D’Alessandro, Chief Financial Officer (949) 900-6833 info@clearpointneuro.com Investor Relations ir@clearpointneuro.comSource: ClearPoint Neuro, Inc.]]>
Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 third quarter on Thursday, November 9, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (800) 715-9871, or at (646) 307-1963 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until December 9, 2023, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 active sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of macroeconomic and inflationary conditions, global instability, supply chain disruptions, and labor shortages; future revenue from sales of the Company’s hardware and software products and biologics and drug delivery consulting services; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s hardware and software products and service offerings, including our biologics and drug delivery partners’ use of our products and services in their delivery of therapies; our biologics and drug delivery partners’ ability to fund their business activities, conduct further research and development, and achieve success in their studies and clinical trials; and risks inherent in the research and development and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2023, both of which the Company filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, which the Company intends to file with the Securities and Exchange Commission on or before November 14, 2023.
Contact: Danilo D’Alessandro, Chief Financial Officer 1-888-979-8369 info@clearpointneuro.com Investor Relations – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its second quarter ended June 30, 2023.
Second Quarter Highlights
- Reported record quarterly revenue of $6.0 million, a 14% year-over-year increase;
- Increased biologics and drug delivery revenue to $3.4 million, a 40% year-over-year increase;
- Announced an example of a milestone-based biologics and drug delivery agreement whereby ClearPoint would earn cash compensation based on the successful progression of a drug candidate through the clinical and regulatory process;
- Installed multiple new PRISM laser therapy units and continued the limited market release in the U.S.;
- Completed construction on the manufacturing clean room at the Carlsbad, California facility;
- Cash and cash equivalents totaled $26.5 million as of June 30, 2023.
Business Outlook
The Company reaffirms its full year 2023 revenue outlook of between $25.0 and $27.0 million.
“We are pleased with our result for the second quarter as we have returned to double-digit growth and delivered record revenue stemming primarily from the launch of new services in the biologics and drug delivery space which grew more than 40%,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “As we look ahead to the second half of 2023, we expect to demonstrate progress toward our continued growth and scale by 1) accelerating revenue growth; 2) adding meaningful strategic and milestone-based biologics and drug delivery agreements; 3) expanding our PRISM limited market release to multiple new centers; 4) executing as many as five FDA submissions directly or through partnerships for new products; and 5) completing the qualification of our new manufacturing clean room facility in Carlsbad, California and producing sellable product. We believe these milestones will contribute to a reduction in operational cash burn compared to the first half of 2023 with continued revenue growth in biologics and drug delivery being the primary driver.”
Financial Results – Quarter Ended June 30, 2023
Total revenue was $6.0 million for the three months ended June 30, 2023, and $5.2 million for the three months ended June 30, 2022, which represents an increase of $0.8 million, or 14%.
Functional neurosurgery navigation and therapy revenue, remained relatively consistent at $2.2 million for the three months ended June 30, 2023 and 2022.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials utilizing our products, increased 40% to $3.4 million for the three months ended June 30, 2023, from $2.4 million for the same period in 2022. This increase is attributable to a $1.8 million increase in service revenue, partially offset by $0.9 million decrease in product revenue.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, decreased 38% to $0.4 million for the three months ended June 30, 2023, from $0.6 million for the same period in 2022 as a result of fewer placements of ClearPoint capital and software.
Gross margin for the three months ended June 30, 2023, was 53%, as compared to a gross margin of 63% for the three months ended June 30, 2022. The decrease in gross margin was primarily due to an increase in biologics and drug delivery preclinical services, which, to date, have had a lower margin than product sales as we launch new services and increase our presence in this space. Increased costs related to the transition to the new manufacturing facility have also contributed to the decrease in gross margin.
Operating expenses for the second quarter of 2023 were $10.3 million, compared to $7.5 million for the second quarter of 2022. The increase was mainly driven by the increase in headcount across the organization and share-based compensation as well as an increase in product development costs.
At June 30, 2023, the Company had cash and cash equivalents and short-term investments totaling $26.5 million as compared to $37.5 million at December 31, 2022, with the decrease resulting primarily from the use of cash in operating activities of $10.8 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2023 second quarter on Tuesday, August 8, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=n0kx7ZK0. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 437-3179, or at (862) 298-0702 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until September 7, 2023, by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; risks inherent in the research and development, and regulatory approval of new products; and risks in the process of developing and establishing manufacturing operations in a new facility. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, both of which have been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2023, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2023.
CLEARPOINT NEURO, INC. Consolidated Statements of Operations (Unaudited) (Dollars in thousands, except for per share data) |
|||||||
For The Three Months Ended June 30, |
|||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 2,337 | $ | 3,457 | |||
Service and other revenue | 3,613 | 1,743 | |||||
Total revenue | 5,950 | 5,200 | |||||
Cost of revenue | 2,824 | 1,945 | |||||
Gross profit | 3,126 | 3,255 | |||||
Research and development costs | 3,605 | 2,411 | |||||
Sales and marketing expenses | 3,474 | 2,387 | |||||
General and administrative expenses | 3,178 | 2,661 | |||||
Operating loss | (7,131 | ) | (4,204 | ) | |||
Other expense: | |||||||
Other expense, net | (2 | ) | (8 | ) | |||
Interest income (expense), net | 81 | (91 | ) | ||||
Net loss | $ | (7,052 | ) | $ | (4,303 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.29 | ) | $ | (0.18 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 24,583,712 | 23,985,577 |
For The Six Months Ended June 30, |
|||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 4,967 | $ | 6,620 | |||
Service and other revenue | 6,416 | 3,611 | |||||
Total revenue | 11,383 | 10,231 | |||||
Cost of revenue | 5,055 | 3,746 | |||||
Gross profit | 6,328 | 6,485 | |||||
Research and development costs | 6,628 | 5,312 | |||||
Sales and marketing expenses | 6,407 | 4,404 | |||||
General and administrative expenses | 6,136 | 4,837 | |||||
Operating loss | (12,843 | ) | (8,068 | ) | |||
Other expense: | |||||||
Other (expense) income, net | (13 | ) | 3 | ||||
Interest income (expense), net | 195 | (197 | ) | ||||
Net loss | $ | (12,661 | ) | $ | (8,262 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.52 | ) | $ | (0.35 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 24,583,439 | 23,834,847 |
CLEARPOINT NEURO, INC. Consolidated Balance Sheets (Dollars in thousands, except for per share data) |
|||||||
June 30, 2023 |
December 31, 2022 |
||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 26,464 | $ | 27,615 | |||
Short-term investments, at amortized cost | — | 9,874 | |||||
Accounts receivable, net | 2,799 | 2,665 | |||||
Inventory, net | 9,204 | 9,303 | |||||
Prepaid expenses and other current assets | 2,244 | 1,723 | |||||
Total current assets | 40,711 | 51,180 | |||||
Property and equipment, net | 1,360 | 806 | |||||
Operating lease, right-of-use assets | 3,956 | 1,895 | |||||
Software license inventory | 407 | 450 | |||||
Licensing rights | 1,051 | 1,028 | |||||
Other assets | 156 | 131 | |||||
Total assets | $ | 47,641 | $ | 55,490 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,273 | $ | 272 | |||
Accrued compensation | 2,339 | 2,824 | |||||
Other accrued liabilities | 1,373 | 2,065 | |||||
Operating lease liabilities, current portion | 493 | 561 | |||||
Deferred product and service revenue, current portion | 724 | 1,066 | |||||
Total current liabilities | 6,202 | 6,788 | |||||
Operating lease liabilities, net of current portion | 3,855 | 1,532 | |||||
Deferred product and service revenue, net of current portion | 253 | 390 | |||||
2020 senior secured convertible note payable, net | 9,921 | 9,893 | |||||
Total liabilities | 20,231 | 18,603 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at June 30, 2023 and December 31, 2022 | — | — | |||||
Common stock, $0.01 par value; 90,000,000 shares authorized at June 30, 2023 and 200,000,000 shares authorized at December 31, 2022; 24,627,674 shares issued and outstanding at June 30, 2023; and 24,578,983 issued and outstanding at December 31, 2022 | 246 | 246 | |||||
Additional paid-in capital | 190,192 | 187,008 | |||||
Accumulated deficit | (163,028 | ) | (150,367 | ) | |||
Total stockholders’ equity | 27,410 | 36,887 | |||||
Total liabilities and stockholders’ equity | $ | 47,641 | $ | 55,490 |
CLEARPOINT NEURO, INC. Consolidated Statements of Cash Flows (Unaudited) (Dollars in thousands) |
|||||||
For The Six Months Ended June 30, |
|||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (12,661 | ) | $ | (8,262 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for credit losses (recoveries) | 454 | (10 | ) | ||||
Depreciation and amortization | 285 | 187 | |||||
Share-based compensation | 2,952 | 1,779 | |||||
Amortization of debt issuance costs and original issue discounts | 28 | 27 | |||||
Amortization of lease right-of-use, net of accretion in lease liabilities | 325 | 267 | |||||
Accretion of discounts on short-term investments | (126 | ) | (23 | ) | |||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (588 | ) | (1,001 | ) | |||
Inventory, net | 94 | (1,786 | ) | ||||
Prepaid expenses and other current assets | (438 | ) | (1,010 | ) | |||
Other assets | (25 | ) | 30 | ||||
Accounts payable and accrued expenses | (282 | ) | 679 | ||||
Lease liabilities | (293 | ) | (261 | ) | |||
Deferred revenue | (480 | ) | 134 | ||||
Net cash flows from operating activities | (10,755 | ) | (9,250 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (461 | ) | (145 | ) | |||
Acquisition of licensing rights | (167 | ) | (116 | ) | |||
Purchase of short-term investments | — | (21,590 | ) | ||||
Proceeds from maturities of short-term investments | 10,000 | — | |||||
Net cash flows from investing activities | 9,372 | (21,851 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from stock option and warrant exercises | — | 256 | |||||
Payments for taxes related to net share settlement of equity awards | (82 | ) | — | ||||
Proceeds from issuance of common stock under employee stock purchase plan | 314 | 260 | |||||
Net cash flows from financing activities | 232 | 516 | |||||
Net change in cash and cash equivalents | (1,151 | ) | (30,585 | ) | |||
Cash and cash equivalents, beginning of period | 27,615 | 54,109 | |||||
Cash and cash equivalents, end of period | $ | 26,464 | $ | 23,524 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 369 | $ | 207 |
Contact: Danilo D’Alessandro, Chief Financial Officer (949) 900-6833 info@clearpointneuro.com Caroline Corner, Investor Relations ir@clearpointneuro.comSource: ClearPoint Neuro, Inc.]]>
Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 second quarter on Tuesday, August 8, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 437-3179, or at (862) 298-0702 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until September 7, 2023, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 65 sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 biologics/pharmaceutical companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research and development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, both of which the Company filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2023, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2023.
Contact: Danilo D’Alessandro, Chief Financial Officer 1-888-979-8369 info@clearpointneuro.com Investor Relations – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
“We are extremely excited to partner with UCB, a global biopharmaceutical leader, with a focus on innovating through the adoption of next generation science and new technologies,” stated Jeremy Stigall, Executive Vice President and General Manager of Biologics and Drug Delivery at ClearPoint Neuro. “Over the past year, we have invested heavily in expanding our Biologics and Drug Delivery team, as well as our product and services portfolio to attract partners of UCB’s caliber. UCB sought comprehensive tools to empower a seamless transition from benchtop testing to commercial success, and that’s precisely what our team can deliver today.”
Under the terms of the license agreement, UCB will utilize ClearPoint Neuro’s proprietary technology and services in connection with the development and commercialization of UCB’s gene therapy products. ClearPoint Neuro will receive success-based milestone payments. Further financial details of the agreement were not disclosed.
Dhaval Patel, Executive Vice President and UCB’s Chief Scientific Officer, said, “We look forward to the ClearPoint Neuro collaboration as we work on advancing UCB’s research and development pipeline in gene therapy. We believe that ClearPoint Neuro are a strong strategic fit for UCB as they are a company dedicated to innovation in the neurology space with a unique portfolio of navigation and drug delivery tools.”
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 active sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, which the Company filed with the Securities and Exchange Commission on May 15, 2023.
Contact: Media Contact – ClearPoint Neuro Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 active sites in the North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
ClearPoint Neuro Contact:
Danilo D’Alessandro, Chief Financial Officer
(949)-900-6833
info@clearpointneuro.com
Caroline Corner, Investor Relations
ir@clearpointneuro.com
Source: ClearPoint Neuro, Inc. ]]>
SOLANA BEACH, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its first quarter ended March 31, 2023.
First Quarter Highlights
- Reported quarterly revenue of $5.4 million, a 8% year-over-year increase;
- Increased biologics and drug delivery revenue to $2.7 million, a 24% year-over-year increase;
- Announced exclusive multi-year licensing agreement with UCSF for Innovative Intra-Cerebral Cellular Delivery Platform;
- Added multiple new biologics and drug delivery partners in the quarter to bring the total to more than 50;
- Installed two additional ClearPoint Navigation systems in the quarter;
- Installed two additional Prism Laser Therapy systems in the quarter;
- Began development of new operating room-based software through an extended partnership with Philips and New England Scientific;
- Submitted construction plans for our new manufacturing site in Carlsbad, California;
- Cash and short-term investments totaled $31.7 million as of March 31, 2023.
Business Outlook
The Company reaffirms its full year 2023 revenue outlook of between $25.0 and $27.0 million.
“ClearPoint enjoyed another record quarter, driven by our continued focus on biologics and drug delivery pre-clinical services which we provide to our growing list of biotech and pharma partners,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “Our four-pillar growth strategy continues to make progress, and to be the backbone of our vision and success as it has informed a number of very important strategic pivots over the past couple of years including expanding pre-clinical services and capabilities, entering the therapeutic device market with the PRISM Laser Therapy System, and evolving our navigation platform beyond the MRI and into the operating room. We believe we are well-positioned for the future and that is a testament to our world class management team and every ClearPoint employee that is dedicated to serving our patients and our customers. Our first quarter performance for both revenue and cash usage are in-line with our plan, and we continue to expect 2023 revenue to be in the range of $25 - $27 million representing 22% to 35% growth year over year.”
Financial Results – Quarter Ended March 31, 2023
Total revenue was $5.4 million for the three months ended March 31, 2023, and $5.0 million for the three months ended March 31, 2022, which represents an increase of $0.4 million, or 8%.
Functional neurosurgery navigation and therapy revenue, increased 5% to $2.4 million for the three months ended March 31, 2023, from $2.2 million for the same period in 2022. The growth was driven by higher service revenue.
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials utilizing our products, increased 24% to $2.7 million for the three months ended March 31, 2023, from $2.2 million for the same period in 2022. This increase is attributable to a $0.8 million increase in service revenue, partially offset by $0.3 million decrease in product revenue.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, decreased 38% to $0.4 million for the three months ended March 31, 2023, from $0.6 million for the same period in 2022 as a result of fewer placements of ClearPoint capital and software.
Gross margin for the three months ended March 31, 2023, was 59%, as compared to a gross margin of 64% for the three months ended March 31, 2022. The decrease in gross margin was primarily due to changes in overhead costs and other inventory costs as well as higher costs for biologics and drug delivery services.
Operating expenses for the first quarter of 2023 were $8.9 million, compared to $7.1 million for the first quarter of 2022. The increase was mainly driven by the increase in headcount across the organization and share based compensation.
At March 31, 2023, the Company had cash and cash equivalents and short-term investments totaling $31.7 million as compared to $37.5 million at December 31, 2022, with the decrease resulting primarily from the use of cash in operating activities of $5.7 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2023 first quarter on Thursday, May 11, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=48votd8a. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or at (862) 298-0702 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until June 11, 2023, by calling (877) 660-6853, or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 65 active sites in the North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 pharmaceutical/biotech companies, academic centers, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research and development of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 2023.
Contact:
Danilo D’Alessandro, Chief Financial Officer
(949) 900-6833
info@clearpointneuro.com
Caroline Corner, Investor Relations
ir@clearpointneuro.com
CLEARPOINT NEURO, INC. | |||||||
Consolidated Statements of Operations | |||||||
(Unaudited) | |||||||
(Dollars in thousands, except for per share data) | |||||||
For The Three Months Ended March 31, |
|||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 2,630 | $ | 3,163 | |||
Service and other revenue | 2,803 | 1,868 | |||||
Total revenue | 5,433 | 5,031 | |||||
Cost of revenue | 2,231 | 1,800 | |||||
Gross profit | 3,202 | 3,231 | |||||
Research and development costs | 3,023 | 2,901 | |||||
Sales and marketing expenses | 2,933 | 2,018 | |||||
General and administrative expenses | 2,958 | 2,176 | |||||
Operating loss | (5,712 | ) | (3,864 | ) | |||
Other expense: | |||||||
Other (expense) income, net | (11 | ) | 11 | ||||
Interest income (expense), net | 114 | (106 | ) | ||||
Net loss | $ | (5,609 | ) | $ | (3,959 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.23 | ) | $ | (0.17 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 24,583,163 | 23,682,442 |
CLEARPOINT NEURO, INC. | |||||||
Consolidated Balance Sheets | |||||||
(Dollars in thousands, except for per share data) | |||||||
March 31, 2023 |
December 31, 2022 |
||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 21,792 | $ | 27,615 | |||
Short-term investments, at amortized cost | 9,943 | 9,874 | |||||
Accounts receivable, net | 2,678 | 2,665 | |||||
Inventory, net | 9,808 | 9,303 | |||||
Prepaid expenses and other current assets | 1,764 | 1,723 | |||||
Total current assets | 45,985 | 51,180 | |||||
Property and equipment, net | 949 | 806 | |||||
Operating lease, right-of-use assets | 1,762 | 1,895 | |||||
Software license inventory | 450 | 450 | |||||
Licensing rights | 970 | 1,028 | |||||
Other assets | 131 | 131 | |||||
Total assets | $ | 50,247 | $ | 55,490 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,352 | $ | 272 | |||
Accrued compensation | 1,454 | 2,824 | |||||
Other accrued liabilities | 1,396 | 2,065 | |||||
Operating lease liabilities, current portion | 571 | 561 | |||||
Deferred product and service revenue, current portion | 1,281 | 1,066 | |||||
Total current liabilities | 6,054 | 6,788 | |||||
Operating lease liabilities, net of current portion | 1,386 | 1,532 | |||||
Deferred product and service revenue, net of current portion | 320 | 390 | |||||
2020 senior secured convertible note payable, net | 9,907 | 9,893 | |||||
Total liabilities | 17,667 | 18,603 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at March 31, 2023 and December 31, 2022 | — | — | |||||
Common stock, $0.01 par value; 200,000,000 shares authorized; 24,582,251 shares issued and outstanding at March 31, 2023; and 24,578,983 issued and outstanding at December 31, 2022 | 246 | 246 | |||||
Additional paid-in capital | 188,310 | 187,008 | |||||
Accumulated deficit | (155,976 | ) | (150,367 | ) | |||
Total stockholders’ equity | 32,580 | 36,887 | |||||
Total liabilities and stockholders’ equity | $ | 50,247 | $ | 55,490 |
CLEARPOINT NEURO, INC. | |||||||
Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
(Dollars in thousands) | |||||||
For The Three Months Ended March 31, |
|||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (5,609 | ) | $ | (3,959 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for credit losses (recoveries) | 171 | (61 | ) | ||||
Depreciation and amortization | 129 | 86 | |||||
Share-based compensation | 1,307 | 899 | |||||
Amortization of debt issuance costs and original issue discounts | 14 | 13 | |||||
Amortization of lease right-of-use, net of accretion in lease liabilities | 142 | 133 | |||||
Accretion of discounts on short-term investments | (69 | ) | — | ||||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (184 | ) | 155 | ||||
Inventory, net | (578 | ) | (880 | ) | |||
Prepaid expenses and other current assets | (42 | ) | 128 | ||||
Other assets | — | 30 | |||||
Accounts payable and accrued expenses | (959 | ) | (692 | ) | |||
Lease liabilities | (146 | ) | (128 | ) | |||
Deferred revenue | 144 | 7 | |||||
Net cash flows from operating activities | (5,680 | ) | (4,269 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (138 | ) | (69 | ) | |||
Acquisition of licensing rights | — | (116 | ) | ||||
Net cash flows from investing activities | (138 | ) | (185 | ) | |||
Cash flows from financing activities: | |||||||
Proceeds from stock option and warrant exercises | — | 3 | |||||
Payments for taxes related to net share settlement of equity awards | (5 | ) | — | ||||
Net cash flows from financing activities | (5 | ) | 3 | ||||
Net change in cash and cash equivalents | (5,823 | ) | (4,451 | ) | |||
Cash and cash equivalents, beginning of period | 27,615 | 54,109 | |||||
Cash and cash equivalents, end of period | $ | 21,792 | $ | 49,658 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 179 | $ | 100 |
Source: ClearPoint Neuro, Inc. ]]>
The following original research abstracts will be presented in the Poster Session:
- May 17 from 12 PM – 2 PM at Board 367: Translational Volumetric Capacity of the Cerebrospinal Fluid Compartment Between Clinical and Pre-Clinical Subjects
- May 18 from 12 PM – 2 PM at Board 1160: Data Compilation and Novel Methods for Convection-Enhanced Delivery Using a SmartFlow® Cannula for Gene Therapy Products to the Nervous System in the Pre-Clinical Setting
Additionally, the Company will speak at PTC Therapeutics’ Exhibitor Showcase “Pioneering in Targeted Gene Delivery to the Brain” on May 17 from 8:15 AM – 8:45 AM in room 511.
Innovations to be showcased include the ClearPoint Maestro® Brain Model which will be shown at ASGCT for the first time since full market release. Maestro is designed to enable highly accurate ClearPoint interventions under MRI guidance by facilitating patient-specific, multi-modal fusion of anatomical information for accurate target identification and trajectory planning. The software, which was originally licensed in 2020 from Philips, a global leader in health technology, gained FDA clearance in 2022. Recent announcements related to Maestro include a partnership with NE Scientific to integrate a gene therapy infusion tool into the model. Attendees who visit the booth (#454) will experience hands-on how Maestro can assist the Company’s pharmaceutical partners with volume calculations for drug delivery trials. The software is currently integrated into pre-clinical and clinical trials and installed for clinical use at select hospitals in the United States.
The Company will also showcase the ClearPoint Pre-Clinical Orchestra™ Frame. This head fixation device and “floating” frame provides study directors with versatile options for pinning and positioning, enabling multiple/bilateral simultaneous infusions, access to hard-to-reach entry points and faster adjustment of frame positioning and re-positioning for multi-trajectory procedures.
Conference attendees are invited to pre-book meetings with the ClearPoint Neuro team directly here.
“At last year’s ASGCT annual meeting we were absolutely overwhelmed by the interest from the pharmaceutical community in ClearPoint’s solutions for CNS gene and cell therapy,” stated Jeremy Stigall, Executive Vice President and General Manager, Biologics and Drug Delivery at ClearPoint Neuro. “We look forward to sharing original research, as well as showcasing novel innovations like Maestro and Orchestra, tools we believe will help streamline drug delivery procedures and reduce variability that may lead to sub-optimal delivery of therapeutics to targets in the brain.”
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 65 sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 biologics/pharmaceutical companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 2023
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/369cceae-0537-4ed7-be5d-a983c974b54f
Contact: Media Contact – ClearPoint Neuro Jacqueline Keller, Vice President of Marketing (949) 900-6833 info@clearpointneuro.com Investor Relations – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke ir@clearpointneuro.com
ClearPoint Neuro to Present Investigational Research and Showcase Novel Innovations at the 26th American Society of Gene & Cell Therapy Annual Meeting in Los Angeles
ClearPoint Neuro to Present Investigational Research and Showcase Novel Innovations at the 26th American Society of Gene & Cell Therapy Annual Meeting in Los Angeles
Investors and analysts are invited to listen to the live broadcast review of the Company’s 2023 first quarter on Thursday, May 11, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or at (862) 298-0702 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until June 11, 2023, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company’s Investor website at https://ir.clearpointneuro.com
About ClearPoint Neuro
ClearPoint Neuro’s mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 65 sites in North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 biologics/pharmaceutical companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 6,000 procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company’s products and services, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research, development, and regulatory approval of new products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2023, which the Company intends to file with the Securities and Exchange Commission on or before May 11, 2023
Contact: Danilo D’Alessandro, Chief Financial Officer 1-888-979-8369 info@clearpointneuro.com Investor Relations – ClearPoint Neuro Caroline Corner, PhD ICR Westwicke ir@clearpointneuro.comSource: ClearPoint Neuro, Inc. ]]>