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 guidan ...

SOLANA BEACH, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced preliminary, unaudited financial results for its fourth quarter and full year ended December 31, 2023. These preliminary unaudited financial results are management's estimates and are subject to revision in the course of completing annual audit processes. Audited results for 2023 will be public ...

Financial Data and Key Metrics - The company reported total revenue of $5.8 million for Q3 2023, a 12% increase from $5.1 million in Q3 2022 [32] - Biologics and drug delivery revenue grew 55% to $3.5 million in Q3 2023, up from $2.2 million in Q2 2022 [13] - Operational cash burn in Q3 2023 was reduced to $1.8 million, the lowest since 2020 [11] - Gross margin for Q3 2023 was 57%, compared to 71% in Q3 2022, primarily due to increased biologics and drug delivery preclinical services and costs related to the new manufacturing facility [33] - Cash and cash equivalents stood at $24.3 million as of September 30, 2023, down from $26.5 million as of June 30, 2023 [50] Business Line Data and Key Metrics - Biologics and drug delivery service revenue increased by 109% in Q3 2023, driven by expanded service offerings to pharmaceutical customers [13] - Functional neurosurgery navigation revenue declined by $0.5 million to $1.9 million in Q3 2023, primarily due to a paused brain-computer interface project [18] - Capital equipment and software revenue decreased by 26% to $0.4 million in Q3 2023, compared to $0.5 million in Q3 2022 [27] Market Data and Key Metrics - The company currently has access to only 10%-20% of the overall patient volume due to limited market release, but expects to increase access to 80%-90% with the addition of 1.5 Tesla scanners and operating room navigation solutions [7] - The company’s navigation system is dominant in MRI navigation, but it represents a small portion of the market, with over 95% of procedures like laser, biopsy, and deep brain stimulation taking place in the operating room [20] Company Strategy and Industry Competition - The company’s four-pillar growth strategy includes biologics and drug delivery, functional neurosurgery navigation, therapy and access products, and achieving global scale [77] - The company plans to launch three new revenue streams in 2024, including GLP readiness in biologics, SmartFrame navigation for the operating room, and the full market release of the PRISM Laser Therapy System [2][47][69] - The company is shifting from outright capital purchases to rental programs, which can fit into hospital operating budgets without lengthy capital committee reviews [66] Management Commentary on Operating Environment and Future Outlook - Management expects operational cash flow breakeven to be achievable in the second half of 2025, with revenue growth outpacing expense growth in 2024 and 2025 [17][87] - The company is focusing on extracting value from existing capabilities and planned product launches in 2024 and 2025, rather than investing in new capabilities [49] - Management is optimistic about the competitiveness of the company’s products, particularly in the laser therapy market, and expects significant revenue traction in 2024 [53][97] Other Important Information - The company has fully exited its Irvine manufacturing facility and is now producing and shipping products from its new Carlsbad facility, ahead of schedule [37] - The company has submitted multiple new products to the FDA for clearance, including the SmartFrame navigation system for the operating room and ClearPoint 2.2 software [73] Q&A Session Summary Question: How is the company managing the balance between growth and profitability? - The company is focusing on profitable growth by prioritizing deals with higher gross margins and avoiding low-margin entry fees, especially in the biologics segment [38][39] - The company is also managing expenses by rolling resources from one project to the next rather than hiring additional staff [59] Question: What are the launch costs for new products like the laser system? - The company is managing launch costs by reallocating existing resources rather than hiring new staff, with expenses being rolled from one project to the next [59][100] Question: How is the company approaching international markets? - The company is currently focusing on supporting existing pharma partners internationally rather than aggressively expanding commercial efforts, due to limited capital resources [114] Question: What is the impact of the shift to rental programs on revenue recognition? - The shift to rental programs spreads revenue recognition over a longer period, but still provides healthy gross margins and cash flow, while accelerating system installations [51]

●● ..... ..... ●● CLEARPOINT® NEURO November 2023 © 2 0 2 3 C L E A R P O I N T N E U R O 2 | --- | --- | --- | --- | --- | |-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | • A Common Installed Base Platform and Clinical Specialist Support team • 35 Active Indications totaling more than 1 million ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Joe Burnett - Chief Executive Officer Danilo D'Alessandro - Chief Financial Officer Conference Call Participants Nelson Cox - Lake Street Capital William Wood - B. Riley Operator Greetings, and welcome to the ClearPoint Neuro, Inc. Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. Comments made on this call may inc ...

• Functional neurosurgery navigation and therapy services: The Company recognizes revenue for such services at the point in time that the performance obligation has been satisfied. • Biologics and drug delivery services and other revenue: ◦ Consultation Services: The Company recognizes consultation revenue over time as the services are delivered to the customer based on the extent of progress towards completion of the performance obligation. ◦ Clinical Service Access Fees: For contracts in which the Company ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Joe Burnett - CEO Danilo D'Alessandro - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Operator Greetings, and welcome to the ClearPoint Neuro Inc. First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation [Operator Instructions]. Comments made on this c ...

FORM 10-Q Commission file number: 001-34822 Securities registered pursuant to Section 12(b) of the Act: Large accelerated filer o Accelerated filer ☐ Non-accelerated filer þ Smaller reporting company þ Emerging growth company o TABLE OF CONTENTS This Quarterly Report contains "forward-looking statements" as defined under the United States federal securities laws. The forwardlooking statements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balance ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2022 Earnings Conference Call March 1, 2023 4:30 PM ET Company Participants Joe Burnett - CEO Danilo D’Alessandro - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Markets Neil Chatterji - B. Riley Financial Operator Greetings, and welcome to the ClearPoint Neuro Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal ...