SOLANA BEACH, Calif., Jan. 22, 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 receipt of European Medical Device Regulation (EU MDR) clearance for the manual SmartTwist® MR Hand Drill and SmartTip® MR Drill Kit. Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carls ...

ClearPoint Neuro, Inc. (CLPT) recently announced its receipt of the FDA’s 510(k) clearance for its SmartFrame OR Stereotactic System. The system is expected to offer flexible workflows to surgeons (including iCT forward projection), thereby enabling precise image-based corrections to achieve sub-millimetric accuracy.The company is currently planning to commence a limited market release in the first half of 2024, with a planned full market release in the second half of 2024.The latest regulatory approval is ...

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 ...

Financial Performance - Total revenue for Q3 2023 was $5.762 million, a 12% increase from $5.146 million in Q3 2022[18] - Product revenue decreased to $2.410 million in Q3 2023 from $3.130 million in Q3 2022, representing a 23% decline[18] - Service and other revenue increased significantly to $3.352 million in Q3 2023, up 66% from $2.016 million in Q3 2022[18] - Gross profit for Q3 2023 was $3.273 million, down from $3.679 million in Q3 2022, reflecting a 11% decrease[18] - Operating loss for Q3 2023 was $4.897 million, compared to a loss of $3.795 million in Q3 2022, indicating a 29% increase in losses[18] - Net loss for Q3 2023 was $4.809 million, compared to a net loss of $3.788 million in Q3 2022, representing a 27% increase in losses[18] - For the nine months ended September 30, 2023, the company reported a net loss of $17.47 million, compared to a net loss of $12.05 million for the same period in 2022, representing a 45.5% increase in losses year-over-year[27] Assets and Liabilities - Total assets decreased to $43.837 million as of September 30, 2023, down from $55.490 million as of December 31, 2022[15] - Total liabilities increased to $19.743 million as of September 30, 2023, compared to $18.603 million as of December 31, 2022[15] - Stockholders' equity decreased to $24.094 million as of September 30, 2023, down from $36.887 million as of December 31, 2022[15] - The company has a cumulative deficit of $167.8 million as of September 30, 2023, indicating ongoing financial challenges since inception[36] Cash Flow - Cash flows from operating activities resulted in a net cash outflow of $12.55 million for the nine months ended September 30, 2023, slightly improved from a net cash outflow of $13.10 million in the same period of 2022[27] - The company recorded net cash flows from investing activities of $9.14 million for the nine months ended September 30, 2023, a significant improvement compared to a net cash outflow of $22.48 million in the prior year[27] - The company’s cash and cash equivalents at the end of the period were $24.34 million, an increase from $18.71 million at the end of the same period in 2022[27] - As of September 30, 2023, the company had $24.3 million in cash and cash equivalents, down from $27.6 million at December 31, 2022[70] Revenue Breakdown - For the nine months ended September 30, 2023, total revenue reached $17.145 million, up 11.5% from $15.377 million in the prior year[63] - Biologics and drug delivery revenue for the three months ended September 30, 2023, was $3.487 million, a 55.3% increase from $2.246 million in 2022[61] - Functional neurosurgery navigation and therapy revenue decreased to $1.918 million in Q3 2023 from $2.420 million in Q3 2022, representing a decline of 20.8%[61] - The company recognized approximately $1.0 million of revenue during the nine months ended September 30, 2023, which was previously included in deferred revenue[65] Share-Based Compensation - The company incurred $4.54 million in share-based compensation for the nine months ended September 30, 2023, compared to $2.95 million in the same period of 2022, reflecting a 53.5% increase[27] - The Company recorded share-based compensation expense of $1.584 million for the three months ended September 30, 2023, an increase of 35% compared to $1.175 million for the same period in 2022[88] - For the nine months ended September 30, 2023, share-based compensation expense totaled $4.536 million, up 53% from $2.954 million in the prior year[90] Customer and Market Insights - The company has more than 50 biologics and drug delivery customers currently evaluating or using its products and services in trials, which represents a significant growth opportunity[34] - The company continues to monitor macroeconomic trends that could impact its operations, including inflationary pressures and supply chain disruptions[35] Inventory and Credit Losses - Inventory as of September 30, 2023, totaled $9.392 million, a decrease from $9.753 million at December 31, 2022[72] - The allowance for credit losses increased to $1.0 million as of September 30, 2023, compared to $0.1 million at December 31, 2022[56] - At September 30, 2023, two customers accounted for 29% and 24% of accounts receivable, indicating a concentration risk[54] Lease and Facility Information - The company entered into a lease for a manufacturing facility in Carlsbad, California, with a right-of-use asset recorded at approximately $2.5 million[29] - The new manufacturing facility lease in Carlsbad, California, commenced on June 1, 2023, and is set to end on May 31, 2033[84] - The Company subleased office space in Solana Beach, California, with a term expiring on December 31, 2026, and has the option to renew for an additional five years[83] Debt and Financing - The Outstanding First Closing Note had a principal of $10 million as of September 30, 2023, with an interest rate of 7.25% due to rising interest rates[158] - As of September 30, 2023, the total scheduled principal payment for the remaining note payable is $10 million, net of unamortized financing costs of $65,000[82] Stock Options and Employee Plans - The Company had 1,485,019 stock options outstanding as of September 30, 2023, with a weighted average exercise price of $8.64[91] - The Employee Stock Purchase Plan (ESPP) allowed the purchase of 51,041 shares at an average price of $6.15 during the first offering period of 2023[96]

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 ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2023 was $5.4 million, representing an 8% increase from $5 million in Q1 2022 [31] - Gross margin for Q1 2023 was 59%, down from 64% in Q1 2022, primarily due to changes in overhead and inventory costs [14] - Cash and equivalents at the end of Q1 2023 were $31.7 million, down from $37.5 million at the end of 2022 [45] Business Line Data and Key Metrics Changes - Biologics and drug delivery revenue increased by 24% to $2.7 million in Q1 2023, up from $2.2 million in Q1 2022 [3] - Functional neurosurgery navigation revenue increased by 5% to $2.4 million in Q1 2023, up from $2.2 million in Q1 2022 [3] - Capital equipment and software revenue decreased by 38% to $0.4 million in Q1 2023 from $0.6 million in Q1 2022 due to fewer placements [14] Market Data and Key Metrics Changes - The company aims to achieve an installed base of 100 individual customers by the end of 2025, with more than 50 hospitals currently active in the acquisition funnel [34] - The company expects to initiate multiple new clinical trials and first patient dosings before the end of 2023, enhancing partnerships with pharma [16] Company Strategy and Development Direction - The company is focusing on a four-pillar growth strategy, including biologics and drug delivery, functional neurosurgery navigation, therapy and access products, and achieving global scale [2] - A new manufacturing facility in Carlsbad, California, is being developed to support growth and improve operational efficiencies [35] - The company plans to expand its market presence with the Prism Laser Therapy System and expects significant growth from this product in 2024 and beyond [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a revenue forecast of $25 million to $27 million for the year, representing a growth rate of 22% to 35% year-over-year [2] - The company anticipates that sales growth will outpace expense growth as it approaches operational cash breakeven by the end of 2025 [35] - Management highlighted the importance of expanding partnerships and preclinical services as key drivers for growth in 2023 [50] Other Important Information - Research and development costs for Q1 2023 were $3 million, a slight increase from $2.9 million in Q1 2022, primarily due to personnel costs [44] - Sales and marketing expenses increased by 45% to $2.9 million in Q1 2023, driven by additional personnel costs and travel expenses [32] Q&A Session Summary Question: Update on the extended agreement with Philips for Maestro - Management discussed the integration of fully automatic sub-nuclei segmentation for DBS procedures and its impact on expanding into the operating room [5] Question: Update on the Prism Neuro Laser Therapy System - Management confirmed the completion of the first five patients in the cohort and the extension to an additional ten patients for data collection [6] Question: Key elements to bridge from $25 million revenue run rate to $50 million by Q4 2025 - Management identified expanded partnerships, preclinical services, and the launch of the Laser Therapy System as critical elements for achieving this goal [7][50] Question: Positioning of the laser system versus competitors - Management highlighted the non-cooled system design as a key differentiator, allowing for faster ablations and reduced complexity during procedures [39]