Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $7.9 million, representing a 32% increase from $6 million in Q2 2023 [8][9] - Gross margin improved to 63% in Q2 2024, up from 53% in Q2 2023, primarily due to lower costs and higher volumes [10] - Operating expenses decreased to $9.7 million in Q2 2024 from $10.3 million in Q2 2023, reflecting operational leverage [11][12] - Cash and cash equivalents increased to $32.8 million as of June 30, 2024, compared to $23.1 million at the end of 2023 [12] Business Line Data and Key Metrics Changes - Biologics and drug delivery revenue rose 28% to $4.3 million in Q2 2024, driven by a 383% increase in product revenue [9][10] - Neurosurgery navigation revenue increased 17% to $2.6 million, attributed to new product offerings and placements [10] - Capital equipment and software revenue surged 148% to $0.9 million, due to increased placements of ClearPoint Navigation and PRISM laser units [10] Market Data and Key Metrics Changes - The company activated 14 new customer sites in 2024, with 8 in Q1 and 6 in Q2, indicating strong demand for its systems [21][32] - The SmartFrame OR platform is gaining traction, with multiple evaluations and approvals underway [22][24] Company Strategy and Development Direction - The company focuses on four growth pillars: biologics and drug delivery, neurosurgery navigation, therapy and access products, and achieving global scale [4][8] - The strategy includes expanding partnerships with pharmaceutical companies and enhancing product offerings to diversify revenue streams [7][19] - The company aims for cash flow breakeven by the end of 2025, supported by a strong cash position and reduced operational cash burn [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing a 36% revenue increase and a 39% reduction in operational cash burn in the first half of 2024 [14][27] - The company anticipates continued demand for its products and services, particularly in the cell and gene therapy market [15][16] - Management noted that funding in the biopharma sector remains healthy, with no significant project pauses observed [42] Other Important Information - The company has executed strategic agreements with pharmaceutical partners, enhancing its role in the cell and gene therapy market [17][19] - The PRISM anchor bolt accessory received FDA clearance, expanding the use of the PRISM laser system [23] Q&A Session Summary Question: Clarification on revenue guidance range - Management explained that the guidance range of $30 million to $33 million reflects uncertainties in timing for pharmaceutical services, which could swing revenue by $1 million to $1.5 million [29][30] Question: Onboarding process for new sites - Management indicated that most new sites activated have been for traditional MRI navigation, with hospitals preparing for clinical trials in gene and cell therapy [31][32] Question: Economies of scale in biologics business - Management highlighted that the same ClearPoint platform supports various procedures, allowing for economies of scale and margin expansion as larger orders are fulfilled [36][38] Question: Involvement in Phase 1 and Phase 2 trials - Management stated that while they do not act as clinical trial monitors, they provide product support and clinical education during these trials [44][45] Question: Revenue cadence with new contract types - Management noted that new contracts may introduce more revenue lumpiness in the short term, but overall growth trends are expected to stabilize over time [46][48]

ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 15.79%. A quarter ago, it was expected that this company would post a loss of $0.19 per share when it actually produced a loss of $0.16, delivering a surprise of 15.79%. Over the last four quarters, the company has ...

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 June 30, 2024 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 Othe ...

Exhibit 99.1 ClearPoint Neuro Reports Second Quarter 2024 Results Second Quarter Revenue Growth +32%; Record Revenue Achieved SOLANA BEACH, CA, August 7, 2024 – 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 second quarter ended June 30, 2024. Second Quarter Highlights | --- | |-------------------------------------------------------------------------- ...

SOLANA BEACH, Calif., July 17, 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 it will release financial results for its 2024 second quarter on Wednesday, August 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 second quarter on Wednesday, August 7th at 4:30 p.m. Eastern ti ...

Company Overview - ClearPoint Neuro, Inc. (CLPT) shares increased by 16.9% to $6.58 in the last trading session, contrasting with a 1.9% loss over the past four weeks [1] - The stock's price surge was driven by investor optimism regarding its partner Aspen Neuroscience, Inc. using the ClearPoint Neuro Navigation System in the ASPIRO clinical trial for Parkinson's disease [4] Earnings and Revenue Expectations - ClearPoint Neuro is expected to report a quarterly loss of $0.18 per share, reflecting a year-over-year change of +37.9% [5] - Revenue for the upcoming quarter is projected to be $7.5 million, which is a 26% increase from the same quarter last year [5] - The consensus EPS estimate for ClearPoint Neuro has remained unchanged over the last 30 days, indicating stability in earnings expectations [6] Industry Context - ClearPoint Neuro operates within the Zacks Medical - Instruments industry, which includes other companies like Alphatec (ATEC) [7] - Alphatec's consensus EPS estimate for its upcoming report is -$0.26, showing a year-over-year change of +39.5% [3]

Core Insights - ClearPoint Neuro, Inc. congratulates its partner Aspen Neuroscience for the successful use of the ClearPoint Neuro Navigation System in the ASPIRO Phase 1/2a clinical trial for Parkinson's Disease patients [1][2] Company Overview - ClearPoint Neuro is a global device, cell, and gene therapy-enabling company that provides precise navigation to the brain and spine, with FDA clearance and CE-mark for its flagship product, the ClearPoint Neuro Navigation System [5] - The company engages with healthcare and research centers globally and partners with innovative pharmaceutical and biotech companies for CNS delivery of therapeutics [5] ASPIRO Trial Details - The ASPIRO trial is an open-label study assessing the safety and tolerability of ANPD001, an autologous dopaminergic neuron cell replacement therapy for moderate to severe Parkinson's Disease [2][10] - The primary endpoint focuses on safety and tolerability, while secondary endpoints include improvements in "on" time, motor symptoms, and quality of life [2] ANPD001 Therapy - ANPD001 is an investigational autologous neuronal replacement therapy that does not require immunosuppressive drugs due to its personalized approach [3] - The therapy involves reprogramming a small sample of the patient's skin cells into induced pluripotent stem cells (iPSCs), which are then differentiated into dopaminergic neuron precursor cells (DANPCs) for transplantation [11][12] Surgical Approach - The transplantation of DANPCs is performed in the putamen using ClearPoint MRI guidance, ensuring minimally invasive delivery with submillimetric accuracy [8][9] - The surgical method was developed by Dr. Paul Larson, a pioneer in MRI-guided stereotactic neurosurgery [8]

"By the time of diagnosis, it is common for people with Parkinson's to have lost the majority of dopaminergic neurons, leading to progressive loss of motor and neurological function," explained Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience. "To replace these lost cells, we must target a very specific area of the brain with a high degree of surgical precision. Utilizing the latest advances in intraoperative MRI guided techniques provided by the ClearPoint system, the patient's new ce ...

ClearPoint Neuro (CLPT) recently announced the full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System. The newly launched technologies are likely to be on display at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Jun 1 to Jun 4 in Nashville. These meaningful innovations are likely to ultimately benefit ClearPoint's surgical customers and many new patients around the world. Price Performance For the past six months ...

SOLANA BEACH, Calif., June 01, 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 announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1st – Tuesday, June 4th in Nashville. "Deep Brain Stimulation ...