Revenue Performance - Quarterly revenue was $8.9 million, a 9% increase year-over-year compared to $8.1 million in Q3 2024[8] - Neurosurgery navigation and therapy revenue increased 20% to $3.4 million from $2.9 million in the same period last year, driven by higher sales of Prism Laser Therapy[10] - Capital equipment and software revenue rose 25% to $1.0 million from $0.8 million in Q3 2024 due to increased hardware sales and rental revenue[11] - Total revenue for Q3 2025 was $8,861,000, an increase of 9.1% compared to $8,122,000 in Q3 2024[24] - Product revenue decreased slightly to $5,361,000 from $5,474,000, while service and other revenue increased to $3,500,000 from $2,648,000[24] - The total combined revenue for ClearPoint Neuro and IRRAS in 2026 is projected to be between $54.0 million and $60.0 million[7] Financial Position - Cash and cash equivalents totaled $38.2 million as of September 30, 2025, compared to $20.1 million at the end of 2024[14] - Cash and cash equivalents increased to $38,221,000 as of September 30, 2025, up from $20,104,000 at the end of 2024[26] - Total assets rose to $60,357,000 from $39,189,000, indicating significant growth in the company's financial position[26] Profitability and Loss - Gross margin improved to 63% in Q3 2025, up from 60% in Q3 2024, primarily due to higher margins on biologics and drug delivery service revenue[12] - Gross profit for Q3 2025 was $5,600,000, up from $4,847,000 in Q3 2024, representing a gross margin improvement[24] - Net loss for Q3 2025 was $5,891,000, compared to a net loss of $4,974,000 in Q3 2024, reflecting a 18.4% increase in losses[24] - Operating loss for the nine months ended September 30, 2025, was $17,119,000, compared to $14,098,000 in the prior year, indicating a 21.4% increase in operating losses[24] Operating Expenses - Operating expenses increased by 9% to $10.9 million from $10.0 million in Q3 2024, mainly due to higher product development costs and increased headcount[13] - Research and development costs for the nine months ended September 30, 2025, were $10,660,000, compared to $9,060,000 for the same period in 2024, reflecting a 17.7% increase[24] Strategic Initiatives - The acquisition of IRRAS Holdings, Inc. is expected to expand the company's market presence and potentially double the size of its commercial organization[5] - The company activated 5 new global customers in Q3 2025, continuing to expand its market reach[3] - The company anticipates continued development and commercialization of its proprietary Robotic Neuro-Navigation platform, with a focus on expanding market opportunities[21] - The company narrowed its full-year revenue guidance to between $36.0 million and $38.0 million[6] Shareholder Information - The company reported a weighted average of 28,137,528 shares outstanding for the nine months ended September 30, 2025, compared to 26,840,119 shares in the same period of 2024[24]

Core Insights - ClearPoint Neuro, Inc. reported a quarterly revenue of $8.9 million, reflecting a 9% year-over-year increase compared to Q3 2024 [1] - The company narrowed its full-year revenue forecast for 2025 to a range between $36.0 million and $38.0 million [1] - ClearPoint Neuro continues to support over 60 active biopharma partners, with nine partner programs accepted for FDA expedited review [1] Financial Performance - Quarterly revenue reached $8.9 million, marking a 9% increase year-over-year [1] - Cash and cash equivalents totaled $38.2 million as of September 30, 2025 [1] Strategic Developments - The company completed the transition to its new Pre-clinical CRO Facility, ClearPoint Advanced Laboratories, which became operational in Q4 2025 [1] - ClearPoint Neuro announced the development of a prototype Robotic Neuro-Navigation System to enhance minimally invasive cranial surgical procedures [1] - The company received FDA 510(k) clearance for the ClearPoint PRISM Laser Therapy System, expanding its compatibility with 1.5T MRI guidance [1] Regulatory and Market Expansion - ClearPoint Neuro achieved several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, totaling 34 countries worldwide [1] - An agreement was signed for the acquisition of IRRAS Holdings, Inc., which will enhance the company's presence in the neurocritical care space [1] - Five new global customers were activated in the third quarter [1]

Core Insights - ClearPoint Neuro, Inc. has announced the acquisition of IRRAS Holdings, Inc., enhancing its drug delivery portfolio and expanding its market presence in the treatment of intracranial bleeding [1] Company Overview - ClearPoint Neuro is a global company specializing in device, cell, and gene therapy, providing precise navigation solutions for brain and spine procedures [1] - IRRAS Holdings focuses on neurocritical care, particularly in treating conditions like intracerebral hemorrhage and chronic subdural hematoma [1] Product Details - The cornerstone product of IRRAS is the IRRAflow® system, which is FDA-cleared and CE-marked, offering continuous irrigation, aspiration, and real-time intracranial pressure monitoring [1] Market Potential - The acquisition positions ClearPoint Neuro to tap into a $0.5 billion market dedicated to the treatment of intracranial bleeding, thereby increasing its commercial scale and adding new indications [1]

WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT November 2025 DISCLAIMER This presentation and discussion contain forward - looking statements within the context of the federal securities laws, including the Company's expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of the Company's products and services, the Company's belief about the outcome of regulatory interactions with respect to its ...

Core Insights - ClearPoint Neuro, Inc. will participate in multiple global healthcare conferences in the fourth quarter of 2025, showcasing its commitment to engaging with investors and stakeholders in the healthcare sector [1][2]. Conference Participation - The company is scheduled to present at the following conferences: - 2025 UBS Global Healthcare Conference on November 10, 2025 [2] - 2025 Stifel Healthcare Conference on November 13, 2025 [2] - 37th Annual Piper Sandler Healthcare Conference on December 3, 2025 [2] - ClearPoint Neuro management will be available for in-person investor meetings at these events [2]. Company Overview - ClearPoint Neuro specializes in device, cell, and gene therapy-enabling technologies, providing precise navigation solutions for the brain and spine [3]. - The flagship product, the ClearPoint Neuro Navigation System, has received FDA clearance and is CE-marked, indicating its regulatory compliance and market readiness [3]. - The company collaborates with healthcare and research centers across North America, Europe, Asia, and South America, and partners with leading pharmaceutical and biotech firms [3]. - Thousands of procedures have been supported by the company's clinical specialist team, highlighting its operational experience and market presence [3].

Group 1: Market Overview - U.S. stock futures showed mixed results, with Nasdaq futures gaining over 100 points [1] Group 2: Kimberly-Clark Corporation - Kimberly-Clark Corporation announced the acquisition of Kenvue in a cash and stock transaction valued at approximately $48.7 billion [1] - Following the announcement, Kimberly-Clark shares fell sharply by 13.6% to $103.50 in pre-market trading [1] Group 3: Other Notable Stock Movements - uniQure N.V. shares dropped 65.3% to $23.40 after receiving FDA feedback regarding its investigational gene therapy AMT-130 [3] - ClearPoint Neuro, Inc. saw a decline of 40.5% to $13.77 in pre-market trading [3] - ALPS Group Inc fell 40.2% to $1.53 following the announcement of a public offering [3] - Biohaven Ltd. shares decreased by 27.4% to $12.48 [3] - Alvotech experienced a 24.1% drop to $5.80 after receiving an FDA Complete Response Letter for its AVT05 biosimilar application [3] - Replimune Group, Inc. dipped 16.7% to $8.10, despite an upgrade from BMO Capital [3] - Praxis Precision Medicines, Inc. declined 9.1% to $180.70 [3] - Vertex, Inc. fell 6.1% to $21.50 after lowering its FY2025 sales guidance [3]

Group 1 - U.S. stock futures showed mixed results, with Nasdaq futures gaining over 100 points [1] - Kimberly-Clark Corporation announced the acquisition of Kenvue for approximately $48.7 billion, leading to a 13.6% drop in its shares to $103.50 in pre-market trading [1] Group 2 - uniQure N.V. experienced a significant decline of 65.3% to $23.40 after receiving FDA feedback regarding its investigational gene therapy AMT-130 [3] - ClearPoint Neuro, Inc. shares fell 40.5% to $13.77, while ALPS Group Inc dropped 40.2% to $1.53 following the announcement of a public offering [3] - Biohaven Ltd. shares decreased by 27.4% to $12.48, and Alvotech fell 24.1% to $5.80 after receiving an FDA Complete Response Letter [3] - Replimune Group, Inc. saw a 16.7% dip to $8.10, despite an upgrade from BMO Capital analyst [3] - Praxis Precision Medicines, Inc. declined 9.1% to $180.70, and Vertex, Inc. fell 6.1% to $21.50 after lowering its FY2025 sales guidance [3]

Core Insights - ClearPoint Neuro, Inc. announced results from a Phase I-II clinical study evaluating the ClearPoint Prism Neuro Laser Therapy System for treating glioblastoma and grade 4 astrocytoma [2] Company Summary - The clinical study was conducted at Skåne University Hospital in Lund, Sweden, involving a cohort of fourteen patients aged 18-80 years [2] - The focus of the study was on the safety, feasibility, and efficacy of the ClearPoint Prism Neuro Laser Therapy System [2] Industry Context - Glioblastoma and grade 4 astrocytoma are identified as among the most challenging tumors to treat, highlighting the significance of advancements in treatment options [2]

The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization. SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 6, 2025 / 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 several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan. ...

Core Insights - ClearPoint Neuro (CLPT) has developed a proprietary Robotic Neuro-Navigation System, enhancing its role in robotics, neurosurgery, and advanced drug delivery [1] - The integration of neuro-navigation software with the FDA-cleared KUKA LBR Med robotic arm aims to improve precision and flexibility in minimally invasive cranial procedures [1] Strategic Fit for Cell and Gene Therapy Launches - The new platform addresses the need for biopharma partners in the commercialization of cell and gene therapies, which require complex delivery into the brain [2] - ClearPoint's approach combines MRI and iCT-guided techniques with robotic assistance, providing standardized execution paths through a single planning module [2] - This hybrid model ensures flexibility for surgeons and uniformity across procedures, which is critical for regulatory approval and large-scale adoption [2] Likely Share Price Movement - ClearPoint's shares have increased by 78% this year, contrasting with a 6.8% decline in the industry and a 15.2% gain in the S&P 500 Index [3] Investor Sentiment and Long-term Growth - The unveiling of the robotic drug delivery system is expected to generate positive investor sentiment, reflecting strategic positioning in the growing cell and gene therapy market [4] - While near-term gains may be modest pending regulatory approvals, the innovation strengthens long-term growth prospects, potentially supporting sustained upward momentum in share price [4] Leveraging Partnerships to Reduce Risk - ClearPoint's strategy involves leveraging KUKA's proven robotic arm while focusing on neuro-navigation software, reducing development risk and accelerating timelines [8] - Collaborations and software focus are aimed at reducing risk and positioning ClearPoint for long-term growth [7] Market Potential and Commercial Readiness - ClearPoint is embedded in the neuro-therapeutics ecosystem through global collaborations with academic centers, biopharma firms, and CROs [9] - The addition of robotic navigation expands its portfolio at a critical moment, as treatment centers are being established for upcoming commercial launches [9] - The initiative underscores ClearPoint's intent to be the preferred partner for cell and gene therapy delivery, potentially driving significant long-term revenue growth [9] Recent Developments - ClearPoint has secured FDA 510(k) clearance to expand its Prism Neuro Laser Therapy System for use with 1.5T MRI scanners, broadening its addressable market [10] - This clearance enables access to hospitals lacking 3T MRI capability, potentially accelerating the adoption of its minimally invasive laser therapy [11] - Prism procedures create a training foundation for future cell and gene therapy applications, viewed as a long-term value driver for ClearPoint [11]