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ClearPoint Neuro, Inc. (symbol: CLPT) is a leading medical device company based in the United States, specializing in the development and commercialization of innovative platforms designed for performing minimally invasive surgical procedures in both the brain and heart, utilizing magnetic resonance imaging (MRI) guidance. Since its inception in 1998, ClearPoint Neuro has been at the forefront of interventional MRI research and product development.
The company's flagship product, the ClearPoint® System, is currently being used in the United States for minimally invasive brain surgeries. This system allows for precision and real-time visualization during complex neurosurgical procedures, significantly improving patient outcomes. The ClearTrace® System, still under development, aims to bring similar advancements to cardiac surgeries, offering minimally invasive solutions for heart procedures.
ClearPoint Neuro's product portfolio includes the ClearPoint System, ClearPoint Services, and ClearPoint Therapeutic Solutions. Their latest innovation, the Prism Neuro Laser Therapy System, received FDA clearance and has been integrated with the company's SmartFrame Array® 1.2 software, enhancing the practicality and efficiency of neuro laser therapies. This integration allows for combined biopsy and laser therapy procedures to be performed in a single setting, reducing setup times and improving procedural accuracy.
Financially, ClearPoint Neuro has shown robust growth. In the fourth quarter of 2023, the company reported a record revenue of $6.8 million, marking a 30% increase. Their strategic partnerships, including those with clinical and pharmaceutical firms, further bolster their financial stability and market reach. The recent equity offering of approximately $15 million has solidified their balance sheet, reinforcing investor confidence in their continued growth and innovation.
ClearPoint Neuro is also deeply involved in advancing gene and cell therapy. Their SmartFlow® Cannula is a key device used globally for delivering approved gene therapies directly to the brain. This device has been instrumental in numerous clinical trials, including those for treating AADC deficiency and Frontotemporal Dementia (FTD).
Overall, ClearPoint Neuro remains committed to driving innovation in the medical field, with a strong focus on improving surgical outcomes through advanced imaging and precise navigation technologies. For more information, visit their website at www.clearpointneuro.com.
ClearPoint Neuro (CLPT) congratulated partner Neurona Therapeutics for administering the first dose in their Phase 1/2 clinical trial of NRTX-1001, aimed at treating mesial temporal lobe epilepsy (MTLE). This innovative regenerative neural cell therapy could address a significant unmet need as 25-35% of epilepsy patients experience ongoing seizures despite existing treatments. The trial will include an open-label dose-escalation study involving up to 10 patients. ClearPoint continues to expand its role in enabling novel therapies for complex neurological disorders.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its certification for the Medical Device Single Audit Program (MDSAP) on June 2, 2022. This certification allows a single regulatory audit to satisfy requirements from multiple jurisdictions, including the U.S. FDA and authorities in Australia, Brazil, Canada, and Japan. Megan Faulkenberry, VP of Quality and Regulatory, highlighted this milestone as crucial for the company's global expansion strategy. ClearPoint's mission focuses on improving patient outcomes through accurate delivery of therapies for neurological disorders.
ClearPoint Neuro has announced a significant milestone as PTC Therapeutics receives a positive opinion from the European Medicines Agency for its gene therapy, Upstaza, to treat AADC deficiency. This marks the first gene therapy to be administered directly into the brain using ClearPoint's SmartFlow® Cannula. ClearPoint’s CEO, Joe Burnett, emphasized that this recommendation validates their biologics partnership strategy and sets a precedent for future brain-targeted therapies. The SmartFlow Cannula has over 5,000 units sold and is key in bypassing the blood-brain barrier for therapeutics.
ClearPoint Neuro announced its first-time presentation at the 25th Annual Meeting of the American Society of Gene & Cell Therapy on May 16, 2022. The session will showcase investigational research on gene therapy delivery methods using convection-enhanced delivery. Dr. Ernesto Salegio will present findings in a poster titled AAV Vectors - Preclinical and Proof-of-Concept. ClearPoint aims to demonstrate the feasibility of its technology for targeting and delivering gene therapies while emphasizing the importance of real-time MRI visualization for monitoring.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) reported a record Q1 2022 revenue of $5.0 million, marking a 25% year-over-year increase. The growth was driven by a 30% rise in biologics and drug delivery revenue to $2.2 million. The company expanded its global presence with four additional sites and partnered with Philips for advanced operating room technology. Full-year revenue is now projected between $21.0 million and $22.0 million, translating to a 30-35% growth compared to 2021. Operating expenses rose to $7.1 million, influenced by increased headcount and development costs.
ClearPoint Neuro (CLPT) announces a collaboration with Higgs Boson Health to develop the MyClearPoint™ digital health app. This app aims to enhance drug delivery to the brain and spine and support brain-computer interface surgeries. It will provide patients with essential services, including education and recovery tracking. The partnership leverages Higgs Boson’s proven ManageMySurgery platform, which has shown to improve surgical outcomes and reduce cancellations. This initiative is poised to reduce healthcare resource utilization and improve patient satisfaction.
ClearPoint Neuro has received FDA clearance for version 1.1 of its SmartFrame Array Neuro Navigation System, designed to improve procedures in MRI suites and operating rooms. The system, in limited market release since May 2021, has been utilized in over 50 procedures across 10 clinical sites. The new version includes a pre-planning module to enhance workflow and reduce procedure time. The company's mission focuses on enabling therapies for complex neurological disorders. The SmartFrame Array's enhanced features aim to streamline clinical trial processes.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced an expansion of its licensing agreement with Philips to incorporate Computed Tomography (CT) into its surgical navigation system. This aims to enhance surgical procedures in the Operating Room (OR), utilizing the ClearPoint Maestro™ Brain Model for improved accuracy. The integration will facilitate the training of surgeons and allow workflows to mirror those used in MRI environments. ClearPoint's navigation system has FDA clearance and is operational in around 60 sites globally, supporting various neurological treatments.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced it will release its financial results for Q1 2022 on May 11, 2022, post-market. Investors can join a live review at 4:30 p.m. ET the same day via a conference call or online. The company focuses on enabling therapies for complex neurological disorders and has FDA clearance for its ClearPoint® Neuro Navigation System, operational in approximately 60 sites across the US, Canada, and Europe. ClearPoint is also engaged with about 40 biologics/pharmaceutical firms for CNS therapeutic delivery.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its participation in the B. Riley Securities Disruptive Biotech Enabling Technologies Mini Conference on April 7, 2022, at 2:30 p.m. Eastern Time. The company specializes in navigating and delivering therapies to treat complex neurological disorders with precision. Its FDA-cleared ClearPoint® Neuro Navigation System is in around 60 active sites across North America and Europe. Currently, ClearPoint is collaborating with approximately 40 pharmaceutical firms and has supported over 5,000 clinical cases globally.
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