ClearPoint Neuro, Inc. - CLPT STOCK NEWS

ClearPoint Neuro reported a record quarterly revenue of $5.2 million for Q2 2022, reflecting a 52% year-over-year growth. The company reaffirmed its full-year revenue outlook of $21.0 to $22.0 million. Significant gains were seen in biologics and drug delivery revenue, which rose by 73% to $2.4 million. Operating expenses increased to $7.5 million from $5.7 million due to higher headcount and product development costs. As of June 30, 2022, cash and short-term investments totaled $45.1 million.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) has received 510(k) clearance for its ClearPoint Maestro™ Brain Model, enhancing its portfolio for brain navigation and therapy delivery. The software automates MRI analysis, facilitating the identification and quantification of brain structures. Developed over a decade, it ensures sub-millimeter accuracy and is supported by extensive research. ClearPoint aims to integrate this tool into its navigation system, enhancing functionality for targeted therapies. The product release is expected to contribute significantly to clinical applications in neurosurgery.

ClearPoint Neuro (Nasdaq: CLPT) has appointed Mary McNamara-Cullinane as Vice President of Regulatory Affairs, strengthening its leadership team. With over 25 years in healthcare, she brings expertise in regulatory and clinical affairs critical for the company’s growth strategy involving new product launches and geographic expansion. CEO Joe Burnett expressed confidence in her ability to enhance the company's regulatory strategy, essential for supporting its portfolio of partners. ClearPoint aims to improve patient outcomes by delivering precise therapies for complex neurological disorders.

ClearPoint Neuro, Inc. (CLPT) will release its second-quarter financial results for 2022 on August 9, 2022, post-market close. A live broadcast will follow the announcement at 4:30 p.m. Eastern time. ClearPoint Neuro specializes in enabling therapies for complex neurological disorders. The company's ClearPoint Neuro Navigation System has received FDA clearance and is deployed in over 60 active sites globally. The press release also includes a caution regarding forward-looking statements and potential risks associated with the company's operations influenced by the COVID-19 pandemic and market acceptance.

ClearPoint Neuro has announced a significant milestone as partner PTC Therapeutics receives marketing authorization from the European Commission for Upstaza™, the first gene therapy approved for direct infusion into the brain. This therapy targets aromatic L-amino acid decarboxylase (AADC) deficiency, a severe condition affecting children, and is now authorized for patients aged 18 months and older across the EU and select countries. ClearPoint's SmartFlow® Neuro Cannula will be utilized in administering this therapy, enhancing the treatment landscape for neurological disorders.

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.