ClearPoint Neuro, Inc. - CLPT STOCK NEWS

ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced that partner Neurona Therapeutics received FDA clearance for its Investigational New Drug (IND) application. This allows Neurona to commence its Phase 1/2 clinical trial for NRTX-1001, aimed at treating drug-resistant mesial temporal lobe epilepsy (MTLE). The trial will first enroll up to 10 patients, followed by a larger group of 30 for blinded safety and efficacy evaluation. ClearPoint's involvement highlights its commitment to advancing neurological treatments, which may benefit many epilepsy patients globally.

ClearPoint Neuro, a leader in brain therapy navigation and delivery, announced its participation in the 2021 Stifel Virtual Healthcare Conference on November 16, 2021, at 10:40 a.m. ET. Interested parties can register by contacting Stifel. An online archive of the presentation will be available for 90 days on ClearPoint's website. The company focuses on improving patient quality of life through precise neurological therapies and collaborates with over 35 partners globally. Its navigation system is FDA-cleared and installed at over 60 sites, supporting over 4,500 clinical cases.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) has appointed Dr. Linda M. Liau to its Board of Directors, enhancing its leadership with her extensive experience in neurosurgery and research. Dr. Liau, a recognized authority in brain tumor treatment and immunology, is currently a professor at UCLA and co-director of the UCLA Brain Tumor Center. ClearPoint aims to innovate in areas such as gene therapy and brain-computer interfaces, emphasizing patient care. This appointment reflects the company’s commitment to advancing neurological therapies and improving patient outcomes.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its 2021 third quarter financial results will be released on November 9, 2021, after market close. The company invites investors and analysts to a live broadcast discussing these results at 4:30 PM Eastern Time. The replay will be available until December 9, 2021. ClearPoint Neuro focuses on enabling therapies for complex neurological disorders, with products installed in over 60 sites across the US, Canada, and Europe, serving over 35 partners in pre-clinical studies and clinical trials.

ClearPoint Neuro reported a strong second quarter with revenues of $3.4 million, a 38% year-over-year increase, and a record case volume of 249, up 98% year-over-year. Biologics and drug delivery revenue rose 19% to $1.4 million. The FDA cleared the SmartFrame Array, marking significant progress. The company expects to support 900-1000 cases in 2021, with estimated revenues between $16.0 and $17.5 million. However, rising expenses in research and development, marketing, and administration were noted, alongside impacts from COVID-19.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced a strategic partnership with adeor medical AG to distribute the Velocity Alpha high-speed surgical drill system in the U.S. This FDA-cleared product will enhance ClearPoint’s offerings for neurosurgeons in cranial and spinal procedures. The partnership also includes developing an MRI conditional version of the drill, allowing exclusive global distribution rights to ClearPoint. The U.S. market for powered drill solutions is valued at approximately $200 million, with the cranial and spine market exceeding $50 million.

ClearPoint Neuro announced the installation of its Neuro Navigation System at Hôpital Fondation Rothschild in Paris, enhancing pediatric neurosurgery through intra-procedural MRI guidance. This collaboration aims to streamline laser interstitial thermal ablations, allowing for procedures to be conducted entirely within the MRI suite. Matt Rabon emphasized the strategic move to establish additional trial centers in Europe, the UK, and the Middle East, facilitating partnerships with pharmaceutical companies. ClearPoint has FDA clearance, is CE-marked, and is active in over 60 sites globally.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) will announce its 2021 second-quarter financial results on August 10, 2021, after market close. A live broadcast will take place on the same day at 4:30 p.m. Eastern time. Those unable to attend can access a replay until September 10, 2021. The Company focuses on enabling therapies for neurological disorders via its ClearPoint Neuro Navigation System, which has FDA clearance and is deployed in over 60 active sites globally. The Company has partnered with over 30 pharmaceutical firms and has conducted more than 4,500 cases to date.

ClearPoint Neuro (Nasdaq: CLPT) and Blackrock Neurotech have formed a joint agreement to develop an automated surgical solution for implanting Brain Computer Interfaces (BCIs) targeting various neurological disorders. This collaboration aims to enhance surgical efficiency and predictability in BCI implantation using ClearPoint's advanced navigation platform. The growing market for BCIs and neuro-navigational systems is estimated to exceed $1 billion annually. Blackrock will partially fund development efforts, seeking to commercialize rapid, automated procedures for improved patient outcomes.