ClearPoint Neuro Inc. - Common Stock (CLPT)

The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization.

New Product Category Will Enable Added Flexibility to Support Commercial Launches of Cell and Gene Therapy

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 25, 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 that Dr. Paul Larson will be joining the company as Chief Medical Officer starting in January 2026. Dr. Larson has a long history of working with ClearPoint Neuro as an advisor, especially supporting education and product development efforts related to cell and gene therapy delivery. Dr. Larson will continue his appointments at both the University of California San Francisco and at Banner Hospital, University of Arizona where he will continue to enroll patients in various ongoing cell and gene therapy clinical trials.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 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 that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance.

Achieved Record Revenue for 2024 and Growth of 31%;

Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United States

Achieved Record Revenue and Growth of 41%; Operational Cash Burn Reduced to $1.2 Million

President and CEO Joe Burnett Interview Highlighted on Bloomberg Intelligence Vanguards of Healthcare Podcast Today

Record Revenue and Substantial Cash Infusion Highlight the Company's ‘Fast. Forward.' Strategy

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / August 4, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) ("Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced multiple key milestones demonstrating the progression of the Company's Biologics and Drug Delivery Portfolio including first commercial infusions in the United States, additional partners accepted for expedited review, creation of cell and gene infusion ICD-10 codes, and record clinical trial patients treated globally in the month of July.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / July 23, 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 that it will release financial results for its 2025 second quarter on Tuesday, August 12th, after the market close.

Record Revenue Highlighted by 70% Growth in Single-Use Navigation and Therapy Products

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / May 12, 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 that it has entered into a note financing arrangement with Oberland Capital Management LLC ("Oberland Capital") of up to $105 Million, with $30.0 million of gross proceeds funded at closing. Additional note financing will be provided to the Company by Oberland Capital under the following terms:

SOLANA BEACH, CA / ACCESS Newswire / April 28, 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, announces that today its partner, Clinical Laserthermia Systems AB (publ) (CLS), completed the submission of its 510(k) application to the FDA, expanding the indication of the ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance.

SOLANA BEACH, CA / ACCESS Newswire / April 25, 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 that it will release financial results for its 2025 first quarter on Tuesday, May 13th, after the market close.

The platform will be showcased at the American Academy of Neurological Surgeons Annual Meeting in Boston on April 25-28, 2025.

SOLANA BEACH, CA / ACCESS Newswire / February 14, 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 that it will release financial results for its 2024 fourth quarter and full year on Wednesday, February 26th, after the market close.

SOLANA BEACH, CA / ACCESS Newswire / February 12, 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 receipt of European Medical Device Regulation (EU MDR) approval for the SmartFlow Neuro Cannula.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 27, 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 it has received 510(k) clearance for its ClearPoint Navigation Software Version 3.0.

SOLANA BEACH, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ: CLPT) a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that it has entered into a multi-year license agreement with UCB (EURONEXT BRUSSELS: UCB), a global biopharmaceutical leader, to partner on drug delivery platforms for UCB’s gene therapy portfolio.