ClearPoint Neuro Announces Full Market Release of ClearPoint Navigation Software Version 3.0 - Delivering the First End-to-End ClearPoint Navigation Solution to the Operating Room
The platform will be showcased at the American Academy of Neurological Surgeons Annual Meeting in Boston on April 25-28, 2025.
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / April 24, 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 the full market release of the ClearPoint Navigation Software Version 3.0 - which introduces an iCT image-guidance workflow option performed in the traditional operating room.
"The new iCT-guided neuro navigation workflow builds on our team's decade of experience with MRI-guided procedures and is designed to deliver the same workflow and precision with greater accessibility and efficiency," said Elizabeth Vasconcellos, Segment Leader of Systems and Software at ClearPoint Neuro. "Throughout the limited market release, we have seen rapid adoption among participating hospital sites, driven by the software's compatibility with standard iCT scanners in any operating room. We believe this will continue to build on the momentum established with SmartFrame OR by leveraging our purpose-built image-guidance software and enabling broader access to ClearPoint's technology when MRI access is limited. This major release also services our MRI-guidance and Prism Laser Therapy users by delivering new features and enhancements specifically to support their needs."
"My initial experience with ClearPoint Navigation Software Version 3.0 using iCT-guidance has demonstrated that it achieves the same accurate placement as with MRI-guidance, without requiring the MRI infrastructure," shares Dr. Ellen Air, Chair of Neurosurgery at Henry Ford Health. "The option to perform DBS placements in either an iMRI or iCT environment allows our team to offer the ClearPoint option at more points of care."
"The ClearPoint Navigation Software Version 3.0 supports procedural accuracy and efficiency," stated Dr. Arjun Khanna, Functional & Stereotactic Neurosurgeon in San Diego, CA. "If the performance of 3.0 continues as I've seen so far, I would love to make this my default navigation for all VIM DBS lead placements in my practice."
The new ClearPoint Navigation Software Version 3.0 supports the ClearPoint Neuro Navigation System. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) (asleep or awake) lead placement.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company's expectation for the future market of its products and services, and other performance and results. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; future revenue from sales of the Company's products and services; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company's products and services in their delivery of therapies; the Company's ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company's ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of the Company's new products and the new products of its biologics and drug delivery partners. More detailed information on these and additional factors that could affect the Company's actual results are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which has been filed with the Securities and Exchange Commission, and the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2025, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 2025. The Company does not assume any obligation to update these forward-looking statements.
