Transverse Medical Inc., an early-stage medical device company specializing in cerebral embolic protection technology, has successfully completed a Series B2 financing round securing over $10 million in new capital. The funding was led by the company's legacy lead investor, described as a large family office, with additional participation from Series B1 investors.
The capital infusion will primarily support ongoing clinical validation of the company's flagship POINT-GUARD™ Cerebral Embolic Protection (CEP) device, which is currently undergoing feasibility clinical studies at Victorian Heart Hospital in Melbourne, Australia. The device is designed to prevent stroke during Transcatheter Aortic Valve Replacement (TAVR) procedures by blocking embolic debris from reaching the brain.
"This successful raise marks a significant milestone for Transverse Medical and reflects strong investor confidence in our technology and mission," said Eric Goslau, President & CEO and Co-Founder of Transverse Medical Inc. "We are now well-positioned to accelerate the development of our Point-Guard Protected™ solution and bring meaningful innovation to patients undergoing complex cardiovascular and structural heart procedures where there is an increased risk of embolic debris and potential for stroke and brain ischemia."
Addressing a Critical Need in TAVR Procedures
TAVR has become a standard treatment option for patients with severe aortic stenosis, but the procedure carries risks of cerebral embolism when debris is dislodged during valve deployment. These embolic events can lead to periprocedural stroke and cognitive decline, representing a significant clinical concern.
The POINT-GUARD™ technology aims to provide complete cerebral protection during these procedures. According to the company, the device is designed with operator ease of use in mind and can accommodate variable arch anatomies while providing full aortic arch stabilization without interfering with the primary procedure.
Funding to Support Multiple Growth Initiatives
Beyond clinical validation, the Series B2 proceeds will fund ongoing development of the company's proprietary cerebral embolic protection platform. Transverse Medical also plans to expand its operational infrastructure and grow its engineering, regulatory, quality, and operating teams as it advances toward pivotal trials and FDA Investigational Device Exemption (IDE) submission.
The company's approach to cerebral protection during structural heart procedures addresses a significant unmet need, as stroke remains one of the most devastating complications of TAVR and similar interventions. By preventing embolic particles from reaching the brain, the POINT-GUARD™ device could potentially reduce neurological complications associated with these increasingly common procedures.
Regulatory Status and Future Direction
The POINT-GUARD™ device is currently in development and has not received FDA approval for human use in the United States. The ongoing clinical trial in Australia is being conducted under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme.
As the company moves forward with its development plans, the successful financing round positions Transverse Medical to advance its technology toward commercialization, potentially offering cardiologists and their patients a new option for reducing the risk of procedure-related stroke during structural heart interventions.
The company describes its next-generation Point-Guard as a "breakthrough advancement" for complete cerebral embolic protection, suggesting that the technology may offer advantages over existing protection devices in the market.
