SAN MATEO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, filed a patent infringement lawsuit against Balt USA, LLC (Balt) alleging infringement of five U.S. patents held by Route 92 Medical that protect the Tenzing® delivery technology. The complaint was filed on August 6, 2025, in the U.S. District Court for the District of Delaware.
“We believe Route 92 Medical has a differentiated portfolio of complete solutions for neurovascular interventional procedures each supported by our proprietary and patented Tenzing delivery technology,” said Tony Chou, M.D., Founder and Chief Executive Officer of Route 92 Medical. “Results using our products published in peer-reviewed journals demonstrate high rates of ability to reach and remove a clot on the first pass. These publications include both our FreeClimb® reperfusion systems and HiPoint® reperfusion systems featuring the Monopoint® approach, all featuring Tenzing delivery technology. We believe the market success of these products is a testament to the clinical outcomes that are achieved with their use. We will continue to vigorously defend the patents that protect our innovations worldwide.”
Tenzing delivery technology is currently protected by a global portfolio of patents, including over 30 U.S. patents. Tenzing catheters offer a soft and tapered tip designed to minimize ledge effect and to provide atraumatic tracking in the neurovasculature without the use of a microcatheter. The Tenzing delivery catheters are available in three sizes, each designed to be delivered together with Route 92 Medical’s HiPoint or FreeClimb catheters as part of a seamless system to enhance the efficacy of neurovascular procedures. These devices have been evaluated in physician-initiated, peer-reviewed studies across multiple vessel sizes and device lengths.
Route 92 Medical’s continued innovation depends upon its ability to protect its products globally. The company continues to expand its patent portfolio as it innovates and has recently secured additional patents covering products in its Monopoint family, including its Tenzing delivery technology.
As part of its ongoing innovation program, Route 92 Medical recently announced results from its SUMMIT MAX clinical trial (NCT05018650), which represents the highest level of clinical evidence as the only prospective, randomized, controlled, endovascular stroke thrombectomy trial of a super-bore catheter. The 250-patient, multicenter, trial evaluated the safety and efficacy of the HiPoint reperfusion system, which included a “super-bore” aspiration catheter with an 0.088-inch inner diameter, for the treatment of a large vessel occlusion, the cause of many acute ischemic strokes. The clinical trial showed delivery of the HiPoint 88 aspiration catheter to the M1 segment of the middle cerebral artery (MCA) using the Tenzing delivery technology was achieved 90.1% of the time compared to the smaller 0.074-inch control catheter, which reached the M1 segment 71.6% of the time. In the trial, the Route 92 Medical arm achieved the highest first pass effect rates reported in a randomized controlled trial with a consistent safety profile.
In May 2025, the company announced receipt of U.S. Food and Drug Administration 510(k) clearance for its HiPoint 88 reperfusion system, which allows direct aspiration of the thrombus with the HiPoint 88 aspiration catheter.
About Route 92 Medical, Inc.
Route 92 Medical is on a mission to improve outcomes for acute ischemic stroke patients undergoing neurovascular intervention and reduce suffering for these patients and their families by consistently reaching the clot, increasing first pass effect rates and simplifying the procedure with our systems. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.
Contacts: For Media Gwen Gordon 858-245-5684 Gwen@gwengordonpr.com
