SAN MATEO, Calif., July 14, 2025 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced results from an independent, real-world study evaluating reperfusion outcomes following use of Route 92 Medical’s HiPoint® Reperfusion System, the first and only FDA-cleared 0.088” reperfusion catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischemic stroke. The study will be presented today by Daniel Tonetti, M.D., M.S., Director, Cerebrovascular Neurosurgery, Cooper University Health Care, at the Society of NeuroInterventional Surgery 22nd Annual Meeting being held in Nashville, Tennessee.
The retrospective, multicenter study collected outcomes data from 193 consecutive patients treated with Route 92 Medical’s HiPoint Reperfusion System who were not part of the SUMMIT MAX trial. The primary endpoints were first-pass effect of mTICI 2c/3 (a measure of clot removal) and first-pass effect, defined as mTICI 2b/2c/3 reperfusion on the first aspiration pass, with secondary endpoints including rate of successful aspiration catheter delivery, number of passes for final reperfusion, and conversion to other systems or devices.
Key study findings include:
- Clinicians successfully delivered the HiPoint Reperfusion System to the stroke-causing occlusion in 96.2% of cases.
- The primary endpoint of first-pass effect mTICI 2c/3 was achieved in 57.5% of cases.
- The primary endpoint of first-pass effect of mTICI 2b/2c/3 was achieved in 68.4% of cases.
- Median number of passes was 1.
“We believed it was important to study the clinical utility of Route 92 Medical’s HiPoint Reperfusion System as a first-line aspiration tool in a real-world environment,” said Dr. Tonetti. “As in SUMMIT MAX and in the SLIC publication, we observed strong delivery and first pass effect data, as well as low complication rates. We’d expect these metrics to continue to improve as more clinicians and sites gain experience with the technology.”
Route 92 Medical also introduced SUMMIT RISE, a prospective 500-patient study to evaluate the efficacy of Route 92 Medical’s portfolio of neurovascular interventional solutions across a wide range of cases. The prospective, core-lab-adjudicated study will begin immediately under the leadership of co-primary investigators Sunil Sheth, M.D., Associate Professor and Director, Vascular Neurology Program at the McGovern Medical School at University of Texas, Houston, Christopher Kellner, M.D., Neurosurgeon at Mt. Sinai Health System, and Albert Yoo, M.D., Medical Director and Director of Research and Technology, Medical City Texas Stroke Institute.
“As with all new medical technologies, it’s critically important to develop independent, real-world evidence to guide future clinical decision-making,” said Dr. Sheth. “By collecting and analyzing data prospectively and having all cases reviewed through an independent adjudication process, the SUMMIT RISE study will enable us to evaluate the effectiveness of Route 92 Medical’s neurovascular interventional devices in real world clinical use and provide insights into technique optimization and performance.”
“We believe the evidence base supporting the use of Route 92 Medical’s technologies in neurovascular interventional procedures continues to grow. With each new study, there is additional support for the use of our Tenzing-based intervention approach, showing its ability to safely and effectively reach and aspirate clots, while improving first-pass effect relative to other catheter products,” said Tony Chou, M.D., founder and Chief Executive Officer at Route 92 Medical. “With SUMMIT RISE, we plan to evaluate patient outcomes over time, across devices and sites, and to provide additional data showing that our tools achieve clinical objectives and help give patients the best opportunity to recover from acute ischemic stroke.”
The HiPoint Reperfusion System is comprised of the HiPoint 88 Reperfusion Catheter, Tenzing® 8 Delivery Catheter, HiPoint 70 Reperfusion Catheter, Tenzing 7 Delivery Catheter, and Base Camp® 2.0 Sheath. It features the Monopoint approach, a streamlined telescoping design that advances from a single point of control. The Tenzing-powered delivery is designed to facilitate atraumatic navigation through tortuous anatomy, offering clinicians the flexibility to deliver vessel-matched, large- and super-bore catheters to the M1 and the ICA/ICA-T occlusions, while enabling the rapid and efficient removal of large vessel occlusions, the cause of many acute ischemic strokes.
There are approximately 800,000 total ischemic stroke episodes in the United States each year, 87% of which are ischemic strokes, in which blood flow to the brain is blocked.1 Despite recent advances in stroke treatment, stroke remains the leading cause of serious long-term disability and remains the fifth leading cause of death in the United States, responsible for approximately 163,000 deaths annually.2
To learn more, visit www.r92m.com.
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.
1 Stroke Facts. U.S. Centers for Disease Control. Available: https://www.cdc.gov/stroke/data-research/facts-stats/index.html. Accessed May 15, 2025.
2 Cerebrovascular Disease or Stroke. U.S. Centers for Disease Control, National Center for Health Statistics. Available: https://www.cdc.gov/nchs/fastats/stroke.htm. Accessed May 15, 2025.
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