Route 92 Medical Announces U.S. FDA Clearance for the FreeClimb® 46 Catheter with Tenzing® 4

October 1, 2026

WEST JORDAN, Utah, Sept. 28, 2026 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced U.S. Food and Drug Administration 510(k) clearance for the FreeClimb^® 46 catheter with Tenzing^® 4. The two components are engineered as an integrated system to provide neurovascular access.

FreeClimb^® 46 and Tenzing^® 4 are the newest offerings in Route 92’s portfolio of advanced neurovascular catheters. The FreeClimb 46 system joins FreeClimb 54, 70 and 88, and complements the HiPoint^® 70 and HiPoint 88 systems, which also feature the company’s proprietary Monopoint^® single-operator system. All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing enable atraumatic, precise, and controlled access through neurovascular anatomy, establishing stable access for the treatment of complex neurovascular diseases.

“In neurovascular intervention, access is critical,” said Matthew D. Alexander, M.D., Medical Director of Neurointerventional Radiology at Sutter Medical Center in Sacramento, California. “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.”

The FreeClimb 46 catheter system, including Tenzing 4, and all Route 92 catheters and systems are covered by a portfolio of more than 200 issued patents in the U.S. and international jurisdictions.

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering, innovative product design and revolutionary procedural change. 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.