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Route 92 Medical Receives Australian Therapeutic Goods Administration Approval for its Portfolio of Neurovascular Interventional Products for Treating Patients with Acute Ischemic Stroke

By: via GlobeNewswire

SAN MATEO, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced approval from the Australian Therapeutic Goods Administration (TGA) for its innovative neurovascular intervention portfolio. Within this portfolio are the first .088” super bore reperfusion systems to be approved for use in Australia, including the FreeClimb® 88 catheter powered by Tenzing® technology and the Monopoint®-based HiPoint® 88 super-bore catheter.

“The receipt of TGA approval is yet another step in our company’s journey to become a global leader in advancing neurovascular intervention,” said Tony Chou, M.D., Route 92 Medical’s founder and chief executive officer. “This registration gives us the ability to secure adoption of our products in a mature market with highly trained neurointerventionalists. As we innovate, simplify, and improve neurovascular intervention, we plan to grow our footprint into additional geographies to address unmet needs.”

Route 92 Medical’s products are covered by a global portfolio of more than 140 patents. The regulatory authorization covers the majority of the company’s products including:

  • HiPoint 70/Tenzing 7 Reperfusion System
  • HiPoint 88/Tenzing 8 Reperfusion System
  • FreeClimb 70/Tenzing 7 Reperfusion System
  • FreeClimb 88/Tenzing 8 Reperfusion System
  • Base Camp Sheath System

“We’ve had great success in our initial evaluation of Route 92 Medical’s stroke-treatment portfolio. It offers superb enhanced delivery with the Tenzing system to navigate easily in the most tortuous of neurovasculature to quickly and efficiently reach the site of stroke vessel occlusion,” said Dr. Hal Rice, Director of Neurointervention at Gold Coast University Hospital. “The system offers robust capabilities that address a broad range of neurovascular intervention challenges, including efficiently navigating to and effectively aspirating stroke-causing clots to deliver rapid cerebral reperfusion and a high proportion of first-pass effect in cases we have recently treated.”

The company will showcase its technology at the Australian and New Zealand Society of Neuroradiology (ANZSNR) annual scientific meeting taking place in Perth, Australia from March 27-29, 2025. For more information about Route 92 Medical, visit www.r92m.com.

About Route 92 Medical, Inc.

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

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Gwen Gordon
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gwen@gwengordonpr.com

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