November 16, 2022
SAN MATEO, Calif., Nov. 16, 2022 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced expansion to a new high-volume manufacturing site in Salt Lake City, Utah. This 40,000 square foot site allows Route 92 to substantially augment its manufacturing capabilities while serving as a clinician training and education center. Route 92 will maintain its headquarters in San Mateo, California, sustaining its existing product manufacturing capabilities and research and development center for the design and production of new products.
“Our expansion to the Salt Lake City region underscores an exciting time in Route 92 Medical’s growth,” said Randy Sullivan, SVP of Operations. “Between our San Mateo headquarters and our new Utah manufacturing site, we are well prepared for expansion. The new site was a major manufacturing facility for a multinational vascular device company and the production footprint and resources will provide additional capacity for current product needs.”
“At Route 92 Medical, we are not only planning for the successful completion of our SUMMIT MAX pivotal trial but also investing to scale our platform and teams over time. Our new facility allows us to increase production of our proprietary Monopoint® operating platform and HiPoint™ 88 super-bore catheter. The alternate location will add a critical training center and allow us to reach more clinician users. Having a second home base for attracting additional talent is all in support of our long-term growth strategy,” said Tony Chou, Founder and Chief Executive Officer of Route 92 Medical. “Our platform’s clinical performance has suggested a remarkable first pass effect (FPE) in the treatment of acute ischemic stroke in multiple initial publications to-date. Buoyed by our product performance, we are ensuring that we have the foundation in place to support the broader use of our solutions to improve patient outcomes in neurointervention over the years ahead.”
About Route 92 Medical, Inc.
Based in San Mateo, CA, Route 92 Medical’s mission is to improve outcomes for patients undergoing neurovascular intervention. Route 92 Medical designed and developed the Monopoint Operating Platform, which includes the HiPoint™ 88 catheter delivered into the neurovasculature using the specialized Tenzing® catheter. The platform is designed to provide superior navigation and robust support in challenging anatomy along with unparalleled simplicity and speed. The Monopoint operating platform received U.S. FDA 510(k) clearance in 2018. The company is currently enrolling the SUMMIT MAX randomized, controlled, multi-center trial under an FDA-approved Investigational Device Exemption to evaluate the performance of its next-generation Monopoint Reperfusion System versus currently available aspiration catheter technology.
Each year, strokes affect about 16 million people and kill an estimated 6 million people globally. In the United States, more than 800,000 patients suffer from acute ischemic stroke each year, with an annual healthcare cost of $104 billion. Stroke is a critically time-sensitive disease and without appropriate diagnosis and treatment, most patients suffer permanent disability or death. Despite recent advances in life-saving endovascular treatment, only approximately 10 percent of eligible stroke patients are treated endovascularly today.