February 8, 2022
San Mateo, CA – February 8, 2022 – (BUSINESSWIRE) – Route 92 Medical, Inc., a private medical technology company dedicated to becoming the performance leader in acute ischemic stroke intervention, today announced the first patient enrollment in its SUMMIT MAX clinical trial. SUMMIT MAX is a randomized, controlled, multi-center trial to evaluate the performance of its next generation Monopoint Reperfusion System versus currently available aspiration catheter technology. The first patient was enrolled at Auckland City Hospital in New Zealand, followed shortly by a patient at West Virginia University Medicine in the United States.
“I am delighted to begin enrollment in the SUMMIT MAX Study”. Said Dr. Ben McGuinness of Auckland City Hospital in New Zealand, “The early results from our initial experience with the Route 92 088 platform in the SUMMIT NZ Study demonstrated an 80% TICI 2b-3 first pass reperfusion rate. It is an exciting opportunity to evaluate the possibility of improving interventional stroke treatment, and I hope the results of this trial will benefit future stroke patients.”
“We are happy to become the first U.S. site to enroll a patient in the SUMMIT MAX clinical trial evaluating the Monopoint System,” said Dr. Ansaar Rai, Professor and Chair of the Neuroradiology Department at the Rockefeller Neuroscience Institute at West Virginia University Medicine. “Randomized clinical trials such as these offer high levels of evidence and are critical in advancing the field of endovascular stroke therapy.”
The SUMMIT MAX Study is a multi-center, prospective, randomized pivotal study and will enroll up to 220 patients at 30 sites across the United States and New Zealand. The study will evaluate the clinical efficacy and safety of Route 92 Medical’s Monopoint System vs. currently available aspiration catheter technology and is intended to build on the recently published results of the SUMMIT NZ study. Results of the study are also intended to provide clinical evidence to support an application for FDA clearance. Drs. Thanh Nguyen, Ajit Puri, and Guillerme Dabus are the Principal Investigators of the study.
“We are honored to partner with the SUMMIT MAX investigators to begin our pivotal clinical trial and look forward to continued enrollment as the study progresses.” said Dr. Tony Chou, Co- Founder and CEO of Route 92 Medical. “We are confident that our Monopoint System featuring the 088 HiPointTM and Tenzing® Catheters is a platform positioned to transform neurovascular aspiration thrombectomy for large vessel occlusions.”
Route 92 Medical’s HiPoint Catheters, Tenzing Catheters and Base Camp® Sheath System received U.S. FDA 510(k) clearance for neurovascular access in 2020 and have also received CE marking for first-line aspiration thrombectomy in the European Union.
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, a majority of 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.
About Route 92 Medical, Inc.
Based in San Mateo, CA, Route 92 Medical’s mission is to become the performance leader in acute ischemic stroke intervention. The Route 92 Medical platform utilizes the Monopoint reperfusion system including an 088 catheter delivered into the neurovasculature using the specialized Tenzing catheter. The system is designed to provide superior navigation in challenging anatomy and robust support, along with unparalleled simplicity and speed.