SAN MATEO, Calif., June 06, 2022 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a private medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of initial results of the SUMMIT NZ clinical trial, a single-arm, multi-center, prospective trial evaluating the proprietary Monopoint operating platform. Results from the first 45 patients demonstrated that the Monopoint platform yielded an 80% first pass effect (FPE1) with primary use of the HiPoint™ 88 (.088in ID) catheter, a super-bore catheter designed to consistently reach the proximal middle cerebral artery (MCA). The Route 92 HiPoint 88 aspiration catheter successfully reached the proximal MCA (M1 segment) in 100% of the cases attempted. The results were published in the Journal of NeuroInterventional Surgery online2.
“The Monopoint operating platform with HiPoint 88 catheters delivered a step change in first pass efficacy in the SUMMIT NZ trial, signaling clear potential for improved patient outcomes given the importance of clearing thrombus to save time and save brain,” said Dr. James Caldwell, attending physician at Auckland City Hospital and the paper’s first author. “The platform is designed to improve catheter deliverability offering the advantage of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”
SUMMIT NZ is a prospective, multi-center, single-arm trial that enrolled patients across New Zealand. The trial evaluated the safety and clinical efficacy of the novel Monopoint operating platform in delivering the super-bore and large-bore HiPoint aspiration catheters (0.088in ID and 0.070in ID) to the M1. The trial is the largest reported to date using 088 aspiration catheter technology for intracranial thrombectomy, offering an encouraging signal that super-bore aspiration catheters may increase first pass reperfusion (mTICI ≥2b).
“An increase in first pass effect is highly correlated with superior outcomes and reduction in disability1. Route 92’s novel platform makes it dramatically easier to deliver the HiPoint 88 super-bore catheter to the target vessel and, by right-sizing the catheter to the clot, allows the application of higher aspiration force which appears to increase first pass effect,” said Warren Kim, MD, PhD, Consultant Medical Director of Route 92 Medical. “These initial SUMMIT NZ results establish a strong foundation for building level 1 evidence of patient benefit, and we look forward to completing Route 92 Medical’s randomized clinical trial SUMMIT MAX, comparing the Monopoint operating platform against the current largest bore catheter system on the market.”
Route 92 Medical’s HiPoint catheters, Tenzing® catheters and Base Camp® sheath system have received U.S. FDA 510(k) clearance for neurovascular access.
About Stroke
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. Recent data has proven that rapid intervention using specialized devices to restore blood flow to brain tissue can dramatically reduce the death and disability associated with acute stroke. Despite recent advances in these life-saving endovascular treatments, only ~10% of eligible stroke patients are treated with intervention today.
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, developing thoughtful product solutions in collaboration with the world’s leading clinicians is at our core. Our portfolio takes aim at the biggest challenges in neurointervention to deliver meaningful solutions.
Investor Contact:
Marissa Bych
Gilmartin Group
[email protected]
SAN MATEO, Calif., April 26, 2022 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced that the U.S. Patent Office (USPTO) has granted the company its 25th U.S. patent for the Monopoint Operating Platform (“Monopoint”), the 40th patent globally. By delivering a large-bore catheter through a single port, Monopoint is designed to provide novel, unmatched device capabilities, with an initial focus on treating the large vessel occlusions which cause acute ischemic stroke. Relative to existing solutions, the platform is intended to facilitate faster access to the target vasculature allowing a single operator to perform even the most complex procedures.
Route 92 Medical’s growing intellectual property portfolio consists of 40 patents globally, including 25 U.S. patents and several patents in the European Union and Asia. Patents issued include claims focused on Monopoint’s individual devices such as the Tenzing and HiPoint™ catheters. Tenzing is designed to pair with conventional and HiPoint catheters to enable predictable delivery in challenging anatomy. The versatile HiPoint catheter is “a fraction of a conventional catheter” designed to reduce friction while being delivered. The company’s patents also cover methods of use of the product family. The HiPoint and Tenzing catheters are key elements in a system designed to eliminate the need for multi-axial catheter techniques so operators can reach any neurovascular location without concern for device length. The Monopoint platform has a single point of control, intended to enhance physician command of individual elements in a system of devices. The cohesive platform design is intended to speed procedure times and positively impact patients by improving clinical outcomes.
“The field of stroke intervention has evolved significantly over the past two decades, but we have yet to evolve the core method of device delivery. The Monopoint Operating Platform is a unique design that creates a bespoke pairing of the HiPoint half catheters with Tenzing to predictably reach distal anatomy while also working seamlessly with conventional tools,” said John Miller, Chief Technology Officer. “These are the tremendous benefits of Monopoint, and we are pleased to ensure the platform’s differentiation for years to come through our robust patent portfolio.”
“We continue building on our foundation as a performance leader in neurovascular intervention. It all starts with truly differentiated technology protected by our patent portfolio, a world-class team, and a culture of innovation. We also benefit from a strong cash position following our recent $111 million Series E and debt financing,” said Tony Chou, Founder and Chief Executive Officer. “We are well positioned to advance our solution to market with randomized clinical data and create a positive impact on the lives of stroke patients and their families.”
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 an 088-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 2020. The company is currently enrolling the SUMMIT MAX randomized controlled trial under an FDA-approved Investigational Device Exemption.
About Stroke
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.
Investor Contact
Marissa Bych
Gilmartin Group
[email protected]
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.
Investor Contact:
Marissa Bych
Gilmartin Group
[email protected]
Plans to execute the SUMMIT MAX trial to obtain FDA clearance for the proprietary Route 92 Medical Reperfusion System
San Mateo, CA – December 14, 2021 – (BUSINESSWIRE) – Route 92 Medical, Inc., a private medical technology company dedicated to becoming the performance leader in stroke intervention, today announced that it has raised over $110 million in a combined Series E and debt financing. The capital raise consisted of a $56 million Series E financing round led by new investors InnovaHealth Partners and Norwest Venture Partners. The round was also supported by existing Route 92 Medical investors The Vertical Group and U.S. Venture Partners. Runway Growth Capital complemented the equity financing with an up to $55 million senior secured term loan.
Proceeds from the financing will be used to enroll the SUMMIT MAX clinical trial with the goal to obtain FDA clearance for the proprietary Route 92 Medical Reperfusion System. Funds will also be used to further develop new products and commercialize its technology in key regions.
“Route 92 Medical is laser-focused on becoming the first neurovascular company to launch an FDA-cleared 088 Aspiration Catheter for the treatment of acute ischemic stroke. We believe that our catheter technology featuring the Monopoint® operating system will ultimately serve as a platform to revolutionize neurovascular aspiration thrombectomy for large vessel occlusions. This financing provides sufficient capital to carry out our US Pivotal trial and a limited commercial release of our products, the next critical steps in our company’s evolution” said Dr. Tony Chou, Co-Founder and CEO of Route 92 Medical.
“Globally, stroke is the second-leading cause of death and the leading cause of long-term disability,” said Dr. Joey English, Chief Medical Officer and Route 92 Medical Co-Founder. “Route 92 Medical has developed a unique, next-generation system designed to improve stroke intervention procedures.”
In conjunction with the Series E closing, Dr. Ariella Golomb, Founder and Managing Director of InnovaHealth Partners, joins the Route 92 Medical Board of Directors. Dr. Golomb brings over 20 years of expertise from her roles across medicine, healthcare strategy and investing, in addition to a wealth of scientific and clinical relationships.
“We have seen remarkable physician response to the Route 92 Medical platform,” said Dr. Ariella Golomb, Managing Director at InnovaHealth. “The company’s Monopoint system featuring the Tenzing® Delivery Catheter is well positioned in the rapidly growing neurovascular market. I am pleased to join the Board of Directors at this exciting time in the company’s growth.”
About Route 92 Medical, Inc.
Based in San Mateo, CA, Route 92 Medical’s mission is to become the leader in neurovascular aspiration thrombectomy. The Route 92 Medical platform utilizes the Monopoint operating system including an 088 catheter delivered to the neurovasculature using the specialized Tenzing catheter. The system is designed to provide superior navigation to challenging anatomy and robust support, along with unparalleled simplicity and speed.
About InnovaHealth Partners
Based in New York, InnovaHealth Partners, LP is a leading private equity firm providing growth capital to the medical technology industry. The firm focuses on a diversified portfolio of lead investment positions and collaborates closely with each management team. InnovaHealth Partners is led by five principals who collectively have over 100 years of experience investing in the medical device space. The team has worked together for over 15 years and has $900 million of committed capital under management between its funds and co-investments. For more information, please visit https://www.innovahealthpartners.com/
About Norwest Venture Partners
Norwest is a leading venture and growth equity investment firm managing more than $12.5 billion in capital. Since its inception, Norwest has invested in more than 650 companies and currently partners with more than 200 companies in its venture and growth equity portfolio. The firm invests in early to late-stage businesses across a wide range of sectors with a focus on consumer, enterprise, and healthcare. The Norwest team offers a deep network of connections, operating experience, and a wide range of impactful services to help CEOs and founders scale their businesses. Norwest has offices in Palo Alto and San Francisco, with subsidiaries in India and Israel. For more information, please visit www.nvp.com. Follow Norwest on Twitter @NorwestVP.
About Runway Growth Capital LLC
Runway Growth Capital LLC is the investment advisor to investment funds, including Runway Growth Finance Corp., which are lenders of growth capital to companies seeking an alternative to raising equity. Led by industry veteran David Spreng, these funds provide senior term loans of $10 million to $70 million to fast-growing companies based in the United States and Canada. For more information on Runway Growth Capital LLC and its platform, please visit our website at www.runwaygrowth.com.
Investor Contact:
Marissa Bych
Gilmartin Group
[email protected]