SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial (NCT05018650) evaluating the safety and effectiveness of its HiPoint™ 88 and HiPoint 70 Reperfusion Catheters as part of the MonopointⓇ Reperfusion System. Route 92 Medical is the first company to complete enrollment in a trial studying the safety and efficacy of a “super-bore” aspiration catheter with at least an 0.088 inch inner diameter for the treatment of a large vessel occlusion, the cause of many acute ischemic strokes.
“SUMMIT MAX is a pivotal, randomized controlled trial (RCT) investigating the safety and efficacy of an 0.088-inch aspiration catheter, a technology advancement the clinical community has believed important to improve stroke care for many years,” said Dr. Thanh N. Nguyen, Professor of Neurology, Neurosurgery and Radiology at Boston University School of Medicine and co-National Principal Investigator along with Drs. Ajit Puri and Guilherme Dabus. “In a field where time is brain, systems of devices that could improve the quality of reperfusion, reduce procedure times and simplify the procedure are needed. SUMMIT MAX is the first FDA-approved aspiration thrombectomy trial which is randomized. Randomized controlled trials provide the best clinical science and the SUMMIT MAX Trial compares the Route 92 Medical Monopoint System to the largest commercially available conventional aspiration system. The data from SUMMIT MAX will provide robust evidence to guide clinical decision-making.”
The HiPoint 88 Reperfusion Catheter is designed to quickly and efficiently reperfuse occluded vessels to treat patients suffering an acute ischemic stroke. As part of the Monopoint Reperfusion System, the HiPoint Catheters are advanced from a single point of control and are delivered by TenzingⓇ 8 or Tenzing 7 Catheters to provide a streamlined unit that is designed to track through vascular curvatures without catching side branches utilizing a one-piece advancement technique. The telescoping design of the Monopoint Reperfusion System, with tapered components, is designed to reduce ledge effect, enabling atraumatic movement through tortuous anatomy.
“Route 92 Medical is leading the way in neurovascular innovation technology, bringing clinicians complete solutions designed to improve endovascular thrombectomy procedure times and outcomes. Randomized controlled trials are the hardest trials for study sponsors to manage and enroll. The completion of this study demonstrates our commitment to advancing clinical science and providing our interventionalist customers with the most complete portfolio of reperfusion solutions available,” said Tony Chou, MD, founder, and chief executive officer at Route 92 Medical. “This study will provide the safety and effectiveness data we need to support our 510(k) application to the U.S. FDA and other global regulatory bodies.”
For more information about the SUMMIT MAX trial, visit https://www.route92medical.com/clinical/.
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.
SAN MATEO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the company’s 100th global issued patent for its innovative neurovascular intervention product portfolio. The company offers a range of solutions for neurovascular interventional procedures including its FreeClimb Catheter Systems and Monopoint® Operating Platform, both powered by its Tenzing® Delivery Catheter.
“Our FreeClimb and HiPoint catheters work as a system with our Tenzing delivery paradigm. Collectively, these solutions work harmoniously as part of our Monopoint Operating Platform to enhance procedural efficiency and enable the delivery of large-bore and super-bore catheters without a microcatheter and with reduced use of a guidewire,” said John Miller, Chief Technology Officer at Route 92 Medical and medical device veteran with over 20 years of neurovascular innovation experience dating back to the earliest stroke intervention devices. “The ability of this technology to simplify stroke treatment is unique. This technology is designed to streamline the procedure, creating single-operator control over all elements, with the goal of reducing procedure time and cost while improving patient outcomes.”
“Route 92 has reinvented neurovascular intervention and will vigorously defend our intellectual property, which underlies our ability to continue to develop new solutions for arterial and venous access and treatment in the brain,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “In 2024, we plan to continue to build the evidence base to support the clinical adoption of our stroke solutions. We will also focus on growing our product portfolio and improving operational effectiveness to enable us to scale our business for commercial success.”
Route 92 Medical’s first step in revolutionizing neurovascular intervention is focused on acute ischemic stroke. The company will be launching a range of reperfusion systems that utilize innovative designs, including the Tenzing® delivery catheter. These cutting-edge products are intricately designed to function seamlessly as a comprehensive system, enhancing the effectiveness of endovascular thrombectomy procedures. This, in turn, empowers healthcare professionals to swiftly restore blood flow to a patient’s brain after an acute ischemic stroke, the prevailing type of stroke affecting patients today.
Route 92 Medical has a global intellectual property position with strong protection for its inventions in key markets including the U.S., Europe, and China. The company’s patent portfolio is growing rapidly with eight patents issued in 2023, including patents with claims across the company’s Monopoint® portfolio, including its Tenzing® and HiPoint™ catheter devices.
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.
SAN MATEO, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced it has raised over $31 million in a Series F financing to accelerate the commercial adoption of a neurovascular intervention portfolio focused on acute ischemic stroke. The oversubscribed capital raise was led by existing venture capital investors: U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and The Vertical Group.
Route 92 Medical has reimagined neurovascular intervention through the development of a suite of reperfusion systems leveraging unique designs including the Tenzing® delivery catheter. These products are designed to work harmoniously as a system to improve the efficiency of endovascular thrombectomy procedures, enabling clinicians to quickly restore blood flow to a patient’s brain following acute ischemic stroke, the most common type of stroke affecting patients today.
Proceeds from the financing will be used to accelerate the U.S. commercialization of the FreeClimb® 70 Reperfusion system featuring the FreeClimb 70 aspiration catheter and the Tenzing 7 delivery catheter. Funds will also be used to complete SUMMIT MAX, an FDA IDE-approved pivotal trial evaluating the HiPoint™ 88 and HiPoint 70 catheter systems, both featuring the Tenzing delivery catheter.
“The launch of the first complete reperfusion system with the Tenzing delivery approach is a tremendous step forward for stroke care,” said Chris Hartman, Chief Commercial Officer of Route 92 Medical. “We have already seen early clinical adoption as the Route 92 organization continues to execute on many fronts: product development and regulatory milestones, scaling manufacturing capabilities, hiring world-class sales personnel, and growing commercial operations.”
The funds will also support the company’s operational growth. Route 92 Medical is completing the process validations of its first commercially available products from its new high-volume manufacturing plant near Salt Lake City, Utah. The new 40,000 square foot facility will provide over 12,000 square feet of production clean room, warehousing, and distribution functions with enough stand-alone capacity to fulfill the growing demand for the Company’s products well into the future.
“We are continuing to build our industry-leading commercial and support teams to bring our Tenzing, FreeClimb, HiPoint, and Monopoint products to the market, serving our interventionalist customers and their patients. This latest investment validates our clinical and commercial performance as we focus on improving outcomes for patients suffering from devastating strokes,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical.
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.route92medical.com or follow the company on LinkedIn.
SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology. The research, conducted across multiple institutions, aimed to evaluate the efficacy, safety, and efficiency of the Tenzing 7 Delivery Catheter in delivering therapeutic devices for mechanical thrombectomy in acute ischemic strokes.Key findings from the study include:
1 Tonetti et al. Novel Tenzing 7 Delivery Catheter for Thrombectomy in Acute Stroke: A Clinical Multicenter Experience. Stroke Vasc Interv Neurol. 2023 Available: https://www.ahajournals.org/doi/10.1161/SVIN.123.0009402 Zaidat et al. First Pass Effect. A New Measure for Stroke Thrombectomy Devices. Stroke 2018; 49: 660-666. Available: https://www.ahajournals.org/doi/10.1161/STROKEAHA.117.020315?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
SAN MATEO, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the appointment of Jonathan Kennedy to the role of Chief Financial Officer. In this role, Jonathan will be responsible for overseeing all financial management for the company, reporting directly to Chief Executive Officer Tony Chou.
“Route 92 Medical’s technology offers uniquely disruptive solutions in the rapidly growing stroke treatment market. The company is well-positioned for long-term growth, continued product innovation, and meaningful improvements in patient outcomes, which makes this an exciting time to join,” said Jonathan Kennedy, Chief Financial Officer for Route 92 Medical. “Expanding the Company’s critical business infrastructure to support this type of growth will accelerate Route 92 Medical’s success.”
Jonathan joins Route 92 Medical after an eight-year stint as Chief Executive Officer and Chief Financial Officer at Natus Medical, a neurology, newborn care, hearing, and balance company. At Natus (Nasdaq:NTUS), he helped build a multi-site, multinational business via acquisition, innovation, and best-in-class customer service. Prior to that, Jonathan served as Senior Vice President and Chief Financial Officer for Intersil Corporation, now part of Renesas, which designs and manufactures high-performance analog semiconductors. During his tenure, he held leadership roles overseeing finance, IT, investor relations/SEC reporting, sales analytics, and mergers and acquisitions. Jonathan holds a BS in Business Administration and Accounting and an MS in Accounting from the University of Central Florida, and earned his CPA in Florida.
“Jonathan has managed very large product portfolios and complex business situations in hypercompetitive markets. He is a leader with a demonstrated history of delivering outstanding financial growth across a variety of companies and industries,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “Route 92 Medical is fortunate to have someone with his extensive experience joining our team as we work together to transform neurovascular intervention.”
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.route92medical.com or follow the company on LinkedIn.
Media Contact
Gwen Gordon
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/16770d06-5a50-4d0a-8d98-db882e9cb9e2
Jonathan Kennedy, Chief Financial Officer, Route 92 Medical
Jonathan Kennedy has just joined Route 92 Medical as Chief Financial Officer.
SAN MATEO, Calif., July 10, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the appointment of Chris Hartman to the role of Chief Commercial Officer. In this role, Chris will be responsible for continuing to build the sales and marketing organizations to grow Route 92 Medical’s global commercial footprint.
“Route 92 Medical has developed remarkable technologies which offer the potential to dramatically improve outcomes for patients who have endovascular procedures in the brain, starting with a game-changing therapy for ischemic stroke,” said Chris Hartman, Chief Commercial Officer at Route 92 Medical. “Realizing the value of these innovations requires us to engage a range of stakeholders across the medical community in thinking differently about endovascular thrombectomy procedures and neurovascular intervention more broadly.”
Chris joins Route 92 Medical with more than 20 years of medical device sales and commercial leadership experience. Most recently, Chris served as President of LivaNova PLC’s epilepsy neuromodulation division, helping deliver three years of sequential growth as a business unit leader. Prior to LivaNova, he was Chief Commercial Officer at private-equity-backed health services company, Option Care Health and Vice President of North America Commercial at Stryker Neurovascular, where he led the commercial launch and growth of the Trevo Pro-Vue stent retriever. He also held sales and commercial roles with Baxter and Boston Scientific/Guidant. Chris is a U.S. Navy veteran and holds an MBA from the Kellogg School of Management at Northwestern University and a BA in economics from the University of Michigan.
“Chris has been remarkably successful in facilitating commercial growth in the neurovascular space and other medical technology categories,” said Tony Chou, CEO of Route 92 Medical. “His breadth of experience and unique perspective will help us drive progress and growth as we continue to commercialize our FreeClimb 70 Reperfusion System, powered by our Tenzing 7 catheter technology, and our pipeline of future products. As a company, we continue to focus on the completion of the SUMMIT MAX clinical trial which will support regulatory submissions for the next-generation Monopoint® Platform, a super-bore HiPoint™ 88 catheter delivered with Tenzing 8 for thrombectomy procedures.”
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.route92medical.com or follow the company on LinkedIn.
Media Contact
Gwen Gordon
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4a1c93ba-7272-4456-9916-a6f59a2a32c7
Chris Hartman
Chris Hartman, Chief Commercial Officer, Route 92 Medical
The FreeClimb 70 Reperfusion System, powered by the Tenzing 7 delivery catheter, enables neurointerventionalists to address critical unmet needs in ischemic stroke treatment
SAN MATEO, Calif., April 24, 2023 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced receipt of 510(k) clearance for the FreeClimb™ 70 Reperfusion System which includes a FreeClimb 70 Aspiration Catheter along with a Tenzing® 7 Delivery Catheter. The FreeClimb 70 Reperfusion System enables physicians to treat patients experiencing an acute ischemic stroke by removing clots rapidly and safely. This innovative, first-to-market system is designed to work together harmoniously for superior deliverability and high procedural efficiency, making it a more refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures.
“In our initial experience with FreeClimb 70 and Tenzing 7, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” stated James Caldwell, MD, an early user of the system at Auckland City Hospital in Auckland, New Zealand. “Tenzing-based delivery can reduce procedure time and may reduce complications. This comprehensive solution will help clinicians overcome challenging neurovascular anatomy with greater ease and efficiency, providing better care for their patients.”
The FreeClimb 70 Reperfusion System is the first fully integrated solution designed around the Tenzing® 7 delivery catheter, which offers superior navigation and predictable access to occluded distal vessels without the need for a guidewire. The system’s advanced design eliminates the ledge effect commonly found in large-bore catheters.
“Route 92 Medical aims to provide neurovascular interventionists with innovative endovascular thrombectomy solutions, helping them maximize their opportunity to restore blood flow to the brain on their first attempt,” said Tony Chou, CEO of Route 92 Medical. “The 510(k) clearance for the FreeClimb 70 Reperfusion System is a key addition to our portfolio of products that are designed to simplify removal of the embolus and seek to improve outcomes.”
The FreeClimb 70 Reperfusion System is part of Route 92 Medical’s growing catalog of endovascular interventional devices being designed to refine and stroke treatment. The company is currently recruiting participants for the SUMMIT MAX clinical trial, which will support regulatory submissions for the next-generation Monopoint® Platform, a super-bore HiPoint™ 88 catheter delivered with Tenzing 8 for thrombectomy procedures.
For more information about the FreeClimb 70 Reperfusion System, visit www.route92medical.com/products. For more information about the SUMMIT MAX clinical trial and the HiPoint 88 and Tenzing 8, visit https://www.route92medical.com/clinical/.
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.route92medical.com or follow the company on LinkedIn.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90284880-82ed-4269-96f5-e1d4b04ccdba
Company continues to innovate across its portfolio to address critical unmet needs in neurovascular intervention
SAN MATEO, Calif.–(BUSINESS WIRE)–Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the company’s 80th global issued patent for its Monopoint® Operating Platform. The Monopoint® Operating Platform is the only neurointervention platform designed to streamline delivery of large and super-bore catheters for aspiration at the most common stroke targets. The single-platform system is designed for efficient and effective neurovascular intervention with a design that eliminates length challenges and provides a single point of control for enhanced single-operator capability.
“Route 92 Medical is poised to disrupt the neuro-interventional market with products that are designed to treat ischemic strokes by enhancing delivery in challenging anatomy using our unique single-point-of-control approach,” said Tony Chou, M.D., founder, and chief executive officer at Route 92 Medical. “Our intellectual property strength, combined with our world-class team, give us a strong position from which we can make a positive difference in the lives of stroke patients and their families.”
The company’s newest patent, U.S. Patent No. 11,576,691, relates to the company’s innovative Tenzing® delivery catheter for advancing catheter systems within the neurovasculature. The Tenzing® catheter is part of the Monopoint® platform, which is designed to enable a single operator to perform even the most complex procedures to treat large vessel occlusions that cause acute ischemic stroke.
“The past twenty years have seen extensive research on patient selection for stroke intervention with limited device innovation,” said John Miller, chief technology officer at Route 92 Medical. “We are focused on simplifying neurovascular procedures so physicians can reduce procedure times and improve clinical outcomes.”
Route 92 Medical has a global intellectual property position with strong protection for its inventions in key markets including the U.S., Europe, and China. The company patent portfolio is growing rapidly with 46 patents issued in 2022 including patents with claims across the company’s Monopoint® portfolio, including its Tenzing® and HiPoint™ catheter devices.
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:
For media:
Gwen Gordon
Gwen Gordon PR
[email protected]
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.
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. 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, Calif., July 25, 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 an investigator-initiated, multicenter SLIC study of its proprietary Monopoint® operating platform showing 82% first pass efficacy. Results from 33 consecutive patients also demonstrated 100% success in reaching the intracranial occlusion with the company’s HiPoint™ 88 (.088in ID) super-bore catheter, a groin-to-recanalization time of 20 minutes, mean groin to clot contact time of 14 minutes, and no serious adverse events or emboli in a new territory (ENTs). Results were published in the Journal of NeuroInterventional Surgery online.1
The SLIC study, which was conducted without input from Route 92 Medical, was a retrospective review of three comprehensive stroke center databases, evaluating the initial clinical feasibility, safety, and efficacy of the Monopoint operating platform using the SLIC technique for stroke. The SLIC technique entails telescopic assembly of the Monopoint operating platform by using the 8F Base Camp® Sheath, HiPoint 88 (088in ID) super-bore catheter, and Tenzing® delivery catheter. The study is the largest reported series using 088 aspiration catheter technology for intracranial thrombectomy.
Route 92 Medical’s HiPoint catheters, Tenzing catheters and Base Camp sheath system have received U.S. FDA 510(k) clearance for introduction of interventional devices into the peripheral and neuro vasculature. These devices are not indicated or cleared by the FDA to treat stroke. The use of the HiPoint catheter for stroke treatment is currently being evaluated in the United States under an FDA-approved investigational device exemption (IDE) study named SUMMIT MAX. The data reported on here are apart from SUMMIT MAX.
“This initial experience across three experienced, high-volume neurointerventional centers using the super large-bore ingestion of clot technique (SLIC) for treatment of acute ischemic stroke due to large vessel occlusion shows high rates of complete clot ingestion resulting in excellent first pass efficacy and reperfusion rates using the HiPoint 88 super-bore catheter,” said Dr. Ajit S. Puri, Professor of Radiology, Neurosurgery and Neurology at the University of Massachusetts Medical Center and the corresponding author of the paper. “Results are encouraging and give reason to continue assessing the Monopoint platform as a potential tool for improved patient outcomes in stroke.” 2
“The conclusion of this analysis reinforces and builds upon the recent results of the SUMMIT NZ trial, which showed an 80% first pass effect with primary use of our HiPoint 88 catheter in the first 45 patients,” 2 said Tony Chou, Founder and Chief Executive Officer of Route 92 Medical. “Evidence continues to indicate that our novel Monopoint operating platform, which is designed to facilitate simple delivery of the HiPoint 88 super-bore catheter to the target vessel and allow the application of high aspiration force, appears from these data to increase first pass effect. We look forward to completing our randomized clinical trial SUMMIT MAX, comparing the Monopoint operating platform against the current largest bore catheter system cleared by the FDA for the treatment of acute ischemic stroke.”
About Monopoint Operating Platform
The Monopoint operating platform is a telescoping neurointervention delivery system comprised of the Base Camp Sheath, the HiPoint catheters and the Tenzing delivery catheters, all of which can be controlled from a single operating zone.
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.
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.
- Massari et. al. Super large-bore ingestion of clot (SLIC) leads to high first pass effect in thrombectomy for large vessel occlusion. Journal of NeuroInterventional Surgery 2021; Epublication.
- Caldwell J, et al. Aspiration thrombectomy using a novel 088 catheter and specialized delivery catheter. Journal of NeuroInterventional Surgery 2021; Epublication.
Investor Contact:
Marissa Bych
Gilmartin Group
[email protected]