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