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]
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.
- Zaidat O, et al. First Pass Effect. A New Measure for Stroke Thrombectomy Devices. Stroke 2018; 49: 660-666.
- 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]
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]