SAN MATEO, Calif., March 27, 2025 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced approval from the Australian Therapeutic Goods Administration (TGA) for its innovative neurovascular intervention portfolio. Within this portfolio are the first .088” super bore reperfusion systems to be approved for use in
Australia, including the FreeClimb® 88 catheter powered by Tenzing® technology and the Monopoint®-based HiPoint® 88 super-bore catheter.
“The receipt of TGA approval is yet another step in our company’s journey to become a global leader in advancing neurovascular intervention,” said Tony Chou, M.D., Route 92 Medical’s founder and chief executive officer. “This registration gives us the ability to secure adoption of our products in a mature market with highly trained neurointerventionalists. As we innovate, simplify, and improve neurovascular intervention, we plan to grow our footprint into additional
geographies to address unmet needs.”
Route 92 Medical’s products are covered by a global portfolio of more than 140 patents. The
regulatory authorization covers the majority of the company’s products including:
- HiPoint 70/Tenzing 7 Reperfusion System
- HiPoint 88/Tenzing 8 Reperfusion System
- FreeClimb 70/Tenzing 7 Reperfusion System
- FreeClimb 88/Tenzing 8 Reperfusion System
- Base Camp Sheath System
“We’ve had great success in our initial evaluation of Route 92 Medical’s stroke-treatment portfolio. It offers superb enhanced delivery with the Tenzing system to navigate easily in the most tortuous of neurovasculature to quickly and efficiently reach the site of stroke vessel occlusion,” said Dr. Hal Rice, Director of Neurointervention at Gold Coast University Hospital. “The system offers robust capabilities that address a broad range of neurovascular intervention challenges, including efficiently navigating to and effectively aspirating stroke-causing clots to deliver rapid cerebral reperfusion and a high proportion of first-pass effect in cases we have recently treated.”
The company will showcase its technology at the Australian and New Zealand Society of Neuroradiology (ANZSNR) annual scientific meeting taking place in Perth, Australia from March 27-29, 2025. For more information about Route 92 Medical, visit www.r92m.com.
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.
APM 4059.A March 2025
Contacts:
For Media
Gwen Gordon
858-245-5684
[email protected]
SAN MATEO, Calif., March 19, 2025 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the results of a first-of-its-kind multicenter study published in Stroke: Vascular and Interventional Neurology, which demonstrated the utility of the Monopoint® system in procedures to treat idiopathic intracranial hypertension (IIH).1 Physicians participating in the study noted that the Monopoint system successfully navigated tortuous patient anatomy and crossed the stenosis, offering improved trackability and sufficient catheter length to enable successful stent delivery.
Intracranial hypertension (IIH) occurs when increased cerebrospinal fluid pressure or venous outflow obstruction leads to elevated intracranial pressure, causing headaches, visual disturbances, pulsatile tinnitus, cognitive and psychological symptoms. The annual incidence of IIH in the western world is approximately 0.9 per 100,000 persons (approximately 3,000 diagnoses per year in the U.S.), but primarily afflicts females with obesity.2
One potential treatment for IIH involves venous stenting and treats the IIH cases that are associated with a venous stenosis identified during imaging studies.3 Such treatment requires passing through tortuous vessels in the venous anatomy to deliver a stent.
The retrospective, multicenter, observational study aimed to understand the effectiveness of using the Monopoint system to access the venous sinus, cross through stenosis and allow delivery of a stent. The study included 71 patient procedures which took place between January 2022 and December 2023 at 13 high volume neurovascular centers in the U.S. This is the first such study using the Monopoint system to facilitate venous sinus stenting.
“Physicians participating in the study rated the Monopoint system as better than conventional approaches 93 percent of the time,” noted Tony Chou, M.D., founder and chief executive officer at Route 92 Medical. “The Monopoint system’s single axial setup and large bore catheter design makes it an ideal choice for complex neurovascular procedures, such as venous sinus stenting where physicians must navigate through tortuous anatomy and a stenosis to reach the target location.”
The Monopoint system is comprised of the Base Camp® 8F Sheath, HiPoint® 88 catheter, and Tenzing® 8 delivery catheter, which solved length compatibility problems that occur with conventional systems. The study showed that the Monopoint system could support the deployment of relatively stiff stent systems. Such systems benefit from a large bore catheter which can reduce the need for complex multiaxial catheter access setups as well as over-the-wire exchange maneuvers. The variable catheter length of the Monopoint system and improved trackability through tortuous anatomy also supported the procedural success.
“We demonstrated that the flexibility of the Monopoint system, with a simple set up and a variable length, is extremely helpful in venous sinus stenting procedures where crossing stenosis to place venous stents can be challenging with less adaptable solutions,” said Oded Goren, M.D., associate professor of neurosurgery and director of vascular and endovascular neurosurgery at Geisinger Medical Center, Danville, Penn. “As a result of their venous sinus stenting procedures, study participants experienced a range of clinical improvements including a reduction in headaches, pulsatile tinnitus, and papilledema.”
Matthew Alexander, M.D., M.S., medical director at Sutter Medical Center Sacramento, will present the study at the Society of NeuroInterventional Surgery Cerebral Venous and CSF Disorders Summit being held March 19-21, 2025, in Honolulu, Hawaii. His presentation will be Friday, March 21, 2025, at 3:45 p.m.
The stents referenced in this publication are not approved for venous stenting. To learn more about the Monopoint system and other Route 92 Medical neurovascular intervention products, visit www.route92medical.com.
About Route 92 Medical
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.
1 Goren, Oded, M.D. et. Al. “Venous Sinus Stenting Using a Ledge-Reducing Catheter, 0.088-in.
Catheter-Extender With an External Single Point of Control: Technique and Multicenter Clinical
Experience.” Stroke: Vascular and Interventional Neurology. March 2025. Available:
https://www.ahajournals.org/doi/epub/10.1161/SVIN.124.001627.
2 Chen, John and Michael Wall. “Epidemiology and Risk Factors for Idiopathic Intracranial
Hypertension.” Int. Ophthalmol. Clin. Winter 2014. Available:
https://pmc.ncbi.nlm.nih.gov/articles/PMC3864361/.
3 Fargen, Kyle M. “Venous Stenting for Idiopathic Intracranial Hypertension: Lessons Learned from
High Volume Practice.” Journal of NeuroInterventional Surgery. 2022. Available:
https://jnis.bmj.com/content/14/6/528.
SAN MATEO, Calif.— Route 92 Medical, Inc., a privately held medical technology company
dedicated to improving outcomes for patients undergoing neurovascular intervention, today filed
a patent infringement lawsuit against Q’Apel Medical alleging infringement of five U.S. patents
held by Route 92 Medical, which protect the Tenzing® delivery catheter. The complaint was filed
October 7, 2024, in the United States District Court for the District of Delaware.
“Route 92 Medical has reinvented neurovascular intervention. Our growing sales are a
testament to the superiority of our solutions,” said Tony Chou, CEO of Route 92 Medical. “In
light of our success, it’s not surprising that other companies have looked for ways to emulate the
customer-preferred features of the Tenzing delivery catheter and other Route 92 Medical
products. Yet, with more than 100 patents protecting our innovations worldwide, we want to
make clear that we will vigorously defend our intellectual property.”
Tenzing delivery catheters, first used clinically in 2019, are currently protected by a global
portfolio of patents including 23 U.S. patents. These catheters offer a unique tapered tip
designed to significantly reduce ledge effect and to provide atraumatic tracking in the
neurovasculature, enabling consistent navigation to reach targeted locations in the brain without
the use of a microcatheter. The Tenzing delivery catheters are available in three sizes and are
designed to be delivered together with Route 92 Medical’s HiPoint® and FreeClimb® catheters
as part of seamless systems, thereby enhancing the effectiveness of neurovascular procedures.
These devices have been evaluated in ten independent, peer-reviewed studies across multiple
vessel sizes and device lengths.
Route 92 Medical’s continued innovation depends upon its ability to protect its products globally.
The company continues to expand its patent portfolio as it innovates and has recently secured
additional patents covering products in its Monopoint®
family, including its Tenzing delivery
catheters. As part of its ongoing innovation program, Route 92 Medical recently completed
enrollment in an extensive clinical investigation of the Tenzing delivery catheter as part of its
Monopoint Reperfusion System. The company’s 250-patient SUMMIT MAX clinical trial
(NCT05018650) was designed to study 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. The prospective, randomized, controlled,
interventional clinical trial was designed to compare the safety and efficacy of the HiPoint 88
reperfusion catheter paired with Tenzing 8 delivery catheter with another large-bore reperfusion
system.
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.
APM 3752.A
For media:
Gwen Gordon
Gwen Gordon PR
[email protected]
Funds from Novo Holdings will support global commercial expansion
Novo Holdings’ Noel Jee joins Route 92 Board of Directors
SAN MATEO, Calif., Sept. 23, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced a new $50 million extension to its previously announced oversubscribed Series F financing, bringing the total raised to $82 million. Novo Holdings joined returning investors U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and The Vertical Group in supporting the round. In connection with the investment, Noel Jee, Partner, Growth Investments, Novo Holdings US, joins the Route 92 Board of Directors. Jee brings over ten years of experience in life science investing and consulting.
Proceeds from the financing will be used to accelerate the global commercialization of the company’s neurovascular intervention portfolio, and to pursue regulatory authorizations in new geographies. Route 92 Medical has streamlined neurovascular intervention by creating a suite of reperfusion and access systems leveraging unique designs, all featuring the patented Tenzing® delivery catheter. These products are designed to work harmoniously as complete systems 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.
The Company’s neurovascular portfolio includes the FreeClimb®70 reperfusion system featuring the FreeClimb 70 aspiration catheter and the Tenzing 7 delivery catheter and the FreeClimb 54 reperfusion system comprising the FreeClimb 54 aspiration catheter paired with a Tenzing 5 delivery catheter and the FreeClimb 88 catheter system comprising the FreeClimb 88 catheter and Tenzing 8 delivery catheter. In addition, the company has completed enrollment in its SUMMIT MAX clinical trial, which is evaluating the safety and effectiveness of the HiPoint® 88 and HiPoint 70 reperfusion catheters as part of the Monopoint® reperfusion system.
“Our company is focused on improving outcomes for patients suffering from acute ischemic stroke, and we are continuing to build our industry-leading commercial and support teams to bring our Tenzing, FreeClimb, HiPoint, and Monopoint products to the market,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “Novo Holdings’ investment validates our clinical and commercial performance and will help us better serve patients and our interventionalist customers.”
“Stroke is an acute event and the difference between life and death is often determined by ease of access and rapid removal of the entire clot. Route 92 Medical’s reperfusion systems provide practice-changing, much-needed innovation for clinicians and patients,” said Noel Jee, Route 92 Board Member. “We look forward to supporting Route 92 Medical’s management team in their efforts to improve care for patients.”
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.
About Novo Holdings
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Principal Investments, Planetary Health Investments and Asia teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets.
As of year-end 2023, Novo Holdings had total assets of EUR 149 billion.
www.novoholdings.dk
SAN MATEO, Calif., July 22, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced commercial launch of the FreeClimb® 88 catheter system comprising the FreeClimb 88 catheter and the Tenzing® 8 delivery catheter, all designed to work with the Base Camp® sheath. The FDA 510(k) cleared FreeClimb 88 catheter system offers reliable navigation through tortuous anatomy in the neurovasculature and is available in 125 cm and 132 cm lengths to provide clinicians with the flexibility they need to reach their targeted locations.
“Route 92 Medical continues to advance neurovascular intervention through a suite of solutions designed to work harmoniously to address acute ischemic stroke,” said Tony Chou, CEO of Route 92 Medical. “The FreeClimb 88 access catheter system, powered by Tenzing, addresses the unmet need for effective, super-bore catheters that can reach the M1 segment of the middle cerebral artery consistently. Route 92 Medical is dedicated to giving clinicians new tools to treat their most complex cases.”
The tapered tip of the patented Tenzing 8 delivery catheter significantly reduces ledge effect and allows the FreeClimb 88 catheter to consistently navigate past the ophthalmic artery and predictably reach the M1 segment of the middle cerebral artery (MCA). Tenzing’s soft, tapered tip provides atraumatic tracking in the neurovasculature, and was designed to reach the targeted locations without the use of a microcatheter.
“Having a broader set of tools gives clinicians greater flexibility when treating difficult cases,” said Dr. Ajit Puri, Professor and Director of Neurointervention and Integrated Cerebrovascular Program at University of Massachusetts medical center and Portsmouth Regional Hospital. “The .088″ catheter systems will make procedures easier by minimizing set-up complexity, providing vessel size matching leading to distal flow control during the delivery of therapeutic devices, and leveraging the strengths of the Tenzing product design to improve navigation.”
Route 92 Medical’s family of FreeClimb and HiPoint® products simplify endovascular thrombectomy procedures by allowing clinicians to select the optimal length and size of access or aspiration catheter for every case. Route 92 Medical’s FreeClimb and HiPoint products are powered by custom-sized Tenzing delivery catheters, allowing for rapid and predictable delivery to the targeted location. The FreeClimb 88 system joins the company’s growing 88 portfolio, including the Monopoint® system, powered by the HiPoint 88 and Tenzing 8 catheters, and Base Camp sheath.
For more information about other Route 92 Medical-developed neurovascular intervention devices, visit www.route92medical.com/products.
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., April 30, 2024 (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® 54 reperfusion system, comprised of the FreeClimb 54 aspiration catheter paired with a Tenzing® 5 delivery catheter. This new system is part of a growing portfolio of neurovascular devices from Route 92 Medical designed to work harmoniously as a complete endovascular thrombectomy solution to address a broad range of neurovascular interventions.
“Route 92 Medical works to provide innovative endovascular thrombectomy solutions to clinicians, 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 FreeClimb 54 reperfusion system is an essential addition to our product portfolio, enabling clinicians to use our products to address a wider range of patient needs.”
The FreeClimb 54 system can telescope through the company’s complementary products allowing physicians to rapidly and predictably reach and remove stroke-causing clots during endovascular thrombectomy procedures. Its robust tip and shaft design facilitates use for multiple passes and compatibility with other technologies. Additionally, the FreeClimb 54 system may be used to remove distal clots when first-line therapies fail to completely remove the clot.
“The launch of the FreeClimb 54 reperfusion system continues Route 92 Medical’s progressive and complete approach to stroke care,” stated Peter Pema, MD, Co-Director, Neurointerventional Surgery at Riverside Methodist Hospital in Columbus Ohio. “This system combines the unparalleled effectiveness and safety of their Tenzing delivery system with an aspiration catheter that can reach far into the cerebral circulation beyond the proximal branch vessels. Thus, the size of the FreeClimb 54 system offers clear advantages to clinicians looking to achieve rapid, safe recanalization of vessels on the first attempt.”
“The FreeClimb 54 system is a game changer,” said Ronald Budzik, MD, Medical Director, Ohio Health Riverside Methodist Hospital Comprehensive Stroke Center and Neurointerventional Radiology. “It is a simple system capable of getting a larger bore aspiration catheter to distal anatomy, especially around tighter turns.”
Route 92 Medical has designed its FreeClimb and HiPoint® families of products to work together to simplify endovascular thrombectomy procedures, enabling physicians to select the optimal length and size of catheter for every case. The FreeClimb 54 complements the FreeClimb 70 reperfusion system, as well as the company’s FreeClimb 88, HiPoint 70 and HiPoint 88 access systems, all of which are powered by custom-sized Tenzing delivery catheters. The navigational capabilities of Tenzing delivery catheters allow rapid and predictable delivery to the target lesion, reducing or eliminating the need for a microcatheter, and ultimately improving procedural efficiency.
For more information about other Route 92 Medical-developed neurovascular interventional devices, visit www.route92medical.com/products.
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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ba73be39-5e25-4d5e-abb9-c058b16990c8
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