Data from 250-patient, 31-center, randomized controlled trial presented at European Stroke Organisation Conference
Three highest enrolling sites reported 96% delivery of the super-bore HiPoint 88 Reperfusion System to MI occlusions and 84% first pass effect
HiPoint 88 Reperfusion System secures 510(k) clearance becoming the first stroke treatment system to achieve super-bore direct aspiration label
SAN MATEO, Calif., May 21, 2025 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced positive results from its SUMMIT MAX randomized controlled clinical trial (NCT05018650) comparing the efficacy and safety of the HiPoint® Reperfusion System including the super-bore .088” HiPoint 88 Aspiration Catheter to a conventional .074” catheter. These data were presented at the European Stroke Organisation Conference (ESOC) in Helsinki, Finland.
In addition, the company announced receipt of its 510(k) NRY clearance for its HiPoint Reperfusion System including the HiPoint 88 Reperfusion System powered by Tenzing® 8 and featuring the Monopoint® approach. Route 92 Medical is the first neurovascular intervention company to receive clearance for direct aspiration of a stroke-causing thrombus with a super-bore .088” catheter in the neurovasculature.
“Route 92 Medical was founded to completely re-imagine neurovascular intervention. We believe that simpler set-ups designed to be used as complete systems will radically transform stroke treatment. Our data show the power in this approach,” said Tony Chou, M.D., founder and chief executive officer at Route 92 Medical. “We are grateful to the investigators, patients and patient families who participated in this trial and shared our faith in the potential of a comprehensive portfolio of vessel-size-matched catheters to improve acute ischemic stroke thrombectomy procedures and ultimately patient outcomes.”
The SUMMIT MAX randomized controlled trial demonstrated the superiority of the HiPoint Reperfusion System when compared with a conventional .074” aspiration catheter in achieving the primary efficacy endpoint, revascularization with any adjunctive therapy considered a failure.
Key primary study findings include:
- Analysis group included 166 study participants.
- Clinicians successfully delivered the HiPoint 88 Aspiration Catheter to the stroke-causing occlusion in 89% of cases.
- The Route 92 Medical arm showed significantly higher revascularization rates compared to the control arm.
- There was no significant difference between the two study groups for the primary safety endpoint of symptomatic intracranial hemorrhage (sICH).
“The clinical community has long believed that an 0.088-inch super-bore aspiration catheter could improve stroke care by improving first pass effect (FPE),” 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. “We require systems of devices capable of improving the quality of reperfusion, reducing procedure times and simplifying the procedure because time equals brain. Having an FDA-cleared solution backed by the robust data we saw in the SUMMIT MAX clinical trial will go a long way towards advancing stroke care in the U.S.”
“These results were similar to the results of the multicenter study Dr. Dabus and I conducted in 2022 whose results were published in the Journal of Neurointerventional Surgery,” said Dr. Ajit S. Puri, Professor at University of Massachusetts Medical Center and Director of the Comprehensive Stroke Center in Portsmouth Regional Hospital. “The high rates of FPE seen in this trial validate our similar findings and show the power of vessel-size-matched aspiration catheters to drive procedural success.”
In addition, the company shared a poster with results from study participants enrolled at the three centers with the largest study enrollment. This sub-study data demonstrated that centers with more experience with the Route 92 Medical products achieved even more impressive results, suggesting the potential for better clinical results as these products are widely adopted.
Key sub-study findings include:
- Analysis group included 57 participants at three centers.
- Clinicians successfully delivered the HiPoint 88 Aspiration Catheter to the target M1 segment of the middle cerebral artery (MCA) in 96% of cases leading to a 96% revascularization rate. The M1 is the most common site of stroke intervention.
- FPE is associated with reduced procedural time and reduced patient disability.1 FPE was significantly higher in the Route 92 Medical arm versus the conventional arm for FPE mTICI ≥2b (84% versus 53%; p=0.02) and FPE mTICI ≥2c (68% versus 30%; p=0.007).2
- There were no cases of sICH in the Route 92 Medical arm.
- Patients in the Route 92 Medical arm required significantly less use of adjunctive devices, such as stent retrievers, to achieve revascularization (4% versus 53%; p < 0.0001).
The HiPoint Reperfusion System is comprised of the HiPoint 88 Aspiration Catheter, Tenzing® 8 Delivery Catheter, HiPoint 70, Tenzing 7 Delivery Catheter, and Base Camp® 2.0 Sheath. It features the Monopoint approach, a streamlined telescoping design that advances from a single point of control. The Tenzing-powered delivery allows for atraumatic navigation through tortuous anatomy, offering clinicians the flexibility to deliver vessel-matched, super-bore catheters to the M1, while enabling the rapid and efficient removal of large vessel occlusions, the cause of many acute ischemic strokes.
“The importance of improving FPE is critical and has been evolving over the past decade,” said Dr. Guilherme Dabus, Co-Director of Interventional Neuroradiology and Director of Clinical Research for Miami Neuroscience Institute, Baptist Health South Florida and Professor of the Wertheim College of Medicine, Florida International University. “Patients experience better outcomes when we can remove a clot and get blood flowing into all parts of the brain more quickly, in one pass. Improvement in FPE to achieve reperfusion of ≥ mTICI 2c is the goal of procedures today and the SUMMIT MAX results show the potential of the HiPoint 88 Reperfusion System as a ‘one-and-done’ workhorse product. We believe having on-label tools with improved FPE rates will enable many more stroke patients to make more complete recoveries.”
There are more than 795,000 people in the United States affected by stroke each year, 87% of which are ischemic strokes, in which blood flow to the brain is blocked.3 Despite recent advances in stroke treatment, stroke remains the leading cause of serious long-term disability and remains the fifth leading cause of death in the U.S., responsible for approximately 165,000 deaths annually.4
To learn more, 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.
Contacts:
For Media
Gwen Gordon
858-245-5684
[email protected]
____________________________
1 Zaidat OO, Castonguay AC, Linfante I, et al. First Pass Effect: A New Measure for Stroke Thrombectomy Devices. Stroke. 2018;49(3):660-666. doi:10.1161/STROKEAHA.117.020315. Available: https://www.ahajournals.org/doi/10.1161/STROKEAHA.117.020315?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Accessed May 16, 2025.
2 Modified treatment in cerebral infarction (mTICI) is the measure of revascularization of a patient’s brain.
3 Stroke Facts. U.S. Centers for Disease Control. Available: https://www.cdc.gov/stroke/data-research/facts-stats/index.html. Accessed May 15, 2025.
4 Cerebrovascular Disease or Stroke. U.S. Centers for Disease Control, National Center for Health Statistics. Available: https://www.cdc.gov/nchs/fastats/stroke.htm. Accessed May 15, 2025.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af21cb3e-ff19-48d8-bd76-093e2dd532e4
SAN MATEO, Calif., May 06, 2025 (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 dispute between Route 92 Medical and Q’Apel Medical has been resolved. Route 92 Medical initially filed suit against Q’Apel Medical in the U.S. District Court for the District of Delaware in October 2024 alleging infringement of five U.S. patents protecting its portfolio of Tenzing® delivery catheters by the Q’Apel Hippo aspiration system and Cheetah delivery tool. Q’Apel Medical has removed the Hippo – Cheetah product from the market permanently.
“We are pleased with the resolution of this litigation,” said Tony Chou, M.D., founder and chief executive officer of Route 92 Medical. “With more than 140 patents protecting our innovations worldwide, and numerous studies showing the best-in-class performance of our Tenzing-powered neurovascular intervention solutions, we remain committed to vigorously defending our intellectual property position should companies seek to replicate our products.”
Tenzing delivery catheters, first used clinically in 2019, are protected by a global portfolio of patents including 26 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 guidewire. 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.
To learn more about Route 92 Medical, 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.
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.