Dora Do, Author at Route 92 Medical

SAN MATEO, Calif., August 7, 2025 — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, filed a patent infringement lawsuit against Balt USA, LLC (Balt) alleging infringement of five U.S. patents held by Route 92 Medical that protect the Tenzing^® delivery technology. The complaint was filed on August 5, 2025, in the U.S. District Court for the District of Delaware.

“We believe Route 92 Medical has a differentiated portfolio of complete solutions for neurovascular interventional procedures each supported by our proprietary and patented Tenzing delivery technology,” said Tony Chou, M.D., Founder and Chief Executive Officer of Route 92 Medical. “Results using our products published in peer-reviewed journals demonstrate high rates of ability to reach and remove a clot on the first pass. These publications include both our FreeClimb^® reperfusion systems and HiPoint^® reperfusion systems featuring the Monopoint^® approach, all featuring Tenzing delivery technology. We believe the market success of these products is a testament to the clinical outcomes that are achieved with their use. We will continue to vigorously defend the patents that protect our innovations worldwide.”

Tenzing delivery technology is currently protected by a global portfolio of patents, including over 30 U.S. patents. Tenzing catheters offer a soft and tapered tip designed to minimize ledge effect and to provide atraumatic tracking in the neurovasculature without the use of a microcatheter. The Tenzing delivery catheters are available in three sizes, each designed to be delivered together with Route 92 Medical’s HiPoint or FreeClimb catheters as part of a seamless system to enhance the efficacy of neurovascular procedures. These devices have been evaluated in physician-initiated, 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 Monopointfamily, including its Tenzing delivery technology.

As part of its ongoing innovation program, Route 92 Medical recently announced results from its SUMMIT MAX clinical trial (NCT05018650), which represents the highest level of clinical evidence as the only prospective, randomized, controlled, endovascular stroke thrombectomy trial of a super-bore catheter. The 250-patient, multicenter, trial evaluated the safety and efficacy of the HiPoint reperfusion system, which included a “super-bore” aspiration catheter with an 0.088-inch inner diameter, for the treatment of a large vessel occlusion, the cause of many acute ischemic strokes. The clinical trial showed delivery of the HiPoint 88 aspiration catheter to the M1 segment of the middle cerebral artery (MCA) using the Tenzing delivery technology was achieved 90.1% of the time compared to the smaller 0.074-inch control catheter, which reached the M1 segment 71.6% of the time. In the trial, the R92 arm achieved the highest first pass effect rates reported in a randomized controlled trial with a consistent safety profile.

In May 2025, the company announced receipt of U.S. Food and Drug Administration 510(k) clearance for its HiPoint 88 reperfusion system, which allows direct aspiration of the thrombus with the HiPoint 88 aspiration catheter.

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for acute ischemic stroke patients undergoing neurovascular intervention and reduce suffering for these patients and their families by consistently reaching the clot, increasing first pass effect rates and simplifying the procedure with our systems. 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]

Company also announces new 500-patient SUMMIT RISE study at the Society of NeuroInterventional Surgery annual meeting

SAN MATEO, Calif., July 14, 2025 (GLOBE NEWSWIRE) – Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced results from an independent, real-world study evaluating reperfusion outcomes following use of Route 92 Medical’s HiPoint® Reperfusion System, the first and only FDA-cleared 0.088” reperfusion catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischemic stroke. The study will be presented today by Daniel Tonetti, M.D., M.S., Director, Cerebrovascular Neurosurgery, Cooper University Health Care, at the Society of NeuroInterventional Surgery 22nd Annual Meeting being held in Nashville, Tennessee.

The retrospective, multicenter study collected outcomes data from 193 consecutive patients treated with Route 92 Medical’s HiPoint Reperfusion System who were not part of the SUMMIT MAX trial. The primary endpoints were first-pass effect of mTICI 2c/3 (a measure of clot removal) and first-pass effect, defined as mTICI 2b/2c/3 reperfusion on the first aspiration pass, with secondary endpoints including rate of successful aspiration catheter delivery, number of passes for final reperfusion, and conversion to other systems or devices.

Key study findings include:

Clinicians successfully delivered the HiPoint Reperfusion System to the stroke-causing occlusion in 96.2% of cases.
The primary endpoint of first-pass effect mTICI 2c/3 was achieved in 57.5% of cases.
The primary endpoint of first-pass effect of mTICI 2b/2c/3 was achieved in 68.4% of cases.
Median number of passes was 1.

“We believed it was important to study the clinical utility of Route 92 Medical’s HiPoint Reperfusion System as a first-line aspiration tool in a real-world environment,” said Dr. Tonetti. “As in SUMMIT MAX and in the SLIC publication, we observed strong delivery and first pass effect data, as well as low complication rates. We’d expect these metrics to continue to improve as more clinicians and sites gain experience with the technology.”

Route 92 Medical also introduced SUMMIT RISE, a prospective 500-patient study to evaluate the efficacy of Route 92 Medical’s portfolio of neurovascular interventional solutions across a wide range of cases. The prospective, core-lab-adjudicated study will begin immediately under the leadership of co-primary investigators Sunil Sheth, M.D., Associate Professor and Director, Vascular Neurology Program at the McGovern Medical School at University of Texas, Houston, Christopher Kellner, M.D., Neurosurgeon at Mt. Sinai Health System, and Albert Yoo, M.D., Medical Director and Director of Research and Technology, Medical City Texas Stroke Institute.

“As with all new medical technologies, it’s critically important to develop independent, real-world evidence to guide future clinical decision-making,” said Dr. Sheth. “By collecting and analyzing data prospectively and having all cases reviewed through an independent adjudication process, the SUMMIT RISE study will enable us to evaluate the effectiveness of Route 92 Medical’s neurovascular interventional devices in real world clinical use and provide insights into technique optimization and performance.”

“We believe the evidence base supporting the use of Route 92 Medical’s technologies in neurovascular interventional procedures continues to grow. With each new study, there is additional support for the use of our Tenzing-based intervention approach, showing its ability to safely and effectively reach and aspirate clots, while improving first-pass effect relative to other catheter products,” said Tony Chou, M.D., founder and chief executive officer at Route 92 Medical. “With SUMMIT RISE, we plan to evaluate patient outcomes over time, across devices and sites, and to provide additional data showing that our tools achieve clinical objectives and help give patients the best opportunity to recover from acute ischemic stroke.”

The HiPoint Reperfusion System is comprised of the HiPoint 88 Reperfusion Catheter, Tenzing® 8 Delivery Catheter, HiPoint 70 Reperfusion Catheter, 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 is designed to facilitate atraumatic navigation through tortuous anatomy, offering clinicians the flexibility to deliver vessel-matched, large- and super-bore catheters to the M1 and the ICA/ICA-T occlusions, while enabling the rapid and efficient removal of large vessel occlusions, the cause of many acute ischemic strokes.

There are approximately 800,000 total ischemic stroke episodes in the United States each year, 87% of which are ischemic strokes, in which blood flow to the brain is blocked. 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 United States, responsible for approximately 163,000 deaths annually.

To learn more, visit www.r92m.com.

About Route 92 Medical, Inc.
Route 92 Medical is on a mission to improve outcomes for acute ischemic stroke patients undergoing neurovascular intervention and reduce suffering for these patients and their families by consistently reaching the clot, increasing first pass effect rates and simplifying the procedure with our systems. 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 Stroke Facts. U.S. Centers for Disease Control. Available: https://www.cdc.gov/stroke/data-research/facts-
stats/index.html. Accessed May 15, 2025.

² 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.

SAN MATEO, Calif., June 18, 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 election of Mitch Hill and Lucas Buchanan to its Board of Directors. The appointment of these industry veterans will bring critical operational and financial experience to the Route 92 Medical Board of Directors as the company continues to commercialize its differentiated portfolio of neurovascular solutions.

Mr. Hill is a seasoned healthcare executive with a strong track record of guiding high-growth, venture-backed companies through key inflection points in the corporate life cycle. Most recently, he served as Senior Business Advisor and Chief Financial Officer of Inari Medical, where he was instrumental in the company’s rapid expansion and eventual $4.9 billion acquisition by Stryker Medical. Before joining Inari, he served as Chief Financial Officer for a number of technology, medical device, and healthcare services companies. He also serves on the Board of Directors for CVRx, Inc. and The Glaucoma Foundation. Mr. Hill holds a BS in Business Accounting from Brigham Young University and an MBA from Harvard Business School.

“Route 92 Medical is entering a pivotal phase as it scales both operationally and commercially,” said Mitch Hill. “The opportunity to support the leadership team in building out robust financial and strategic infrastructure is compelling, particularly as the company continues to expand access to its technologies globally.”

Mr. Buchanan is an experienced medtech executive and investor with deep expertise in scaling healthcare companies across both operational and strategic roles. Most recently, he was Chief Financial Officer and Chief Operating Officer at Silk Road Medical, where he helped scale the company from inception through its $1.3 billion sale to Boston Scientific. His background includes leadership roles at The Vertical Group, Impax Laboratories, Medtronic, and Ernst & Young. He also serves on the Board of Directors for Aerin Medical, Inc., Procyrion, Inc., and Endologix LLC and is a strategic advisory board member of CRG LP. He holds a BA in Economics from Duke University and an MBA from The Wharton School at the University of Pennsylvania.

“Route 92 Medical has established a strong foundation with its differentiated approach to stroke intervention,” said Lucas Buchanan. “I look forward to contributing to the company’s continued focus on execution, advancing clinical adoption, optimizing reimbursement strategies, and driving disciplined commercial growth.”

“Mitch and Lucas each bring decades of leadership experience across high-growth medtech companies,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “They understand firsthand the challenges and opportunities that come with scaling innovation in complex healthcare markets, from building the operational backbone needed for sustainable growth to aligning strategy with clinical and commercial execution. Their insights will help strengthen our foundation as we expand access to our technologies and advance the standard of care in 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.r92m.com or follow the company on LinkedIn.

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

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.

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).¹Physicians 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.³Such 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

¹Goren, 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.
²Chen, 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 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.