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New global patents protect Route 92 Medical’s ongoing innovation as the company works to  address critical unmet needs in neurovascular treatment 

WEST JORDAN, UTAH — Route 92 Medical, Inc., a privately held medical technology company  dedicated to improving outcomes for patients undergoing neurovascular intervention, today  announced the company’s 200th global issued patent for its innovative neurovascular  intervention product portfolio. Route 92 holds intellectual property across a range of solutions for  neurovascular interventional procedures including the HiPoint® Reperfusion Systems and  FreeClimb® Reperfusion Systems, both powered by its Tenzing® Delivery Catheter. 

Among the recently issued patents are U.S. Patent No. 12,622,713, entitled “Methods and  Systems for Treatment of Acute Ischemic Stroke,” which relates to the delivery of a large-bore  intracranial catheter with a tapered tip delivery catheter to an intracranial occlusion, and U.S  Patent No. 12,582,802, entitled “Aspiration Catheter Systems and Methods of Use,” which  relates to the company’s ASCENTTM aspiration technique for removal of clot by maximizing clot  engagement and optimizing catheter positioning at the clot with the use of the Company’s  Tenzing® Delivery catheter. These are techniques core to the single-operator Monopoint® approach to neurovascular intervention.  

“Route 92 Medical set out to revolutionize neurovascular intervention—and we’ve done it,” 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 range of solutions we’ve brought to the market, covered by our robust patent  portfolio and the strength of our clinical data, are testaments to our success in addressing the  patient and market need for simple, effective tools to improve stroke care.” 

The company’s neurovascular portfolio includes the HiPoint 88 Reperfusion System, featuring  the Monopoint approach, the first “super-bore” aspiration catheter with a mono-axial procedural  approach and a 0.088-inch inner diameter FDA-cleared for the treatment of large vessel  occlusions, the cause of many acute ischemic strokes. It joins a suite of purpose-built stroke  treatment solutions including the HiPoint 70 Reperfusion System, FreeClimb 70 Reperfusion  System, FreeClimb 54 Reperfusion System, and the FreeClimb 88 Access System all powered  by Tenzing Delivery Catheters and supported by the Base Camp® Sheath System. 

“Route 92 continues to innovate and expand our global intellectual property portfolio, and we  are committed to a vigorous defense of our patent rights against all those who infringe,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “Our core technologies,  including Tenzing and Monopoint, have established a strong and growing beachhead for Route  92 in ischemic stroke. However, they have potential to offer similar benefits in many other areas,  and we look forward to helping improve clinical outcomes for patients across neurovascular  care.”  

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 25 patents issued so far in 2026, including patents with claims across the  company’s product portfolio. A list of the company’s U.S. patents is available at  www.route92medical.com/patents. 

About Route 92 Medical, Inc. 

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular  intervention through cutting-edge engineering, innovative product design and revolutionary  procedural change. 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 
[email protected] 

Procedures follow Health Canada Medical Device License for the Company’s advanced  neurovascular portfolio

More than 100,000 patients suffer from strokes annually in Canada  

WEST JORDAN, UTAH – (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held  medical technology company dedicated to improving outcomes for patients undergoing  neurovascular intervention, today announced the first commercial cases in Canada. The  procedures follow receipt of a Health Canada Medical Device License for the Company’s  portfolio of advanced neurovascular technologies.  

Route 92 Medical’s HiPoint® 88 system featuring the unique Monopoint® approach was used in  the first commercial Canadian procedures by Vitor Mendes Pereira, M.D., at St. Michael’s  Hospital in Toronto, one of Canada’s leading neurovascular centers. 

“In the cases we performed, Route 92 Medical’s platform enabled smooth, atraumatic navigation  through complex neurovascular anatomy and successful delivery of implants to the target  vessels,” said Vitor Mendes Pereira, M.D., Professor of Surgery and Medical Imaging at the  University of Toronto and Director of Endovascular Research and Innovation at St. Michael’s  Hospital. “The ability to advance the system without guidewires from a single point of control  simplifies access and supports procedural efficiency. Moreover, the telescoping design coupled  with the Tenzing delivery catheter allows for atraumatic navigation, particularly in challenging  anatomy.” 

More than 100,000 patients suffer from strokes annually in Canada, including acute ischemic  strokes, many of whom could benefit from endovascular treatment. The country’s established  neurovascular treatment infrastructure and reimbursement pathways provide a significant  commercial opportunity for Route 92 Medical’s differentiated portfolio. 

“Receiving Health Canada authorization marks an important milestone in Route 92 Medical’s  international expansion and enables us to bring our differentiated neurovascular intervention  platform to physicians and patients across Canada,” said Tony Chou, M.D., founder and Chief  Executive Officer of Route 92 Medical. “We are particularly encouraged by the successful first  clinical experience at St. Michael’s Hospital and look forward to supporting Canadian physicians  treating patients with acute ischemic stroke and other neurovascular conditions.” 

The Canadian regulatory authorization covers the company’s product portfolio, including: 

• HiPoint 70/Tenzing® 7 Reperfusion System 

• HiPoint 88/Tenzing 8 Reperfusion System 

• FreeClimb® 54/ Tenzing 5 Reperfusion System 

• FreeClimb 70/Tenzing 7 Reperfusion System 

• Base Camp® Sheath System 

For more information about Route 92 Medical, visit www.r92m.com.

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]

May 18, 2026, 8 a.m. EST

WEST JORDAN, Utah— Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the appointment of Raj Denhoy to the role of Chief Financial Officer (CFO) effective today. 

“Route 92 Medical has built a strong position in neurovascular intervention,” said Raj Denhoy, CFO at Route 92 Medical. “The company’s innovative technologies, the talented team, and, most importantly, the dedication to the mission of improving patient outcomes, set it apart. I could not be more excited to join the company and look forward to contributing to its continued success.”

Raj Denhoy has more than 25 years of experience in medical technology, both as a CFO and as a top-ranked equity research analyst. He joins Route 92 Medical from Establishment Labs Holdings Inc. (Nasdaq: ESTA) where he served as CFO for five years and was responsible for finance, strategy, and investor relations. Mr. Denhoy was previously a managing director and senior medical device equity research analyst with Jefferies LLC, and held medical device equity research analyst positions with leading banks including J.P. Morgan Securities LLC, and Piper Sandler & Co., among others. Mr. Denhoy holds a BA in Biology from the University of California, Berkeley, an MS in Human Physiology from Georgetown University, and an MBA from the Johnson Graduate School of Management at Cornell University.

“Raj is an accomplished financial leader with deep strategic and operational experience across medical device organizations,” said Tony Chou, M.D., Founder and CEO at Route 92 Medical. “His proven track record in corporate finance and in leading multinational finance teams will be invaluable as we continue to grow Route 92 Medical. I am delighted to welcome him to the company and look forward to working closely with him as we advance our mission to transform neurovascular intervention.”

About Route 92 Medical, Inc.

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.route92medical.com or follow the company on LinkedIn.

Media ContactGwen Gordon
[email protected]

New investor Sectoral Asset Management joins growth financing round to support acceleration of commercial growth

WEST JORDAN, Utah— Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced a $50 million growth financing. New investor Sectoral Asset Management joined lead investor Novo Holdings and returning investors U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and The Vertical Group in the financing round. 

Proceeds from the financing will support the next phase of Route 92 Medical’s growth strategy by helping to accelerate global commercial expansion, advance clinical evidence to support broader adoption of the company’s neurovascular procedural approach and invest in continued product innovation across its platform.

“We’ve seen rapid growth in the adoption of our products over the past year, attributable to the clinical performance of our Monopoint approach, and the growth and dedication of our commercial organization,” said Tony Chou, MD, Chief Executive Officer and Founder of Route 92 Medical. “We’re on a mission to improve outcomes for patients suffering from acute ischemic stroke and our rapidly growing sales are a testament to the differentiated, physician-preferred attributes of our neurovascular thrombectomy solutions.”

“We believe Route 92 Medical is positioned for long-term growth with robust manufacturing capacity, a clearly defined market, and a well-differentiated product portfolio,” said Michael Sjöström, CFA, Co-Founder and Partner of Sectoral Asset Management. “Our investment aims to accelerate its commercial growth, helping the company reach many more hospitals and patients.” 

The company’s neurovascular portfolio includes the HiPoint® Reperfusion System, featuring the Monopoint® approach, the first “super-bore” aspiration catheter with a mono-axial procedural approach and a 0.088-inch inner diameter FDA-cleared for the treatment of large vessel occlusions, the cause of many acute ischemic strokes. It joins a suite of purpose-built stroke treatment solutions including the HiPoint 70 Reperfusion System, FreeClimb® 70 Reperfusion System, FreeClimb 54 Reperfusion System, and the FreeClimb 88 Access System. 

This news follows the completion of the company’s SUMMIT MAX clinical trial (NCT05018650), a 250-patient, multicenter, prospective, randomized, and controlled endovascular stroke thrombectomy trial evaluating the safety and efficacy of the HiPoint Reperfusion System featuring the Monopoint approach. Data from the trial demonstrated favorable safety performance and the highest first pass effect ever reported in a randomized, controlled endovascular stroke thrombectomy study. The investigational device exemption (IDE) trial results were submitted to the FDA and, in May 2025, the HiPoint Reperfusion System received neurothrombectomy marketing clearance from the FDA. Accordingly, Route 92 Medical is the first neurovascular intervention company to receive clearance for direct aspiration of a stroke-causing thrombus with a super-bore 0.088-inch catheter in the neurovasculature. The company’s 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. 

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.

Media Contact

Gwen Gordon
[email protected]

SUMMIT RISE is expected to enroll up to 500 patients to evaluate the performance of Route 92 Medical’s neurovascular intervention device portfolio

WEST JORDAN, Utah, March 9, 2026 – (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced enrollment of the first patient in SUMMIT RISE (NCT07436156), a prospective 500-patient real-world post-clearance study to evaluate the performance of Route 92 Medical’s portfolio of neurovascular interventional solutions across a variety of stroke scenarios and vessel sizes. The study is expected to enroll patients at 50 clinical centers, including academic medical centers and community hospitals.

“We developed our portfolio of complete neurovascular interventional systems with one goal – improving outcomes for patients being treated for acute ischemic stroke,” said Tony Chou, M.D., Founder and Chief Executive Officer of Route 92 Medical. “Building from our prior studies and trials, including SUMMIT MAX, we expect SUMMIT RISE to give us comprehensive data across anatomies, physician users, devices, patients and clinical sites, enabling us to evaluate and collect wide-ranging data on the family of Route 92 Medical reperfusion systems including the HiPoint 88 reperfusion system, the only FDA-cleared super-bore catheter system for direct aspiration of large vessel occlusions in patients experiencing an acute ischemic stroke.”

SUMMIT RISE is a prospective, multi-center, open-label, core-lab-adjudicated study to assess real-world performance of the Route 92 Medical reperfusion systems that is being led by 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 Kelner, 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. “The SUMMIT RISE study is designed to collect and analyze data prospectively, and review all cases through an independent adjudication process, to impartially evaluate the effectiveness of Route 92 Medical’s devices across a range of patient presentations, clinician experience levels, and health system settings,” said Sunil A. Sheth, MD, Associate Professor of Neurology at UTHealth McGovern Medical School and co-primary investigator of SUMMIT RISE. “We hope these data elucidate insights that support technique optimization, ultimately improving device
performance and patient outcomes.”

“New medical technologies require rigorous, independently-developed, real-world evidence to support their widespread adoption,” said Robert Regenhardt, M.D., Ph.D., Assistant Professor of Neurology at UTHealth McGovern Medical School and the first to enroll a patient in SUMMIT RISE. “The data we collect in this study will enable the refinement of clinical best practices for stroke treatment.”

For more information about Route 92 Medical’s devices and clinical evidence, 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]

San Mateo, CA / West Jordan, UT, November 6, 2025 — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the election of Pat Mackin to its Board of Directors. His appointment brings deep commercial, operational, business development, and executive leadership experience in medical technology companies to Route 92 Medical’s Board of Directors as the company continues to grow its differentiated portfolio of neurovascular solutions globally. 

“Pat has a strong track record as a seasoned and strategic leader of medical technology companies, helping them catalyze new markets and scale internationally,” said Tony Chou, Chief Executive Officer and Founder at Route 92 Medical. “His experience building successful commercial and operational teams will support our growth as we advance a new standard of care for patients experiencing acute ischemic stroke.”

Mr. Mackin is an experienced medical technology executive with a strong track record in the vascular and cardiac care spaces at both privately held and public companies. He serves as President and CEO of Artivion, a publicly traded medical device company focused on the treatment of aortic diseases. Previously, he held senior executive roles at Medtronic in the U.S. and Europe, including Vice President of vascular/endovascular and subsequently President of cardiac rhythm disease management, the company’s largest business unit. He also held senior roles at Genzyme prior to its acquisition by Sanofi and served as an officer in the U.S. Army. In addition to Artivion, Mr. Mackin has served on the Board of Directors at Wright Medical Group (acquired by Stryker) and Opsens Medical (acquired by Haemonetics). He holds a Bachelor of Science in engineering from the United States Military Academy at West Point and a Master’s in management from the Kellogg Graduate School of Management at Northwestern University. 

“Route 92 has pioneered a novel set of solutions that dramatically simplify complex stroke treatment procedures,” said Pat Mackin. “I look forward to working with their leadership team to support the commercial and operational organizations to facilitate long-term growth.” 

Pat joins a robust Board of Directors with the recent additions of directors Mitch Hill (former CFO, Inari Medical) and Lucas Buchanan (former COO and CFO, Silk Road Medical), skilled medtech leaders with operational and financial management prowess. The Board of Directors also includes Jack W. Lasersohn (The Vertical Group), Jonathan Root (U.S. Venture Partners), Casper de Clercq (Norwest Venture Partners), Ariella Golomb (InnovaHealth Partners), and Noel Jee (Novo Holdings). It is chaired by Route 92 Medical’s CEO, Tony Chou.

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] 

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 Monopoint family, 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:

“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.

Hipoint_088_Reperfusion_System

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:

“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:

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]

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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