Route 92 Medical Announces Results of SUMMIT MAX Clinical Trial Showing Highest First Pass Effect Ever Reported in a Randomized Endovascular Stroke Thrombectomy Study

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

/EIN News/ -- 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
gwen@gwengordonpr.com

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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