Simpson Interventions Announces First Patients Treated in Clinical Trial for its Acolyte™ Catheter System

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CAMPBELL, Calif.--(BUSINESS WIRE)--Aug 14, 2025--

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image-Guided Crossing and Re-Entry Catheter System has been successfully used to treat the first patients in the Acolyte™ study, a pivotal IDE clinical trial designed to assess the safety and effectiveness of the system in treating coronary chronic total occlusions (CTOs) with persistent symptoms following medical therapy.

“Our team is thrilled to have successfully treated the first patients with the Acolyte System,” said Dr. Bill Nicholson, Director of Interventional Cardiology for Emory University and primary operator on the first cases. “The ability to clearly visualize the CTO in real-time and precisely position a guidewire with the same device potentially represents an important leap forward in efficiently and predictably treating coronary CTOs.”

“We are pleased to be the first site to treat a patient in this important trial,” added Dr. Wissam Jaber, Medical Director of Cardiac Catheterization Laboratory at Emory University Hospital and Principal Investigator for the Acolyte Study. “CTOs have long been regarded as ‘the final frontier’ of PCI due to their inherent complexity and lack of suitable devices. The Acolyte System represents a promising approach to enable interventional cardiologists to more effectively, consistently and safely treat these complex lesions, potentially allowing more patients to benefit from a minimally invasive PCI approach.”

According to the Journal of the American College of Cardiology: Cardiovascular Interventions, sixteen to twenty percent of patients with coronary artery disease have CTOs 1, which occur when a coronary artery is completely blocked by plaque buildup, posing significant challenges for interventional cardiologists who currently lack effective tools to reliably cross these lesions with current standard of care options. If a CTO cannot be crossed with an interventional wire, minimally invasive revascularization options such as angioplasty and stent placement cannot be performed. Hence, many CTO patients are instead sent for invasive coronary artery bypass (CABG) surgery or are left treated with medical therapy alone. The Acolyte Real-time Image-Guided Crossing and Re-Entry Catheter System is designed to overcome the current challenges. The technology is designated by the FDA as a Breakthrough Device and has enrolled in the FDA Total Product Life Cycle Advisory Program (TAP), which is focused on developing high-quality, safe, effective, and innovative devices critical to FDA’s public health mission.

"We are excited to have enrolled the first patient in this pivotal trial for our novel technology,” said Dr. Joseph Knight, Chief Executive Officer of Simpson Interventions. “The goal for all interventional cardiologists is to treat every patient with the safest and most predictable and minimally invasive approach. We believe that the Acolyte System will provide the medical community with a valuable tool to conquer CTOs, which will, most importantly, be a win for cardiologists, hospitals, payers, and most of all, the patients.”

For more information about Simpson Interventions and its innovative medical technologies, please visit www.simpsonint.com.

About Simpson Interventions:

Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements about the efficacy and safety of the Acolyte System, and reflects Simpson Interventions’ current belief and expectations. However, as with any medical device, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that the Acolyte System will receive additional regulatory approvals, or that Simpson Interventions will execute its strategy as planned.

For more information: www.simpsonint.com

1https://www.jacc.org/doi/10.1016/j.jcin.2021.09.027

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CONTACT: Media Contact:

Steve Kelly

Simpson Interventions

Email:[email protected]

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES CLINICAL TRIALS RESEARCH SCIENCE CARDIOLOGY BIOTECHNOLOGY

SOURCE: Simpson Interventions, Inc.

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PUB: 08/14/2025 10:00 AM/DISC: 08/14/2025 10:02 AM

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