Jul 11, 2023

Cagent Vascular announces initial RECOIL Study results: Serranator demonstrates 49% less recoil than POBA in BTK arteries

BUSINESS WIRE: July 11, 2023. (Wayne, PA)

Cagent Vascular, the exclusive developer of serration technology for vessel dilatation in endovascular interventions, announced the results of its Below-the-Knee (BTK) RECOIL study. This Core Lab-Adjudicated Recoil analysis, the first of its kind, evaluated vessel recoil in lesions treated with Serranator® verses Plain Old Balloon Angioplasty (POBA). The study results demonstrated that lesions treated using Serration Angioplasty exhibited 49% less average recoil than POBA. Dr. Stefan Stahlhoff, MD (Arnsberg Clinic, Arnsberg, Germany) and Dr. Venita Chandra (Stanford University, Stanford, CA USA) led the RECOIL study as co-principal investigators.

The Serranator PTA Serration Balloon Catheter (Serranator) is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). The device is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.

Thirty-six subjects with 39 lesions up to 22cm in length were matched 1:1 using either the Serranator or POBA. The study objectives were to assess the ability to define and measure post treatment recoil in infrapopliteal arteries and to show preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection. In each procedure the lumen diameter was measured immediately post angioplasty and then again at 15 minutes post inflation. The degree of vessel recoil was assessed angiographically and then corelab adjudicated. These data showed a mean percent recoil of only 6% in the Serranator group versus 55% in the POBA group representing a 49% reduction in recoil using serration angioplasty. Notably, there were no flow limiting dissections in either lesion treatment group, suggesting that optimal inflation technique impacts dissection rates, but not recoil rates.

“The recoil phenomenon is well understood as one of the greatest headwinds to successful BTK treatment and ultimately wound healing,” stated Dr. Michael Lichtenberg who participated in the study. “The 49% difference demonstrated in the RECOIL study between Serranator® and POBA is statistically significant and in my view also clinically relevant. Wound healing requires a durable lumen to support brisk blood flow, and 55% recoil for POBA treated lesions is a signal that our current 40-year POBA standard therapy is inadequate. I believe this study is a further step in demonstrating Serration Angioplasty as a definitive treatment for BTK lesions.”

Dr. Chandra added, " We know that BTK interventions are highly susceptible to vessel recoil, however the impact of recoil on residual stenosis at 15-minutes post procedure makes the true severity of this challenge clear. Our CLTI patient population is particularly vulnerable and at greater risk of limb loss and the associated increase in mortality that accompanies amputation. While this initial RECOIL study did not follow patient outcomes, in the future we intend to evaluate how impactful Serration Angioplasty’s recoil improvement is to healing BTK wounds and saving limbs. The results from this comparative RECOIL study are indicative that Serration Angioplasty may be the tool that finally addresses this longstanding challenge with POBA."

Carol A. Burns, President and CEO of Cagent Vascular stated, “We’re very encouraged and humbled by the results of this study. We believe Serration Angioplasty can move the needle for this critical community of patients. Prior studies have shown the positive impact this novel technology can have towards achieving a greater lumen with fewer complications, and ultimately providing more blood flow to support wound healing. We look forward to understanding how this technology may enhance longer term patient outcomes.”

About Cagent Vascular

Cagent Vascular's vision is to be the leader for treating atherosclerotic disease with the first and only serration balloon technology to restore blood flow. It is the second cardiovascular company formed by co-founders Carol Burns, President and CEO, Peter Schneider, MD, Vascular Surgeon, Chief Medical Advisor and Robert Giasolli, Chief Technology Officer. The team previously co-founded Intact Vascular.

The information contained herein obtained from Cagent Vascular management is believed to be reliable. This does not constitute the solicitation of the purchase or sale of securities. Except for historical information contained herein, matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties.

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