Cagent Vascular Raises $11.87M to Fund the Growth and Expansion of the Serranator Family of Percutaneous Transluminal Angioplasty (PTA) Serration Balloon Catheters

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular®, a developer of next generation angioplasty balloons using proprietary serration technology, announced the completion of $11.87 million in Series B funding. The round was led by two strategic investors including one that participated in the Series A financing. Additional participants included Balestier Investments, Ben Franklin Technology Partners1, Synergy Ventures, and other private investors. Proceeds will be used to scale manufacturing and initiate a limited launch of Cagent Vascular’s first product, the Serranator® Alto. Further uses of proceeds include supporting development efforts to build upon existing confirmatory data, expanding indications, and receiving additional regulatory clearances. The next product in the Serranator family of PTA serration balloon catheters will be the Serranator Bass, for use in infrapopliteal arteries.

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Cagent Vascular Presents Positive Results from the PRELUDE Study at LINC 2018

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular interventions announces positive results from the First-in-Human PRELUDE Study. Dr. Andrew Holden (Auckland, New Zealand), Principal Investigator, presented 30-day and preliminary 6-month results using the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter at the Leipzig Interventional Course last week.

The PRELUDE Study is a prospective, single-arm, multicenter feasibility study designed to show safety and efficacy of the Serranator® device used in critical lesions in the superficial femoral artery (SFA) and/or popliteal arteries. The study enrolled 25 subjects at centers in New Zealand and Europe.

“The fascinating part of the trial is that although we had patients, by definition, who were excluded with severe calcification, there was a significant core lab adjudicated group of persons who had lesions with moderate to severe calcification. We could achieve luminal gain to nominal using very low pressures in that subgroup which tells us that this is something quite different from plain balloon angioplasty. Not only being able to dilate these vessels to nominal, which is an achievement on its own, but to do it without a significant incidence of dissection is an achievement. Although the numbers are small this is a really encouraging sign that the serration mechanism of action is a very different way of treating the artery,” said Dr. Holden.

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Incorporating Serration Technology into a 40-year old Procedure

Angioplasty has been around for 40 years.  This procedure, which is used to restore blood flow in blocked arteries, has needed an upgrade for decades.  EuroPCR, the largest Interventional Cardiology conference in the world, is celebrating 40-Years of Angioplasty next month in Paris.  However, despite angioplasty’s long history, angioplasty balloons have not evolved enough to keep up with the changing landscape of arterial intervention, until now.

Serranator™ Alto PTA Serration Balloon Catheter

Cagent Vascular (Wayne, PA) received FDA 510(k) Clearance in February for the Serranator™ Alto PTA Serration Balloon Catheter for treatment of stenotic lesions in the leg arteries located above the knee.   The device has four stainless steel serrated strips embedded on the outside of the balloon.  The Serranator™ is the one and only FDA cleared balloon with Serration Technology designed to create linear, interrupted scoring inside the artery to aid arterial expansion. Fortunately for physicians, the Serranator™ is built on the same simple, familiar, easy-to-use platform as standard angioplasty.  The Serranator™ Alto is intended for use in the iliac, femoral, ilio-femoral and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today, we are treating more complex lesions that require better tools.  We believe Serration Technology will prove to be effective in treating these complex lesions and will evolve into the new standard of care for vessel dilatation,” says Co-Founder and Vascular Surgeon Peter Schneider, MD.

“The concept of creating serrations is used across multiple industries. However, what is new is applying it to angioplasty. The Serranator™ is designed to create multiple longitudinal lines of interrupted micro-serrations to enable arterial expansion along those lines.”

Peripheral Artery Disease (PAD)

Peripheral artery disease (PAD) affected over 19 million people in the US in 2016[1].  PAD is caused by the build-up of plaque within the peripheral arteries, most commonly the leg arteries.  Atherosclerotic plaque within the artery walls can limit blood flow, therefore causing claudication or pain when walking.  Common treatments for PAD range from changes in diet and exercise to percutaneous transluminal angioplasty (PTA).  If PAD is left untreated, patients can develop critical limb ischemia (CLI) and in the most extreme cases, can lead to tissue loss and amputation.

Eighty two percent of physicians surveyed “strongly agree” that the peripheral arteries they are treating today are more complex than ten years ago. [2]  Lesion complexity usually refers to the length of disease and the amount of calcium or hard plaque found inside the vessel.  Increased rates of diabetes, obesity, and the aging population contribute to the rise of challenging PAD cases.

Patients with PAD will likely undergo an angioplasty procedure.  However, plain balloon angioplasty has its limits and doesn’t always produce a positive, long lasting result.  Flow-limiting dissections and residual stenosis are two of the most common negative effects of plain balloon angioplasty and often require the placement of a stent.  Plain angioplasty has proven itself in simpler lesions but isn’t enough for more challenging lesions that are calcified and longer in length.  New technologies like the Serranator™ will expand treatment options for physicians and have the potential to change the standard-of-care for the treatment of peripheral lesions.

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[1] Guggenheim Report, 2017.

[2] Cagent Vascular Marketing Research Survey, 2016.