H.I.G. Capital News

Intact Vascular Closes on Additional Series B Funding to Advance Development of the Tack Endovascular System® for Peripheral Artery Disease Treatment

WAYNE, PA - January 3, 2017 - Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that current investors New Enterprise Associates, Quaker Partners and H.I.G. BioHealth Partners have exercised their right to invest additional capital as part of the Company’s Series B financing, bringing the total raised to $46 million. The Series B financing initially closed in May 2015. The funds will be used to advance the Company’s broad clinical development program, encompassing both above-the-knee (ATK) and below-the-knee (BTK) clinical trials, as well as a host of product development initiatives aimed at expanding the utility of the Tack Endovascular System for the treatment of peripheral artery disease.

The Tack Endovascular System is a new, endovascular technology for repairing arterial dissections following percutaneous transluminal angioplasty (“PTA”). The Tack® system permits highly targeted repair of diseased arteries, while minimizing the metal left behind and inflammation of the artery wall, both of which are significant problems associated with the current method of dissection repair: stenting.

Intact Vascular is currently sponsoring three large, international clinical trials: Tack Optimized Balloon Angioplasty II (“TOBA II”), TOBA II BTK, and TOBA III. TOBA II and TOBA III are investigating the safety and efficacy of the Tack system in the treatment of ATK peripheral artery disease in combination with both PTA and drug coated angioplasty balloons. TOBA II BTK is focused on use of the Tack system in conjunction with PTA to treat BTK peripheral artery disease, which is also known as Critical Limb Ischemia or “CLI”. The TOBA II BTK trial is the first pivotal trial approved by the Food and Drug Administration (“FDA”) for the treatment of CLI with a vascular implant below the knee. See http://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s clinical development program.

Peripheral arterial disease (“PAD”) impacts more than 200 million people worldwide and more than 19 million people in the U.S. The prevalence of PAD among American adults exceeds that of coronary heart disease, and its growth is being driven by the triad of obesity, diabetes and advancing age.

“We welcome the additional investment from our investors and greatly appreciate their vote of confidence in us,” said Bruce Shook, Intact Vascular’s President and CEO. “We are well positioned to use this new investment to rapidly advance our clinical and product development initiatives.”

“The team at Intact Vascular has made substantial progress since our initial investment,” stated Dr. Justin Klein, partner at NEA. “Intact is poised to bring a truly innovative endovascular technology to the peripheral vascular market place, and we are pleased to be a part of that important effort.”

About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize percutaneous balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

About New Enterprise Associates
As one of the world’s largest and most active venture capital firms, NEA has developed deep domain expertise and insight into multiple industries. The NEA team channels that knowledge into every technology and healthcare investment they make -- at any stage, in any location, around the globe. Visit www.nea.com.

About Quaker Partners
Quaker Partners is an East Coast-focused healthcare investment firm. Quaker’s industry expertise includes pharmaceuticals, biotechnology, healthcare services, and medical technologies such as devices, tools and human diagnostics. Visit www.quakerpartners.com.

About H.I.G. BioHealth Partners
H.I.G. BioHealth Partners is the dedicated life-science investment affiliate of H.I.G. Capital. H.I.G. BioHealth Partners invests in a broad range of healthcare opportunities across sectors and stages, principally in companies developing therapeutic drugs, medical devices, and diagnostics for significant unmet medical needs. With approximately $400 million in committed capital, H.I.G. BioHealth Partners invests $5 million to $40 million per company over the life of an investment. Visit www.higbio.com.

This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, adunkle@intactvascular.com, 1-484-253-1048

Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
The 6 French Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC. (4 French pending)
Not Available for sale or use in the United States.
Under U.S. Federal Law, the Tack Endovascular System is Limited to Investigational Use only, in the TOBA II (ATK) and TOBA II BTK studies.