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Intact Vascular Announces Launch of the Tack Endovascular System® in the EU and First Commercial Use in Germany

WAYNE, PA - January 7, 2019 - Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System® in multiple hospitals within Germany. A novel therapy for dissection repair following balloon angioplasty, the Tack® implant is a first-of-its kind device for patients with peripheral arterial disease (PAD) and/or critical limb ischemia (CLI).

“The Tack System provides a much needed therapeutic option for treating dissections in the superficial femoral or popliteal arteries following balloon angioplasty,” said Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. “I am very pleased with my experience using the implant and I am excited to incorporate this technology into my above and below the knee treatment algorithms going forward.”

Patients treated with balloon angioplasty frequently suffer from dissections. Often overlooked, undiagnosed and untreated, dissections can lead to acute thrombosis and arterial occlusions, which lower long-term patency rates and require repeat procedures. Designed to resolve these dissections while leaving minimal metal behind, the Tack implant is uniquely designed to preserve vessel integrity, minimize vessel inflammation and enhance blood flow.

“With the Tack System, balloon angioplasty results are improved regardless if it is drug-eluting or not,” noted Dr. Michael K.W. Lichtenberg, Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Germany. “Based on my initial experience, I am confident this new paradigm of focal dissection repair will become standard of care for patients undergoing PAD interventions.”

“Commercializing the Tack Endovascular System is a major achievement for our company and ultimately for patients undergoing balloon angioplasty,” stated Howard Rosen, Vice President of Marketing & Business Development at Intact Vascular. “We are excited to bring this impactful technology to market and look forward to expanding our commercial efforts in Europe.”

About Intact Vascular and the Tack Endovascular System
Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack implant with plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has completed enrollment. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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.

1Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.

CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.

Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM) are trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.