H.I.G. Capital News

Intact Vascular Announces Enrollment of First European Patient in Tack Optimized Balloon Angioplasty II below the Knee (TOBA II BTK) Clinical Trial with the Tack Endovascular System ®

WAYNE, PA - July 18, 2017 - Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial has commenced enrollment in Europe, with the first patient treated by Professor Dr. Marianne Brodmann and Dr. Peter Reif at Medical University Graz, Austria.

The TOBA II BTK study, which enrolled its first patient in February 2017, is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system is intended to provide physicians with an alternative for repair of dissections while leaving a minimal amount of foreign material in the artery, which reduces mechanical stress on the artery and preserves future treatment options. We believe TOBA II BTK is the first industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

“We are pleased to be the first center in Europe to commence enrollment in TOBA II BTK,” commented Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria. “I believe the Tack Endovascular System is a very promising technology designed to optimize dissection repair while leaving a minimal metal footprint behind post-implantation.”

The TOBA II BTK study will be conducted at up to 50 global sites and will enroll 232 patients in total. Eligible patients will have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately following angioplasty.

“The spiral dissection we treated in this first patient was ideally suited for the Tack Endovascular System since it is the only device uniquely designed to treat below-the-knee dissections following angioplasty,” stated Dr. Peter Rief.

"Critical limb ischemia (CLI) is a serious disease that all too often leads to amputation. It is vital that we develop new technologies to restore and maintain blood flow to the lower leg and foot. I am pleased that we have commenced enrolling patients in European centers,” said Dr. Andrej Schmidt, Division of Interventional Angiology, University Hospital Leipzig, Germany and European Principal Investigator for the TOBA II BTK clinical trial. “The Tack Endovascular System represents a major step forward in the endovascular treatment of CLI.”

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® device with both plain and drug-coated balloon angioplasty in the arteries above the knee. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee. TOBA III is currently underway in Europe and is investigating the combination of the Tack Endovascular System with drug-coated balloon angioplasty. Visit http://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.

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 peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

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.