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| The Tack Endovascular System being deployed--Courtesy of Intact Vascular |
Startup Intact Vascular expects the $38.9 million Series B it has raised will help it get its peripheral artery disease implant and delivery system into pivotal testing and through the FDA. It's been a long time since the company's $15.5 million first institutional round in September 2012.
But venture capital investors are ready to make the leap based on three international clinical trials for the company's Tack Endovascular System, two of which are still ongoing. In January, Intact Vascular disclosed 12-month data for the Tack system from a study dubbed TOBA.
The European TOBA study is in 128 patients with severe peripheral arterial disease in one or both legs; they were treated with the Tack Endovascular System following standard balloon angioplasty in the superficial femoral and popliteal arteries. The data show that 90% of patients were free of lesion revascularization at 12 months; 76% of them achieved a sustained, improved blood flow.
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| The Tack Endovascular System--Courtesy of Intact Vascular |
"The TOBA experience demonstrates that the long term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach that minimizes vessel trauma and the metal we leave behind," said study co-principal investigator Dr. Marc Bosiers, head of the department of vascular surgery at A.Z. St. Blasius Hospital in Belgium, in a statement at the time. "The Tack supports the dissection and allows the vessel to heal, while preserving future treatment options for patients."
The ultimate goal is to use multiple clinical trials to address arteries both above and below the knee. The idea of the Tack system is to improve upon a standard angioplasty in which a balloon on the top of a catheter is inflated to reopen the artery. Typically, stents can be used to help keep it open.
The Tack system is expected to offer less force on the vessel wall, thereby reducing trauma; to offer more focused treatment, given its 6-mm length; and to permit greater flexibility than might otherwise be offered by stents. Tack includes the actual implant, as well as a delivery system for its placement.
Intact Vascular was founded in 2012 by Dr. Peter Schneider, director of the division of vascular therapy at the Kaiser Foundation Hospital in Honolulu, HI. He was looking for a better method for repairing arterial dissections following percutaneous transluminal angioplasty. Schneider was looking for a solution that, unlike stents, minimized the metal left behind and the associated arterial wall inflammation.
"Intact Vascular's approach to peripheral artery disease is truly novel and has the potential to significantly improve treatment of this rapidly growing disease," said NEA Partner Dr. Justin Klein in a statement. He has joined the company's board as part of the financing. Existing investors Quaker Partners and H.I.G. BioVentures also participated in the round.
- here is the release