Medical device company Intact Vascular, which is developing tools to help the 8 million people with peripheral artery disease, has raised fresh capital. It has also started enrollment for a multi-center study to gather data supporting the safety and performance of a device to improve blood flow for participants with critical limb ischemia caused by vascular disease below the knee.
Intact Vascular’s Tack It Endoscopy System, is a permanent metal implant with four self-expanding tacks that are designed to create tissue apposition along artery walls and improve blood flow. The makers see the device as a way to surmount potential complications from angioplasty procedures such as irregularly shaped lumen and tissue dissection that can lead to acute or long-term complications resulting in tissue loss or amputation.
The medical device technology was designed by Robert Giasolli, a co-founder and the company’s chief technology officer and vice president of research and development.
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The Wayne, Pa.-based company has raised about $4.7 million from five investors, according to a document filed with the Securities and Exchange Commission. Among its investors are Quaker Partners and H.I.G. BioVentures, as well as angel investors. Last year it raised $11 million after securing a CE Mark approval from European regulators.
A previously enrolled and ongoing clinical trial recruited patients with claudication due to vascular disease for the above-the-knee indication, according to a company statement.
The company has been gathering data as part of a long-range plan to seek 510(k) clearance for its device from the U.S. Food and Drug Administration.
Peripheral artery disease is a blockage by fatty plaque in peripheral blood vessels that carry blood to the heart, a condition that can be caused by atherosclerosis. It can occur in the arms and legs, but is more common in the legs.