|Avinger CEO John Simpson|
Avinger has raised $35 million toward its ongoing U.S. pivotal trial of a lumivascular catheter that combines intravascular imaging with arterial plaque removal. The total target for this financing is $49 million and 65 undisclosed investors have participated thus far, according to an SEC filing.
Founded in 2007, this is the eighth startup from cardiologist John Simpson, who is the CEO. His companies have sold for more than $1.7 billion in aggregate, including Advanced Cardiovascular Systems in 1981 to Eli Lilly ($LLY), Devices for Vascular Intervention to Lilly in 1990, Perclose to Abbott ($ABT) in 1999 and FoxHollow Technologies, which merged with ev3 in 2007.
In July, Avinger started the VISION trial for its Pantheris catheter for the treatment of peripheral artery disease (PAD). The study is a non-randomized, prospective, global, single-arm trial that is evaluating the safety and effectiveness of Pantheris to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
If approved, the company expects Pantheris to be the first imaging artherectomy catheter for PAD patients in the U.S. The system offers real-time, video-quality intravascular imaging during surgery.
Hospitalization costs of PAD exceed $21 billion annually largely due to late detection and difficulties after bypass surgery or amputation, according to the company. There are an estimated 12 million people with PAD in the U.S.
|Avinger's first product, the Ocelot--Courtesy of Avinger|
Avinger's first product was Ocelot, a lumivascular system used to open totally occluded arteries in the legs; it was received a CE mark in 2012. The startup markets a series of lumivascular catheters of different sizes that have been used in more than 20,000 PAD patients, as well as a visual display compatible with them.
"We are convinced that Avinger's Pantheris catheter will be a major step forward for our patients and for the entire medical community as the increased precision allowed by direct visualization is immediate and significant," VISION Co-Principle Investigators Dr. William Crowder and Dr. J. Gray Bennett of St. Dominic Hospital of Jackson, MS, said in a July statement.
- here is the SEC filing and the press release on the July trial start