The story coming out of Avinger Inc. isn’t so much that the Redwood City, Calif.-based company significantly lowered guidance for 2016 revenue, but rather it received FDA clearance for an enhanced version of its lumivascular atherectomy system.
Analysts sang tunes of praise – almost totally overlooking the firm’s ultra conservative stance on revenue. Consensus had estimates at $38 million, but Avinger gave guidance at between $25 million and $30 million.
“The approval of Pantheris is the most important milestone in the company’s [nine-year], history,” said Jason Mills, an analyst with Canaccord Genuity. Analysts are championing Pantheris, as a product with the potential to significantly impact the way peripheral arterial disease patients are treated.
Pantheris, which already has CE mark, allows physicians to see inside the artery using optical coherence tomography (OCT). The feature offers more accurate navigation to access and treat PAD lesions, with less risk of damaging the artery walls and is radiation free.
The key to Pantheris’ success – is it’s imaging component.
“Over and over again, we’re asked what makes Pantheris that different from all the other interventional catheters? We say there are many things of course but perhaps the most important is the camera,” said John Simpson, Avingers, founder and executive chairman during a recent earnings call. “This of course leads to the next question which is how do you make a camera that small? This then of course commits us to - we have admit that this is not a traditional camera but rather a laser and fiber optic system that creates an image of the vessels what acts like a camera, but it's even better than a camera because it's not only seems from inside of the vessel, but it actually sees through the vessel wall, and this is the information that allows the physician to determine the distribution of plaque in the vessel wall with extraordinary accuracy, and target the treatment only on the disease portion of the vessel leaving the healthy portion of the vessel alone.”
There are other technologies on the market – and ironically have direct ties to Avinger’s founder. He founded and was CEO of Foxhollow Technologies Inc., which has the leading market share for catheters used in the atherectomy market. Foxhollow before it was acquired by Plymouth, Mass.-based Ev3 for $780 million in 2007. About three years later Covidien acquired Ev3 for $2.3 billion in 2010. Medtronic then made its bid to acquire Covidien for $43 billion (Medical Device Daily, June 17, 2014).
“I want to say that exhilaration is maybe an understatement for the way we feel it upon on the approval of the first ever OCT-guided directional atherectomy catheter, and we welcome Pantheris to lumivascular family at Avinger,” Simpson said. “What a great journey, along the way we met many wonderful patients, physicians, staffs, and helpers.”