Avinger, Inc. (NASDAQ:AVGR) announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular™ technology, sending shares rising nearly 20% to $0.53. AVGR has a 1-year high of $12.50 and a 1-year low of $0.35. The stock’s 50-day moving average is $0.50 and its 200-day moving average is $2.30.
The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris® system to perform directional atherectomy while, for the first time ever, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016.
Twenty four (24) month follow-up results from 89 patients were presented by Patrick Muck, M.D., Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, at New Cardiovascular Horizons (NCVH) in New Orleans, Louisiana. This includes an additional 34 patients beyond the interim data set presented on January 25, 2017. Data presented today remain subject to adjustment based on final statistical analysis and review by the study’s clinical events committee.
Key highlights of the presentation include:
- Kaplan Meier survival probability measured 82% freedom from target lesion revascularization (TLR) at 12 months by patient (84% by lesion) and 74% freedom from TLR at 24 months by patient (76% by lesion)
- The VISION 24-month Kaplan Meier freedom from target lesion vascularization at 24 months remained stable between 18 and 24 months
- Statistically significant improvements in ankle brachial index (ABI) and Rutherford classification at 30 days were maintained through 24 months
- A majority of lesions were treated using standalone optical coherence tomography (OCT) guided atherectomy with the Pantheris catheter, with only 9.6% (n=19/198) receiving adjunctive drug coated balloon (DCB) therapy and only 5% (n=10/198) receiving adjunctive stent therapy
“The complete VISION 24-month data demonstrates positive longer-term sustained results for patients treated with Pantheris, and importantly, these patients have largely avoided the need for a repeat procedure in a two-year timeframe,” commented Dr. Muck. “Considering that the outcomes were generated at the hands of brand new users with a first-generation clinical trial device, such positive results represent an important step forward for Pantheris in the clinical setting.”
“These excellent results continue to reinforce our enthusiasm for the Pantheris System,” said Dr. John B. Simpson, Avinger’s Founder and Executive Chairman. “We are gratified that Lumivascular technology is improving the lives of patients with PAD, including many facing amputation. In the meantime we continue to refine the system, with Pantheris 3.0, our next-generation atherectomy catheter, and a lower-profile Pantheris device currently in development.”
According to TipRanks, 2 research analysts have assigned a Hold rating on AVFR and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $2.33 which is 447% above where the stock opened today.
Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral artery disease, or PAD. Its products include Pantheris, Lightbox, Ocelot, Ocelot MVRX, Ocelot PIXL, Pantheris, Wildcat, Juicebox and Kittycat 2. The company offers its products to interventional cardiologists, vascular surgeons, and interventional radiologists.