Redwood City, Calif.-based Avinger said the deal with Cowen & Co. doesn’t oblige it to sell any shares. Last week the company said it would immediately launch an enhanced version of the Pantheris device after winning FDA clearance. Pantheris won its 1st nod from the agency in October 2015; Avinger said the new version features improved ergonomics, physician controls and manufacturability.
The device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to treat peripheral artery disease. Avinger floated a $65 million initial public offering in January 2015. Last September the company pulled in a $55 million term loan.
Lumivascular technology utilized in the Pantheris system allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT.
“I am excited and eager to commercially launch the most recent version of Pantheris. I offer a special thanks to all the patients and investigators who have made this possible,” founder & chairman Dr. John Simpson said in prepared remarks. “Our goal has always been to bring to market the most advanced technology for physicians and their patients affected by PAD. With that in mind, we have used the past several months to integrate physician feedback to further improve Pantheris. We are excited to introduce the system to patients and physicians, fulfilling our mission to radically change the treatment of vascular disease.”
“Commercialization of Pantheris is a tremendous milestone for Avinger, and the organization has demonstrated exceptional performance against the critical path milestones we established,” added president & CEO Jeff Soinski. “In advance of launching Pantheris, we have continued to increase our installed base of lumivascular accounts and programs to drive utilization, while simultaneously strengthening our sales and marketing infrastructure. I believe we are well positioned to move towards our next stage of growth.”
Avinger last week reported widening losses for its 4th-quarter and all of 2015 on single-digit sales declines. Losses grew 65.4% to -$13.5 million, or -$1.07 per share, on sales of $2.9 million for the 3 months ended Dec. 31, 2015, a sales decline of -7.0% compared with Q4 2014. Full-year losses grew 55.6% to -$49.7 million, or -$4.38 per share, on sales of $10.7 million, a -4.5 slide compared with 2014.
“2015 was a transformational year for Avinger. We achieved the primary strategic objectives we established for the year, including successful completion of the VISION trial and 510(k) clearance for Pantheris; a substantial increase in lumivascular accounts and programs to drive catheter utilization; and the development of our sales and marketing infrastructure,” Soinski said. “As we enter 2016, I am confident that we are well positioned for growth, driven by the commercial launch of Pantheris and continued expansion of our installed base of lumivascular accounts.”
Avinger said it expects to post net losses per share of -$4.35 to -$4.55 this year, on sales growth of 134% to 180% to between $25 million and $30 million.
AVGR shares were trading at $11.82 apiece in mid-day activity today, down -1.5%. The stock is off -25.8% since its March 1 earnings announcement.