Avinger (Nasdaq:AVGR) – maker of the Lumivascular image-guided, catheter-based system to treat peripheral artery disease (PAD) – continued to experience declining sales as it retrenched during the third quarter, according to its newest earnings report.
The Redwood, Calif.–based company has been cutting jobs and other costs – and focusing on existing accounts and winning FDA clearance for new devices.
Avinger had 73 employees, including 20 sales employees, as of Oct. 15. The number is down nearly two-thirds from the 197 employees, including 70 in sales, that the company had at the end of 2016, according to SEC filings.
Meanwhile, sales continue to decline. Revenue was $2.1 million for the third quarter ended Sept. 30, down 61% from the same quarter a year ago. Net losses were $10.4 million, compared to $13 million for the third quarter of 2016.
On the bright side, Avinger inked a $15 million stock purchase agreement with Lincoln Park Capital Fund earlier this month.
The company is betting on a new generation of devices, as well as a greater focus on treating in-stent resenosis.
Avinger won CE Mark approval in September for treating in-stent resenosis with its Pantheris Lumivascular atherectomy system. Enrollment started last month on a pivotal clinical study to evaluate the safety and effectiveness of Pantheris in treating ISR.
“While Pantheris is not contraindicated for ISR, the results of this study are intended to support a 510(k) submission with the FDA to expand the Pantheris product label to specifically include the ISR indication and enable us to directly promote Pantheris for this purpose in the U.S.,” CEO Jeff Soinski said during an earnings call transcribed by SeekingAlpha.
“We are optimistic about Pantheris’s potential role in this challenging area, which represents approximately 20% of PAD procedures in the U.S.,” Soinski said.
Avinger’s R&D team is completing verification and validation testing so that the company can file a 510(k) submission next month for the Pantheris 3.0, the company’s next-gen image-guided atherectomy catheter, according to Soinski.
The company also plans to file for 510(k) clearance of its below-the-knee atherectomy device during the second quarter of 2018.
“Looking ahead we are focused on readying the company for the launch of our new products, while we drive utilization of our current devices and also expand our clinical program,” Soinski said.