REDWOOD CITY, CA - Avinger, Inc. (NASDAQ:AVGR), a medical device company, is refocusing its efforts on its coronary artery disease (CAD) program and scaling back its peripheral artery disease (PAD) operations. The company announced a 33% reduction in the workforce dedicated to its peripheral business, a move expected to result in significant cost savings in the latter half of 2024.
Jeff Soinski, President and CEO of Avinger, expressed optimism about the potential of their coronary product development program to lead in a substantial market that currently faces challenges with complex and often unsuccessful procedures.
He highlighted the advantages of Avinger's proprietary image-guided technology and portable Lightbox 3 platform, which are anticipated to enhance success rates for crossing chronic total occlusions (CTO) and reduce procedure times. The company plans to file an Investigational Device Exemption (IDE) application with the FDA later this year and initiate a clinical trial upon approval.
While reducing costs in its peripheral business, Avinger aims to maintain the availability of its therapies for physicians. The company also anticipates the U.S. commercial launch of its new Pantheris LV image-guided atherectomy catheter in the third quarter of this year.
Avinger's Lumivascular platform includes the Lightbox imaging consoles, the Ocelot and Tigereye® family of CTO catheters, and the Pantheris® family of atherectomy devices for PAD treatment. The company is also developing a product for CAD treatment, which could redefine the approach to CTO-crossing in coronary arteries.
This announcement follows Avinger's ongoing efforts to achieve regulatory registration for its image-guided products in the greater China market, in collaboration with a strategic partner.
The information in this article is based on a press release statement from Avinger, Inc. Forward-looking statements in the press release reflect current expectations but come with risks and uncertainties that could cause actual results to differ materially. These include the company's ability to manage with fewer employees and obtain regulatory approvals, among other factors detailed in their filings with the Securities and Exchange Commission.
In other recent news, Avinger Inc . has formed a strategic alliance with Zylox-Tonbridge to broaden its market footprint in the greater China region. This partnership encompasses a $15 million investment from Zylox and exclusive distribution and manufacturing rights for Avinger's devices in China.
Avinger's financials for the first quarter of 2024 show a total revenue of $1.9 million and a gross margin of 18%, but a notable net loss of $5.5 million. The company also disclosed operating expenses of $5.4 million and cash reserves of $7.2 million as of the end of March.
Avinger is actively progressing its coronary development program, aiming to submit an IDE to the FDA in the third quarter of 2024 for its CTO crossing device. The company anticipates achieving registration and manufacturing capabilities in China by the end of 2025.
Avinger is also exploring opportunities to distribute Zylox's CE-marked products in Germany, capitalizing on its existing CE Mark certification. These are the latest developments for Avinger Inc.
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