Avinger Shares Rise 9% After 510(k) Clearance for Tigereye ST Image-Guided CTO Crossing System

By Chris Wack

Avinger Inc. shares were up 9% at 61 cents after the company said it has received 510(k) clearance from the U.S. Food & Drug Administration for Tigereye ST, its next-generation image-guided chronic total occlusion crossing system.

The commercial-stage medical device company said its Tigereye ST expands and advances its proprietary image-guided chronic total occlusion product line with new features and benefits.

The new Tigereye ST incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions, as well as design enhancements for ease of image interpretation during the procedure.

Avinger will initiate a limited launch of Tigereye ST in the current quarter with plans to expand to full commercial availability in the U.S. in the third quarter of 2023.

The company also said Wednesday that its stock price was no longer in compliance with Nasdaq's minimum bid price rule, and it has until Oct. 23 to regain compliance.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

April 26, 2023 10:10 ET (14:10 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.