Interim Data from IMAGE-BTK Clinical Trial Presented at AMP 2022

Rhea-AI Summary

Avinger (NASDAQ:AVGR) announced promising interim data from the IMAGE-BTK clinical study for its Pantheris SV device at the AMP conference. The study focuses on patients with below-the-knee (BTK) lesions, a significant cause of critical limb ischemia (CLI). Dr. Thomas Davis reported zero complications in the first 24 patients enrolled, with 100% freedom from target vessel restenosis at 6 months. Patency rates were also high, at 96% after 6 months and 93% after 12 months. Avinger aims to complete the study and believes Pantheris SV has the potential to become the new standard of care for treating PAD.

Positive

• Zero complications reported in the first 24 patients of the IMAGE-BTK study.
• 100% freedom from target vessel restenosis at 6 months for enrolled patients.
• High patency rates: 96% after 6 months and 93% after 12 months.
• Potential to establish Pantheris SV as a new standard of care for treating PAD.

Negative

• None.

REDWOOD CITY, CA / ACCESSWIRE / September 1, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today announced the presentation of interim data from the IMAGE-BTK clinical study for Pantheris SV at the annual AMP (Amputation Prevention Symposium) conference in August.

AMP focuses on education and technologies for treating critical limb ischemia (CLI), an advanced stage of peripheral artery disease (PAD), in patients facing a life-altering amputation. The conference features lectures by internationally recognized faculty, live case symposia, hands-on workshops, and exhibits supporting the mission of amputation prevention.

Dr. Thomas Davis, a faculty member at AMP and interventional cardiologist at Eastlake Cardiology in Michigan, highlighted the extremely promising interim results from the IMAGE-BTK clinical trial featuring Avinger technology in his presentation "IMAGE-BTK: Assessment of the Utility of the Pantheris SV System to Address Lesions Below-the-Knee." IMAGE-BTK is a post-market study designed to evaluate the safety and efficacy of Pantheris SV in treating below-the-knee lesions. In his presentation, Dr. Davis noted that below-the-knee (BTK) lesions are a major contributor to CLI, that 73% to 95% of patients with CLI will have a major amputation if not treated within one year of diagnosis, and that 24% of patients have an increased risk of mortality at one year. Furthermore, minor complications in BTK procedures can result in serious consequences, with most existing treatments exhibiting high rates of recurrence.

Dr. Davis highlighted that through the first 24 patients enrolled in IMAGE-BTK, zero complications or adverse events have occurred within 30 days of the index procedure. Importantly, even in a patient population with advanced PAD, 100% of enrollees with subsequent follow-up had freedom from target vessel restenosis (TVR) at 6 months and 93% had freedom from TVR at 12 months. Interim results have also shown patency amongst these patients at 96% after 6 months and 93% after 12 months. Patency with duplex ultrasound assessment is often considered a gold standard for effective outcomes in these types of procedures.

"This level of durability and safety for patients with advanced peripheral disease represents a significant advancement for the difficult-to-treat patient population suffering from BTK disease," commented Dr. Davis. "The unique combination of onboard image-guidance with a targeted plaque removal mechanism in Pantheris SV allows me to create unparalleled luminal gain during the intervention, without causing damage to healthy vessel structures or creating other complications. With the initial enrollees in IMAGE-BTK, we have seen a 90% reduction in percent stenosis of lesions treated without any major adverse events. Should these outcomes continue, Pantheris SV could become a new standard of care for patients with BTK disease and CLI."

Jeff Soinski, Avinger's President and CEO, noted, "These interim findings from IMAGE-BTK validate the clinical results we have monitored in the field since we launched Pantheris SV. We look forward to completing enrollment of this study and publishing the outcomes in a peer-reviewed publication, as we believe Pantheris SV can benefit a wide population of patients suffering from PAD. The AMP conference, as one of the preeminent platforms for advancing the treatment of clinical limb ischemia and amputation prevention, represents an impactful stage to share these powerful early outcomes."

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians, for the first time ever, to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT. During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions to deliver safe and effective outcomes, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.

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Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the interim data from the IMAGE-BTK clinical study for Pantheris SV and the potential impact on the Company if the outcomes from such study were to continue. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; the resource requirements related to our products; the timing and outcome of clinical trial results; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 22, 2022 and our Quarterly Reports on Form 10-Q filed on May 10, 2022 and August 11, 2022. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.

Investor Contact:
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com

Public Relations Contact:
Phil Preuss
Chief Marketing Officer
Avinger, Inc.
(650) 241-7942
pr@avinger.com

SOURCE: Avinger, Inc.

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https://www.accesswire.com/714232/Interim-Data-from-IMAGE-BTK-Clinical-Trial-Presented-at-AMP-2022

FAQ

What were the results of the IMAGE-BTK clinical study for AVGR?

The interim results showed zero complications in the first 24 patients, with 100% freedom from target vessel restenosis at 6 months.

What does the Pantheris SV device treat?

Pantheris SV is designed to treat below-the-knee (BTK) lesions in patients with Peripheral Artery Disease (PAD).

What is the significance of the AMP conference for Avinger?

The AMP conference is a key platform for sharing advancements in the treatment of critical limb ischemia (CLI) and amputation prevention.

What are the next steps for Avinger after the IMAGE-BTK study?

Avinger plans to complete enrollment in the IMAGE-BTK study and publish the outcomes in a peer-reviewed journal.

How might the interim results impact Avinger's stock performance?

Positive outcomes from the IMAGE-BTK study could enhance investor confidence and potentially drive the stock price upward.