Ground-Breaking Clinical Data from INSIGHT Trial Presented at VIVA

Rhea-AI Summary

Avinger has announced positive results from its INSIGHT study for the Pantheris system, aimed at treating in-stent restenosis (ISR) in lower extremity arteries. Presented at the VIVA conference, the study followed 85 patients, showing an 82% luminal gain post-procedure, with 93% freedom from target lesion restenosis at 6 months and 89% at 12 months. Notably, there were no amputations reported. The results support a pending FDA 510(k) submission for an ISR indication. With ISR affecting up to 40% of stents placed annually, the data position Pantheris as a potential frontline therapy.

Positive

• 82% luminal gain following the Pantheris procedure.
• 93% freedom from target lesion restenosis at 6 months.
• 89% freedom from target lesion restenosis at 12 months.
• No amputations reported in the study cohorts.
• 0.96 mean ankle-brachial index at 6 months, up from 0.69 pre-procedure.
• 71% improvement in Rutherford Class at 6 months.

Negative

• Pantheris currently lacks ISR indication approval in the US.

Study Outcomes Demonstrate Safety and Efficacy of Pantheris for Treatment of In-Stent Restenosis

REDWOOD CITY, CA / ACCESSWIRE / October 7, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that clinical data from the INSIGHT study were presented during the Late-Breaking Clinical Trials session at the VIVA (Vascular InterVentional Advances) conference in Las Vegas. The INSIGHT trial was designed to evaluate the safety and effectiveness of Avinger's Pantheris image-guided atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries.

Jon George, M.D., Interventional Cardiologist and Endovascular Medicine Specialist at University of Pennsylvania Health System, presented 6 and 12-month follow-up results from 85 and 76 patients, respectively. Data from the study were used to support a 510(k) submission to the U.S. Food and Drug Administration (FDA) for an expanded in-stent restenosis indication for Pantheris in June 2021. The 510(k) submission is currently under review by the FDA. Pantheris does not have an ISR indication in the US at this time.

Key outcomes presented from the trial include:

• 82% luminal gain (increase in channel for blood flow) following the procedure
• 93% freedom from target lesion restenosis at 6 months post-procedure
• 89% freedom from target lesion restenosis at 12 months post-procedure
• No amputations for the 6 or 12-month cohorts of patients
• 0.96 mean ankle-brachial index at 6 months from a baseline of 0.69 pre procedure
• 71% improvement in Rutherford Class (a measure of disease severity) at 6 months

Commenting on the data, Dr. George noted, "The clinical outcomes generated in the INSIGHT trial demonstrate the excellent safety and efficacy profile of Pantheris for patients suffering from in-stent restenosis, especially in comparison to other available treatment options. Of particular note is the extremely high 12-month freedom from target lesion revascularization, and the stability of this endpoint between 6 and 12 months. With the combination of onboard image-guidance and directional atherectomy to safely deliver unsurpassed luminal gain, Pantheris offers physicians significant advantages in treating ISR, and the INSIGHT data support its use as a frontline therapy for this clinical application."

INSIGHT is a prospective, global, single-arm, multi-center trial conducted at 17 sites. The primary safety endpoint is freedom from major adverse events through 30-day follow-up and the primary and secondary effectiveness endpoints are the proportion of target lesions with a residual diameter stenosis less than 50% post-atherectomy, and freedom from TLR at 6 months, respectively. An independent core lab adjudicated all images and a clinical events committee assessed adverse events. While 30-day and 6-month endpoints support the expanded clinical indication, patients were followed out to 12-months to track longer term outcomes. Key data points and outcomes from INSIGHT as compared to EXCITE-ISR are shown in Table 1. EXCITE-ISR was a randomized controlled study comparing laser atherectomy plus percutaneous transluminal angioplasty (PTA) versus angioplasty alone for treatment of femoropopliteal in-stent restenosis.

Table 1: EXCITE-ISR and INSIGHT Data

	Laser + PTA1	Pantheris + PTA
Baseline mean stenosis	82%	83%
Mean stenosis post-procedure	17%	15%
Freedom from MAE* (6-month)	79%	94%
Freedom from amputation (6-month)	100%	100%
Freedom from TLR** (6-month)	74%	93%
Freedom from TLR (12-month)	<45%	89%
Mean ABI*** pre-procedure	0.60	0.69
Mean ABI post-procedure (6-month)	0.71	0.96

*MAE = major adverse event
**TLR = Target lesion revascularization
***ABI = ankle-brachial index

With approximately 200,000 stents placed in the femoral and popliteal arteries annually, and 30% to 40% of these stents expected to develop in-stent restenosis within 3 years of implantation, the treatment of in-stent restenosis represents both a significant market and healthcare burden.² In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, reducing blood flow. Physicians often face challenges when treating ISR both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques, such as X-ray fluoroscopy, and the inability to control the directionality of other treatment modalities creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis, such as balloon angioplasty, do not actually remove occlusive material and have high rates of recurrent renarrowing within stents.

Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray 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, due to real-time OCT images generated from inside the artery, 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 imaging console, 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 timing and potential approval of our 510(k) application for a new Pantheris clinical indication, the potential benefits of our products for patients and healthcare providers, our ability to expand into the ISR treatment market, the potential market opportunities for Pantheris if the 510(k) application is approved, and the development and regulatory of other products. 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 Pantheris, Tigereye and our Lightbox imaging console; the 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 11, 2021. 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:

Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
ir@avinger.com

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

¹ Dippel et al. JACC: Cardiovascular Interventions 2015; 8(1): 92-101. 12-month freedom from TLR estimated based on graph included in publication.

² Lichtenberg MK, Carr JG, Golzar JA. Optical coherence tomography: guided therapy for peripheral artery disease. The Journal of Cardiovascular Surgery 2017; 58(4):518-527.

SOURCE: Avinger, Inc.

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FAQ

What were the outcomes of the INSIGHT study for AVGR?

The INSIGHT study showed a 82% luminal gain, 93% freedom from target lesion restenosis at 6 months, and 89% at 12 months.

When was the Pantheris 510(k) submission made to the FDA?

The submission for the Pantheris ISR indication was made in June 2021.

What is the significance of the INSIGHT trial results for Avinger?

The results support Pantheris as a potential frontline therapy for treating in-stent restenosis, addressing a significant market need.

What risks are associated with the Pantheris treatment according to the INSIGHT trial?

While the trial indicated strong safety, Pantheris's ISR indication is not yet approved by the FDA.

How many patients were involved in the INSIGHT trial?

The INSIGHT trial involved 85 patients for the 6-month follow-up and 76 patients for the 12-month follow-up.