Avinger, Inc. (NASDAQ:AVGR) Q3 2023 Earnings Call Transcript

Pantheris LV represents a new device category for us, not a replacement or upgrade of an existing device. The Pantheris LV device is designed to treat vessels 3 millimeters to 7 millimeters in diameter and is ideally suited to treat lesions in the larger SFA and popliteal arteries above and behind the knee where the majority of PAD procedures are performed. Pantheris LV incorporates several design features from our highly successful Pantheris SV small vessel device and like Pantheris SV does not require a balloon for plaque opposition. Pantheris LV operates at significantly higher rotational speeds than our current atherectomy offerings with variable speeds up to 3,000 RPM during treatment. It also introduces enhanced Guidewire management and plaque management systems to the platform.

We initiated limited launch for Pantheris LV in August and consistent with our process, we are using the limited launch period to fully understand the clinical capabilities of the new device, gauge product performance and reliability in a real-world clinical setting and prepare our clinical sales team for full national launch. We have now completed 25 cases at 10 clinical sites and expect to gain additional case experience in approximately 12 current and new sites by year end. Pending additional learning from our limited launch process, we anticipate expanding the full commercial launch early next year. While we are excited about the introduction of these new devices, our highly differentiated Pantheris SV small vessel atherectomy device continues to deliver exceptional patient outcomes in daily clinical use and in our groundbreaking IMAGE-BTK clinical study.

Pantheris SV is primarily used to treat patients with below-the-knee lesions, many of whom suffer from critical limb ischemia or CLI, the most severe form of PAD. The unique and compelling benefits of using Pantheris SV to treat these challenging patients was highlighted in three podium presentations at the AMP Amputation Prevention Symposium in August. During his presentation at AMP, Dr. Tom Davis, a key opinion-leading interventional cardiologist shared updated interim data from the IMAGE-BTK post-market study designed to evaluate the safety and efficacy of Pantheris SV in treating below-the-knee lesions. The majority of the 46 patients enrolled in the study suffered from an advanced stage of peripheral disease with an average stenosis or blockage of 94% prior to the procedure.

Treatment with Pantheris SV is proving to be highly effective. Average stenosis was reduced to 26% following treatment with Pantheris SV alone and to 9% following the use of adjunctive therapy, representing a 90% reduction in the blockage following the procedure. Safety data are equally compelling with 100% freedom from major reverse events reported in the study. Perhaps most exciting are the longer-term results demonstrated in the study. Patients who have completed their 12-month follow-up exhibited 96% freedom from target lesion revascularization and 93% patency in limbs treated. This is unprecedented data for the treatment of advanced disease below the knee. We look forward to providing further updates on IMAGE-BTK as the final cohort of patients reached the 12-month endpoint of the study.

As we look to the future, we are excited to bring the benefits of our image-guided platform to a large and growing coronary artery disease market. We have discussed our first product application extensively, targeting development of a superior image-guided solution to the complex, expensive and uncertain procedures currently used across chronic total occlusions in the coronary arteries. We believe Avinger can redefine the standard-of-care in this market by leveraging our proprietary technology platform to create the first and only fully integrated image-guided system for crossing coronary CTOs. Our development program focuses on low-profile catheter designs that combine real-time OCT guidance with precise control and steerability to facilitate an integrated approach intended to allow a larger number of physicians to safely and efficiently cross coronary CTOs. Like our peripheral catheters, our coronary devices will incorporate a precise measurement capability to help physicians properly sized balloons or stents prior to placement, which is critical for optimal outcomes.

Our CTO crossing device would access existing reimbursement codes for both the therapeutic procedure, as well as for coronary OCT diagnostic imaging immediately upon FDA clearance. We believe that an OCT-guided catheter designed for crossing efficiency, combined with an immediately available attractive reimbursement scenario provides the opportunity for a highly compelling economic value proposition. We are making excellent progress on the development of this exciting new device. Early in the third quarter, we completed a second round of animal studies with advanced product prototypes. Later in the quarter, we completed a first round of product evaluation in an innovative cadaver heart model at a top KOL center and expect to complete additional testing in this model in the fourth quarter.