Avinger Announces Full Commercial Launch of Pantheris SV
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 the full commercial launch of the Pantheris SV (small vessel) image-guided atherectomy system in the U.S. All current and prospective Lumivascular accounts are now eligible to order the Pantheris SV device.
Avinger launched Pantheris SV at select Avinger sites in late July in order to demonstrate the product's ease of use and efficiency across a variety of user approaches and vascular conditions in a real-world clinical setting, as well as train clinical support and sales personnel in best practices with this new device. During the limited launch, physicians at 13 sites used Pantheris SV to successfully treat more than 60 patients in the United States. With the start of the national roll-out in September, Avinger has now shipped Pantheris SV to 25 U.S. accounts and will be accepting orders from additional accounts as sites continue to integrate this new technology into their therapeutic capabilities. In addition, the Company is shipping the device to accounts in Germany and expects to further expand international distribution in the fourth quarter of 2019.
"We approached the launch of Pantheris SV in a structured, disciplined way and are excited to now leverage these exciting clinical results in our transition to full commercial sales availability," said Jeff Soinski, Avinger's President and CEO. "The clinical feedback we have received, the pace at which our limited launch sites have adopted the technology, and, most importantly, the positive patient outcomes, demonstrate Pantheris SV is an exciting new commercial technology for the treatment of some of the most challenging cases of peripheral artery disease. This new product addresses a significant unmet clinical need in below-the-knee interventions, which we believe will expand the addressable market for our products by as much as 50% and accelerate the growth of our overall Pantheris business."
Pantheris SV, a product line extension of Avinger's onboard image-guided atherectomy platform, expands Avinger's portfolio of atherectomy devices for the treatment of PAD and is expected to increase the number of addressable procedures for the Company's Lumivascular technology. Pantheris SV features a longer 140 cm catheter length and a smaller six French (6F) profile to allow physicians to target more distal regions of the vasculature in smaller diameter vessels, including those below-the-knee. During the limited launch, physicians used Pantheris SV to successfully treat lesions within a variety of treatment scenarios in all of the major arteries between the knee and ankle. Treating physicians have provided positive feedback on the device's ease of use, image clarity, cutting efficiency, and user control.
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray images as well as 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 the 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-ever image-guided, catheter-based system that diagnoses and treats 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 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.
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 our future performance, expectations regarding the number of active Lumivascular accounts, the increase of our available atherectomy market, the impact of Pantheris SV on our addressable market, patient outcomes, and expansion of international distribution of Pantheris SV. 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; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; reliance on third-party vendors; dependency on physician adoption; and reliance on key personnel; 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 6, 2019, as well as in our Quarterly Reports on Form 10-Q. 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.