Avinger Stock

Avinger, Inc. operates as a commercial-stage medical device company.

The company designs, manufactures, and sells real-time high-definition image-guided, minimally invasive catheter-based systems that are used by physicians to treat patients with peripheral artery disease (‘PAD’).

The company designs, manufactures, and sells a suite of products in the United States and select international markets. The company’s Lumivascular platform consists of products, including the company’s Lightbox imaging console, the Ocelot and Tigereye family of devices, which are image-guided devices designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion (‘CTO’), and the Pantheris family of catheters, the company’s image-guided atherectomy catheters, which are designed to allow physicians to precisely remove arterial plaque in PAD patients.

The company is in the process of developing CTO crossing devices to target the coronary CTO market.

The company received CE Marking for the company’s original Ocelot product in September 2011 and received from the U.S. Food and Drug Administration, or FDA, 510(k) clearance in November 2012. The company received 510(k) clearance from the FDA for commercialization of Pantheris in October 2015. The company received an additional 510(k) clearance for an enhanced version of Pantheris in March 2016 and commenced sales of Pantheris in the United States and select European countries promptly thereafter. In May 2018, the company received 510(k) clearance from the FDA for the company’s next-generation version of Pantheris. In April 2019, the company received 510(k) clearance from the FDA for the company’s Pantheris Small Vessel (‘SV’), a version of Pantheris targeting smaller vessels, and commenced sales in July 2019. In September 2020, the company received 510(k) clearance of Tigereye, a next-generation CTO crossing system utilizing Avinger’s proprietary image-guided technology platform. Tigereye is a product line extension of Avinger’s Ocelot family of image-guided CTO crossing catheters. In January 2022, the company received 510(k) clearance from the FDA for the company’s Lightbox 3 imaging console, an advanced version of the company’s Lightbox that allows for easy portability and offers significant reductions in size, weight, and production cost in comparison to the incumbent version.

In July 2022, the company submitted a 510(k) application to the FDA for the Tigereye Spinning Tip (‘ST’) device, a next generation CTO crossing system. Tigereye ST is a line extension of the company’s Ocelot and Tigereye family of CTO crossing catheters. This new image-guided catheter has an integrated outer spinning tip that pairs with the rotation of the inner tip to penetrate challenging blockages and CTO caps. Tigereye ST incorporates an advanced shaft design for pushability and torque response and a three-marker system, similar to Ocelot's, to facilitate consistent image interpretation across the platform. Tigereye ST continues to provide the high definition, real-time intravascular imaging, user-controlled deflectable tip, and faster rotational speeds introduced to Avinger's CTO portfolio with the commercial launch of Tigereye in early 2021. The low-profile Tigereye ST has a working length of 140 cm and 5 French sheath.

In January 2023, the company submitted a 510(k) application to the FDA for the Pantheris LV device, a next generation image guided atherectomy system for the treatment of larger vessels, such as the superficial femoral artery (‘SFA’) and popliteal arteries. Pantheris LV is a line extension of the company’s Pantheris and Pantheris SV family of atherectomy products. This catheter offers higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque excised during the procedure, and enhanced guidewire management.

The company’s Lumivascular platform is the only technology that offers radiation free, high-definition real-time visualization of the inside of the artery during PAD treatment through the use of optical coherence tomography, or OCT, a high resolution, light-based, radiation-free imaging technology. The company’s Lumivascular platform provides physicians with high-definition real-time OCT images from the inside of an artery, and Ocelot and Pantheris are the first products to offer intravascular visualization during CTO crossing and atherectomy, respectively. This approach will significantly improve patient outcomes by providing physicians with a clearer picture of the artery using radiation-free image guidance during treatment, enabling them to better differentiate between plaque and healthy arterial structures. The company’s Lumivascular platform is designed to improve patient safety by enabling physicians to direct treatment towards the plaque, while avoiding damage to healthy portions of the artery.

During the first quarter of 2015, the company completed enrollment of patients in VISION, a clinical trial designed to support the company’s August 2015 510(k) submission to the FDA for the company’s Pantheris atherectomy device. VISION was designed to evaluate the safety and efficacy of Pantheris to perform atherectomy using intravascular imaging and successfully achieved all primary and secondary safety and efficacy endpoints. The data from VISION allows the company to demonstrate that avoiding damage to healthy arterial structures, and in particular disruption of the external elastic lamina, which is the membrane between the outermost layers of the artery, reduces the likelihood of restenosis, or re-narrowing, of the diseased artery. Although the original VISION study protocol was not designed to follow patients beyond six months, the company worked with 18 of the VISION sites to re-solicit consent from previous clinical trial patients in order for them to evaluate patient outcomes through 12 and 24 months following initial treatment. Data collection for the remaining patients from participating sites was completed in May 2017, and the company released the final 12- and 24-month results for a total of 89 patients in July 2017.

During the fourth quarter of 2017, the company began enrolling patients in INSIGHT, a clinical trial designed to support a submission to the FDA to expand the indication for the company’s Pantheris atherectomy device to include the treatment of in-stent restenosis. Patient enrollment began in October 2017 and was completed in July 2021. Patient outcomes were evaluated at thirty days, six months and one year following treatment. In November 2021, the company received 510(k) clearance from the FDA for this new clinical indication for treating in-stent restenosis with Pantheris using the data collected and analyzed from INSIGHT. The company expects this will expand the company’s addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated or effective treatment options.

The company is pursuing additional clinical data programs including a post-market study, IMAGE-BTK, that is designed to evaluate the safety and efficacy of Pantheris SV in the treatment of PAD lesions below-the-knee. The company is enrolling patients, and the company expects to complete enrollment in 2023.

The company focuses its direct sales force, marketing efforts and promotional activities on interventional cardiologists, vascular surgeons and interventional radiologists. The company also works on developing strong relationships with physicians and hospitals that the company has identified as key opinion leaders. Although the company’s sales and marketing efforts are directed at these physicians because they are the primary users of the company’s technology, the company considers the hospitals and medical centers where the procedure is performed to be the company’s customers, as they typically are responsible for purchasing the company’s products. The company is designing additional future products to be compatible with the company’s Lumivascular platform, which the company expects to enhance the value proposition for hospitals to invest in the company’s technology. Pantheris qualifies for existing reimbursement codes utilized by other atherectomy products, further facilitating adoption of the company’s products.

Products

The company’s products include its Lightbox imaging consoles and the company’s various catheter-based devices used in PAD treatment. All the company’s revenues are derived from sales of the company’s various PAD catheters and Lightbox imaging consoles and related services in the United States and select international markets. Each of the company’s products is, and the company’s future products will be, designed to address significant unmet clinical needs in the treatment of vascular disease.

Lumivascular Platform Overview

The company’s Lumivascular platform integrates OCT (optical coherence tomography) visualization with interventional devices and is the industry’s only system that provides radiation free, high definition real-time intravascular imaging simultaneously with treatment in PAD procedures. The company’s Lumivascular platform consists of a capital component, Lightbox, and a variety of disposable catheter products, including the Ocelot, Tigereye and Pantheris family of catheters.

Lightbox

Lightbox is the company’s proprietary video imaging console, which enables the use of Lumivascular devices during PAD procedures. The console contains an optical transceiver that transmits light into the artery through an optical fiber and displays a cross-sectional image of the vessel to the physician on a high-definition monitor during the procedure.

Lightbox displays a cross-sectional view of the vessel, which provides physicians with detailed information about the orientation of the catheter and the surrounding artery and plaque. Layered structures represent relatively healthy portions of the artery and non-layered structures represent the plaque that is blocking blood flow in the artery. Navigational markers allow the physician to orient the catheter toward the treatment area, helping to avoid damage to the healthy arterial structures during a procedure. Lightbox received FDA 510(k) clearance in November 2012 and CE Marking in Europe in September 2011.

In January 2022, the company received 510(k) clearance from the FDA for the company’s next generation Lightbox 3 imaging console, the Lightbox 3, a version of the company’s Lightbox that delivers important advancements in imaging, portability and capability in comparison to the incumbent version. Lightbox 3 incorporates advanced features, including an advanced solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system with a highly intuitive user interface that emphasizes efficiency and ease-of-use into a significantly smaller size and weight console. The company initiated a limited launch of Lightbox 3 in the United States in the first quarter of 2022 and expanded to full commercial availability in the subsequent quarter.

Pantheris

Pantheris is the first atherectomy device to incorporate radiation free high-definition real-time OCT intravascular imaging to guide the procedure. Pantheris may be used alone or following a CTO crossing procedure using Ocelot or other products. Pantheris is a single-use product and provides physicians with the ability to see a cross-sectional view of the peripheral artery to guide the removal of blockages throughout the procedure. The Pantheris device restores blood flow by shaving strips of plaque using a high-speed directional cutting mechanism that enables physicians to specifically target the portion of the artery where the plaque resides while minimizing disruption to healthy arterial structures. The excised plaque is deposited, collected and contained into the nosecone of the Pantheris device and removed from the artery within the device.

In October 2015, the company received 510(k) clearance from the FDA for commercialization of Pantheris. The company made modifications to Pantheris after the completion of the VISION trial and commenced sales in the United States and select international markets following receipt of FDA approval for this initial version of Pantheris in March 2016. The company first received CE Marking for Pantheris in June 2015. The company received CE Marking in December 2017 and 510(k) clearance in May 2018 for a next-generation version of Pantheris, which includes new features and design improvements to the handle, shaft, balloon and nosecone of the device. The next-generation Pantheris atherectomy device is available for commercial sale in the United States and select international markets. All previous versions of Pantheris have been discontinued.

The company also offers a line extension of its Pantheris image-guided atherectomy platform, Pantheris SV, a lower profile version of Pantheris. The Pantheris SV has a smaller diameter and longer length and is designed for use in smaller vessels 2.0 to 4.0 millimeters in diameter. The company received CE Marking in October 2018 and 510(k) clearance in April 2019 for this product and commenced sales in the United States in July 2019.

The company recently developed another line extension of the company’s Pantheris platform, Pantheris LV. The Pantheris LV has a larger diameter and shorter length than the Pantheris SV and is designed for use in larger vessels 3.0 to 7.0 millimeters in diameter. The company submitted a 510(k) application for Pantheris LV to the FDA in January 2023.

Ocelot and Tigereye

Ocelot is the first CTO crossing catheter to incorporate radiation free high-definition real-time OCT intravascular imaging, which allows physicians to see the inside of a peripheral artery during a CTO crossing procedure. Physicians have traditionally relied solely on fluoroscopy and tactile feedback to guide interventional catheters through complicated blockages. Ocelot allows physicians to accurately navigate through CTOs by utilizing the OCT images to precisely guide the device through the arterial blockage, while minimizing disruption to the healthy arterial structures. A successful CTO crossing and placement of a guidewire allows the physician to subsequently treat the vessel with a minimally invasive therapeutic device. The company received CE Marking for Ocelot in September 2011 and received FDA 510(k) clearance in November 2012.

The company also offers Ocelot PIXL, a lower profile CTO crossing device for below-the-knee arteries and Ocelot MVRX, which offers a different tip design for peripheral arteries above-the-knee. The company received CE Marking for Ocelot PIXL in October 2012 and received FDA 510(k) clearance in December 2012. The company received FDA 510(k) clearance for Ocelot MVRX in December 2012.

Tigereye is a product line extension of the company’s Ocelot family of image-guided CTO crossing devices. Its design elements include an upgrade of the image capture rate to provide high definition, real-time intravascular video imaging similar to the Pantheris image-guided atherectomy system and a user-controlled deflectable tip designed to assist in steerability across the blockage. The company received CE Marking for Tigereye in December 2019 and received FDA 510(k) clearance in September 2020.

The company recently developed another line extension of the company’s Ocelot family of catheters, Tigereye ST. The Tigereye ST has a comparable diameter and length to the Tigereye catheter. This new image-guided catheter has an integrated outer spinning tip that pairs with the rotation of the inner tip to penetrate challenging blockages and CTO caps. Tigereye ST incorporates an advanced shaft design for pushability and torque response and a three-marker system, similar to Ocelot's, to facilitate consistent image interpretation across the platform. The company submitted a 510(k) application for Tigereye ST to the FDA in July 2022.

Other Products

The company’s first-generation CTO crossing catheters, Wildcat and Kittycat 2, employ a proprietary design that uses a rotational spinning technique, allowing the physician to switch between passive and active modes when navigating across a CTO. Once across the CTO, Wildcat and Kittycat 2 allow for placement of a guidewire and removal of the catheter while leaving the wire in place for additional therapies. Both products require the use of fluoroscopy solely rather than the company’s Lumivascular (OCT-guided) platform for imaging. Wildcat was the company’s first commercial product and has both FDA 510(k) clearance in the United States and CE Marking in Europe for crossing peripheral artery CTOs. Kittycat 2 has FDA 510(k) clearance in the United States and CE Marking in Europe for the treatment of peripheral artery CTOs. The company discontinued selling these products as the company is focusing on the promotion of the company’s Lumivascular platform products.

Clinical Development

The company has conducted several clinical trials to evaluate the safety and efficacy of the company’s products in both pre-market and post-market assessments. The company received FDA clearance for the Ocelot CTO crossing device in 2012, for the Pantheris device for atherectomy in peripheral arteries in October 2015 and then in November 2021 for the indication for use of the Pantheris device to include treatment of in-stent restenosis following completion of clinical trials of these devices.

CONNECT II (Ocelot)

The company’s clinical trial for Ocelot, known as CONNECT II, was a prospective, multi-center, non-randomized trial that evaluated the safety and efficacy of Ocelot in crossing CTOs in arteries of the upper leg using OCT intravascular imaging. The CONNECT II trial enrolled 100 patients with CTOs at 13 centers in the United States and 2 centers in Europe. Patients were followed for 30 days post-procedure and an independent group of physicians verified the results to confirm the primary efficacy and safety endpoints. Results from the CONNECT II trial demonstrated that Ocelot surpassed its primary efficacy endpoint by successfully crossing the CTO in 97% of the cases following unsuccessful attempts to cross with standard guidewire techniques. Ocelot achieved these rates with 98% freedom from MAEs.

VISION (Pantheris)

VISION was the company’s pivotal, non-randomized, prospective, single-arm trial to evaluate the safety and effectiveness of Pantheris across 20 sites within the United States and Europe. The objective of the clinical trial was to demonstrate that Pantheris can be used to effectively remove plaque from diseased lower extremity arteries while using on-board visualization as an adjunct to fluoroscopy. Two groups of patients were treated in VISION: (1) optional roll-ins, which are typically the first two procedures at a site, and (2) the primary cohort, which are the analyzable group of patients. The data for these two groups were reported separately in the company’s 510(k) submission to the FDA. Based on final enrollment, the primary cohort included 130 patients. In March 2015, the company completed enrollment of patients in the VISION clinical trial and the company submitted for 510(k) clearance from the FDA in August 2015. In October 2015, the company received 510(k) clearance from the FDA for commercialization of Pantheris. The company made modifications to Pantheris subsequent to the completion of VISION and received 510(k) clearance an enhanced version of Pantheris in March 2016, and received 510(k) clearance in May 2018 for a next-generation version of Pantheris, which included new features and design improvements to the handle, shaft, balloon, and nose cone of the device as well as 510(k) clearance in April 2019 for Pantheris SV, a lower profile Pantheris.

INSIGHT (Pantheris)

The INSIGHT Trial was a prospective, global, single-arm, multi-center trial to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis (‘ISR’) in lower extremity arteries. ISR occurs when a blocked artery previously treated with a stent becomes narrowed again, thereby 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 X-ray fluoroscopy, and the inability to control the directionality of other atherectomy devices create concerns about impacting the integrity of the stent during the procedure. In terms of efficacy, therapies for in-stent restenosis, such as balloon angioplasty, have high rates of recurrent narrowing within stents.

The INSIGHT trial enrolled 97 patients at sites in the United States and Europe. Patient enrollment began in October 2017 and concluded in July 2021. Patients were evaluated at thirty days, six months and one year following treatment.

The results from the INSIGHT trial demonstrated that the Pantheris catheter is safe and effective when used to address in-stent restenosis. The study endpoints achieved the effectiveness performance goals while demonstrating a strong safety profile indicating that the Pantheris catheter can be used to safely excise tissue from occluded vascular stents with precision. The study results also demonstrate extremely low, acute device-related adverse events.

A 510(k) application to the FDA was submitted in June 2021 and the company received clearance to add ISR treatment to the indication for use for the Pantheris catheter in November 2021.

Other Studies

The company is pursuing additional clinical data programs, including a post-market study, IMAGE-BTK, that is designed to evaluate the safety and efficacy of Pantheris SV in the treatment of PAD lesions below-the-knee. The company is enrolling subjects and expect to complete enrollment by the end of 2023.

Sales and Marketing

The company focuses its sales and marketing efforts primarily on the approximately 10,000 interventional cardiologists, vascular surgeons and interventional radiologists in the United States that are potential users of the company’s Lumivascular platform products. The company’s marketing efforts are focused on developing strong relationships with physicians and hospitals that the company has identified as key opinion leaders based on their knowledge of the company’s products, clinical expertise and reputation. The company also uses continuing medical education programs and other opportunities to train interventional cardiologists, vascular surgeons, and interventional radiologists in the use of the company’s Lumivascular platform products and educate them as to the benefits of the company’s products as compared to alternative procedures such as angioplasty, stenting, bypass surgery or other atherectomy procedures. In addition, the company works with physicians to help them develop their practices and with hospitals to market themselves as centers of excellence in PAD treatment by making the company’s products available to physicians for treating patients.

Intellectual Property

As of December 31, 2022, the company held 54 issued and allowed U.S. patents, 1 U.S. pending provisional application, 22 U.S. utility patent applications and 4 PCT applications pending. As of December 31, 2022, the company also had 84 issued and allowed patents from outside of the United States. As of December 31, 2022, the company had 35 pending patent applications outside of the United States, including in Australia, Canada, China, Europe, India, Japan and Mexico. The company’s issued patents expire between the years 2028 and 2037.

‘Avinger,’ ‘Pantheris,’ ‘Lumivascular,’ and ‘Tigereye’ are trademarks of the company.

As of December 31, 2022, the company held six registered U.S. trademarks. In Europe, the company holds three registered trademarks. In the United Kingdom, the company holds three registered trademarks. In addition, the company held one International Registration under the Madrid Protocol with granted extensions to China, Europe, Japan, and Korea (reflected in the three European registrations noted above).

Research and Development

The company’s research and development expenses were $4.4 million during the year ended December 31, 2022.

Manufacturing

The company’s manufacturing operations are subject to regulatory requirements of 21 CFR part 820 of the Federal Food, Drug and Cosmetic Act, or FFDCA; the Quality System Regulation, or QSR, for medical devices sold in the United States, which is enforced by FDA; the Medical Devices Directive 93/42/EEC, which is required for doing business in the European Union; and applicable requirements relating to the environment, waste management and health and safety matters, including measures relating to the release, use, storage, treatment, transportation, discharge, disposal and remediation of hazardous substances, and the sale, labeling, collection, recycling, treatment and disposal of products containing hazardous substances.

The company has registered with FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Public Health, or CDPH. The company and its component suppliers are required to manufacture the company’s products in compliance with FDA’s QSR in 21 CFR part 820 of the FFDCA. The QSR regulates extensively the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of the company’s products.

The company has opted to maintain quality assurance and quality management certifications to enable the company to market the company’s products in the member states of the European Union, the European Free Trade Association and countries which have entered into Mutual Recognition Agreements with the European Union. The company’s Redwood City facilities meet the requirements set forth by ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes and MDD 93/42/EEC European Union Council Medical Device Directive.

Government Regulation

The company is registered with the FDA as a medical device manufacturer and have obtained a manufacturing license from the CDPH. The FDA has broad post-market and regulatory enforcement powers. The company is subject to unannounced inspections by the FDA and the Food and Drug Branch of CDPH to determine the company’s compliance with the QSR and other regulations.

The company is subject to the Physician Payment Sunshine Act.

The Foreign Corrupt Practices Act obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, if any, and to devise and maintain an adequate system of internal accounting controls for international operations.

History

Avinger, Inc. was founded in 2007. The company was incorporated in 2007 as a Delaware corporation.