- The stock price of Avinger Inc (NASDAQ: AVGR) increased by 65.48% this past month. This is why it happened.
The stock price of Avinger Inc (NASDAQ: AVGR) – a commercial-stage medical device company marketing the first-ever image-guided and catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD) – increased by 65.48% this past month. There were several reasons why it happened.
December 1 – Nasdaq Extension
On December 1, Avinger announced that it received a Nasdaq extension until May 19, 2021 to regain compliance with the Nasdaq minimum bid price requirement for continued listing. And the company recommended that stockholders vote for all proxy proposals.
Previously, the company had until November 20, 2020 to regain compliance and received its extension notice on November 24, 2020. In order to ensure Avinger will successfully resolve its minimum bid price requirement, either through organic growth in its stock price or via a reverse stock split, Avinger had included a proposed authorization for the Board of Directors to effect a reverse stock split at a ratio not less than 1-for-5 and not greater than 1-for-20 to maintain Avinger’s Nasdaq listing.
The company’s management and Board of Directors recommend that stockholders eligible to vote at the company’s upcoming annual meeting vote for all proposals, including the reverse stock split proposal. And both Institutional Shareholder Services (ISS) and Glass Lewis (two leading proxy advisory services firms) have recommended voting for the proposed reverse stock split.
“We recommend that stockholders immediately vote FOR all proxy proposals to ensure that Avinger has every tool available to maintain its Nasdaq listing,” said Avinger’s President and CEO Jeff Soinski. “Should a reverse stock split be needed to maintain our listing, and stockholders do not vote in favor of the authorization at the annual meeting on December 10, Avinger would need to hold another meeting within just three to four months at significant cost, diverting personnel and cash resources from our growth plans for 2021 and beyond. We believe that voting FOR all proposals at the regularly scheduled meeting on December 10 avoids this needless time and expense. Further, we believe that voting FOR the proposals now addresses what would otherwise be ongoing uncertainty around our listing status.”
Soinski also highlighted the company’s progress in 2020 despite the COVID-19 pandemic. Soinski added: “While it has been a challenging year, we believe our third-quarter results showed solid progress, including FDA clearance of our new Tigereye CTO catheter and the launch of 10 new user sites. During 2020, we took steps to fund our growth capital needs for 2020 and 2021, positioning Avinger with a strong balance sheet to support our strategic initiatives. We have also maintained a number of the operating expense cuts enacted earlier in 2020, emerging a leaner, more efficient growth business ready for the year ahead. With three best-in-class products, our new L300 Lightbox development advancing well and exciting clinical studies to continue documenting our patient outcomes, 2021 should be a transformative year for Avinger. We believe that a vote FOR the reverse split proposal reduces future administrative costs and is in the best interest of all shareholders.”
December 4 – Expansion Of Avinger’s Tigereye Limited Launch
On December 4, Avinger provided an update on the limited launch of its Tigereye next generation image-guided chronic total occlusion (CTO) crossing system. And Avinger is conducting a limited launch at clinical centers in the U.S. and Germany during the fourth quarter of 2020 prior to a planned expansion to full U.S. commercial distribution in the first quarter of 2021.
Upon clearance by the U.S. Food and Drug Administration, Avinger announced the completion of first U.S. cases with Tigereye in three clinical sites in October 2020. And since that time, Avinger has launched the new Tigereye catheter into five additional clinical centers in the U.S. and one hospital in Germany where Tigereye was initially introduced under CE Marking.
The first sites in the U.S and Germany continue to treat additional patients with the device. And a total of 10 sites have now used Tigereye with over 40 cases successfully performed to date. Based on positive clinical results and excellent product reliability experienced in the limited launch program, Avinger expects to expand the commercial availability of Tigereye for U.S. national launch in January 2021.
“Tigereye’s performance in a variety of cases during this important limited launch phase has generated overwhelming excitement and confidence amongst users,” stated Dr. Jaafer Golzar an interventional cardiologist and Avinger’s Chief Medical officer. “Based on my personal initial case experiences and feedback from other physicians, the enhanced imaging, higher rotational speeds and ability to precisely control the device with variable deflection inside the vessel improve our ability to safely and effectively cross challenging CTOs… I have been very pleased with the efficiency of workflow and how rapidly we have been able to cross complex CTOs. We have learned a lot from these initial cases, and I believe we are just beginning to understand the true potential and harness the power of Tigereye in a variety of complex lesion subsets.”
Soinski pointed out that the limited launch experience reaffirmed the belief that Tigereye represents an important growth opportunity in addressing the CTO segment with “unparalleled” imaging and control for physicians seeking better solutions on behalf of their patients. The expansion to full commercial availability is expected to happen in January 2021.
Tigereye is known as being a product line extension of Avinger’s Ocelot family of image-guided CTO crossing catheters. ANd its design elements include high definition, real-time intravascular imaging, and a user-controlled deflectable tip designed to assist in steerability within the lumen.
Tigereye also has a new distal tip configuration with faster rotational speeds up to 1000 RPM designed to penetrate challenging lesions. And the Tigereye catheter has a working length of 140 cm and 5 French sheath compatibility for treatment of lesions in the peripheral vessels both above and below the knee. Tigereye is also complementary to Avinger’s image-guided atherectomy line up, including the Pantheris Next Generation and Pantheris SV devices.
And 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 (OCT) that is displayed on Avinger’s Lightbox console. And physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. Through the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions (thanks to the real-time OCT images generated from inside the artery) without exposing healthcare workers and patients to the negative effects of ionizing radiation.
December 11 – Annual Meeting of Stockholders Adjourned
On December 11, Avinger announced that its annual meeting of stockholders scheduled for and convened on December 10, 2020, has been adjourned to December 23, 2020, at 1:00 p.m. Pacific Time.
And a quorum was present for the authorization of the meeting on December 10, 2020, and the stockholders entitled to vote at the Annual Meeting had voted to approve the proposal to adjourn the Annual Meeting (Proposal 4) for the purpose of continuing to solicit votes in favor of proposal 3, the reverse stock split proposal, contained in the Company’s Proxy Statement.
“While the Nasdaq extension has been granted, we have limited time to come into compliance with the minimum bid price requirement to maintain the Company’s Nasdaq listing. If stockholders do not immediately vote FOR the reverse split authorization as part of the December meeting, we will likely need to commence another costly meeting in as little as three months. Approving the matter now saves time and cash that is intended to help drive growth in 2021, not cover the cost of an avoidable meeting,” acknowledged Soinski. “We strongly encourage all stockholders to vote FOR this matter immediately. Any stockholder that has voted against the reverse stock split proposal can change their vote to FOR.”
Avinger said that it believes approval of Proposal 3 in December 2020 is important to its future success as a reverse stock split may be necessary to maintain the listing of Avinger’s common stock on the NASDAQ Capital Market. And a delisting of the common stock from Nasdaq could significantly impair the price for Avinger’s common stock and may impact a stockholder’s ability to trade shares of common stock.
Both Institutional Shareholder Services (ISS) and Glass Lewis, two leading proxy advisory services firms, have recommended that stockholders vote FOR the proposed reverse stock split at this meeting. And most voting Avinger stockholders have supported Proposal 3 with nearly 60% of the votes cast in favor of the proposal. But the favorable votes were less than the majority of all outstanding shares needed for approval. Proposals 1, 2, and 4 received the required number of votes for approval at the Annual Meeting.
December 23 – Annual Meeting Results Announced
Avinger announced the results of its annual meeting of stockholders, concluded on December 23, 2020. At the Annual Meeting, proposals were presented to elect one director to serve until the 2023 annual meeting, to ratify the appointment of the company’s public accountant for the year ended December 31, 2020, to approve an amendment to the company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split and to adjourn the Annual Meeting for the purpose of continuing to solicit votes with respect to the proposals presented.
And the stockholders entitled to vote at the Annual Meeting approved the proposals to elect one director to serve until the 2023 annual meeting, ratify the appointment of the Company’s public accounting for the year ended December 31, 2020, and to adjourn the Annual Meeting for the purpose of continuing to solicit votes. However, the reverse stock split proposal was not approved.
Even though a majority of the votes received were cast in favor of the reverse stock split proposal, Avinger did not receive the approval of the majority of the shares outstanding required in order to approve the reverse split proposal.
“While the Nasdaq extension has been granted, we did not receive the required votes to approve the reverse stock split proposal at this time. We intend to commence preparations in 2021 for another meeting in order to ensure we have every opportunity to maintain our Nasdaq listing, either through organic share price improvement or a reverse stock split,” noted Soinski. “As we look ahead to 2021, we are excited about Avinger’s current position. We enter the year with a well-funded balance sheet, with capital to cover our 2021 growth plans. In January, we expect to begin the full commercial launch of our Tigereye CTO device… In order to drive further growth, we continue to advance our next generation Lightbox 3 imaging console, clinical studies in support of our products, and the development of new image-guided catheters for peripheral and coronary applications.”
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