Peripheral arterial occlusive disease

Initial $7.5 Million Strategic Investment Strategic Partnership Opens Pathway to Access Greater China Market Strengthened Balance Sheet and Three-Year Extension of Existing Debt Terms REDWOOD CITY, CA / ACCESSWIRE / March 6, 2024 / Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today announced a new strategic partnership with Zylox-Tonbridge Medical Technology Co., Ltd. (2190.HK, "Zylox-Tonbridge"), a leading medical device company in the neuro- and peripheral-vascular interventional market in China. Based in Hangzhou, China and listed on the Hong Kong Stock Exchange, Zylox-Tonbridge has developed and launched 36 products into the Greater China interventional markets since its founding in 2012. With a sales and marketing organization of more than 130 people and a vast distribution network, Zylox-Tonbridge achieved the equivalent of approximately $58 million in sales in the most recently reported 12-month period (ended June 30, 2023), representing a growth rate of greater than 50% compared to the prior year period. The strategic partnership provides up to $15 million of equity funding from Zylox-Tonbridge in two tranches, a licensing agreement providing access for Avinger's products in the Greater China region, and a technology transfer agreement to build cost-efficient manufacturing capacity to support global sales. In addition, the parties have signed a strategic collaboration agreement which provides the opportunity for Avinger to access certain Zylox-Tonbridge peripheral vascular products for distribution in the U.S. and Germany. Key Terms of Financing Agreement Under the terms of the financing agreement, Zylox-Tonbridge will invest up to $15 million into Avinger through the purchase of preferred and common stock in two tranches. The initial $7.5 million investment was priced at-the-market under Nasdaq rules at a purchase price of $3.66 per share on an as converted to common stock basis. A second tranche of $7.5 million will be funded upon achieving key milestones, including successfully registering Zylox-Tonbridge as a manufacturer of Avinger's products with the U.S. Food & Drug Administration ("FDA") and Avinger achieving $10 million in aggregate revenue over four consecutive quarters. Avinger's obligation to accept conversion of the initial shares of preferred stock and issue and sell shares of preferred stock upon completion of the milestones are each subject to receipt of the approval of Avinger's stockholders. Concurrent with the Zylox-Tonbridge first tranche investment, CRG Partners, the primary holder of Avinger debt and preferred equity exchanged its Series A preferred stock with an aggregate liquidation preference of approximately $60 million for new Series A-1 preferred stock with a value of $10 million. The new Series A-1 preferred stock is convertible at the same price as the Zylox-Tonbridge transaction and carries no liquidation preference or dividends. Additionally, CRG extended principal payments on Avinger's debt from the first quarter of 2024 to the first quarter of 2027, with interest payments accruing during this time. Key Terms of License, Technology Transfer and Strategic Collaboration Agreement Under the terms of the license and technology transfer agreement, Zylox-Tonbridge has exclusive rights to distribute and manufacture Avinger's proprietary image-guided devices in the Greater China region, including mainland China, Hong Kong, Macao, and Taiwan (the "Territory"). Zylox-Tonbridge will lead all regulatory activities for the registration of the Avinger products in the Territory. Avinger will supply product to Zylox-Tonbridge until such time Zylox-Tonbridge's manufacturing capability has been established. All sales of Avinger products in the Territory will be royalty bearing to Avinger. In addition, the parties have signed a strategic cooperation framework agreement, which provides the opportunity for Avinger to access certain Zylox-Tonbridge peripheral vascular products for distribution in the U.S. and Germany. The agreement also provides the option for Avinger to source finished goods from Zylox-Tonbridge following registration of their manufacturing facility with the FDA. "We are excited to announce this strategic transaction with Zylox-Tonbridge, a dynamic leader in the peripheral interventional market in China," said Jeff Soinski, Avinger's President and CEO. "Our broad-reaching partnership creates an exciting new pathway for Avinger products to enter the large and growing Greater China market through an established commercial channel. It also provides the opportunity for a more cost-efficient manufacturing structure to support the growth of global sales, as well as the potential for Avinger to access Zylox-Tonbridge's high-quality peripheral products for distribution in the U.S. and Germany." Dr. Jonathon Zhao, Chairman and CEO of Zylox-Tonbridge, said, "We are pleased to partner with Avinger to provide Chinese healthcare professionals and patients with cutting-edge medical technologies and disruptive innovative products. We believe this collaboration will expand the company's Peripheral Vascular Intervention product portfolio, reinforce our market leadership, and accelerate the growth of the vessel preparation business in China's peripheral vascular intervention market. By leveraging our leading manufacturing capabilities and working with Avinger, we are confident in bringing patients more cost-efficient and high-quality products. We are looking forward to cooperating with global partners to share growing market opportunities by offering high-quality and affordable innovative medical products and services." Mr. Soinski continued, "Concurrent with this transaction, we have significantly improved our balance sheet with a cash infusion, the exchange of our Series A preferred stock for new Series A-1 preferred stock, and the deferral of principal payments on our existing debt for three years. Combined, these transactions represent a strong show of confidence in our product portfolio. "With this transaction, we have positioned Avinger to access exciting new growth opportunities in China and improve its operating cost structure as global manufacturing comes online. We have also provided the opportunity for new revenue growth and increased sales productivity in our current markets through the potential distribution of Zylox-Tonbridge products in the U.S. and Germany. We are excited to move forward in 2024 as we continue to drive sales of our best-in-class commercial peripheral products and ready our groundbreaking image-guided coronary CTO-crossing device for IDE submission later this year." Detailed terms of the Zylox-Tonbridge transaction will be filed on Form 8-K with the United Stated Securities and Exchange Commission. About Avinger, Inc. Avinger is a commercial-stage medical device company that designs and develops the first image-guided, catheter-based system for the diagnosis and treatment of patients with vascular disease in the peripheral and coronary arteries. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices for the treatment of peripheral artery disease (PAD), estimated to affect more than 200 million people worldwide. Avinger is developing its first product application for the treatment of coronary artery disease (CAD), an image-guided system for CTO-crossing in the coronary arteries, which provides the opportunity to redefine a large and underserved market. Avinger is based in Redwood City, California. For more information, please visit . Follow Avinger on Twitter and Facebook. About Zylox-Tonbridge Zylox-Tonbridge is one of the leading players in the neuro- and peripheral-vascular interventional medical device market in China. The Company was founded in 2012 and is headquartered in Hangzhou, China. As an integrated medical device company supported by in-house R&D and manufacturing capabilities, proprietary technological platforms, and commercialization capabilities, Zylox-Tonbridge strives to provide all patients, regardless of their ethnicity, age and economic conditions, with accessible medical devices and services. 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 benefits of the strategic transaction with Zylox-Tonbridge, benefits to our manufacturing structure, the pathway for Avinger products to enter the Greater China market, benefits of accessing Zylox-Tonbridge's peripheral products, the potential expansion of the Peripheral Vascular Intervention product portfolio of Zylox-Tonbridge, potential benefits to patients of the collaboration with Zylox-Tonbridge, the improvement in our operating cost structure, the opportunities for new revenue growth and increased sales productivity, and obtaining stockholder approval to facilitate the equity financing. 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; the adoption of our products by physicians; our ability to obtain regulatory approvals for our products; 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 16, 2023, as amended, and 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. Investor Contact: Matt Kreps Darrow Associates Investor Relations (214) 597-8200 mkreps@darrowir.com Public Relations Contact: Phil Preuss Chief Commercial Officer Avinger, Inc. (650) 241-7942 pr@avinger.com SOURCE: Avinger, Inc. View the original press release on accesswire.com

TAICHUNG, Feb. 24, 2024 /PRNewswire/ -- In winter, cardiovascular diseases are more prevalent, which significantly increase the likelihood of arterial blockage. In addition to increasing the possibility of accompanying myocardial infarction or stroke, seniors should be especially cautious about Peripheral Arterial Occlusive Disease (PAOD). In mild cases, impaired walking, numbness and weakness during running are experienced; in cases of severe blockage, patients are at risk of developing gangrene (a dry, black sore) and frequently have their foot amputated eventually. If the event comes quickly - so called acute PAOD, even after receiving standard treatment, the mortality and amputation rates remain in the 20-30% range. Continue Reading Chang, a 72-year-old female, (first from the right) has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation, as well as right lower extremity coldness with unusual pain. Dr. Hsu Chung-Ho (middle) examined thrombi in the popliteal artery of her right lower extremity, resulting in severe obstruction of blood flow in the lower extremity. Since 2016, China Medical University Hospital (CMUH) in Taiwan has established the "24-hour thrombolysis team" to conduct research and treatment in response to this deadly disease. For acute PAOD patients, after emergent survey at Emergency Room (ER), Pharmacomechanical Thrombectomy (PMT) with Rotarex based atherectomy with or without Ekosonic Endovascular System (EKOS) are performed to treat patients with acute and severe arterial blockage in the lower extremities if indicated. The clinical amputation and mortality rates in regard of acute PAOD significantly reduced from 20-30% to 3%. The clinical results were published in the medical journal "International Angiology." "To prevent permanent necrosis of the muscle tissues and to lower mortality, a 24-hour standby medical team must be available to perform emergent thrombi removal within 'golden' hours before irreversible events develop." says Dr. Chung-Ho Hsu, director of the section of peripheral vascular disease, division of cardiovascular medicine, department of internal medicine, CMUH, Taiwan. Miss Chang, a 72-year-old female, has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation. In spite of this, Chang experienced right lower extremity coldness with unusual pain suddenly. Following an ultrasound examination by Dr. Hsu, thrombi were discovered in the right popliteal artery, resulting in severe obstruction of blood flow in the lower extremity. CMUH convened the "24-hour thrombolysis team", where an emergent catheter-based thrombectomy/thrombolysis operation was performed under local anesthesia immediately. After PMT with Rotarex and thrombolysis with EKOS, Chang's blood circulation was greatly improved, and the amputation crisis was successfully averted. Mr. Kou is another case of successful lower limb salvage treatment. Mr. Kuo is an 80-year-old patient with multiple chronic conditions: hypertension, diabetes, coronary artery occlusion, persistent atrial fibrillation, and heart failure, as well as chronic obstructive pulmonary disease. Mr.Kuo rushed to the ER in CMUH after experiencing right lower extremity coldness and sharp pain. Dr. Hsu discovered thrombi in the anterior tibial artery of Mr.Kuo's right lower extremity during an examination, resulting in poor blood circulation in the lower extremities. The thrombi were successfully removed after an emergent catheter-based thrombolysis with EKOS, as well as the use of drug-coated balloons and stents, and blood flow returned to normal, avoiding the fate of an amputation that could have resulted in severe disability. Acute PAOD is frequently the result of atrial fibrillation, which causes thrombi to fall from the heart to the arteries of the lower extremities, resulting in a sudden and severe blockage. According to Director Hsu at CMUH, acute PAOD is most prevalent in the lower extremities, and symptoms include decreased temperature of the affected limb (frequently feeling cold), pain, pallor, numbness, poor walking ability, pulselessness, and paralysis. In the most severe cases of acute PAOD, muscle tissues develop ischemic necrosis, and patients are even forced to have limbs amputated or lost their life. Mortality will be as high as 100 percent if left untreated. Importantly, after amputation, these patients are likely to face life-threatening risks again, and condition will deteriorate due to less exercise after amputation, making this disease difficult to treat. As for how to determine if one has PAOD, Dr. Hsu explains that the disease can be divided into four stages based on its severity and clinical manifestations (Fontaine stage): Stage 1 (asymptomatic): No symptoms, only diseased lower limb arteries identified. Stage 2: The legs are prone to fatigue and weakness during walking, but the patient can continue to walk after a short rest. The recurrence of the initial symptoms appears later on, which is given the name intermittent claudication. Stage 3: Severe vascular obstruction and inadequate local circulation while at rest, which results in chronic pain,so called ischemic rest pain. Stage 4: Ulcers and necrosis begin in the toes and spread to the feet and ankles as the skin changes color from pink to dark purple as a result of ischemia. However, if the symptoms worsen quickly with either pain, pallor, poikilothermia, paresthesia, pulselessness, or paralysis, one should think about acute PAOD, which is a medical emergency and need to rush to the ER immediately. For acute PAOD, CMUH will arrange vascular ultrasound immediately at ER and decide which is the clinical stage. If the condition is feasible, 24-hour thrombolysis team will be initiated to perform endovascular therapy immediately to save legs, also save lives. Acute PAOD often stems from atrial fibrillation, a condition that leads to the formation of thrombi in the heart which can then dislodge and block the arteries in the lower extremities, causing sudden and severe blockage. In light of this, Director Hsu strongly advises patients with atrial fibrillation to adhere to a regular regimen of anticoagulants to prevent thrombotic events. CMUH successfully r educed clinical amputation rates from 30% to 3%, and death rates from 30% to 3%. The clinical results were published in the medical journal "International Angiology" in April of 2022. Under the care of the "24-hour thrombolysis team" led by Director Hsu, their health and mobility have been restored. Media contact: Carolyn Chen, [email protected].tw SOURCE China Medical University Hospital

Peripheral artery disease contributes to about 400 amputations performed each day in the U.S. Peripheral artery disease (PAD) is one of the leading causes of non-trauma-related amputations, but 70% of Americans have never heard of this disease, according to a new survey. To help change this, four leading heart and vascular societies, in collaboration with industry sponsors including Philips, have united to form the PAD Pulse Alliance. The alliance aims to increase awareness about the condition and encourage patients to discuss their symptoms with their doctors. PAD is a common condition where a buildup of fatty deposits in the arteries restricts blood supply to leg muscles, which can cause leg pain, and is a form of cardiovascular disease. The PAD Pulse Alliance said in a press release that this contributes to about 400 amputations performed each day in the U.S. To boost awareness, the campaign has launched a new website called “Get a Pulse on PAD” that sets out resources for patients to use and asks visitors to “be your own PAD champion.” Linked to the campaign is also a new survey which has shown that up to 70% of Americans do not know about the disease. The survey, conducted among 1,000 Americans in the general population along with two additional groups comprising 500 individuals from the Black community and 500 from the Hispanic community, revealed that nearly 75% of Black and Hispanic adults surveyed either have or know someone with diabetes, high blood pressure or is a smoker. Surprisingly, only 30% believe they could be at risk. “This is in stark contrast to real-world impact,” the alliance said in the release, as Black people are twice as likely to suffer from PAD and up to four times more likely to undergo an amputation compared to white people. Hispanics present with more progressive PAD leading to worse outcomes including greater risk of amputation. Nearly all the survey respondents (91%) would dismiss pain as just part of getting older, but pain in your leg when walking that goes away with rest is one of the first symptoms of PAD. Meanwhile, just over half (53%) of respondents would wait more than a week with ongoing leg pain before calling their doctor. “Screening for PAD is easy, quick, and non-invasive. Yet, this survey confirmed that critical patient-provider conversations addressing common symptoms aren't happening,” said Society of Interventional Radiology President Alda L. Tam, M.D., an interventional radiologist and professor in the Department of Interventional Radiology at the University of Texas MD Anderson Cancer Center in Houston, in the release. “If we can educate more people on the risk factors and early warning signs associated with PAD, it's our hope we can foster dialogue earlier between providers and patients to kick off screening and treatment, ultimately preventing amputations and saving lives.” The alliance is sponsored by Gore, Shockwave Medical and Philips, the last two of which market medical tech for cardiovascular disease and PAD.