Zhitong Finance App News, Guichuang Tongqiao-B (02190) announced that in order to enhance the company's peripheral vascular intervention device portfolio, the company has entered into a series of licensing and investment agreements with Avinger Inc. (Avinger). Avinger is an American innovative medical device company and a third party independent of the company and its affiliates. Under such agreements, the Company will:

1. Obtain exclusive rights to localize, manufacture and commercialize the entire product line of optical coherence tomography (OCT) consoles, OCT guided peripheral vascular plaques cutting devices, and chronic complete peripheral vascular occlusion (CTO activation) devices developed by Avinger in the Greater China region (including mainland China, Hong Kong, Taiwan, and Macau, China);

2. Become an authorized OEM manufacturer of licensed products sold by Avinger or its agents outside of Greater China after obtaining regulatory approval and/or filing;

3. A number of peripheral vascular intervention products developed by distribution companies in the US and Germany in cooperation with Avinger; and

4. Invest USD 15 million in Avinger in two installments by subscribing for Avinger's newly issued common shares and preferred shares (USD 7.5 million each, subject to achieving certain milestones and meeting other delivery conditions).

Over the years, Avinger has been committed to developing and promoting peripheral artery disease (PAD) treatment devices in the US and Europe. Its disruptive flagship products licensed to the company mainly include Pantheris (OCT Guided Peripheral Vascular Plaque Cutting Device Series) (Pantheris) (approved to treat peripheral vascular disease and stent restenosis (ISR)), Ocelot and Tigereye (two series of OCT guided peripheral vascular CTO opening devices) (Ocelot and Tigereye), and LightBox 3 (OCT imaging console). This series of products is the only PAD treatment device with real-time imaging function in the world. More importantly, Avinger has completed a number of clinical trials, including VISION Study, INSIGHT Study, and CONNECT Study, all of which clearly show the clinical safety and efficacy of the relevant devices. Headquartered in California, USA, Avinger has mature manufacturing technology, excellent R&D capabilities, and an experienced management team composed of many industry veterans.

According to Millennium Research Group's market research data, as of 2022, there were more than 8 million PAD patients in the US. Atherosplectomy has become a common treatment, bringing the overall potential market size of atherosclerotic plaques to about US$760 million in 2022. Compared to the US market, epidemiological data from Chinese expert consensus released by relevant professional medical associations shows that as of 2020, the number of PAD patients in China was about 40 million, and it is still growing rapidly. With the continuous penetration of drug-coated balloons in interventional treatment, the demand for better vascular preparation to optimize post-intervention effects has increased dramatically over the past few years.

Currently, due to the risk of intravascular damage, atherosclerotic plaques approved in China have not been widely used. The doctor can only rely on a fluoroscopy platform during surgery, and cannot get a glimpse of the condition inside the blood vessels. At the same time, all approved products need to be imported, and the high price limits the expansion of their application in the Chinese market. With the introduction of Pantheris (a series of devices for cutting atheroma plaques with OCT function), doctors can see real-time intravascular images, greatly reducing the risk of vascular damage and paving the way for further treatment with drug-coated balloons or stents.

Regarding CTO opening devices, the Ocelot and TigerEye series opening terminals are also equipped with an OCT imaging system to clearly show the structure of diseased blood vessels. These devices improve the success rate of opening and maintain the actual lumen tube (that is, the initial channel in blood vessels), which is a key pain point in opening guide wires.

The company believes that cooperation with Avinger will enable both parties to accelerate the release of potential and unmet clinical needs in the field of vascular disease treatment in the Chinese peripheral vascular intervention market. The company will use its extensive marketing and sales network to promote advanced technology developed by Avinger to bring high-quality and affordable innovative medical device products and solutions to more Chinese patients. We expect that the localized manufacturing and supply of Avinger products in China will help it reduce production costs and gain a cost advantage in global market competition. Additionally, we expect to work with Avinger to explore the synergy between our products on a global scale. The company believes that this cooperation is another key step for us to establish our leading position in the PAD interventional device market. After successfully partnering with Avinger, the company will have a full product portfolio to meet the clinical needs of CTO opening, vascular preparation, and lesion treatment.