We are a leading innovative medical device company in China focusing on providing “leave nothing behind” treatment solutions for vascular diseases. We have developed a suite of interventional medical devices featuring world-leading technologies, notably in the fields of drug-coated balloons (DCB) and thrombus aspiration catheters. We developed and launched the first peripheral DCB product in China in 2016, approximately four years ahead of the closest runner-up, and had a dominating market share of approximately 86.9% in the peripheral DCB market in China in terms of revenue generated in 2020. Our second DCB product was designated as a “breakthrough device” by the FDA in 2019 as it provides for more effective treatment in irreversibly debilitating human conditions and offers significant advantages over existing approved or cleared alternative medical devices. The designation also indicates that the product represents breakthrough technology and its availability is in the best interest of patients. After the designation, the product was entitled to an expedited process of the development, assessment, and review by the FDA. The product also obtained the NMPA approval in December 2020, making it the world’s first (and, as of the Latest Practicable Date, only) below-the-knee (BTK) DCB product receiving regulatory approval based on multi-center randomized controlled clinical trial results. Our DCB products feature one of the most advanced drug-coating technologies among all the DCB products worldwide, and had demonstrated good clinical performance based on the results of the clinical trials conducted by us for such products. We are also in the process of developing a comprehensive product pipeline, with 24 product candidates in various stages of development as of the Latest Practicable Date. We believe our first-mover advantages, world-leading technologies, dominating market share in China, and comprehensive product pipeline established high entry barriers difficult for our competitors to surpass. Our mission is to become a global leader that provides full-suite “leave nothing behind” interventional solutions for vascular diseases. We are also expanding indications of our DCB products for the treatment of AVF stenosis, VAO stenosis and vasculogenic ED. There are unique challenges, risks and uncertainties associated with this. We may not be able to successfully develop and market our Core Products indicated for these diseases.
Interventional treatment of vascular diseases caused by atherosclerosis is regarded as one of the most innovative fields of modern medical research. In recent years, the growing prevalence of vascular diseases caused by atherosclerosis such as peripheral artery disease (PAD), coronary artery disease (CAD), and stroke boosted the adoption of minimally invasive interventional procedures worldwide. Treatment solutions used in these interventional procedures have evolved from percutaneous transluminal angioplasty (PTA) balloons to stents, and further to DCBs. The major drawback of PTA balloons is the high incidence of short-term vessel restenosis. Stents are effective in preventing vessel restenosis, but may cause complications such as thrombosis, stent fracture, and in-stent restenosis (ISR). DCB therapy is an innovative therapy using angioplasty balloons coated with anti-proliferative drugs. As compared to PTA balloons, DCB can effectively inhibit neointimal hyperplasia, thereby reducing the risks of vessel restenosis. As compared to stenting, DCB therapy can significantly reduce the risk of thrombosis, avoid stent fracture and ISR, and more importantly, offers a unique value proposition of “leaving nothing behind” in human bodies. As a result of such benefits, DCBs are becoming increasingly popular and have been progressively replacing stents in vascular interventions, according to Frost & Sullivan. We primarily focus on the peripheral artery disease DCB market, which accounted for approximately 13.4% of the overall DCB market in China in 2019, but is expected to account for approximately 50.0% of the overall DCB market in China by 2030, according to Frost & Sullivan.
The concept of DCB therapy was first envisioned by our CTO, Dr. Ulrich Speck, who invented the first DCB product in the world, the drug-coating technology used in B. Braun’s SeQuent Please, the world’s No. 1 coronary DCB product in terms of sales volume up to the Latest Practicable Date, as well as the drug-coating technology used in Medtronic’s IN.PACT, the world’s No. 1 peripheral DCB product in terms of sales volume up to the Latest Practicable Date, according to Frost & Sullivan. Thereafter, Dr. Speck made several other breakthrough discoveries in drug-coating technology, which we use in our DCB products and product candidates.
As of the Latest Practicable Date, we had two DCB products approved by the NMPA.
‧ AcoArt OrchidR & DhaliaTM, our Core Product, is indicated for treating superficial femoral artery (SFA) and popliteal artery (PPA) lesions. AcoArt OrchidR & DhaliaTM was approved by the NMPA in May 2016, approximately four years ahead of the closest runner-up. We started to sell AcoArt OrchidR in China since June 2016 and AcoArt DhaliaTM in China since August 2016. As of the Latest Practicable Date, we had launched AcoArt OrchidR & DhaliaTM in China and AcoArt OrchidR in eleven other countries, including medically-advanced countries such as Germany, Italy and Switzerland.
‧ AcoArt TulipTM & LitosTM, our Core Product, is indicated for treating BTK lesions. We obtained the NMPA approval for AcoArt TulipTM & LitosTM through a fast-track program in December 2020. We started to sell AcoArt TulipTM & LitosTM in China since January 2021. According to Frost & Sullivan, as of the Latest Practicable Date, AcoArt TulipTM & LitosTM was the only BTK DCB product approved by the NMPA, and there was no ongoing clinical trial conducted in China for any other BTK DCB product candidates. We expect that we can maintain our leading position in the BTK DCB market in China for at least five years considering that AcoArt TulipTM & LitosTM was the first BTK DCB approved for market in China, and as of the Latest Practicable Date, there was no ongoing clinical trial conducted in China for any other BTK DCB product candidates. AcoArt LitosTM was designated as a “breakthrough device” by the FDA in 2019, and was the first (and, as of the Latest Practicable Date, one of the only four) domestically-manufactured device(s) receiving such designation, according to Frost & Sullivan. As of the Latest Practicable Date, we had launched AcoArt TulipTM & LitosTM in China and eleven other countries including Germany, Italy and Switzerland.
We are also a pioneer in expanding indications of DCB products. The narrowing of arteries may result in different types of diseases. Depending on the different arteries affected, such diseases include CAD, PAD, stroke, arteriovenous fistula (AVF) stenosis in hemodialysis (HD) patients and erectile dysfunction. DCB therapy, as a proven therapy for the treatment of CAD and PAD, is a promising therapy for treating these other types of vascular diseases. We do not plan to devote our resources competing in the CAD DCB market, which accounted for approximately 86.6% of the overall DCB market in China in 2019, but is expected to account for only approximately 42.0% of the overall DCB market in China by 2030, according to Frost & Sullivan. We are actively exploring the opportunities to expand the indications of our Core Products to nephrology, neurology and andrology, to address the unmet or underserved clinical needs of patients suffering from other types of vascular diseases, such as arteriovenous fistula (AVF) stenosis, vertebral atherosclerotic stenosis and erectile dysfunction. With our strong research and development capabilities, accumulated experience in product registration, and our established commercialization network, we believe that we can efficiently replicate our success in the lower extremity DCB market, and capture the growth potential of the large and fast growing vascular disease treatment market in China.
We are also offering and developing many other therapeutic, procedural and ancillary medical devices such as thrombus aspiration devices and radiofrequency systems.
Source: Acotec-B (06669) Prospectus (IPO Date : 2021/08/12) |