Blue Sail Medical Expands Structural Heart Portfolio with Strategic Partnership on Biodegradable PFO Occluder

Source:Bluesail MedicalOfficial WeChat

Recently,Bluesail Medical (002382)Cardiovascular Division, Mainly Bluesail Baisheng, Signs Strategic Cooperation Framework Agreement with WYTD Medical Technology (Shenzhen) Co., Ltd. ("WYTD"). Relying on Bluesail Baisheng's global localized team, professional registration capabilities, and leading channel coverage, the company will assist in the research, development, registration, and market access process for WYTD’s PFO (Patent Foramen Ovale) bioresorbable occluder on a global scale. This cooperation will also serve as an opportunity to facilitate overseas market entry and domestic and international distribution partnerships, promoting the commercialization of this product in key global markets.

PFO is one of the common structural congenital heart diseases. About 25% of adults in China have incomplete closure of the foramen ovale, with a population base of nearly 287 million. Long-term non-closure may lead to complications such as stroke and migraine. With the continuous improvement of clinical guidelines, the number of PFO closure surgeries has shown explosive growth in recent years, with the actual number of implants in China exceeding 80,000 cases in 2024.

Compared with traditional metal occluders, bioabsorbable occluders are made from biodegradable materials. After completing the occlusion function, they can be absorbed and degraded by the human body, avoiding potential risks such as thrombosis and endocardial tissue abrasion caused by long-term retention of metal foreign bodies. They are considered the next-generation direction in this field. In the recent provincial alliance procurement, bioabsorbable occluders were explicitly excluded from the procurement scope due to their advanced technological advantages, preserving sufficient market space for their commercialization.

WYTD's self-developed PFO bioabsorbable occluder is the first innovative green channel product in this field, featuring a globally pioneering rivet-free integrated structural design. As the latest generation of occluders, it boasts pre-assembled integration, flexible connection, rivet-free at both ends, and adjustable waist height. The models are divided into the AB series to meet different clinical application needs. Currently, the product has been approved by the National Medical Products Administration (NMPA) in March 2026 (Registration Certificate No.: GuoXieZhuZhun 20263130458) and was showcased on April 7-8 at Fuwai Hospital, Chinese Academy of Medical Sciences.Hospital (884301)Fu Wai Hospital, Chinese Academy of Medical SciencesHospital (884301)SHENZHENHospital (884301)The first clinical implantation in China after the Conbrella biodegradable PFO occluder system received NMPA market approval was successfully completed. Postoperative ultrasound showed that the occluder had a good shape, stable position, no residual shunt, and satisfactory occlusion effect.

Bluesail Baisheng's structural heart disease business has gained a competitive edge in Europe and some emerging market countries and regions, becoming a significant growth driver for the company. The structural heart disease business, which shares synergies with the company’s traditionally strong coronary intervention business channels, has achieved deep integration across all functional teams, supported by the company’s well-established market and sales network.

The ALLEGRA TAVR (Transcatheter Aortic Valve Replacement) system, equipped with the latest generation Imperia delivery system under the company, continues to accelerate growth in the global market. In the first quarter of 2026, the ALLEGRA series saw a significant increase in sales, setting a new historical high. Globally, sales volume increased by over 160% year-over-year and over 40% quarter-over-quarter, demonstrating the product's strength and market recognition with solid performance. Through this collaboration with WYTD, Bluesail Baisheng aims to extend its mature global commercialization capabilities in the structural heart disease field from aortic valve replacement to the cutting-edge niche area of PFO, forming a more complete product portfolio.

According to the agreement, Beijing Lanfan Baisheng Medical Technology Co., Ltd. will provide services in the areas of clinical, registration, market access, pricing planning, sales agency and more for the product in the advantageous regional channels of EMEIA (Europe and emerging markets), APAC (Asia-Pacific region), and mainland China. It will also introduce corresponding external resources to systematically support WYTD.

Bluesail Baisheng has a well-established channel network that penetrates medical institutions at all levels across China, as well as a top-tier academic promotion and clinical service team. It has also built a full-process system covering R&D, clinical trials, production, registration, and sales. In the APAC and EMEIA regions, Bluesail Baisheng has respective localized marketing and sales teams of over a hundred people. With this competitive barrier, Bluesail Baisheng has successfully...NorthX Life（688712）, Baixinan, Wofuman and other domestically producedInnovative Healthcare（002173）Device companies provide full-chain services from product registration, clinical support to sales promotion, covering the hottest tracks in multiple vascular intervention fields from intravascular imaging to renal artery ablation.

In recent years, the company has systematically laid out multiple high-growth sectors, including coronary intervention, structural heart disease, neurointervention, and peripheral intervention, through various forms such as self-research, agency, and investment incubation.Innovative Medical (002173)Device Track.

Beijing Lanfan Baisheng Medical Technology Co., Ltd. leverages its global platform network, forming a complementary partnership with WYTD's innovative technology. This collaboration is not only expected to seize the global market opportunity of the high-value PFO bioresorbable occluder but also promote domestically-produced innovative medical devices.Going Overseas (885840)Provide more competitive combination solutions.