China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced that it will initiate a clinical study in Japan for its rapamycin drug-eluting balloon, aimed at treating in-stent restenosis. This marks a significant step in the company’s efforts to expand its presence in the Japanese market and address a common complication following percutaneous coronary intervention (PCI).
Product Profile
The product is a rapamycin drug-coated balloon (DCB) catheter, featuring a drug-eluting formulation that includes rapamycin, amphiphilic liposomes, biodegradable polymer sustained release agents, and dispersants. This formulation is designed to achieve efficient transfer, lasting release, safety, and effectiveness of the drug coating through a specific ratio. Rapamycin is encapsulated by biodegradable nanoparticles to form drug-loaded nanoparticles, which can achieve ultra-long release in target vascular tissues for about 90 days. The amphiphilic liposomes significantly enhance the transfer ability of microspheres micelles into target vascular tissues.
Clinical and Market Context
In-stent restenosis is a common complication after PCI, and DCBs have been recommended for its treatment. Compared to paclitaxel-based drug stents currently on the market in Japan, Bio-Heart Bio’s product offers higher safety, a wider treatment range, and anti-inflammatory effects. The company expects its product to be the first of its kind in Japan, positioning it to address a significant unmet medical need.
Future Implications
The initiation of the clinical study in Japan underscores Bio-Heart Bio’s commitment to advancing innovative medical devices and expanding its global footprint. This move is expected to enhance the company’s market presence and contribute to the treatment of in-stent restenosis, a critical area in cardiovascular medicine.-Fineline Info & Tech
