China-based Biotyx Medical (Shenzhen) Co.,Ltd, known as the world’s only developer of iron-based absorbable stents, has reportedly raised over RMB 200 million (USD 27.4 million) in a Series B financing round. The investors in this round include Gongqingcheng Huayi Private Equity Fund Management, Guangfa Qianhe Investment, IDG Capital, and Shanghai Baoquan Investment Partnership.
Product Portfolio and Market Access
Biotyx Med boasts a range of fully degradable iron-based bioabsorbable stent products that cater to various medical needs, including coronary heart disease, pediatric pulmonary vascular stenosis, and subgenular artery stenosis. The company’s three core products have all received fast-track statuses in China, highlighting their potential impact on the medical device market.
Regulatory Milestones and Global Expansion
The absorbable drug-eluting coronary stent has completed Phase III enrollment in China and has filed for marketing in the European Union. The children’s iron-based absorbable vascular stent has obtained approval from the US FDA for compassionate use, along with a Malaysian registration certificate and EU CE registration certificate, securing market access qualifications. The absorbable drug-eluting peripheral stent has been approved for compassionate use by the US FDA and has received ethical approval from multiple ethical centers in Europe, with the first subject enrolled in Italy in July this year.-Fineline Info & Tech
