BISORB®Drug-Eluting Sinus Absorbable Stent System Successfully Registered and Approved in Indonesia
Date:2024-06-12 17:30:09
“BISORB®Drug-Eluting Sinus Absorbable Stent System Successfully Registered and Approved in Indonesia
Puyi (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as "the Company") announced on December 12, 2022, that its BISORB®Drug-Eluting Sinus Absorbable Stent System has successfully been registered and approved in Indonesia. The product is registered in Indonesia as "BISORB Drug-Eluting Sinus Absorbable Stent System." After rigorous review by the Indonesian authorities, the product meets the local medical device market access requirements and is approved for registration, with a validity period extending to December 12, 2027.
This product is specifically designed for patients with chronic rhinosinusitis (CRS) who undergo endoscopic sinus surgery (ESS). Its main functions include supporting and separating the wound surface during and after surgery, fixing and repairing the mucosal flap, and slowly releasing hormones to control edema, prevent adhesion, ensure smooth drainage, continuously fight inflammation at the target site, and promote healing. The fully biodegradable sinus drug-eluting stent system consists of a stent and a delivery system, and it has been sterilized using electron beam irradiation to ensure safety and hygiene during use.
The registration and approval of this product in Indonesia marks an important step forward in the internationalization of the Company's products. It will facilitate the promotion and sales of the Company's related product lines in the Indonesian market, further enhancing the Company's core competitiveness. This achievement is expected to have a positive impact on the Company's future business development.