Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
Microport Neurotech Ltd.’s shares started at HK$24.7 (US$3.15) per share, fell 0.162% and closed at HK$24.60 apiece on its first day of trading of July 15, 2022.
Venus Medtech (Hangzhou) Inc. received the green light in China for its transcatheter pulmonic valve replacement (TPVR) system Venusp-Valve. It is a self-expanding TPVR product for the treatment of severe pulmonary regurgitation (≥3+) in patients after a congenital heart defects procedure with native right ventricular outflow tract.
Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
Rainmed Medical Ltd. raised HK$146 million (US$19 million) in an initial public offering in Hong Kong. Its shares debuted at HK$5.60 and dropped as much as 15.38% to close at HK$5.28 on July 8, 2022, the first trading day. Jiangsu, China-based Rainmed Medical plans to use 80% of the proceeds to support the development and commercialization of its core products – a coronary angiography-derived fractional flow reserve (caFFR) system and a coronary angiography-derived index of microvascular resistance (caIMR) system.
Shanghai Sanyou Medical Co. Ltd. will be working with Implanet SA to get the latter’s Jazz platform for treating spinal pathologies approved and distributed in China. “Through this partnership, Sanyou Medical will be Jazz’s exclusive distributor. We are currently working on obtaining registration in China with the authorities. We will have a better view on the commercial launch timing later this year,” Ludovic Lastennet, CEO and founder of Implanet, told BioWorld.
Volpara Health Technologies Ltd. joined forces with Microsoft Corp. to accelerate the research and development of software that uses mammograms to identify potential cardiovascular issues.
Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with its regenerative nerve repair device Remplir.
Peijia Medical Ltd. has received two marketing approvals from China’s NMPA for its catheters to be used in neurointerventional surgery. They are the balloon guide catheter (BGC) Fluxcap and delivery balloon dilation catheter Fastunnel. Both were developed by Peijia’s wholly owned subsidiary Achieva Medical Ltd.
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