After a challenging 2021, nerve repair company Axogen Inc. is focusing on building clinical data to turn around its luck. The Alachua, Fla.-headquartered company reported disappointing fourth quarter results, with procedure volume negatively impacted due to COVID-19 and hospital staffing. The Nasdaq-listed company is anticipating results from a major phase III pivotal study comparing its flagship nerve graft product Avance to commercially available products in the second quarter of 2022. Read More
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics. Read More
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair. Read More
Sihuan Pharmaceutical Holdings Group Ltd.’s subsidiary Beijing Meiyan Kongjian Biology Medicine Co. Ltd. has acquired an 80% equity stake in Shenzhen Yimei Medical Technology Co. The deal is to be completed via a mix of capital and equity transfers. Sihuan Pharmaceutical is interested in Shenzhen Yimei’s two-in-one patented technology of collimated ultrasound and superficial focused ultrasound. Read More
Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.” Read More
If the U.S. SEC adopts a rule it proposed March 21, all public companies registered with the regulator, including biopharma and med-tech firms, will have to add disclosures about climate change to their other reporting obligations. Read More
New hires and promotions in the med-tech industry, including: Akumin, Arcuro Medical, Avacta, Clearcut Medical, Osler Diagnostics, Single Pass. Read More
Med-tech firms raising money in public or private financings, including: Ehealth Exchange, Innovega, Ortho Regenerative Technologies, Recora. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADCIS, Åkrn, Axion Biosystems, BD, Cynosure, Cytosmart, Embecta, Evolucare, Jeisys, NAMSA, Ophtai, Optomed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Broncus. Read More
