Bioventrix Inc. acquired Materacor Inc., the developer of a heart failure therapy that uses an injectable alginate-based hydrogel and a minimally invasive endocardial delivery system to restructure the left ventricle and reverse or stop the progression of ischemic or non-ischemic congestive heart failure with reduced ejection faction (HFrEF). The terms of the transaction were not disclosed.
The FDA has issued a safety notification regarding the tubes used in enteral feeding sets, which can lead to inadvertent strangulation of infants and toddlers. The agency said it has received two reports of deaths of toddlers due to strangulation in 2021, but at this time is only recommending that caregivers exercise special caution in ensuring that tubes not be left where strangulation is a possibility.
Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.
LONDON – Orthox Ltd. is primed for an assault on the mountain that is knee cartilage repair after raising $12.5 million in a series A funding round. After more than a decade of translational and preclinical research, these funds will allow the company to start a trial of Fibrofix, a tissue regeneration product derived from silk, in the middle of this year. An initial cohort of six patients in the U.K. will be treated for sports injury-related cartilage damage, with six months follow up to demonstrate safety. Assuming positive results, that will be followed by treating a further 75 patients in the U.K., Hungary and elsewhere in mainland Europe.
Second Sight Medical Products Inc. has struck a deal to acquire Nano Precision Medical Inc. (NPM) in an all-stock transaction. NPM will merge with a wholly owned subsidiary of Second Sight, and the combined company will focus on the development of drug and device medical implants. The deal comes less than a year after Second Sight’s proposed acquisition of French company Pixium Vision LLC fell through in controversial fashion. The company will issue approximately 134 million shares of its common stock to acquire full ownership of NPM and shareholders will acquire approximately 23% equity of the combined company
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Sirtex.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Guard Medical, Philips, Sense Biodetection, Solta Medical, Una Health.
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