Tensive Srl's Regenera, a bio-absorbable breast implant, promises to help the millions of women who undergo breast cancer surgery every year, to feel whole again. “While surgery will save many lives, it comes at the cost of losing something very personal, which is the sense of a woman's wholeness. I think that's what has been a major challenge,” Sanjay Kakkar, CEO told BioWorld.

The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.

A little over two months after the granting of its very first patent which described computer-based systems for diagnosing psoriasis, Belletorus Corp. welcomed the publication of two continuation-in-part child filings on similar such systems for the diagnosis of eczema and determining the severity of skin diseases such as psoriasis, eczema and skin cancer.

The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.

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.

China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.

China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.

Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer.

Viveon Health Acquisition Corp. (VHAQ) reported a merger deal with regenerative aesthetics company Suneva Medical Inc. According to the terms of the deal, the special purpose acquisition company (SPAC), will issue 25 million shares and up to 12 million earnout shares to Suneva shareholders. The pro forma equity valuation of the companies is expected to be approximately $511 million, with the merger slated for completion in the first half of 2022.

Despite that the device has been available for more than a decade under the 510(k) program, an FDA advisory committee voted narrowly that the benefits of the Surgimend device for breast reconstruction do not outweigh the risks. Another interesting feature of the application is that the pivotal study was based on real-world evidence (RWE), but while the FDA had direct access to the data, Integra Lifesciences Holdings Corp. did not, thus raising questions about whether RWE is necessarily useful for class III device premarket applications.