Surgical Innovation Associates said yesterday that it raised $4 million in an oversubscribed Series A round for the development and commercialization of its reconstructive and aesthetic surgery devices. Chicago-based Surgical Innovation, a medical device spinout from Northwestern University, said it has raised $6.5 million since its 2016 inception. The investor base for the recent $4 […]
Cosmetic/Aesthetic
FDA OKS Avita Medical trial for Recell in soft tissue reconstruction
Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device. The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional […]
Sofregen raises $8.1m in equity offering
Sofregen Medical has raised more than $8 million in a stock offering, according to an SEC filing. The Medford, Mass.-based soft-tissue aesthetics company opened the offering August 16, 2019, attracting three investors who purchased $8.1 million of its shares. Sofregen did not disclose how it plans to use the proceeds. In January, the early-stage commercial biotech […]
Judge approves $160k settlement between ex-Sientra CEO Zeini, SEC
A California federal judge last week approved a settlement between former Sientra (NSDQ:SIEN) CEO Hani Zeini and the U.S. Securities & Exchange Commission, ordering him to pay a $160,000 fine and barring him from working as an officer or director at publicly traded companies for five years for his alleged scheme to hide a problem at […]
SofWave Medical closes $8.4 million financing round, announces Louis Scafuri as CEO
SofWave Medical secured an $8.4 million financing round, led by co-founder and chairman Shimon Eckhouse and XT Hi-Tech, as the Israeli-based company develops non-invasive fractional ultrasound technology for skin tightening. “This financing round of SofWave Medical will enable us to execute aggressively on our plan to build and position the company as a leader in […]
InMode pulls down $70m with IPO
InMode (NSDQ:INMD) yesterday closed its initial public offering, saying it grossed $70 million for the radiofrequency devices it’s developing for aesthetic medical procedures. Proceeds from the flotation of 5 million shares at $14 apiece are earmarked for hiring additional sales and marketing personnel and expanding those programs and for funding R&D, working capital and general […]
UPDATE: FDA asks Allergan to recall textured breast implants
UPDATED July 24, 2019, with new FDA statement. The FDA said today that it asked Allergan (NYSE: AGN) to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma. The federal safety watchdog said that nearly 84% of the 573 […]
AirXpanders abruptly pulls the plug
AirXpanders (ASX:AXP) abruptly pulled the plug yesterday, saying it plans to lay off nearly all its employees and file for Chapter 7 bankruptcy by the end of the month. The Palo Alto, Calif.–based company makes the AeroForm device for post-mastectomy breast reconstruction. It’s designed to expand and stretch the skin and underlying muscle prior to […]
Australia eyes ban on textured breast implants
Australia’s TGA said last week that it concluded breast implants do not need to be removed as breast implant-associated anapestic large cell lymphoma (BIA-ALCL) is rare. The regulatory body said in April that is was considering implementing a ban on textured breast implants and was seeking new data from suppliers of the implants to decide […]
Soliton raises $9m in private placement
Soliton (NSDQ:SOLY) said today that it raised $9 million in a private placement for the acoustic tattoo removal aid it’s developing. Houston-based Soliton, which licenses its technology from the University of Texas, is develop a rapid acoustic pulse device that’s designed to make tattoo-removal lasers more effective. The device won 510(k) clearance from the FDA […]
Sientra closes $115m offering
Sientra (NSDQ:SIEN) last week closed a $115 million underwritten public offering, with plans to use the net proceeds to implement sales and marketing initiatives, as well as grow its U.S. and global commercial organizations. The medical aesthetics company offered 17,391,305 shares of its common stock and 2,608,695 additional shares of common stock in options to the […]