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.

The use of dermal fillers has spiked in recent years for a number of reasons, but so have the associated adverse events. An FDA advisory committee made several associated recommendations, including that a patient’s vision be prospectively evaluated prior to any peri-ocular treatment with fillers, but this could be a simple count-the-fingers check, something that should not appreciably increase procedure times or affect the volume of procedures.

PARIS – Bellaseno GmbH recently completed a phase I trial of its Senella absorbable soft tissue reconstruction scaffold on an Australian patient with congenital pectus excavatum.

Baltimore-based Lifesprout Inc., a Johns Hopkins University startup, said it has closed a $28.5 million series A financing. It is planning to use the proceeds to support clinical development of therapeutic products from its Regenerative Matrix platform.

Baltimore-based Lifesprout Inc., a Johns Hopkins University startup, said it has closed a $28.5 million series A financing. It is planning to use the proceeds to support clinical development of therapeutic products from its Regenerative Matrix platform. Redmile Group LLC led the round, with new institutional investors Nexus Management LP, Emerald Development Managers LP, and the Abell Foundation also joining.

Soliton Inc., of Houston, unveiled positive proof-of-concept (POC) study results out to 12 weeks using its Rapid Acoustic Pulse (RAP) device for the treatment of fibrotic scars. Overall, the treatment of fibrotic scars using the device proved safe and tolerable during this POC study.

Duluth, Ga.-based Sebacia Inc., which is focused on dermatology and aesthetics, has introduced its new CEO and reported the acquisition of all assets related to Sienna Biopharmaceuticals Inc.'s silver photoparticle technology, which is being reviewed by the FDA for light hair removal.

Establishment Labs SA, from the Virgin Islands and with main manufacturing and marketing operations in Alajuela, Costa Rica, where it was founded, is entering the Japanese market with what it says is a revolutionary breast implant solution, starting this month.

Roughly two and half years after it picked up Cynosure, Hologic Inc., of Marlborough, Mass., has reported its intention to sell it to private equity firm Clayton, Dubilier & Rice (CD&R) for a total purchase price of $205 million in cash, subject to certain closing adjustments. The company expects net cash proceeds of about $138 million. CD&R Partner Derek Strum expressed enthusiasm about the deal, noting that his firm expects “to continue to invest behind the company's strong brand and large global installed base to accelerate growth via expanded sales & marketing efforts and bring new products and technologies to market[.]”