Silk Medical Aesthetics Injectable Biomaterial Granted FDA IDE Approval to Initiate Human Clinical Study

By - AMS posted Apr 22, 2020 11:00 AM


Silk Medical Aesthetics, Inc., a spin-off of the green chemistry company Evolved By Nature, today announces receipt of FDA IDE approval to initiate a human clinical trial of the industry's first all-natural, silk-based dermal filler. The trial will study an injectable form of Evolved By Nature's patented Activated Silk™ technology in the nasolabial fold of the face for volume correction. This novel and reversible injectable represents a breakthrough technology over standard hyaluronic acid (HA) fillers, and stands to advance both the field of aesthetic medicine and the treatment of volume loss in the skin.

Silk Medical Aesthetics, in partnership with Evolved by Nature, will begin preparing for a U.S. trial, with the goal of enrolling participants after the pandemic recedes and it is once again safe for doctors and patients to participate.  Evolved By Nature will continue to develop and out-license its novel biomaterial technology in other medical fields outside of aesthetic medicine.

In the interim, Silk Medical Aesthetics would like to take the opportunity afforded by this approval to acknowledge the dedication of the FDA staff, who honored their Congressional-mandated timetables for IDE submission review while also rapidly responding to the critical influx of applications regarding new COVID-19 treatments and PPE. The rapid review and approval were critical to sustain Silk Medical Aesthetics' forward momentum as a small business and employer of scientists in the Boston area. 

"During this unprecedented time in the nation's recent history, we wanted to express our gratitude to the doctors, scientists and staffers at FDA who now find themselves on the front lines of this pandemic, though behind the scenes and out of view," said Evolved By Nature CEO and co-founder, Dr. Greg Altman. 

The company's President and COO, Dr. Rebecca Lacouture added "We would like to express our thanks to the FDA for showing up and doing all they can to keep the American public as safe as possible during this extraordinarily challenging time."

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