Biotechnology company Evolved by Nature announced today that sister company Silk Medical Aesthetics has received Investigational Device Exemption (IDE) approval from the FDA to initiate a pivotal clinical trial for its new dermal filler for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
| BOSTON, Jan. 12, 2022 /PRNewswire/ -- Biotechnology company Evolved by Nature announced today that sister company Silk Medical Aesthetics has received Investigational Device Exemption (IDE) approval from the FDA to initiate a pivotal clinical trial for its new dermal filler for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The new filler leverages Evolved by Nature’s all-natural Activated Silk™ protein technology platform, infusing it within a crosslinked hyaluronic acid gel with lidocaine. It is designed to be biodegradable and reversible for use in soft tissue augmentation such as for wrinkle filling and volumizing. The filler is the first in a differentiated product line being developed to provide both the patient and physician with new options in aesthetic medicine to address needs from facial skin smoothing and contouring to enhancing skin attributes for improved patient outcomes. The randomized, controlled, blinded, prospective pivotal clinical trial will establish the Activated Silk dermal filler’s safety and efficacy versus a commercially FDA-approved available control. Silk Medical Aesthetics will initiate the study with multiple centers in Q1 2022, and trial results will be submitted in a future Premarket Approval (PMA) application to the FDA to support regulatory approval. Primary endpoint data for the feasibility clinical trial on the Activated Silk filler, announced in late 2021, demonstrated a favorable safety profile with high patient satisfaction and clinically meaningful improvement in NLF severity. Zero device-related adverse events were reported, and 83.7% of patients had a clinically meaningful improvement in wrinkle severity at the 13-week primary timepoint. 100% of clinicians and patients reported improvement on the Global Aesthetic Improvement Scale (GAIS). Evolved by Nature CEO, Dr. Greg Altman, commented, “We’ve always known that Activated Silk protein technology has the potential to dramatically restore or improve barrier function, on everything from skin to textiles used by the fashion industry, and more. This IDE approval is a tremendous benchmark as we rapidly expand our development pipeline, exploring and developing medical devices, therapeutics, and bioactive molecules for regenerative medicine.” About Evolved by Nature: About Silk Medical Aesthetics:
SOURCE Evolved By Nature |
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