BOSTON, Jan. 12, 2022 /PRNewswire/ — Biotechnology firm Evolved by Nature introduced in the present day that sister firm Silk Medical Aesthetics has acquired Investigational Device Exemption (IDE) approval from the FDA to provoke a pivotal scientific trial for its new dermal filler for the correction of reasonable to extreme facial wrinkles and folds, corresponding to nasolabial folds.
The new filler leverages Evolved by Nature’s all-natural Activated Silk™ protein know-how platform, infusing it inside a crosslinked hyaluronic acid gel with lidocaine. It is designed to be biodegradable and reversible for use in mushy tissue augmentation corresponding to for wrinkle filling and volumizing. The filler is the first in a differentiated product line being developed to present each the affected person and doctor with new choices in aesthetic medication to deal with wants from facial pores and skin smoothing and contouring to enhancing pores and skin attributes for improved affected person outcomes.
The randomized, managed, blinded, potential pivotal scientific trial will set up the Activated Silk dermal filler’s security and efficacy versus a commercially FDA-approved accessible management. Silk Medical Aesthetics will provoke the research with a number of facilities in Q1 2022, and trial outcomes will likely be submitted in a future Premarket Approval (PMA) software to the FDA to help regulatory approval.
