BOSTON, Nov. 18, 2021 /PRNewswire/ -- Silk Medical Aesthetics, alongside sister company Evolved by Nature, the developer of Activated Silk™ biotechnology, announced today the results of a 44-patient feasibility study under an FDA-approved IDE clinical trial for its all-natural dermal filler for Nasolabial Folds (NLFs). The ABOUT FACE™ BY NATURE dermal filler is designed to be biocompatible, biodegradable and reversible for soft tissue augmentation. The 13-week results demonstrate a favorable safety profile with high patient satisfaction and clinically meaningful improvement in NLF severity. The company also announced that it has received FDA-approval to initiate an IDE for a 50-patient feasibility clinical trial to study the product for lip volume enhancement and fine lines around the mouth—the trial has now been fully enrolled. This news coincides with former Allergan Aesthetics executive, Karina Guillen joining Evolved by Nature as their new VP of Regulatory Affairs.
At the 13-week primary endpoint in the nasolabial fold feasibility clinical trial, zero device-related adverse events were reported, and common injection site responses, such as discoloration, redness, swelling, pain, tenderness, lumps, bruising, and itching, occurred at low rates with most resolving within 2-weeks. At 13 weeks, 83.7% of patients had a clinically meaningful improvement in wrinkle severity with a mean improvement of 1.0 in the Wrinkle Severity Rating Scale (WSRS), and 100% of clinicians and patients reported improvement on the Global Aesthetic Improvement Scale (GAIS). The clinical trial continues to follow patients over the course of 12 months.
"Activated Silk, made from pure silk protein, is the first technology to advance biomaterials for dermal fillers since the introduction of HA and lidocaine," said Dr. Greg Altman, CEO & Co-Founder of Evolved by Nature. "It can create products that outperform and redefine current benchmarks, and our current clinical results show we are well on our way."
Silk Medical Aesthetics has exclusively licensed Evolved by Nature's robust patent portfolio for hyaluronic acid and lidocaine with Activated Silk for use in injectable aesthetic medicine and is developing the next-generation dermal filler platform to address all needs in volume restoration and the enhancement of the skin's look and feel.
With a scaled and fully integrated manufacturing process for medical grade Activated Silk, Evolved by Nature is supplying Silk Medical Aesthetics to minimize capital expenditures and facilitate an expeditious time to the US & EU markets. At scale, these all-natural dermal fillers open the possibility of minimizing the mass amounts of beauty and personal care products consumed to achieve desired results, which result in the disposal of billions of units of unsustainable plastic packaging each year in the US alone.
With executive Karina Guillen, PHD, joining Evolved by Nature as VP of Regulatory Affairs, the two companies anticipate supporting commercialization of the products in the US/EU as early as 2023. Karina was recently Executive Director and Head of Global Regulatory Affairs for Fillers at Allergan Aesthetics, an Abbvie Company, where she spent over twelve years.
About Silk Medical Aesthetics:
Silk Medical Aesthetics is a Boston-based company on a mission to create the next-generation dermal filler platform by leveraging the power of natural silk. A sister company of biotechnology company Evolved by Nature, Silk Medical Aesthetics was founded by silk experts Drs. Greg Altman and Rebecca Lacouture in 2018, received more than $18 million in Series A and B financing, and is backed by a diverse group of investors. www.silkmedicalaesthetics.com
About Evolved by Nature:
Founded in 2013 in Boston, MA, Evolved by Nature is a biotechnology company that creates renewably sourced solutions to human health needs, petrochemicals in supply chains, and the need for better performing product ingredients through its advanced Activated Silk platform. Activated Silk leverages naturally derived silk protein to create sustainable molecules that protect, repair, and enhance the barrier function of anything with a surface. Enabling the next generation of products that advance the health of people and the planet, Evolved by Nature has unlocked breakthrough applications for Activated Silk within textiles, skincare, cosmetic and medical treatments, and more, with limitless possibilities. www.evolvedbynature.com