SAN DIEGO, CA – May 7, 2019 – Recros Medica, Inc. announced today that its de novo regulatory submission for the Nuvellus™ Focal Contouring System has been accepted for review by the US Food and Drug Administration (FDA). Nuvellus™, which utilizes the company’s proprietary Rotational Fractional Resection (RFR) technology, may provide medical aesthetic physicians a minimally-invasive single treatment option to improve submental (neck and jowl) contouring.
Based on anticipated regulatory timelines, Recros expects to receive FDA clearance in Q4 2019.1 Following FDA clearance, Recros plans to launch Nuvellus™ to select medical aesthetic experts, with a broader market rollout to follow.
Nuvellus™ is a novel alternative to current skin contouring approaches such as traditional surgery and energy-based devices. The Nuvellus™ system will be comprised of an integrated console, reusable surgical handpiece and differentiated consumable attachments for specific contouring applications.
“The entire Recros Medica team is excited about bringing our novel Nuvellus™ system to aesthetic physicians, and today’s submission represents a critical step in that journey,” commented Tom Albright, CEO of Recros Medica. “We are confident that Nuvellus™ will offer customers significant efficacy and versatility, and look forward to working with the FDA to achieve commercial clearance and introduce Nuvellus™ for one of the largest unmet needs in aesthetic medicine.”
About De Novo Submission
The FDA’s de novo submission program is used to expedite regulatory review and ensure accurate classification of medical devices with low-to-moderate risk profiles and no comparable, predicate devices in market. To learn more about de novo submission guidelines, please visit www.fda.gov.
1 Regulatory submission timelines are determined based on the most up-to-date information at time of publication, and are subject to change.