BALTIMORE, Jan. 23, 2025 /PRNewswire/ -- LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has filed for CE Mark registration for Lumina.
Lumina is the first product from LifeSprout’s proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.
“The CE-mark submission marks a significant milestone for LifeSprout and brings Lumina an important step closer to benefiting patients,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout and Associate Professor of Plastic and Reconstructive Surgery and Biomedical Engineering at Johns Hopkins.
The Lumina submission was prepared in compliance with the EU Medical Device Regulation (MDR) and submitted to BSI Group, LifeSprout’s Notified Body. Qi Liu, LifeSprout’s Quality Director, stated, “We are fully committed to allocating resources to support an efficient and interactive review process. We anticipate that this regulatory review could lead to CE Mark approval as soon as late 2025.”
The submission follows the successful completion of Lumina’s double-blind, randomized, controlled pivotal clinical trial for the correction of moderate-to-severe nasolabial folds (NLF) at five sites across three countries in Europe. As previously announced, Lumina achieved its primary efficacy endpoint of non-inferiority when compared to active control, Restylane Defyne® in a 1:1 split-face design across 119-subjects. The study confirmed Lumina’s positive safety profile with comparable Common Treatment Site Responses (CTRs) observed in both arms of the trial, and no product related Serious Adverse Events (SAEs).
In tandem with the CE mark filing, LifeSprout is focusing on discussions with leading aesthetics companies in Europe to explore licensing opportunities for Lumina. This follows the recent successful completion of a licensing agreement with Boyang Trading Co., Ltd., granting rights to develop and commercialize the Lumina dermal filler in mainland China, Hong Kong, Macau, and Taiwan. “As we approach regulatory approvals, we are seeing increasing interest from leading companies in the aesthetics industry and are excited to continue pursuing business development opportunities globally,” said Kevin Colbert, LifeSprout’s co-founder and Head of Business Development.
About LifeSprout, Inc.
LifeSprout, Inc. is a privately held company developing revolutionary products for aesthetic and regenerative medicine. LifeSprout’s proprietary Regenerative Matrix platform comprises biomimetic, biocompatible materials engineered to look and feel like natural tissue. The first product from this platform — Lumina™ — is a next-generation aesthetic dermal filler that combines the proven safety of hyaluronic acid with biostimulatory effect. LifeSprout is turning this technology into a suite of products for the millions of patients with tissue losses from aging, cancer treatment, and trauma. For more info, please see www.lifesproutbio.com/.Media contact:
LifeSprout, Inc.
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SOURCE LifeSprout Inc.
