#United States #Baltimore #Johns Hopkins #Lumina #LifeSprout

LifeSprout Advances with CE Mark Submission for Lumina™

LifeSprout Inc., a privately-held company specializing in regenerative medicine, has recently announced its submission for CE Mark registration for its revolutionary product, Lumina™. This submission marks a significant milestone for LifeSprout, as Lumina is the first product to emerge from its proprietary Regenerative Matrix platform, which was developed using advanced technology licensed from Johns Hopkins University.

Innovation in Aesthetic Medicine

Lumina™ represents the next generation of aesthetic dermal fillers, engineered to replicate the appearance and texture of natural tissues. Utilizing cutting-edge regenerative science, Lumina is designed to not only enhance aesthetic outcomes but also integrate more seamlessly with the body's own tissues. The formulation consists of biomimetic, biocompatible, and biodegradable materials, offering patients an innovative solution that aims to improve both safety and efficacy in aesthetic applications.

Dr. Sashank Reddy, co-founder of LifeSprout and an Associate Professor at Johns Hopkins, affirmed the importance of this milestone, stating, "The CE-mark submission is a pivotal step toward bringing Lumina closer to patients who can benefit from its unique properties."

Meeting Regulatory Standards

LifeSprout has ensured compliance with the EU Medical Device Regulation (MDR) in preparing the Lumina submission, which has been lodged with the BSI Group, the designated Notified Body for the company. Qi Liu, LifeSprout's Quality Director, has expressed the team's commitment to facilitating a thorough and interactive review process. The anticipation is that this review could result in CE Mark approval by late 2025.

The submission follows the promising results from Lumina's double-blind, randomized, controlled pivotal clinical trial aimed at correcting moderate-to-severe nasolabial folds (NLF). This significant trial took place across five sites in three European countries and demonstrated not only promising efficacy but also a favorable safety profile, with no serious adverse incidents reported.

Expanding Market Opportunities

Alongside the CE Mark submission, LifeSprout is actively pursuing collaboration opportunities with leading aesthetics companies throughout Europe. This is part of a larger strategy to license Lumina, following a recent agreement with Boyang Trading Co., Ltd. This licensing agreement grants rights to develop and commercialize Lumina in greater China, including mainland China, Hong Kong, Macau, and Taiwan.

Kevin Colbert, LifeSprout's co-founder and Head of Business Development, noted the increasing interest from key players in the aesthetics sector as regulatory approvals get closer. "As we achieve these significant milestones, we are witnessing growing enthusiasm from leading companies in the market, which positions us well for future business development initiatives globally," he said.

The Future of Aesthetic Treatments

LifeSprout, Inc., with its focus on pioneering products for aesthetic and regenerative medicine, aims to leverage the success of Lumina to build a portfolio that addresses the needs of millions dealing with tissue loss due to aging, medical treatments such as cancer care, and trauma. Their commitment to innovation and patient safety is evident through their strategic partnerships and careful regulatory planning.

For further details about LifeSprout and its groundbreaking research and products, visit www.lifesproutbio.com.