Exclusive License and Commercialization Agreement Reached in Greater China Geography Following a Successful Nasolabial Fold (NLF) Clinical Trial Readout for Lumina
Lumina's US and European Regulatory Approvals Targeted for 2025
BALTIMORE, Jan. 31, 2024 /PRNewswire/ -- LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has entered into a definitive agreement with Boyang Trading Co., Ltd. to exclusively develop and commercialize the Lumina™ dermal filler in mainland China, Hong Kong, Macau, and Taiwan.
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.
"This license marks a major step towards realizing our strategic and commercial ambitions for LifeSprout," stated Sashank Reddy, MD, PhD, co-founder of LifeSprout and Associate Professor of Plastic and Reconstructive Surgery and Biomedical Engineering at Johns Hopkins. "We are excited to work with the team at Boyang Trading to bring Lumina to patients in Greater China. Their long commercial history in aesthetics and complimentary portfolio of products provide a strong foundation for the launch of our breakthrough platform."
Under the terms of the agreement, LifeSprout will receive an upfront payment, and is eligible to receive future milestone payments related to pre-defined clinical and regulatory events as well as commercial milestones and royalties on sales in Greater China. LifeSprout retains the right to develop and commercialize Lumina in all territories outside of Greater China, and continues to hold active discussions with other leading aesthetics companies regarding licensing opportunities for Lumina and the company's broader platform in the US, EU, and other major geographies worldwide.
This license agreement follows the recent successful completion of Lumina's double-blind, randomized, controlled pivotal clinical trial for the correction of moderate-to-severe nasolabial folds (NLF). 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. More recently, subjects have completed their final follow-up visits and the database has been locked, confirming 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). LifeSprout is targeting regulatory approvals for Lumina in the United States and European Union in 2025, and concurrently initiating additional clinical trial and registration plans with Boyang Trading for geographies in Greater China.
"In our view, the Lumina technology is unique amongst injectables in its ability to achieve true tissue regeneration, yet with the potential safety and reversibility of leading hyaluronic acid products," stated Mr. Lu Handong, the Chairman of Boyang Trading. "We strongly believe regenerative products like Lumina represent the future of the medical aesthetics industry, where our patients can receive natural tissue restoration that feels like native tissue."
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/.
About Boyang Trading
Boyang Trading Co., Ltd., an affiliate of SHIBO Medical, stands as one of the largest medical aesthetic companies in China. SHIBO is positioning itself to be the exclusive distributor of high-end medical aesthetic products throughout China, and currently distributes US-brands including Solta Medical's Thermage radiofrequency system and Fraxel laser devices for skin tightening and resurfacing.
Contact
contact@lifesproutbio.com
SOURCE LifeSprout Inc.
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