Nov 03, 2022, 08:00 ET
BALTIMORE, Nov. 3, 2022 /PRNewswire/ -- LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced positive six-month interim results from its pivotal clinical trial of Lumina™, a revolutionary dermal filler. Lumina achieved its primary endpoint of correction of moderate-to-severe nasolabial folds (NLF) with good safety.
"We are delighted by the positive interim clinical readout and believe that Lumina will be a class-defining dermal filler," said Michael L. Kranda, CEO. "Lumina uniquely combines the proven safety of hyaluronic acid with our proprietary Regenerative Matrix to safely deliver the immediate and natural aesthetic restoration that patients desire."
Lumina is the first product from the company's proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue. By permitting host cell ingrowth, the biodegradable materials are gradually replaced by native tissue for lasting, natural restoration. LifeSprout technology has been studied extensively in multiple nonclinical models, and the underlying science has been published in leading peer-reviewed publications, including Science Translational Medicine and Plastic and Reconstructive Surgery.1,2
The ongoing pivotal trial to support regulatory submission is being conducted in a double-blinded, randomized, controlled fashion to evaluate the safety and effectiveness of Lumina in a 1:1 split-face design, using Restylane Defyne® as the active comparator. The clinical trial enrolled 119 subjects across five centers. Study investigators used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point rating scale of wrinkle severity, as the primary effectiveness endpoint, and a variety of other aesthetic improvement scales and patient satisfaction measures. Comparable Common Treatment Site Responses (CTRs) were observed in both arms of the trial, and there were no product related Serious Adverse Events (SAEs).
"LifeSprout was founded to develop truly revolutionary products for tissue replacement and regeneration," said Sashank Reddy, MD, PhD, Associate Professor of Plastic and Reconstructive Surgery and Biomedical Engineering at Johns Hopkins and co-founder of LifeSprout. "The positive interim readout for our first clinical program is a critical step towards realizing that goal and builds the framework for continued company success."
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. The Company is supported by Redmile Group, Triskelion Investments, Catalio Capital Management, Emerald Development Managers, and other leading institutional and family office firms. For more info, please see www.lifesproutbio.com/.
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1. Li X, Cho B, Martin R, Seu M, Zhang C, Zhou Z, Choi JS, Jiang X, Chen L, Walia G, Yan J, Callanan M, Liu H, Colb1ert K, Morrissette-McAlmon J, Grayson W, Reddy S, Sacks JM, Mao HQ. Nanofiber-hydrogel composite-mediated angiogenesis for soft tissue reconstruction. Sci Transl Med. 2019 May 1;11(490):eaau6210. doi: 10.1126/scitranslmed.aau6210. PMID: 31043572.
2. Henn D, Fischer KS, Chen K, Greco AH, Martin RA, Sivaraj D, Trotsyuk AA, Mao HQ, Reddy SK, Kneser U, Gurtner GC, Schmidt VJ, Sacks JM. Enrichment of Nanofiber Hydrogel Composite with Fractionated Fat Promotes Regenerative Macrophage Polarization and Vascularization for Soft-Tissue Engineering. Plast Reconstr Surg. 2022 Mar 1;149(3):433e-444e. doi: 10.1097/PRS.0000000000008872. PMID: 35196680.
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