This Project Grant award, made by the National Institute of General Medical Sciences (NIGMS) under the Biomedical Research and Research Training program (CFDA 93.859), supports the development of Dermisphere, an advanced dermal regeneration scaffold product by Fesariustherapeutics Inc. The $349,345 award aims to demonstrate the feasibility of using Dermisphere to manage acute major burn wounds. Preliminary studies have shown that Dermisphere can support rapid and sustained cellular...
This Project Grant award from the National Institute of General Medical Sciences (NIGMS) Biomedical Research and Research Training Program (CFDA 93.859) is supporting the development of an optimized, off-the-shelf alternative to autologous fat grafting for soft tissue repair. The $293,983 award to Insoma Bio, Inc., a biotechnology company in Durham, North Carolina, will evaluate the combination of Insoma Bio's Fractomer tissue repair matrix and the Renuva adipose allograft material from MTF...
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has awarded Collamedix Inc. a $300,000 Project Grant under the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846) to establish the feasibility of their "CollaLink" collagen-based scaffold for augmenting primary repair of anterior cruciate ligament (ACL) mid-substance tears. The project aims to demonstrate that the CollaLink scaffold, when placed around an ACL tear, can provide a...
The National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research Federal Grant Program (CFDA 93.121), awarded a $1,029,497 Project Grant to Oridivus LLC to develop an innovative oral regenerative therapy leveraging immunoregenerative mechanisms. The goal is to compare the efficacy of FTY720 nanofibers (FTY720-NF) versus platelet-rich plasma (PRP) in improving oral wound healing in rodent and porcine animal models, as a step toward potential...
This $830,712 SBIR Phase II award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS, CFDA 93.846) will support the development and validation of a novel "Smart Cavity Creator Drill" technology for use in lumbar interbody fusion surgeries. The project aims to simplify the surgical procedure, improve safety, and enhance efficiency compared to current manual techniques. Key planned activities include in vitro validation against the current gold standard...
This Cooperative Agreement from the National Institutes of Health (NIH) under the 21st Century Cures Act: Regenerative Medicine Initiative (CFDA 93.370) provides $538,200.00 to The Regents of the University of Colorado, doing business as the University of Colorado-Denver, to conduct a Phase 1 pilot study on the safety and efficacy of induced pluripotent stem cell (iPSC)-based therapy for recessive dystrophic epidermolysis bullosa (RDEB). The study will evaluate the use of genetically...
This $588,952 Project Grant award from the National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research program (CFDA 93.121), aims to develop a bio-inspired scaffold (called "PerioPatch") for regenerating Sharpey's fibers and the overall periodontal ligament (PDL) structure. The research, conducted by the University of Missouri System, seeks to address a major challenge in periodontal tissue regeneration by integrating crucial...
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) awarded a $296,256 Project Grant (CFDA 93.846) to Advanced Molecular Healix Inc., a small disadvantaged business, to develop a novel therapeutic strategy using HIF-1α mRNA to promote vascular perfusion and survival of pedicle flaps in wound healing. The research project aims to quantify HIF-1α mRNA expression and downstream gene induction following intradermal injection in animal models, and then assess the in vivo...
This Project Grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), under the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846), provides $600,475 to the University of California, Davis to develop a collagen-based scaffold modified with specific integrin ligands and extracellular vesicles derived from placental mesenchymal stem cells. The goal is to synergistically recruit and guide endogenous stem cells for vascularized bone...
This Project Grant award from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $295,000 to Biodynamik, a for-profit organization, to develop a novel implantable system that leverages distraction osteogenesis as a treatment for diabetic foot ulcers (DFUs). The objectives of this Phase I SBIR project are to complete the design and development of a low-profile implantable transverse tibial transport device that can...
AN ADVANCED DERMAL REGENERATION SCAFFOLD FOR RECONSTRUCTIVE SURGERY - PROJECT SUMMARY/ABSTRACT DUE TO THE INABILITY OF THE DERMIS TO REGENERATE ON ITS OWN, LARGE FULL THICKNESS SKIN LOSS CANNOT BE RESTORED NATURALLY. THE CURRENT GOLD STANDARD TREATMENT INVOLVES AUTOLOGOUS TISSUE TRANSFER IN WHICH THE PATIENT SERVES AS THEIR OWN DONOR, WHICH MAY BE CHALLENGING DUE TO LIMITED AVAILABILITY OF FULL THICKNESS SKIN DONOR SITES AND DONOR- SITE MORBIDITY. DERMAL REPLACEMENT SCAFFOLDS (DRS) AIM TO RECREATE DERMIS, THEREBY PREVENTING WOUND CONTRACTION. HOWEVER, BECAUSE CURRENTLY AVAILABLE DRS LACK UNIQUE CUES TO GUIDE CELL INFILTRATION, THEY MAY FAIL TO VASCULARIZE SUFFICIENTLY. THE CRITICAL BARRIER TO PROGRESS IN THIS FIELD IS TO CREATE A SCAFFOLD THAT 1) PROMOTES RAPID CELLULAR INFILTRATION AND ANGIOGENESIS AS REQUIRED FOR NEODERMAL FORMATION IN FULL THICKNESS WOUNDS, AND 2) INCREASES THE INCIDENCE AND QUALITY OF HEALING IN BOTH TYPICAL/HEALTHY WOUNDS AND DIFFICULT TO HEAL SITES. TO ADDRESS THIS SIGNIFICANT CLINICAL GAP, FESARIUS THERAPEUTICS, INC. IS DEVELOPING DERMISPHERE, AN INNOVATIVE DRS PRODUCT THAT WILL REGENERATE DERMIS IN FULL THICKNESS SKIN LOSS WOUNDS MUCH FASTER (=7 DAYS, I.E. >75% FASTER) THAN THE REGENERATION ACHIEVED USING THE MARKET-LEADING DRS PRODUCT, INTEGRA. ONCE DERMIS HAS REGENERATED IT CAN BE COVERED WITH A THIN EPIDERMAL SKIN AUTOGRAFT, YIELDING SKIN THAT IS MORE FLEXIBLE, FUNCTIONAL, AND RESILIENT THAN WOUNDS HEALED WITH SPLIT THICKNESS SKIN GRAFTS ALONE. THE COMMERCIALIZATION OF DERMISPHERETM IS EXPECTED TO IMPROVE CLINICAL PRACTICE IN THE SURGICAL FIELDS WHERE FULL THICKNESS SKIN LOSS IS COMMON INCLUDING, BUT NOT LIMITED TO, TRAUMA, BURNS, INFECTION AND POST ONCOLOGIC RECONSTRUCTIVE SURGERY, BY SIGNIFICANTLY DECREASING THE TIME REQUIRED TO ACHIEVE A HEALED WOUND IN A SCENARIO OF LARGE FULL THICKNESS SKIN LOSS, WHICH WILL DIRECTLY RESULT IN DECREASED PATIENT SUFFERING AS WELL AS LOWER EXPENDITURE OF VALUABLE HEALTH CARE RESOURCES. OUR PRELIMINARY DATA SUGGESTS THAT THE CURRENT DERMISPHERE FORMULATION WILL SUPPORT ALL THESE UNMET CLINICAL SCENARIOS. WE HAVE DEMONSTRATED IN A SWINE MODEL OF FULL THICKNESS SKIN LOSS THAT DERMISPHERE SUCCESSFULLY SUPPORTS COMPLETE SPLIT THICKNESS SKIN GRAFT (STSG) TAKE WHEN THE TWO COMPONENTS ARE APPLIED SIMULTANEOUSLY. IN ADDITION, A SMALL ANIMAL MODEL OF FULL THICKNESS SKIN LOSS SHOWED THAT DERMISPHERE SUPPORTED RAPID AND SUSTAINED LATERAL AS WELL AS VERTICAL CELL INVASION, RESULTING IN SUCCESSFUL STSG "TAKE" IN CHALLENGING CASES OF WOUND BEDS WITH AVASCULAR PORTIONS AND WAS ABLE TO REVASCULARIZE TEMPLATES UP TO 3MM THICK. WE HAVE RECENTLY BROUGHT THE DERMISPHERE DERMAL REGENERATIVE TEMPLATE FORMULATION TO DESIGN FREEZE USING A CGMP-MATERIAL BASED FORMULATION THAT IS TERMINALLY STERILIZED AND ARE FAST PROGRESSING IN OUR TECHNOLOGY TRANSFER TO A CONTRACT MANUFACTURING ORGANIZATION. THE OVERALL OBJECTIVE OF THIS DIRECT TO PHASE II SBIR IS TO COMPLETE A POWERED, CLINICALLY RELEVANT LARGE ANIMAL STUDY (AIM 1), SCREEN THE DERMISPHERE PRODUCT IN CHALLENGING WOUNDS (AIM 2), PERFORM BIOCOMPATIBILITY TESTING (AIM 3), AND PERFORM USER VALIDATION STUDIES (AIM 4). COMPLETION OF THESE AIMS WILL RESULT IN THE ADVANCEMENT OF DERMISPHERE TECHNOLOGY TOWARDS 510(K) APPROVAL AND FIRST IN HUMAN STUDIES.