Project Grant R44DK137615
- This federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $268,377 to The University of North Texas Health Science Center at Fort Worth (UNTHSC) to develop and evaluate a novel device for accelerating the healing of diabetic foot ulcers (DFUs) using high-frequency, low-amplitude vibration (HFLAV). The key objectives are to: 1) enhance...
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded a $687,416 Project Grant under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) to Lynntech Inc., a small business technology development company based in College Station, Texas. The grant will support the development of a cutaneous gel to deliver a therapeutic with an intriguing mechanism of action to effectively treat diabetic foot ulcers (DFUs). The project aims to: (1) prepare,...
- This Project Grant award from the National Science Foundation's (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) program will fund the development of an advanced wound care product to treat diabetic foot ulcers. The $305,000 award to Therapeutic Bandage Products, Inc. will support the creation of a patented microneedle bandage that delivers three therapeutic agents to disinfect the wound, prevent bacterial biofilm formation, and attract white blood cells to aid healing. This...
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded Gelsana Therapeutics Inc. a $649,984 Project Grant under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop Provasliex Gel, a zwitterionic hydrogel that delivers controlled release of platelet-derived growth factor (PDGF). The goal is to improve wound healing for diabetic foot ulcers by reducing inflammation, promoting vascularization, and accelerating the wound...
- This federal Project Grant award of $1,024,812 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), aims to develop novel treatments for diabetic foot ulcers (DFU). The award supports research conducted by Epoulosis Therapeutics Inc. to leverage single-cell RNA sequencing data and in vivo studies to repurpose the drug metrifonate for enhancing wound healing in DFU...
- The federal Project Grant award of $310,438 from the National Institute of Diabetes and Digestive and Kidney Diseases (CFDA 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research program) to Htic, Inc. (UEI: XAMZMYUY9UA9) is focused on establishing proof-of-concept studies to develop a novel humanized monoclonal antibody (hCITH3-mAb) for the treatment of diabetic wounds. The project aims to formulate a topical delivery system for hCITH3-mAb and conduct in vivo studies to demonstrate...
- This $100,000 Project Grant from the National Science Foundation's Technology, Innovation, and Partnerships program will support the development of an advanced wound care technology at Florida International University. Specifically, the university will create a bandage-integrated platform that provides feedback-mediated wound therapy to enable personalized care. The conformable platform is designed to non-invasively monitor multiple wound biomarkers in spatial detail and then apply targeted...
- The National Science Foundation (NSF) awarded a $295,000 SBIR Phase I Project Grant under the Technology, Innovation, and Partnerships (CFDA 47.084) program to Biodynamik, a small business located in Lake Forest, CA. The grant supports the development and testing of a novel implantable system that leverages distraction osteogenesis as a treatment for diabetic foot ulcers (DFUs). The project aims to design and develop a low-profile, transverse tibial transport device with an active mechanical...
- This $367,577 Project Grant award from the National Institute on Aging (CFDA 93.866 Aging Research) to Adepthera LLC aims to develop a regenerative peptide therapy to accelerate pressure ulcer healing. Specifically, the award will fund research to identify an optimal formulation of a self-assembling adrenomedullin (ADM) analog gel that can improve local blood circulation and wound healing in aging and diabetic mouse models. The proposed therapy would be administered weekly or biweekly via...
- This Project Grant award from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286), aims to improve the assessment of cutaneous wound healing by quantitatively measuring biomarkers of vascular perfusion and hypoxia. The University of Wisconsin-Madison is the awardee, receiving $427,625 for this 2-year project from September 1, 2025 to August 31, 2027. The...
STRAIN-PROGRAMMED BIOADHESIVE PATCH FOR ENHANCED DIABETIC WOUND HEALING - ABSTRACT THE OBJECTIVE OF THIS PROPOSAL IS TO OPTIMIZE AND VALIDATE THE STRAIN-PROGRAMMED BIOADHESIVE PATCH IN COMPLIANCE WITH FDA REGULATORY GUIDANCE FOR THE FDA IDE APPROVAL IN ADVANCE OF THE FUTURE PIVOTAL CLINICAL TRIAL AND ULTIMATE REGULATORY CLEARANCE AND COMMERCIALIZATION. IN LIGHT OF THE HUGE AND RAPIDLY GROWING CLINICAL AND ECONOMIC COSTS OF CHRONIC DIABETIC WOUNDS AND ASSOCIATED COMPLICATIONS, VARIOUS TREATMENTS INCLUDING SKIN SCAFFOLDS AND GROWTH- FACTOR-BASED DRUGS HAVE BEEN PROPOSED AND CLINICALLY TESTED. TO DATE, HOWEVER, THE EXISTING APPROACHES STILL FACE SEVERAL LIMITATIONS FOR DIABETIC WOUND HEALING INCLUDING LIMITED THERAPEUTIC EFFICACY AND/OR HIGH COST OF PRODUCT/TREATMENT. TO ADDRESS THESE LIMITATIONS OF EXISTING SOLUTIONS, DURING THE PRIOR DEVELOPMENT (PHASE I- EQUIVALENT), OUR COLLABORATIVE TEAM DEVELOPED A PROOF-OF-CONCEPT PROTOTYPE OF A STRAIN-PROGRAMMED BIOADHESIVE PATCH FOR ENHANCED DIABETIC WOUND HEALING BY UNIQUELY UTILIZING PRO-REGENERATIVE MECHANICAL MODULATION. THE PRELIMINARY PRE-CLINICAL VALIDATION AND ANALYSIS BASED ON IN VIVO DB/DB MICE, DIABETIC PORCINE, AND DIABETIC HUMANIZED MICE MODELS REVEALED THE PROMISING THERAPEUTIC POTENTIAL AND UNDERLYING MECHANISMS OF THE STRAIN- PROGRAMMED BIOADHESIVE PATCH FOR THE ACCELERATED HEALING OF DIABETIC CUTANEOUS WOUNDS. BUILDING UPON THE PROMISING OUTCOME OF THE PRIOR DEVELOPMENT, UNDER THE SCOPE OF THIS DIRECT PHASE II SBIR PROPOSAL, WE WILL FURTHER OPTIMIZE AND VALIDATE THE STRAIN-PROGRAMMED BIOADHESIVE PATCH IN COMPLIANCE WITH RELEVANT FDA REGULATORY GUIDANCE FOR THE EFFECTIVE AND BROADLY AFFORDABLE TREATMENT OF CHRONIC DIABETIC WOUNDS SUCH AS DFU. IF SUCCESSFUL, THE PROPOSED PROJECT WILL ALLOW SANAHEAL TO PREPARE AND SUBMIT THE FDA IDE PACKAGE IN ADVANCE TO A PIVOTAL CLINICAL TRIAL AND ULTIMATE COMMERCIALIZATION WITH FAR-REACHING BENEFITS FOR PATIENTS AND THE HEALTHCARE SYSTEM.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $1.1m | 8/7/24 | ||
| Not listed | $0 | 8/6/24 | ||
| Not listed | $1.1m | 9/7/23 |