This is a novel, non-systemic hydrogel comprising a proprietary conjugate of Hyaluronic Acid and Metformin. It is the first-in-class topical regenerative therapy designed to restore near-normal skin architecture and adnexal structures following severe cold-induced injuries like frostbite.
Description
The technology combines hyaluronic acid (HA) with metformin through covalent conjugation to create a biocompatible hydrogel with dual regenerative and anti-inflammatory properties. The HA component provides a protective, moisture-retaining matrix that supports tissue scaffolding, while the conjugated metformin is released in a controlled manner to reduce inflammation, enhance microvascular perfusion, and reduce thrombotic risk at the injury site. The conjugate is synthesized through EDC/NHS-mediated coupling, forming stable amide bonds between HA's carboxyl groups and metformin's amino groups, with typical conjugation at 1-10% of available carboxyl sites.
The hydrogel formulation can be applied directly to frostbite injuries in the field or clinical settings, forming a protective film that delivers therapeutic agents directly to damaged tissue. The formulation incorporates anti-freezing agents like propylene glycol or glycerol to maintain stability at freezing temperatures, making it uniquely suited for cold-weather deployment. Pre-clinical studies demonstrate complete re-epithelialization, organized collagen remodeling, balanced type I/III collagen distribution, restored adnexal structures (hair follicles, sebaceous glands, sweat glands), and robust vascularization within two weeks of treatment.
Applications
- Military and Defense: Field treatment for soldiers and personnel exposed to extreme cold environments during operations or training.
- Emergency Medical Services: Pre-hospital care for frostbite victims in civilian settings, mountain rescue operations, and disaster response scenarios.
- Outdoor Recreation Industry: Treatment supplies for mountaineering expeditions, polar exploration, skiing facilities, and cold-weather sports venues.
- Occupational Health: Protection for workers in cold storage facilities, arctic research stations, fishing vessels, and other cold-exposure occupations.
- Veterinary Medicine: Treatment of cold-induced injuries in working animals, livestock, and domestic pets exposed to extreme weather.
Advantages
- Regenerative Treatment: Promotes complete re-epithelialization and the regeneration of adnexal structures (e.g., hair follicles), restoring near-normal skin architecture that existing systemic treatments fail to achieve.
- Field-Deployable: Designed for topical, non-systemic application, making it practical for immediate pre-hospital or field use where systemic treatments are impossible.
- Reduced Scarring & Pain: Mitigates fibrotic remodeling, significantly lessening scar tissue formation, and has been shown to suppress pro-inflammatory cytokines that contribute to chronic neuropathic pain.
- Vascular and Cellular Protection: Offers a dual mechanism of action that targets both acute ischemia–reperfusion injury and chronic maladaptive inflammation, enhancing microvascular perfusion and helping prevent thrombosis.
- Amputation Risk Reduction: By preserving tissue viability and locally modulating the severe inflammatory response, the hydrogel may prevent the progression of injury to necrosis and subsequent amputation.
Invention Readiness
The conjugate has been successfully synthesized and fully characterized using advanced analytical techniques, including FTIR, ¹H NMR, and HPLC. Proof-of-concept has been established in vivo using a validated experimental animal model of cold-induced skin injury. The compelling data generated demonstrates superior healing, including the reduction of scar tissue, restoration of epidermal thickness to near-normal levels, and regeneration of hair follicles. The next stages of development require scaling up manufacturing processes and transitioning to pivotal safety and efficacy studies in larger animal models as a precursor to human clinical trials.
IP Status
Patent Pending
