Matregenix Inc.

Matregenix Inc. is a minority-owned, self-certified small disadvantaged business manufacturer based in Mission Viejo, California, specializing in advanced nanofiber-based biomaterials and medical devices. The company develops synthetic, biologically-free solutions focused on regenerative medicine, wound healing, and tissue restoration technologies designed for military and civilian healthcare applications. Matregenix has established a substantial track record securing federal research and development funding from the U.S. Air Force Research Laboratory and the National Institutes of Health, demonstrating expertise in creating innovative medical technologies that address critical healthcare challenges while meeting stringent military deployment requirements.

Through its federal contract portfolio, Matregenix has received nine prime Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) contracts from the Air Force Research Laboratory, all designated as total small business set-asides and structured as firm fixed-price purchase orders. The contract awards, ranging from $74,472 to $1.8 million and totaling approximately $8.2 million, support the development of novel amino acid-based nanofiber membranes and handheld applicator devices for diverse medical applications. Specific contract deliverables include a streamlined synthetic amniotic membrane for ocular penetrating injuries and burns with extended shelf life and simplified logistics (Phase I awarded May 2024, $74,832; Phase II awarded August 2025, $1.25 million); a surge-capable, non-biologic amino acid-based wound-healing matrix for rapid trauma care (Phase II awarded July 2025, $1.25 million); bi-layer biologically-free amino acid nanofiber membranes for guided bone regeneration in dental and craniomaxillofacial surgery (Phase I awarded January 2025, $74,472); a biologically-free amino-acid nanofiber scaffold for rotator cuff repair with enhanced shelf life (two substantially identical Phase II awards in August 2024, each valued at $1.25 million); DERMASPIN, a handheld device for contactless application of an antibacterial nanofiber matrix for point-of-care wound healing (STTR Phase II awarded August 2024, $1.8 million); MATRINOVA, a biologically-free amino-acid nanofiber for soft tissue restoration with simplified logistics (SBIR Phase I awarded December 2023, $74,628); and SPINHEAL, a handheld device for contactless antibacterial nanofiber application (STTR Phase I awarded December 2023, $109,921). All contracts emphasize the elimination of animal-derived and biologic materials, simplified military logistics, extended shelf life, and practical field deployment capabilities.

Matregenix has received two prime federal grant awards from the National Institute of Dental and Craniofacial Research (NIDCR) under the Oral Diseases and Disorders Research program (CFDA 93.121). The first grant, awarded September 1, 2022, with a completion date of August 31, 2023, supported research on electrospun amino acid-based poly(ester urea) biodegradable barrier membranes for guided bone regeneration, focusing on developing tunable nanofiber membranes composed of L-valine and L-phenylalanine monomers with limited inflammatory response for dental implant applications. The second grant, a substantially larger Project Grant awarded July 1, 2025, valued at $1.952 million with completion scheduled for June 30, 2027, supports the development and large animal study validation of MATRINOVA, an animal-free, amino acid-based bilayered barrier membrane for oral and craniomaxillofacial bone regeneration. This Phase II grant specifically funds efficacy and clinical significance studies using porcine models to support submission of a 510(k) regulatory clearance package to the FDA, positioning MATRINOVA as a cost-effective and scalable synthetic solution addressing limitations of current collagen-based barrier membranes in dental and craniomaxillofacial surgical procedures.