A.M. Jorgensen, M. Loll, D. Hickerson, W. Hickerson
SiOxMed, LLC,
United States
Keywords: Medical Devices, Wound Matrix, Full Thickness Wounds, Burns, Ulcers, ECM, Wound Healing
Summary:
Successful wound care requires a fine balance of the wound environment for proper healing, which remains problematic for currently marketed wound care devices. To address this challenge, SiOxMedTM has developed a biocompatible wound matrix, SiOxDTM Wound Matrix. The SiOxDTM Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption to promote a moist environment for the body’s natural healing process. The matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. The SiOxDTM Wound Matrix received 510(k) clearance in November 2022, and is intended for use in the management of wounds. Wound types include: Partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds. Evaluation of the SiOxDTM Wound Matrix was performed in accordance with ISO standards. In vitro analysis demonstrated that the matrix was non-cytotoxic and nonpyrogenic. The matrix was non-toxic in both acute and subacute systemic toxicity testing. A full thickness porcine wound healing study found equivalent wound healing performance for the SiOxD Wound Matrix when compared to another similar device and controls. Human repeat insult patch testing demonstrated that the matrix was non-irritating and non-sensitizing. In summary, all testing passed showing the device met all biocompatibility and performance requirements for its intended use. SiOxMedTM is now scaling up GMP manufacturing of the matrix in preparation for first-in-human use and commercialization of the product.