Miromatrix, has announced that on August 4th the first subject enrolled into their multi-center Hard-to-Heal Diabetic Foot Ulcer study was treated with MIRODERM Biologic Wound Matrix by Dr. Payam Rafat of A Step Ahead Foot Care in New York. Dr. M. Mason Macenski, Head of Clinical Affairs at Miromatrix, said, “I am pleased to initiate this trial and have the opportunity to further demonstrate the healing potential of this unique wound care matrix.”
A pilot series by Study Principal Investigator Dr. Robert Fridman of Foot Associates of New York, demonstrated that MIRODERM had substantially improved the healing of recalcitrant diabetic foot ulcers that previously failed other advanced wound therapies. In the pilot study MIRODERM closed 50% of the subjects’ hard-to-heal wounds within 12 weeks. This is notable in that the subjects’ wounds had been open for an average of more than 2 years and had received a median of 4 treatments with other advanced biologic products. This motivated Miromatrix to initiate a larger multi-center trial. “It is important to treat and rapidly close diabetic foot ulcers. persistent wounds are predictive of poor clinical outcomes, including infection and possible amputation,” says Dr. Fridman. “The pilot study results showed that MIRODERM was able to heal challenging, long-standing wounds that have failed other advanced therapies and biologics. I am excited to have the opportunity to further evaluate MIRODERM in a larger, multi-centered clinical trial.”
MIRODERM Biologic Wound Matrix is the first-and-only wound matrix derived from porcine liver. MIRODERM is manufactured using Miromatrix’s patented Perfusion Decellularization technology allowing the wound matrix to retain the intact extracellular matrix of the original biologic material including all vascular channels. MIRODERM is available in a variety of sizes both solid and fenestrated and is cleared for the management of wounds including but not limited to pressure ulcers, venous ulcers, chronic vascular ulcers and diabetic ulcers. MIRODERM received an innovative technology contract from Vizient and was awarded a federal supply schedule contract for government sales.
Miromatrix, is a biotechnology company engaged in the development of fully biological human organs to solve the chronic shortage of transplantable organs, utilizing its patented perfusion decellularization/recellularization technology, as well as organ-derived biological products such as MIROMESH® and MIRODERM® for soft tissue reinforcement and advanced wound care. Miromatrix’ perfusion decellularization/recellularization technology is protected by a series of issued patents and pending patent applications in all major markets around the world. In addition to MIROMESH and MIRODERM, internal development programs at Miromatrix focus primarily on creating fully implantable human organs including livers, kidneys and heart products, with collaborators including The Mayo Clinic, Texas Heart Institute and Mount Sinai Hospital, and aim at eliminating the organ transplant waiting list.
Jeff Ross, Ph.D. CEO