MicroVascular Tissues Reports Positive Results for HIFLO Trial Demonstrating Increased Closure and High Quality of Healing Using mVASC® Microvascular Tissue Graft
Data From 100-Patient Randomized, Controlled Trial on Nonhealing Diabetic Foot Ulcers Presented at SAWC Fall 2020
SAN DIEGO, Nov. 10, 2020 /PRNewswire/ -- MicroVascular Tissues, Inc., (MVT), a regenerative medicine company, today announced positive results of its HIFLO Trial assessing patient outcomes after treatment with mVASC® Microvascular Tissue Graft product compared to standard of care alone (SOC). The findings were presented at the Symposium on Advanced Wound Care (SAWC) Fall 2020 meeting held Nov. 4-6.
The HIFLO trial was a Level 1, prospective, single-blind, randomized clinical trial conducted at six U.S. sites that assessed outcomes in 100 subjects with Wagner grade 1 and 2 neuropathic diabetic foot ulcers (DFUs). Subjects were randomized 1:1 to SOC or mVASC plus SOC. Rigorous, prespecified, peer-reviewed criteria were used to evaluate wound closure along with blinded independent adjudication by wound care experts. The study also assessed the quality of healing via improvements in perfusion and neuropathy. The primary endpoint was the percentage of ulcers healed within 12 weeks. Additional secondary and research endpoints included wound area percent reduction, time to closure, improvement in blood flow (perfusion) and peripheral neuropathy.
At 12 weeks, 74% (37/50) of the mVASC treated subjects' DFUs were healed versus 38% (19/50) in SOC treated subjects (p=0.00029). The trial additionally found that mVASC treatment increased the odds of healing by 9X. Statistically significant improvements were also demonstrated in percent wound area reduction, time to healing and local neuropathy. Improvements in blood flow and regional neuropathy were seen in sub-studies of mVASC versus SOC treated subjects. However, additional studies will need to be performed to confirm these results in a larger population.
The HIFLO trial's principal investigator, Lisa Gould, M.D., Ph.D., past-president of the Wound Healing Society, commented, "The HIFLO trial sets a new standard for evaluating advanced wound care tissue therapies. This is one of the largest prospective randomized controlled studies of high-risk diabetic foot ulcers. Two key factors in trial design are noteworthy: 1) The trial employed a rigorous definition for wound closure consisting of predefined criteria and confirmation from an independent panel of adjudicators and 2) a rigorous standard of care that included active topical treatment in the control arm. The fact that mVASC significantly outperformed the robust standard of care used in this study speaks to the potential of microvascular tissue therapy to benefit this challenging patient population."
"We're pleased to be recognized as one of the highest scoring submissions at SAWC Fall and proud to share the results of this foundational study with the medical community," said Glen Gong, Ph.D., CEO of MicroVascular Tissues. "The HIFLO trial demonstrates statistically significant wound healing with mVASC versus SOC in large, deep DFUs. These results are attributed to treating vascular deficiencies with a vascular solution. Our commercial release of mVASC offers wound care clinicians a highly differentiated and effective microvascular tissue product for use in complex wounds."
About mVASC® Microvascular Tissue Graft
mVASC® is a ready to use, off-the-shelf human microvascular tissue allograft. mVASC provides the foundation for tissue repair by preserving natural microvascular tissues fragments, associated nonviable cells and inherent biological factors. It is lyophilized, terminally sterilized, and stable at room temperature for five years. mVASC is marketed in accordance with FDA HCT/P regulations and is restricted to homologous use for the repair, reconstruction, replacement or supplementation of microvascular tissues.
About MicroVascular Tissues
MicroVascular Tissues, Inc. (MVT), is the leader in Microvascular Tissue Science. MVT is an evidence-based regenerative medicine company commercializing mVASC, a product used in the repair, reconstruction, replacement or supplementation of microvascular tissues. MVT recently completed the HIFLO Trial, demonstrating mVASC's superiority in closing nonhealing diabetic foot ulcers and reducing neuropathy. In addition to advanced wound care, MVT intends to develop this new concept of microvascular tissue therapy for applications in other diseases caused by deficient microvascular tissue, with a pipeline including vascular medicine, orthopedics and soft tissue reconstruction. For more information, visit www.mvtissues.com.
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