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MicroVascular Tissues Announces Peer-Reviewed Publication of Positive HIFLO Clinical Trial Results Using mVASC® Graft

Data on Nonhealing Wagner 1 & 2 Neuropathic Diabetic Foot Ulcers Published in IWJ. Additional Data to be Presented at Upcoming 2021 SAWC and DFCon Meetings.

SAN DIEGO, CA, UNITED STATES, October 20, 2021 /EINPresswire.com/ -- MicroVascular Tissues, Inc., (MVT), a regenerative tissue company, today announced that the results of its HIFLO Trial assessing patient outcomes after treatment with mVASC® Microvascular Tissue Graft product have been published in an article entitled, “Improved Healing of Chronic Diabetic Foot Wounds in a Prospective Randomized Controlled Multicenter Clinical Trial with a Microvascular Tissue Allograft” in the International Wound Journal (IWJ), one of the preeminent journals aimed at improving patient care in the wound care industry.

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 nonhealing Wagner grade 1 and 2 neuropathic diabetic foot ulcers (DFUs). The primary endpoint was the percentage of ulcers healed within 12 weeks. Secondary and research endpoints included wound area percent reduction, time to healing, improvement in blood flow (perfusion) and peripheral neuropathy.

As reported in IWJ, weekly application of mVASC resulted in significantly increased complete wound closure, greater percent wound area reduction, decreased time to healing, and improved local neuropathy compared to the control arm. The trial found that mVASC treatment increased the odds of healing by 9X. Exploratory results suggest that increased wound site perfusion and reduction of regional neuropathy accompanied wound resolution accelerated by mVASC. Taken together, these findings support the utility of microvascular tissue to restore a functional microcirculation as a new approach to treating chronic DFUs.

The HIFLO Trial’s principal investigator, Lisa Gould, M.D., Ph.D., past-president of the Wound Healing Society and lead author on the paper, commented, “My co-authors and I are delighted that with the publication of our manuscript in IWJ, additional details of the HIFLO trial have now been shared with our colleagues in the wound care community. The fact that mVASC significantly outperformed the robust standard of care treatment speaks to the potential of microvascular tissue therapy to benefit this challenging patient population.” Glen Gong, CEO of MicroVascular Tissues, added “mVASC represents a unique and highly effective vascular solution for vascular deficiencies such as neuropathic diabetic foot ulcers.”
The company announced that it will be participating in two upcoming translational meetings, the Diabetic Foot Conference (DFCon) 2021, taking place on Oct. 21-23, and the Symposium on Advanced Wound Care (SAWC) Fall 2021 meeting, to be held Oct. 29-31. At both conferences, clinical posters reporting additional results on the novel exploratory perfusion and neuropathy endpoints as well as detailing the minimization of bias in the HIFLO Trial will be presented.

About mVASC® Microvascular Tissue Graft
mVASC is a ready to use, off-the-shelf human microvascular tissue graft containing small blood vessels, extracellular matrix, 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 tissue company developing and commercializing products that address vascular deficiencies using vascular solutions, including mVASC, an allogeneic structural microvascular tissue graft product. For more information, visit www.mvtissues.com.

Doug Arm
MicroVascular Tissues, Inc.
+1 858-522-0633
darm@mvtissues.com