Amniox Medical touts foot ulcer study data

Amniox Medical today released results from a retrospective study of its Neox wound allograft in treating chronic diabetic foot ulcers touting an 87% rate of healing in patients treated with the allograft.

Findings from the study were presented at Superbones Superwounds East 2016 in Teanack, N.J. last week.

“These findings are quite positive for the application of umbilical cord allograft for diabetic foot ulcers. A close review of this data in comparison to other published studies also suggests more frequent applications most likely translates to faster healing, even considering larger initial wound size. High levels of the HC-HA/PTX3 protein complex in the umbilical cord appear to play a central role in successful healing in these cases. The tissue’s demonstrated effectiveness and ease-of-use make it a valuable option for these patients and the physicians overseeing their care,” study author Dr. Allen Raphael said in prepared remarks.

The 29-patient, 32-wound study reported 28 wounds, or 87.5% of all wounds, achieved complete healing, with an initial average wound area of 10.6 cm squared. The ocmpany said that is a substantially larger area than a typical diabetic foot ulcer.

Average time to healing for patients in the study treated with the Neox was 13.8 weeks, and the average applications were 1.68, the company said. Each wound in the study was debrided in an operating room before the Neox allograft was placed over the wound and secured in place with sutures.

“The body of clinical evidence regarding umbilical cord tissue in regenerative healing is continuing to grow further. If one compares this finding of an 87.5 percent healing rate with rates published for multiple alternatively processed amniotic membrane options, including for instance bioengineered skin substitutes and cryopreserved or dehydrated amniotic membrane, this is clearly a positive alternative, especially considering the larger-than-typical average wound size and fewer applications required for healing. Coupled with the storage flexibility Amniox tissues offer, and the ease of handling and application, the benefits are magnified,” CEO Tom Dugan said in a press release.

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