Actionable news
All posts from Actionable news
Actionable news in MDXG: MiMedx Group, Inc,

MiMedx Provides Update On Key Clinical Trials

MARIETTA, Ga., Aug. 30, 2016 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, provided an update today on the status of key clinical trials.

Plantar Fasciitis Investigational New Drug ("IND") Study Receives FDA Approval for Protocol Amendment Reducing Follow-up Requirements by One Year

Pursuant to the Company's agreement with the Food and Drug Administration ("FDA") to pursue a Biologics License Application ("BLA") with the Company's AmnioFix® Injectable product, MiMedx entered a Phase IIB Randomized Control Trial ("RCT") for the treatment of plantar fasciitis in August, 2014. The FDA approved the clinical study protocol which targets 146 subjects at up to 20 clinical sites. The study has met a very significant milestone. In the initial protocol, a 24-month follow-up blood draw was requested by the Agency in order to determine if the micronized dHACM injection elicited an immune response in patients. An amendment was submitted to the FDA based on generated data requesting a protocol amendment to remove the 24-month follow-up requirement for this clinical trial. Because of the excellent safety profile and the lack of immunogenic response seen in the study patients thus far, the FDA has agreed that two year data is NOT needed and reduced the requirement to one year. This is a major milestone for this study.

Parker H. "Pete" Petit, Chairman and CEO, said, "At present, 109 of the 146 patients have been consented and 103 randomized in the plantar fasciitis study, in a total of 13 sites, and the study should be fully enrolled by the end of the year. In terms of cost, the total expenditure for this study is projected to be slightly over $2 million, a large portion of which has already been expensed since the inception of the study in late 2014."

Bill Taylor, President and COO, stated, "In anticipation of additional needs for future regulatory and/or reimbursement purposes, we have had two large, multi-center chronic wound studies under way since 2014. One study is for diabetic foot ulcers ("DFUs") and the other is for venous leg ulcers ("VLUs"). These large studies follow the multiple clinical trials with EpiFix® concluded over the years, including the published 100 patient comparative effectiveness trial against a competitive product, and complete the DFU and VLU clinical trials for EpiFix. As with the comparative effectiveness study, the two studies that are underway follow the 2006 FDA Guidance for Industry-Chronic Cutaneous Ulcer and Burn Wounds. This is the guidance document that outlines clinical trial design for Premarket Approval ("PMA") and BLA products."

The multi-center DFU study was designed to have in excess of 10 sites and a target enrollment of 130 patients. This study currently has 12 sites enrolling patients, with 105 enrolled to date. The Company expects to complete enrollment by the end of this year. This study has been ongoing since 2014. The total cost of the study is expected to be less than $2 million, and a large portion of this estimated $2 million has already been expensed by the Company.

The multi-center VLU study targeted in excess of 10 sites and 120 patients. At present, 11 sites have enrolled 123 patients. MiMedx expects that this study will conclude enrollment shortly, and will...