- In a statement issued today, MiMedx Group (OTC:MDXG -2.3%) takes issue with a press release issued yesterday by Osiris Therapeutics (OSIR -3.3%) touting "results" from a retrospective analysis of medical records at a 70-bed Montana hospital that showed Osiris' Grafix placental membrane allograft was more effective in healing wounds than MiMedx's EpiFix, an amniotic membrane allograft.
- According to Osiris, the analysis was based on 79 patients with 101 acute/chronic wounds who received at least one application of either Grafix or EpiFix between February 2014 and March 2016 at the Bozeman Health Deaconess Hospital, Wound and Hyperbaric Center. 39 patients with 55 wounds received EpiFix and 40 patients with 46 wounds received Grafix.
- The analysis showed a 63.0% complete wound closure rate (n=29/46) in the Grafix group compared to 18.2% (n=10/55) for EpiFix. A p value <0.0001 was provided to lend credibility to the difference, but it is meaningless considering the retrospective non-random nature of the data. 90% of the wounds in both groups achieved closure by week 12. Several other metrics were cited that showed Grafix was more effective than EpiFix.
- MiMedx cites a laundry list of problems with the analysis, including the lack of matching comparable wounds and treatments, the failure to take into account comorbidities, infections, wound type and age, an ill-defined treatment period of 12 weeks, the lack of information re the number of allograft applications and the absence of information about patients who discontinued treatment or were lost to follow-up. In addition, the company's sales of EpiFix to the medical center failed to correlate with expected volumes based on appropriate treatment of 55 patients during the review period.
- Wound care products accounted for ~74% of MiMedx's Q1 revenue of $53.4M.