More ties to Forest Park, active breach of federal sales regulations, knockback of “independent” research and the dead-on-arrival of international expansion.
The fraud at MiMedx continues to unravel as the company announced it would have to restate more than half a decade’s worth of financials, doctors receiving bribes from MiMedx and that its short selling commentary cannot be relied upon. Viceroy have identified further issues with the company including:
- The announcement of MiMedx’s international expansion was a sad attempt at distracting investors from the Company’s compliance updates.
- In the UK, the technology commentary from the NHS appears very skeptical as to the efficiency and economic viability of MiMedx’s EpiFix product compared to existing solutions. EpiFix has been available in the UK for 2 years as of January 2018, and the product was only stocked in 1 National Health Service (“NHS”) facility.
- Viceroy have begun contacting international regulators to present evidence.
- A major stumbling block to regulatory approval, as indicated by UK regulators, is the lack of independent research into MiMedx products’ efficacy and significant difference between company funded/sponsored reports and limited independent patient data.
- Viceroy have uncovered an AmnioFix study conducted by Forest Park Medical Center employee, John Dulemba, and MiMedx consultant and former Matria healthcare Director of Clinical Research, Niki Istwan.
- The study has no disclosures on compensation or relationships with MiMedx.
- Istwan appears on multiple MiMedx studies sometimes as a MiMedx consultant and other times as an “independent”. We believe this obfuscation of relationships to the company is intentional and used by MiMedx to create an illusion of independence. MiMedx does not report payments to Doctors despite the legal requirements.
- One of three individuals recently indicted for fraudulently accepting payments from MiMedx was also part of a clinical study into MiMedx products. The implication that MiMedx clinical research is directly influenced by the Company is likely to deter international approval altogether. More so for paying bribes to Doctors. MiMedx denied paying bribes or inducements in legal filings and illegal short selling commentary, but the Grand Jury disagrees.
- MiMedx is in breach of federal procurement regulations (FAR/DFAR) due to the conditioning of settlement agreements and litigation settlements with former employees and whistleblowers on a requirement for withdrawal of complaints to, and prohibition of communication with, regulatory authorities. We have reported this to the relevant authorities and believe their findings will corroborate our own.
For further background on this issue, please refer to Viceroy’s MiMedx Greatest Hits report: