I was wondering if anyone can speak to how the marketing and sales pitch will change now that MiMedx has to stick to just "wound covering" for its sheet products? Will there be a wholesale change to all of the marketing pieces that currently exist? Thanks for any insight.
I would not expect a significant change pending discussions with FDA. Certainly no change in sales as everyone in the marketplace knows what EpiFix is and does, regardless of what bureaucrats at the FDA say.
Not giving a damn about what "bureaucrats" say while telling investors you're as pure as the driven snow seems to be the recurring theme with the Petit gang. Even though the black and white of the guidance document says "An amniotic membrane product is used for wound healing and/or to reduce scarring and inflammation. This is not homologous use because wound healing and reduction of scarring and inflammation are not basic functions of amniotic membrane" it's just guidance...let's throw a press release out that says we're "well positioned in light of what FDA has said" and then completely ignore what they've said in actual practice. News flash: one of the reasons amniotic tissue shows up multiple times in the guidance document as an example for interpreting the document is due to the abuse of 361 HCT/P for using it in everything from wound care to tympanoplasty. If MiMedx persists in using marketing claims associated with what FDA will consider non-homologous use, get ready for enforcement action that will be leveraged by the competition and payers to their benefit. On the other hand, if MiMedx self-polices and changes the claims themselves (the right thing to do), the competition and payers still gain the benefit when EpiFix is properly called a "wound covering". But none of this may matter anyway since Petit seems to have an infatuation with digging his own grave with short sellers...a hobby that has earned him an entirely different group of bureaucratic observers.
Mimdx is really in a bind here, they need to completely change all marketing , brochures , case studies , sales pitches, etc under this new FDA guidelines. This means no more talking about wound healing, scarring, tissue. This is going to cost millions Or they will need to go through full double blind prospective studies to get PMA approval to create a new type of medical device. This will take years and a lot more money , but in the long run more lucrative.
Relationships sell. Having the best product on the market makes it faster to generate revenue. Yes I work here and no I am not in management. I am sick and tired of all of this BS talk. When and IF this company starts to decline we will lock arms and come out on top. There are a lot of good people here up for the challenge. Here is a rare CafePharma FACT for all of you geniuses that have it figured out...WE ARE WINNERS
Haha, Wow, ..you are rally drinking the Kool-Aid! Off label selling, against FDA Guidence, no real published third party data. It is now just a Wound Dressing, bottom line.
When you get to that locking of arms stage, you may want to avoid doing so with the ones in handcuffs.
EpiFix was, is, and always will be a WOUND COVERING unless MDXG goes through a BLA for claims otherwise. This is not a new thing with the final guidance, and was never unclear to anyone except MDXG. The only difference up until now is that MDXG chose to play "come catch me" with FDA and claim otherwise, while most of the other competitors played by the rules.
Time will tell if Mimedx learns to play by the rules or gets slapped with a hefty fine for off label use. Yes surgeons have the power to use the product off label, but reps can't talk about it and I am pretty sure 90% of your sales can't come from off label use. Sounds like the short sellers will win out if they are in it for the long haul.
It is far more serious than off label marketing. Anti Kick back statute violations, accounting fraud, Dodd Frank violations, etc.
