I have to say this about Parker Petite:
Below is my response to Parker.
Parker posted a self-serving defense of MiMedx and his actions linked HERE.
My response is forthcoming.
Below is the full lawsuit against Parker H. Petit and MiMedx. Click on the link below to read!
SENATOR JOHNNY ISAKSON HAS COMMITTED MANY DIRTY DEEDS.
It is time for him to come clean. NOW!
Below is a letter from my attorney to Senator Iskason requesting that he disclose the truth about his interactions with the FBI and Parker Petite. All we got back was a bunch of redacted documents. Click here to see what we got.
In response my attorney sent the following letter to the Ethics Committee. Read the full letter here.
The Cover Up is Always Worse than the Crime… Doing Parker Petite’s Dirty Work has Caught Up With You Now!
Here are the FOIA’d Emails! If there is nothing to hide, why not release all communications? Read all the emails here.
Senator Johnny Isakson needs to RESIGN AT ONCE. It was never about “tweets,” just an abuse of power covering up for SERIAL FRAUDSTER Parker Petite! Read more from the Wall Street Journal here.
Merry Christmas to the last few passengers on the Titanic. Hopefully you will be able to find legitimate employment in the future…
Business is so bad at MiMedx and the company is so out of control under David Coles’ complete lack of leadership, that MDXG is having to discard/throw away 100s (if not 1000s) of donated placentas.
This falls on Debbie Dean who continues to “spy” for Parker Petite. One of her jobs is “Placenta Procurement,” which, of course, she has failed at miserably.
Northside Hospital in Atlanta will, I am sure, be livid when they realize this. I plan on contacting them in the New Year with this news.
Women are forced to jump through hoops and have been defrauded into believing that their organs are used to help people. This is another FALSE NARRATIVE told by MiMedx.
Please stop the fraud NOW, David Coles, and FIRE the employees responsible for these and other unacceptable issues at MiMedx. If you want a list you know where to find me.
Please donate to the Rice Voelker Fund For Recovery! This is a very worthy charity, I will match donations up to $100,000 between now and year end!
Good on NASDAQ for doing the right thing on the fraud known as MiMedx. It’s time for David Coles to come clean! Read the full letter linked here:
…and reveal who the “Nationally Recognized Revenue Recognition Expert” is.
Let’s also release the “Special Audit Report” that was “public.” The lies that have been and are being told by MiMedx are staggering and the people behind the fraud are still at the company.
Below is an answer Parker H. Petite gave on an investor conference call on September 21, 2017.
1) Who was the “outside law firm?”
2)Who was the “outside Consultant of Revenue Recognition?”
3) Since this was made public many, many months ago, where the hell is it?
MiMedx disclosure has been, and continues to be, terrible. David Coles, why are you carrying the water for Parker H Petite and his “gang?” It’s high time for you to lead!
It’s also high time you clean house, for there are 100’s of cockroaches that need to be removed from the MiMedx kitchen!
It has almost been a YEAR and, though people were warned, the FRAUD at MiMedx is still happening! It’s time for ADULTS to do their jobs! Below is a letter I wrote to Parker about the fraudulent activity happening at MiMedx (or read it by clicking HERE)!
Dear Mr. Petit:
You and I have engaged in a verbal battle over the past few weeks and months about the business practices and accounting at the company you lead, MIMEDX. You have claimed that I am part of a conspiracy to deflate the MiMedx stock price and that I have made false allegations about the company. I, on the other hand, have reported on information provided to me by ex-employees, and I have read the analyses by Viceroy and Aurelius, two companies that you have now sued in what I believe is an attempt to stifle criticism of you and your company.
Now I have received evidence from a current employee, in the form of an email attached to this letter, that raises very serious claims about misconduct by Mimedx and its executives. The employee – who sent the email anonymously because of his or her fear of you – claims the following, among other things (full email attached, with sender’s name redacted):
1. Management has deleted information and evidence from MiMedx’s computers. If true, and if it was done when MiMedx knew about an SEC investigation or inquiry, that may be a crime.
2. You and other managers “instructed people to avoid credits that would have destroyed most quarter sales and today’s [October 10, 2017] announcement is the final straw.”
3. “Mr. Petit was fully aware of the federal VA shelf stuffing in 2014, 15 and 16. By fully, he had dialogue with a number of us and also tasked Lou Roselli and others with avoiding a massive credit to avkare that would have destroyed the company report figures (I have the exact emails).”
4. “Please stop lying.”
5. “Mr. Petit knows the events about the revenue and the conduct of MM
individuals is true including the distributors with obscene orders at the end of
6. There are emails from the US Veterans Administration reflecting concerns
about consignments and shipments by MiMedx of unordered products.
7. MiMedx has engaged in channel stuffing by sending unordered products or consignments to doctors and others and then recording those shipments as sales. “Mr. Petit knows about this, in one quarter alone there was $3M was shelving product to recognize sales when there was no sale. I can show other quarters with $2m+. … Since 2015 I know it’s false.”
8. The employee alleges that he/she has text messages reflecting orders from mangers to create fake sales at the end of multiple quarters, and was told “it would be ironed out; we just had to hit the quarter.”
9. You and other managers have retaliated against employees who raised concerns in the “Dear Pete” letter program that you established for complaints. “People stopped putting in the letters of concern (Dear Pete) when they became a trend of report a problem, get fired …. I and a few others have kept their mouths shut and do as we are told.”
10. “I personally heard Mr. Petit state he would destroy them and their families when speaking about employees.”
11. “When I read the Aurelius and Viceroy Reports [two analysts you have sued] they are sadly accurate. They miss lots of things that I can personally testify to.”
Mr. Petit – you have accused short sellers of improperly targeting your company,
but you don’t seem to understand that a well-run, financially responsible company has little to fear from short sellers or from analysts who write negatively about a company because those companies’ stock prices are largely unaffected by negative criticisms. Your company, on the other hand, has adopted the “attack the critics” tactics of such infamous and now defunct companies as Lernout & Hauspie, Media Vision Technology, NovaStar Financial, AremiSoft, California Micro Devices, Network Associates, Concordia International Corp., Home Capital Group, Krispy Kreme Donuts, Boston Chicken, and others.
I ask you publicly to stop attacking the critics and buckle down and respond to the criticisms. You may have to do it twice or more: once to the public and then again to government regulators and prosecutors.
But, as Justice Louis Brandeis once wrote: “Publicity is justly commended as a remedy for social and industrial diseases. Sunlight is said to be the best of disinfectants; electric light the most efficient policeman.”
Those familiar with this website know all about the “Dirty” MiMedx Reps. First and foremost, Frank Braly. Frank had numerous side jobs other than MiMedx, including Spinelogix, whose website now has gone dark. Spinelogix.com no longer exists and I wonder how long Frank lasts at Mimedx. Check out the Spinelogix LLC filing HERE.
David Coles, if you want to even attempt to clean up the rats nest you are CEO of, then Braly, Cashman, Blocker, Haden, Palmer, Andolino, Ball, Sutherland, Carlton, Cuntz, and Schultze need to walk the plank. And soon!
Parker the Barker fired numerous employees for selling competitive products. Bonus question Mr. Coles: how many millions of said products has Braly sold?
A new shareholder derivative suit was filed on 9/27 (Case 1:18-cv-04514-ELR). The shareholder had sent a demand letter to the Board earlier in the year urging them to conduct an investigation into the internal investigation into the audit committee and other matters including:
(i) the circumstances surrounding the indictment of the three VA employees on charges they accepted bribes from MiMedx; (ii) the circumstances surrounding the Company’s need to restate more than five years of financial statements; (iii) the sudden departures of defendants Senken and Cranston; (iv) the independence of the Company’s Audit Committee members conducting the investigation into MiMedx’s sales and distribution practices; and (v) the improper corporate culture the Company’s fiduciaries promoted or allowed to continue for a number of years.
The shareholder says that:
Nearly three months after plaintiff sent his initial Demand, the Board finally responded. In a letter dated July 2, 2018, Edmund Polubinski III (“Polubinski”) from the law firm of Davis Polk & Wardwell LLP, stated that the Board had created the Special Committee to investigate plaintiff’s Demand, and that his firm was retained to assist the Special Committee. The letter explained that the Special Committee was unable to provide an estimate of when the investigation would be complete, as it had yet to begin its investigation.
The suit attached a letter from Davis Polk (below) in July —confirming that they have begun an investigation that states “I invite you to provide any additional information that you have concerning purported breaches of fiduciary duty or other allegedly improper conduct by the Company’s directors or Officers”(below). Therefore, I believe this is clearly a 3rd internal investigation into matters including conduct of the Audit committee.
This is the attorney who wrote the letter:
Edmund Polubinski III
1. New York
+1 212 450 4695
Mr. Polubinski is a partner in Davis Polk’s Litigation Department, representing clients in securities, derivative, acquisition-related, and other complex litigation in federal and state trial and appellate courts around the country, as well as in arbitration. He also represents companies, funds, and boards of directors in internal investigations, as well as in investigations and other proceedings before various governmental authorities, including the Securities and Exchange Commission, the Commodity Futures Trading Commission, and the Department of Justice. His recent clients include Citigroup, Crestview Partners, Cross River Bank, FINRA, Hitachi, Morgan Stanley, Pattern Energy, Prosensa, Roche, Tailwind Partners, Toll Brothers and the independent directors of MF Global.
Mr. Polubinski has been recognized for his work in securities litigation in leading industry publications. In Chambers USA, sources have described him as “terrific,” “superb,” “very conscientious and extremely smart,” and highlight his “excellent judgment.” He has also been recognized in Benchmark Litigation and The Legal 500 U.S.
Petite Parker I WON’T BACK DOWN UNTIL YOU and MDXG ARE FULLY EXPOSED!
This re-post proves how right I have been on the FRAUD at MiMedx. It’s time for this charade to end with Parker and his gang BROUGHT TO JUSTICE! MiMedx needs to come with an 8k detailing what Parker Petite and Bill Taylor were caught doing. The Audit Committee and Chairman Evans need to RESIGN AT ONCE! After all, you guys were there watching what Parker Petite was doing, and, even though DOCUMENTATION was provided to you, you DID NOTHING and ALLOWED Parker to CARRY ON. You RUINED innocent peoples lives and BLAMED others for his FRAUD.
Read all my statements by clicking the following link:
Below is a preview:
1. Cohodes Statement:
“Petite Parker and his management team are LIARS”
Cohodes and group are the liars. MiMedx and its Management team are not liars. We have repeatedly stated factual information, not baseless allegations. Another MiMedx whistleblower, Mike Fox, has now emerged with detailed allegations that MiMedx has engaged in a fraudulent revenue recognition scheme orchestrated by Pete Petit and senior executives. Fox even cites transcripts that are point in case to channel stuffing. Further, MiMedx’s own sales data, emails and photographic evidence on the internet show MiMedx has engaged in channel-stuffing.
Threatening people, especially women, as an ADMITTED PROXY for Parker Petite gets my attention. The Rats are all turning on each other! Stay tuned and read more about David Furstenberg HERE!
DR. ALAP P. SHAH
MiMedx Medical Studies should not be relied upon given the significant undisclosed conflicts of interest. The below screenshot is from the bottom of his study.
He also did a much touted Epifix Study linked HERE!
You are either a puppet for the Board and Parker Petite, or you are negligent in your duties as CEO. There is no reason to get blamed for Parker’s bad deeds! I recommend you come clean with investors and stop with the cover-up! I also recommend you 8k the reason why Parker and Taylor were fired. Please click here to read the letters I have sent to Coles and the FDA.
“Double Red” is Quite The Terminology
Based off recent WSJ articles about Epifix and Amniofix not being covered by United Healthcare and Amniofix not being covered by BCBS, why is anyone covering them at all? These are products promoted by flawed and fake science and by a disgraced CEO. Read the full document HERE.
Read the full article HERE!
How in the world can you live with yourself given what you are covering up at MiMedx? It’s time you come clean and tell the truth! Parker Petite’s footprints are all over the MiMedx current business model and you are setting up David Coles to FAIL. Please stop with the coverups!
Read more here.
It’s time for them to stop covering this DANGEROUS UNAPPROVED DRUG!
Just when you thought you’ve seen it all; now comes Ricky Palmer (who readers of this site know all to well), marketing an UNAPPROVED drug thru a MiMedx press release. Not only are these studies corrupted (see prior posts), but marketing and openly promoting this unapproved drug is illegal. David Coles, this is now your ship and you are the adult, so please take action at once! The punchline is: why not show the doctors the study? Why the baseless press release, which happens to be the 3rd re-hash of the same news?
The Barker Dogs are closing in on him and MiMedx!
This is an email sent by Ricky Palmer of MiMedx fame to his minions. He is one of the many at Mimedx who has stuffed this product into his accounts. what are you doing back at HQ Ricky?
Tom Tierney, Mary Armstrong and Robyn Scott are heroes! Tierney went to MiMedx management and confronted the company about the fact that they were using SLR to obtain bogus revenue and engaging in illegal kickbacks. His reward for being a good, law-abiding citizen and exposing the obvious illegal practices at MiMedx was wrongful termination! MiMedx Management was blatantly lying about the existence of missing consignment tissue and when Tierney said he refused to take part in this fraudulent channel-stuffing scheme, they fired him and warned him against ever exposing their secrets. Tierney did everything right. Parker Petite should be in jail and the board of MiMedx should resign immediately! Click here to read the suit Tierney is bringing against MiMedx.
The below came to me today from a source in the field. People are waking up to how MiMedx stuffs facilities and overcharges for their products. This is just the tip of the iceberg.
“Just heard from a hospital where legal made the call to kick out Epifix. Also a similar thing is happening at another major hospital…all the MD’s are talking about it. It hasn’t reached corporate level yet, but it’s gonna get there.”
These execs need to be FIRED on the spot! Click here to read the whole document!
Not only is MiMedx a fraud and complete clown show, from a disclosure standpoint who is really on first here? Draw your own conclusions, but another 8k needs to be filed on Parker Petite and Bill Taylor’s Separation Agreement.
As you can see by the recent MiMedx disclosures, I have been speaking and writing the truth while Parker Petite was defrauding investors. Parker and his henchman Bill Taylor have been fired and a bankruptcy expert is now the CEO. It turns out that all of my allegations are true and MiMedx is a massive financial fraud. Their liabilities far exceed their assets and there is little IF ANY value to the equity. Parker Petite and his henchmen belong in prison for what they have done!
MiMedx has man size problems and this lawsuit is just one more headache caused by Parker The Barker.
I think I am starting to move the needle and people are starting to understand what I am trying to do. I got this the other day:
I’m a 31 yr old bush worker from northern Ontario. I don’t have much of a portfolio, or much education, but the market is my passion and hobby when not running chainsaw. And I gotta say, one of my favourite things to do the last few months has been researching your work and listening to the MDXG work you’re doing. I throw on my headphones, throw on my chainsaw, and listen to you shit on these corporate rats for 30 mins. It just makes my day. I wanted to drop a message and say congrats on the forward progress, and all the luck in the world to putting Parker away.
Parker Petite is intent on bankrupting Mike Fox (a whistleblower in MiMedx) to prove a point. Mike has spent $300,000 defending himself and now has started a GoFundMe page. Please support Mike if you have made money on this trade or if you have just been watching.
A fundraiser will be held later in the year featuring Collective Soul for the legal funds of all MiMedx whistleblowers. I believe this is a very worthy cause and know it will be money well spent.
As an aside, I don’t know Mike, nor have we spoken about the fraud at MiMedx while his legal battle has been going on. I look forward to meeting him one day.
Parker, you continue to put out false statements and must resign AT ONCE!
Time for Parker to resign or be removed from his duties, USING HIS OWN WORDS! Draw your own conclusions, but lots has changed in 7 months. The Board of Directors at MiMedx will be held liable along with ALL of Parker’s enablers including Tom Price and Johnny Isakson. Details on their involvement are pouring in.
Read the full letter here.
DRAW YOUR OWN CONCLUSIONS
A possible major malfeasance (which is discoverable through research) would be to see if Healogics paid less for Epifix products than government facilities. This would be a major problem. Government pricing for Epifix is publicly available. Given the Healogics settlement paid today to the DOJ (which was expected and negotiated for quite some time), it would be my bet that if there is malfeasance, they would probably want to come out in front of it. The full article is below and also linked HERE.
Heatlogics Agrees to Pay Up to $22.51 Million to Settle False Claims Act Liability for Improper Billing of Hyperbaric Oxygen Therapy
The Justice Department announced today that Healogics, Inc. has agreed to pay up to $22.51 million to settle allegations that it violated the False Claims Act by knowingly causing wound care centers to bill Medicare for medically unnecessary and unreasonable hyperbaric oxygen (“HBO”) therapy. Healogics, a Florida-based company, manages nearly 700 hospital-based wound care centers across the country.
“Medicare beneficiaries are entitled to care based on their clinical needs and not the financial goals of healthcare providers,” said Acting Assistant Attorney General Chad A. Readler for the Justice Department’s Civil Division. “All providers of taxpayer-funded federal healthcare services, whether contractors or direct billers, will be held accountable when their actions knowingly cause false claims for medically unnecessary services to be submitted.”
Medicare covers HBO therapy, a modality in which the entire body is exposed to oxygen under increased atmospheric pressure, as an adjunctive therapy to treat certain chronic wounds. The settlement announced today resolves allegations that from 2010 through 2015, Healogics knowingly submitted or caused the submission of false claims to Medicare for medically unnecessary or unreasonable HBO therapy.
Under the settlement, Healogics has agreed to pay $17.5 million, plus an additional $5.01 million if certain financial contingencies occur within the next five years, for a total potential payment of up to $22.51 million.
“Civil healthcare fraud enforcement has always been a core part of the mission of our office,” said United States Attorney Maria Chapa Lopez for the Middle District of Florida. “With this settlement, our Civil Division confirms its commitment to our nation’s critical struggle against practices that put public health programs at risk.”
In addition to resolving its False Claims Act liability, Healogics has entered into a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General which includes, among other things, a claims review and a systems review – both to be conducted by an Independent Review Organization.
“When greed is the primary factor in performing medically unnecessary health care procedures on Medicare beneficiaries, both patient well-being and taxpayer funds are compromised,” said Special Agent in Charge Shimon R. Richmond of HHS OIG. “We will continue to thoroughly investigate health care companies that engage in such fraudulent schemes.”
The allegations resolved by this settlement arose from a lawsuit filed by James Wilcox, a former Director for Research and Quality for Medical Affairs at Healogics, and a separate lawsuit filed by Dr. Benjamin Van Raalte, Dr. Michael Cascio, and John Murtaugh, two doctors and a former program director who worked at Healogics-affiliated wound care centers. The lawsuits were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens with knowledge of fraud against the government to bring an action on behalf of the United States and to share in any recovery. The settlement provides for a whistleblower share of up to $4,276,900.
The settlement was the result of a coordinated effort by the Civil Division’s Commercial Litigation Branch, the United States Attorney’s Office for the Middle District of Florida, and the Department of Health and Human Services Office of Inspector General.
The cases are captioned United States ex rel. Van Raalte, et al. v. Healogics, Inc., 14-cv-283 (M.D. Fla.) and United States ex rel. Wilcox. v. Healogics, Inc., et al., 15-cv-1510 (M.D. Fla.).
The claims settled by this agreement are allegations only, and there has been no determination of liability.
Just when you think MiMedx can’t dive any deeper into the dumpster to find its new executives, they continue to make the skeptics happy with their latest hire. You can’t make this up.
MiMedx touted new hire John Harris from CYTX.
As the CEO of a struggling stem-cell therapy company, Hedrick needs to don brightly colored pom-poms just to grab investors’ attention. Unfortunately, believing the fairy-tale story Hedrick spins to Benzinga requires ignorance of Cytori’s ugly past and an inability or unwillingness to actually conduct any due diligence on the company outside of Hedrick’s assertions.
Cytori has not conducted clinical trials proving its stem cell therapies are effective or safe treatments for any disease. BUT regulatory agencies in certain countries still allow the company to sell its stem-cell processing device. Cytori revenue has declined because there is no proof that its stem-cell therapies help patients.
Mimedx trials and science are tainted by conflicts and questionable payments. Here is a description of why any data about AmnioFix Injectable should not be relied upon. It’s unclear whether the study is ongoing and who has been incentivized to produce “results” not disclosed under the Sunshine Act. There is also a pattern of adverse events being destroyed or covered up, but when you dont report under the Sunshine Act, this is what happens. The Sunshine Act forces companies to make payments public. It’s time to disclose how much everyone in this study has been paid in a both stock and cash!
What’s the status of the study?
This is VOO-DOO and the results CAN’T be trusted.
Read more about the worst offenders HERE.
Some (like Dr. Senatore and Dr. Garoufalis) should be familiar from the Sunshine Act!
“Bucketshop Ed Borkowski” and I last tangled when he was the CFO at Concordia which now trades at 19 CENTS…he is the perfect CFO to guide MiMedx into BANKRUPTCY. Just a tremendous hire.
Borkowski had his finger on the trigger when Concordia went bankrupt, and clearly that is the path MiMedx is on. He has a past and his association with Stock Pumpers and Touts should be quite troubling to Regulators. Please go back and read my piece from March 27 when I said “MiMedx is Pro Forma Bankrupt” (which indeed they are). It’s time for Parker Petite to be fired and the few adults who remain at the company to COME CLEAN with what is really going on!
April $AZRX 10K filing reveals that new $MDXG CFO Borkowski was actually employed by MiMedx well prior to last week's announcement. Simultaneously at highly-suspect bucket shop named Alexander Capital. pic.twitter.com/yHIrkdisTo
— Aurelius (@AureliusValue) June 11, 2018
Mimedx Should Change It’s Symbol to ME2
Just when you think the Crackers at MiMedx couldn’t stoop any lower, this lawsuit gets filed. Thornton Kuntz and Lexie Haden should be fired on the spot for this kind of behavior! Meagan would not succumb to MiMedx pressure to stuff the channel or engage in illegal activity, so they fired a pregnant woman after invading her privacy. How low can you scumbags go? I applaud Meagan Maxwell for filing this suit. For this to happen in 2018 is disgusting and hopefully the MSM picks up on this. Read the full complaint HERE.
Meagan Maxwell is not the first woman who I’ve heard was subject to discrimination and abuse. I am sure many more will come forward with stories and/or lawsuits.
I have said that MiMedx is the biggest perpetrator of fraud I have seen in my career and today’s news only reinforces that view! It makes little sense that the two finance execs would depart, leaving the senile CEO in place, other than to try and keep a short term bid in the stock.
Responsible adults are finally waking up and no longer covering this MiMedx version of Snake Oil!
Health Alliance is an IL/IN insurer and dropped Amniofix from its formulary: 2017 formulary index
P15 from the 2017 formulary as referred from index
2018 formulary index
No longer in the general medical section:
No longer in the general medical section:
The Walls are quickly closing in on MiMedx at United Healthcare as well.
United Health Care Community plan added to their medical policy in Aug 2017:
Read the full document here
The Bully was just punched in the mouth!
Discovery is going to be a nightmare for Parker and his gang. Who was “paid” to do what? No matter what Parker tries here, he loses and loses big…it’s Game On. Read the full complaint HERE!
MiMedx does the exact same things across all of their product lines and has been doing so for YEARS! It’s time for this dangerous and illegal practice to STOP!
A perfect example of breaking the law:
This was from May 5 2018:
MiMedx issues are 100x worse!
This is an example of how MiMedx is trying to “Trick Fuck ” BCBS. Amniofix Injectable is a dangerous unapproved drug and BCBS should audit all payments made for this product going back 24 months. You would be surprised what this was actually used for and how you were ripped off. There will be plenty of time to figure out who defrauded whom but now is a great time to start an audit.
This “sheet” is what MiMedx gives its reps to help them sell this drug. Coding guidance…really? Oftentimes, the forms are filled out by MiMedx reps.
The only way Amniofix Injectable is reimbursed is through billing/medicare/insurance fraud now.
This is a very big deal! People are starting to pay attention!
Amniofix Injectable is a dangerous, unapproved drug that should NOT be on the market. Clinical Studies need to be done by Doctors who are not on the “take” from MiMedx.
BCBS needs to audit all past reimbursement.
This looks to be impossible to explain without some form of Medicare/Medicaid Fraud attached to it.
Clearly large sizes are more profitable but not used that often. Why would you try to defraud the government? Good business acumen?
I wonder how many 7×7’s were shipped to the Greenville, SC CBOC (community based outpatient clinic) on March 31st 2016? My guess would be around 30. Or exactly 30. That would equate to $182,491.80…on the last day of the quarter. Kickbacks? Yes. Proven. Kickbacks to buy the ability to Channel stuff their shelves?? There is more to today’s story. What outpatient wound care center would ever use 7×7’s like that in a reasonable amount of time??? Great question for any one of the managers that had access to the shipping reports from 2016. I’d be will to bet you won’t find POs for them. I’d also be willing to bet that if you look at the bigger consultants MdXG was paying (i.e. Garfoulis), they would be the same locations that got shipped 15, 20, or 30 7×7’s the last 5 days of the each quarter.
15 7x7s = $91,245.90
30 7x7s = $182,491.80
The Time to Come Clean is Now
THE DATA BEHIND THE POSTERS AND STUDIES IS TAINTED AND CAN’T BE RELIED UPON DUE TO UNDISCLOSED MONEY PAID TO THESE DOCTORS.
How many of these VA Docs received undisclosed Bribes from MiMedx?
Read the full press release exposing the doctors here.
The Alder Lane Sunshine Act is working hard to expose doctors like Matthew Garoufalis and Jeffrey Frenchman who have received undisclosed payments. I’m guessing 90% (at least) of the doctors on this page received $$ and/or gifts from MiMedx. There are a couple on here authored by MiMedx employees (Massee), but Frykberg wasn’t the only one forced out of the Phoenix VA last month. Edward Tierney and Arthur Tallis (who are both listed with him on his poster) were forced out at the same time.
The ghost of Advanced Biohealing is a contributing factor that should not be underestimated, as well, isn’t that right Ricky Palmer? Have you no shame?
MidMedx has engaged in fraud and it’s numbers should not be relied upon! MiMedx is all over the below indictment. Click here to read the full document!
Parker Petite is a liar. His statements to the investment public and his numbers should not and cannot be relied upon.
This was sent to me by a third party who understands the fraud at MiMedx and agrees that it needs to be exposed.
I will continue to expose Parker Petite’s many lies.
My thoughts on these numbers:
The term “unreviewed” is important as it is a term of art that describes one of the two levels of financial reporting that can offer the reader “assurance” that the numbers are in any way accurate. By issuing “unreviewed” numbers, we do not know if they were “compiled” (which would at least require a CPA to look them over, but not fact check them completely) or if the numbers are, in fact, an even lower tier of bookkeeping.
Shining a Bright Light on the Doctors MiMedx is Paying to Hype Their Products with Bogus Claims
If you thought Insys speaker programs were bad, MiMedx makes them look tame!
More on Dr. Hawkins:
Speaking at MiMedx AND taking the family to Disneyland…if you are going to sporting events and Disneyland, how do you use so much Epifix? Do you work 24 hours a day?
You are a greedy scum bag and on the take from MiMedx. How can you live with yourself? You should tell your patients how much you are being paid.
The Sunshine Act is here to expose this kind of graft! Parker, you are NOT above the law.
Dr. John Roy Senatore
Why are you touting MiMedx stock and bad mouthing the skeptics? How much have you been paid? Isn’t doing the Amniofix study at your hospital, a significant conflict?
Senatore’s hospital, MedStar Union Memorial Hospital, is involved in MiMedx’s vaunted Plantar Fasciitis trial for the injectable.
How unethical are you Dr. Senatore and why do you care? You should withdraw from the study ASAP.
Yet he chirps critics on Twitter…
Dr. Som Kohanzadeh, Dr. David Pougatsch, and (the one that started it all): Dr. Lee Rogers
All three are paid consultants for MiMedx and avid users of Epifix and MiMedx products. The below seems suspicious, doesn’t it?
Also! Pete claims to be a staunch Georgia Republican and has raised money for Donald Trump, Tom Price, and Johnny Isakson among others. Why then would Pete and his wife, Janet, donate a combined $5,200 to the primary campaign for a Democrat representing a congressional district in California? What could possibly be the MOTIVE behind this donation other than to bribe another doctor? Click here to see Pete’s donation to Rogers’ campaign.
Below is an excerpt from Rogers’ Wikipedia page
Political endeavorsRogers, a Democrat, ran for US Congress in California’s 25th district. He lost after giving incumbentCongressman Buck McKeon a strong challenge. After speculation that Congressman Buck McKeon will retirein 2014, Rogers announced his candidacy for the seat again and was endorsed by the Los Angeles Times.Two Republicans edged out Rogers in California’s new top two primary for the run off in the June 2014 election.Rogers endorsed Republican Steve Knight over Republican Tony Strickland which drew criticism from theDemocratic Party, but Rogers stated, “I didn’t create the rules and I care too much about our district to let it fallto a dishonest carpetbagger who is interested only in himself, like Tony Strickland.” He later withdrew hisendorsement of Knight over his refusal to ban the sale of the Confederate Flag in the California Capital
It’s interesting that Dr. Rogers wrote in an article that stated “the Sunshine Act could hinder podiatric education in the future.” Click here to read more about his attempt to cover up the money he receives from corporations.
Dr. Matthew Garoufalis
He is the Associate Chief of the Podiatry Section at Jesse Brown and Hines VA Medical Centers. Dr. Garoufalis is a past president of the Illinois Podiatric Medical Association and of the American Podiatric Medical Association. He is the current Vice President of the International Federation of Podiatrists.
How much have you been paid in cash and stock from MiMedx? Based on information and belief, Advanced [Garoufalis company] billed insurance companies over $300,000.00 for services it performed for which no accounting has been provided. Click here to read more. How can you sleep at night pushing this? Have you no shame? No wonder you are attached to the hip of Parker Petite.
Click here to watch a video of Dr. G sponsored by MiMedx.
How much have you been paid by MiMedx?
Dr. Ko, has been a “consultant” for MiMedx for 6 years while working at the Bronx VA.
Dr. Ko, care to share what MiMedx pays you as a “consultant”? Just money? Or money AND stock?
I wonder if the government is concerned that this could be a conflict of interest?
You would think the VA would be concerned with their Doctors taking “unreported compensation” from MiMedx.
“We don’t get paid, if you don’t get paid” … “due to our error”
What Kind of Medicare/Insurance Fraud is MiMedx trying to pull off here?
MiMedx is following in ABH’s footsteps. Don’t believe me?
Click here to take a look at the full Qui Tam lawsuit. You’ll see it’s exactly what MiMedx is doing with reimbursements. They also hired 75 former ABH Sales Reps. Who were “vetted” by Parker.
How is the “dermagraft reimbursement hotline” any different from what MiMedx is doing?
If the below is true, why is BCBS paying for AmnioFix? Click here to read the full BCBS medical policy.
Click here to read the rest of the above document!
Steve Blocker and Ricky Palmer: Now Key Players at MiMedx
(And they’ve only gotten worse)
Check out some samplings below from qui tam suits in regards to the ABH Indictment
Qui tam 2
DOCTOR FRYKBERG: FROM THE ADVANCED BIO HEALING FURNACE TO THE MIMEDX FIRE
Dr. Frykberg: Desert Foot Conference Chairman
Click here to read more about Frykberg & Cafepharma
In light of the Osiris Lawsuit that was posted yesterday, this is a very important document!
Osiris Therapeutics has sued MiMedx.
NEW PARTY MEMBERS!
Take a look at the documents linked below to learn more about MiMedx.
FDA 11/2017 Final Guidance on HCT-P products
Refer to Example 10-2 ( page 14) for micronized products Regulatory Status
Refer to Example 19-4 ( page 22) for amniotic sheet status
We have raised serious questions about the internal investigation by MiMedx.
Click here to read my lawyer’s letter to the Board of Directors!
MiMedx is violating their agreement with the FDA–selling products directly to patients with cash! They have been skipping the middleman and avoiding government quality assurance and regulation. The FDA must get involved.
Click here to read my letter to the FDA!
With only $33 million in cash on the balance sheet at the end of December, MiMedx is pro forma bankrupt.
Selling General and Administrative (SG&A) expenses ran over $60m in the last reported quarter, or about $55m even without stock based compensation. If MiMedx has had to use its cash to meet payroll, then cash on the balance sheet is already down the drain.
An inability to file timely financial statements will put MiMedx in technical default and choke off their credit line. Ernst & Young said they were reviewing prior years which will not be a quick process, especially with prior years audited by Cherry Bekaert, which is not exactly a household name.
MiMedx’s Real Sales, if any, are now in free fall but expenses are not.
Professional fees for an army of lawyers and forensic accountants will run into the tens of millions and accelerate cash burn.
MiMedx is now in what is known as a “death spiral” as it struggles to stabilize sales while cash evaporates and employees leave or are fired.
Look for more shoes to drop. There’s never just one cockroach in the kitchen.
MIMEDX FINANCIAL STATEMENTS NUMBERS CANNOT BE RELIED UPON.
Why did Parker the Barker host a special “Shareholder Call” on January 18th during which he made a “formal presentation” to the investing public and said,
“We expect the audit to go smoothly. We expect our interaction with the SEC investigation to continue to move along at a good pace, and we look forward to separating fact from fiction with them”
Parker knowingly lied about the audit. Nothing he says should be trusted.
It’s time for MiMedx to come clean about the multiple federal agencies investigating them. It’s time for Parker to resign until the investigations are complete.
MiMedx is a massive channel stuffing fraud, worse then Media Vision, which quickly became worthless.
We have shared reams of evidence with numerous divisions of the federal government which show MiMedx is a criminal operation.
Details to follow in further updates.
Bloomberg reports about Parker the Barker’s attempt to use the FBI as his own personal gestapo to coerce me from exposing the fraudulent and illegal activities at MiMedx.
I will NOT be silenced.
The FBI agents sent as Parker’s henchmen to invade my home:
- had no warrant
- admitted I was NOT the subject of any investigation
- refused to leave a business card
- refused to show complete credentials
- threatened me to return “with consequences” if I didn’t shut up
- and wouldn’t leave until I called the sheriff, whose report can be found here
Is it the proper role of the FBI to suppress a whistleblower exposing the corrupt criminal acts of a man who calls himself “The Donald Trump of Georgia?”
Former employee Amy Powers has taken to Twitter to start the discussion of “Me Too” issues at MiMedx:
Her brave actions should be commended, and others should come forward to tell their stories to responsible adults, the authorities, and regulators.
Lost in all the rhetoric is the email from a current employee whistleblower that raises very serious claims about misconduct by MiMedx and its executives.
Everyone should re-read this email and the letter I sent CEO Parker about it:
Because he doesn’t want investors to know the facts exposed in this email, Parker wants investors to believe the email is fake.
We stand by the email’s authenticity and demand Parker resign so an independent investigation can begin.
When an audience member at the JP Morgan conference pointed out Parker’s history of “selling to dead people,” Parker had no answer, only muttering “This is how ridiculous this nonsense is.”
When Viceroy proved his involvement in Matria’s illegal conduct of selling to dead people, Parker also had a similar non-response:
The discrediting of the Viceroy Report Part 13 is very simple. As usual, they have amassed a tremendous amount of publically available financial and business information on Matria Healthcare. However, they either do not understand this information or they purposely misrepresent their hypotheses on such information to make their fallacious “conclusions.” The report is full of confused conclusions, misinformation and in some cases lies. There is no impact of this report on MiMedx because of Viceroy’s inability to draw correct and reasonable conclusions from financial and business information.
Parker’s “argument” is nothing more than an empty ad hominem. His history of selling to dead people is well documented fact.
Parker and his management team have a track record as bad actors which they have continued at MiMedx.
Parker has still not answered the question about who he has given shares as “advisors” and “independent contractors.”
This question needs to be answered.
The issuance of shares is (barely) disclosed but never EXPLAINED in MiMedx’s filings.
If the 1.4 million shares issued is only one part of the more than 3 million shares MiMedx issued since the end of 2016, then the question is expanded not answered: In 2016, MiMedx issued more than 3 million shares of restricted stock to whom and for what?
“Mike Senken, the Company’s CFO, told him those were shares issued to employees,” but what do you say, Petite Parker?
Were ALL the shares issued to employees, or what shares were given to “consultants and advisors” or “independent contractors?”
Did you give Tom Price MiMedx shares as an “independent contractor?”
How many doctors are “independent contractors” and how much stock did they receive?
Were ALL the shares issued to employees, or what shares were used in “transactions” to “acquire companies” or “distribution agreements” as mentioned in the risk factors to the 10-K?
Were ALL the shares issued to employees, or what shares were given to “any entity which is a wholly- owned alter ego of such employee?”
“The MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan” referenced in Footnote 9 gives MiMedx broad discretion in who is “eligible” to receive shares if Petite Parker “determines that such Person or entity has contributed significantly or can be expected to contribute significantly to the profits or growth of the Company or any Affiliate or if it is otherwise in the best interest of the Company or any Affiliate for such Person or entity to participate in this Plan.”
Excerpts from MiMedx’s 2016 proxy:
Any employee of the Company or an Affiliate (including an entity that becomes an Affiliate after the adoption of this Plan), a member of the Board or the Board of Directors of an Affiliate (including an entity that becomes an Affiliate after the adoption of the Plan) (whether or not such Board or Board of Directors member is an employee), an Independent Contractor of the Company or an Affiliate (including an entity that becomes an Affiliate after the adoption of the Plan) and any entity which is a wholly- owned alter ego of such employee, member of the Board or Board of Directors of an Affiliate or Independent Contractor is eligible to participate in this Plan if the Committee, in its sole discretion, determines that such Person or entity has contributed significantly or can be expected to contribute significantly to the profits or growth of the Company or any Affiliate or if it is otherwise in the best interest of the Company or any Affiliate for such Person or entity to participate in this Plan. With respect to any Board member who is (i) designated or nominated to serve as a Board member by a stockholder of the Company and (ii) an employee of such stockholder of the Company, then, at the irrevocable election of the employing stockholder, the Person or entity who shall be eligible to participate in this Plan on behalf of the service of the respective Board member shall be the employing stockholder (or one of its Affiliates). To the extent such election is made, the respective Board member shall have no rights hereunder as a Participant with respect to such Board member’s participation in this Plan. An Award may be granted to a Person or entity who has been offered employment or service by the Company or an Affiliate and who would otherwise qualify as eligible to receive the Award to the extent that Person or entity commences employment or service with the Company or an Affiliate, provided that such Person or entity may not receive any payment or exercise any right relating to the Award, and the grant of the Award will be contingent, until such Person or entity has commenced employment or service with the Company or an Affiliate.
Participant means an employee of the Company or an Affiliate, a member of the Board or Board of Directors of an Affiliate (whether or not an employee), an Independent Contractor of the Company or an Affiliate and any entity which is a wholly- owned alter ego of such employee, member of the Board or Board of Directors of an Affiliate or Independent Contractor and who satisfies the requirements of Article V and is selected by the Committee to receive an Award.
Person means any individual, corporation, partnership, limited liability company, joint venture, incorporated or unincorporated association, joint- stock company, trust, unincorporated organization or government or other agency or political subdivision thereof or any other entity of any kind.
1.21 Independent Contractor
Independent Contractor mans an independent contractor, consultant or advisor providing services to the Company or an Affiliate.
Affiliate, as it relates to any limitations or requirements with respect to incentive stock options, means any “subsidiary” or “parent” corporation (as such terms are defined in Code Section 424) of the Company. Affiliate otherwise means any entity that is part of a controlled group of corporations or is under common control with the Company within the meaning of Code Sections 1563(a), 414(b) or 414(c), except that, in making any such determination, fifty percent (50%) shall be substituted for eighty percent (80%) under such Code Sections and the related regulations.
We are aware of MiMedx paying significant undisclosed kickbacks to physicians.
We WILL name names.
It’s best to come forward and turn yourself in before you’re disgraced.
Petite Parker wants investors to think the email I received from a current MiMedx employee that I sent to him in my still unanswered letter from October is somehow “fraudulent” and written by an “illegal short seller,” but Parker offers no evidence of any kind.
Bernie Madoff got away with his scheme for years, so “if I were guilty they would have got me by now” is not a convincing excuse to avoid answering difficult questions.
Since Parker is knowingly deceitful, MiMedx needs an independent reputable law firm to conduct an investigation and dig the answers out of him.
Why was Tom Price at the MiMedx presentation? Did MiMedx compensate him?
If you have credible information about healthcare providers, politicians, or others receiving kickbacks in stock or otherwise, please share your story.
At the JP Morgan Healthcare conference in San Francisco on January 10, 2018, CEO Parker and friends were asked some tough questions about share count. In response, they chose to LIE ABOUT THEIR OWN FINANCIAL STATEMENTS rather than answer the question.
You’ve issued 1.4 million shares of restricted stock since the end of 2016 which is unexplained in your filings. That’s not stock issued to executives, employees, or consultants for share based compensation or stock issued for services performed because those are separate line items. So were those stock issued to
-pay for MiMedx product
-induce MiMedx sales
-factor MiMedx receivables
-or if not where did they go?
Instead of answering the question, both CEO Parker and CFO Senken shouted “your figures are incorrect,” which is an OUTRIGHT LIE.
Did they lie to cover up shares issued to, for example, Tom Price, in attendance at MiMedx’s presentation:
Please note MiMedx management failed to read the safe harbor disclaimer, making their LIE to investors about a material amount of shares particularly problematic.
Since the SEC is asking Parker questions “EVERY DAY,” they should demand to see all MiMedx shares issued, who they were issued to, for what, whether they were used as collateral for a loan, and what they have done with them since.
MiMedx needs an internal investigation by an independent and reputable law firm not Parker’s “friend from Georgia Tech,” which even Parker admits is “fair,” while continuing to refuse do it.
“An off-balance sheet agreement that says [physicians] don’t have to pay [MiMedx] unless [physicians] have been paid” breaks Anti-kickback law. It’s easy to see why it’s illegal because it allows MiMedx to gain market share while the physician takes no risk.
Crossing this line means MiMedx could receive what’s known as “the death penalty” for medical product manufacturers because “Violation of the Anti-Kickback Statute may also lead to exclusion from Federal health care programs.”
See page 139-140 of the deposition posted yesterday:
Q. So there was a document that you produced. And that is an invoice that you received from MiMedx?
A. After, it looks like, 90 days after the use of the product.
Q. You seem to be focusing on that. What’s the — what is your meaning of pointing that piece of information out?
A. Because usually it takes 90 days to get paid after we use the product. So this invoice was generated 90 days after the use of it. So somebody went to the little freezer, pulled out the product, had the procedure. The invoice was not generated for 90 days. Which is inconsistent with the letter from Pete Petit below the Anti-kickback statements that state in exhibit — wherever — that we only had 30-day terms.
Please click here for the full “Spreadsheet Evidence of [MiMedx] breaking anti-kickback.”
Why wouldn’t the CFO send a letter, why Petite Parker? Because Petite Parker knows MDXG is breaking the law and trying to snuff this guy out from making it a bigger issue through a form of polite intimidation. If the invoices need to be paid then why suddenly extend terms from net 30 to net 60?
Q. Well, tell me about the conversation that y’all had.
A. I still was uncomfortable. It seems very strange. And I said to them, I said, you — it seems very strange. We have an agreement for however many years in the way we do business. A controller shows up and says that agreement never existed.
Within 24 hours the CEO of a public company sends me a letter reiterating that that never existed. Extends the terms. It just — it was just — it made me very nervous. Because I have been doing this for awhile. It just didn’t make sense.
And then we had dinner. And I contacted the doctor, I said, hey, if this all — how many patients — again, it all comes down to the patients. It this stuff stops, how bad are the patient outcomes? Because, again, I can’t mess with the patients. That’s our job to care.
And the doctor said, hey, let’s try to quell your nervousness and we had dinner with the sales guys. And I explained to them. And their response was, geez, I wish the letter never — no, there’s nothing to it and la-da-da, whatever.
And still my instincts tell me it just seems very odd that we would have a normal course of business and then — in fact, it just seems very odd that on the second visit they still totally deny that this whole methodology exists. And a letter comes from the CEO, not the CFO, but the CEO saying it never existed. And, oh, by the way, Anti-kickback and all this. The facts are the facts.
How could MiMedx have 60 days of receivables with unpaid balances from 2013? None of these options are good, and “the real answer” is the worst:
A. So I asked him [Mr Cranston]. I said, well, one of three things is happening. One, you are really bad at your job and you just don’t know how to collect because these are 2013 invoices. It’s 2016, and we owe you a boatload of money.
Two, you are just gouging the heck out of us and you don’t care whether we pay or not.
Or, three, there is an off-balance sheet agreement that says we don’t have to pay unless we have been paid. Which is the real answer. But there’s no way that he’s going to say that. So when he says, Answer Number 1, I’m really bad at my job. I’ve got patients out there scheduled for surgery. And I figure we are going to — if I say, current with regards to the monies owed. Now, we do owe money. I will tell you that we owe money. Because even though once we pay when we get paid, the margins on this were still upside-down.
Whistleblowers have been flooding in to corroborate:
What Village Podiatry is saying is absolutely how Mimedx operated. Consignment inventory was sent in, reps would run the insurance verification, the product was applied, reps would work will the billers to ensure it was coded and billed correctly, we’d check the eob when it came back to ensure it was fully reimbursed. Only at that point did we enter the implant information into Salesforce, which generated the invoice, which had the 30-day payment terms. If the insurance denied payment, the reps would just change the consignment product to “no charge evaluation” [i.e. SG&A expense] units so the doctor and patient weren’t out the money. We were told by managers that this was legal because as long as the insurance company didn’t reimburse the product, it wasn’t fraud.
But since Petite Parker knows it is indeed fraud, knowingly ordering his managers to carry it out would mean MiMedx is systematically breaking the law.
Note: Even though the exhibits above are public court documents, we blocked out the patients’ names because we care about them. Evidently, MiMedx does not.
Some key words to search include jail, revenue recognition, three years, Anti-kickback, HBOC, controller, color-coding and color-coded, 2013, and 2016.
Exhibits will be published shortly.
If MDXG wants to continue to sell its tissue as a wound healing product, they will have to do Real FDA approved trials to keep their products on the market before the end of 36 month grace period. The true efficacy of the product will now be exposed.
In the meantime, the company can longer make the claims of healing and superiority over other competing products. See below from the final guidance released yesterday:
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.
Will commercial payers and Medicare continue to reimburse the usage of amniotic membrane as a “wound cover” in treating DFUs considering now they are nothing more than a glorified band aid? Coverage and pricing are material risks now in addition to the material volume risks associated with trying to continue to stuff a stuffed channel. For example, United Health uses the words “Foster Wound Healing” in its coverage decision from February. As of January, the government has used HCPCS (hixpics) code Q4131 for Epifix according to this website. This code is listed as a “type C” meaning “Carrier Judgement,” so the insurance providers can choose to cover or not. They are not mandated by CMS to cover the product.
In the face of this double threat to top-line, MDXG already has a cost structure so high it earns next to nothing on gross margins of nearly 90%. Now, in addition to these costs, MiMedx will now have to conduct Real clinical trials, and the company reminds us:
Additionally, there are significant costs associated with clinical trials that cannot be estimated until the IND is approved. Moreover, data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all.
Please click the links below for MiMedx’s now defunct and/or illegal marketing materials:
Believe or don’t believe the channel stuffing allegations. We believe MDXG’s channel stuffing is significant, and we believe Petite Parker and friends are breaking the law.
Completely separate from the above, the FDA just put an Axe in MDXG’s forehead.
Today, FDA guidance was finalized that first came out in draft form in 3Q 2015. When the stock crashed to around $7, Petite Parker issued a press release to say:
In terms of the impact to MiMedx, we find the significant price decline in our stock today to be an overreaction of the market to this issue, likely because the market misunderstands the significance of the documents and the lengthy process that is involved in bringing matters to closure,” continued Petit. “What has been released by the FDA is an initial proposed draft, which is subject to modification as comments are received and testimony is submitted. Additionally, a determination will need to be made as to whether the process will involve rulemaking and legislative oversight, which will further extend the process.
On the call, Petite Parker continued,
Now I also want to follow up on the press release we sent out regarding the FDA’s guidance document agenda for 2017. Every year, they publish a calendar year guidance agenda — a calendar for the guidance agenda. This is a schedule that projects the release dates of guidance documents, both draft guidance as well as final guidance documents. The 2017 agenda did not include any reference to the minimum manipulation or homologous use of HCT/Ps. This was not a surprise to us as we’ve been told that the FDA received many thousands of comments; the vast majority of them taking issue with the draft guidance as proposed. So we’re very encouraged that the FDA is taking the time to carefully review the input. And based on the calendar it has published, we don’t expect any significant updates in this area for about a year or possibly more.
Another consideration that we think is very positive is that the people that are in the current consideration for the position of FDA Commissioner generally believe that new technology should be made available to the public once safety is assured, much like what was stated in the 21st Century Cures Act. So that gives us comfort that we are not likely to see something coming out of left field like the untitled letter or the draft guidance that’s coming — in the coming years.
So much for that.
Today’s significant update shows that comfort was completely misplaced. Don’t take our word for it. Just read MDXG’s risk disclosure in their 10-k:
FDA Untitled Letter and Draft Guidance
On August 28, 2013, the FDA issued an Untitled Letter alleging that the Company’s micronized allografts do not meet the criteria for regulation solely under Section 361 of the Public Health Service Act and that, as a result, the Company would need a biologics license to lawfully market those micronized products (the “Untitled Letter”). Since the issuance of the Untitled Letter, the Company has been in discussions with the FDA to communicate its disagreement with the FDA’s assertion that the Company’s micronized allografts are more than minimally manipulated. To date, the FDA has not changed its position that the Company’s micronized products are not eligible for marketing solely under Section 361 of the Public Health Service Act. The Company continues to market its micronized products but is also pursuing the Biologics License Application (“BLA”) process for certain of its micronized products.
On December 22, 2014, the FDA issued for comment “Draft Guidance for Industry and FDA Staff: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.” Essentially the Minimal Manipulation draft guidance takes the same position with respect to micronized amniotic tissue that it took in the Untitled Letter to MiMedx 16 months earlier. The Company submitted comments asserting that the Minimal Manipulation draft guidance represents agency action that goes far beyond the FDA’s statutory authority, is inconsistent with existing human cells, tissues, and cellular and tissue-based products (“HCT/P”) regulations and the FDA’s prior positions, and is internally inconsistent and scientifically unsound.
On October 28, 2015, the FDA issued for comment, “Draft Guidance for Industry and FDA Staff: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The Company submitted comments on this Homologous Use draft guidance as well. On September 12 and 13, 2016, the FDA held a public hearing to obtain input on the Homologous Use draft guidance and the previously released Minimal Manipulation draft guidance, as well as other recently issued guidance documents on HCT/Ps. The Company awaits further decision from the FDA on the draft guidances, but anticipates this will be a lengthy process.
If the FDA does allow the Company to continue to market a micronized form of its sheet allografts without a biologics license either prior to or after finalization of the draft guidance documents, it may impose conditions, such as labeling restrictions and compliance with current good manufacturing processes (“cGMP”). Although the Company is preparing for these requirements in connection with its pursuit of a BLA for certain of its micronized products, earlier compliance with these conditions requires significant additional time and cost investments by the Company. It is also possible that the FDA will not allow the Company to market any form of a micronized product without a biologics license even prior to finalization of the draft guidance documents and could even require the Company to recall its micronized products.
Obtaining and maintaining the necessary regulatory approvals for certain of our products will be expensive and time- consuming and may impede our ability to fully exploit our technologies.The process of obtaining regulatory clearances or approvals to market a biologic or medical device from the FDA or similar regulatory authorities outside of the United States is costly and time consuming, and there can be no assurance that such clearances or approvals will be granted on a timely basis, or at all. As discussed above, we intend to pursue approval of a Biologics License Application (BLA) for certain of our micronized products. Additionally, the FDA may take the position that some of the other products that we currently market require a BLA as well. Some of the future products and enhancements to our current products that we expect to develop and market may require marketing clearance or approval from the FDA. There can be no assurance, however, that clearance or approval will be granted with respect to any of our products or enhancements or that FDA review will not involve delays that would adversely affect our ability to market such products or enhancements. The process of obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources and may take years to complete. The fee for filing a BLA and the annual user fees payable with respect to any establishment that manufactures biologics and with respect to each approved product are substantial. Additionally, there are significant costs associated with clinical trials that cannot be estimated until the IND is approved. Moreover, data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. Like the process of obtaining an approved BLA, the process of obtaining a PMA requires the expenditure of substantial time, effort and financial resources and may take years to complete. The FDA may not grant approval on a timely basis, or at all. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.