Background On Ozzie Smith IMAC Clinic

IMAC Enters the Scene

This past two years or so, I have seen quite a few press releases put out by a company based primarily in Kentucky, and a few other states, called IMAC Regeneration Centers. Interestingly, the company seemed to be focusing on starting franchised clinics, each with the name of a local athlete. These clinics seemed chiropractic focused, but they also had medical doctors and physical therapy. I didn't think too much of the small clinic chain until having an interesting dialogue with their chief scientific officer on LinkedIn. In my opinion, this was strange enough that it made me want to dig deeper, as their websites, like so many chiro clinics, make it really hard to find much detail. 

An Interesting Science Dialogue on LinkedIn and a Coincidence

Just before the holidays, I posted a fascinating interview with Lisa Fortier, DVM, PhD, from Cornell on her findings that all of the birth tissue products that they tested demonstrated dead, nonviable tissue. This not only confirmed our tests, but it also contradicted the claims of many of these companies and providers who use this stuff. On that thread, an Ian White, PhD, chimed in with his position that these products did contain viable cells. Given that I thought I was getting into a scientific debate, I immediately posted links to our data and Dr. Fortier's abstract. Rather than arguing the science on its merits, this PhD went another less professional direction. That really interested me, so I tried to pull this guy's profile. That's when it got really fascinating.

I was able to find that Dr. White had founded a company called BioFirma. A search on that revealed this from Bloomberg:

"BioFirma, LLC develops cell regenerative therapies and products. The company's product 'NeoCyte' is a umbilicalcord-derived mononuclear cell product. The company was incorporated in 2018 and is based in Miami, Florida. As of August 20, 2018, BioFirma, LLC operates as a subsidiary of IMAC Holdings, Inc."

So Dr. White was somehow associated with IMAC Holdings, the company I had been seeing issue press releases? This was really fascinating to me, as what was a PhD researcher doing with a chiropractic-owned clinic chain? More interestingly, why was the company that Dr. White founded now owned by IMAC? 

However, this information now put Dr. White's comments in context. Ian White owns a company that produces a product called "NeoCyte," which is an umbilical cord product. Hence, it would make sense, in my opinion, that he may have a vested interest in opposing scientific conclusions that show that birth tissue products have no live stem cells.

Finding information on this umbilical cord product proved difficult. When I Googled NeoCyte, I could only find a single page with contact info and no product description. I did eventually find one other page describing Dr. White on the NeoCyte website. However, all of this only led back to IMAC. 

I went on with my holidays, but then, out of the blue, a colleague sent me a copy of an S1 document on IMAC Holdings. This was a true coincidence as the colleague had no knowledge of the LinkedIn exchange but, as someone who devours these financial documents, thought the information would interest me. To those who don't know, an S1 form is one a bevy of documents that the SEC requires public companies to submit. They often contain much more information about a company than one can usually find online, and this one didn't disappoint. 

What Does IMAC Stand For?

At first, I had no idea as I couldn't easily find this on their website. However, the S1 form makes it clear that it's "Integrated Medicine and Chiropractic." This makes sense as the founder is a Kentucky chiropractor by the name of Matt Wallis, DC. 

The next most logical question for me to answer was then, who are the MDs who make up the medicine part of that moniker? I was able to find out that a Paducah neurosurgeon by the name of Sean McDonald, MD, is the medical director of the company. I then Googled his name to see why a neurosurgeon would be working in a chiropractic-owned clinic, a reasonable question to ask. I then found that Dr. McDonald was sentenced in 2017 to two years probation for diverting narcotics for personal use. This is from the article: 

"In fact, Monday we learned that when the doctor was confronted about the diverting, he had dilaudid in his socks. 'It was a terrible place to be. Instead of asking for help, I self-medicated' McDonald told the court."

Dilaudid is a very strong narcotic drug. I then checked the Kentucky medical board website and found that Dr. McDonald has a 2016 permanent ban on ordering narcotics and must undergo periodic drug and alcohol testing. Interestingly, on the IMAC Centers of Western Kentucky website, this is the only medical doctor listed. 

Who Are the Other IMAC Medical Doctors?

I then dug deeper, looking at individual IMAC clinics online, trying to see who else makes up the medical part of IMAC. The fist I clicked on was the Ozzie Smith IMAC Regeneration Center in Chesterfield, Missouri. A Devin Bell, DO, is listed as the "Medical Director." My first question was whether we would qualify Dr. Bell to be on the Regenexx network. Given his qualifications in family medicine and practice focus listed on his personal website, the likely answer is no. Why? While we have a few family medicine physicians that we have agreed to add, they all have extensive experience in ultrasound-guided peripheral joint injections, which Dr. Bell doesn't list as a skill on any of the online listings that I found, which go back about a decade.

I then dug a bit deeper, as I was curious to see if the IMAC centers, like many chiro clinics, use more physician assistants and nurse practitioners than MDs. I called the location in Chesterfield and asked if I could see Dr. Bell if I scheduled an appointment for stem cell therapy on my knee. Nope. I could see the nurse for the evaluation, and then Dr. Bell would perform the injection.

I then looked up the location in Brentwood, Tennesee, but the website didn't list a physician at that location and, in fact, just took me back to the Western Kentucky site. Confused, I called the Brentwood site and found out that David Smithson, MD, works there. I then asked if I would be seeing Dr. Smithson if I booked an appointment. I again found out that I would not and would be seeing a physician assistant instead, and Dr. Smithson would only be brought in if I wanted an injection done. Who is David Smithson, MD? Near as I can tell from my online searches, he's an internal medicine doctor. 

In addition, on our network, midlevel providers (physician assistants and nurses) are not permitted to be used to evaluate Regenexx patients. Why? Interventional orthopedics and which procedures work best in specific patients is complex, and in our view, midlevel providers, while cheaper than physicians, don't have the expertise or qualifications to make these decisions. 

I did reach out to Jeff Ervin, the CEO of IMAC holdings for his comment on this issue. Here is what he wrote, "IMACuses a nurse practitioner or physician assistant to evaluate the patient's condition. If the patient has a condition that could benefit from regenerative medicine, the physician performs a further evaluation. The physician determines whether stem cells could be a beneficial treatment."

Digging Deeper into the S1

So you can follow along, this is the link to the S1. From reading the investment prospectus, we learn some history on the company:

"Dr. Matthew Wallis, DC, our Chief Operating Officer, opened the first IMAC Regeneration Center in Paducah, Kentucky in August 2000, which remains the flagship location of our current business. Dr. Jason Brame, DC joined Dr. Wallis in 2008. In 2015, Drs. Wallis and Brame hired Jeffrey S. Ervin as our Chief Executive Officer to collectively create and implement their growth strategy. The result was the formal creation of IMAC Holdings, LLC to expand IMAC clinics outside of western Kentucky, with such facilities to remain owned or operated under the group using the IMAC Regeneration Center name and services. In June 2018, we completed a corporate conversion in which IMAC Holding, LLC was converted to IMAC Holdings, Inc. to consolidate ownership of existing clinics and implement our growth strategy."

Given that we were the first clinic on earth to begin offering stem cell treatments for common orthopedic problems, like knee arthritis, in 2005, the date of 2000 as a start date for IMAC Regeneration Centers above seems way off. Meaning, I had never heard of these guys before about two years ago. Hence, I ran a search on the Internet Archive, and the first appearance of the use of the domain www.imacregeneration.com is in 2014 and NOT in 2000. I then dug deeper and ran a Google search under the name Matthew Wallis, the founder listed. I found several websites linked to his name, so I searched each using the same archive. One which was www.regenerativemedicinenow.com/ was begun in 2016. So I couldn't confirm the existence of IMAC Regeneration prior to 2014. Reading further into the S1, it's clear that it's likely that what was begun in 2000 was a chiropractic clinic and that the current IMAC concept began in 2014 or 2015. 

BioFirma and IMAC

This is what the SEC S1 document says about the relationship between Dr. White, BioFirma, and IMAC:

"Our recent investment in BioFirma, LLC was executed in order to research and develop regenerative medicine products and supplies. We intend to use a portion of the net proceeds from the offering to fund this research with the goal of identifying innovative treatments to deliver within IMAC Regeneration Centers, as well as producing approved products for distribution into the broader medical community."

So how much did IMAC Holdings invest in BioFirma? We read this next:

"On August 20, 2018, we acquired a 70% ownership position in BioFirma, LLC (“BioFirma”) for $1,000 in cash...BioFirma owns a trademark on NeoCyte, an umbilical cord-derived mononuclear cell product following the FDA’s current Good Clinical Practices (or cGCPs) regulations. We intend to use approximately $1,500,000 of the net proceeds of this offering for further research and product development of NeoCyte and other regenerative medicine products, including obtaining approvals, certifications or designations from the FDA. A portion of the funds for BioFirma will be used for the employment of Ian A. White, Ph.D., Chief Scientific Officer, for a three-year period, as well as for equipment and manufacturing of the product. When it is market-ready, we intend to sell the NeoCyte product at our IMAC Regeneration Centers and other medical clinics."

So it's now clear how Ian White, PhD, got involved with IMAC. IMAC acquired 70% of his company BioFirma for $1,000. In return, IMAC is raising 15 million dollars through this SEC offering and will employ Dr. White and use some of that money so that he can get his product manufactured and registered with FDA. Hence, in essence, Dr. White gets a salary plus 30% of the eventual profits from products that his former company sells to IMAC and others. In this case, an umbilical cord-blood product. 

The S1 Reveals That IMAC Is Using a Regulatory Vehicle with Reduced SEC Reporting Requirements

The next thing we learn is that the company is using an SEC pathway to raise money that has fewer requirements than a traditional initial public offering, but that allows it to access nonaccredited investors. This investment vehicle is called an "emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting requirements that are otherwise generally applicable to public companies." 

In English? IMAC Holdings can raise small investments from average Joe investors by selling stock, much like a company on an exchange like NASDAQ. However, it has far fewer initial regulatory requirements to protect investors. 

Ian White and IMAC

So who is Ian White? His bio claims he works at the Bascom-Palmer Eye Institute in Florida as a stem cell researcher. This is what the investor presentation from IMAC Holdings says online: 

"Adjunct position at Miami University Healthcare, Bascom Palmer Eye Institute where he leads the Translational Ocular Regenerative Medicine Unit."

That is, of course, the University of Miami where the Bascom Palmer eye institute is located and not Miami University (which is in Ohio). However, using several Google searches, including this one, I couldn't confirm that Ian White works at Bascom-Palmer. I then went to the Bascom-Palmer website and searched under his name; again, no hits. Finally, I performed this Google search, "Translational Ocular Regenerative Medicine Unit bascom palmer" and this page came up as the number-one result. On this "Meet Our Researchers" page, Ian White is not listed as a researcher at Bascom-Palmer. So I can't confirm, through multiple Internet searches, this part of Ian White's bio.

In an IMAC press release, Dr. White is described as follows: "Subsequently, Dr. White relocated to the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine." Hence, the next Google search I ran was on Ian White and the Interdisciplinary Stem Cell Institute at the University of Miami, This brought up this page for the Interdisciplinary Stem Cell Institute, which, again, lists no Ian White. 

The online IMAC Holdings web presentation also says the following about Dr. White: "Leading expert in the field of regenerative medicine with 20 years of experience." Given that I'm a physician with more than 25 peer-reviewed publications in the use of stem cells or regenerative medicine in orthopedics and not a full-time researcher, from what I have observed of academics, I would assume that a full-time Ph.D. researcher of 20 years would have between 50–200 published papers. In addition, since the IMAC company is holding up Ian White as a major asset to the company and the company is focused on treating primarily orthopedic injuries (as described in the prospectus), I assume that Dr. White's research would be in the field of orthopedic stem cell and regenerative medicine. So what did I find?

I first ran multiple PubMed (US National Library of Medicine) searches under various search terms, including stem cells, ocular and stem cells, and variations of "White I" and finally "White IA." I then included a couple of cardiac searches based on the various IMAC online listings. Near as I can tell, Ian White has five peer-reviewed publications listed. These are cardiac and vascular related. In addition, we can learn much about Dr. White's contributions to these works by looking at his placement in the author chain. In academia, the first author did the most work toward the research, and then the authors are listed in order of contribution. The last spot is usually reserved for the supervisor or someone who is running the lab where the research is performed. So the first and last spot are the most critical. So how does Dr. White's position analysis stack up? He's the first author on only one paper. He's in 7th, 5th, 9th, and 5th position on the other four. In no papers is he listed as the last supervising author. 

So in the final analysis, I can not confirm that Dr. White currently works for or is affiliated with Bascom-Palmer or the U of M Interdisciplinary Stem Cell Institute. From the affiliations listed on the few papers where he is listed as an author, it looks like at one point he did have some sort of affiliation at the Interdisciplinary Stem Cell Institute.

A Summary of What I Found 

First, I apologize for the length of this blog post, but I'm summarizing two days worth of research. When I began this project, I knew very little about IMAC or Dr. White. However, as you can see, as I dug deeper and found new information, that allowed me to find even more. 

Second, while Regenexx has an elite network of highly trained physicians with a very serious quality-control system, I know of physicians out there that do high-quality interventional orthopedics and who use orthobiologics. Hence, if I had a patient to refer in city X where there was no Regenexx physician, I would be happy to refer to these providers out of my respect for their skill. I've done this many times. So, after what I've learned, I will apply the same standard here. Hence, would I refer a patient to an IMAC Regeneration Center? No. Why? Let me break it down:

1. The Use of Midlevels as Clinical Decision Makers—As I've written, a trend I see in chiropractic-owned or managed practices is that they use midlevels, like physician assistants or nurses, in a way that in my medical opinion reduces the quality of care. In the case of IMAC, based on what the two clinics I called told me, they are using these providers to make critical clinical decisions about who is a candidate for which procedure. This is very concerning, as in our network (and outside it), that important decision is made by a doctor who has more training. 

2. Lack of Physician Qualification and Training—Practicing interventional orthopedics at a high level is very difficult. As an example, at Regenexx, we would qualify the doctor as first having a musculoskeletal knowledge base and image-guided injection skills before he or she would be allowed to train. For example, we would not accept most family physicians, any internists, or even a neurosurgeon. In fact, we've already turned away one neurosurgeon for lack of experience using X-ray-guided spine injections. In the case of the internist at IMAC, he was trained in sports medicine some three decades before ultrasound guided injections were popular, so it's unknown if we would qualify him to be accepted on our network.

Once the provider qualifies, the training program we use is intense. There are 14 different courses to take, which include hands-on cadaver training and observation-based and written competency testing. Then, after all of that, these physicians must record a certain number of cases per year to be clinically competent and to maintain that competency. I don't see any of that structure at IMAC. Nor, in my opinion, would it be appropriate for the neurosurgeon medical director, who has no training in image-guided interventional orthopedics, to develop such a program. To understand more about interventional orthopedics, see my video below:

3. Lack of Clinical Data Collection—I see no evidence that IMAC is collecting clinical data. Even if they began tomorrow, it would be years before anyone had any idea of how effective or not their treatments were over several years. It would also be a decade before anyone knew that the treatments were truly safe in the long run. Finally, even if they pull the trigger on a small clinical trial that is high-level, that will only be in one area of the myriad of clinical conditions that patients present with on a day to day basis. For example, at Regenexx, we've been collecting clinical data for 14 years and post that online for all to see in full transparency. We have also published on one randomized controlled trial and have three more in the works. 

4. No Published Data—At the end of the day, it's publish or perish in medicine. Meaning, at some point you have to take the data you've collected and publish it through the peer-review process. I see zero publications on the techniques used by IMAC. Contrast this to the 19 clinical data publications amidst 25 total publications that apply to regenerative medicine that Regenexx has logged. 

5. Where Is the Back-End Science? While IMAC has hired a Ph.D. who is working on an umbilical cord product, where is the expertise in lab-based regenerative orthopedics? For example, on our science team, we have a full-time chief science officer who is a Ph.D., a separate Ph.D. in charge of clinical research, several lab staff, and a full-time biostatistician. Having run a lab and clinical research team now for 14 years at our company, I can tell you that expertise in orthopedic injuries is earned through years of experience. For example, we published the definitive paper on how local anesthetics impact stem cells. Why? Because the existing research was poorly done, and the use of local anesthetics around stem cells is common in orthopedic treatments. In addition, we noted that the clinical data we were getting by treating tendons with high-dose PRP injection was better than the in-vitro research would have predicted, so after finding significant experimental flaws in that existing published data, we redid our own experiments with high-dose PRP and tenocytes. That peer-reviewed publication will be out in the next few weeks. I see none of this happening at IMAC. 

The upshot? I had no idea what I would find once I began a deep dive into IMAC Regeneration Centers. I think what I found was interesting and thought-provoking. Based on what I uncovered, my ultimate conclusion is that I wouldn't refer a patient to these clinics. However, like everything, that could change if they dramatically up their game. Meaning, they have years of physician qualification, training, data collection, publication, and research before I would feel comfortable allowing one of my patients to be treated by IMAC. 

___________________________________________________________

12/31/18-I reached out to the IMAC CEO Jeff Ervin via Linkedin yesterday to ensure that all aspects of this blog were correct. The only point of clarification so far is that the IMAC physicians are full-time employees. I have asked him if any additional clarifications are needed or if any changes need to be made. Will update the blog as I get more information. 

1/1/19-Jeff Ervin responded and provided some additional information. I made a few edits above. One was that the Internist Dr. Smithson had some additional qualifications in sports medicine, so corrections were made. However, he was trained in sports medicine in 1982, so it's unknown if he would have the ultrasound skills required to meet our strict Regenexx network entry criteria, as ultrasound guided injections didn't become popular until the early 2000s. 

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