This article is part two of my interview with Matthew Feshbach, CEO and Co-Founder of Okyanos (pronounced “Oh – key – AH – nos”). Founded in 2011, Okyanos specializes in treating patients with chronic, degenerative conditions. Located in Freeport, Grand Bahama, just 55 miles from the United States, Okyanos Cell Therapy combines a blend of stem and regenerative cells derived from a patient’s own adipose (fat) tissue.
Treatment is performed in their state-of-the-art surgical center by a team of U.S. licensed medical doctors. Okyanos is also fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards.
Using technology from Cytori Therapeutics, the company offers a highly characterized cellular product that is administered via a robust protocol by a renowned medical team within a world-class facility. It is my opinion, that Okyanos is a company that is setting the standard for others practicing cellular therapy with adipose-derived stem and regenerative cells.
Enjoy this second half of the interview. If you haven’t read it yet, click here to view Part 1.
Part 2 – Q&A with Matthew Feshbach, Co-Founder and CEO of Okyanos
Cade Hildreth: What are your three-to-five year goals for Okyanos?
Matthew Feshbach: Our three-to-five year goals are to become the leading provider of cell therapy in the world. By that, I do not just mean that we will serve more patients than any other clinic or make more money. Cell therapy is a new category of medicine and I believe that we can be at the forefront of this new paradigm.
We are extremely dedicated to doing this right, which is why we went to such great lengths to determine the best cells, the best protocols, the best possible delivery technology, the best medical team and the best facility. We now have a world-class facility with a $2 million dollar cath lab, that is in the top 3% of all the cath labs in the world. We have done things at a level that places the potential safety and efficacy of our therapy in a different class altogether, as compared to non-compliant, substandard stem cell clinics in the United States.
As a result, we can offer patients a more defined experience, because we have always been dedicated to our standard of care and continual improvements to it. In comparison, other clinics will ask, “How can I do this cheaper?” I am not interested in doing it cheaper. I am only interested in doing it better, and if it costs more to do it right, then we will always do it right.
Cade Hildreth: What types of collaborations interest you? Are you interested in product or technology partnerships, fundraising efforts, or other types of collaboration?
Matthew Feshbach: All of the above. Yes, we are very interested in collaborating with academic institutions, with technology providers, and with institutional purpose-driven investors.
Cade Hildreth: What trends are you observing in the cell therapy space and how do you think will they affect Okyanos?
Matthew Feshbach: Whether it is right or wrong, it is very clear that the FDA is up-regulating stem cell therapy. About six months ago, the associated press wrote an article calling stem cell therapy the “Wild West.”
There are networks of stem cell clinics that use inferior technology and are clearly non-compliant to FDA standards, so now the FDA has begun to up-regulate against them. I think an unfortunate side effect of this is that the FDA has decided to define our own biology as a “drug” that needs approval and that is, I think, too complex.
I think that they should have some pathway for legitimate companies to show that they can provide a safe, effective product to patients, and then let the doctors practice their medicine. Instead they are saying, “You have to complete Phase III trials even if you have successfully and safely used this product in Europe. You have to start over in the United States and prove that these cells do what “has been documented in 65,000 papers.” That seems inappropriate.
Cade Hildreth: Is it beneficial to Okyanos that you can practice in the Bahamas within a regulated environment, and therefore, offer options to patients that are not available in the U.S.?
Matthew Feshbach: I have never thought that we needed a monopoly or lack of competition. As an example, with the demographic, aged 65 and older, about 80% of them will have two or more chronic diseases or morbidities. There are about 40 million people in the United States that are 65 and older, plus you are probably getting about 10,000 new people entering this age group each day. So, there is no reason to avoid competition.
However, I would like to see a level playing field where the regulatory standards for compliance are such that the doctors and companies can and are required to go out and do this right. And as long as doctors, clinics, and hospitals are treating people with a high standard of care using approved technologies, I think that should be allowed. In the U.S. today, this is simply not the case.
Cade Hildreth: Why has stem cell therapy been slow to be commercialized and adopted within the United States?
Matthew Feshbach: I have heard different opinions in this area and various conspiracy theories. However, I think for adult cell therapy, there are two factors.
Institutional investors, the FDA, and big pharma tend to think of stem cells in the same way they think about small molecules; in other words, that pharmacological effects occur through a single mechanism of action which addresses the key factor of a disease, such as an immunosuppressant for autoimmune diseases or steroids for inflammation. They tend to ask questions like, “Can this cell do one single action, like grow new brain cells to help an Alzheimer’s patient regain mental function?”
Unfortunately, they do not understand that every one of these diseases, like diabetes or heart failure or Alzheimer’s, involve multiple factors – or put another way, there are multiple diseases within the primary diagnosis. One mechanism is not going to resolve these types of diseases. You need multi-potent cells, such as ADRCs, to solve them.
Therefore, I think what holds back progress more than anything is that these groups have a pharmacological paradigm fixation.
The other major issue holding back progress is that stem cells are not easily patentable, as it is difficult to patent somebody’s own biology.
So, large companies and investors don’t really want to invest in it. One of the reasons that Okyanos went with the “service model” is that this way we do not require a drug that nobody else can manufacture. If someone else comes up with a better cell source, a better cell type, better cell processing technology, a better protocol, or a better delivery method, we can pivot directions and evolve.
Cade Hildreth: How well is the FDA regulating the cell therapy in the United States and what can be improved in future changes?
Matthew Feshbach: I think they are doing a poor job at both ends of the barbell. When it comes to getting an approval for cell therapy products, this research only entered in the marketplace in the late 1980s and early 1990s. For bone marrow, I believe there have only been one or two stem cell products approved in the past 25 years. Obviously, the FDA is making the approval process incredibly onerous, because they are taking a pharmacological approach to it.
On the other side of the barbell, the FDA has regulations, CFR 1271 to be specific, about SVF, calling it a “drug” and requiring it to go through a drug approval process that they do not enforce. So, now there is a group of non-compliant doctors and clinics, for example, the Cell Surgical Network, the Lung Institute and U.S. Stem Cell clinics, using inferior technology and getting mixed results. It is not that they never see patients benefits as stem cells even in very low dosage can work to some degree or another. The issue is that their results are mixed in terms of how profound the benefit can be to the patient and how sustainable it is. And we do hear of adverse events at these clinics that are not honestly reported by them.
As one person said, “If they will violate FDA regulations how can you trust them to not cut other corners.”
As an FDA official recently stated, “The law has not changed,” she said. “What the agency released are “guidelines” that FDA hopes will help the industry and the public understand the law. “People need to understand how to implement the regulations,” she said. “The guidelines are just to explain the regulations.”
What I think the FDA should do now is to say, “Hey, these are your own cells, we know they are safe, and can we find a way like Japan did, to make this available to people now?” That’s the same case in Europe in certain circumstances, where patients can get cell therapy now. Their system is definitely more flexible and they are not hurting people. That is the crazy thing. Please bear in mind, people can be hurt if the provider does not have the technology to provide a sterile product. You do have to be sure about certain things so that cells do not clump in the vasculature.
However, at the end of the day, the FDA needs to find a balance between a patient’s right to try new therapies and their overarching concern for patient safety. They also need to ask, “How safe it is to let people die due to chronic diseases?” That does not sound very safe to me.
Cade Hildreth: How can people get in touch if they want to learn more about Okyanos?
Matthew Feshbach: Our website contains a great deal of information about our facility and the conditions we treat: www.okyanos.com.
Matthew Feshbach: We want to talk to the patients who wants to be educated about cell therapy and who have a chronic condition that we believe we can help alleviate. We do not treat cancer and we do not treat blood disorders. We do not treat genetic or congenital or structural issues.
What we do is treat conditions that involve inflammation, immune response, ischemia, scarring, and tissue degeneration, because we have a large body of clinical evidence and scientific literature that supports these applications.
Cade Hildreth: Thank you for the honor of doing this interview and for sharing your expertise in the area of adult stem cell therapy for heart disease and chronic diseases.
Click here if you haven’t yet read Part 1 of this Q&A interview.
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