The CEO of RegenerAge, Dr. Joel Osorio, explains the transformative power of Bioquantine—a novel biological complex used in regenerative treatments—in improving the lives of patients suffering from chronic degenerative diseases, and explains the company’s plans to fully launch its beauty aesthetics line, initiate phase III clinical trials, and eventually file for IPO towards the tail end of 2017.
To begin, Dr. Osorio, can you explain the underlying factors that motivated to you establish RegenerAge in 2015?
“With Bioquantine, we are tapping into a whole new aspect of human regenerative biology, that goes far beyond the domain where stem cells work.”
We created the company almost two years ago now. But the concept was born when I was finishing my master’s degree in health sciences and services at Victoria University in Melbourne, Australia. The majority of my co-founders and I originally come from Bioquark Inc., the U.S. based life sciences company that owns the intellectual property for Bioquantine, a state-of-the-art polypeptide complex purified from amphibian ooplasm that reprograms, remodels, and rejuvenates human DNA. Our principle goal is to utilize this biologic complex to create true cures for people with common, chronic degenerative diseases responsible for human suffering and death, as well as potentially increase the health and lifespans of such patients. The ability to affect several layers of genetic regulatory architecture, both at the genetic and epigenetic levels, allows us to address a wide range of disease processes, as opposed to just their output (symptoms).
This unique polypeptide complex has undergone initial phase I/II human studies and shown excellent tolerability, safety, and signs of efficacy in a range of metabolic, neurologic, and oncology indications For instance, among a population of patients diagnosed with late stage cancers, who had failed multiple courses of chemotherapies, the substance was very successful in improving their biologic and biomarker conditions and restoring quality of life. We’re now conducting what we call evidence-based medicine studies all over the world.
In early 2016, our team at Bioquark also initiated a project in India called ReAnima, which focuses on potentially regenerating and reanimating the central nervous systems of recently diagnosed, brain-dead patients. We’ve since brought this project to Mexico, where we’re treating patients with cerebral palsy, persistantvegetative states, as well as patients with no remaining therapeutic options, such as those with late-stage cancer, pulmonary fibrosis, rheumatoid arthritis, and ALS.
With a special permit from COFEPRIS, we can mix Bioquantine with many other treatments (medications, stem cells, plasma, etc.) to accommodate our patients’ needs, with a wide range of administration methods including subcutaneous, intramuscular, and intrathecal.
From a commercial perspective, we created a skincare line under RegenerAge to help develop the consumer side of the business as well as generate the additional cashflows to help finance our pharma R&D efforts. Biotechnology, at its very core, goes far beyond standard pharmaceuticals. However, this market segment is getting increasingly crowded, so it’s important we always assess current and future market needs to maintain a competitive advantage. In fact, we have plans to file for an IPO at the end of this year, while also pursuing phase III and IV trials here in Mexico, targeting two of the country’s most pervasive chronic diseases—diabetes and renal failure.
What qualities differentiate Bioquantine from other regenerative technologies on the market such as stem cells?
It’s important to note that Bioquantine goes far beyond the capability of stem cells. Traditionally, stem cells are used to treat less complex tissues that have suffered a lack of oxygen or are chronically inflamed. They can certainly help by providing new cells to try and repair damaged tissues, but they cannot reprogram, repair, and rejuvenate human DNA., which is at the heart of complex regeneration (amphibains, planarians, etc.) in nature.
With Bioquantine, we are tapping into whole new aspect of human regenerative biology, that goes far beyond the domain where stem cells work. With an analogy of building a house, if you think of stem cells as the new “bricks” in the regenerative process, Bioquantine additionally provides the “mortar” and the “blue prints”. These peptides allow for reprogramming / reconditioning the tissue micro-environment of the region regeneration and repair to one of morphogenic activity, and away from the typical morphostatic, negative paracrine signaling, inflammation, etc. typically found in tissues following damage in humans, which has been a current “Achilles heel” of the“stem cell-centric” approaches to disease.
And as I mentioned, the beauty of this substance, in addition to its ability to be used across tissue types (stem cell therapy requires a new lineage for any new tissue type treated) is that due to the fact it has Rx and non-Rx possibilities, we can combine it with a range of other products and treatments in synergistic fashion. For example, we recently created a super-food concept called CocoQuantine, which is essentially a combination of coconut water and Bioquantine. And now, we have five different products for the OTC skin care segment that we’ll be producing and launching here in Mexico.
We already have our own distribution channels in the US, through Bioquark’s existing laboratories. However, the US will only target the beauty side, as our treatments have not yet received FDA approval, and are strictly only available on an experimental basis at the moment.
RegenerAge has a broad portfolio of services such as clinic compassionate use, medical-touristic procedures, Last Generation Clinic Protocols, and Bio-medical advanced regenerative therapy (Bioquantine®). Could you expand on the differences and the added value of each segment?
Our service offering includes complementary regenerative medicines including bioidentical hormone replacement treatments and human growth hormones, while also offering aesthetic medicines
We design different protocols for different patients needs, essentially creating highly customized and personalized treatments protocols according to their needs.
However, a certain level of stratification is required, as each of our services has possesses its own value. The level of guidance for patients that be treated on an out-patient basis, for example, completely differs from patients that cannot walk and have to be treated in hospitals
Mexico is often characterized as being in an epidemiologic, demographic, and economic transition, with an increasingly stronger focus on chronic diseases, an aging population, and a growing middle class. In terms of skincare, how have these trends affected your business outlook?
The global skincare industry has long utilized peptides to regenerate skin cells and diminish the consequences of an aging body. However, the amount of active peptides in a typical product averages two to three, whereas Bioquantine provides 93, optimized by evolution and nature.
So, there’s no comparison and it’s just about us getting the correct formulation in any skincare line—the key area where we differentiate ourselves.
Bioquantine can be aligned with virtually any treatment. In the last four years, we’ve performed over 5,000 platelet-rich plasma (PRP) injections, a trendy medical aesthetic procedure whereby plasma is re-injected into the body to stimulate skin regeneration, whether that’s encompassing texture, lines, colors, etc.
Also, with skincare, the top pharmaceutical products exhibit many of the same qualities such as growth factors and strong antioxidants, but we’re not directly competing with these skincare lines. Our treatments don’t just repair damaged tissue, but also reprogram and rejuvenate the skin over time and fortify its resistance to degenerative effects.
Health and beauty are connected now. Customers and patients alike are becoming increasingly informed. It’s not just looking young in a week, but an emphasis on long-term health and wellness.
Other companies may have their own skincare range, while others may not. But we have to flexibly pursue all avenues with Bioquantine, as it’s not the substance itself that’s patented, but actually the process to obtain it.
Moving forward, we’ll need to conduct many additional trials to determine which direction our portfolio will expand. But that’s also why we decided to enter the skincare line of business initially, particularly given the lower startup costs and lower barriers to entry.
The director general of Mexico’s social security institute (IMSS) Mikel Arriola has pinpointed prevention as a prominent avenue to ensure the financial sustainability of the institution. When it comes to prevention, what value do RegenerAge’s products bring?
With consumers being health-conscious, it also affects governments. They’re bedinning to take a stance on their health and advocate for avenues to improve their own health. People can consume Bioquantine in the form of super foods; people these days love the organic label. This can be coined as “smart prevention.” The costliest expense in life is bad health. You can be extremely wealthy but when you’re suffering a disease, the financial, physical, and mental tolls are boundless. The focus is to get into the market where we can sell products to people who care about what they eat, put on, and how they look.
With more and more companies entering this arena, how will RegenerAge go about remaining at the forefront of regenerative medicines?
There are plenty of products that are out there on the market with specific nutritional benefits. We simply use as Bioquantine as another ingredient. More than just blindly conducting R&D, we’ll follow the market as it grows to best determine where to put Bioquantine as an added ingredient
That being said, we don’t want to become the next cool kid on the block. We strive to become a revolutionary biotech-driven company that delivers unprecedented value through our technology and fulfills unmet patient needs.
And as we have such a passion for this field, a lot of our efforts won’t just pour into marketing, but also education. We find that more and more people, whether they’re consumers or practitioners, want to learn about what exactly goes into their bodies and how a substance might impact their health. We thus place education in a very serious light and put on workshops and seminars whenever possible.
We’re partners with the mobile health company Astrum Salud Móvil, which focuses on harnessing the power of telemedicine, mobile health applications, applying various digital strategies to encourage patient empowerment through knowledge for the Spanish-speaking population. Also serving as a catalyst of e-Learning for Continued Medical Education, our alliance includes our upcoming online courses, and through their platform, take care of our Spanish-speaking patients with a personalized secure digital service with professional medical videoconferencing solutions.
In addition, our academic focus has allowed us the opportunity and honor to ally with WAMS, The World Academy of Medical Sciences—a prestigious institution based in Enschede, Netherlands—empowering our reach with such a reputable global forum and consortium of leaders in the field in a solid platform to share standards and best practices for clinical and basic medical sciences. Furthermore, our alliance extends our possibilities by offering our own medical training courses through their online education platform as a corporate member.
As CEO, what would you identify as the primary objectives for the company in the next three to five years?
International expansion is our next step, as we have a global vision to do business. We will soon initiate the FDA registration process in the US, while also beginning our entry into Europe through a partner company.
Subsequently, our priorities will center on properly establishing the beauty arm of the company, as this division is the one driving our commercial potential on the consumer side, and in turn, R&D financing. We aim to eventually become a household name in the beauty and aesthetics world. Of course, every market will be tailored to the needs and constraints of the local population.
We also hope to initiate phase III and IV trials by September.
Having founded multiple ventures over your career, can you share any words of wisdom that you’ve picked up as a serial entrepreneur.?
We all have the innate capacity to develop and pursue our goals. We’re merely blind in the things we do not know. As humans, we have a tendency to stay within our comfort zones. Often people do not know their potential until experiencing some sort of externality. For me, I had previously lived a very comfortable life in Mexico, having lived a cushy life as a medical doctor and having been invited on weekly TV segments. But at some point I experienced a life-changing event that made me more sensitive towards patients and their needs.
I now focus all my energy with my business partners to develop a product that can conceivably benefit millions of lives around the world.
From an entrepreneurial point of view, everything is possible. And success is not primarily contingent on the people, skills, or money, but on whether or not you have the will to push through the hard times and bring your dream to fruition—no matter what.
All four of us founders are very different, but we all have a true passion for health that overrides any fear of jumping into unknown territories.