Stem cell technology has been a prominent topic since its introduction. In recent years, the advancement in stem cell therapy has reached a promising level. This advancement has brought great possibilities into light. Researchers are now working on finding ways to extend this therapeutic strategy to prevalent chronic ailments such as neurodegenerative diseases, diabetes, and heart disease.
The ability of stem cells to self-renew and give rise to successive regenerations with varying degrees of differentiation capacity opens up a myriad of possibilities around creating tissues that might potentially replace diseased and damaged parts of the body with minimal danger of rejection and negative effects.
According to a recent study, noncommunicable diseases account for six of the top seven causes of death worldwide. Regenerative medicine may be our best hope against such ailments. Patients are looking forward to these new innovations and BioRestorative Therapies is engaged in the arena by developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells.
In the following interview, Lance Alstodt, the Chairman and CEO of BioRestorative Therapies, sheds light on the company’s journey, its role in cell-based treatments, and the future of regenerative medicine.
Please brief our audience about BioRestorative Therapies, its USPs, and its role in the regenerative medicine space.
We are a growing cell-based therapeutics development company in the field of regenerative medicine. We have two platform technologies. Our lead clinical program is BRTX-100, an engineered stem cell for treating chronic lumbar disc disease, which is cleared by the FDA for a Phase 2 clinical trial, and our ThermoStem program, which uses cell-based therapeutics to target and address metabolic disorders, such as Type 2 diabetes, obesity, COVID-related ARDS and hypertension.
In November 2021, we completed a financial restructuring pursuant to which we eliminated all debt, raised $23 million of capital, enhanced our governance and leadership and uplisted to the NASDAQ Capital Market. We are now on the precipice of initiating our Phase 2 clinical trial as well as accelerating the development of our secondary programs.
Our lead clinical product, BRTX-100, is novel and highly differentiated relative to other cell-based therapeutics targeting disc disorders. Based on our differentiated approach and our history of treating patients with no safety concerns and strong outcomes, we are confident and optimistic that our FDA Phase 2 clinical trial will also yield such significant positive clinical outcomes.
What other solutions and services does BioRestorative Therapies offer that gives it an edge over its competitors?
We don’t have a one-size-fits-all cell-based therapeutics to treat everything. Our programs are targeted for particular indications that take advantage of the various therapeutic properties of different cell types. For example, in chronic lumbar disc disease, the disc is highly compromised and has a cellular environment that isn’t receptive to cell-based intervention. In particular, the oxygen content is very low due to minimal blood flow.
BRTX-100 are stem cells that are manufactured in a low oxygen environment to enrich the cells that will survive this difficult environment. Providing enhanced cell survivability will enable the cells to provide optimal therapeutic benefits and potentially result in better clinical outcomes than what others have been able to realize.
What is your opinion on the impact of the current pandemic on the global healthcare sector, and what challenges did you face during the pandemic and subsequent lockdowns?
The global pandemic has had a tremendous impact on the global healthcare sector and how healthcare is administered. What is truly amazing is seeing how the regulatory path to bring a novel product to market can be adjusted when the need arises. When there is a need, science always finds a way. At the very onset of the pandemic, BioRestorative, under previous management, filed for Chapter 11 protection and faced the possibility of liquidation and closure.
Between March and November 2020, Lance Alstodt and Francisco Silva restructured the entire company, settled all outstanding creditor claims and preserved the publicly traded entity. The company demonstrated tremendous resolve and execution expertise in order to emerge from Chapter 11 in November 2020 and raised capital all while advancing and continuing to develop its technology and intellectual property, the cornerstone of the company today.
With constant development in medical technologies, in your opinion, what could be the future of the regenerative medicine space?
Regenerative medicine is advancing at such a fast pace. The combination of gene modification and cell-based therapeutics is providing groundbreaking treatment options for patients who otherwise had no options.
Specifically, within spine, many of the large spine centers across our country have initiated programs and teams dedicated to regenerative medicine. It is the future of spine and orthopedics among other applications.
What would be your advice to the budding professionals aspiring to venture into the biotech industry?
Having spearheaded BioRestorative’s emergence from Chapter 11, its $23 million capital raise and its uplist onto the Nasdaq Capital Market, I had a first-hand view of how a company with great science and technology was at the brink of closing because of some critical issues pertaining to capital structure and financing.
It is critical that aspiring biotech professionals understand not only the scientific aspects of their programs and technologies but the mechanics and process behind capital markets within their sector and how best to leverage assets in order to fund clinical programs.
How do you envision scaling BioRestorative Therapies’ operations and offerings in 2022?
Since we now have $23 million on our balance sheet and are debt free, we are turning all our focus on initiating our Phase 2 clinical trial. We have already begun expanding our cGMP manufacturing facility and are looking to expand the number of employees we have in order to reach our goal of being first in man with BRTX-100 by mid-2022.
About the Leader
Lance Alstodt began his journey in the healthcare industry as an investment banker at JP Morgan, Bank of America Merrill Lynch (BAML) and Leerink Partners, advising on some of the largest and most significant transactions in the life sciences sector. A disproportionate amount of his time was spent in Orthopedics and specifically within the Spine sector.
Helping to create and shape a multi-billion-dollar industry through equity and debt related financings and M&A activity, he has had the good fortune of working with and advising Medtronic, Nuvasive, Globus, J&J, Zimmer, Stryker, Biomet, Mazor Robotics, Alphatec, Seaspine, and many other emerging growth companies that have been acquired by the large strategic players in the sector or financed to become larger independent companies.
Mr Alstodt founded Medvest Capital, a healthcare fund that invests primarily across the healthcare spectrum, from healthcare services to biopharma. The fund has grown organically and, through domain expertise, he has been able to assist many of the companies within the fund with operating, regulatory and financial issues. His leadership at BioRestorative is a natural fit, given the challenges that the company has faced and the opportunities that are now in front of it.