BioRestorative Therapies | Top Spine Solutions Company 2023

MedTech Outlook Magazine

BioRestorative Therapies
Delivering Breakthrough Treatments with the Prowess of Regenerative Medicines

Lance Alstodt, President, CEO and Chairman and Francisco Silva, Chief Scientist and VP, R&D, BioRestorative TherapiesLance Alstodt, President, CEO and Chairman and Francisco Silva, Chief Scientist and VP, R&D
In recent times, regenerative medicine has shown great potential in enhancing patient outcomes and improving the quality of care—especially for those suffering from chronic lower back pain. For years, the prevalent treatment options included opioid pain relievers, steroid injections, and invasive surgeries that come with increased risks pertaining to opioid addiction or side effects and do not deliver the required clinical outcomes and sustained therapeutic benefits. On the other hand, regenerative medicine utilizes the unique capability of stem cells to regenerate and remodel damaged or diseased tissues. Its implications are game-changing as stem cell therapies promise to regenerate and remodel damaged tissues, providing sustained and long-term clinical benefits.

Leveraging this ground-breaking technology in a novel manner is one of the leading biotech clinical developers, BioRestorative Therapies. The company is pioneering the idea of conditioning one’s own regenerative potential to treat and cure major diseases. “We are going to introduce a paradigm-shifting technology within the spine treatment forte, revolutionizing the entire orthopaedic space. With our proprietary products BRTX-100TM and ThermoStemTM, we aim at improving the quality of care for patients enduring chronic lumber disc disease and metabolic disorders including obesity and diabetes,” states Lance Alstodt, the President, CEO, and Chairman of the Board at BioRestorative Therapies.

BRTX-100TM is anticipated to be a safer, cost-effective, and viable alternative product to treat damaged and degenerated discs compared to the current standard of care. This product is designed and engineered to target the disc area and other avascular zones under low oxygen tension. It is an autologous stem cell product that employs one’s own mesenchymal stem cells to help with the healing process. BRTX-100TM is an individualized or a complimentary surgical solution by utilizing the patients’ stem cells to foster therapeutic benefits. This product leverages a proprietary method of harvesting the stem cells and culturing them in a low oxygen environment called hypoxia, to imitate the same environment of the disc within the body.
The company then adds the patients’ autologous platelet lysates (APL) to these cultured cells, creating BRTX-100TM. APL contains several growth factors that support the stem cells to initiate their tissue repair through angiogenesis, cellular chemotaxis, and remodeling of the extracellular matrix. Once ready, the product is delivered through a single injection into the nucleus of the patient’s disc, which would foster regeneration, healing and act as an anti-inflammatory agent. These properties have been achieved through several years of preclinical research, building out animal models, optimizing the number of cells used for delivery, and improving the overall manufacturing process.

  • We are going to introduce a paradigm-shifting technology within the spine treatment forte, revolutionizing the entire orthopaedic space. With our proprietary products BRTX-100TM and ThermoStemTM, we aim at improving the quality of care for patients enduring chronic lumber disc disease and metabolic disorders including obesity and diabetes


To target metabolic diseases such as obesity and type 2 diabetes, BioRestorative Therapies has developed its ThermoStemTM program, an allogenic cell-based therapy that utilizes brown adipose-derived stem cells to generate new brown fat tissues. The company was the first firm to identify and produce data regarding this novel approach to stem cell population, employing one cell source to treat several patients. Based on the preclinical data and clinical outcomes on the animal models, once a patient is transplanted with the artificial brown adipose tissue construct, it mimics the naturally occurring brown adipose depots that help regulate metabolic homeostasis in humans. Based on animal models, expected positive clinical outcomes include weight loss, decreased circulating glucose levels, and reduced lipid levels. In effect, patients will face lesser risks associated with obesity and diabetes. ThermoStemTM is expected to work effectively on patients suffering from metabolic diseases and associated co-morbidities.

At present, BRTX-100TM is undergoing a phase two clinical trial under the authorization of the FDA, after which the company will be able to validate that this technology meets its clinical endpoints of decreasing pain and improving function. ThermoStemTM is expected to proceed into trials by early 2022. “With our novel approach, we leverage the strength of the body and its therapeutic potential to maximize clinical outcomes. This will help us emerge as a clinical stage biotech company of the future aimed at meeting the unmet needs of patients,” concludes Francisco Silva, the Chief Scientist and VP, R&D at BioRestorative Therapies.

Top 10 Spine Solutions Companies - 2022

Company
BioRestorative Therapies

Management
Lance Alstodt, President, CEO and Chairman and Francisco Silva, Chief Scientist and VP, R&D

Description
BioRestorative Therapies, Inc. is a biotechnology company based in the United States. It focuses on the development of regenerative medicine products and therapies using cell and tissue protocols, primarily involving adult (non-embryonic) stem cells. The company’s two core development programs include the Disc/Spine Program, which involves cell therapy candidate, BRTX-100, a product formulated from autologous cultured mesenchymal stem cells collected from the patient’s bone marrow.

BioRestorative Therapies News

BioRestorative Therapies Announces Key Milestone of Dosing Completion in Safety Cohort of Phase 2 Trial Targeting Chronic Lumbar Disc Disease

Clinical data expected to be reviewed by independent data safety monitoring board (DSMB) as to initial safety dosing profile of BRTX-100
MELVILLE - BioRestorative Therapies, Inc. announced that the final subject in its BRTX-100 Phase 2 clinical trial safety cohort has been dosed. Four study participants were dosed at a 3:1 ratio with either BRTX-100 or control.
BRTX-100, the Company’s lead clinical candidate, is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. BRTX-100 is currently being evaluated in a Phase 2 clinical trial to treat chronic lumbar disc disease (“cLDD"). The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, with 40 million cells intradiscally injected into the nucleus of the lumbar disc. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.
The initial safety run-in part of the study is intended to assess the initial safety of a dose of BRTX-100. If no dose limiting toxicity (“DLT”) occurs among the four BRTX-100 treated subjects, enrollment will transition and expand to the 2:1 randomization scheme planned for the main component of the study. Establishing the safety profile and DLT of patients dosed with BRTX-100 will allow for open enrollment across all activated clinical sites participating in the clinical trial and accelerate patient recruitment.
“We are excited to announce this important clinical milestone as we continue to drive the development of BRTX-100 as a potential treatment for patients suffering from lower back pain,” said Lance Alstodt, CEO of BioRestorative. "I am extremely impressed with the effort of our clinical and operational teams, working collectively throughout the early stages of the trial to coordinate and successfully complete dosing our safety cohort. Open enrollment will enable us to rapidly increase patient recruitment and allow us to work toward the completion of our Phase 2 trial.”

BioRestorative Therapies’ Chief Scientist Named New Section Editor of the Prestigious Journal of Translational Medicine

- New journal section will focus on emerging and translation work in the field of regenerative medicine –
MELVILLE - BioRestorative Therapies, Inc. announce that its Chief Scientist and Vice President of Research and Development, Francisco Silva, has been named Section Editor of the newly launched Regenerative Medicine section of the Journal of Translational Medicine.
The Journal of Translational Medicine is a peer-reviewed open-access medical journal which has been published since 2003. According to the Journal Citation Reports, the journal had a 2021 impact factor of 8.440, ranking it among the top 3% of journals worldwide. It covers all areas of translational medicine but also has several special sections, Regenerative Medicine being its newest addition.
"We are excited to expand the journal’s focus on regenerative medicine and are thrilled to have found someone with Francisco’s demonstrated research excellence, pioneering clinical experience, and ability to serve as a respected ambassador to become our newest Section Editor,” said the Journal of Translational Medicine’s Editor-in-Chief, Francesco Marincola, MD.
Mr. Silva has extensive experience in developing and translating cell-based therapeutics. At BioRestorative, he leads a team of scientists developing cell-based therapeutics targeting musculoskeletal and metabolic disorders. Currently, he is the principal investigator of an ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy clinical-stage candidate, in treating chronic lumbar disc disease (cLDD). More recently, Mr. Silva began developing BioRestorative’s novel allogeneic, off-the-shelf ThermoStem® metabolic disease program. Through that work, he was the first to develop an artificial 3D brown adipose transplant using human brown adipose stem cells.
Earlier in his career, in 2008, Mr. Silva was one of the first to publish on the use of stem cells in patients suffering from spinal cord injury. In addition, his research has led to the discovery of novel cell types isolated from umbilical cord, bone marrow and adipose tissue. He has authored several peer-reviewed papers focused on regenerative medicine, and has been issued numerous U.S. and international patents in the field. Mr. Silva earned a degree in Biology from California State Polytechnic University, where he also obtained a Graduate Presidential Fellowship and a Minority Biomedical Research Support (MBRS) Fellowship.
"I am deeply honored to have been selected to help launch this important new special section of the Journal of Translational Medicine," Mr. Silva said. “Today, most regenerative medicine research remains confined to the bench rather than the bedside. But if our cell-based therapy development progress at BioRestorative, as well as that at several other companies, is any indication, it may not be long before the full clinical potential of the field is realized. I am energized by this unique opportunity to work with my scientific colleagues from around the world to help fulfill that vision.”