OTC: BSEM
An eight-quarter profit streak, clinically validated allografts, an eventual NASDAQ uplisting, and a $25.50 Zacks target — are all reasons why this under-the-radar MedTech company should be watched closely!
In a surging regenerative medicine landscape, discover why small cap company BSEM is standing out.
Healthcare companies are often considered a defensive play in uncertain times. Despite economic downturns, consumers are still spending on healthcare.
The surge in demand for medical devices is influenced by factors such as an aging population, increasing prevalence of chronic diseases, and a focus on improving healthcare infrastructure globally.
The demand is also attributed to innovative therapies and ongoing technological advancements in medical devices to address unmet needs in the healthcare sector.
The MedTech sector is often overlooked but is just as innovative as many of the top tech names. Two massive multi-billion-dollar markets for its regenerative therapies has positioned BioStem Technologies Inc. (OTC: BSEM) as one of the top medtech stocks to keep an eye on!
The last couple of years of success have established a solid foundation for the BSEM’s future expansion, which now includes a potential uplisting to the NASDAQ exchange!
The company has filed with the SEC to register its shares pursuant to the Securities Exchange Act of 1934, which is an important step in its plan to uplist to the NASDAQ.
The medical-technology (MedTech) sector is not just booming – it's evolving at warp speed. Against a backdrop of aging populations, soaring chronic disease rates, and rising global healthcare spend, regenerative medicine has emerged as one of the most exciting and underleveraged arenas.
Traditional pharmaceuticals treat symptoms; regenerative therapies aim to heal. BioStem Technologies (OTC: BSEM) sits squarely at this inflection point, unlocking the natural power of perinatal (placental) tissue to heal chronic, hard-to-treat wounds.
As the capital markets increasingly pour money into biotech, BioStem’s mission — to bring structurally preserved, growth-factor-rich allografts to market — puts it in the sweet spot of high impact and high growth!
The company’s manufacturing facility is FDA-registered and accredited by the AATB (American Association of Tissue Banks).
Originally founded to leverage perinatal tissue in wound-care applications, BioStem has built a product lineup including:
AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®,
American Amnion and American Amnion AC™
These are marketed for non-healing wounds such as diabetic foot ulcers and venous leg ulcers.
The market for products BSEM has developed and is continuing to develop is extensive and this cutting-edge technology can prove to be a game-changer to many patients suffering from painful and slow recoveries.
Both the diabetes wound care market and surgical recovery wound care market are growing at a tremendous rate.
“We reiterate our belief in the direction of BSEM and our strong appreciation for the way management has navigated challenges and grown the company in a smart fashion and urge investors to take a look at the stock and consider adding it to a portfolio.”
Ernst & Young LLP (EY US) announced that Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies (OTC: BSEM), was named an Entrepreneur Of The Year 2025 Florida Award winner!
Entrepreneur Of the Year is the preeminent competitive awards program for entrepreneurs and leaders of high-growth companies. For 40 years, EY US has celebrated ambitious entrepreneurs who are transforming industries, impacting communities and creating long-term value.
These included regenerative medicine, utilizing material derived from a human umbilical cord, that was being used to help restore tissues or organ damage because of age, disease, injury or other issues.
In 2013, Van Vurst and his father discovered South Florida-based Caribbean International Holdings, a provider of stem cell treatments.The regenerative medicine therapy proved to be a great success for Van Vurst’s father, who regained his speech, and vastly improved his motor skills and overall quality of life.
It’s no secret that the human body has an amazing ability to heal itself. You may have heard the term regenerative medicine before. It’s basically where the body uses its own systems to rebuild tissues and organs.
With its potential to heal, regenerative medicine has become a VERY hot topic and is expected to revolutionize healthcare.
The market for regenerative medicine is expected to experience significant growth over the next few years. It comes as no surprise that some of the biggest companies in healthcare are working hard to make advances in this vital space. This includes major players like Amgen, Sanofi, and Gilead Sciences.
An allograft is a tissue that is transplanted from one person to another. The prefix allo comes from a Greek word meaning “other.” (If tissue is moved from one place to another in your own body, it is called an autograft.)
More than 1 million allografts are transplanted each year.
BioRetain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure.
The company’s portfolio of quality brands includes:
VENDAJE™, VENDAJE™ AC,VENDAJE™ OPTIC and AMNIOWRAP™.
Each BioStem Technologies placental allograft is processed at the Company's FDA-registered and AATB-accredited site in Pompano Beach, Florida.
BioStem’s proprietary BioREtain® process isn’t a commoditized graft — it’s engineered to maximize the therapeutic potency of perinatal tissue.
By preserving the tissue structure and critical growth factors, the allografts retain far more biological activity than many competing products. That means better healing, more durable outcomes, and real clinical differentiation.
The company’s brands — including:
VENDAJE, VENDAJE AC, VENDAJE OPTIC, AmnioWrap2, American Amnion, and American Amnion AC
— all leverage this patented process, giving BioStem a robust and defensible product portfolio.
The company is focused on the application of tissue engineering in wound healing and has curated a suite of versatile products called Vendaje.
Vendaje is the company’s primary product and harnesses elements of perinatal tissue and the body’s innate biology to repair and restore damaged tissue in wounds, resulting in speedier healing with reduced pain.
Vendaje comes in several different forms and sizes and is a human connective tissue matrix comprised of amniotic tissue. This amniotic tissue is processed using the company’s proprietary BioRetain process, which creates a dehydrated human amniotic membrane allograft.
Placentally-derived human amniotic membrane (AM) is a source of pro-healing growth factors and anti-inflammatory cytokines and has successfully been used in regenerative medicine for over a century.
BSEM has entered an agreement with leading US wound market solutions provider, Venture Medical, LLC., for the nationwide release of its innovative product, AmnioWrap2™.
A leading wound market solutions provider called Venture Medical, LLC., will lead the company’s commercialization of AmnioWrap2™!
AmnioWrap2 is a versatile allograft solution for wound applications. It is an advanced biologic skin substitute that is meticulously processed to offer an extensive range of wound healing and wound care solutions.
"AmnioWrap2™, is the latest addition to BioStem's product portfolio, and is developed using its proprietary BioREtain process.
This process creates an allograft derived from amniotic tissue, optimized to cater to diverse wound care applications."
The launch of AmnioWrap2 signifies a pivotal milestone as the company expands its spectrum of innovative solutions within the wound care market.
According to the company, early users of AM for wounds and post-surgical applications noted how the membrane seemed to disappear and integrate with the patient’s own tissue without a host reaction. This apparent immune neutrality is a result of mechanisms that suppress and modulate the immune system.
The increased adoption of perinatal tissues has allowed for its significant penetration into the multibillion-dollar soft tissue repair market, which is expected to reach around $8.6B by 2030!
This isn’t speculative science — BioStem’s BioREtain allograft has been evaluated in a peer-reviewed, Level 1 randomized controlled trial (RCT) for diabetic foot ulcers (DFUs), showing 53% probability of complete wound closure versus only 31% under standard of care.
That’s not just statistically significant — it’s transformational. A durable, well-documented healing effect in a notoriously hard-to-treat patient population is exactly what payors, physicians, and regulators pay attention to.
Diabetic foot ulcers are a serious and chronic condition affecting millions of individuals within the diabetic population.
According to the American Podiatric Medical Association (APMA), a leading authority on foot and ankle health, approximately 15% of people with diabetes will develop foot ulcers.
Alarmingly, 6% of these individuals may require hospitalization due to infections or other complications related to their ulcers. The risks for diabetic patients are substantial, as DFUs are the leading cause of lower extremity amputations in the U.S. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation.
The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the U.S. alone. As the population continues to age, this financial strain is expected to intensify, underscoring the need for more effective and accessible treatment options such as what BSEM offers.
Dr. Bert Slade, Chairman of BioStem’s Medical Advisory Board, called the results “strong evidence of treatment benefit,” reinforcing BioStem’s leadership in regenerative tissue technology.
These findings not only validate the company’s proprietary BioRetain® process but also highlight its potential to transform the $27 billion global wound care market.
The venous leg ulcer trial is progressing ahead of schedule, with top-line results expected in Q1 2026. This is just around the corner…
On the reimbursement front, BioStem already has serious momentum.
The company is navigating a shifting Centers for Medicare & Medicaid Services (CMS) landscape and is optimistic about its positioning under new reimbursement models — leveraging its strong clinical data to justify value-based adoption.
They’ve made inroads into high-value channels, including federal programs (like the VA), state Medicaid (e.g., Texas), and hospital / ambulatory surgical center (ASC) networks.
The Desert Foot Conference launch of American Amnion underscores growing adoption in specialized and institutional settings.
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