(OTC:BSEM)
This could be the biggest pull back that we have seen with *BSEM* We have ridden this wave from $1.00 all the way to the 52 week high which is over $20!!
The company had a breakout year in 2024! and 2025 Is looking to be HUGE!
This could be one of the biggest bounces that we have seen in 2025!
We have seen this run in the past and were gonna keep a very close eye on this moving forward!
For those who are new and have yet to hear the full success story on *BSEM* Read the full report below!
Here we go HUMANS!!
*OTC:BSEM* Let's GOOOOOOOO!!
*BSEM* Full Profile Below
BSEM IS AN EMERGING COMPANY IN THE MEDTECH SPACE THAT SAW RECORD REVENUES in 2024 and CURRENTLY CARRIES A $25.50 ZACKS PRICE TARGET!
The Company has recently reported preliminary Q2 2025 results with $49.3 million in net revenue, $2.5 million in positive adjusted EBITDA (its sixth consecutive profitable quarter), and an increased cash balance of $30.8 million!
BIG VISION – REAL IMPACT – AND NATIONAL RECOGNITION!!
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.
Mr. Matuszewski was chosen by an independent panel of past winners, top CEOs, private equity and venture capital investors and business leaders. Judges assessed candidates on long-term value creation, entrepreneurial spirit, purpose-driven commitment and significant growth and impact.
This is a very competitive awards program. It speaks in volumes for them to choose BSEM's CEO and to recognize the company's efforts to improve lives of patients suffering from chronic, non-healing wounds.
Despite uncertainty around the Trump administration, tariffs, and economic concerns, the healthcare sector has been striving in 2025. 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!
2023 was a pivotal year for BSEM and 2024 was a year for record revenues. The last couple of years of success have established a solid foundation for the company's future expansion, which now includes a potential uplisting to a senior stock exchange!
STRONGEST FIRST QUARTER IN THE COMPANY'S HISTORY!
Financial Results for the Three Months Ended March 31, 2025:
- Net revenue for Q1 2025 was $72.5 million, a 73% increase compared to Q1 2024. The increase was driven by strong performance across the Company's wound care portfolio, led by VendajeAC, supported by expanded commercial coverage and sales force expansion.
- Gross profit was $71.7 million, or 99% of net revenue, compared to $39.7 million or 95% of net revenue in Q1 2024. The improvement reflects product mix benefits, scale efficiencies, and increased contributions from Vendaje AC, which does not incur licensing fees.
- Operating expenses totaled $66.4 million, up from $35.1 million in Q1 2024, primarily driven by increased sales and marketing costs associated with the Venture Medical distribution agreement.
- Adjusted EBITDA for the first quarter was $7.8 million, compared to $7.9 million in Q1 2024. The slight decline reflects higher gross profit being offset by increased operating expenses, including sales and marketing costs—primarily Bona Fide Service Fees tied to elevated sales volume—along with higher research and development expenses related to three active clinical trials, and increased general and administrative costs driven by expanded headcount as the company scales.
- GAAP net income was $4.5 million or $0.27 per share, compared to $3.3 million or $0.20 per share in Q1 2024. This marks BioStem's fifth consecutive quarter with positive GAAP net income.
- Quarter-end cash balance of $26.7 million, up from $22.8 million as of December 31, 2024.
First Quarter 2025 and Recent Corporate Highlights:
In Q1 2025, BioStem announced key milestones that further solidify its leadership in placental-derived products for wound care.
- The Company has received Institutional Review Board (IRB) approval to initiate a new clinical trial evaluating BioREtain® Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLUs). This study is BioStem's third prospective clinical trial and reflects its ongoing commitment to building a robust body of clinical evidence that demonstrates superior patient outcomes and supports wider adoption of its advanced wound care solutions.
- BioStem also launched its BR-AM-DFU clinical trial to evaluate Vendaje®, the Company's proprietary amniotic membrane product, in the treatment of non-healing diabetic foot ulcers. This trial will evaluate Vendaje against the current standard of care, offering an opportunity to further validate the clinical efficacy of the BioREtain technology platform and accelerate commercial growth in the diabetic wound care segment.
- Additionally, BioStem has expanded its intellectual property portfolio with the U.S. Patent and Trademark Office. With a total of 55 patents that have been issued and 52 pending patents, the Company continues to reinforce its innovation leadership and lay the groundwork for the development of next-generation products in regenerative medicine and wound care.
"I am pleased to report the strongest first quarter in BioStem's history, with Q1 2025 revenue increasing 73% compared to the first quarter of 2024. With the launch of Vendaje AC® in Q4 2024, we have seen rapid adoption of that product through our commercial partnership with Venture Medical."
"On the capital markets front, we remain in active review with the SEC regarding our Form 10 registration and uplisting process, and we look forward to completing this milestone and becoming listed on Nasdaq. We want to thank our shareholders for their continued support."
CEO Jason Matuszewski
Preliminary Financial Highlights for Q2 2025:
- Generated net revenue of $49.3 million for the second quarter 2025
- Achieved the sixth consecutive quarter of positive adjusted EBITDA with $2.5 million reported for the second quarter 2025
- Increased the cash balance to $30.8 million as of the end of the second quarter 2025, an increase of $4.1 million from $26.7 million as of March 31, 2025
Recent highlights also include the appointment of Brandon Poe as CFO, completion of enrollment in a pivotal BioREtain® Amnion Chorion trial for diabetic foot ulcers (with results expected in Q4 2025), expansion of the commercial team to reach new care sites, and growth of its patent portfolio to 58 issued and 68 pending patents.
Zack's Small Cap Research has a $25.50 price target on shares!
What is Zack's SCR saying?
"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."
The medtech arena is not the easiest to navigate given how many kinds of companies are in it. It's all about finding emerging players like BSEM who have successfully navigated the regulatory process (a real barrier to entry) and show real growth.
BioStem Technologies, Inc. is growing fast, with record revenue and profitability in 2024 and 2025 is looking to be another impressive year of revenue!
The company has continued to release positive news throughout the quarter including initiating a new study and exciting study results.
BSEM has initiated the BR-AM-DFU (BioREtain® Amniotic Membrane - Diabetic Foot Ulcers) clinical trial to evaluate Vendaje® versus standard of care for patients suffering with non-healing diabetic foot ulcers.
The BR-AM-DFU trial is a multicenter, randomized, controlled study that will enroll 60 patients with non-healing DFUs at approximately twelve sites across the United States. The study will focus on a patient population with diabetic foot ulcers (DFUs) that have adequate perfusion and no clinical signs or symptoms of infection. Weekly visits will be conducted to monitor compliance with wound care protocols and off-loading, as well as to document when wound closure is achieved. A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up will consist of a four-week period with two visits at each two-week interval.
BSEM has also released study results that showed the company's signature technology, BioREtain, showed superior performance over the traditional standard of care.
According to the company, in this study, researchers conducted a retrospective analysis to evaluate the effectiveness of a sterile, dehydrated amnion/chorion membrane processed using a proprietary method (BioREtain-AC) compared to a cohort of patients treated with standard of care measures in healing hard-to-heal diabetic foot ulcers in a real-world environment. A total of 21 subjects met the study's inclusion criteria, which included factors such as wound type, medical history, and previous treatment involving the BioREtain-AC placental membrane product. The wounds in the study were considerably larger than those typically included in randomized controlled trials, averaging nearly 14 cm², compared to an average wound size of about 5 cm² in most trials.
The study demonstrated that patients treated with BioREtain experienced an 8.53% higher probability of achieving full wound closure compared to the standard of care group after 12 weeks. For those wounds that did not achieve complete closure, the BioREtain group still showed a 93.6% improvement in expected area reduction, while the standard of care group stalled or grew larger.
AND ON ANOTHER EXCITING FRONT, A NASDAQ LISTING COULD BE AROUND THE CORNER FOR THE COMPANY!
BSEM 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 stock exchange.
BSEM on the NASDAQ would open up the stock to new investors, especially on the institutional front!
COMPANY OVERVIEW
Biostem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies.
The company is providing a vital service to the human population while working to provide economic value to shareholders as well.
BSEM manufactures perinatal tissue allografts and is focused on the diabetic wound care market and the surgical wound care market.
What is the company's mission? "To discover, develop, and produce the most effective regenerative medicine products in the world."
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Notable clients and partners include:
The Back Story
BioStem CEO Jason Matuszewski and Chief Operating Officer Andrew Van Vurst co-founded the company in 2014. When Van Vurst's father developed side effects from radiation treatment for cancer, resulting in partial paralysis and speech impairment, Van Vurst returned from the military to explore treatment options that would help his father regain motor function, speech and overall quality of life.
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. Due to the success of the treatment, Van Vurst and his father developed a passion for regenerative medicine and BioStem was born.
Future Medicine: Regenerative Therapies
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.
A report from Grand View Research projects that the global stem cell market will reach a massive US$18.4 billion by 2028.
The research firm sees "the rising number of stem cell banks, growing focus on increasing therapeutic potential of these, and extensive research for the development of regenerative medicines" as drivers of this market.
Grand View Research has also highlighted that many studies have been conducted over the years to assess the true potential of stem cells, leading to a variety of applications in the fields of genetic disease treatment, neurological disorders, oncology, and organ regeneration.
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Harnessing Placental Tissue for Regenerative Therapies
BSEM manufactures tissue allografts that come from the human placenta. This is essentially a tissue transplant product from the placenta. In the space of skin substitutes, it is like xenografts or grafts from an animal.
What is an allograft?
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.
The Company's Allografts Are Not Just Any Allografts….
They Are Best-In-Class Placental Tissue Allografts!
The proprietary BioRetain® processing method.
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 AMNIOWRAP2.
Each BioStem Technologies placental allograft is processed at the Company's FDA-registered and AATB-accredited site in Pompano Beach, Florida.
Already Working with Notable Clients and Partners, BSEM is Paving the Way in Modern Medicine with Substantial Growth Potential!
BSEM 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.
Vendaje is the result of the modernization of this science.
- VENDAJE™ is offered to all Medicare providers across the United States. On January 1, CMS established and published the national pricing data for reimbursement based on the Average Sales Price ("ASP") of VENDAJE™. Establishing national pricing for VENDAJE™ enables BioStem to offer its product to all Medicare providers across the U.S.
- VENDAJE™, VENDAJE ACTM, VENDAJE OPTICTM, and AMNIOWRAP2TM are the only allografts available that leverage the company's proprietary BioREtain processing technology.
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!
As more doctors become familiar with the BSEM technology, it could open doors to many revenue opportunities!
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Two Big Markets
Perinatal tissue allografts have been successfully used since the early 1900's as an alternative modality for the treatment for chronic wounds.
More recently physicians have used these products to treat ocular surface disorders, chronic non-healing diabetic wounds, and in a variety of surgical procedures.
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.
Because diabetes and issues from diabetes are increasing worldwide, this offers an opportunity for BSEM's allografts to help patients.
- The global wound care market in terms of revenue was estimated to be worth $20.8 billion in 2022 and is poised to reach $27.2 billion by 2027, growing at a CAGR of 5.4% from 2022 to 2027.
- The US advanced wound care market in terms of revenue was estimated to be worth 11.2 billion in 2022 and is poised to reach 17.7 billion in 2027 at a compound growth rate (CAGR) of 9.4% from 2022-2027.
- The global diabetic foot ulcer treatment market size was valued at $4.67 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.9% from 2022 to 2030.
There is promising potential for BSEM to impact patients and expand the company's business in an exponential way as more doctors become familiar with the company's technology!
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BREAK THROUGH RESULTS!
Breakthrough results published in the peer-reviewed journal, International Wound Journal. The study validates the clinical efficacy of BioREtain®-processed placental membranes (RE-AC) compared to the standard of care (SOC). Utilizing a real-world population with large, hard-to-heal, complex chronic diabetic foot ulcers (DFUs), the study demonstrates a clear advantage in 12-week wound healing rates for the RE-AC-treated group compared to the SOC group.
BSEM released study results that showed the company's signature technology, BioREtain, showed superior performance over the traditional standard of care.
According to the company, in this study, researchers conducted a retrospective analysis to evaluate the effectiveness of a sterile, dehydrated amnion/chorion membrane processed using a proprietary method (BioREtain-AC) compared to a cohort of patients treated with standard of care measures in healing hard-to-heal diabetic foot ulcers in a real-world environment. A total of 21 subjects met the study's inclusion criteria, which included factors such as wound type, medical history, and previous treatment involving the BioREtain-AC placental membrane product. The wounds in the study were considerably larger than those typically included in randomized controlled trials, averaging nearly 14 cm², compared to an average wound size of about 5 cm² in most trials.
The study demonstrated that patients treated with BioREtain experienced an 8.53% higher probability of achieving full wound closure compared to the standard of care group after 12 weeks. For those wounds that did not achieve complete closure, the BioREtain group still showed a 93.6% improvement in expected area reduction, while the standard of care group stalled or grew larger.
This confirms that BSEM technology is superior and very helpful to patients. More doctors are turning to BioStem for treatments, resulting in increasing sales.
Also likely helping to boost sales was the company's announcement that the Center for Medicare Services has established a national pricing for the company's product Vendaje AC!
CEO Jason Matuszewski notes that, "With CMS's national pricing approval, Vendaje AC is now accessible to more patients across the country."
Receiving a Q Code
BSEM was awarded a Q code that became effective on January 1, 2024!
It applies to drugs, biologics, and medical equipment and services that are not identified by the national code needed for Medicare claims processing. It allows these "Q" products to be reimbursed by Medicare.
Zacks Smallcap Research previously noted: "With the company's recent announcement of a Q code, we believe rapid growth is set to continue and are raising our valuation level as a result."
With BSEM's revenues skyrocketing, the company securing a CMS Q code, game-changing partnerships, a successful capital raise, and the start of a crucial clinical trial for diabetic foot ulcers… BSEM is a stock to watch.
More Reasons to Have BSEM on Your Radar:
- Working with notable clients and partners including the Center of Medicare Services (CMS), and the U.S. Department of Veterans Affairs (VA).
- Specially trained salespeople recently installed could be very effective in explaining the benefits available from using the company's product. BSEM has added industry veterans Mirlene Guerre as Vice President of Sales and Neal Bhattcharya as Vice President of Marketing. Ms. Guerre has extensive experience leading sales teams and organizations in wound care, burn, plastics, general, and oral/ent surgical markets. Mr. Bhattacharya has held progressive positions in marketing for well-known national brands in both consumer packaged goods and medical device companies, including Kimberly-Clark, Novartis, Covidien and Trividia Health, Inc. The company has entered into an Agreement to acquire the majority of the assets of Auxocell Laboratories, Inc., a leading solid tissue processing equipment manufacturer. The acquisition will enable BSEM to expand its intellectual property portfolio, both domestic and foreign, in the perinatal tissue space and provide additional value to clients and shareholders
- To date, the company has produced over 20,000 allografts, including its own Vendaje® line of products as well as contract manufacturing for many key industry players.
- BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB®"). The company's facility is also FDA-accredited.
In Summary
After a year that was marked by robust revenue growth, BSEM is navigating 2025 for another year of success. Recent preliminary revenues showcase the stellar growth BSEM continues to see.
AND… an uplisting to the NASDAQ exchange is on the horizon!
BSEM recently announced that it 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 stock exchange.
With BSEM's revenues skyrocketing, game-changing partnerships, a successful capital raise, and the start of a crucial clinical trial for diabetic foot ulcers… this all reads like a recipe for tremendous shareholder value.
As regenerative medicine continues to find its way into the mainstream, emerging biotech company BioStem Technologies, Inc. (OTC: BSEM) is making waves for its focus on harnessing elements of perinatal tissue derived from the human placenta for manufacturing structural tissue allografts to heal wounds.
- The company's products have the potential to save millions of lives while building market capitalization growth for BSEM in the process.
- With a highly experienced commercial team, the company aims to stay ahead of the competition through the company's unique processes and versatile offerings in wound healing, focusing on TWO big markets.
- Revenues continue to surge and future growth looks encouraging with all of the milestones recently achieved.
- Allografts derived from the human placenta, known as perinatal allografts, have been in use for over a century for a wide range of clinical specialties and BSEM is looking to ride the upward growth trajectory of the soft tissue market.
- Being offered to all Medicare providers across the United States could make sales increase dramatically! Especially now that the company has secured a Q code.
- Zack's Small Cap Research now has a $25.50 price target on the stock.
Many investors may overlook MedTech healthcare stocks, but these companies often demonstrate unlimited potential. Unlike their pharma counterparts, MedTech healthcare stocks are often nimbler and more innovative. These companies are leveraging global trends.
BioStem Technologies (BSEM) is actively working to reshape the future of medicine and is still at the beginning stages!
BioStem Technologies (BSEM) is actively working to reshape the future of medicine and is still at the beginning stages
