“2024 has been an extraordinary and transformative year for BioStem, defined by record-breaking growth and a series of groundbreaking milestones that underscore our leadership in advanced wound care. Achieving over 1,700% year-over-year revenue growth is a testament to the relentless execution of our strategic initiatives, the innovation behind our products like AmnioWrap2™ and the newly-launched Vendaje AC®, and the dedication of our team.
CEO Jason Matuszewski
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.
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.
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.
BSEM on the NASDAQ would open up the stock to new investors, especially on the institutional front!
The company has continued to release positive news throughout the quarter including study results….
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.
As a result of the quarterly results and impressive continued growth, as well as the solid management execution, we are boosting our price target to $32.50 per share. These announcements further our belief that BioStem is a company worth paying attention to and that BSEM has solid upside potential. Additionally, we continue to be impressed with the leadership of BioStem, headed by CEO Jason Matuszewski, which has remained confident in its products and science, while also focusing on getting the improved solution out to patients and accelerating commercial growth—as is demonstrated by continuing to test its proven technology and expand the availability of the company’s treatments.
With Q3 Results on the Way, Could Another Price Target Increase be Imminent?
AND ON ANOTHER EXCITING FRONT, A NASDAQ LISTING COULD BE AROUND THE CORNER FOR THE COMPANY!
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.
BSEM on the NASDAQ would open up the stock to new investors, especially on the institutional front!
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.”
Notable clients and partners include:
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.
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.
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 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.
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!
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.
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!
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.”
Being 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.
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. The Company announced preliminary Third Quarter Net Revenue of $102.9 Million, with Full-Year 2024 Net Revenue Expected to Reach $301.8 Million!
- 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 $32.50 price target on the stock after the company reported Q3 results. Could another price target lift be on the way?
Third quarter results are on November 12th!! Keep an eye out!
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.
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