Biostem Tech Stock Price, News & Analysis
Company Description
BioStem Technologies, Inc. (OTC: BSEM) is a MedTech company in the medicinal and botanical manufacturing industry that focuses on the development, manufacturing, and commercialization of placental-derived products for advanced wound care and regenerative therapies. The company works with perinatal tissue to create allografts used as protective coverings for acute and chronic wounds, positioning BioStem within the broader regenerative medicine and advanced wound care markets.
BioStem emphasizes the use of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies and advanced wound care. Its products are processed using the company’s proprietary BioRetain® (also referenced as BioREtain®) processing method. According to company disclosures, BioRetain has been developed by applying research in regenerative medicine and advanced wound care, with a focus on maintaining growth factors, preserving tissue structure, and retaining the native structural and molecular composition of perinatal tissue.
The company’s portfolio of brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion™, and American Amnion AC™ (also referenced as American Amnion and American AC). These products are described as placental-derived, minimally manipulated dehydrated tissue allografts that serve as protective coverings for soft tissue wounds or as coverings for acute or chronic wounds. Some products, such as VENDAJE and VENDAJE AC, are referenced in the context of treatment for diabetic foot ulcers and venous leg ulcers, while American Amnion and American Amnion AC are described as human connective tissue allografts intended for homologous use as protective coverings for acute or chronic wounds.
BioStem reports that all of its placental allografts are processed at an FDA-registered and American Association of Tissue Banks (AATB) accredited site in Pompano Beach, Florida. The company states that its quality management system and standard operating procedures have been reviewed and accredited by AATB and are established in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP). These elements form a core part of BioStem’s positioning in regulated tissue processing and manufacturing for medical use.
Within advanced wound care, BioStem highlights the use of its BioRetain-processed allografts in chronic wound indications such as diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers. The company has reported results from a multicenter randomized controlled clinical trial (BR-AC-DFU-101) evaluating a BioRetain-processed amnion chorion allograft (BR-AC) versus standard of care in non-healing diabetic foot ulcers. In that study, BioStem states that the probability of healing in the BR-AC arm was higher than in the standard of care arm when complete closure over a defined period was used as the endpoint, and that the trial focused on “hard-to-heal” wounds by excluding patients whose wounds responded substantially to standard care during a run-in period.
BioStem also references additional clinical and scientific data, including randomized controlled trial results and comparative retrospective studies, that it has submitted to the Centers for Medicare & Medicaid Services (CMS) and its Medicare Administrative Contractors (MACs) in connection with reimbursement determinations for skin substitutes and cellular and tissue-based products. The company notes that its BioRetain-preserved placental allografts have been evaluated in published studies comparing outcomes such as probability of wound closure, time to closure, and number of applications required, including comparisons to standard of care and to a competitor’s dehydrated human amnion and chorion membrane product.
On the reimbursement side, BioStem’s products VENDAJE and VENDAJE AC have been discussed in the context of CMS Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products for DFUs and VLUs. The company has reported that these products were placed in a “12-Month Status Quo” category under certain LCD updates, allowing continued reimbursement eligibility during a defined period, and later commented on the withdrawal of specific LCDs that would have affected coverage. In addition, BioStem has announced expanded reimbursement through inclusion of VENDAJE and VENDAJE AC on Florida Medicaid’s list of covered skin substitutes, and has stated that these products are covered by multiple Medicaid programs.
Beyond Medicare and Medicaid discussions, BioStem has highlighted its engagement with the U.S. Department of Veterans Affairs (VA) through the launch of the American Amnion product line and a partnership with a Service-Disabled Veteran-Owned Small Business. The company has also referenced its support of veterans in the community through sponsorship of a program recognizing U.S. military veterans at Florida Panthers home games near its Pompano Beach headquarters.
From an operational perspective, BioStem has described a vertically integrated manufacturing environment for its placental allografts, noting that its BioRetain manufacturing process is intended to maintain the native tissue’s structural and molecular components while providing what the company characterizes as structurally efficient economics and scalable production. The company has reported that its cost structure and manufacturing approach are aligned with evolving reimbursement frameworks, particularly CMS reforms aimed at standardizing reimbursement for skin substitutes and emphasizing clinical performance.
BioStem trades on the over-the-counter (OTC) market under the ticker symbol BSEM. The company has publicly discussed restating prior financial statements to change the classification of certain bona fide services fees associated with a distribution agreement, reclassifying them as contra revenue rather than sales and marketing expense. According to the company, this restatement affects reported revenue and certain margin metrics but does not change EBITDA, net income, or cash flow. BioStem has also reported periods of positive net income and positive adjusted EBITDA and has discussed the appointment of a new independent registered public accounting firm.
The company has indicated plans related to future operational expansion, including the purchase of land in the Research Park at Florida Atlantic University in Boca Raton, Florida, for a future headquarters that is expected to house administrative offices, manufacturing, and distribution. BioStem has noted that it has not set a timetable for relocation but views this site as part of its long-term vision and as a way to access regional talent and technology resources.
Overall, BioStem Technologies presents itself as a MedTech manufacturer focused on placental-derived allografts for advanced wound care and regenerative therapies, supported by its proprietary BioRetain processing method, AATB-accredited quality systems, FDA-registered facilities, and a portfolio of branded products aimed at chronic and acute wound indications.
Business model and activities
According to its public statements, BioStem’s core activities include:
- Developing and manufacturing placental-derived allografts using perinatal tissue.
- Commercializing branded products such as AmnioWrap2, VENDAJE, VENDAJE AC, VENDAJE OPTIC, American Amnion, and American Amnion AC for use as protective coverings in acute and chronic wounds.
- Operating an FDA-registered, AATB-accredited processing site in Pompano Beach, Florida, under cGTP and cGMP-compliant procedures.
- Conducting and supporting clinical research, including randomized controlled trials and retrospective studies, to evaluate BioRetain-processed allografts in indications such as diabetic foot ulcers and venous leg ulcers.
- Engaging with payers and regulators, including CMS, MACs, and state Medicaid programs, regarding reimbursement for its products.
- Working with distribution partners, including regional distributors and organizations serving Medicaid and VA populations.
Regulatory and quality framework
BioStem emphasizes that its quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks. The company states that its systems are established in compliance with current Good Tissue Practices and current Good Manufacturing Processes. It also notes that its facility is FDA-registered and that its placental allografts are processed at this site. BioStem has publicly referenced FDA inspections, including a 361 inspection, and has stated that it addressed concerns raised in a prior inspection and subsequently completed an inspection with no nonconformances, comments, or observations.
Clinical and reimbursement context
BioStem’s disclosures place significant emphasis on clinical evidence and reimbursement. The company has reported:
- Randomized controlled trial data in non-healing diabetic foot ulcers where a BioRetain-processed amnion chorion allograft (BR-AC) was associated with a higher probability of lasting wound closure compared with standard of care alone.
- Published studies comparing BioRetain-preserved dehydrated human amnion and chorion membrane products to standard of care and to a competitor’s product, with reported differences in wound closure rates, time to closure, and number of applications.
- Submissions of clinical data to CMS and MACs in support of coverage determinations for skin substitutes and cellular and tissue-based products.
- Placement of certain BioStem products in a “12-Month Status Quo” reimbursement category under specific LCDs, allowing continued reimbursement eligibility during a defined period, and clarification that some LCDs apply only to specific indications such as DFUs and VLUs.
- Expanded Medicaid coverage for VENDAJE and VENDAJE AC, including inclusion in Florida Medicaid’s list of covered skin substitutes and coverage in multiple state Medicaid programs.
Geographic and operational footprint
BioStem identifies its processing site as being located in Pompano Beach, Florida, where its FDA-registered and AATB-accredited facility processes placental allografts. The company has also announced the purchase of land for a future headquarters in the Research Park at Florida Atlantic University in Boca Raton, Florida, with plans for that site to house administrative offices, manufacturing, and distribution. BioStem has indicated that it intends to remain in South Florida and participate in the regional life sciences and MedTech ecosystem.