BioStem Technologies, Inc. (OTC: BSEM) is launching American
Amnion, a new product line of placental-derived biologics for advanced wound
care. The official debut is scheduled for the 2025 Desert Foot
Multi-Disciplinary Limb Salvage and Wound Care Conference, with a strategic
focus on serving the significant wound care needs of military veterans. The
product line consists of two variants: American Amnion, a dehydrated
human amnion membrane (DHAM), and American Amnion AC, a full-thickness
dehydrated human amnion and chorion membrane (DHACM).
The core innovation behind the product line is BioStem's proprietary BioRetain® process, designed to preserve the native structural and molecular composition of perinatal tissue. This includes retaining the intermediate layer between the amnion and chorion, which is rich in growth factors, cytokines, and other components essential for healing.
Recent clinical evidence underscores the efficacy of this technology. A 2025 multi-center randomized controlled trial by McCoy et al. found that a BioRetain-preserved product achieved a 53% probability of wound closure, nearly double the 31% rate observed with the standard of care. Furthermore, a 2024 comparative study by Frykberg et al. demonstrated that the product outperformed a leading competitor in both clinical and cost-effectiveness, showing a 14% reduction in time to closure while requiring 27% fewer applications. This combination of advanced biologic preservation and strong clinical data positions American Amnion as a significant advancement in the treatment of acute and chronic wounds.
Product Line Overview
BioStem Technologies, a MedTech company specializing in
placental-derived biologics, is expanding its portfolio with the American
Amnion product line. These allografts are intended for homologous use as a
protective covering for acute or chronic wounds. The launch strategy
targets explicitly the veteran population, which is identified as an
underserved group with a disproportionately high risk of non-healing wounds.
Product Variants
The American Amnion line includes two distinct allografts,
both manufactured using the proprietary BioRetain® process and both retaining
the intermediate tissue layer.
- American
Amnion AC: A human connective tissue matrix comprised of a
full-thickness dehydrated human amnion and chorion membrane (DHACM). The
combination of both membranes results in an allograft that is thicker, has
higher tensile strength, and contains a richer and more varied profile of
growth factors compared to amnion-only products. It is indicated for
applications in which clinicians believe a thicker, pro-healing-factor-rich covering is needed.
- American
Amnion: A human connective tissue matrix comprised of dehydrated human
amnion membrane (DHAM).
Core Technology: The BioRetain® Process
The central technological advantage of the American Amnion
line is the proprietary BioRetain® process. This manufacturing method is
designed to create a minimally manipulated allograft by optimizing the preservation of the natural structural and molecular components of
fresh placental tissue.
Key Differentiators and Preserved Components
The BioRetain® process focuses on preserving the tissue's inherent biological properties to support the body's natural healing
processes.
- Preservation
of the Intermediate Layer: Unlike some other DHACM products, American
Amnion AC preserves the intermediate layer between the amnion and chorion.
This layer contains its own distinct components, including chemokines,
growth factors, interleukins, and protease inhibitors.
- Rich
Biological Composition: The process is designed to preserve the
natural reservoir of growth factors, extracellular matrix (ECM)
components, and cytokines. An analysis of American Amnion AC allografts
(n=6) confirmed the retention of numerous critical substances:
|
Category |
Specific Components Retained |
|
Cytokines |
IL-1 receptor antagonist (naturally inhibits
pro-inflammatory effects of IL-1) |
|
Growth Factors |
Epidermal growth factor (EGF), Vascular endothelial growth
factor (VEGF), Basic fibroblast growth factor (bFGF), Keratinocyte growth
factor (KGF) |
|
ECM Components |
Collagens I, III, IV, V, and VI; Elastin; Laminin;
Fibronectin; Proteoglycans |
|
Hyaluronic Acid (HA) |
Average concentration of 48,355,062 picograms/cm²,
nearly 8 times that of the company's single-layer
allograft. |
The chorionic layer provides a significantly higher amount
of growth factors than the amniotic layer, with the exception of EGF.
Clinical Evidence and Efficacy
Allografts produced with the BioRetain® technology have
demonstrated superior clinical performance in several recently published
studies, positioning American Amnion as an evidence-driven solution for wound
care.
McCoy et al. (2025) - Randomized Controlled Trial
- Publication:
International Journal of Tissue Repair
- Study
Design: Multi-center randomized controlled clinical trial.
- Product:
BioRetain-preserved full-thickness amniochorion product (referenced as
BR-AC).
- Key
Finding: Patients treated with the BR-AC product demonstrated a probability
of wound closure of 53%, which was almost twice the 31%
probability observed in patients treated with the standard of care.
Frykberg et al. (2024) - Comparative Retrospective Study
- Publication:
Health Science Reports
- Study
Design: Comparative retrospective study against a leading competitor.
- Product:
BioRetain-preserved DHACM.
- Key
Findings: The product outperformed the competitor in both clinical and
cost-effectiveness, achieving:
- A 14%
reduction in time to closure.
- A
requirement of 27% fewer applications to achieve closure.
Retrospective Analysis on Diabetic Foot Ulcers (DFUs)
- Study
Focus: A retrospective analysis comparing the effectiveness of a
retention-processed Amnion/Chorion membrane (RE-AC) versus Standard of
Care (SOC) for treating chronic DFUs.
- Methodology:
The study utilized retrospective observational data from electronic health
records of patients at three outpatient wound care centers. A synthetic
control group of SOC patients was matched from a wound registry using
Coarsened Exact Matching (CEM). The analysis employed advanced statistical
methods, including Bayesian Regression and Hurdle Gamma ANCOA models, to
enhance precision and control for confounding variables.
- Primary
Metrics: The study focused on Probability of Complete Wound Closure
and Expected Percent Area Reduction (xPAR).
Market Strategy and Corporate Positioning
BioStem Technologies is launching American Amnion with a
clear market focus and a strategy that leverages clinical data and community
engagement.
Launch Event
- Venue:
2025 Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference
in Phoenix, Arizona (December 10-13, 2025).
- Key
Activities:
- Hands-On
Workshops: "Superior Science that Delivers Optimal Results:
Preserving the Natural Integrity in Amniotic Tissue for Advanced Wound
Care" (Dec. 11, 10:30 am - 1:30 pm MST).
- Scientific
Presentation: "Optimizing Preservation of Inherent Properties in
Placental Membranes: Impact on Clinical Outcomes in Advanced Wound
Care" by Wendy Weston, PhD (Dec. 11, 2:30 pm - 3:00 pm MST).
Target Market: The Veteran Population
The company has identified veterans as a key demographic for
this product line, citing compelling statistics and a mission-driven approach.
- Identified
Need: CEO Jason Matuszewski stated, "Veterans represent a
significantly underserved population with a disproportionately high risk
of chronic, non-healing wounds."
- Market
Trend: The use of placental-based products has increased by 50% over
the last five years within the VA system.
- Corporate
Goal: "By bringing innovative, evidence-driven solutions to
market, we are not only improving outcomes and quality of life for our
veterans, but also helping our clinician partners deliver more efficient,
cost-effective care." - Jason Matuszewski, CEO.
Community Engagement
BioStem supports the veteran community through its exclusive
sponsorship of the Florida Panthers’ Heroes Among Us program, which
publicly recognizes a United States military veteran before every home game at
the Amerant Bank Arena.
Product Specifications and Practical Information
Allograft Properties and Handling
- Storage:
The allografts have a 4-year shelf life and can be stored at
ambient temperatures.
- Application:
Products are held in place via hydrostatic tension and can be used in an
open incision or placed as a dermal substitute. Standard fixation methods
can also be used.
- Processing:
Allografts are aseptically processed and terminally sterilized via e-beam
irradiation.
- Functional
Properties: The dehydrated human amnion/chorion membrane provides a
barrier for protection, helps prevent moisture loss, and provides a
structure for tissue integration.
Quality and Regulatory Compliance
- FDA
Designation: Designated as a Human Cell, Tissue, and Cellular and
Tissue-Based Product (HCT/P).
- Processing
Standards: The product is minimally manipulated and produced in
accordance with the FDA regulations for current Good Tissue Practices
(cGTP) (21 CFR 1270, 1271) and current Good Manufacturing Processes
(cGMP).
- Accreditation:
BioStem's quality management system is accredited by the American
Association of Tissue Banks (AATB).
- Manufacturing:
All allografts are processed at the company’s FDA-registered and
AATB-accredited facility in Pompano Beach, Florida.
Contact Information
- Product
Hotline (Local): 954-380-8342
- Product
Hotline (Toll-Free): 1-888-948-BSEM (2736)
- Email
Inquiries: orders@biostemtech.com
- Investor
Relations Email: ir@biostemtech.com
