BioMedic develops and delivers clinically focused placental allograft solutions — protective biologic barriers processed under rigorous FDA and AATB oversight for use across acute and chronic wound care.
BioMedicAdvances Wound Care with a Full Range of Placental Allograft Configurations
A configuration for every wound bed
BioMedic placental allografts are offered in a range of membrane configurations, so clinicians can match graft thickness and composition to the clinical need.
Single-Layer Amniotic Allograft
A single layer of amnion membrane — a thin, highly conformable protective barrier suited to delicate or contoured wound beds.
Dual-Layer Amniotic Allograft
Two amnion layers laminated into a single dual-layer membrane for added thickness, strength and handling — our most widely used wound covering.
Amnion–Chorion Allograft
Dual- and triple-layer constructs that pair the protective amnion with the more substantial chorion membrane for a robust biologic barrier.
Quad-Layer Placental Allograft
A four-layer amnion/chorion construct — the most robust configuration in the portfolio and the validated master product family for terminal sterilization.
9 graft sizes, 1×1 cm to 12×15 cm
Single patient, single use
Terminally sterilized to SAL 10⁻⁶
5-year shelf life
Ambient storage 15–30 °C
Indicated across acute
Placental allografts support the body’s ownhealing environment across abroad range of wound types in wound care andsurgical settings.
Backed by documented regulatory evidence
Every BioMedic allograft is supported by acomplete chain of regulatoryregistration, accreditation and process validation— the documentation thatreviewers and procurement teams expect to see.
Regulated as an HCT/P under Section 361
Recovered and processed as a Human Cell, Tissue and Cellular & Tissue-Based Product, regulated solely under Section 361 of the PHS Act and 21 CFR Part 1271. The processing establishment is FDA-registered.
Written FDA classification recommendation
The FDA Tissue Reference Group has issued a written recommendation confirming the product meets the criteria for regulation solely under Section 361 of the PHS Act.
Accredited tissue establishment
Recovered, processed, stored and distributed by a tissue establishment accredited by the American Association of Tissue Banks, in accordance with current AATB Standards for Tissue Banking.
Quality management system
Manufactured under an ISO 13485-aligned quality management system governing design controls, process controls, document control and risk management.
Terminal sterilization
Electron-beam irradiation validated by VDmax dose substantiation and dose mapping to a sterility assurance level of 10⁻⁶.
Traceability
Each allograft is uniquely identified and tracked from donor to final disposition, supporting full lot-level traceability.
Donor eligibility
Every donor screened and tested with FDA-licensed assays for HIV, hepatitis B & C, syphilis, HTLV and West Nile virus, with final eligibility determined by a medical director.
Packaging integrity
Dual sterile barrier — foil and Tyvek — validated to a five-year shelf life through accelerated and real-time aging studies.
Manufacturing process
Processing validated under 21 CFR 820.70 and 820.75 and FDA current Good Tissue Practices, with bioburden, residual-moisture and handling acceptance criteria.
Distribution & storage
Ambient shipping conditions evaluated and validated — products remain stable through normal transit without a cold chain.
Become a partner
We’re partnering with leading scientists, institutions, and companies conducting clinical research into the gut microbiome, with a focus on personalized biomarker discovery and novel product development.
By leveraging our technology, our partners receive continuous, comprehensive microbiome data generation and AI-enabled bioinformatics for unprecedented insight into the microbiome’s role in health and disease.
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