Stem
Biologics
Stem Biologics
Stem Biologics LLC

The Standard in Biologics Distribution

A medical distribution company supplying human tissue allografts and point-of-care systems to licensed healthcare providers — with complete documentation on every lot.

Our Solutions Contact Us
SB
Who We Are

Built on Documentation, Not Claims

Stem Biologics LLC is a medical distribution company serving licensed healthcare providers. We source human tissue allografts and point-of-care systems, verify their regulatory status and documentation, and deliver them under validated handling conditions. We do not manufacture products, and we do not direct clinical care.

Verified Sourcing
We source from FDA-registered tissue establishments and prioritize processors accredited by the American Association of Tissue Banks. Regulatory classification is provided in writing.
Provider Support
We supply the documentation, handling requirements, and logistics support providers need so the compliance file is complete before a product is ever opened.
Full Traceability
Donor eligibility determinations, infectious disease testing records, and lot-specific certificates of analysis accompany every shipment we distribute.
What We Offer

Our Solutions

Inquire Now
01
Allograft Tissue Products

Amniotic, placental, and other human tissue allografts sourced from FDA-registered establishments. Donor eligibility documentation and lot-specific certificates of analysis supplied with every shipment.

02
Point-of-Care Systems

FDA-cleared platelet-rich plasma and autologous processing systems for point-of-care use, supplied with device documentation, instructions for use, and in-service training.

03
Regulatory Documentation

Written regulatory classification, establishment registration, donor screening and testing records, and certificates of analysis — assembled for your file before first use.

04
Cold Chain & Handling

Validated shipping, storage specifications, and receiving protocols so product remains within its labeled conditions from processor to point of care.

05
Practice Integration

Documentation, coding, and workflow guidance reflecting current CMS payment policy, including the 2026 changes to skin substitute reimbursement.

06
Physician Education

Training and consultation on product handling, storage, regulatory classification, and use consistent with each product's labeling.

Intended Use & Regulatory Status

Stem Biologics LLC is a distributor. Products are supplied to licensed healthcare professionals for use consistent with each product's labeling and applicable regulatory classification. Human tissue allografts distributed as 361 HCT/Ps under 21 CFR Part 1271 are not FDA-approved or licensed products, and are intended for homologous use only. Nothing on this site is a representation that any product diagnoses, treats, cures, or prevents any disease, or an offer to sell any product for a use outside its labeling. Regulatory classification for any product is available in writing on request.

Latest News

Insights & Research

Repair
The Science
How Your Body Actually Heals

Hemostasis, inflammation, proliferation, remodeling. A plain-language walk through the four overlapping phases of wound healing — and a look at why some wounds stall along the way.

July 2026 · Read Article
Behind the Science
From Donor to Clinic: The Journey of a Tissue Allograft

Consent, screening, recovery, processing, traceability. The regulated chain of custody most people never see — and why every step generates a record.

July 2026 · Read Article
Explainer
A Plain-Language Guide to Regenerative Medicine Terms

Autologous, allograft, PRP, HCT/P, minimal manipulation — and the difference between “FDA registered,” “cleared,” and “approved.”

July 2026 · Read Article
Stay Informed

Sign Up for Updates

Get the latest research, product updates, and industry news delivered to your inbox.

Get in Touch

Drop Us a Line

Whether you're a physician, researcher, or distributor — we'd love to hear from you.

Website
www.stem-biologics.com