— THE LAB —

One lab. Named, registered, accountable.

Every biologic we educate on comes from a single FDA-registered U.S. partner — screened, quarantined, and released with a Certificate of Analysis for every lot.

In partnership with

Renvi Health in partnership with Regenerative Research Group (RRG)
Modern laboratory processing of regenerative tissue products
21+
Years in the lab
500+
Partner clinics nationwide
100%
Chain of custody
14-day
Quarantine + testing per lot

FDA-REGISTERED·CLIA-CERTIFIED·GMP/GTP-COMPLIANT

A trusted laboratory partner.

Most operators in this category source from anonymous resellers and aggregators. We chose a different path. Renvi works with a single, established laboratory partner — selected for the seriousness with which they approach sourcing, processing, and documentation. Their standards are the foundation of ours.

Trusted source lab
An established laboratory partner with a published quality program and a track record in the field.
Quality standards
Tissue handling, processing, and storage governed by industry standards for safety and consistency.
Donor screening
Required testing performed in certified laboratories before any product is released for distribution.
Traceable process
Documentation maintained from the donor through each step — so nothing about the science is anonymous.

Where the science comes from is the most important compliance and quality decision in this category. We made it deliberately.

Why Renvi

Screened, quarantined, and verified — every lot.

Most operators in this category stay anonymous about who oversees the work and where the materials come from. We don’t. Two things sit at the center of how Renvi operates.

Lab-verified quality

One lab. One standard.

Our biologics are sourced and processed by a single, dedicated U.S.-based laboratory partner. Nothing in the supply chain is anonymous.

21+ yrs
FDA-registered, U.S.-based lab
6 audits
Successful FDA inspections
14-day
Quarantine + NAT testing
500+
Clinics nationwide trust our lab partner
  • Triple-layer donor screening & characterized, quality-verified tissue
  • QR-code Certificate of Analysis released to documented spec
Regenerative Research Group
Our biologics partner

Renvi’s single laboratory partner is Regenerative Research Group (RRG) — an ethically-sourced, quality-verified biologics program. RRG supplies the biologic suite our independent providers may discuss with you.

EXM is a 361 HCT/P intended for homologous use, administered by intramuscular or intra-articular injection. EXO and EXS are research-grade biologic products. These statements have not been evaluated by the U.S. Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. Educational information only; not medical advice. All therapies are elective and should be discussed with a licensed medical provider. Results vary and are not guaranteed.

▶ VIDEO

An overview of the field, courtesy of Mayo Clinic. Renvi-specific lab footage coming soon.

— THE PROCESS —

From donor to recipient. Documented every step.

1
Source
Informed donor consent. Required testing in certified laboratories. Recovery in controlled environments under written protocols.
2
Process
Minimal manipulation under good tissue practice. Each lot tested and documented before release. Cold-chain integrity maintained throughout.
3
Deliver
Validated transport with continuous monitoring. Distributed only to vetted independently licensed providers in our network.

Why we made this choice.

One source.

Healthy, informed U.S. donors aged 18–25, with three-generation health screening and healthy, scheduled C-section births only — no smoking, alcohol, drugs, or vaping.

Real documentation.

100% chain of custody from donor to recipient, released with a Certificate of Analysis and full lot tracking on every batch.

Honest standards.

Processed in an FDA-registered, CLIA-certified, GMP/GTP-compliant U.S. lab — with no cell expansion (per 21 CFR Part 1271) and a 14-day quarantine plus full disease testing on every lot.

The U.S. standard we hold to

  • FDA-registered, CLIA-certified, GMP/GTP-compliant processing
  • Documented perinatal tissue with a full chain of custody — donor to recipient
  • Three-generation donor health screening; healthy, scheduled C-section births only
  • No in-vitro cell expansion, per 21 CFR Part 1271
  • Sterility and release testing on every lot, with a Certificate of Analysis

What we won’t accept

  • ×Anonymous or overseas sourcing with little traceability
  • ×Pooled material from multiple donors
  • ×Cell expansion not permitted in the U.S. without specific FDA licensing
  • ×Unverified cell counts and inconsistent or absent sterility testing

An educational comparison of sourcing and processing standards — not a statement about treatment outcomes.

For licensed providers.

Nurse practitioners, physicians, and clinics interested in distribution, lot specifications, or compliance documentation are welcome to reach out. Renvi works with clinicians who share our commitment to careful sourcing and patient-first practice.

Request information →

Renvi Health is a management services organization. Tissue products discussed are sourced from a single FDA-registered laboratory partner and are regulated as Section 361 HCT/Ps under 21 CFR Part 1271. They are not approved by the U.S. Food and Drug Administration to diagnose, treat, cure, mitigate, or prevent any disease. Information presented is educational. See our Disclaimer for the full statement.

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