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Particle count claims: how to read them

How clinic buyers should interpret particle-count claims on exosome products.

Reviewed 2026-10-27

Analytical figures are not outcomes

Particle counts and growth-factor panels, when listed, are analytical. They are not proof of clinical performance.

Compare how each supplier ties figures to lots before comparing magnitudes.

Method matters

Ask about measurement method, dilution, and whether the number is lot-specific.

Brochure-only numbers are weak evidence for purchasing decisions.

Compare methods before magnitudes

List each candidate SKU by tissue type, presentation, storage class, and stated analytical fields. Ignore superlatives and disease-oriented marketing when building the shortlist.

Prefer suppliers that answer with documents over suppliers that answer with testimonials.

Operational checklist for exosome particle count claims

Before ordering under the topic exosome particle count claims, confirm storage class, receiving owner, and which documents will be required at release.

Close open items in writing. Do not infer missing COA fields from a different lot or SKU.

FAQ

Frequently asked questions

Does an analytical figure prove clinical performance?+

No. Analytical figures characterize a lot; they are not clinical endpoints.

Should we call these stem cell products?+

No. Precision Biologics does not market these items as stem cell therapies.

Can literature replace a COA?+

No. File literature separately from lot evidence.

Does this page determine how we may use products discussed under exosome particle count claims?+

No. Intended use remains with the ordering physician and clinic counsel.

Sources

  1. FDA Public Safety Notification on Exosome Products ↗FDA
  2. FDA: Minimal Manipulation and Homologous Use guidance ↗FDA