mPDEV for Dermatology Clinics in Chicago
Early-access waitlist for dermatology and aesthetic medicine clinics in Chicago, the Chicagoland area, and across Illinois. Same MISEV2023-aligned characterization and batch-specific Certificate of Analysis offered to Canadian clinics. FDA / MoCRA cosmetic facility registration and product listing are in progress; the waitlist secures supply for the launch window in your market.
How to evaluate an exosome skincare product for your clinic
Five criteria separate a characterized EV preparation from a label that uses the word "exosome" without backing it. None are optional. A defensible product answers all five.
- 01
Source and biogenesis
Confirm the EV source — plant, mammalian stem cell, platelet, or other — and that biogenesis (not just size) was demonstrated. Marker panel must include EV-associated proteins (CD9, CD63, CD81, TSG101, Alix where applicable) and the absence of contaminants.
- 02
Particle concentration
Concentration must be reported per mL on a batch-specific basis, measured by an orthogonal method (Nanoparticle Tracking Analysis is the field standard). Claims without a measured value belong in marketing copy, not a Certificate of Analysis.
- 03
Certificate of Analysis
Every shipment ships with a batch-specific CoA covering particle concentration, characterization method, marker panel, and contamination screen. Generic product sheets are not CoAs.
- 04
Isolation method and the biomolecular corona
Isolation method changes what is in the vial. Harsh methods strip the biomolecular corona; gentler methods preserve it. The corona is part of the active ingredient. Ask which isolation route the manufacturer uses and why.
- 05
Cold-chain integrity
EV preparations are biologically active and temperature-sensitive. Verify cold-chain handling from manufacturer to clinic, including transit excursion logging where the formulation requires it.
The long-form version of this framework, with source literature and worked examples, lives at How to evaluate an EV or exosome product before stocking it.
How US clinics join the early-access waitlist
Direct from BioThera's Ottawa facility to verified US dermatology, aesthetic medicine, and medspa partners once FDA / MoCRA alignment is complete. Same Certificate of Analysis and characterization standard offered to Canadian clinics. The waitlist secures supply for launch.
Step 1
Verify credentials
BioThera ships mPDEV directly to verified dermatology and aesthetic medicine practices. Submit your clinic credentials (regulatory license number, ordering physician, shipping address) through the contact form.
Step 2
Request a batch-specific CoA
Receive the active batch CoA before ordering. The CoA reports NTA particle concentration, EV marker panel, contamination screen, and MISEV2023 characterization disclosures.
Step 3
Confirm cold-chain logistics
Shipments leave Ottawa with cold-chain packaging suited to the destination. Confirm delivery windows, signature-on-receipt requirements, and storage conditions on intake.
Step 4
Place your initial order
Initial orders are sized to a single treatment cycle. Repeat orders run on a clinic-specific cadence agreed with the BioThera team. Pricing is disclosed to verified clinics; volume discounts apply.
Shipping mPDEV to Chicago clinics
Origin
Ottawa, Ontario
Shipped directly from the BioThera Solutions facility. No distributor handoff once the US launch window opens.
Transit (post-launch)
Cross-border, 3–5 business days post-launch
Cold-chain packaging sized to the destination. Signature on receipt available on request.
Quality
Batch-specific CoA
Every shipment includes the Certificate of Analysis for the batch in the box. MISEV2023 disclosures available on request.
Regulatory note — United States
mPDEV is a Health Canada-notified cosmetic. For the United States, BioThera is completing MoCRA cosmetic facility registration and product listing under the FDA's Modernization of Cosmetics Regulation Act of 2022. Direct supply to US clinics opens at the conclusion of that process. The waitlist reserves supply for early-access partners in your market.
Frédéric St-Denis-Bissonnette, PhD
Founder & CEO, BioThera Solutions. Named contributor, MISEV2023.
The evaluation framework on this page is the same one used inside BioThera's own characterization workflow. It is published openly so that clinicians can hold every EV product — including ours — to the same standard.
Join the US clinic waitlist
Verified US clinics on the waitlist receive batch CoA previews, MISEV2023 disclosures, and first allocation at the close of FDA / MoCRA alignment.