Needle-free assisted program — EV consumables matched to partner applicator hardware
Consumable matched to partner applicator hardware.
- Line Precision Microcrystal™ line fact-sheet
- Audience Professional & clinic
- Technology Injection
- Dosage form Injection & suspension
- Status Exploration
Where it fits
Professional & clinic program. Hardware-matched consumables for device partners.
Clinic-channel program: professional-use labeling, protocols and training included, scoped per practice. Evaluation samples on request while the protocol set is finalized.
Specifications
| Item | Value |
|---|---|
| Vial | Sterile single-use vial |
| EV concentration | 5–100 billion particles/mL tiers (configurable) |
| Administration | Professional use only, with protocol and training |
| Vesicle size (NTA) | 80–150 nm |
| QC panel | NTA, TEM, endotoxin (LAL), sterility / microbial limits; batch COA |
| Storage | Material line: −20 °C up to 60 days / −80 °C up to 360 days; finished goods per program |
| Compliance (material line) | FDA DMF Type II 044197 · INCI 41316 · China national standard (drafting) |
| Typical program | Pilot from 500 units · production from 2,000 units · standard lead 15 workdays |
Specifications are indicative pending batch COA release data; final values follow the batch COA and quotation.
What's included
- Sterile single-use vials
- Administration kit + protocol documents
- Cold-chain pack with temperature logging
How to use
- Administered by the clinic's trained staff only; the kit never ships for self-use
- Follow the protocol documents and operator training included in the kit
- Keep the cold chain intact; the pack ships with temperature logging
Quality & compliance
- Material chain — FDA DMF Type II 044197 and INCI 41316 on the EV material line; batch COAs travel with every shipment.
- Closed line — EV material produced on the fully enclosed 0.5–5 L micro-batch platform.
- Claim discipline — routine-and-experience wording only; efficacy references stay in internal observational files with journal citations.
About the Precision Microcrystal™ line
The Precision Microcrystal™ line covers guided-placement formats; this kit adapts the same characterized EV material into a home mesh-nebulizer session. The Precision Microcrystal™ line fact-sheet lists every dosage form, the characterization baseline and the filing status in one place; this page documents a single program from that line.
Start a pilot for Needle-free assisted program — EV consumables matched to partner applicator hardware.
Share your brand stage and target category, and we’ll return sample specs, an MOQ framework, and characterization samples (typical: sample kits in 3–5 days); to review the full-line design first, head to Knowledge · Solutions.