ExoBreath™ — single-dose EV nebulization solution + patented mesh device
ExoBreath™ is TONGNIAN's inhaled line: a single-dose EV nebulization solution paired with a patented portable mesh device, built for brands running respiratory-wellness and mucosal-comfort programs. The EV solution is filled and sealed on the fully enclosed 0.5–5 L micro-batch line; every batch ships with a COA and a characterization summary, and the device carries its own certification file per destination market.
Who this line serves
- late-night professionals (30–40) — an evening breathe-reset ritual for dry, air-conditioned, high-exposure urban routines.
- recovery-program retail (35–55) — comfort-focused programs alongside humidifier and nasal-care devices.
- Silver-age respiratory care (60+) — gentle mist rituals positioned within healthy-aging routines.
- Device + consumable partners — hardware partners license the device; brands run the refill-vial program under their own label (OBM-ready).
Line programs
| Program | Population | Dosage form | Status |
|---|---|---|---|
| Breathe Reset Set (device + 6 vials) | Urban professionals | 5 mL single-dose vials + mesh device | Pilot-ready (sample kit 3–5 days) |
| Refill packs 6 / 12 / 30 | Urban professionals · recovery retail | Single-dose sealed vials | Subscription refill consumable |
| Silver-age comfort program | 60+ routines | Gentle-mist single-dose vials | Program design stage |
What this line does
- Fine, low-noise mist — mesh nebulization tuned for a comfortable ten-minute reset ritual.
- Sealed single doses — each vial opened once in-device; no storage worry between sessions.
- Consumable model — the device sells once; vial refills recur on the same characterization baseline.
- Documented batches — batch COA with every shipment; extended panels available per channel requirement.
Specs & characterization
| Item | Value |
|---|---|
| Nebulizer | Portable mesh, low-noise, USB-C rechargeable (patented mechanism; sample styling) |
| Vial format | 5 mL single-dose sealed EV solution (sample) |
| EV concentration | 2 billion particles per mL (sample tier; 5–100 billion configurable on the material line) |
| Vesicle size (NTA) | 80–150 nm (sample) |
| QC panel | NTA, TEM, endotoxin (LAL), sterility, microbial limits; batch COA |
| Storage | Vials 2–8 °C light-protected (sample); raw material line: −20 °C up to 60 days, −80 °C up to 360 days |
| Shipping | Insulated cold chain; dry ice option for long-haul |
| Compliance status | EV material line: FDA DMF Type II 044197 · INCI 41316; device: certification route per market |
| Typical program | Pilot from 500 sets · production from 2,000 sets · standard lead 15 workdays |
Quality & compliance
- Material chain — DMF Type II 044197 and INCI 41316 on the EV material line; batch COAs travel with every shipment.
- Device chain — patented nebulizer mechanism; device certification routed per destination market (FCC in the US, CE in the EU, local equivalent elsewhere).
- Closed filling — vials filled and sealed on the fully enclosed micro-batch platform.
- Claim discipline — wellness-routine positioning only; no respiratory therapeutic claims.
Literature anchor (internal reference): nebulized extracellular-vesicle administration is currently in registered clinical investigation for lung conditions (ClinicalTrials.gov NCT07515066). Referenced as administration-route background — not a product claim.
Work with this line: share your brand stage and target channel via Request a quote, or review the OBM program for device + refill co-development.
Customize ExoBreath™ dosage forms and skin feel for your brand.
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.