For Partners
re:H™ SSCM — Selective Smart Control Microneedle
1. What is re:H™?
re:H™ is a “positive/negative‑pressure” microneedle platform developed by Curiosis, South Korea.
It employs SSCM™ technology, which regulates both air pressure (vacuum ±) and needle depth in real time:
1. A brief negative pressure “lifts” the skin surface.
2. A controlled positive pressure then “pushes” the drug or skin‑booster precisely into the targeted dermal layer.
The result is lower leakage, bruising, and pain compared with conventional microneedling.
2. Core Architecture & Key Specifications
| Component | Details |
|---|---|
| Balloon Tip™ | 13‑pin disposable cartridge; adjustable depth 0.235 – 4.0 mm. Integrated “balloon” regulates pressure for even drug delivery. |
| Blow Tip™ / Stacking Mode | Optional tips for small/large areas or multi‑layer injections. |
| Output Power | 180 VA – ensures consistent needle propulsion. |
| System Size / Weight | 510 (W) × 550 (D) × 1200 (H) mm; 60 kg – movable within a clinic. |
| Regulatory Status | Korean patent KR 10‑2604909; registered as a medical device with KFDA. |
3. Clinical Advantages
- Precise dosing – Depth and volume are controlled via real‑time sensors and pressure feedback.
- Reduced pain & downtime – Vacuum secures tissue, minimizing sub‑dermal bleeding; topical anaesthetic time is shorter.
- Lower contamination risk – Single‑use cartridges.
- Versatility – Compatible with multiple actives (HA, PDRN, exosomes, hair‑growth cocktails, etc.) and a built‑in “Hydro Toning” mode.
4. Limitations & Points to Consider
| Issue | Explanation |
|---|---|
| Evidence base | Mostly case reports and user experience from Korea/Hong Kong; few peer‑reviewed RCTs published. |
| US/EU approvals | No FDA 510(k) yet; CE‑MDR filing in progress. Western‑market rollout will require additional regulatory lead‑time. |
| Cost | Premium‑tier device (≈ USD 25 – 35 k). Per‑procedure cost varies with tip and solution usage. |
| Operator learning curve | Staff must master pressure/depth calibration; improper settings can cause over‑delivery or bruising. |
5. Ideal Clinic / Business Profiles
- Dermatology or aesthetic centers where skin‑booster therapy is a flagship service and fast turnover is critical.
- Hair‑transplant / scalp‑mesotherapy units requiring dense, multi‑point injections.
- Asia‑Pacific operators not immediately constrained by FDA requirements.
6. Strategic Recommendations Before Purchase
1. Request additional clinical data – White papers, pre/post photos, ≥ 3‑month safety outcomes, patient‑reported pain scores.
2. Run an ROI simulation – Compare needle‑tip + solution cost per session against course pricing; focus on net profit per physician hour.
3. Train the team – Emphasize depth/pressure calibration for different facial zones and scalp.
4. Audit after‑sales support – Parts availability, expected downtime, hotline responsiveness, warranty terms.