Build your CMF business with us.
We are building a global network of exclusive distribution partners for the Additive Manufacturing Patient-Matched Skull Reconstruction System. If you have a strong neurosurgery channel in your market, we want to talk to you.
The world's first Class III validated PSI platform.
Class III product
NMPA approved, CE-MDR in progress, FDA 510(k) scoping. The only patient-matched cranial implant validated by a large-cohort prospective clinical study.
Strong economics
Attractive distributor margins with no local manufacturing investment. The unit economics work for both price-sensitive and premium markets.
Marketing support
Co-marketing budget, KOL engagement support, congress presence, digital marketing tools, and clinical evidence dossiers.
Training & certification
Surgeon training programme, sales team certification, online learning platform, and certified surgeon-engineer MEI workflow support.
Service & logistics
Direct factory-to-hospital logistics. 5–7 working day lead time. ±10% backup implant. Quality system support.
Regulatory partnership
Joint regulatory strategy. We provide the documentation, you provide the local regulatory expertise.
Who we're looking for.
Established neurosurgery channel
You have a sales team calling on neurosurgeons today, with a track record of winning tenders in CMF, spinal, or other neurosurgical device categories.
Quality system maturity
ISO 13485 certified (or equivalent). GDP experience. A working knowledge of Class III device handling, storage, and distribution.
Capital & commitment
Working capital for 6–12 months of inventory. Long-term commitment to the partnership — this is a multi-year, multi-product relationship.
Clinical relationships
Access to KOLs in your market. Willingness to co-invest in KOL engagement, training, and clinical studies.
From first contact to first shipment.
Initial discussion
30-minute call to understand your market and capabilities
NDA & due diligence
Mutual NDA, financial / regulatory review
Commercial terms
Territory, pricing, marketing commitments
Quality & regulatory
Quality agreement, local registration planning
First shipment
Training complete, marketing plan live, first order shipped
Apply to become a distributor.
Send us your company profile, target market, and current neurosurgery portfolio. We'll get back to you within a week.