Device-based intervention and clinical site for clinical trials

ETER-MED Sp. z o.o. combines a medical device developer with an affiliated healthcare provider, allowing us to contribute both the intervention and the clinical setting in which it is evaluated.

The opportunity encompasses:

1. The intervention. An ozone-based device platform for hard-to-heal diabetic foot ulcers: ozonated-water hydrosurgical debridement using an SL-DBD plasma electrode, semi-automated ozone autohemotherapy, and ozonide-based topical actives. Current maturity: TRL 5

2. Clinical site and patient recruitment. Recruitment of diabetic foot syndrome patients through our affiliated outpatient and wound care services in Gdańsk.

3. Trial conduct. On-site data collection including patient-reported outcome measures, and preparation of documentation for the bioethics committee and the Polish competent authority (URPL).

4. Regulatory pathway. EU MDR 2017/745 strategy for a Class IIb device, clinical investigation design under ISO 14155, risk management and biocompatibility.

5. Exploitation. As an SME we bring IP, CE-marking and route-to-market planning — the commercial exploitation route this topic explicitly encourages.

Poland adds a Central and Eastern European health system with a high diabetes burden to multi-country consortia.

We are looking for: a coordinator and clinical lead with a mature trial protocol, additional trial sites, and partners covering health-economic/RWD analysis and SSH.