Viromed Medical AG has received approval in Turkey for its medical device ViroCAP® med, a cold plasma technology for treating open wounds and intraoperative use. The approval, announced via NEWMEDIAWIRE, comes earlier than expected—the company had anticipated a decision no sooner than February or March 2027—and represents a significant milestone in its international market development.
The timing matters because Viromed already holds binding minimum orders for 7,000 ViroCAP® derma/med devices through the end of 2028 for the Turkish market, with deliveries now able to proceed on the basis of the granted approval. The reimbursement process with Turkish health insurers is already running in parallel, which could further accelerate commercial adoption. Turkey is strategically important for Viromed, and the approval lays the foundation for broader market penetration.
ViroCAP® med is designed for professional use by qualified medical personnel, supporting contactless and mobile treatment of open wounds and intraoperative application of cold atmospheric plasma. Each application is planned to last one to two minutes while skin temperature remains below 40 degrees Celsius, making it suitable for clinical settings.
The approval also serves as a catalyst for Viromed's broader expansion strategy. Together with its partner Umeco, the company has initiated local approval procedures for ViroCAP® med in additional Asian countries. A prerequisite for these efforts was the product's prior approval as an MDR Class IIa medical device in the EU, which Viromed has now leveraged to pursue country-specific registrations with distribution partners.
Beyond Turkey, Viromed has achieved its first reimbursement of ViroCAP® by a statutory health insurer. A selective contract was concluded with a health insurer in Lower Saxony for an indication in intensive care: the treatment of patients with a left ventricular assist device (LVAD), focusing on preventing infections at the driveline exit site. The company is also in advanced discussions for further selective contracts with health insurers in three additional German federal states, signaling growing payer acceptance.
Further clinical evidence is expected to support these commercial efforts. In November, a successfully completed retrospective study on the prevention of postoperative wound infections will be published. Additionally, Viromed is starting a randomized study on the use of ViroCAP® in LVAD patients and a further study on the technology's use in the field of heart valves. These studies could strengthen the case for broader reimbursement and adoption.
Viromed Medical AG, listed on the stock exchange since October 2022, specializes in the development, manufacture, and distribution of medical products through its wholly owned subsidiary Viromed Medical GmbH. The company aims to further advance the use of cold plasma technology in medicine and realize corresponding growth potential. For more details, see the full release.
