Viromed Medical AG, a German medical technology company specializing in cold plasma technology, has received approval in Turkey for its ViroCAP® med device, the company announced. The approval, granted as an MDR Class IIa medical device, allows the product to be used for medical applications in the Turkish market, particularly for the treatment of open wounds and intraoperative use.
The approval arrived earlier than expected. Uwe Perbandt, CEO of Viromed Medical AG, stated that the company had anticipated approval no earlier than February or March 2027, following the summer registration of ViroCAP® derma with Turkey’s National Medical Device Tracking System (ÜTS). “The approval of ViroCAP® med in Turkey is a significant success for our international market development,” Perbandt said, calling it another important milestone for the commercial launch of ViroCAP® technology in a strategically important healthcare market.
Viromed already holds binding minimum orders for 7,000 ViroCAP® derma/med devices through the end of 2028 for the Turkish market, and deliveries will now proceed based on the granted approval. In parallel, the process for reimbursement by Turkish health insurers is already underway. The approval is part of Viromed’s broader international expansion strategy and lays the foundation for further development of the Turkish market.
ViroCAP® med is designed for professional use by qualified medical personnel and supports the treatment of open wounds and intraoperative use of cold atmospheric plasma. The application is contactless and mobile, with each session planned to last one to two minutes while skin temperature remains below 40 degrees Celsius.
Beyond Turkey, Viromed and its partner Umeco have initiated approval processes 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. Outside the EU, local approval in each target country is required and is being pursued with distribution partners.
Viromed also reported 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 in advanced discussions for further selective contracts with health insurers in three additional German federal states.
Further clinical evidence is expected. In November, a successfully completed retrospective study on the prevention of postoperative wound infections will be published. Viromed is also starting a randomized study on the use of ViroCAP® in LVAD patients and a further study on the technology’s use in heart valves. More information is available through the original release and at www.viromed-medical-ag.de.
