Viromed Medical AG, a German medical technology company specializing in cold plasma technology, has received approval in Turkey for its medical device ViroCAP® med (MDR Class IIa), the company announced. The product is now approved for medical applications on the Turkish market, particularly for the treatment of open wounds and intraoperative use. The approval comes earlier than expected, as the company had anticipated it no earlier than February or March 2027.
Uwe Perbandt, CEO of Viromed Medical AG, said the approval is a significant success for the company's international market development. He noted that following the registration of ViroCAP® derma with Turkey's National Medical Device Tracking System (ÜTS) in the summer, the approval for ViroCAP® med marks another important milestone for the commercial launch of the ViroCAP® technology in a strategically important healthcare market. The company already holds binding minimum orders for 7,000 ViroCAP® derma/med devices through the end of 2028 for the Turkish market, with deliveries to be made based on the approval now granted. The process for reimbursement by Turkish health insurers is already running in parallel.
ViroCAP® med is designed for professional use by qualified medical personnel and supports the treatment of open wounds as well as intraoperative use of cold atmospheric plasma. The application is contactless and mobile, with each application planned to last one to two minutes while skin temperature remains below 40 degrees Celsius.
In parallel, Viromed and its partner Umeco have started the approval process for ViroCAP® med in additional Asian countries. A prerequisite was the prior approval of the product 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 together with distribution partners.
Viromed also 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 the intensive care area: 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.
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 as well as a further study on the use of the technology in the field of heart valves.
The approval and commercial progress matter because they signal tangible traction for Viromed's cold plasma platform beyond its core DACH market. The Turkish orders provide near-term revenue visibility, while the first statutory reimbursement in Germany—even under a selective contract—establishes a payment pathway that could be replicated in other German states and indications. The announced studies may generate clinical evidence to support broader adoption. For readers and the medical technology industry, the developments illustrate how EU MDR certification can serve as a springboard for country-by-country approvals and reimbursement negotiations. Viromed, listed on the stock exchange since October 2022, distributes its cold plasma technology through wholly owned subsidiary Viromed Medical GmbH. Further details are available via www.viromed-medical-ag.de and the www.newmediawire.com release.
