Viromed Medical AG, a German medical technology company specializing in cold plasma technology, has announced that it has received approval in Turkey for its medical device ViroCAP® med (MDR Class IIa). The approval, reported via NEWMEDIAWIRE, allows the product to be used for medical applications in the Turkish market, particularly for the treatment of open wounds and intraoperative use. The timing is notable: the company had expected approval no earlier than February or March 2027, making this a significant acceleration of its international market development.
Uwe Perbandt, CEO of Viromed Medical AG, called the approval “a significant success” and “another important milestone for the commercial launch of our ViroCAP® technology in a healthcare market that is strategically important for us.” The approval follows the earlier registration of ViroCAP® derma with Turkey’s National Medical Device Tracking System (ÜTS) in the summer, signaling steady progress in the region.
The commercial implications are immediate. 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 on the basis of the granted approval. In parallel, the process for reimbursement by Turkish health insurers is already running, which is critical for widespread adoption. This approval not only validates the company’s regulatory strategy but also 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 as well as 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. These features make the technology suitable for clinical settings where efficiency and patient comfort are paramount.
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 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 these are being pursued together with distribution partners. This suggests a broader international rollout is underway, leveraging the EU approval as a foundation.
In Germany, 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. This reimbursement milestone is significant because it provides a pathway for public funding of the technology, which could accelerate adoption in the German healthcare system.
Further clinical evidence is expected soon. 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. These studies could strengthen the clinical basis for ViroCAP® and support broader acceptance among medical professionals and payers.
For a company listed on the stock exchange since October 2022, these developments represent tangible progress in commercializing its cold plasma technology. With approvals, orders, reimbursement contracts, and ongoing studies, Viromed is positioning itself to expand its footprint in both established and emerging markets. More details can be found in the original release on www.newmediawire.com.
