Galmed Pharmaceuticals Ltd. (EOCN), identified in the release as Eocene Ltd., said its wholly owned subsidiary Colospan Ltd. entered its first European commercial distribution agreement for CG-100 with Hospital Line SA. Hospital Line received exclusive rights to market, sell and distribute the device in Greece and Cyprus. The agreement includes mutually agreed commercial targets and currently covers CG-100 only; additional Colospan products may be added as they become commercially available.
The planned launch in Greece and Cyprus is expected to proceed alongside Colospan’s ongoing U.S. pivotal study, and Colospan said it plans to launch CG-100 at the upcoming 17th Hellenic-Cypriot Surgical Conference. CG-100 is described as an intraluminal bypass device intended to protect colorectal anastomoses and reduce the need for diverting stomas. It has FDA Breakthrough Device Designation, is CE marked under the European Union Medical Device Regulation and is approved for investigational use in the United States under an FDA-approved IDE; it is not approved for commercial use in the United States.