Somahlution Enrolls First Patient in DuraGraft Registry

Somahlution announces the first German patient enrolled in its DuraGraft European Registry clinical trial. The patient was treated by Dr. Prof. Herbert Vetter, chief physician at Helios Hospital Wuppertal. Patient enrollment has also begun at the Helios Heart Center Leipzig by Prof. Martin Misfeld, M.D., Ph.D. Somahlution is a global biotechnology company developing products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications. The registry will evaluate the company’s flagship product DuraGraft, a vascular graft treatment that significantly improves long-term clinical outcomes following Coronary Artery Bypass Grafting (CABG) surgery.
 
“DuraGraft provides a novel treatment option to improve graft patency and improve cardiac bypass surgery outcomes. We are thrilled to be the first center in Germany to enroll patients and utilize new technologies like DuraGraft to improve CABG surgery and patient outcomes,” said Vetter, the sites lead investigator.

The Helios Hospital Wuppertal is a leading hospital in Germany and a maximum care clinic with over 1,000 beds and the Helios Heart Center Leipzig is one of the largest heart centers worldwide.

“Initiation of the DuraGraft Registry marks an important milestone in the future of CABG surgery. Vein grafts have remained a concern, however we are now hopeful that DuraGraft will provide a new treatment option to better treat these conduits,” said Prof. Misfeld, deputy director of Helios Heart Center Leipzig.
 
Patients undergoing CABG only or CABG plus Valve surgery will be consented to participate in this registry. For these patients, baseline clinical and angiographic characteristics, as well as certain procedural and post-op clinical events will be recorded. Clinical outcomes will be assessed post CABG through hospitalization, at 30 days, and annually up to five years.
 
DuraGraft is the first commercial product based on the GALA technology platform licensed by Somahlution from the U.S. Department of Veterans Affairs. DuraGraft is a specially formulated vascular graft treatment to maintain structural and functional integrity of the vascular graft. DuraGraft maintains normal graft function and improves clinical outcomes by reducing the incidence of complications of graft failure. DuraGraft is CE Marked in Europe and available in other global markets for CABG and peripheral bypass indications, and is not yet commercially available in the United States.
 
Somahlution develops products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications. The company’s flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications associated with graft failure. DuraGraft enhances CABG outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.