An acellular tissue-engineered vessel (artificial blood vessel) used for surgeries on patients facing the risk of limb amputation due to trauma from traffic accidents, workplace injuries, and wars has been approved for commercialization in the United States, making it the world's first of its kind. This approval is expected to be a significant milestone in the field of regenerative medicine.
According to the Korea Bio Association on the 24th, the acellular tissue-engineered vessel 'Simbess,' developed by the U.S. life science company Humacyte, was approved by the U.S. Food and Drug Administration (FDA) on the 20th (local time).
Simbess is a disposable product used for transplantation to replace the patient's blood vessels. It is made up of human extracellular matrix (ECM) proteins, utilizing smooth muscle cells derived from human aortic tissue. The FDA stated, "Treatment methods for vascular trauma have been limited, and this decision to approve a new technology will be a significant advancement in addressing unmet medical needs."
Vascular trauma caused by arterial rupture can lead to severe complications, including bleeding and blood clotting, resulting in a crisis that may necessitate limb amputation. The FDA has granted approval for the use of Simbess in adult patients deemed unsuitable for autologous vein grafts during vascular reconstruction (restoration of blood flow) to avoid imminent limb loss.
According to Humacyte, Simbess has been used in clinical trials to treat injuries from automobile accidents, shootings, and industrial accidents. It has also been used in frontline hospitals in war-torn Ukraine. Previously, the Ministry of National Defense had designated it as a priority product.