Sisram Medical Ltd. received the clearance from the U.S. Food and Drug Administration ("FDA") on June 12, 2023 for marketing in the United States. The Device was granted a patent in the United States on November 29, 2022 (Patent No.: US 11511031). The Device is intended for the closed-loop processing of microfragment adipose tissue for re-injection in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a lipoplasty system.

It is also intended for use in the following surgical specialties while the transfer of harvested adipose tissue for aesthetic body contouring is desired: orthopedic surgery; arthroscopic surgery; neurosurgery; gastrointestinal and affiliated organ surgery; urological surgery; general surgery; gynecological surgery; thoracic surgery; laparoscopic surgery; and plastic and reconstructive surgery. As at the date of this announcement, the Company has received wide indications for the Device. The Company believes that FDA's clearance of the Device will further strengthen the Company's product portfolio and product competitiveness and will also solidifies the Company's position as one of the technology and market leaders in the global aesthetic market.