The new Sealed Source and Device (SSD) approval enables the commencement of clinical trials in leading hospitals across the U.S. with the company’s breakthrough cancer treatment, Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy).
Boston, MA, August 21st 2018 -- Israel MedTech startup, Alpha Tau Medical, is proud to announce that the Massachusetts Radiation Control Program (RCP), under agreement with the U.S. Nuclear Regulatory Commission (NRC), approved the company’s treatment, the Alpha DaRT, as a Sealed Source and Device (SSD). The new approval enables the initiation of clinical trials in leading cancer centers across the U.S which are interested in investigating the Alpha DaRT as a treatment for various types of solid tumors.
Developed by Prof. Yona Keisari from the Faculty of Medicine and Prof. Itzhak Kelson from the Physics Department at the Tel Aviv University, Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy) enables the first alpha-radiation-based cancer treatment for various types of solid tumors.
Alpha DaRT delivers high-precision alpha radiation, that is released when radioactive substances decay inside the tumor. The short-range alpha particles effectively kill the cancer cells while sparing the surrounding healthy tissue. Preliminary clinical results showed that Alpha DaRT is safe and effective for treating squamous cell carcinoma tumors, with all patients’ tumor sizes reducing and more than 70% of patients’ tumors completely disappearing within few days after treatment.
“With promising early clinical results demonstrated in Europe and Israel, we are delighted to achieve this final milestone SSD approval, and to enable hospitals throughout the U.S. to benefit from the Alpha DaRT treatment in their clinical trials,” said Uzi Sofer, CEO Alpha Tau Medical.
Mr. Sofer further explained that clinical trials will investigate Alpha DaRT as a treatment for cancer using different protocols across a variety of indications, including:
Head and neck cancer
“The high potency and targeted activity of alpha radiation to kill cancer cells has been known for some time in the medical community. The SSD certificate confirms the safety of the innovative Alpha DaRT technology and gives the go-ahead for hospitals throughout the U.S. to investigate its treatment benefit for solid tumors,” said John J. Munro III, PhD, Alpha Tau Radiation Safety Office.
The company is currently establishing a new production facility in the United States to meet the high demand anticipated for the Alpha DaRT cancer treatment. Alpha Tau’s Chief Operations Officer, Amnon Gat, will head the US operations.
About Alpha Tau Medical
Founded in 2016, MedTech startup Alpha Tau Medical is focusing on R&D and commercialization of its breakthrough cancer treatment, Alpha DaRT, originally invented in 2003 by Prof. Itzhak Kelson from the Physics Department and Prof. Yona Keisari from the Faculty of Medicine at Tel Aviv University. The company collaborates with key cancer physicians and researchers worldwide to investigate the Alpha DaRT as a treatment for various indications.
+1 (617) 435 6552