Hogan Lovells counsels P-Cure in FDA market authorization of a new proton therapy device for cancer treatment
Washington, D.C., 10 April 2023 — Global law firm Hogan Lovells advised P-Cure, an Israeli med-tech company, in securing U.S. Food and Drug Administration (FDA) market clearance for a proton therapy system for targeted cancer treatment where the patient is treated in a seated position rather than the conventional proton therapy systems which rely upon supine positioning. The gantry-less system allows for imaging and treatment in the same position, ensuring that the noninvasive therapy is delivered to the targeted tumors.
The P-Cure proton therapy system is a single room treatment system with a smaller footprint that the conventional proton therapy systems which require 200 tons of proton equipment and most often exceed US$50 million per single room. The space and cost requirements of these other systems prevent access to the technology, with only 1% of hospitals providing proton therapy treatment. By securing FDA clearance, the company can deliver this long-awaited treatment modality to many more radiotherapy departments. Read more here.
The FDA clearance was granted 20 March. “We are honored to have assisted our client in this long-awaited development in the fight against cancer,” said Medical Device regulatory partner Jonathan Kahan, who is based in Washington, D.C. “We are pleased with the FDA’s decision to grant availability in the US of this innovative medical technology.”
Lina Kontos, another Hogan Lovells partner, stated, “The positioning of patient in a seated position puts patient care at the forefront of cancer treatment, allowing the patients to remain upright during their treatments at eye level with the healthcare professionals.”
The Hogan Lovells team for P-Cure was led by Medical Device regulatory partners Jonathan Kahan, Dr. John Smith, and Lina Kontos (all Washington).
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