News | Proton Therapy | April 03, 2023

P-Cure announced clearance of its Adaptive Proton Therapy Solution by the FDA for sales in the USA. P-Cure, an Israel-based high-med-tech company, has developed affordable proton therapy technology for targeted treatment of cancer with significantly reduced treatment related side effects

P-Cure announced clearance of its Adaptive Proton Therapy Solution by the FDA for sales in the USA

April 3, 2023 — P-Cure announced clearance of its Adaptive Proton Therapy Solution by the FDA for sales in the USA.

P-Cure, an Israel-based high-med-tech company, has developed affordable proton therapy technology for targeted treatment of cancer with significantly reduced treatment related side effects. Treatment of cancer with proton therapy is considered the gold standard for treating many types of cancer sites with unique clinical capabilities. However, current legacy technology requires 200 tons proton equipment, and with the cost exceeding $50 million per single room (equipment and construction) significantly limits establishment of proton therapy services at most cancer care facilities globally. Until today, only less than 1% of hospitals offer proton therapy to their patients. P-Cure managed to reduce the size and the cost of the proton therapy equipment, enabling establishment of this long-awaited treatment modality virtually in all radiotherapy departments. The P-Cure innovative upright solution is the world’s first FDA approved methodology for patient ready cancer treatment.

“P-Cure started by designing a patient-centric image guided adaptive positioning system, and has now expanded the offer by providing the most compact full proton therapy system that simulates, plans, positions and treats patients with enhanced patient comfort and clinical results, treating all indications with adaptive, personalized proton therapy protocols,” said CEO Michael Marash.

“The possibility to install proton therapy within existing linac treatment rooms opens up a unique marketing opportunity for P-Cure. This radiotherapy replacement market accounts for sales of approximately 1,000 radiation therapy modalities every year. We truly believe that this is a new era of radiation therapy, and a new opportunity for P-Cure to become a market leader in providing the most targeted modality to treat cancer with radiation. The P-Cure solution radically reduces the cost of installing a proton therapy system, eliminating large rotating gantries, allowing for faster installation, and reducing operational costs,” Marash adds.

The FDA clearance has been granted in parallel to announcing the clinical research initiation for the use of the system in treatments of patients in Israel. The company solution will be used by the clinical team of the Hadassah Medical Center under the leadership of Prof. Aron Popovtzer, the study principal investigator and the Head of Oncology Institute at Hadassah. The company collaboration with Hadassah is the first ever established initiative to provide access to Israeli patients to receive this focused treatment in the country saving enormous emotional and financial cost for patients, their families, and the national healthcare system. Until now, eligible Israeli patients have been urged to travel to Europe and the US for months spending at least $140,000 for a single treatment course.

“Uniquely, the Hadassah patients will be treated using a fully operational clinical facility within the P-Cure Clinical Development Center. The site is conveniently located between Tel Aviv and Jerusalem and hosts the world’s most compact proton therapy system, which is installed within the footprint of a standard radiotherapy linac vault. The site is established as a clinical platform of excellence to deliver and develop proton therapy protocols for patients as well as train existing and new customers. This training will enable fast technology adaptation by new treatment providers not familiar with proton therapy. The comprehensive site comprises a fully operational clinically designed proton treatment system, including a compact accelerator, a 360 o gantry-less treatment room, and access to all treatment and delivery planning – all within the space of existing linac vaults,” Marash said.

The company is supported by investors from the US, Canada, Israel and Hong Kong. Among the Israeli investors is Medipress Venture.

Prof. Joseph Press, the Medipress CEO, who previously headed the only Children Hospital in Israel, comments that “The P-Cure achievement shifts the use of Proton Therapy from marginal to mainstream clinical practice allowing virtually all radiotherapy departments to install the solution in existing treatment rooms.” Prof. Press adds that because of the P-Cure solution, the financial barriers are eliminated to adding the proton therapy treatment option at medical facilities world-wide.

The FDA clearance of the P-Cure system is another evidence of the unprecedented impact of Israel in the fight against cancer, saving lives and avoiding suffering for millions of patients in Israel and abroad.

“P-Cure is proud to become a member of the world-wide research community expanding the clinical benefits of proton therapy and demonstrating what is the most cost-effective system available to existing oncology centers,” said Marash.

For more information: www.p-cure.com


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