ZAP Surgical’s Gyroscopic Radiosurgery Platform Receives Japanese Shonin Approval
ZAP Surgical Systems, Inc. today announced it has received Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its ZAP-X® Gyroscopic Radiosurgery® platform. As part of the approval, ZAP-X is now cleared for clinical use in Japan.
To facilitate a robust market introduction effort, ZAP also announced a partnership with MC Medical Inc. to lead Japanese sales and marketing initiatives. Joining the effort, a partnership with Chiyoda Technol Corporation has also been established to provide Japanese technical services and also act as a sub-dealer to MC Medical Inc. for product sales.
“We are very excited to partner with ZAP Surgical Systems,” explains Shinya Taniguchi, CEO of MC Medical. “With our shared vision for advancing the field of radiosurgery for the brain, we are looking forward to introducing the globally recognized ZAP-X in Japan.”
“ZAP-X is a breakthrough device that provides the highest quality of care,” said Toshikazu Hosoda, CEO of Chiyoda Technol Corporation. “Combined with the utmost consideration for safety, including one-of-a-kind innovations such as real-time dose monitoring, we are extremely pleased to partner with ZAP.”
Stereotactic radiosurgery (SRS) is a well-studied and effective treatment for many brain cancers including primary and metastatic brain tumors. Considered an alternative to surgery for select indications, SRS is a non-invasive outpatient procedure that often provides equivalent outcomes, yet no surgical incision, and little to no recovery period.
To generate the radiation necessary for SRS, ZAP-X uses a modern linear accelerator to eliminate the historical use of Cobalt-60 and the related costs and challenges of handling live radioactive isotopes. The ZAP-X system is also acclaimed for incorporating a unique vault-free design that typically eliminates the need for costly shielded radiation treatment rooms.
“Japan has always been at the forefront of the most modern, most innovative radiosurgical thinking,” said Dr. John Adler, CEO of ZAP Surgical Systems, and professor emeritus of neurosurgery and radiation oncology at Stanford University. “Now with ZAP-X, that tradition will certainly continue.”
As part of the upcoming Japan Neurosurgical Society 79th Annual Scientific Meeting, Dr. Adler will present a ZAP-X system introduction via webcast on October 15. For more information about JNS 2020, please visit: http://jns2020.jp/.
For additional information about the ZAP-X, please visit: https://zapsurgical.com/. Detailed system overview animations can be found at https://youtu.be/9ph-cdb5QO0 (English) or https://youtu.be/B6esYyYBWfQ (Japanese).
About ZAP Surgical Systems, Inc.
ZAP Surgical Systems, Inc. designs and manufactures the ZAP-X® Gyroscopic Radiosurgery™ platform. ZAP was founded in 2014 by John R. Adler, MD, professor emeritus of neurosurgery and radiation oncology at Stanford University, and founder & CEO of ZAP Surgical Systems. Dr. Adler is also the inventor of the CyberKnife® and founder of Accuray, Inc. FDA-cleared in September 2017, ZAP-X utilizes a modern linear accelerator to eliminate the historical use of Cobalt-60 and the related costs and challenges of handling live radioactive isotopes. ZAP-X also incorporates a unique vault-free design that typically eliminates the need for costly shielded treatment rooms. Learn more at http://www.zapsurgical.com.
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