ZAP Surgical Receives National Medical Products Administration (NMPA) Approval in China

2023-06-29 15:48

SAN CARLOS, Calif.--(BUSINESS WIRE)--Jun 29, 2023--

ZAP Surgical Systems, Inc., a leading innovator in the field of surgical robotics, today announced that the company received National Medical Products Administration (NMPA) approval in China for its ZAP-X® Gyroscopic Radiosurgery® platform.

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ZAP-X® Gyroscopic Radiosurgery® platform. ZAP-X treatment suite image courtesy of European Radiosurgery Center Munich. (Photo: Business Wire)

ZAP-X was previously granted NMPA’s Chinese Medical Device Evaluation (CMDE) Green Pathway, an accelerated path for the examination and approval of innovative medical devices. As part of the priority review, a pre-approval clinical study was completed at PLA General Hospital 301 (PLAGH 301) in Beijing, China, which confirmed the overall patient safety and treatment efficacy of ZAP-X. PLAGH 301 is the largest hospital in China with more than 20,000 outpatient treatments per day.

“Following an intensive, multi-year effort we’re incredibly excited that the ZAP-X has finally received its regulatory approval in China,” said Dr. John R. Adler, Stanford Professor of Neurosurgery and Founder & Chief Executive Officer of ZAP Surgical Systems. “In time, China will become ZAP’s largest single market, which will benefit millions of Chinese brain cancer patients.”

With its ground-breaking design, the ZAP-X system uses unique gyroscopic mobility to direct radiosurgical beams from hundreds of unique angles to precisely concentrate radiation on the tumor target. This pioneering approach supports the clinical objective of protecting healthy brain tissue and preserving patient cognitive function.

The vault-free, cobalt-free ZAP-X is also renowned for eliminating the expense of building costly shielded radiation treatment rooms, and removing the need to maintain, secure and regularly replace live radioactive isotopes for radiation beam production.

About ZAP Surgical Systems, Inc.

ZAP Surgical Systems, Inc. designs and manufactures the ZAP-X® Gyroscopic Radiosurgery® platform. ZAP was founded in 2014 by Dr. John R. Adler. In addition to being CEO of ZAP, Dr. Adler is Emeritus Dorothy & TK Chan Professor of Neurosurgery and Radiation Oncology at Stanford University. Dr. Adler is also renowned as the inventor of the CyberKnife ® system and founder of Accuray, Inc. The ZAP-X platform incorporates a unique vault-free design that typically eliminates the need for costly shielded treatment rooms. ZAP-X also utilizes a modern linear accelerator to eliminate legacy use of Cobalt-60. Learn more at ZAP Surgical and follow us on LinkedIn and Twitter.

View source version on businesswire.com:https://www.businesswire.com/news/home/20230627623673/en/

CONTACT: Mark Arnold, ZAP Surgical Systems, Inc.

Senior Vice President, Marketing

+1 650 492 7797, ext. 101

Email:info@zapsurgical.com

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: ROBOTICS MEDICAL SUPPLIES HEALTH TECHNOLOGY SURGERY RADIOLOGY

SOURCE: ZAP Surgical Systems, Inc.

PUB: 06/29/2023 03:49 AM/DISC: 06/29/2023 03:46 AM

http://www.businesswire.com/news/home/20230627623673/en