India Regulators OK ZAP-X Gyroscopic Radiosurgery Platform

ZAP Surgical Systems Inc. has received regulatory approval in India for its first ZAP-X Gyroscopic Radiosurgery platform in the form of a No Objection Certificate (NOC) from the Atomic Energy Regulatory Board (AERB).
 
With NOC approval in India, ZAP is one step closer to bringing the benefits of SRS to a broader worldwide population of patients. Consequently, the company has opened a ZAP office in Gurgaon, India, to oversee further market penetration and commercialization of its radiosurgery system.

Radiosurgery, also commonly referred to as SRS, is well-recognized as a non-invasive alternative to surgery for effectively treating many brain tumors, including brain metastases and functional disease. Unique from surgery, however, radiosurgical procedures require no incision, are painless, and patients often immediately return to normal activities.
 
“At ZAP, our mission is to expand SRS access to millions of potential patients who currently lack access throughout the world,” said Saloni Singh, Country Head of India at ZAP Surgical. “By reducing the costs and complexities of prior delivery technologies, ZAP-X is enabling broader adoption of such technology and is primed to make a significant impact on patient care in India.”
 
The ZAP-X system is the latest advance in stereotactic radiosurgery in nearly half a century. Unlike historical technologies, ZAP introduced the concept of vault-free SRS, which eliminates the need for costly radiation-proof treatment bunkers. Additionally, by removing the need to host volatile live radioactive isotopes, ZAP-X removes the effort and expense associated with continued source decay, recurring replacement, as well as regulatory licensing and source security.
 
“By introducing innovations such as self-shielding and a modern linear accelerator, ZAP-X has removed many of the financial and logistical constraints that previously prohibited centers from acquiring SRS technology,” said Ahmed Salem, IMEA Regional Business Director at ZAP Surgical. “Where state-of-the-art SRS has historically been concentrated primarily amongst the most well-funded, urban academic hospitals, ZAP-X now makes SRS also feasible in suburban and rural settings, thus bringing potentially life-saving care to previously underserved populations.”
 
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 serving as CEO, Adler is Emeritus Dorothy & TK Chan Professor of Neurosurgery and Radiation Oncology at Stanford University. Adler is also 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.