ZAP Surgical Systems, Inc. today announced that the company 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).
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.
With NOC approval in India, ZAP is one step closer to bringing the benefits of SRS to a broader worldwide population of patients. To this end, the company has opened a ZAP office located in Gurgaon, India to oversee the further market penetration and commercialization of its novel radiosurgery system.
“At ZAP, our mission is to expand world-class SRS access to the 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 all historical technologies, ZAP introduced the concept of vault-free SRS which eliminates the need for costly radiation-proof treatment bunkers. Additionally, by removing the historical 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 leading-edge 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.”
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