Nanox, an Israeli startup that has developed what it says is the first fundamental change in X-ray technology since its invention in 1895, said Friday that it had received U.S. Food and Drug Administration approval for its first product, the Nanox.ARC.
Compact and lighter than conventional X-ray machines, the Nanox.ARC generates 3D images, emits less radiation and costs a fraction of the price of conventional imaging devices. Based on technology originally developed by Japan’s Sony, it uses a proprietary silicon chip embedded with 100 million nanocones that generate X-rays. Alone, each chip produces very little light, but together they produce a stable X-ray source.
The FDA granted 510(k) clearance for its single-source Nanox.ARC. The company expects to get the same approval for its multisource Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multisource Nanox.ARC will be the company’s commercial imaging system that it expects to deploy broadly across the globe.
“We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024,” CEO and Chairman Ran Poliakine, said.
The device promises to change the way medical imaging is used and make it much more widely available by cutting the cost, which today averages $300 a session.
“We believe we are well-positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited or no meaningful access to imaging or the preventative screening that it offers,” Poliakine said.
The company went public last August in the United States in a $190 million initial public offering at $18 a share. Its shares soared in its first two weeks of trading, only to tumble when short sellers discounted the importance of its technology. It raised another $193 million in February at $62.50 a share. Nanox shares traded down 0.3% Friday at $41.33, before the FDA announcement was made, giving it a market cap of $1.9 billion.