What happened
Shares of Nano-X Imaging (NNOX -3.18%), commonly called Nanox, soared on Wednesday after it revealed it's taken the next step toward commercializing its flagship medical device. As of 12:20 p.m. ET, Nanox stock was up 21%.
So what
Nanox had its initial public offering (IPO) in 2020, promising to disrupt the X-ray industry with its digital-3D imaging machines that will be cheaper for doctors to use. Nanox received clearance from the U.S. Food and Drug Administration (FDA) in April 2021 for the single-source version of its medical device. However, the device it intends to commercialize is its multisource Nanox.ARC. And progress with the FDA for the multisource machine has been slow.
Shortly after receiving FDA approval for its single-source machine, Nanox submitted paperwork for its multisource device. However, it subsequently withdrew its application so it could submit a Q-Submission form, which allows it to dialogue with the FDA to better understand its concerns.
In August, Nanox's management said that its next step was to resubmit its application for FDA approval for its multisource Nanox.ARC. And today, the market is celebrating that it finally did it. According to today's filing with the Securities and Exchange Commission (SEC), Nanox submitted its paperwork to the FDA on Sept. 26.
Now what
By submitting paperwork, Nanox is indirectly saying that it believes it's addressed the FDA's concerns and will likely gain approval. That's why the stock is up so dramatically today.
However, it's important to temper expectations. The FDA could still reject the application. And even an approval could take time.
Moreover, gaining FDA approval is just one crucial part of a complex, multiphase journey for Nanox. Assuming its multisource machine is FDA approved, it still needs to rise to the occasion regarding manufacturing and selling. So while today's an important day for Nanox investors, there will be plenty of important days in the future for this to be a long-term winning investment.
