Nanox has had a blockbuster year so far: After snagging FDA clearance in the spring for its single-source digital X-ray bed and making plans to begin the machine’s commercial rollout by the end of 2021, the company proceeded to submit the multisource version of the bed for regulatory clearance and, just this month, made a deal to add disease-spotting artificial intelligence software to its digital imaging platform.
But it’s not all smooth sailing for the “biobed” developer. According to forms (PDF) filed with the SEC this week, the FDA has temporarily paused its review of the multisource Nanox.ARC while it waits for Nanox to provide additional information about the X-ray bed.
The Nanox.ARC differs from traditional X-ray beds with its reliance on “cold cathode” hardware rather than heated filaments to power the imaging technology, a change Nanox says makes its offerings more affordable and accessible.
The company didn’t offer up specifics about the FDA’s concerns but noted in the filing that the agency had provided on Aug. 12 a “list of deficiencies” that arose from the device’s 510(k) filing submitted in June. Nanox will have 180 days to respond to those concerns, a deadline it said it intends to meet.
In the meantime, Nanox said it will continue to develop its technology and may even submit a separate regulatory application for an upgraded version of the multisource machine by the end of this year, aided by the FDA’s feedback about the version currently under review.
After the forms were filed with the SEC, Nanox saw its stock price drop to a low of $21.39 on Thursday, nearly 10% below Wednesday’s closing price of $23.68. As of Friday, however, shares had slowly but surely begun to rise, hovering around the $22.30 mark throughout the morning.
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The regulatory roadblock likely won’t hold Nanox back for too long. The Israeli company faced a similar situation regarding the 510(k) filing for the single-source Nanox.ARC earlier this year.
In that case, the FDA placed the submission on hold on Jan. 30, pending Nanox’s response to a request for further information about the X-ray bed. In another SEC filing (PDF), Nanox noted that the agency had asked for “additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device.”
Once again, Nanox pledged to answer the FDA’s questions in a timely manner. It clearly followed through on that pledge, as the device ended up receiving 510(k) clearance barely two months after the FDA’s request for clarification.
With that regulatory OK, Nanox is free to market the single-source Nanox.ARC throughout the U.S. Upon receiving clearance, the company said it would begin that process in the fourth quarter of this year, but noted that once the multi-source machine is cleared, it’ll replace the single-source iteration as Nanox’s flagship product, with a wider distribution plan.
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Alongside the proposed upgrades to the multi-source X-ray bed, Nanox is also making strides to expand the diagnostic capabilities of its technology. Earlier this month, it announced a proposed deal to acquire Zebra Medical, which develops AI systems that can spot signs of cancer, stroke and other diseases in X-ray images.
Under the terms of the deal, Nanox will pay $100 million up front to merge Zebra Medical’s AI into the Nanox.ARC platform, with another $100 million on the table if the subsidiary is able to hit specific milestones in the ensuing months and years.
With the addition of Zebra Medical’s technology, Nanox is aiming to be able to offer an end-to-end diagnostic solution that would not only perform lower-cost X-ray scans but also automatically flag those scans for potential signs of disease.