Israeli "digital X-ray" startup Nanox filed a Form F-1 with the SEC on Friday that outlines plans to raise $125 million in an IPO.
The company has applied to list its shares on the Nasdaq exchange as "NNOX," and according to a representative has entered its quiet period prior to the IPO.
Nanox, which has raised $110 million from investors since November 2019, is building a two-part offering comprising a low-cost, in-hospital digital-imaging device (called Nanox.ARC) and an accompanying end-to-end software platform for image storage, analysis, clinical decision support and billing (called Nanox.Cloud).
As of last week, the company boasted deployment agreements in 13 countries across five continents.
WHY IT MATTERS
Nanox's filing provides the most comprehensive look yet at its long-term business strategy and operations.
The company's aim is to sell its systems worldwide through a price-per-scan model that would provide the services at a "substantially lower cost than currently available medical imaging systems," the company wrote in its prospectus summary.
It submitted a 510(k) to the FDA for a version of the Nanox.ARC in January, but said it needed to delay the timeline for supporting functional and safety test data due to Q3 2020 due to COVID-19.
It will be submitting another 510(k) for the version of the Nanox.ARC that will become its commercial imaging system in Q4 2020, the company wrote. It does not expect that the Nanox.CLOUD software platform will require any regulatory approvals, but notes that it hasn't had feedback from the agency on this regulatory strategy.
With this in mind, the company is aiming to deploy its first Nanox.ARC in Q1 2021, hit a minimum installed base of 1,000 full Nanox Systems by H2 2021 and finalize deployment of 15,000 systems by 2024.
Nanox reports a net loss of $13,786,000 in the first half of 2020, and $22,563,000 for the full year of 2019. It holds a cash balance of $39,524,000, and an accumulated deficit of $54,387,000.
THE LARGER TREND
Other startups out of Israel, such as Zebra Medical Vision and Aidoc, offer an alternatives to Nanox's end-to-end digital-imaging approach by focusing solely on artificial intelligence-based interpretation and clinical decision support. Meanwhile, larger tech firms like Nvidia and GE are also promoting their role in tech-driven medical-imaging support.
Nanox's interest in an IPO comes amidst an upswell in support from the public markets for digital health technologies.
In 2020, One Medical and Accolade have each performed well in their own IPOs. Hims and SOC Telemed are respectively reported and confirmed to be entering the market via "blank check" acquisitions. And thanks in part to COVID-19, Teladoc Health and Livongo have both seen their share prices skyrocket over the past half year.