Business
Nanox Announces First Quarter 2021 Results and Provides Business Update
Announced FDA 510(k) clearance for the single source Nanox Cart X-Ray System Scaling up Company’s semiconductor fabrication plant in South Korea Ended Q1 with
About this update from Nano-x Imaging Ltd
[{"type":"text","content":"Announced FDA 510(k) clearance for the single source Nanox Cart X-Ray System Scaling up Company’s semiconductor fabrication plant in South Korea Ended Q1 with cash and cash equivalents of $219 million and no debt Management to host conference call and webcast today, May 11, at 8:30 AM ET NEVE ILAN, Israel, May 11, 2021 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2021 and provided a business update. “We were very pleased in April to receive FDA clearance for our single source Nanox Cart X-Ray System, a critical achievement for our company, and an important reference point as we prepare to submit for approval of our multi-source device this year,” stated Ran Poliakine, Chairman and Chief Executive Officer of Nanox. “In addition, we are making solid progress, despite the impact of the pandemic, on the technology transfer of MEMs chip technology to our interim clean-room facility in Korea and the construction of our new state-of-the-art fabrication facility.” Due to delays with the original third-party supplier of the second-generation high-power ceramic tube, which were compounded by the COVID-19 pandemic, Nanox is currently working with two alternative tube suppliers for the multi-source system. As a result, while the Company does not expect to meet its previously announced milestone of shipment of 1,000 multi-source Nanox units by the first quarter of 2022, the Company believes that it will be able to gain ground during the year to reach the shipment milestone of 1,000 multi-source Nanox units during 2022, and possibly more, if the multi-source Nanox.ARC is cleared by the FDA and authorized by other similar regulatory agencies. Nanox continues to expect submission of a 510(k) premarket notification to the FDA with respect to the multi-source Nanox.ARC and the Nanox.CLOUD during 2021 and deployment of an initial wave of approximately 15,000 Nanox.ARC units by the end of 2024. “While we have experienced delays, compounded by the world pandemic, in the production of our second-generation high-power tube by a third-party manufacturer, which caused us to revisit certain timelines associated with the shipment of multi-source units, we believe that the manufacture and shipment of at least ...