Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of its Population Health Offering
NANO-X IMAGING (NNOX) announced the 8th FDA clearance for its Coronary Artery Calcium solution, enhancing its population health offerings via Zebra Medical Vision. This follows a merger agreement with Zebra aimed at expanding AI-based diagnostic capabilities for chronic conditions. Nanox aims to revolutionize medical imaging with its digital X-ray technology, potentially lowering costs and improving access to early detection services. The company highlights risks linked to acquisitions and regulatory clearances in its forward-looking statements.
- Secured 8th FDA clearance for CAC solution enhancing population health offerings.
- Acquisition agreement with Zebra Medical Vision may improve diagnostic capabilities.
- Innovative digital X-ray technology aims to significantly lower medical imaging costs.
- Potential risks related to the completion of merger negotiations.
- Uncertainties in obtaining regulatory approvals for technology.
- Possible disruptions to current operations due to merger announcements.
NEVE ILAN, Israel, Sept. 27, 2021 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that Zebra Medical Vision secures 8th 510K FDA clearance for its Coronary Artery Calcium (CAC) solution as part of its population health offering.
On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD. This agreement, once consummated, will put Zebra-Med on track to expand its mission of helping to diagnose populations at scale with its AI-based solutions, enabling IDNs and commercial payers to detect and treat patients at risk for chronic conditions while accurately adjusting their covered population risk.
About Nanox:
Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli corporation developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging services for all. For more information, please visit www.nanox.vision.
Forward-Looking Statements
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements contained in this press release that are not historical facts are forward-looking statements and you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. This includes any statements relating to the initiation, timing, progress and results of Nanox's potential acquisitions, research and development, manufacturing and commercialization activities with respect to its X-ray source technology and the Nanox.ARC.
Forward-looking statements are based on information Nanox has when those statements are made or management's good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the negotiations and any subsequent definitive agreements with respect to the proposed acquisitions, and the possibility that the terms and conditions set forth in any definitive agreements with respect to the proposed acquisitions may differ materially from the terms and conditions set forth in the term sheet, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed acquisitions and any definitive agreements with respect thereto, (3) the inability to complete the proposed transaction, including due to failure to fulfill conditions to closing, (4) the impact of the COVID-19 pandemic on the parties’ ability to negotiate and consummate the proposed acquisition, (5) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed transactions, (6) the risk that the proposed transaction disrupts current plans and operations as a result of the announcement and consummation of the proposed transaction, (7) the ability to recognize the anticipated benefits of the proposed transactions, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably and retain its key employees, (8) costs related to the proposed transactions, (9) the demand for the combined company’s services together with the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors, (10) Nanox's (i) ability to successfully demonstrate the feasibility of its technology for commercial applications; (ii) expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its X-ray source technology and the Nanox.ARC from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iii) ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (iv) the market acceptance of the Nanox.ARC and the proposed pay-per-scan business model; (v) expectations regarding collaborations with third-parties and their potential benefits; (vi) ability to conduct business globally, and (11) risks and business interruptions related to the COVID-19 pandemic, among others. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox's actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2020 and subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this video clip to conform these statements to actual results or to changes in Nanox's expectations.
Company Contact:
Tamar Aharon Cohen
Nanox Imaging
IR@nanox.vision
Bob Yedid
LifeSci Advisors
bob@lifesciadvisors.com
FAQ
What recent FDA clearance did NANO-X IMAGING announce?
What is the significance of the merger with Zebra Medical Vision for NNOX?
How could the FDA clearance affect NANO-X IMAGING's market position?
What are the risks associated with NANO-X IMAGING's acquisition of Zebra Medical Vision?
How is NANO-X IMAGING addressing the challenges of its technology?
