November 11, 2022
The company, which developed an x-ray device with a digital source, received Helsinki approval and will present findings later this quarter. The company will hold a virtual demonstration event next week. Nanox is currently awaiting FDA approval and is starting to deploy the first systems in Nigeria
The Nanox company (Nano-X) received permission from the Helsinki Committee for Human Experiments to conduct clinical research on the digital X-ray device it developed – this is what the company revealed yesterday (Thursday) with the publication of the financial report for the third quarter. The research will be carried out at “Shamir” hospital (Asaf Harofeh), and the company is expected to present the findings of the research, which will include scans of human internal organs carried out on the company’s device, later in the current quarter. Also, Nanox will hold a virtual webinar next week, at the company’s headquarters in Neve-Ilan, where they will demonstrate the operation of the device.
These steps are intended to present to the medical community the capabilities of the technology, and also to remove quite a few doubts that have been voiced in recent years in view of the company’s promise to “disrupt the X-ray world” with a very cheap X-ray and CT scanner, in which the X-ray flashes are produced by a chip and not by incandescent light bulb. In September, the company submitted to the FDA a 510k marketing authorization request for the system, and this after a lengthy dialogue that also included requests from the FDA for additions and clarifications. Nanox has also started a regulatory approval process in the European Union (CE Mark).
The company refrains from estimating when approval will be received from the FDA, but in fact Bennox intends to start commercializing the system this year, regardless of FDA approval, with the deployment of first systems in Nigeria and then in Ghana. In fact, at least according to the company’s vision, developing countries of this type, where the population has little access to census scans, are the company’s primary target markets, and not necessarily developed markets such as the United States and Europe.
“We believe that as soon as we start deploying the Nanox.ARC system in Nigeria and other first countries, the health system, hospitals and distributors will prove the benefits provided by the system,” said company CEO Erez Meltzer. In total, the company received orders for 6,850 systems in different countries in the world during the last few years. However, it should be noted that most of these orders were made a long time ago and we have to wait and see if they have validity even now with the start of commercialization of the system. CEO Meltzer noted that the company is in continuous contact with the customers and some of them even come to Israel from time to time to witness the progress.
Income from the companies it acquired
Nanox’s revenues in the third quarter amounted to $2.4 million, compared to $2.2 million in the previous quarter. The net loss amounted to 19.1 million dollars. The company’s cash register has approximately 117.1 million dollars. At this stage, the company’s revenue originates from the activities of the three companies it acquired at the end of last year: Zebra Medical, which under Nanox is called Nanox AI, the American radiology services company USRAD and MDW, a platform that connects imaging centers and radiologists. All these companies should be part of a complete ecosystem of end-to-end advanced radiology services, from the scanning stage to the interpretation and diagnosis through both artificial intelligence and expert radiologists.
Nanox has developed an imaging device based on the production of X-rays using a MEMS component instead of using an incandescent lamp, the heating of which results in the emission of electrons. Nanox’s “cold” system is a paradigm shift compared to the “warm” imaging systems. According to the company, the new technology will make it possible to produce more mobile and accessible imaging systems at a lower price compared to other systems on the market and in the service model (SAAS).
Posted in the categories: profit reports, news, medical devices
Posted in tags: FDA, Nanox
