IMDS form 10 Q out... should be trding soon OTC QB.. The Company’s next focus, after having obtained CFDA approval in China, is on obtaining marketing clearance of its CTLM® Breast Imaging System through the US FDA. The PMA process for U.S. marketing clearance is expected to take much longer than the Chinese process. Sales in China are expected to commence in the second half of fiscal 2019. No sales in the U.S. are expected in fiscal 2019 or fiscal 2020. The Company has received the CE Mark which would allow it to sell its CTLM® System in the European Union and other countries that recognize the CE Mark; however, the Company does not expect material sales in Europe until it receives U.S. marketing clearance. As of January 27, 2019, Underwriter's Laboratory has not renewed our CE mark as we were not able to provide sufficient evidence in time to meet the deadline. We are working with UL to provide the evidence required to renew the CE Mark. Until the CE Mark is renewed, we will not be able to sell CTLM devices in Europe.
On August 28, 2018, we filed a Form 10 registration statement to register issued and outstanding shares held by our shareholders and to become a fully reporting company under the Securities Exchange Act of 1934 (the “Exchange Act”). The Form 10 was amended in response to SEC comments on October 5, 2018 and November 14, 2018. On February 7, 2019, the SEC confirmed that it has no further comments, on the Form 10. Now that the SEC comment process is completed, we plan on having our stock quoted on the OTCmarkets.com in the QB category. Under the Exchange Act, our registration became effective on October 29, 2018, i.e. 60 days after filing the Form 10.