Fabulous NEWS.IMDS approved China FDA.On November 17, 2018, Imaging Diagnostic Systems, Inc. ("IDSI" or “we” or “our”) received notice from Xi'an IDI Laser Imaging Co., Ltd.("Xi'an") our licensee (as described below) that the CTLM® Breast Imaging System had been approved by the Shaanxi Drug Administration on November 16, 2018 and would be effective until November 15, 2023. The Peoples Republic of China issued a Registration Certificate for Medical Device, Certificate No.: Shaanxi 20182060079. This approval allows Xi'an to manufacture, sell and distribute the CTLM® in China.
In June 2017, we entered into a Technology Licensing Agreement (the “Xi’an Agreement”) with Xi’an, of Xi’an, Shaanxi Province, China. Xi’an is an affiliate of Viable International Investments, LLC which owns a majority interest of IDSI. Under the terms of the Xi’an Agreement, Xi’an has the exclusive right to manufacture the CTLM® in China and sell the CTLM® in China, Hong Kong, Macau and Taiwan. Xi’an is required to pay to IDSI on a quarterly basis a royalty of 25% of the gross revenues from the sale of the CTLM® and related parts and accessories. We expect Xi’an to sell the CTLM® in China for approximately $300,000 per unit.
