Going Concern and Management's Plans

3 Months Ended

Sep. 30, 2018

Going Concern and Management's Plans [Abstract]

GOING CONCERN AND MANAGEMENT'S PLANS

(2) GOING CONCERN AND MANAGEMENT'S PLANS

The accompanying financial statements are prepared assuming the Company will continue as a going concern. As of September 30, 2018, the Company had an accumulated deficit of $131,790,623, a stockholders' deficit of $772,444, and a working capital deficiency of $797,673. For the three months ended September 30, 2018, net loss totaled $401,142. The net cash used in operating activities for the three months ended September 30, 2018 totaled $453,049. These matters raise substantial doubt about the Company's ability to continue as a going concern for a period of twelve months from the date these financial statements are issued. The ability of the Company to continue as a going concern is dependent upon increasing sales and obtaining additional capital and financing. While the Company believes in the viability of its strategy to increase sales volume and in its ability to raise additional funds, there can be no assurances to that effect. Finally, there can be no assurance that we will obtain FDA marketing or China FDA (CFDA) or other new international marketing clearances, that the CTLM® will achieve market acceptance or that sufficient revenues will be generated from sales of the CTLM® to allow us to operate profitably. If our majority shareholder Viable International Investments, LLC ("Viable") fails to continue funding, the Company would be materially adversely affected and may have to cease operations due to a lack of funding. These matters affect the Company's liquidity profile, and management's plans in those regards are discussed in the paragraphs that follow.

For the remainder of fiscal year 2019, we anticipate that losses from operations will continue until we obtain marketing clearance through CFDA and begin to generate revenues through the sales of CTLM® systems in China. These losses will be primarily due to an anticipated increase in marketing, manufacturing and operational expenses associated with the international commercialization of the CTLM®, expenses associated with our CFDA and FDA approval processes, and the costs associated with advanced product development activities.

The Company is currently focused on obtaining marketing clearance of its CTLM® Breast Imaging System through the CFDA in China. 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. 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 received U.S. marketing clearance.

The Company's ability to continue as a going concern and its future success is dependent upon its ability to raise additional capital in the near term to: (1) satisfy its current obligations, (2) continue its research and development efforts, and (3) successfully develop, market, and sell its products. The Company believes that it will be able to complete the necessary steps in order to meet its cash flow requirements throughout fiscal 2019 and continue its development and commercialization efforts. However, there can be no assurance that IDSI will generate sufficient revenue to provide positive cash flows from operations or that sufficient capital will be available, when required, to permit the Company to realize its plans. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.