Titan Medical is seeing difficulties in finance

"More recently, the Company has been notified by its principal development suppliers that they have decided to temporarily suspend development work of the SPORT Surgical System until such time that the Company has sufficient financing to cover current and future work orders projected over a six-month period. As well, the previously announced US $16.0 million equity investment from Shanghai JuGu Equity Investment Fund Co. Ltd. (“Shanghai JuGu”) that was expected to close on June 30, 2016, and was subsequently extended to August 15, 2016, has not closed as of the date hereof. There can be no assurance that the investment from Shanghai JuGu will be completed on the terms previously announced, if at all. The Company’s Board of Directors is exploring strategies to raise financing necessary to allow the Company to resume its development of the SPORT Surgical System. The Company remains committed to accomplishing its next major milestones towards achieving submission of its 510(k) application to the U.S. Food and Drug Administration (“FDA”). However, due to the suspended development work the Company’s milestone and 510(k) submission timeline may need to be revised if the delay extends past the end of August.
The Company’s development process is well-defined and includes completing the development of the technology as well as completing testing that will provide the results that demonstrate substantial equivalence between the SPORT Surgical System and predicate devices. Titan’s management team has worked to identify the predicate devices to which the Company must demonstrate substantial equivalence. The refined timeline to accomplish the remaining milestones incorporates our current and best analysis, as well as input from a variety of sources, to reflect recent developments in the industry. A very meticulous approach to the process is being executed and documented in preparing data for a 510(k) application."


Popular Posts