"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."
Comments