Titan Medical Inc (TMDIF)

[elMoose]

So this is what hardware freeze means according to their release notes. That is what FDA approval requires according to this, hardware freeze. They can still massage the Gui interface to make it more user friendly or whatever but obviously it does not change the functionality of the device or the design as it is clear from their release notes .


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Hardware design freeze is an essential milestone in the system design process as it allows Titan to complete various design verification and validation activities such as preclinical studies conducted under Good Laboratory Practices (“GLP”) and Summative Human Factors studies, in preparation for submitting an Investigational Device Exemption (“IDE”) to the U.S. Food and Drug Administration (“FDA”) for human confirmatory studies. The assembly of systems for the GLP studies is well underway, and Titan has begun procuring hardware for the production of systems for the IDE studies.

“Design freeze is a significant achievement for us, and we are delighted to reach this important inflection point within our stated timeframe,” said David McNally, Chief Executive Officer of Titan Medical. “Thanks to the tremendous effort by our development team including our product development partners and valuable feedback by our surgeon KOLs, we now have what we consider to be a world-class, differentiated surgical robot. We look forward to conducting GLP and IDE studies this year, as we continue on track to file by year-end 2019 our 510(k) application with the FDA and our technical file for the CE mark in Europe.”

The Company notes that software integration and advanced Graphical User Interface features will continue to be implemented on a rolling basis.

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http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20190430:nBwbtMS0Ma