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Tuesday, 11/16/2021 12:13:20 PM

Tuesday, November 16, 2021 12:13:20 PM

Post# of 15706
10-Q has an update on the clinical trials.

As of November 10, 2021, clinical trial agreements have been drafted and agreed upon, the budget at one institution has been agreed upon and is under negotiation at the other institution. The LuViva devices have been prepared and have passed bench testing in order to begin the study. All requested materials have been submitted for review by the respective hospital institutional review boards (IRBs). Once the IRB’s have approved the study, enrollment may begin, which is expected prior to the end of this year and last approximately eight to nine months; however, there can be no assurance that the study will begin in 2021 or that it will be completed by the end of 2022.

In China, the study protocol and budgets have been agreed upon at two clinical centers and the study has begun at one center, with two more to be added this year. This study will enroll approximately 320 women and is expected to be completed in the first half of 2022, although there can be no assurance that the study will be completed within this time frame.

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