GTHP 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• We have not yet obtained clearance or approval from the U.S. FDA. However, we have completed patient enrollment in the clinical trial required to support an application for FDA approval to market and sell LuViva in the United States. As of April 2026, the status of the FDA application is as follows:

• Approximately 480 patients were enrolled, of whom 428 were evaluable for efficacy analysis. Both totals satisfy the a priori criteria as set forth in the study protocol.

• No adverse events related to the use of LuViva have been reported.

• All four clinical study sites adhered to the study protocol and completed required case report forms in accordance with FDA standards.

• Close-out activities have been completed at all sites, and all LuViva devices have been retrieved in good working order.

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• results related with the termination of the license agreement with SMI and potential partnership agreement with other parties;

• In the United States, the Company is actively pursuing FDA approval by conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with …

• On August 13, 2025 the Company announced that it had surpassed the minimum number of enrolled subjects, both for each individual site and for the entire study. Based on this achievement, data analysis has begun. The initial analysis will focus on determining the number of study subjects with and wit…

• As of November 1, 2025, approximately 460 patients have been enrolled and tested, which is above the target minimum number needed to file the application with the FDA. Analysis of these data indicate that enough women both with and without cervical disease have been enrolled and tested.

• There have not been any adverse events reported related to the use of LuViva.