GUIDED THERAPEUTICS INC
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001477932-25-005887
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001477932-25-008196
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 2 previous paragraphs and 4 current paragraphs.
1 unchanged; 1 reworded; 2 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (2)
Current report
In October 2025, a partial shutdown of the U.S. federal government began, resulting in reduced staffing and limited operations at certain agencies, including the U.S. Food and Drug Administration (“FDA”). The Company is currently pursuing FDA clearance for the LuViva Advanced Cervical Scan, and a prolonged shutdown could delay the timing of regulatory reviews and approvals, which in turn could adversely affect product commercialization timelines, revenue opportunities, and cash flow forecasts. The duration and potential impacts of the shutdown are uncertain and could vary depending on the extent of agency operations and the resolution of the federal budget process.
Current report
Regarding the Chinese market, the ability of SMI to timely achieve NMPA approval and be able to successfully market LuViva in China is a risk factor of increasing magnitude, given repeated delays over the past year. While SMI has been able to bring new partners to the table which has resulted in increased sales to China in the past year, full NMPA approval will be necessary to achieve significant sales over the long term.
Reworded paragraphs (1)
Previous wording
There have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 31, 2025.
Current wording
Except as noted below, there have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 31, 2025.