Guided Therapeutics Inc (QB) (GTHP)

A little bit of volume today.

Too soon for PMA approval, but someone is interested!

PMA Amendment Timeline:PMA Amendments (§ 814.37)
An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information. FDA may request that the applicant amend their PMA or PMA supplement with any information about the device that is necessary to complete the review of the PMA or PMA supplement.

If the applicant submits a major PMA amendment on his or her own initiative the review period may be extended up to 180 days. A major amendment is one that contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted.
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-supplements-and-amendments

GTHP#$$: Hey Bulba and JuneBugs, when this Loin Puppy is FDA Appoved . The Big Boys Medical companies will be circling with Buyout offers .And with world-wide distribution , it will fetch Billion$ . Can you imagine in 1-2yrs this being a $25 a share stock ?

They met their Q2 forecast. Now let's see if all those FDA meetings over the past ten years pay off with a fast approval.

The results of the clinical study are impressive - even better than the China results. Of the 428 women that completed the study, 99 were determined by expert independent pathology to have significant cervical disease that can lead to cancer, and of these, 32 cases of disease (32.3%) went undetected by the current standard of care consisting of colposcopy-directed biopsy. The primary goal of the study was to show that LuViva could detect a significant number of these "missed" precancerous lesions.

The results showed that LuViva detected 21 of the 32 (66%) disease cases that were missed by the current standard of care, increasing the detection rate from 68% without LuViva to 89% with LuViva. Moreover, all primary and secondary endpoints regarding the sensitivity and specificity of LuViva were met with a high degree of statistical certainty (p < 0.0001). There were no safety issues or adverse events related to LuViva reported among the study participants.

GTHP#$$: Hey Bulba and JuneBugs . They filed the PreMarket Clinicat Trail Approval Application with the FDA today. The Clinical Trail Results is outstanding. It is my belief that there is a 95% chance that the FDA will approve the device for use in the U.S. as well as Fast Track the device . Having worked in the Medical Field for 50 yrs and several at the Renounced Research Medical Center in Durham , N.C. , I will say the "Luviva Cervical Scanner " is a Go ! I will be buying $50k more before the projected approval comes out . This Loin Puppy is getting ready to Break it's Chain , Leap and go on a Epic Run North.

It has been a very long road with many obstacles but I have to give a big shout out to management and insiders who continued to support and believe....HUGE DAY FOR GTHP!!!!!!!!!!!

Not much in the 10-Q. No new revenue. No NMPA decision. No FDA submission.

The good news: still on track to submit the PMA in Q2. Data analysis was completed and the results were good so I'm optimistic that the PMA will be approved, and since it's an amendment to the existing PMA and not a new PMA, approval should be relatively quick. Take that word "relatively" with a grain of salt.

I'm going to guess that the NMPA will eventually decline that China application. It shouldn't have taken this long. Oh well. They submitted as a Class II Device and I think it's a Class III Device, hence the PMA in the USA instead of a 510(k), so I don't think expectations were high, but the company got the China clinical results out of that SMI debacle. Since the China clinical trials used the same protocol, Guided can submit the China clinical results in the PMA addendum as extra proof.

Two large clinicals with 400 participants each. Feeling good about it.

What do you mean by that? I don't understand. 

Thank you very much!!!!

not much new in the 10-K -- I'll read it closer sometime in the next week or two, but here is my take:

* FDA filing delayed from Q1 into Q2. They give a reason (or an excuse, LOL) but the bottom line is that it didn't happen in Q1. See the copy/paste paragraph below.

* NMPA: looks like NMPA decided it's a Class III application, not a Class II, although that is speculation on my part. No surprises there, since the Luviva Scan is Class III in the USA, but SMI (and Guided) suggested Class II in the past, and Class III approval takes longer. It hasn't been rejected yet, if you want a silver lining. The required manufacturing inspection has not happened yet -- it's forecast for May 2026 with possible approval in Q3 but let's not hold our breath.

* SMI is officially gone (thank goodness). New Chinese partners HDMT and YMIC have purchased and paid for devices and hardware, but seriously, they can't be expected to buy much until NMPA approval happens.

* US clinical results look better than expected, but we'll have to wait for a PR for the actual results. I'll copy/paste the paragraph below so you don't have to search for it:The study was completed with approximately 480 patients enrolled, of whom 430 were evaluable for efficacy. Both totals meet the prospective enrollment criteria of the study protocol. The clinical study data and results are expected to be filed with FDA in the second quarter of 2026. We originally planned on filing the clinical study results with FDA in the first quarter of 2026, but a short delay in filing occurred when one of the reference pathologists involved in the study took a new position and her replacement was delayed in completing their independent diagnoses of biopsy samples, as required by FDA as part of the study protocol. This has been resolved and as of March 25, 2026, all pathology samples have been diagnosed by two independent expert pathologists as set forth in the study protocol. This allows the key performance metrics of sensitivity and specificity of the LuViva test to be determined and filed with FDA. As we reported in December 2025, clinical site pathology findings indicated that 25% of significant cervical disease was missed by the current standard of care of colposcopy followed by biopsy for women at risk for cervical cancer due to an abnormal Pap and/or HPV test. Preliminary analyses of the independent expert pathology diagnoses indicate that an even greater percentage of disease is being missed by the standard of care and that LuViva was able to detect the majority of these missed cases, thus providing support for successfully meeting the primary endpoint of the study.

Add to my wish list: an NMPA update. I'm on the fence about the odds for China approval: the longer it takes, the worse the odds, and it's been a long time.

Sometimes, Guided likes to release a PR just before a financial filing. Wouldn't that be nice.

Form 4's for Acquiring stock don't worry me. The insiders are not selling.

The only stock he DISPOSED of were some Preferred Series E shares that he converted to common stock.

The strike prices were already set. He was going to convert these at some point. These were relatively small amounts, IMO, but that's just my opinion. I'm far more interested in the status of the PMA and whether or not the Diagonal Lending loans were paid or converted -- both of which we'll learn in the 10-K which is due at the end of March.

Here's a Copy/Paste of what happened from the Form 4. I'll refrain from adding conjecture: Explanation of Responses:
(1) On December 18, 2025, Dr. Imhoff converted $13,682.19 outstanding under a September 25, 2025 Convertible Promissory Note into 195,460 shares of common stock at a conversion price of $0.07 per share. The amount converted consisted of $10,000 of principal and $3,682.19 of accrued interest. Following the reported conversion, $150,000 of principal remains outstanding under the convertible promissory note. Upon the occurrence of an event of default, the remaining balance is convertible into common stock at a variable conversion price determined in accordance with the terms of the note.

(2) These shares were issued for payment of accrued dividends on the reporting individual's Series E preferred stock, at a conversion price of $0.3157.

(3) On February 2, 2026, Dr. Imhoff converted $21,890.41 outstanding under a September 25, 2025 Convertible Promissory Note into 312,720 shares of common stock at a conversion price of $0.07 per share. The amount converted consisted of $20,000 of principal and $1,890.41 of accrued interest. Following the reported conversion, $130,000 of principal remains outstanding under the convertible promissory note. Upon the occurrence of an event of default, the remaining balance is convertible into common stock at a variable conversion price determined in accordance with the terms of the note.

(4) During February 2026, Mr. Imhoff signed an exchange agreement pursuant to which 500,000 warrants to purchase shares of common stock with an exercise price of $0.50 were exchanged for 500,000 warrants with an exercise price of $0.20. The newly issued warrants were subsequently exercised upon payment of $100,000. In connection with the exchange agreement, the expiration date of 500,000 warrants with exercise price of $0.65 was extended for one year, until September 1, 2027.

(5) On February 27, 2026, Mr. Imhoff converted 100 shares of Series E preferred stock into 400,000 shares of common stock. The Series E preferred stock had a stated value of $1,000 and $0.25 conversion price.

(6) On February 26, 2026, Dr. Imhoff converted $10,926.03 outstanding under a September 25, 2025 Convertible Promissory Note into 156,086 shares of common stock at a conversion price of $0.07 per share. The amount converted consisted of $10,000 of principal and $926.03 of accrued interest. Following the reported conversion, $120,000 of principal remains outstanding under the convertible promissory note. Upon the occurrence of an event of default, the remaining balance is convertible into common stock at a variable conversion price determined in accordance with the terms of the note.

Great post Franken!!!

All of the above plus the ones below?

How should I interpret the Form 4 with Imhoff converting another 1.5 million shares since 12/18?

1. "Nothing to see here folks, move along, move along"? 
2. "I converted a ton of them at 7 cents so I can sell them before this thing tanks (again)"?
3. "I'm going to have to announce great progress soon and I want to own as many shares as I can right now"?

I just saw that I've been here following GTHP since 11/2014, waiting for this to take off. Endless romantic? Perhaps. Hate my money? Likely.

Everything takes longer than expected. I'm surprised that GoJo hasn't come back to complain.

If it's any consolation.... remember how many years they merely TALKED about starting the new US clinical trials.

Any thoughts or speculation on why the long silence? Is it my impatience?

The 60 days is up.

I wish it were easier to find information about the NMPA.

It's been quite awhile since we had an NMPA update. Originally I expected the NMPA to reject the application just because SMI was so inept, but stranger things have happened.

I wish I still had my 8 million shares I had before the splits! Slowly had to build back up just to get to 24k.

Counting stars by candlelight
All are dim but one is bright:

My dad was investing in Guided back when it was still SpectRx. What a trip. My first shares were bought in 2018. Some rise, some fall, some climb to get to Terrapin

GTHP#$$: Hey Bulba and Junebugs. This Loin Puppy will see $1.50 with in the next next 5 trading days. 10-Bagger is on the Horizon . Let him stretch his legs . This Loin Puppy is getting ready to Break its Chain, Leap and go an Epic Run North. Get on Board , this Train is going to be leaving Pennyland. When this hit $1.50 and News hit , we will see a 1000% Volcano. People this is about to get Real . I've held this Puppy for 7yrs . '2026 is it's year. Very Low Float .

GTHP Ownership Updated:

Hedge Funds________4,248,474 (unchanged) ______4.94%
Private companies____6,095,386 (unchanged) ______7.09%
VC/PE Firms________9,135,152 (unchanged) ______10.06%
General public______29,628,823 (increased) ______34.05%
Individual Insiders___36,850,623 (unchanged) ______42.09%

O/S Total: 86,153,918

Held at DTC: 12,227,341

https://simplywall.st/stocks/us/healthcare/otc-gthp/guided-therapeutics/information



GTHP

We're finally starting to see some volume. 91,499 yesterday and 152,583 today.

The float is low. If/when the manipulators find this stock, it could really pop.

And to think it was under a dime back in March!

Happy New Year, all! Especially to the few who've been here awhile.

Let's hope so!!!!!!!

GTHP#$$: Hey Bulba, if this Loin Puppy get FDA Approval , there will be a 10-Bagger+ jump to $5+. More than likely it will be brought out by a much larger company . It's very hard to get shares now.

When GTHP submits to the FDA they only need to submit a PMA Amendment, not a new PMA.

They can also submit the China clinical results which were robust (over 400 participants) and successful.

The China submission to the NMPA was Class II, I believe, so who knows if that will float.... but we should be getting an update on that pretty soon. We know this from the 10-Q:SMI submitted the NMPA application on October 16, 2024.......

......The NMPA application was accepted as complete and is under review. SMI has informed us that a mandatory inspection of their manufacturing site has delayed until of 2026, which is consistent with NMPA approval in the first half of 2026.... OK so the weird part about THAT, IMO, is: SMI is out of the picture, FINALLY, so what manufacturing site will the NMPA inspect?



GTHP

All study sites are closed and monitoring completed. Final clinical results are expected to be filed with FDA within about 30 to 60 days. From today's PR.

YES!!!!!!!!!!!!!!!!!!!!!

I'm so relieved that SMI is gone.

$200,000 should take care of Diagonal Lending's loans that are maturing soon.

News out......

Great synopsis!!!!!!

Thank you

And so we wait..........

I'm not finding anything important to add to my post last night. Dilution still holding off, although Diagonal Lending has some loans coming due. Basically we're still stuck in a holding pattern. The 10-Q is suggesting, with typical Safe Harbor verbiage, that they'll tie up a lot of loose ends by 12/31, including the shipment to Indonesia and the US clinical trials. Nothing concrete on either topic, though.

I'm happy to see SMI replaced by HDMT in China. That's where the $60,000 in revenues came from. There is also mention of a mysterious new Chinese partner: Guided Therapeutics is currently in discussions with a new partner that works with SMI to assume the responsibilities formerly under the purview of SMI. Here's the Turkey thing: In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this would potentially involve up to 20 million tests annually in Turkey paid for by the Turkish national healthcare system. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of October 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use Cervical Guides. Funds are expected to be released in 2025 and the study concluded in the first half of 2026. I'm skeptical about Turkey because (a) I remember all the Turkey hype from several years ago that came to nothing, and (b) Turkey plans to complete an 800-patient study in six months when it took twice that long for both China and the US to complete 400-patient studies. However, this study won't cost Guided anything, so that's a positive!

Russia! Based on regulatory approval of LuViva in Russia granted on August 11, 2025, our distribution partner, Newmars Medical Technologies (“Newmars”), is shifting its emphasis from smaller East European countries to the larger Russian market, LOL it looks to me like Newmars hasn't sold a single device in "smaller East European countries" so it might be rather generous to say "shifting its emphasis....." but this is not BAD news.

HOPEFULLY there is something in there for us to hang our hats on.........

10-K out.

I'll read it more closely tomorrow but here are some skimmed excerpts:

$60K revenue booked in Q3

SMI officially kicked to the curb: During the nine months ended September 30, 2025, SMI made a required $130,000 payment, and the Company recognized $183,525 of previously deferred revenue in “Other income” in connection with reimbursement of prior-period costs.

As of September 30, 2025, SMI did not achieve required commercialization milestones or obtain NMPA approval within the agreed timeframe and did not cure such breaches. Accordingly, SMI no longer retains rights to manufacture, market, or distribute LuViva. SMI has entered discussions with third parties to transition commercialization efforts in China. One such entity, Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”), entered into a contract to purchase 35 LuViva devices for $700,000. As of September 30, 2025, the Company received $100,000 under the HDMT contract and delivered three devices. Maybe China NMPA approval in 2026? The NMPA application was accepted as complete and is under review. SMI has informed us that a mandatory inspection of their manufacturing site has delayed until of 2026, which is consistent with NMPA approval in the first half of 2026 US Clinical Trial: They still expect it to finish in 2025.

Indonesia, Russia, and Turkey sections are interesting, but I just got home from a trip and and I'm too tired to look more closely tonight.

I'm confident that the US trials finished successfully.

Hopefully, the 10Q will give us some clues about a timeline for PMA addendum submission.

GTHP Ownership:

Hedge Funds________4,248,474 (unchanged) ______5.08%
Private companies____6,095,386 (unchanged) ______7.29%
VC/PE Firms________9,135,152 (unchanged) ______10.90%
General public______27,269,521 (increased) ______32.60%
Individual Insiders___36,850,623 (increased) ______44.10%

O/S Total: 83,599,156

https://simplywall.st/stocks/us/healthcare/otc-gthp/guided-therapeutics/ownership

Financials will be interesting because:

* we'll know how many sales they booked as revenues
* we'll know how much SMI actually paid
* they will give us SOME kind of update on US clinical trial.

clinicaltrials.gov hasn't been updated in a long time, but that could possibly be due to government shutdown.

https://clinicaltrials.gov/study/NCT04915495?tab=results

"Hey Bulba"...... Haven't heard that bs in a long time. 

GTHP#$$: Hey Bulba and Junebugs, if this Loin Puppy get FDA Approval, we are going to be be rich! The Big Boys will Bid this up and a Big Medical Company will by this out . Heck i been holding it for 6 yrs.

Don't see the news to which you refer.

If you mean the Form 4's -- more insider holding increases. Insiders own a lot of stock. I always consider that to be positive. They're exercising warrants.

I'll post some updated ownership info next week when it's available.

Sooooo, in laymens terms, what does todays news to share price? Should this be seen as a look of confidence that FINALLY, they can get the final FDA nod? GS,OK, what is your interpretatikn?

10-Q has some good news. I'll paraphrase a few items:

US clinical trials: We already knew that enrollment was completed qat 430 participants, but the news is "data analysis has begun. "

"SMI has informed us that a mandatory inspection of their manufacturing site has been scheduled for October of 2025, which is consistent with NMPA approval later this year."

SMI is in contractual default (again) but Guided might be taking a harder stance -- they said "If the defaults are not cured to the satisfaction of the Company, we have the right to seek additional partners and agreements such as we have with HDMT." (HDMT is the "Chinese Partner" who placed the $700,000 order.)

Speaking of HDMT: their first three devices are expected to ship in Q3.

"on August 11, 2025, we were informed by Newmars that full approval to market and sell LuViva in Russia had at last been granted."

Turkey MOH (Ministry of Health) is going to conduct and PAY FOR an 800-patient clinical trial that should "take less than six months to complete."

They expect to ship the devices from last year's Indonesia order in Q3.

Otherwise... nothing terrible. Diagonal Lending is still a creditor. The float is still low but there was some dilution at 20 cents..... another note paid off at 18 cents.... the O/S is up to 80 million.

Deferred Revenue $697,000.

$117,000 sales, which means none of the Indonesia or HDMT "big order" shipped yet.

$64,000 "other income."

Regarding Turkey: who else here remembers the Turkey hype from several years back that never amounted to anything? I remember. As a result, I'm always skeptical when I see anything about Turkey, but if the Turkey MOH is paying for the clinical trial, fine, let them.

SERIOUSLY!!!!!!!!!!!!

now if we would just get our RDGL news!

Excellent

Thank You

completion of clinical study:

https://www.otcmarkets.com/stock/GTHP/news/Guided-Therapeutics-Provides-Update-on-Completion-of-US-FDA-Clinical-Trial?id=489114

Approximately 430 patients enrolled -- more than enough.

Waiting for other catalysts, but the 10Q should reveal some interesting things about payments from China and Indonesia.

Guided booked $670,000 deferred revenue at the end of Q1. There's been no PR about shipping anything to Indonesia since then, though. They can't book it as revenue until they ship the goods.

This $100,000 from SMI's partners in Q2 should get booked as "other revenue" (I'm pretty sure, we'll see):

https://www.otcmarkets.com/stock/GTHP/news/Guided-Therapeutics-Receives-100000-from-SMIs-Investment-Partners-to-Continue-Commercialization-Process-of-LuViva-in-Chi?id=478496

This $700,000 will be Deferred Revenue because the PR says they will start shipping in July:

https://www.otcmarkets.com/stock/GTHP/news/Guided-Therapeutics-Receives-700000-Purchase-Order-and-Initial-Payment-from-New-Chinese-Distributor?id=482425

An additional $117,462 should get booked as Q2 revenue because Guided shipped something to China on June 27 and if I'm reading this correctly, it's in addition to the $700k order, not part of it:

https://www.otcmarkets.com/stock/GTHP/news/Guided-Therapeutics-Makes-Initial-Shipment-to-New-Chinese-Distribution-Partner-Hangzhou-Dongye-Medical-Technology-Ltd?id=484664

The $1.13M convertible debt that's overdue converts at 50 cents and 80 cents. I'm not too concerned about that debt. When the PPS rises to a point where it looks attractive to convert those loans, fine with me.

Ticking time bomb: Diagonal Lending. the company got the 2025-maturing debt down to $30k as of 3/31/2025 but they borrowed another $270,000 from Diagonal Lending this year, and those loans mature in 2026. Those newer loans are not convertible until they default, so we definitely want Guided to pay those off on time because we don't want Diagonal Lending to hold convertible debt. Diagonal Lending is toxic. Diagonal Lending is bad, people.

GTHP and RDGL are the two biggest long-term holdings in my gambling account. It's going to be feast or famine for both, I'm thinking. GTHP is looking more like a sure thing but it's still on simmer. They just need enough revenues to keep the doors open until FDA approval.

RDGL, well, that's for the RDGL board, where I don't post because it has too many amateurs and fools.

I'm checking this GTHP trial website every day:
https://clinicaltrials.gov/study/NCT04915495?tab=results

I bought a few more shares today. I think they licked their wounds after the last tragedy and learned a lesson. I'll continue to buy on dips.

I have live Buy orders but hopefully the price is too low to execute. If the MM's dip down and take out somebody's Stop Loss, I want them to throw me some table scraps. But realistically, I'm just holding too.

Finishing the US clinical trial will generate a PR but I don't think it's going to move the PPS unless an OTC manipulator sees it and decides to run good ol' GTHP up the flagpole to see if anyone salutes. Trial RESULTS a couple months later, on the other hand, should open some eyes and pocketbooks.

I'm not sure what triggers the manipulators to pick one ticker over another, but at some point they're going to give GTHP a shot, and when they do, the low float should yield some impressive results.

Guided thought the PMA was a slam dunk last time and had no backup plan. We all know how THAT worked out. This time, they have two new 400-patient clinical trials, both of which have a protocol designed with FDA input. It's as close to a slam dunk as an FDA submission can get, IMO.

I really have no feel for the NMPA and how the market might react to news of NMPA approval. $$$ millions from SMI's partners will turn heads, though, if the NMPA approves the device. I have no illusions about timelines though. The SMI Agreement sets a deadline for commercialization of September 2025 but SMI Deadlines don't mean anything.

Best of luck to All Ye Faithful!