is saying, "You're not as 'powerful' as you think."
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Well, it "sounds" like they haven't been sitting around with their thumbs stuffed in the a$$.
Guided Therapeutics Plans Growth for 2020 After Closing Significant Financing
January 28, 2020
Since Release
$0.1908
0.0425
28.66%
Guided Therapeutics Plans Growth for 2020 after Closing Significant Financing
Significant Reduction of Debt and Improved Cap Structure Also Achieved
Contacts
Mark Faupel
Guided Therapeutics
770-242-8723
Guided Therapeutics, Inc. (Pink Sheets: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced today the Company’s plans for 2020.
The Company’s main goals for this year are:
Restart discussions with the FDA and begin work on a small confirmatory study to support the claims of the previously completed pivotal study – The Company has already contacted FDA and informed them to expect the updated protocol for review. The outline for the protocol was previously agreed to during previous meeting between FDA and the Company. FDA also agreed to reduce the criteria for sensitivity of the test, a benchmark that was reached in the completed pivotal study of 2,000 women. Based on these developments, the company intends to discuss with FDA completing the smaller confirmatory study under one of three possible approval scenarios: 1) as part of the normal premarket approval process 2) via the de novo 510(k) route for new technologies or 3) as part of post-marketing studies. The latter two strategies would likely reduce the time to US market launch and would need to be agreed to by FDA.
Start clinical studies for Chinese FDA approval and achieve approval by Q4 2020 – Company intends to fill near term purchase order of 5 devices in Q1 2020 and, once our Chinese distribution partner Shandong Medical Instrumentation Co, Ltd. files with Chinese FDA as a Class 2 device, start to receive payments on larger $2.5 million Purchase Order.
Start taking new orders for Europe and Russia based on final assembly of LuViva at new manufacturing site in Hungary – Contract manufacturer is now ISO 13485 approved to assemble LuViva. New CE Mark with expanded claims has been applied for and expected to be granted in Q1 or Q2 of this year.
Jumpstart sales growth in Middle East and Indonesia - New agreements and subsequent sales with current distributors and addition of new distributor covering a total of 19 countries are expected to generate significant new orders in 2020.
Financial Filings – The Company anticipates releasing Q2 2019 (10Q) financial results later this month and 2019 Q3 (10Q) financial results early in February to catch up with its SEC filings.
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink Sheets: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200128005060/en/
News powered by iR Direct — Copyright © 2020 Issuer Direct Corporation.
All Rights Reserved.
Geee, I thought it said 3,300,000. Maybe I should invest in an eyeglass company.
Outstanding Shares 3,319,469 01/22/2020
Authorized Shares 3,000,000,000 01/22/2020
Nothin' yet. Where's the dough?
Another nice day. Bring on my 10 bagger!
Hopefully the Phoenix and not Hoboken.
Ed, I'm sure the test must be a lot of, "FUN", as you. Perhaps they can sell tickets. Tesla? Tesla?
I hope you're right, USA Dave.
I respectfully but completely disagree. With 3 billion shares to dilute they can raise a little bit of money but allegedly they won't need to for a while.
My only concern is where are the announcements on any potential orders and sales? Financing a company that doesn't produce revenues is flat-out stupid. There MUST be a potential revenue stream to be announced.
I try to remember and to keep in perspective that Gene inherited this mess, he didn't start it. His pedigree doesn't say, "stay here at this piece of s*** to retire" unless he can see things that can happen in the future. He certainly doesn't have to be here. And he's doing a much better job than you or I could do, or anyone else on this message board. Thankfully we all know what we bought when we purchased this stock. There were no surprises.
I'm a big fan of orders, sales and espacially GROSS MARGIN (read: disposables...). Unfortunately I haven't seen orders since financing was announced. That MUST be soon or myjo ends up correct. Financing funds get squandered and we do the shampoo again (wash, rinse, repeat).
I think that may be next, USA Dave. Not sure who'd bother wasting all this time on this even though money is paltry unless there was a potential revenue stream in very near future.
No, you said BK was next. Nothing more and nothing less. No one here has a short memory, sir.
I think it's pretty amusing that nobody really knows anything, yet we've all whipped ourselves up into a lather on different sides predicting doom and gloom or glorious days ahead.
What? No Friday news bad news dump going into the weekend with no one around to talk about it? Scandalous! BK ON THE WAY (...not...)!
Patience Luke.
I'm sure all of that will change once there's an announcement and we can figure out what's really going on.
Well, it certainly has been a long time coming. Like a year since the announcement about all the debt forgiveness. A friend of mines wife has espoaghal cancer right now and years ago we lost another one to cervical. Another friend died in December 2019, a different type of cancer, bladder, but overall, I have a big f'n personal axe to grind with cancer.
Vendors for gave debt. Not saying it's going to happen here but I watched it over and over again, with companies like Coleman, Pepsi ,Frito-Lay, Fram, Lee, Millbrook Fisher-Price etc. I know it's a different industry and they sell different widgets but I think in theory it would look the same. In theory..... In the case with Pepsi Pepsi ended up paying money to our company to keep Coca-Cola out. With Coleman after they forgave a lot of the debt and we emerge from bankruptcy they gave us what they considered to be dead merchandise which we were selling at 99% gross margin. It does take place. I'm not saying it's going to happen here. To me it would just make sense to try.
That's not correct. I've been there, twice with the same company, and seen it first hand. However I'm not saying that's going to be the case here. I'm certainly not worthy of being a CEO but I've seen others do it and do it successfully.
I guess we'll just have to wait and see what the hell's really going on
There's a lot of people on this message board that have way more experience than I have investing and playing the stock market. But I have worked for a couple of companies that have gone into bankruptcy and depositor in possession financing. One thing I learned and learned early was that when you're negotiating to come out of bankruptcy or to avoid going in it you can get a lot of your vendors to forgive a tremendous amount of your debt if you're willing to continue doing business with them in the future. I know some feel this management team is inept yet is highly educated. My bet is they know what they're doing and it's not an a+ b equals c transaction for any kind of a financing deal. No freaking way.
Thanks for the reply! Already in but at a higher level. Adding tomorrow.
We be at the bottom. Me thinks it's uppity up from here.
You can record anything you want. But you can't use it in a court of law unless you have the other parties permission. You should ask permission before you start recording. Let us few remaining here know how that goes.
You kind of sound hostile. Perhaps it's time to sell (quickly now, as you have predicted immediate bankruptcy filings.....) And move along as there's nothing to see here. Nothing left to see..........
Sorry, I forgot to wish you a Happy New Year!
Also, I was reviewing posts from several months ago and saw that many times posters mentioned the "phones were shut off" or the "number was disconnected". I called the number to see. It rang and picked up on the phone tree. So, Gene Cartwright the CEO asked you to call him and you, ahhhemm, didn't bother? OK. Makes sense. Personally, if I had money in I would have done it. You clearly sold your shares previously?
I've been through bankruptcy before and, it's true, it costs a tremendous amount of money for the process. It ain't that. But we're all entitled to our opinions and we get to see what shakes out.
Disagree on the Bankruptcy. You don't turn the phones on to file bankruptcy. But, I'm just a Schultzy. I see nothing, I know nothing. I would have to agree on possible/probable massive dilution. Any financing deal for a company with no sales, no revenues, no etc and has cleared the deck of nearly 3 billion shares by RS, almost all now available? Yeah. That's a better bet now that the phone lines are back up.
But here's the rub... they would need MILLIONS of dollars to get going on the long-promised China FDA trials. What idiot would finance this stone UNLESS there were assurances/plans/agreements/orders, etc. that showed that someone's hard-earned money wouldn't be squandered AGAIN? I'm trying to think of an analogy but I'm deep into the Vesica. HELP ME.
By the way, its nice to see debate on here again, good or bad. Sometimes I think it's just me, USA and Eddie.
.…..and I thought I had a crapload of shares.
Some of you must have a Google on your phones. I have one but its probably an older model and not as up to date as the ones you kids probably have. But my older Google has great information in there on this technology. Tonight I sit here having a(nother) glass of Glenlivet 15 (yes, it's on ice, I'm not a total animal...) and am encouraged that the very loud flushing sound I heard this afternoon was not my investment and 31,000 shares given up at fire sale prices AFTER finding out that someone paid a phone bill at the corporate headquarters. Right now I think I'm sitting pretty with the number of shares I have. Sitting pretty. Check out the BOD... no deep pockets? Pffft!
Patents
Granted United States Patents
5,792,049
Spectroscopic System with Disposable Calibration Device
5,860,421
Spectroscopic System With Disposable Calibration Device
5,924,981
Disposable Calibration Target
6,002,482
Disposable Calibration Target
6,045,502
Analyzing System with Disposable Calibration Device
6,055,451
Apparatus and Method for Determining Tissue Characteristics
6,088,606
Method And Apparatus For Determining A Duration Of A Medical Condition
6,192,734
Disposable Calibration Target
6,226,541
Apparatus and Method for Calibrating Measurement Systems
6,400,875
Method For Protecting A Fiber Optic Probe And The Resulting Fiber Optic Probe
6,577,391
Apparatus And Method For Determining Tissue Characteristics
6,590,651
Apparatus and Method for Determining Tissue Characteristics
6,870,620
Apparatus And Method For Determining Tissue Characteristics
6,975,899
Multi-Modal Optical Cancer Diagnostic System
7,006,220
Apparatus and Method for Determining Tissue Characteristics
7,301,629
Apparatus and Method for Determining Tissue Characteristics
8,644,912
System and method for determining tissue characteristics
8,781,560
Method and apparatus for rapid detection and diagnosis of tissue abnormalities
D714,453
Hand Held Unit for Diagnostics or Measurement
D724,199
Medical Diagnostic Stand Off Tube
D746,475
Mobile Cart
Technology
Biophotonics is the science of harnessing light to image, detect and manipulate biological materials.
The products developed by Guided Therapeutics are derived from our biophotonic technology platform. We use light to scan tissue and detect chemical and structural changes at the cellular level. These changes from normal conditions can indicate the early stages of cancer. Unlike most conventional cancer diagnostics, our technology is designed to provide a result immediately after the scan and with no painful biopsy tissue sample to be sent to the laboratory.
The scanning technology can see below the surface of the tissue to detect disease before it may be visible to conventional testing methods such as cytology or pathology.
Biophotonics can detect disease before it becomes obvious on the surface.
Biophotonics is used in medicine to study tissue and blood at the macro (large-scale) and micro (very small scale) level to detect, diagnose and treat diseases in ways that are non-invasive to the body.
The LuViva® Advanced Cervical Scan uses reflectance and fluorescence spectroscopy to detect both physical and chemical changes in tissue that are markers of cervical disease.
Reflectance
Reflectance spectroscopy measures the color and intensity of reflected light and can be used to determine if structural changes are taking place in tissue. In the case of LuViva, structural changes that effect light reflectance are: epithelial thickening, nuclear size and content and increased blood flow.
Fluorescence
Fluorescence spectroscopy measures the wavelength of light that is re-emitted from an object that has been illuminated. It is used to determine the presence and concentration of certain chemical markers present in tissue. In the case of LuViva, fluorescent markers present that may indicate the early stages of cancer are: tryptophan, flavins and/or collagen.
Other Cancers
The platform technology that is LuViva can be applied to other forms or carcinoma. We’ve conducted human testing with the technology on patients at risk for esophageal cancer with promising results. While a great deal more testing and development work needs to be done on that product, we believe that there is a need for our technology in the esophageal market.
Other cancers, in addition to cervical and esophageal, where the technology can be applied:
Head and Neck Cancer
Anal Cancer
Colorectal Cancer
Skin Cancer
Management Team
Gene Cartwright - Chief Executive Officer
Mr. Cartwright was appointed CEO in January 2014. He brings over 30 years of experience working in the In vitro diagnostics industry. He joins Guided Therapeutics from Omnyx, LLC, a Joint Venture between GE Healthcare and the
University of Pittsburgh Medical Center, where, as CEO for over four years he founded and managed the successful development of products for the field of Digital Pathology. Prior to his work with Omnyx, LLC, he was President of Molecular Diagnostics for GE Healthcare.
Before joining GE, he was Divisional Vice President/General Manager for Abbott Diagnostics’ Molecular Diagnostics business. In his 24 year career at Abbott, he also served as Divisional Vice President for U.S. Marketing for five years.He received a Masters of Management degree from Northwestern’s Kellogg School of Management and also holds a Ph.D. in chemistry from Stanford University and an AB from Dartmouth College.
Mark L. Faupel, Ph.D. - Chief Operating Officer
Dr. Faupel currently serves as a managing member of Shenghuo Medical, LLC (“Shenghuo”), a company with licensing rights in several Asian countries for the Company’s LuViva Advanced Cervical Scan. He previously served on the Company’s board of directors through 2013 and has more than 30 years of experience in developing non-invasive alternatives to surgical biopsies and blood tests, especially in the area of cancer screening and diagnostics. Dr. Faupel was co-founder of the Company and also served as the Company’s Chief Executive Officer from May 2007 through 2013. Prior thereto was the Company’s Chief Technical Officer from April 2001 to May 2007. Dr. Faupel has served as a National Institutes of Health reviewer, is the inventor on 20 U.S. patents and has authored numerous scientific publications and presentations, appearing in such peer-reviewed journals as The Lancet. Dr. Faupel earned his Ph.D. in neuroanatomy and physiology from the University of Georgia.
Richard L. Fowler - Sr. Vice-president, Engineering
Mr. Fowler is responsible for identifying new technical and business opportunities for Guided Therapeutics. These opportunities include new technologies, product lines or business acquisitions that are strategic to the Company's business. Mr. Fowler was formerly VP of Engineering at Guided Therapeutics where he oversaw the successful development of the BiliChek®Non-invasive Bilirubin Analyzer.
Mr. Fowler has more than 20 years experience in developing and bringing to market electro-optical devices. Prior to joining Guided Therapeutics, Mr. Fowler was President of Laser Atlanta Optics, Inc. where he developed and launched a new, low-cost laser range finder. He has also held management positions with GEC Avionics, Inc. and General Dynamics. Mr. Fowler holds a degree in Electrical Engineering from the University of Texas.
Board of Directors
Michael C. James, Managing Partner, Kuekenhof Capital Management, LLC - Chairman
Mr. James has served as a member of our board of directors since March 2007. Mr. James is also the Managing Partner of Kuekenhof Capital Management, LLC, a private investment management company. He also holds the position of Managing Director of Kuekenhof Equity Fund, L.P. and Kuekenhof Partners, L.P. Mr. James currently sits on the Board of Directors of Millennium Biotechnologies Group, Inc. Mr. James was Chief Executive Officer of Nestor, Inc. from January 2009 to September 2009. He was on the Board of Directors of Nestor, Inc. from July 2006 to June 2009. He was employed by Moore Capital Management, Inc., a private investment management company from 1995 to 1999 and held position of Partner. He was employed by Buffalo Partners, L.P., a private investment management company from 1991 to 1994 and held the position of Chief Financial and Administrative Officer. He was employed by National Discount Brokers from 1986 to 1991 and held positions of Treasurer and Chief Financial Officer. He began his career in 1980 as a staff accountant with Eisner LLP. Mr. James received a B.S. degree in Accounting from Fairleigh Dickinson University in 1980. He is chairman of the audit and compensation committees.
Richard P. Blumberg - Member
Mr. Blumberg has been a long-time investor in the Company. Since 1978, Mr. Blumberg has been a Principal at Webster, Mrak & Blumberg, a medical-legal and class action labor litigation firm. He is also currently the Managing Member of Shenghuo Medical, LLC (“Shenghuo”), a company with licensing rights in several Asian countries for the Company’s LuViva Advanced Cervical Scan, and is the Managing Member of Elysian Medical, LLC, a company with world-wide rights for certain breast cancer detection technology. He served from 2004 to 2007 as Chief Executive Officer of Energy Logics, a wind power company that developed projects in Alberta, Canada and Montana. Mr. Blumberg holds a B.S. in Electrical Engineering and Computer Science from the University of Illinois and received a J. D. from Stanford University. He also brings extensive experience as a venture capitalist specializing in high-tech and life science companies.
John E. Imhoff, M.D., Southeast Eye Center (Formally Imhoff Eye Center) - Member
Dr. Imhoff has served as a member of our Board of Directors since April 2006. Dr. Imhoff is an ophthalmic surgeon who specializes in cataract and refractive surgery. He presently serves as a member of the Hawaiian Eye Foundation’s Scientific Advisory Board. He is also one of our principal shareholders and invests in many other private and public companies. He has a B.S. in Industrial Engineering from Oklahoma State University, an M.D. from the University of Oklahoma and completed his ophthalmic residency at the Dean A. McGee Eye Institute. He has worked as an ophthalmic surgeon and owner of Southeast Eye Center since 1983. He serves on the compensation and audit committees.
Gene Cartwright - Member & CEO
Mr. Cartwright was appointed CEO and to the board of directors in January 2014. He brings over 30 years of experience working in the In vitro diagnostics industry. He joins Guided Therapeutics from Omnyx, LLC, a Joint Venture between GE Healthcare and the
University of Pittsburgh Medical Center, where, as CEO for over four years he founded and managed the successful development of products for the field of Digital Pathology. Prior to his work with Omnyx, LLC, he was President of Molecular Diagnostics for GE Healthcare.
Before joining GE, he was Divisional Vice President/General Manager for Abbott Diagnostics’ Molecular Diagnostics business. In his 24 year career at Abbott, he also served as Divisional Vice President for U.S. Marketing for five years.He received a Masters of Management degree from Northwestern’s Kellogg School of Management and also holds a Ph.D. in chemistry from Stanford University and an AB from Dartmouth College.
Mark L. Faupel, Ph.D. - Member and COO
Dr. Faupel currently serves as a managing member of Shenghuo Medical, LLC (“Shenghuo”), a company with licensing rights in several Asian countries for the Company’s LuViva Advanced Cervical Scan. He previously served on the Company’s board of directors through 2013 and has more than 30 years of experience in developing non-invasive alternatives to surgical biopsies and blood tests, especially in the area of cancer screening and diagnostics. Dr. Faupel was co-founder of the Company and also served as the Company’s Chief Executive Officer from May 2007 through 2013. Prior thereto was the Company’s Chief Technical Officer from April 2001 to May 2007. Dr. Faupel has served as a National Institutes of Health reviewer, is the inventor on 20 U.S. patents and has authored numerous scientific publications and presentations, appearing in such peer-reviewed journals as The Lancet. Dr. Faupel earned his Ph.D. in neuroanatomy and physiology from the University of Georgia.
So, something must be up. Phones back on? Out of nowhere? After half a year of being shutoff (unpaid bill?)? The company has been rumored to be destitute unless a financing deal is made, and now the phones are back on? Ha! Financing rumors abound.... Did Gene get it done? The guy has no reason to be here with this boat anchor of a company considering the strength of his resume UNLESS something legit is going on. Everyone must draw their own conclusions but it's clear to me what's happening.
Thanks to all. I appreciate it.
Hey, thanks IG, I'll keep getting ready.
Been watching and reading this for a while. Anyone care to share thoughts on where the bottom lies?
Chrissomebody, I'm aware that people have been able to speak to the CEO from numbers and emails provided on this forum. I've never bothered to call the main number for the office myself until this morning. I only called the number because things here have appeared to be either really bleak, or ready to take off. Please accept my apologies for dismissing your efforts to call. I'm better than that before I start drinking (after that, all bets are OFF).
Hmmmm… That's the correct number and the phone lines are open today. Give them a jingle? Perhaps someone is there now to answer a phone. Maybe this is a good sign? Someone somehow paid the phone bill?
I just called the phone number to the main office in Peachtree Corners, GA. You know.... the phone number that everyone has been saying on here is "not in service"? That's crap. I got the phone tree. So those of you poo-poo'ers claiming you called, try calling the number for real this time. Gee whiz, we all can do better than that.
Agreed, HUGE potential. I usually just watch and read here, I wanted to post to let those know who've never had to wear a CPAP machine that this is quite possibly incredibly market changing for this CPAP market.