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Ultrasound costs tens of thousands more, requires trained medical staff to administer, requires waiting for the lab to get results back, has to be administed in a clinical setting and to top it all off is 5 times less sensitive in measurement all in comparison to LXGTF HeartSentry.
The current gold standard for measuring endothelial function is ultrasound. HeartSentry wins that competition hands down.
Competition has nothing on LXGTF for sure.
Yes you too bro. Toss back a few for me. LXGTF will pop here soon.
Mm hmm, and being noninvasive means HeartSentry should slide easily through FDA Clearance as well. Can't say that for all cardiovascular devices.
Seeems like IRB focuses on any ethical concerns that might come up before human trials are authorized.
Yeah, just goes to show you why MD's are MD's.
Nice green close for $NMUS
Good Synopsis Here:
Lexington Completes IRB Submission in Preparation for Clinical Study
https://www.marketwatch.com/story/lexington-completes-irb-submission-in-preparation-for-clinical-study-2018-01-18
Published: Jan 18, 2018 9:00 a.m. ET
--Another milestone achieved as the Company moves towards HeartSentry human trials
VANCOUVER, British Columbia, Jan 18, 2018 (GLOBE NEWSWIRE via COMTEX) --
Lexington Biosciences, Inc. (cse:LNB) (otcqb:LXGTF) (the "Company" or "Lexington"), a development-stage medical device company, is pleased to announce it has completed its requisite documentation and submitted an application for Institutional Review Board ("IRB") approval of its pilot clinical study.
In preparation for commercialization of the HeartSentry device, the pathway for regulatory approval includes a clinical study utilizing human subjects. In preparation for the study, approval by an IRB, or ethics board, is necessary before all but the most informal human research can begin. The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study before it allows the study to commence. In some instances, it may require changes in study procedures or in the explanations given to the patient. Lexington engaged professional regulatory and clinical advisory assistance to ensure accuracy and diligence of its clinical protocol and procedures prior to submission.
Lexington's President Eric Willis comments, "Our IRB submission signals the start of a whole series of steps required to achieve eventual FDA clearance for our HeartSentry device. We worked diligently to submit a comprehensive application and look forward to a timely response. Once an approval is in-hand we can immediately move ahead into the investigative phase of the study. It is an exciting time at Lexington and we are really pleased to be on schedule with the execution of our strategic plan. 2018 is expected to be a pivotal year for us, with all our hard work coming to fruition as we continue to build a viable and sustainable venture providing real help for millions of potential consumers."
To find out more about Lexington Biosciences, interested readers are invited to visit our website and view our video featuring principal HeartSentry inventor Dr. Jonathan Maltz, Ph.D., which provides an excellent overview of our business proposition and opportunity ahead. Please also follow us on Facebook, Twitter and LinkedIn.
About Lexington Biosciences, Inc. (cse:LNB) (otcqb:LXGTF)
Lexington Biosciences is a medical device company developing the HeartSentry, a new non-invasive diagnostic device to measure and monitor cardiovascular health by assessing the function of a person's vascular endothelium - the vital innermost lining of a person's cardiovascular system. Currently, the standard of care is measurement using expensive external ultrasound by a highly trained technician. The HeartSentry core technology was developed at the University of California Berkeley over a fifteen-year R&D period involving many research studies and product iterations resulting in a portfolio of multiple pending and issued patents licensed to the company. Our aim is to make HeartSentry accurate, quick, and cost effective so it can become the standard of care for cardiologists, general practitioners, and ultimately patients for first line evaluation of a person's cardiovascular health. Lexington is engaged with the US FDA and other regulatory agencies on the required product approvals for the HeartSentry. For more information about the company please visit: https://lexingtonbiosciences.com/.
On Behalf of the Board,
"Eric Willis"
Eric Willis
CEO & Director
CAUTIONARY DISCLAIMER STATEMENT: The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
This news release contains forward-looking statements relating to the completion of the listing of the Company's shares on the Canadian Securities Exchange and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the failure to satisfy the conditions of the Canadian Securities Exchange and other risks detailed from time to time in the filings made by the Company with securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
CONTACT:
Lexington Biosciences, Inc.
+1 (800) 320-2640
info@lexingtonbiosciences.com
www.lexingtonbiosciences.com
Renmark Financial Communications Inc.
Laura Welsh: lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com
$LXGTF timeline to commerciaization is now clearer thanks to the most recent PR. First IRB clearance, then formal clinical testing with human subjects, then FDA clearance, then to market. Lots of posters on this board where not reckoning with IRB clearance, but its a necessary step.
2018 will be a stellar year for LXGTF for certain.
74K buys, to 87K sells today. Not sure why anyone would be selling at this level, while we are waiting for the results from the IRB.
Thats an interesting thought. I guess everyone hopes that hospitals would be more altruisitic than that.
$LXGTFHeartSentry monitor is the only device coming to market that portabley, affordably, accurately measures endothelial function with an eye to prevent heart attack and stroke.
$LXGTF chart shows we've been stuck in this lateral channel for several weeks now: https://www.barchart.com/stocks/quotes/LXGTF/technical-chart?plot=CANDLE&volume=total&data=I:120&density=H120&pricesOn=1&asPctChange=0&logscale=0&im=120&indicators=HLMA(10,8);RSI(14,100)&sym=LXGTF&grid=1&height=500&studyheight=100
RSI at 50, trading laterally. We really need something to shake this up, Hailstorm at the home office, anything.
Slow day in the Crypto cap market as well. But overall market cap holding above a half Trillion so I think the panic selling is done. The major coins: BTC, ETH seem to have stabilized as well. So all that spells relief for $ADAC.
$LXGTF up 14% on the 100 d mov av. But it needs a kick to break past that .45 resistance.
$LXGTF churning today in the low 40s.
$ADAC down 5% good time to load up.
LXGTF good place to consolidate your position before it makes its move to .50.
LXGTF looking like we should see a pop soon.
Looking for a starter position in ADAC at opening.
$ADAC looks ready to make a big move.
Actually they PR'd reception of the devices back in November, so more like they received the first devices several months, not weeks ago. And they are still well within the timeframe they publicised in LXGTF's material posted on their own website for FDA approval and commercialisation. If some poster here on the board were overenthusiastic in their projections of the time it would take to FDA clearance that shows how getting carried away in your enthusiasm for a worthy product can make you skip a few beats. LXGTF has been keeping us updated on the consulting they have been engaged to assure medical coverage compliance and that they have retained Diablo Research. And preparing the application for the IRB approval to commence testing on human subjects doesn't sound as easy as writing a home class book report either.So I think they have been keeping their nose to the grind stone. As far as working on the HeartSentry device for 15 year? No one has said that. The kind of tech, such as bluetooth uploading of data to the cloud for analysis, didn't even exist back then. Now the science behind endthelial diagnostics and the link to cardiavascular disease and stroke, that does go back 15 years. Johnathan Maltz, principal inventor of HeartSentry and Chief Science Advisor to LXGTF, spearheaded a lot of that at Berkely labs. But thats the pace of doing groundbreaking, paradigm shifting, peer-reviewed research on the modern biomedical research scene. Its the way modern medicine works. It may seem painstakingly slow, but would you really want biomedical companies to start sacrificing the scientific method to get to market faster? All that being said, once again, $LXGTF itself is well within the timeframe they posted in the literature on their website. 2018 should be a great year for them and for us investors.
$ADAC seems to want to follow the Overstock.com model? Big shoes to fill and a ton of upside potential. Considering a starter position before this goes up more.
Digital money is anything but old news. Its a volatile market and it gets knocked down, but it has way too much vitality to get knocked out at this point. Digital currency is an idea who's time has come. $ADAC
Thanks for the tip. I'm hearing good things about $ADAC.
Either way, looks like they haven't changed the expected schedule:
Thats GREAT NEWS for LXGTF: "Lexington Completes IRB Submission in Preparation for Clinical Study"
$LXGTF lunchtime slowdown. We should see it pickup now.
Let's get back over .45 today and establish a base there.
.40 support is rock solid. I'm looking to add here.
Looking good here as usual.
Back over .003 today?
We could test .001 during power hour.
Grabbed 3M LDSR to start off with
Added more let's close above the .0025 resistance!
$FERN added .003s