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Funny they hadn’t even submitted there application to the FDA one year ago!
Funny, we said the same thing one year ago
Technically there were insiders purchasing because at least half reached into their own pockets to cover taxes on shares versus selling shares to cover those same taxes.
The average time for this type of devices is 8 months. I'm expecting it by the end of this month hopefully if there's no delay due to covid.
Gotcha. Well fingers crossed these research partners are impressed with the accuracy. Also I keep checking insider trading and only automatic sells in the last 3 months which is good. No purchases though.
You have all the information that is out there at this point.
I've been bullish on Endra for a couple years now, but as we await further news about FDA and in light of the recent Colorado and European university collaborations, do you guys recall seeing any independent data showing TAEUS efficacy compared to the current standard of care (MRI)? Is there any possibility that these universities come back and say, "Nope, sorry your product is not sufficient at determining liver fat in an acceptable manner"? I do recall seeing something that they had data based on their protoype and ENDRA saying that the commercialized product would be even better and more accurate than their prototype.
Any day the sky turns blue.
https://www.accesswire.com/630080/ENDRA-Life-Sciences-Announces-New-Clinical-Study-Partnership-with-Inselspital-University-Hospital-in-Bern-Switzerland I know it is a couple of weeks old but still good news!
Got me 12k shares maybe 13k for luck. Stalking this biatch for a month 321 like my number lol
What’s that you say up sharply?
Bet you would rather be in NDRA today then our other stock.
Yep I bought more just like you with your fav.
Down sharply!!!
Looking forward for the 10k. Sometimes in mid march?
Interesting...A shell company. Not that there is anything wrong with that. Paper..
No not even close. We won't see earnings report until March most likely.
The Key issue right now is FDA decision.
CriTech Research designed the TAEUS software for NDRA.
From the CriTech website: " Our work has a 100% first-time acceptance rate from FDA."
CriTech was founded in 1994, specializes in medical software development, has completed over 450 projects and has 100% submissions approved by both FDA & EU over 27 years of experience.
NDRA submitted its FDA 510k application late June 2020. Likely approval is due anyday now.
Check out the CriTech website:
https://www.critech.com/compliance/
The design & manufacturing of the TAEUS platform is outsourced to Starfish Medical & CriTech Research. NDRA does not plan to bring the manufacturing in-house. NDRA is partnered with GE Healthcare who is helping with marketing & introducing TAEUS to their GE customer base. This is all consistent with NDRA's light asset model business strategy & will greatly reduce manufacturing & commercialization costs.
Yes excellent. You know something's afoot when the first 100 Warrant Buy of mine went off at .489899 this AM....
$NDRA
Pumped about this, was making me nervous prior to the run-up.
Endra now in compliance at the NASDAQ.
https://listingcenter.nasdaq.com/noncompliantcompanylist.aspx
I've thought for some time that ENDRA is a monster. Awaiting FDA approval, followed by sales of TAEUS. ENDRA could achieve a hefty market share in liver diagnostics globally.
$NDRA/W
HUGE for NDRA's TAEUS diagnostic platform:
Rebecca Winderman, MD, Director of the Dept of Pediatric Gastroenterology, Hepatology & Nutrition at Jamaica Hospital Medical Center in Richmond Hill, N.Y. :
"Well this is a bombshell. Huge meta-analysis evaluating some 4,000 patients showed 25% of patients with Non-Alcoholic Fatty Liver Disease (NAFLD) had normal ALT. Numbers weren’t any better for patients who had advanced to Non-Alcoholic Steatohepatitis (NASH) 19% of whom also had normal ALT value."
"We DESPERATELY need non-invasive bio markers for NAFLD and NASH. For now, liver biopsy remains gold standard."
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage... it is unreliable with NAFLD & NASH...
Bottom line, the medical community is desperate for the TAEUS technology which is approved for CE Mark in Europe & pending FDA 510k approval.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961232/
Yeah definitely not normal
anticipation of the 510k plus flippers to join in for a quick buck. I said few days ago the off hour trades look not normal to me, it seems like a trap.
But what explains the run up on no news? Rumors?
healthy pullback . added today and will add more if it goes back to 1.5 area
So what's the consensus here on the run up on no news followed by the pull back on no news.
Wonder if this will run up Post Market, and Pre Market tomorrow?
NDRA/W
Here she comes again. This is crazy
Yep patterns like that get discovered and don't last. IMO
This is why I don't follow my own advice. If i bought yesterday with intentions of selling in today's premarket I'd be getting my butt kicked
Not that I am aware. The worst case is they could say they need a de novo approval which would take another 3-4 months.
Is there any reason why FDA wouldn’t approve? What concerns might they have? Seems unlikely they’d have concern on this technology.
IMO it's FOMO on FDA approval.
ENDRA Life Sciences Further Strengthens TAEUS(R) System Intellectual Property Protection with Issuance of 14th U.S. Patent
Tue, January 26, 2021, 5:00 AM
ANN ARBOR, MI / ACCESSWIRE / January 26, 2021 / ENDRA Life Sciences Inc. (''ENDRA'') (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), has recently been issued U.S. Patent 10898166 (the ‘166 patent) from the United States Patent & Trademark Office (USPTO). This new patent, titled "Systems and Methods for Imaging Biological Tissue Structures," defines a hybrid integrated ultrasound/ thermoacoustic system and method that locates and registers the ultrasound and thermoacoustic portions of the invention relative to one another.
The ‘166 patent complements ENDRA's U.S. patent 10028662, which relates to an ultrasound/thermoacoustic system and method that utilizes separate ultrasound/ thermoacoustic systems concurrently. In addition, it is the parent application to recent patents that have issued in Europe and China, European Patent 3294142B1 and Chinese patent ZL 2016 8 00267062, respectively.
"The ‘166 patent supports ENDRA's goal to develop applications for our proprietary TAEUS® technology in areas of high unmet clinical need and with no practical existing tools. It is a key step forward in the development of optimized hybrid ultrasound and thermoacoustic imaging systems for a wide variety of clinical applications, including Non-Alcoholic Fatty Liver Disease (NAFLD)," explained ENDRA's Chief Executive Officer, Francois Michelon. "Our IP portfolio continues to grow and currently stands at 80 assets, which we define as patents issued, filed, licensed or in preparation. As we advance TAEUS® commercial launch plans, it is essential to protect our valuable intellectual property in priority global markets."
ENDRA's commercialization of TAEUS® includes establishing clinical research partnerships worldwide, with an initial focus on Europe and the U.S. To date the company has established five research partnerships including two in Europe and three in the U.S. In December 2020 ENDRA renewed its collaboration agreement with the GE Healthcare unit of General Electric Company, extending the agreement's term by two years to December 16, 2022. GE Healthcare is the global leader in clinical ultrasound and has been ENDRA's partner since 2016.
TAEUS® is currently cleared for sale in countries that recognize the CE mark, including those in the European Union, and a 510(k) application has been submitted to the U.S. Food and Drug Administration.
About NAFLD
NAFLD is a condition closely associated with obesity, diabetes, hepatitis C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects over 1 billion people globally and is estimated to cost the U.S. healthcare system over $100 billion annually. NAFLD is often asymptomatic and if left untreated, can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical, and include expensive Magnetic Resonance Imaging (MRI) or an invasive surgical biopsy.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with the over 1 million ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over 1 billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.
Forward-Looking Statements
All statements in this news release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. Examples of forward-looking statements include, among others, estimates of the timing of future events and achievements, such as the expectations regarding commercializing the TAEUS® device, establishing evaluation reference sites and initial sales in Europe, receipt of U.S. Food and Drug Administration regulatory approval and expectations concerning ENDRA's business strategy. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others, our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of COVID-19 on our business plans; our ability to find and maintain development partners, market acceptance of our technology and the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA's filings with the Securities and Exchange Commission. The forward-looking statements made in this news release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
Company Contact:
David Wells
Chief Financial Officer
(734) 997-0464
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com
SOURCE: ENDRA Life Sciences Inc.
View source version on accesswire.com:
https://www.accesswire.com/625884/ENDRA-Life-Sciences-Further-Strengthens-TAEUSR-System-Intellectual-Property-Protection-with-Issuance-of-14th-US-Patent
very interesting off hour market actions. it's been going on for last few weeks already. seems like they want to push the price up in off hours. im afraid it's a trap by shorts.
Seriously! You can set your watch to it.
Any thoughts as to why?
You could make a living buying this when the market opens and selling it in the pre market next day.
Volume Precedes Price...
NDRA set a record for the highest volume day in its history last Tuesday 1/19/21 with 18 million shares traded only for the record to be broken the very next day with 33 million traded. That wasn't day traders, it was accumulation as witnessed by the share price not only holding but increasing in the following days. NDRA also had 4 Fidelity Funds buying shares for the first time recently. In addition, the NDRAW volume has surged this past week after being DOA in 2020. This is Very Bullish action.
The FDA 510k submission was June 2020 & everyone knows the likely approval is coming sooner than later, whether it is this week or next month. It will be a game changer for NDRA & sales will soon follow.
Tuesday will be the 10th consecutive day closing at $1.00 or above so NASDAQ compliance is in sight...
The funds & investors currently buying NDRA are not scared of the daily chart. Yea, the share price has doubled this past week. Some are waiting for the trap door to open with a major price drop but it hasn't happened. Instead, the share price is rising... Why? Look at NDRA's market capitalization of $88 million...that is tiny. NDRA has leading edge technology in its TAEUS platform that will be 50X cheaper than MRI. NDRA already has a Vietnam distribution agreement signed. NDRA is partnered with GE Healthcare. With FDA 510k approval NDRA will be worth a market cap of $200 million to $300 million.
The daily chart is important but the share volume & market capitalization is where the truth lies...
Up 20% Pre-market. Warrants up 25%. 83,300 Bid @ $2.70.
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