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Well that was a nice 20 min run. Curious what happened that it couldn't maintain after the announcement that their patent was issued.
Yes it does plus they will probably being exercising their warrants from the 12/19 offering some time soon which will be like another insider buy.
Gotta love seeing the executives taking a 33% pay cut in order to receive options. Shows faith in the future of the company.
CEO Michelon confirmed in today's PR release that NDRA is Anticipating 2020 Sales in BOTH Europe & USA.
3/26/20 Conference Call will provide more updates & further clarification.
"ENDRA's rigor with the European regulatory process yielded a successful outcome with the receipt of the CE Mark earlier than planned, in March. The CE Mark enables commercialization of ENDRA's TAEUS liver device in Europe"
"We are adapting our commercial plan where necessitated by COVID-19, but otherwise It Does Not Materially Affect Our Plan"
"some additional verification testing that was conducted during Q1"
"A Q2 submission positions us to receive approval of TAEUS FLIP in the U.S. in H2, and to initiate U.S. Commercial Activities in 2020."
"Our U.S. TAEUS clinical partners, including Rocky Vista University and the University of Pittsburgh Medical Center, will generate clinical data that will support our commercial activities"
I'm still buying as funds become available. I can't find a growth stock with better potential, better management or a better partner than NDRA.
I have been buying a few already have an oversized position.
Are you guys accumulating shares of NDRA during this time or staying put with current positions? I keep taking small nibbles trying to get my cost basis down but don't want to throw too much liquidity at it.
Very encouraging for when we return to some sense of normalcy.
ENDRA Life Sciences Provides European Commercialization Update
Executing Tactical Elements of EU Commercial Plan to Support Initial Launch Activities
ANN ARBOR, MI / ACCESSWIRE / March 17, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced more details today regarding its commercialization plan, which leverages the recent receipt of Conformité Européene ("CE") Mark approval for its TAEUS FLIP (Fatty Liver Imaging Probe) System.
"The CE Mark approval announced last week is a key milestone, and was earned earlier than anticipated," said Francois Michelon, CEO of ENDRA. "We have a solid foundation in place to move forward with initial launch activities in the EU, thanks to the pre-commercial activities we began implementing in 2018 and continue to execute as we move to commercialize the TAEUS liver device in our target markets. We are adapting our commercial plan where necessitated by COVID-19, but otherwise it does not materially affect our plan."
"We have been encouraged by the strong reception to date of our ongoing pre-commercial activities focused on the European clinical community, which have reinforced our excitement about the potential for TAEUS to address a significant clinical need and technology gap for a safe, non-invasive, and cost-effective point-of-care tool to the assess liver fat in patients with management of chronic liver conditions like NAFLD and NASH," said Renaud Maloberti, Chief Commercial Officer of ENDRA. "Our EU-based commercial team will work closely with EU clinical reference sites and our commercial partner GE to bring this exciting new technology to clinicians and their patients."
As a reminder, ENDRA is targeting over 200,000 global clinicians with an interest in liver health, specifically:
Radiologists focused on abdominal and liver imaging;
Gastro-Hepatologists focused on liver disease and treatment;
Endocrinologists, Internal Medicine and Primary Care physicians, focused on metabolic disorders, diabetes, and obesity.
"Recall the landscape of NAFLD-NASH today," continued Michelon. "At the front end, you have over a billion people globally affected by these conditions. At the back end, you have the first ever therapies to reduce liver fat rapidly approaching commercial availability, including the recent approval of Zydus' saroglitazar in India. While the advent of available therapeutics for patients is exciting, the lack of a practical liver fat measurement tool to screen-in patients and monitor their response to therapy will be a substantial barrier to getting patients properly evaluated and onto the therapies they need. MRI and liver biopsy are completely impractical tools for the scale and profile of NAFLD-NASH, creating an opportunity for a technology like TAEUS to fill that clinical treatment gap."
ENDRA is implementing its EU commercial plan with the following key elements:
1H 2020
Establish clinical evaluation reference sites in each target European market, including Germany, France, Switzerland and the U.K, to build clinical experience and serve as commercial springboards in each market.
Add ENDRA clinical specialists to provide direct support to clinical reference site partners and work with commercial partner GE Healthcare's commercial teams at a local level.
Initiate TAEUS product marketing communication campaign including direct marketing and social medial outreach to ENDRA's database of opt-in clinicians.
Launch a liver-focused company website in multiple European languages highlighting the CE-approved TAEUS liver system, providing local country sales contact information, and helping to build the commercial pipeline.
Mitigate COVID-19 related cancellation or rescheduling of trade shows (E.g., AIUM in New York and EASL in London) by creating digital education tools to maintain clinical relationships and continue generating interest in TAEUS.
2H 2020
Participate in key European hepatology and radiology conferences including the EASL International Liver Congress (August, U.K) NAFLD Summit (September, Ireland), and Drei Lander (October, Austria).
Deploy CE-approved commercial TAEUS systems to European evaluation sites, and support sites in their training, and clinical trialing of the device.
Expand TAEUS product training of GE commercial teams in each European market, leveraging ENDRA's in-country clinical evaluation sites as training venues.
Host a series of regional "lunch & learn" educational events in each key European market, targeting ENDRA's database of opt-in clinicians and local country introductions by GE, delivering hands-on group demonstrations of TAEUS.
ENDRA will provide additional details on EU commercial launch plans and activities on the previously announced Q4 and year-end report and conference call scheduled for Thursday, March 26th, 2020.
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 CT or MRI, but at 1/50th of the cost, at the point of patient care. TAEUS is designed to work in concert with the over one 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 one 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. www.endrainc.com
Forward-Looking Statements
All statements in this 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, statements we make regarding expectations regarding the registration of our TAEUS device in European jurisdictions and the timing of a U.S. 510(k) regulatory submission for our TAEUS device; plans relating to our supply chain and commercialization of the TAEUS device, including its adoption by clinicians; and expectations concerning ENDRA's product development and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; our ability to find and maintain development partners, market acceptance of our technology, 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 release speak only as of the date of this release, 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
Media & Investor Relations Contact:
MacDougall
Amanda Houlihan
(781) 235-3060
endra@macbiocom.com
SOURCE: ENDRA Life Sciences Inc.
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I love it! Seems like a great long term buying opportunity right now. It's just that all the good news has been diluted by the larger global issue we're facing right now.
The opinion on NDRA that counts is that of GE Healthcare & they want to lock up the rights to TAEUS.
TAEUS just received CE Mark approval for sales in Europe, we will get a commercialization update on the 3/26 scheduled CC.
GE Healthcare did extensive research on NDRA, renewed their Collaborative Research Agreement & is negotiating with NDRA for a TAEUS Exclusive Ultrasound Manufacturing Relationship.
Those facts demonstrate significant confidence in the technology that NDRA has developed & GE will assist NDRA with TAEUS marketing & sales.
The ALT blood test that checks for liver damage is unreliable with NAFLD & NASH, the medical community is desperate for TAEUS.
NDRA is not just targeting hospitals & medical centers for TAEUS sales but also NASH/NAFLD pharma companies & research labs.
Also consider the positive opinions of 800+ radiologists, pathologists, gastroenterologists & endocrinologists who have volunteered to collaborate with the TAEUS rollout.
And back down again...I am going to take my loss on this one and move into #RMSL.
replace amusing with "a sign". How spell check came up with that I will never know.
Hopefully that is amusing of things to come. Several potential catalysts are coming soon.
The Private Placements were a sophisticated move by NDRA. CFO David Wells deserves a lot of credit for crafting this.
To simplify things just focus on the common share count, that's what the float consists of. The private placements only added 900k common shares so the float now is 8.4M.
The other financial instruments in the private placements (Preferred, Warrants, etc) are NOT counted as common shares so they don't affect the float.
Despite the bears false claims, no hedge funds were part of this deal so we don't have short termers looking for a quick buck. NDRA recruited long term focused private investors, trust funds etc. I suspect many will hold until an eventual buyout. If some decide to "cash out" sooner that's when the amount of common shares in the float would begin to increase.
This strategy is Much More shareholder friendly than the typical financing that biotechs do when they sell all common shares into the market at once or god forbid sign up with a predatory lender/short seller like Sabby.
NDRA longs are in good hands with this management team.
16.3M shares issuable upon future conversion of Preferred Stock.
Half of those are questionable as they represent future dividends on the preferred that may or not be paid.
Reading the 8k / S-3 forms for the 2 December 2019 private placements is the best antidote to the bears spreading fear, uncertainty & despair.
The S-3 filing for all potential shares & warrants was required within 30 days of completing the 2nd private placement. The SEC wants its money for registration fee.
"Such registration does not mean that the "Selling Stockholders" will actually offer or sell any of the Securities offered by this prospectus."
"If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box = YES"
904,526 common shares issued increasing outstanding shares 7.5M to 8.4M. Company received $7.9M proceeds.
16.3M shares issuable upon future conversion of Preferred Stock.
8.3M shares issuable for future exercise of Warrants.
NDRA is now fully funded for the start of its commercialization phase.
How do you see this playing out in the near term? What benefits will accrue to the company, the shareholders, the warrant holders, etc.?
This comment from the Seeking Alpha article is particularly confusing.
"The company won't receive any proceeds from stock sales, but could receive proceeds from the exercise of warrants."
The Form S-3 that was filed Friday is from the 12/11/19 private placement when the share price was $0.90. It's "old news" so to speak & the share price has doubled since then to $1.81.
Can anyone explain what just happened with the appearance of these 25.6M shares???
The only rumor I want to come true is a purchase of Endra by an OEM of ultrasound for over $500mm.
Great day everyone. Many rumors are floating around about this stock. One thing is for certain through all the chaos is the chart tend. NDRA Chart is one of the most beautiful things I have seen in a long time. Very similar to $SAVA. Higher highs and higher lows
Better update the O/S it is at least 8.5MM at this point.
Sure he is and your going to replace Trump in the fall too.
You will see..... FM WILL BE OUT!!
I would be really surprised if FM was out pure BS by you IMO.
You haven’t heard wow
No CEO FM isn’t going any where. I think you put this on the wrong board.
The next news events;
1. FDA submitted
2. GE
3. CE approval
I also expected news about the new CEO within the next week!!!!
The key level of support will be 1.65 and 1.60. If we get above 1.80 this thing will fly!!!
If we stay above 1.60 this weeks this will make a charge to the 2 dollar land. Possibly by Friday or into earlier next week.
NO RAISE NEEDED TO COMMERCIALIZE 2020.
Private placement is done, cash is good at least thru the start of 2020 sales, probably longer.
One of the most efficient pre-revenue biotechs at managing their cash is NDRA. They're using the"asset light model" & will extend it beyond the development stage into the 2020 commercialization phase.
This business strategy saves money on staff & overhead, allows NDRA a low burn rate.
Partners Starfish Medical & CriTech Research helped create the hardware/software solutions. Starfish will also manufacture TAEUS.
NDRA is partnered with GE Healthcare & using GE sales staff to help sell TAEUS. In addition, CCO Renaud Maloberti:
"The customer relationship management system that we implemented will help us to manage and effectively target our growing list of over 800+ radiologists and pathologists, gastroenterologists and endocrinologists, who have already opted in to learning about and collaborating with NDRA."
If clay came around down whey go back to the 0,90 ore lower. It was a good clime. Waiting for the next ride. Or swing
* * $NDRA Video Chart 12-19-2019 * *
Link to Video - click here to watch the technical chart video
Probably not until after CE approval unless someone like a drug company or GE commits to a pre approval unit. Or issue a PO for once approval is attained.
Hi does someone know when the first sale takes place? This will be a big milestone for the company.
End, not to be a sticker, but the word is here..
"I feel bad for the folks taking a loss hear. "
Tax loss selling or folks fearing the next raise. They will be approved and selling product within 6 months.
I feel bad for the folks taking a loss hear. It appears totally unnecessary.
Not enough cash to survive I expect. They are down to 2.3 million
Apollo1452 is a very smart trader. Just sayin. Dont know the guy but his hunch is SPOT ON,
I know a $$ maker when I see one. Great opportunity and a trend to boot.
Market Makers are traders. Their job is to keep a balanced market but they are also responsible for being profitable. They can be bullish or bearish on any ticker. Some dive into the fundamentals of various companys. Don't assume MMs are always long , they can & do short sell a stock & profit on downtrends. Just like some of the MMs did for 3 weeks in September with NDRA.
After CFO Wells bought 10k shares recently some of us saw a 45k order listed on the Level 2 ask. Friday NDRA closed at $1.15, +.07 regular session on volume of 41,369 shares...what happened to the 45,000 share order at 1.14??? Fake order by a Market Maker to make Longs think there was excess supply. That MM hasn't covered his short position yet, so expect games to continue next week.
Some MMs have started soaking up size on the NDRA bid, building inventory to later sell at a higher price = bullish sign. They list a bid for 100 shares but actually will absorb 1000's at that price. Sneaky. When retail places a bid 100 = 100.
The manipulation on the ask is starting to abate last 3 days allowing limited bullish runs.
Short Interest decreased 7.5% last 2 reports but I suspect past retail short sellers might take another shot at NDRA soon. However, the pps is 1.15 now not 1.85 & the MMs are no longer decidedly bearish.
The recent private placement has secured funding thru 2020 Q1. The Robarts Research Institute top line data release for TAEUS was very good & the full bottom line report is due anyday now. Euro CE Marking submission will quickly follow & approval will come about 4-6 weeks later. NDRA has 500+ "early adopters" who are interested in TAEUS so early sales could seriously surprise. All of this for a Market Cap of only $8.5 Million...
Bottom line the Product Works and their is a significant market demand for it.
To understand last weeks PR read the following written by a guy with a PHD who understands this information well;
Sensitivity and specificity tell you how often the device makes a mistake. Great sensitivity means you catch all of the cases (you don't miss people who have the disease.) Great specificity means you don't accidentally tell people they have the disease when they don't.
That means MRI is really good at not telling people they have the disease, when they don't, but it misses a few cases. TAEUS is really good at finding all the cases, but accidentally tells people they have the disease when they don't.
Biopsy, is good at both, but means having someone poke a hole in you and pull out a piece of liver.
This is really good because we now have two complementary methods to screen for the disease. TAEUS will catch them all, and if they're not sure, they'll send them to MRI to confirm.
We actually don't care too much about accuracy of patients with less than 5% liver fat anyhow - they clearly don't need treatment.
The peer reviewed final data report on TAEUS from partner Robarts Research Institute that will be released in a matter of weeks is the key IMO. Formal documentation opens the door to GE, Tutes, etc. All they have now is a top line data PR.
But Endra won't sell for that cheap neither will I.
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