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I have a constant buy order in at .78 now.
If it gets filled I add a new one. Seems to be working pretty well for the time being. I've gotten a bunch filled
Wait until there is some good news which should be soon. This may have been generated by someone taking a big position in the warrants NDRAW.
This thing went from 90 cents to 80 cents in what, 20 minutes? Crazy shit
Based on the chart pattern, 2 high vol up days followed by a flag/pennant formation, next move up if we do break out is to about a buck. TA doesn't always work with these penny stocks though.
I was trying to the same.
I can see that. I tried to pick some up at .78 this afternoon but unsuccessful. Left the order open though
The virus has significantly slowed their efforts in Europe.
Seems like, with the market cap so small, most people agents giving the CE Mark much value.
I think the Robarts Trial played into getting the CE and FDA.
What did they have to do to get the CE Mark? Were there clinical trials involved or is it just a matter of the product not harming anybody and you get the CE?
I agree I think the key is one of the coming catalysts most likely the FDA approval when it happens.
Thanks for that. Finally had a half hour to check it out, that's a pretty impressive presentation. Im still adding under 80 cents. Seems like the share price does mice nicely on news.
Love it. I'm long and excited about the presentation and the potential!
It is also in Ivins, UTAH and that is where the trail will occur. It took me literally 5 seconds to verify that.
"Rocky Vista University is a private, for-profit osteopathic medical school with campus locations in Parker, Colorado and Ivins, Utah. The school opened in 2006 as the only modern for-profit medical school in the United States, although several other for-profit schools have since opened. Wikipedia"
The efficacy will be proven by the trial as it should be.
Extensions are easy to come by witht he NASDAQ not a big concern. Just need to get the stock over $1.00 for 10 days should happen easily with any of the multiple catalysts about to happen.
FDA approval, Sales, Trials, Partnerships, New Ge agreement,etc
I thought it was a great presentation and mgmt did a good job of explaining the product, the need within the industry, and how they plan to go about positioning themselves as a cost effective point of case resource for clinicians. What I don't know and I think what scares me is the accuracy of efficacy % of their product and whether or not it's tolerable within the industry. I also found it interesting that CEO said their actual install at Rocky Mountain Vista would be better than their "prototype". Would have been nice for him to elaborate how the TAEUS installed at Rocky Mountain was superior.
Did anyone else notice that he referenced what I believe is Rocky Mountain Vista being in Utah? It's in CO, he should know that.
Market cap is SCARY low which is very concerning. Also would have liked them to touch upon the NASDAQ compliance issue and how they intend to get back into compliance. Does anyone know when they have until?
Have you got a link to that virtual presentation?
There is a reason the market cap is minuscule.....
I shall. Thanks
Listen to today's presentation
I might get my .80's filled yet. Dipped down to 82 cents earlier
Personally I hope not. Lol
Got my last fills under .70 a few days ago.
Looks like that won't happen, but I adjusted my order to 80 cents to add to my long term position. Might not get that filled either.
Yes it is. Im hoping to pick up some more around 70 cents with a little luck.
This is niiiiice!
ANN ARBOR, MI / ACCESSWIRE / November 12, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), a developer of enhanced ultrasound technologies, today announced that Rocky Vista University College of Osteopathic Medicine ("RVUCOM") has begun scanning patients in its clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS?) clinical system to assess Non-Alcoholic Fatty Liver Disease ("NAFLD"). The studies are being conducted at RVUCOM's Ivins, Utah location will be the first real-world cases to be performed with TAEUS in the U.S.
ENDRA has received the CE mark to sell the TAEUS system in Europe, and is awaiting clearance by the U.S. Food and Drug Administration for its 510(k) application to begin sales in the U.S. The data from the RVUCOM study, along with other announced and future studies, will be used to further build the clinical evidence base and establish the clinical utility of the TAEUS system in patients with NAFLD to support current and future commercialization efforts.
The goals of the RVUCOM study, include:
Comparing results obtained with ENDRA's commercial design TAEUS liver device against a baseline measure of liver fat as determined by MRI-PDFF (magnetic resonance imaging proton density fat fraction);
Scanning a target of 200 volunteers including fatty liver patients and healthy controls to contribute additional diversity and volume of patient data; and,
Providing ENDRA with ongoing clinical feedback regarding TAEUS product design, clinical workflow and clinical performance.
The principal investigator in the RVUCOM study, Jing Gao, M.D., who is a member of ENDRA's scientific advisory board ("SAB"), commented, "This is an exciting step for ENDRA and for Rocky Vista University as we advance use of the TAEUS platform in a real-world clinical setting. We believe TAEUS has the potential to address a significant unmet clinical need for the robust, practical, non-invasive assessment of liver fat."
"Working with RVUCOM and other leading clinical reference sites is an essential part of building our base of clinical evidence to support commercialization efforts for TAEUS," said ENDRA Chief Commercial Officer Renaud Maloberti. "We look forward to supporting and learning from RVUCOM, as well as other medical facilities that will be evaluating TAEUS."
This should do to mid 1’s quickly easily with good news. IMO
Yep, those will hopefully at least stop the bleeding. Im still holding a core position, though I must admit to trading an additional position a bit, buying at .69 and selling at .75 usually.
You should use Think or Swim which is part of TD it shows all the PR's.
On yesterday's Renaud said installations as in plural today was only one I expect a total of 3-4 in the next 2 months possibly one more in the next week to start.
Hopefully it is the beginning of many good things to come ie; Partnerships, new markets, sales growth, etc.
I did not. TD Ameritrade never shows NDRA news items or PR's.
Now that I know there are some I can find em though.
Did you see the PR's in the last 2 days? My guess more to come.
Something must be goin on today.
Yes the market cap is ridiculously low compared to a TAM of $21B.
The FDA approval can’t come quickly enough IMO.
Personally I was expecting the guy to have SOME opinion of ENDRA, one way or the other. But nothing
Says he uses MRI. Good thing is maybe this will go somewhere if we can get the word out. Freaking market cap is miniscule right now.
Hey Sunshine personally I question the visibility of CYDY more than I do NDRA.
There are many more serious NASH and NAFLD therapies in development that Endra is considering working with.
Just look at their Investor presentation for names. The last presentation was targeted towards that audience at HC Wainwright.
But I digress because I know you think you have Endra all figured out.
Good luck.
I know a guy who owns allot of CYDY and some NDRA. He actually knows allot about both.
Not surprised about your other guy CYDY while touching on liver seems to be after other diseases more. IMO
Good for CYDY, bad for Endra. When they just linger on for three years plus with just promises that approvals are coming soon, they usually don’t go anywhere. Story of ENDRA. Plus, they are running on fumes.
ADXS has followed a very similar path..
I ran into a guy involved with 3 NASH trials over at the CYDY board. He knows absolutely knowing about ENDRA or TAEUS, which surprised me a bit. I don't know whether this is good or bad truthfully.
Hopefully one of many to come.
Nice little run to close out the week!
Tell me about it. But I think it will work out well. $6 or more is great for me.
Very nice! I've kept adding as it's been dropping. Getting to an uncomfortable place however with how much I'm holding. Scared money don't make money!
HC Wainwright
Where is this from?
TAEUS Commercialization Is Within Sight; Reiterate Buy and $6 PT
European commercialization looks possible by year-end 2020.
Recall that in March 2020, ENDRA Life Sciences received CE Mark
approval for ENDRA’s fatty liver imaging probe (FLIP) as a non-invasive
liver assessment tool for NAFLD and non-alcoholic steatohepatitis
(NASH). Recall also that ENDRA’s collaboration agreement with the
GE Healthcare unit of General Electric (GE; not rated) extends through
January 2021, and under the terms of the partnership, GE Healthcare
is to provide support for ENDRA’s TAEUS commercialization activities
in a fatty liver disease (FLD) application. In return, ENDRA is providing
GE Healthcare certain rights of first offer with respect to manufacturing
and licensing rights for TAEUS in FLD. We expect the GE Healthcare
partnership to lower the hurdles of ramping up commercial activities in
Europe, and potentially later in the U.S. More specifically, we expect
the launch of TAEUS to leverage GE Healthcare’s strong position in
the ultrasound market. ENDRA’s sales team is already working closely
with the GE team in the initial target markets, which include Germany,
France, Switzerland, and the UK, to introduce its TAEUS technology to
existing and new GE ultrasound clients in radiology. While the strategic
partnership is extended for only one year, we think extension of the
agreement is highly likely, as the uniqueness of TAEUS provides a
first-mover advantage in the marketplace, where there is a significant
clinical need and technology gap for a safe, non-invasive, cost-effective
diagnostic tool to evaluate liver fat in patients with chronic liver disease.
We look for potential announcement of the TAEUS launch as a positive
catalyst by year-end 2020 or early 2021, and therefore, reiterate our Buy
rating and $6 PT.
An extensive pre-commercialization strategy was executed over
the last several years. Current options used to diagnose and monitor
liver fat in NAFLD patients, namely MRI and liver biopsy, are difficult
to integrate into clinical practice. On the back of its robust clinical
utility, affordability, and the availability in a point-of-care setting, we
believe ENDRA’s TAEUS liver device is well-positioned to fill the void
in clinical treatment options. Furthermore, we think the device’s ability
to accurately quantify fat in the liver at the point-of-care at a fraction
of the cost of MRI and biopsy should provide a distinct competitive
edge in the commercialization of the product. With commercialization
activities already in motion, we look for the company to capitalize on
its extensive pre-commercial activities, which was established in the
background by ENDRA during the last several years, and thus, be
able to leverage its CRM network of over 3,500 global clinicians. As
a part of its EU commercialization strategy, ENDRA plans to initially
focus on establishing clinical evaluation reference sites that have used
TAEUS to measure and monitor liver fat, and execute product marketing
communication and education campaigns in the target markets. ENDRA
has devised a hybrid commercial strategy, where it leverages both its
own direct sales team as well as GE Healthcare sales channels to
drive sales. While GE Healthcare would facilitate the sales uptake in its
core market, radiology, ENDRA’s sales team would drive awareness,
interest, and trial outside of GE Healthcare’s ambit, specifically targeting
clinicians in hepatology, endocrinology, and primary care.
ENDRA is strategically using pre-approval time to generate additional data in the U.S. We think it notable that to further
strengthened its 510(k) application, ENDRA is conducting additional verification testing. If everything goes as planned, the
company expects to begin commercial activities in 2021. Recall that on June 8, the company announced that it partnered with
the Medical College of Wisconsin for a clinical study to evaluate TAEUS in non-alcoholic FLD (NAFLD). The proposed study
is expected to enroll 75 subjects with NAFLD to compare TAEUS against a baseline measure of liver fat as determined by the
current standard of care, MRI-PDFF, a specialized method of magnetic resonance imaging (MRI). Along with data expected
to be generated at ongoing or planned studies, we expect data points from this study to further support the body of clinical
evidence already generated with TAEUS. Notably, along with the GE Healthcare partnership and the feasibility study conducted
by the Robarts Research Institute, which used healthy volunteers to establish the safety and efficacy of TAEUS technology,
we note that this marks the third clinical research partnership for the company in the U.S. In our view, by generating important
additional clinical data ahead of U.S. approval, we look for a strong launch in the U.S., a potentially positive year-end 2020
but more likely early 2021 catalyst.
ENDRA expects its TAEUS FLIP device to be classified by the FDA as a Class II device. This type of classification
is typically "cleared to market" by the FDA through the 510(k) submission process. As expected, in June 2020, ENDRA
submitted a marketing application for its TAEUS FLIP device via a 510(k) application. The company is eyeing FDA clearance
and commercialization of its product by the end of this year. However, we believe with reports we’ve reviewed that the FDA’s
docket of applications for review being rather full through year-end, we think an early 2021 timeline is more likely. Similar to its
European commercialization plan, which includes establishing clinical evaluation reference sites, ENDRA has secured three
evaluation sites spread out throughout the U.S., including one at the University of Pittsburgh Medical Center for the Mid-Atlantic
region, Medical College of Wisconsin in the Midwest, and Rocky Vista University in Utah in the Southwest. Again, while clinical
data from these three evaluation sites is not currently required for FDA clearance, the company plans to utilize these centers
as reference sites and exploit data to support the anticipated U.S. commercial launch.
Intellectual property strengthened ahead of the TAEUS launch. Recall that on October 13, ENDRA announced that the
World Intellectual Property Organization (WIPO) issued international registration certificates (the equivalent of U.S. patents) to
the company. The issued patents cover proprietary designs for ENDRA’s TAEUS FLIP, its thermoacoustic imaging probe, and
its thermoacoustic imaging probe with outdents. Of note, while one certificate protects the basic appearance of the FLIP device,
including relevant combinations of shapes and surface indicia, the second certificate protects a user-friendly embodiment of
the first certificate. The company now has 73 patents either licensed, issued, filed or in preparation, which in our opinion, should
provide robust intellectual property protection as ENDRA begins to commercialize its TAEUS technology in Europe.
Financial challenges remain but we think partnership with GE has already paved a smooth launch ramp. On August 17,
ENDRA reported its financial results for 2Q20, which included operating expenses of $2.9M, a 24% jump from the same period
in 2019 that was driven by increased product development and pre-commercialization costs. Net loss came at $2.9 million in
2Q20, or ($0.20) per share, and cash and cash equivalents of $0.7M as of June 30, 2020. Driven by voluntary early warrant
conversions, pro forma cash totaled approximately $2.4M as of August 14, 2020. We believe ENDRA has adequate funds for
operations ahead of the first sale of TAEUS systems in 4Q20, but look for the company to raise $2M to $5M in additional funds
to secure a smooth runway for the TAEUS launch going into 2H21.
Valuation and risks. Our $6 PT was derived by using a 20% weighted-average cost of capital for ENDRA shares to discount
free cash flows from annual sales of TAEUS, the company’s next-generation imaging technology platform, dividing them by
our projected number of shares for each year to account for the effects of share dilution, and then factoring in a 0% terminal
growth rate and 78% clinical program probability of success observed, 2013-2016, for Class II devices prior to 510(k) regulatory
submission. Risks to our investment thesis include failure of clinical trials, regulatory requirements for additional clinical studies,
unproven commercialization strategy, failure of products to show sufficient differentiation in targeted therapeutic indications,
patent expiry or invalidation, and potential to raise additional funds under poor market conditions.
They will perform a reverse split I expect..
The de-listing issue should resolve itself.
Several catalysts that should help FDA approval, Trials starting, Sales, and potential new partnerships.
Crickets here, huh? You guys still optimistic on NDRA? I'm starting to get concerned about the lack of news as well as how many days sub $1 with the potential to get de-listed by the NASDAQ
I have always understood that most companies like this don't get taken out until after CE Mark (which they have) and FDA approval (4th Qtr).
Time will tell.
I’ve been following this for two years and there really hasn’t been much clinical progress, but a WHOLE lot of new stock issued. If this really had the technical value you claim, this would have been taken out by now. Good luck.
TAM up to $21+ Billion in 2020 over $25 by 20’s. Per HC Wainwright presentation. All this potential with a current market cap of $20 Million.
The current MC is very low for the potential.
At these prices and the TAM this could be the easiest 10 bagger ever. Time will tell on that though.
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