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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.
Sure ultra Sound is good enough until something better arrives. Wouldn't it be nice it pts. only needed one scan (TAEUS) and didn't need a next step to get diagnosed. (the majority at least)
I am sure he did his DD. Reading the white papers. website, etc
How does your doc know Endra has a great tool if he knows nothing about it? Very little clinical results made public. Almost seems like it is still in beta..
No, wife isn’t sick. No further testing required. I think you are missing the point of discussion. The point is Standard ultrasound can be used to prescreen individuals for fatty liver. The results of the scan determine the next step, if any.
Maybe his the reason they didnt dilute even more you'r right no clue why his on the board
No saying your wify is sick .
That's exactly one of the bigger issues with liver fat if not using a specialist. Too many false negative and false positive. Resulting in people getting pushed through to a specialist and generate huge health care costs without being sick, and of cause the worst, sick people not getting treatment because they didn't use an specialist.
93% of patients referred to a specialist are false negative only about 7% of those declared healthy are in fact sick and progress until they are found.
Second big issue is that people dont get testet period, at least not before they are sick for real.
Ultrasound is great but not for measuring liver fat although SOC until TAEUS arrives.
This video compares most non invasive measurements and is very informative. look @16:30
Maybe but folks on the new drugs that are coming will need to measure the progress as will the Dr's. A radiologist I know who see's more and more Fatty Liver weekly then he was seeing 5-10 years ago thinks this is a great tool.
You sound like me and Zoom I didn't see the need should have invested.
Ultrasound told us it was minimal, so a regular ultrasound machine can determine if one’s fatty liver needs further tests.
They can't quantify mildly fatty can they?
Check out the new presentation especially at the end where it compares the various options.
https://s3.amazonaws.com/cdn.irdirect.net/PIR/957/4797/ENDRA%20Life%20Sciences%20Investor%20Presentation%20Sept%202020%20Final%20V2.pdf
Is her liver over 5 or 25%? If it was my liver I would want to know?
Endra TAEUS can tell you normal Ultrasound cannot.
Not sure, I know. He has a good relationship with one of the other board members who is also a large shareholder.
Why is Lou B on the Board? That makes no sense. What value does someone like him add?? First Clearsign, then leaves. Now Endra.
“
Endra looks very promising, but they need to publish more data and should test in combination with standard non invasive markers, such as blood tests, BMI ect ect, as these are done anyway at the PCP.
All adds up to a better Sensitivity / specificity.”
This is key and Endra doesn’t want to share comparative results.
As I’ve mentioned my wife had an ultrasound on her liver and the medical report indicated a mildly fatty liver with no further tests required.
What additional specificity is provided by Endra’s device?
Great info and read on it, thank you!
I always value your opinion, so much appreciated!!
I think very few knows about Endra.
The point many misses is that gold standard is achieved by a very expensive MRI scanning, and is really not part of standard of care in the early lines of NAFLD, which is where the big market opportunity is for Endra. To diagnose and start treatment of NAFLD in the early stage.
I think the implementation of TAEUS, based on current data, is to replace biopsy, fribroscan and ultrasound at specialist after their Primary Care Physician has established suspicion of NAFLD.
Fact that current major share holders want to buy more shares is great. They paid about .84. Had it been a public offering they would have had to give 15-20% discount on sp anyway, so we might be better of this way.
Endra looks very promising, but they need to publish more data and should test in combination with standard non invasive markers, such as blood tests, BMI ect ect, as these are done anyway at the PCP.
All adds up to a better Sensitivity / specificity.
I know you didn’t ask me but thought I would add my .02.
I don’t think the Market really knows about TAEUS yet that will come with sales and FDA approvals.
The warrants exercised at .70 but they paid approximately.14 for each warrant for a total cost .84 to the investor.
The insiders exercised their warrants a couple of weeks earlier at full price of .87 plus the .14 they paid. Bullish IMO.
Do you think the market is not impressed with these figures and they're not "gold standard" enough to be a disrupter? Also, thoughts on the recent exercise of warrants generating $5 mill for the company? Said that ENDRA "accepted reduced exercise prices".
Interesting video. TAEUS reached AUROC .91 and 0.88 at MRI-PDFF values of 6% and 15%, respectively. So not quite up to gold standard above 6%. So guess TAEUS can be used in the early stages of the disease only as the gold standard of non invasive markers and just rival other non invasive markers >6% but below gold standard. The number here comes from NDRAs own Clinical Feasibility Study on their website. At least this is how I understand the numbers and the essence the video.
During the COVID-19 pandemic, it is important to increase diagnostics for liver disease because a growing number of studies have found that fatty liver increases the risk for severe COVID-19 symptoms. Healio Gastroenterology spoke with Francois Michelon, CEO of ENDRA Life Sciences,
https://www.healio.com/news/hepatology/20200811/qa-new-tool-may-detect-liver-fat-early-on-to-prevent-nash-nafld
What’s the cost of making that kit?
Not a bid deal just needs to go above a dollar for 10 days.
Spoke with IR won’t be a concern if that doesn’t happen by next year.
Any thoughts on the below disclaimer on my TD Brokerage account? Is this b/c of time they've spent below $1? Anyway for us to confirm if it's that or some other listing requirement?
*Nasdaq FSI: *Deficient: Issuer Failed to Meet NASDAQ Continued Listing Requirements
a new white paper providing a comprehensive review of the NAFLD-NASH diagnostic technology landscape.
It is posted on ENDRA's website (https://endrainc.com/research-and-media) and we believe it will be of interest to investors, clinicians and potential strategic partners.
I think everyone realizes the pieces are in place and we are waiting.
Europe progress(made difficult by the virus but still in progress), FDA approval, the first P.O., and operating funds are all things in process we are waiting for to occur. Probably some things we don't know that will be positive surprises.
Funding will not be an issue, see the latest SEC filings.
Insider buying is great.
It's hanging on nicely around $1 and where'd all the chatter go?????
ENDRA Life Sciences Granted Additional European Patent As Commercialization Begins
New grant expands coverage of key U.S. platform patent to Europe
ANN ARBOR, MI / ACCESSWIRE / July 22, 2020 / ENDRA Life Sciences Inc. (''ENDRA'') (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), has recently been issued European Patent 3328285 from the European Patent Office (EPO).
"The granting of our second European patent comes at an opportune time, as we're currently focusing on finalizing our first clinical evaluation reference sites in Europe and initiating sales in this key market, where the TAEUS Fatty Liver Imaging Probe System received CE Mark Approval in the first half of the year," said ENDRA's Chief Executive Officer, Francois Michelon.
Kai Thomenius PhD, a research scientist at the Institute of Medical Engineering & Science at The Massachusetts Institute of Technology (MIT) and co-inventor of the patent, said, "This is a novel approach to correcting fat induced image distortion in ultrasound imaging, leveraging the inherent fat and lean tissue contrast of thermoacoustics."
"While our European patent grants are significant because they apply to our platform capabilities in our first commercial market, it is important to understand these patents are supported and strengthened by the fact they are part of a growing IP portfolio, which currently stands at 72 assets, which cover other critical aspects of our technology," concluded Michelon.
Of course Chinese patents are priced at the same value as toilet paper in today’s market..
No clue but the only thing stopping it at this point is the ask at 1.05 with about 40,000 shares.
Any thoughts as to what's happening today? Taking off and love to see this volume!!!
ENDRA Life Sciences Expands Global Technology Protection With New Chinese Patents
Grants further protect ENDRA's TAEUS® platform capabilities in key international market with over 400 million potential NAFLD patients
ANN ARBOR, MI / ACCESSWIRE / July 13, 2020 / ENDRA Life Sciences Inc. (''ENDRA'') (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), has recently been issued Chinese Patents ZL 2016 8 00267289 and ZL 2019 3 04324291 from the Chinese Intellectual Property Office.
"The granting of these patents further expands the protection of our platform technology in the key international market of China, where an estimated 29.2% of the population is affected by Non-Alcoholic Fatty Liver Disease, according to a recent study published in Hepatology," said ENDRA's Chief Executive
There was no interpretation by me. It was a posting from Endra’s web site..
I don’t believe your interpretation.
It is information straight from Endra’s web site: “Read the clinical trial posted on their website. Seems to me that they are missing about 20% of patients with liver fat >6%. “
Seems believable if it was posted there don’t you think?
Very. I have done enough DD on my own rather then take a strangers interpretation on the internet (who I know nothing about) in regards to a very technical document.
Revealing that you would comment on my understanding but would not answer my question on your understanding, which was:
dndodd's comment:
"It is my understanding TAEUS is very close to being as good as an MRI in quantifying liver fat"
My comment:
dndodd, Your understanding would be incorrect.
I have spoken to several experts that don’t concur with your interpretation.
"It is my understanding TAEUS is very close to being as good as an MRI in quantifying liver fat"
Your understanding would be incorrect.
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