Biotech Values

[Titan V]

FWIW, Michael Thornton, NDRA CTO at the CC yesterday:

Absolutely the Pharma’s that we've spoken to, they are absolutely interested in monitoring the fat along with the inflammation markers because an efficacy of a drug should show reversal in both indexes inflammation markers and fat content.

https://seekingalpha.com/article/4218446-endra-life-sciences-ndra-ceo-francois-michelon-q3-2018-results-earnings-call-transcript?part=single

EU commercialization is planned in 1H 2019 as you mentioned. It seems the CE mark is more of a safety requirement as opposed to the 510K approval, which is more of an efficacy requirement. Hence they should have an easier path to approval in Europe. Also the market seems to be much larger in Europe than in the US.

Brooks O’Neil (Lake Street Capital, also covers TNDM)

...So I was hoping you talked quite a bit about, the steps you're taking with the CE mark effort and getting regulatory approval for the European Union. Could you just help us to understand your assessment of the size and the attractiveness of the European market as well as the steps you need to take to get approval in the United States and sort of how you assess the market opportunity in the U.S.?

Francois Michelon (CEO)

Sure. Thanks. I'll speak first to the European market opportunity. The reason we're going to Europe, first is multifold. Number one, if you look at our investor presentation, our addressable market in terms of ultrasound units on the ground in use that we could target and sell to is actually higher than in the U.S. We have about 78,000 estimated ultrasounds in the European Union alone.

Number two, the regulatory path as many of you know, for the CE mark, while rigorous is mostly a safety designation and therefore slightly easier, I would say, than the 510(k) in the U.S., which is an efficacy designation. So that's another benefit. Thirdly, the reason we're going to Europe, there is a larger share of radiologists using ultrasound in Europe than in the U.S. where very often there are highly skilled technicians and scenographers.

Lastly, the SP has held well above the recent raise price of $2.10. The "institutional positions" don't seem to be big enough to warrant 13F/G filings however.

Subsequent to the quarter ended, we raised $3.1 million from the sale of 1,477,750 shares of common stock. The sale was completed at $2.10 per share and without the issuance of warrants to the purchasers. Although, we priced our offering on an unforeseen market downturn, we were pleased with the demand for our shares and for the subsequent appreciation in our share price and trading volume.

We were also encouraged that multiple high quality institutional and retail investors participated in the transaction. As the market remains choppy and unpredictable, we are continually evaluating our capital needs in real-time to ensure adequate capital to support our clinical, regulatory and operational activities. And we'll continue to do so as we prepare for EU commercialization.

As has been emphasized before and in summary, we believe the combination of our asset-light operating model and continued effective and efficient use of cash will position ENDRA to commercialize our TAEUS liver product in the European Union as scheduled.