Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| And with CytoSorb and DrugSorb-ART driving sales, we expect to drive accelerated sales growth of the company with the goal of profitability soon thereafter |
| And while it is gradual, we are continuing to see improvements in the marketplace, including our sales team's ability to better access health care workers in the hospitals, a return to face-to-face discussions with the physicians in the market as well |
| International usage and trial safety to date gives us confidence |
| CytoSorbents benefits from the global endorsement and push on Fresenius, massive sales and marketing platform |
| Should the data, which currently remain blinded support US FDA and Health Canada regulatory approval, we'd open up an estimated $650 million total addressable market in these two countries alone, where we expect rapid adoption and strong user demand, reflecting our FDA breakthrough designation |
| We believe we've made excellent progress on both of these programs so far this year and are specifically pleased to report a 20% product sales growth in Q3 of this year versus a year ago that Kathy will discuss in more detail and our nearing database lock of the pivotal US and Canadian STAR-T trial and data analysis before year end |
| I think with the ATM -- it is a very useful and good vehicle that we've used previously very successfully |
| And I think that this is helping to drive our recovery in terms of German sales |
| I think that it is much better than it had been particularly during COVID, where there was very tight ICU bed availability, but limited ICU beds overall |
| We believe this gives CytoSorbents the potential upside of a biotechnology company with a lower risk profile of a high-margin medical device company with bill |
| We have strong validation by customers, partners, and government agencies and current sales support near breakeven, less clinical trial costs, which we believe helps to derisk the company and the investment opportunity |
| We believe CytoSorb represents the fuel for future strong anticipated growth targeting the $20 billion to $30 billion worldwide total addressable market of major unmet medical needs in critical care, cardiac surgery as well as liver and kidney disease |
| CytoSorb forms as the company's foundation with an EU approved product that's sold around the world has generated approximately $205 million in sales since launch, has a high margin -- |
| The market leader in dialysis worldwide with a massive installed base of blood purification machines in ICUs around the world |
| So very high penetration, dominant position of ticagrelor in Canada |
| This predicted improvement in gross margins is expected to continue as we ramp up production at our new facility in Princeton, New Jersey |
| The Star Rating helps hospitals differentiate themselves based on objective quality criteria, helping to drive patient traffic and procedural revenue, which is what all hospitals want |
| Today CytoSorb drives our growth |
| So it does represent a very exciting market for us |
| We think the addition of Canada, our initial TAM analysis brings the substantial upside that you see in the subtext of your question that you noted |
| And on top of this, we may also help to improve a hospital's Quality Star Rating as defined by CMS or Medicare & Medicaid by reducing serious adverse events like bleeding |
| The partnership again expands the dimension of blood purification with excellent synergy between the two companies |
| With supportive data, our goal is to submit to the US FDA and Health Canada for regulatory approval in early 2024 with the potential of a faster review with our FDA breakthrough device designation targeting potential US FDA marketing approval by late '24 or early 2025 For many discussions with cardiac surgeons in the United States, Canada, and abroad, we continue to validate the potential value proposition that DrugSorb-ART could have a successful and things that we're already seeing with CytoSorb in Europe |
| Three of the most recent four quarters have demonstrated sequential quarter over quarter growth in product sales |
| And in return, we have agreed to subsidize this effort with a 0.9% royalty to Fresenius on ex US CytoSorb sales, making it a win-win for both organizations |
| Meanwhile, encouraging initial results from the International Star Registry demonstrate low rates of serious perioperative bleeding when CytoSorb, which uses an equivalent polymer technology to DrugSorb-ART, is used for this indication |
| And congrats on a good quarter |
| When turning to CytoSorb, we are proud to say that we have now received trademark designation for the term expanding the dimension of blood purification in Europe |
| They potentially major second engine of growth working in Canada with CytoSorb to drive sales |
| That said, CytoSorb and DrugSorb could soon be dual growth engine for the company |
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| And what we have seen is that the availability of ICU beds continues to be low, which I think speaks to the muted market in Germany |
| And we note that sales in the third quarter of the year are historically low due to seasonality as surgical procedures in the EU are lower during the summer months of July and August |
| This is down significantly from our average quarterly burn of $9.9 million in the same period of 2022 |
| If these patients go to surgery, however, with these blood thinner onboard, they will bleed |
| With the world struggling in the aftermath of the pandemic with war, natural disasters, and illness, we believe our life-saving therapy has never been more relevant |
| These are common everyday ICU conditions like sepsis, trauma, burn injury, respiratory failure, liver failure, and complications of surgery where mortality is high despite standard therapies |
| It seems like a little bit of a tick-up |
| It's lower because of the recent completion of several grants |
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