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[posting]59893944[/posting]hier noch ein paar interessante Auszüge aus dem cc: First, we expect to introduce three next-generation JOTEC products into select international markets in 2019. These include our next-generation Frozen Elephant Trunk called E-vita Open Neo, our second-generation thoracic stent graft called E-nya, and our -- and the first-ever off-the-shelf branched thoracoabdominal device called E-nside. Second, we are continuing to advance our regulatory approvals. As you recall, we completed the enrollment of our clinical trial for BioGlue China in 2018, and we remain on track for regulatory submission in the first quarter of this year. Third, we also recently completed the enrollment of the PerClot study of United States, setting us up for a PMA submission to the FDA in early 2020. This is delayed compared to our previous guidance due to work establish -- to establish our large-scale manufacturing process and the related verification and validation work including shelf-life studies to support the anticipated launch post approval. Fourth, we are excited about the upcoming Ross Master Class at the upcoming AATS Meeting in May. Dr. Paul Stelzer from Mount Sinai, New York will be presenting a subset of the 600-plus Ross procedures with up to 20-year follow-up. The Stelzer series when combined with the recent JACC publication by Mazene [ph] coworkers provides a retrospective look at more than 4,600 patients from 10 different literature reports that underwent the Ross procedure. For those who are unfamiliar with the Ross procedure, it is a double valve a procedure where pulmonary allografts are used to replace the patient's native pulmonary valve which has been moved into the aortic position. We've seen an uptick in the Ross procedure over the last couple of years and it has helped to drive over cardiac tissue revenues. The data shows that the Ross procedure restores normal life expectancy to patients and it appears to be the best option for young to middle-aged patients with the diseased aortic valve. The symposium will highlight the very compelling long-term efficacy data for the procedure and should be a clear positive for our cardiac tissue business. Fifth, we are investing in the development of our distribution channels in Asia-Pacific and Latin America. Last year, we strengthened our commercial leadership team with the addition of two seasoned sales professionals to lead our commercial efforts in these geographies. We will begin migrating to a direct sales model in the second quarter in Brazil with our legacy CryoLife products. And sixth, we will enhance our sales channel across Asia-Pacific with a focus on China, where we expect to have new distributors in place by mid-year. We expect these initiatives to deliver high-single-digit revenue growth in each of the next five years. And with that, we are providing 2019 revenue expectations between $280 million and $284 million. +++ I would like to highlight several important opportunities in our pipeline. First, we have submitted our IND for the PROACT 10A trial and are hoping to begin enrolling patients in the first half of this year. We held an investigators meeting in late January at the Society of Thoracic Surgeons Meeting and there's significant enthusiasm for the trial and great anticipation for the commencement of the study. Through this trial, we will seek to obtain FDA approval with the On-X aortic valve using Eliquis rather than Coumadin as the blood thinner. We look forward to working with the FDA; we'll provide more details as they become available. +++ And fourth, beginning in 2023, we look to leverage our JOTEC product line, which is currently not approved for sale in United States. We plan to conduct clinical trials in the United States with the three next-generation JOTEC products that are slated for launch in Europe this year, with the goal of obtaining FDA approval for each product. |
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| aus der Diskussion: | Gewinnerbranchen der Jahre 2006 bis 2040 |
| Autor (Datum des Eintrages): | clearasil (17.02.19 11:56:08) |
| Beitrag: | 85,019 von 94,068 (ID:59894007) |
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