TransEnterix - vergleichbar mit ISRG ?
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RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company has received FDA 510(k) clearance for expanded indications of its Senhance Surgical System.
The Company received FDA 510(k) clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System's total addressable annual procedures in the U.S. has more than doubled to over three million.
“This indication expansion immediately doubles the addressable market for Senhance in the US and validates our regulatory strategy to successfully add to our indications for use,” said Todd M. Pope, president and chief executive officer of TransEnterix. “These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.”
In the U.S., Senhance is now cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery. This enables Senhance to be used for some of the most common abdominal surgeries, including procedures in general surgery and gynecology.
“We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution,” said Professor Dr. Frank Willeke, Chief of Surgery at St. Marien Hospital in Siegen, Germany. “We believe this procedural expansion for the US will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.”
About TransEnterix
TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today's value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.
https://www.nasdaq.com/de/symbol/isrg/after-hours
The federal safety watchdogs expanded 510(k) decision doubles the Research Triangle Park, N.C.-based companys addressable market, president & CEO Todd Pope said in prepared remarks.
These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice, Pope said.
We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery and colorectal procedures at our institution, added Dr. Frank Willeke of Germanys St. Marien Hospital. We believe this procedural expansion for the U.S. will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.
The news sent TRXC shares up 28.8% to $4.03 apiece today in pre-market trading.
der nötige Katalysator.
Jungs anbei noch ne kleine Zusammenstellung was noch so bevorsteht:
Quelle Stocktwits
Gratulation an alle Longies!
Usw.
Das zB. 10 Senhance pro Quartal verkauft werden-->
Wäre mal ein kurzmittelfristiges Ziel.
Aktie ist gut gestiegen letzter Zeit, warum sollte es jetzt eine Explosion geben?
Slowly Jungs, slowly!
Jetzt warten wir hoffnungsfroh auf Verkäufe, dann wird es stetig nach oben gehen.
40-Millionen-Dollar-Zusatzfinanzierung
erweiterte FDA Zulassung (laparoskopische OP`s z.B. zur Entfernung von Gallenblasen) und damit eine Verdoppelung der möglichen Eingriffsmöglichkeiten durch Senhance
zweiter USA Verkauf an die Louisiana State University
Pope hat wieder darauf hingewiesen, ein erfolgreicher Abschluss mit einer Klinik dauert bis zu 18 Monate
Mit Boudrez hat man sich den erfolgreichsten "Verkäufer" der Branche in Europa geholt - schätzte man hat nun weltweit ein Sales Team von ca. 20 (?) Leuten vs. ISRG mit knapp 50.
In Europa sind die Kliniken über wenige Ausstatter (wie Vamed) organisiert, damit kann man hier sehr effektiv arbeiten.
Pope meinte 9/17 man hat ca. 500 Kliniken weltweit im "Auge" welche für neues Equipment in Frage kommen.
Seit knapp 8 Monaten erfüllt man die Ausschreibungsbedingungen vieler Kliniken bzw. derer Ausstatter, hier gibt es als mittel/langfristig noch gewaltige Möglichkeiten für Kurssprünge.
https://bit.ly/2Jj5Rjj
das ist keine Zulassung sondern nur eine Einreichung bei der FDA für eine Zulassung.
Entscheidung wird bis Ende November erwartet.