TransEnterix - vergleichbar mit ISRG ?
| eröffnet am: | 12.04.16 13:59 von: | Tuedi2005 |
| neuester Beitrag: | 29.09.21 21:59 von: | Stefanoieder |
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29.05.18 12:59
#201
cultom4president
FDA News ist raus
https://finance.yahoo.com/news/...a-clearance-expanded-105000816.html
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.
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.
29.05.18 13:21
#202
Ribald_Tauschma.
neuigkeiten
TransEnterix Inc. shares TRXC, +28.75% surged 12% in premarket trade Tuesday, after the company said it has won U.S. Food and Drug Administration approval for expanded indications for its Senhance Surgical System. Specifically, the company said the FDA has cleared the medical device company 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.," the company said. "With this clearance, Senhance System's total addressable annual procedures in the U.S. has more than doubled to over three million." Senhance is now approved for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery. Shares have gained 566% in the last 12 months, while the S&P 500 SPX, -0.24% has gained 13%.
29.05.18 13:43
#204
Nobsy11
..vergleichbar mit ISRG ?
...warum nicht ;-)
https://www.nasdaq.com/de/symbol/isrg/after-hours
https://www.nasdaq.com/de/symbol/isrg/after-hours
29.05.18 14:25
#205
Ribald_Tauschma.
FDA
TransEnterix (NYSE:TRXC) said today that it won expanded indications from the FDA for its Senhance robot-assisted surgery device, which is now cleared for hernia and gallbladder procedures.
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.
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.
29.05.18 14:42
#206
Mr.Limki
FDA nach endlich
der nötige Katalysator.
Jungs anbei noch ne kleine Zusammenstellung was noch so bevorsteht:
Quelle Stocktwits
Gratulation an alle Longies!
29.05.18 16:15
#208
Nobsy11
...nicht gleich resignieren...
..der Tag ist noch lang - ich denke der Kurs fängt sich wieder...
29.05.18 16:56
#209
leveleast
10%
Das ist nun doch etwas enttäuschend. Ich hätte da mit mehr Feuerwerk gerechnet.
29.05.18 17:34
#213
Ribald_Tauschma.
naja
es könnte durchaus etwas wahres dran sein. Zwar bin ich erst seit wenigen Wochen hier und Neuling, aber er könnte darauf abzielen, dass es sich bei der jetzigen Konsolidierung um Gewinnmitnahmen handelt. (Immerhin hat die Aktie einen kurzweiligen wie steilen Aufwärtstrend hinter sich.) Wohingegen die (u.a. ich) Käufer, die zu den guten Neuigkeiten erst kürzlich eingestiegen sind, für die nächste Stufe sorgen könnten.
Usw.
Usw.
29.05.18 20:07
#214
Mr.Limki
ihr zwei lustigen
ratiodep meint mit den Verkäufen der OP-Roboter.
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!
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!
29.05.18 21:03
#216
macSteve0702
Entwicklung
Mr. Limpki hat recht - die Stimmung ist wieder positiv und die letzten Wochen haben eine gute Basis geschaffen. Hatte durch die ergänzende FDA Bestätigung auch nicht mehr an Kursgewinn gerechnet.
Jetzt warten wir hoffnungsfroh auf Verkäufe, dann wird es stetig nach oben gehen.
Jetzt warten wir hoffnungsfroh auf Verkäufe, dann wird es stetig nach oben gehen.
30.05.18 09:40
#217
Nobsy11
...interessanter Beitrag
https://seekingalpha.com/article/...ansenterix-upside-powerful-grower
31.05.18 13:21
#219
franzelsep
und hier die angesprochenen Verkäufe
http://ir.transenterix.com/news-releases/...mpletes-purchase-senhance
01.06.18 10:26
#220
leveleast
Verkäuf
Wie ich mir schon gedacht habe. Nach der FDA Zulassung kommen die Verkäufe rein. Sehr schön!
02.06.18 10:57
#221
macSteve0702
Verkäufe
Die letzten Tage hat sich wirklich etwas bewegt:
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.
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.
08.06.18 08:26
#223
leveleast
FDA 510(k) Submission for 3mm Senhance Instrument
Und hier schon die nächste FDA Zulassung. Dieses mal für die 3mm Instrumente. Sensationell!
https://bit.ly/2Jj5Rjj
https://bit.ly/2Jj5Rjj
08.06.18 08:41
#224
franzelsep
@leveleast
!!! Achtung,
das ist keine Zulassung sondern nur eine Einreichung bei der FDA für eine Zulassung.
Entscheidung wird bis Ende November erwartet.
das ist keine Zulassung sondern nur eine Einreichung bei der FDA für eine Zulassung.
Entscheidung wird bis Ende November erwartet.