TransMedics yesterday set the range on its forthcoming initial public offering, which would gross more than $75 million at the midpoint. Andover, Mass.-based TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. A year ago TransMedics won pre-market approval from the FDA […]
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TransMedics registers for $86m IPO
TransMedics last week registered for an initial public offering worth more than $86 million for the organ transplant transportation system it developed. The Organ Care System is designed to keep donated hearts, lungs and livers in near-living condition until transplantation; the company touts it as the only such system designed for more than one organ. […]
TransMedics wins FDA approval for OCS Lung transplant system
TransMedics said today that it won pre-market approval from the FDA for its OCS Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation. The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the […]
FDA panel recommends approval for TransMedics lung transplant device
An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told […]
TransMedics adds $13m to $51m funding round
TransMedics said yesterday that it added $12.5 million to the $51.2 million equity round it closed in May, taking its total raise to more than $63.7 million. Andover, Mass.-based TransMedics developed the Organ Care System, which is designed to perfuse donor organs with warm, oxygenated blood and monitor its status until transplantation. “We are thankful and excited to be supported by a […]
TransMedics closes $51.2m round to support its Organ Care System
TransMedics said today it closed a $51.2 million round of equity financing to support its Organ Care System organ preservation device. The company’s flagship Organ Care System is designed to perfuse donor organs with warm, oxygenated blood and monitor its status until transplantation. “We are thankful and excited to be supported by a world-class syndicate of new and existing life science […]
TransMedics launches pivotal trial for OCS liver transplant system
TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver […]
FDA cancels TransMedics advisory panel meeting
The FDA said it cancelled a meeting of 1 of its advisory panels that was scheduled to review the pre-market approval bid for the organ preservation device made by TransMedics. The FDA’s Gastroenterology & Urology Devices panel was slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart […]
TransMedics wins FDA panel date for organ preservation device
The FDA plans to convene an advisory panel to review the pre-market approval bid for the organ preservation device made by TransMedics. The FDA’s Gastroenterology & Urology Devices panel is slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart with warm, oxygenated blood and monitor its status until […]
TransMedics heart preservation system used in Aussie transplants
Transmedics said surgeons in Australia used its organ care system to preserve and assess a trio of hearts from donors whose organs had stopped beating, before the hearts were successfully transplanted.
TransMedics notches 1st U.S. “breathing lung” transplant
Organ-transport system maker TransMedics notched a U.S. 1st in accommodating a "breathing lung" transplant at Ronald Reagan UCLA Medical center.
Using the same technology that made possible the "heart in a box" experiment, in which a donor heart was delivered warm and beating to a recipient rather than frozen in an ice cooler, doctors implanted a 57-year-old man with a functioning and "breathing" lung delivered in TransMedics’ Organ Care System.