TransMedics (NSDQ:TMDX) beat The Street on both sales and earnings for the third quarter and maintained its outlook for the rest of the year. In its second publicly traded quarter, Andover, Mass.-based TransMedics reported losses of -$8.28 million or -$0.39 per share on sales of $7.025 million for the three months ended Sept. 30. The […]
TransMedics touts long-distance organ transport
(NSDQ:TMDX) said today that its OCS lung transport system was used to ship donor lungs from Hawaii to the mainland U.S. for successful implantations in two patients. Donor lungs retrieved from Hawaii initially were not accepted for transplantation due to limitations of cold static storage, according to the Andover, Mass.-based company. The OCS system was […]
Transplant Biomedicals touts kidney transport device study results
Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
TransMedics slides on Q1 results
Newly public TransMedics (NSDQ:TMDX) shares traded down today after the medical device maker reported first-quarter results yesterday in its debut earnings release. TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. In April 2018 the company won pre-market approval from the FDA for […]
TransMedics wins expanded indication for donated lung preservation device
TransMedics (NSDQ:TMDX) said today that it won an expanded indication from the FDA for the transportation system for lung transplants it designed. In April 2018, Andover, Mass.-based TransMedics won pre-market approval from the FDA for its OCS Lung device for standard double-lung transplantation procedures; in Europe, the OCS Heart and OCS Lung devices are already on […]
TransMedics reaps $105m in IPO
TransMedics (NSDQ:TMDX) yesterday closed an initial public offering that, including a fully subscribed over-allotment, grossed nearly $105 million. 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 it won pre-market approval from the FDA for its OCS Lung transplant device for […]
TransMedics prices IPO at $91m
TransMedics added more than $10 million to the previous top end for the initial public offering that’s slated to launch today, saying it now expects to raise $91 million. 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 sets IPO range with $75m midpoint
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 […]
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 OCD 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 316-patient […]
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 […]
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