TransMedics Group Inc. shares were up 15.53% in premarket trading at $39.88 at last check.
During the last trading session, TransMedics stock closed at $34.52, dropping 13.75% or $5.55. The daily price range for TMDX stock was between $32.81 and $40.89. A total of 3.69 million shares of TMDX stock were exchanged, more than its 50-day average volume of 0.98 million shares and year-to-date average volume of 0.79 million shares.
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During the past 12 months, the TMDX stock has increased by 183.88%, and in the last one week, it has dropped by -13.18%. Because of an approval vote on a cardiovascular device trial by the authorities, TMDX stock is rising.
Why did a trial take place?
World leader in extracorporeal warm perfusion for portable tissues, TransMedics is the leading company in assessing donor organs for transplantation. A Massachusetts-based company, TMDX was founded to find new ways to improve organs for transplantation, increasing their number and quality.
TMDX also develops technologies to assist the treatment of end-stage heart, lung, and liver failure by preserving the quality of donor organs, assessing their viability prior to transplantation, and potentially increasing the efficiency of organ and tissues donation.
FDA inspected TransMedics Group’s clinical evidence from the OCSR Heart EXPAND trial and associated Continued Access Protocol (CAP) data, as unveiled the TMDX in press release today.
- Additionally, the FDA convened the Circulatory Systems Device Advisory Panel, the OCS Heart PROCEED II trial.
- The FDA has suggested to the Office of Health Technology 2 (Cardiovascular Devices) that approval be given to the TMDX’s OCS Heart System based on the evidence gathered.
- The panel voted 12 to 5 and with 1 abstention that the OCS Heart System by TMDX is safer than its risks.
- The panel voted 10 to 6 in favor of TMDX providing reasonable assurance that the OCS Heart System by TransMedics (TMDX) is effective, with 2 abstaining.
- 9 to 7 of the members of the panel voted in favor of TMDX while 2 of them abstained.