TransMedics Group Inc. (TMDX) stock rose 2.8%. The company recently received full FDA approval for its Next-Generation OCS ENHANCE Heart trial IDE. This approval follows previous FDA approvals for the DENOVO Lung IDE and a conditional ENHANCE Heart IDE. The ENHANCE Heart study is designed to prolong heart perfusion in brain-death donations. According to the news source, this approval is significant to the company's investment narrative, which now depends on successful commercial rollout of these advanced platforms.
Read full analysisTransMedics Group Inc. (TMDX) stock rose 2.8%. The company recently received full FDA approval for its Next-Generation OCS ENHANCE Heart trial IDE. This approval follows previous FDA approvals for the DENOVO Lung IDE and a conditional ENHANCE Heart IDE. The ENHANCE Heart study is designed to prolong heart perfusion in brain-death donations. According to the news source, this approval is significant to the company's investment narrative, which now depends on successful commercial rollout of these advanced platforms.
TransMedics develops the Organ Care System (OCS), a portable platform that keeps donor organs warm and functioning during transport, expanding the pool of viable organs for heart, lung, and liver transplantation. The company reported Q3 2025 revenue of $143.8 million, up 32% year-over-year, and recently received FDA IDE approval for its next-generation ENHANCE Heart trial. Today's scheduled Q4 2025 earnings report — with analysts expecting $155.3 million in revenue and $0.41 EPS — is the dominant near-term catalyst.