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TransMedics raises 2026 revenue guidance after $203M quarter and new FDA trial approvals

🇺🇸 TransMedics Group, Inc. (TMDX) · Thu 05 Nov 2026

The organ-transplant technology company reported third-quarter revenue of $203.0 million and net income of $17.1 million, alongside FDA IDE approvals and a first European logistics tender win in Italy.

TransMedics Group reported third-quarter 2026 results on 5 November, with revenue of $203.0 million and net income of $17.1 million. The company's headline described the revenue as up 41% on the prior year.

It raised its full-year 2026 revenue guidance to a range of $764 million to $774 million. The company said the range includes PAD Aviation.

On the regulatory side, the company reported that the US Food and Drug Administration granted investigational device exemption (IDE) approvals in October for two trials: OCS ENHANCE Heart Part B and DENOVO Lung. An IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data in support of a marketing application.

The FDA also approved a continued access protocol for the ENHANCE Heart trial. In addition, TransMedics reported its first win in a European transplant logistics tender, in Italy. The summary available does not give further detail on the trial designs, tender terms or timelines.

What it means for your team

  • Regulatory teams tracking organ-perfusion technologies should note the two new IDE approvals, for the OCS ENHANCE Heart Part B and DENOVO Lung trials, as signals of the company's US clinical pipeline.
  • The FDA-approved continued access protocol for ENHANCE Heart indicates a pathway for further patient access to the device under the trial framework.
  • Market-access and procurement teams in Europe may wish to follow the Italian transplant logistics tender win as an early indicator of the company's European service model.
  • Full trial details and tender terms were not available, so any assessment should await the company's full release and filings.

Company's press release (SEC filing): TransMedics Group, Inc. ↗

Article written by VigiEye from the official source (TransMedics Group, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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