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Traferox Technologies Receives FDA Premarket Approval for the TorEx Lung Perfusion System
◆ Published
22 July 2026
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opportunities
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Fusion42 · 22 July 2026 · Fusion42 review
Traferox Technologies has received FDA Premarket Approval for the TorEx Lung Perfusion System, an ex vivo lung perfusion platform that enables functional assessment of donor lungs outside the body before transplantation. The technology addresses a critical bottleneck: approximately 80% of donor lungs in the US are currently discarded due to assessment uncertainty, but TorEx has demonstrated that ~67% of marginal donor lungs can be safely transplanted after evaluation.
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◆ The Wire takeaway
If you're in transplant logistics, hospital supply chains, or organ procurement, you now have a proven buyer who needs to scale production fast—and a $20m annual cost saving in Ontario alone proves the economic case to hospitals. The real opportunity is supplying the consumables (perfusate, tubing, sensors) that TorEx will need to run on thousands of procedures: that's your beachhead.
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◆ Topics
Digital Health · transplantation · medical-devices · fda-approval · organ-utilization · deeptech-biotech