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  "documentTitle": "TransMedics (TMDX)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2025-01-10 00:00:00",
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      "text": "Off-label use is allegedly openly known and promoted at TransMedics",
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      "text": "Off-label use is allegedly openly known and promoted at TransMedics\nQ: “Did you ever say this is off-label or would you have gotten fired if you said it?”\nA: “They will tell you that this is off-label; it’s not something hidden.”\nQ: “Who will tell you it’s off-label?”\nA: “Everybody there. They were like, “This is off-label.” It’s abnormal anatomy, using it off-label.”\nQ: “Did the TransMedics staff say you were using it off-label or the surgeon?”\nA: “Yeah-yeah, everybody knows.”\nQ: “Wow”\nA: “Yeah, everybody knows..it’s not something that they’re trying to hide. It’s documented on the liver anatomy page where the OPO has to sign.”\nQ: “I see. Contraindications: “The OCS liver should not be used for livers with moderate or severe traumatic injury, livers with active bleeding, e.g., hematomas, split livers, donor livers with accessory arterial blood supply requiring back-table anastomosis.” Is that what you’re talking about?”\nA: “Yeah, they will use it for back table; they will do that.”\nQ: “That’s what you mean by the arterial abnormality?”\nA: “Yeah, they will use it for abnormal artery.”\nQ: “And that’s what you’re saying is about maybe a third of the cases, just very roughly.”\nA: “Yeah, and I’m aware also that Duke actually used it for split livers as well. I mean, the liver is going to go on the pump as a whole, and then they will take it out and split it afterwards.”\nQ: “So, there’s a lot of off-label usage of this thing.”\nA: “Yeah, it’s not uncommon.” – Transplant procurement surgeon previously working with TransMedics",
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      "text": "The surgeon indicated that off-label misuse was promoted and directed by TransMedics in various, overt ways – by definition, as 1) their retrieval surgeons are allegedly, as ex-employees told us, directed to place every organ on the pump, 2) only TransMedics device technicians are allowed to operate the device. The surgeon stated that “they will tell you that this is off-label; it’s not something hidden.” We asked who would tell him it’s off-label: “everybody there...they were like, ‘This is off-label’...it’s abnormal anatomy, using it off-label...yeah, yeah, everybody knows...it’s not something that they’re trying to hide...you can’t...it’s documented on the liver anatomy pages where the OPO has to sign...they will use it for back table; they will do that.”",
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      "text": "“Yeah, it’s not uncommon.” — Transplant procurement surgeon previously working with TransMedics",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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