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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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  "notes": "The slide uses a Q&A format to substantiate the claim of reckless off-label usage.",
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      "text": "TransMedics is therefore, we believe, extremely reckless, as the off-label use occurs by its own device technicians, known as OCS Specialists – who hospitals must use.",
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      "text": "An executive at one of the largest OPO’s stated that “I’ve never seen a device manufacturer so boldly engage in off-label use themselves” - “It’s their technician...they don’t permit anyone to operate the device...you have to go through their national program...they are the ones operating it.” While physicians have latitude to use devices off-label, it is illegal for medical device companies to market or promote their devices for off-label use. TransMedics is therefore, we believe, extremely reckless, as the off-label use occurs by its own device technicians, known as OCS Specialists – who hospitals must use. Moreover, ex-employees stated that the company’s case coordinators direct the NOP retrieval surgeons and clinically decide that an organ is acceptable and to place it on the pump, suggesting that they jump the gun in the case of expedited offers before a center has even accepted the organ, thereby implicating TransMedics directly in off-label usage – where the rubber meets the road in terms of legal jeopardy.",
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      "text": "TransMedics allegedly engages “in off-label use themselves”\nQ: “The problem is if a company promotes off-label usage, have you heard TransMedics promote the convenience of the pediatric usage?\nI mean, to some extent, by definition, they’re promoting it because they’re the ones using it, their technician, their surgeon.”\nA: “That’s exactly right. It’s their technician. They don’t permit anyone to operate the machine. You have to go through their national program. They are the ones operating it. They’re the ones doing it. I’ve never seen a device manufacturer so boldly engage in off-label use themselves.” – Executive at a West Coast OPO, longtime industry veteran",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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