{ "docId": "019dd923-622c-750b-8b9a-40e2965928db", "docSlug": "e5bffbaac707", "documentTitle": "TransMedics (TMDX)", "authorId": "58_Scorpion_Capital", "authorName": "Scorpion Capital", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2025-01-10 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 174, "pageCount": 342, "prevPage": 173, "nextPage": 175, "slideType": "expose_contradiction", "function": "expose_contradiction", "density": "dense", "nDataPoints": 3, "notes": "The slide contrasts the author's claims of widespread off-label use with the official FDA 'Indications for Use' text.", "elementsJson": [ "paragraph", "screenshot" ], "metadataConfidence": 0.95, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-40e2965928db/174", "deckHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db#slide-174", "components": [ { "bbox": null, "kind": "callout", "text": "by our estimate, almost every organ placed on the device violates one or more of these criteria and is therefore off-label use.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-5373-719d-a97e-ba9100546bae", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.22, "w": 0.8, "x": 0.13, "y": 0.68 }, "kind": "paragraph", "text": "The TransMedics® Organ Care System (OCS™) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) ≤55 years old and with ≤30 mins of warm ischemic time, macrosteatosis ≤15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c2bdc5a3-d3f8-4519-80cc-83ce5b134183", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Off-label misuse of TransMedics device is, we think, centered on two aspects. The first, utilization for surgeon lifestyle and convenience with no clinical indication or benefit, exploits hospitals and payors who incur six-figure sums per case so surgeons can work hours of their own choosing. The second type of misuse is just as prevalent but far more insidious: placing dubious, high-risk organs on the device in violation of specific criteria on the FDA label – by our estimate, almost every organ placed on the device violates one or more of these criteria and is therefore off-label use. We focus on the liver version of OCS as it is the core of the company’s revenue and growth, as the heart and lung pumps are basically a failure. Per the label, the device is only allowed for livers that meet 3 critical parameters of viability, plus a fourth not explicitly mentioned in the label but which was key in the pivotal trial and FDA approval: 1) the DCD donor is ≤55 years old; 2) ≤30 minutes of warm ischemic time; 3) ≤15% macrosteatosis; and 4) the time the liver is on the device. We explain the significance of each in turn.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d1f6f9ca-a529-4258-9dca-f3583903b6e3", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "The TransMedics® Organ Care System (OCS™) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) ≤55 years old and with ≤30 mins of warm ischemic time, macrosteatosis ≤15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient. — FDA PMA Approval Order Statement, Summary of Safety and Effectiveness Data – Sept 28, 2021", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-5373-719d-a97e-be5eeaf2da0f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.5, "x": 0.07, "y": 0.59 }, "kind": "source-note", "text": "FDA PMA Approval Order Statement, Summary of Safety and Effectiveness Data – Sept 28, 2021", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "022c0cb8-4a04-4485-8d0a-50c87f2614ee", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.55, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts; https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200031B.pdf", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "644b0520-3585-4cef-9175-ac76170e998e", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.63 }, "kind": "title", "text": "II. INDICATIONS FOR USE", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "7d9b1677-954b-4c05-bfb1-8065a73a6c64", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }