{ "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": 155, "pageCount": 342, "prevPage": 154, "nextPage": 156, "slideType": "expose_contradiction", "function": "expose_contradiction", "density": "overcrowded", "nDataPoints": 2, "notes": "The slide uses a 'fraud-exposure' framework to contrast alleged real-world usage with official FDA labeling.", "elementsJson": [ "paragraph", "callout_box" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-40e2965928db/155", "deckHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-40e2965928db#slide-155", "components": [ { "bbox": null, "kind": "callout", "text": "In our opinion, payors – the government and a few private ones – are defrauded out of $100,000 to $400,000 per case with NOP charges, under false pretenses, to improve surgeon lifestyles.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-5373-719d-a97d-57f32c65ec68", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.12, "w": 0.86, "x": 0.07, "y": 0.47 }, "kind": "paragraph", "text": "In our opinion, payors – the government and a few private ones – are defrauded out of $100,000 to $400,000 per case with NOP charges, under false pretenses, to improve surgeon lifestyles. The indication on the label is exclusively clinical, using OCS liver as an example.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "05a2ce54-c93a-4d28-bfd1-b1934682d78c", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.22, "w": 0.8, "x": 0.13, "y": 0.69 }, "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": "7e8556ec-9094-48c7-9944-a466a0bb2b89", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "Upon extensive research, we conclude that the vast majority of TransMedics device usage is off-label, to such an extreme degree that we believe it to be the largest off-label racket we have ever encountered and likely one of the largest in US medical device history.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c1622bad-9c3b-4b2d-8666-4b28064c51ed", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.22 }, "kind": "paragraph", "text": "The purported purpose of the pump is clinical – to preserve and assess organs during transportation to increase their utilization and improve outcomes. However, according to dozens of interviews with ex-employees, large OPO’s, and the transplant surgeons and centers who are its highest volume users - who were unusually transparent with us - the primary use case is non-clinical, with no clinical benefit: scheduling and convenience for surgeons and OR staff, who park organs on the pump for highly prolonged periods to stack cases and avoid late night work.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "cb8d877b-a75b-4668-b8ae-1937f214eab9", "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-a97d-5b50f05e844e", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.5, "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": "1c33bae5-6b84-474b-aa0e-bf157a3b7d0d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "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": "3c5149a3-f0f9-4c25-b8f0-b133c3b4bdb2", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.3, "x": 0.07, "y": 0.64 }, "kind": "title", "text": "II. INDICATIONS FOR USE", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c8734160-ee7b-4f7c-82ad-c2f9dbff5861", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [ { "name": "fraud-exposure", "slug": null, "matchId": "b9211217-296c-4c4a-a821-4d32e6d52dd3", "evidence": "The slide explicitly claims a 'racket' and 'defrauded' payors, contrasting this with official FDA documentation.", "confidence": 0.95 } ], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }