{
  "docId": "019dd923-622c-750b-8b9a-0a80d2583138",
  "docSlug": "fef6b00ff609",
  "documentTitle": "TransMedics (TMDX)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Kir Kahlon",
  "documentKindSlug": "regulatory-filing",
  "documentKindLabel": "Regulatory filing",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2024-01-14 00:00:00",
  "orientation": "portrait",
  "aspectRatio": 0.77272725,
  "pageNumber": 2,
  "pageCount": 6,
  "prevPage": 1,
  "nextPage": 3,
  "slideType": "preempt_rebuttal",
  "function": "expose_contradiction",
  "density": "overcrowded",
  "nDataPoints": 6,
  "notes": "This is a page from a regulatory petition or report alleging corporate misconduct and safety risks.",
  "elementsJson": null,
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-0a80d2583138/2",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-0a80d2583138",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-0a80d2583138.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-0a80d2583138#slide-2",
  "components": [
    {
      "bbox": {
        "h": 0.08,
        "w": 0.78,
        "x": 0.11,
        "y": 0.64
      },
      "kind": "list",
      "text": "Transplant centers which are high-volume users of OCS Liver reported to us that a substantial percentage of livers placed on the device are from donors >55 years of age, typically well into their 60's.",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "b662e8f0-a63d-407b-aa33-9bdf2796e62e",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.08,
        "w": 0.78,
        "x": 0.11,
        "y": 0.82
      },
      "kind": "list",
      "text": "High-volume TransMedics OCS Liver users report using the device for livers far in excess of the 15% limit for macrosteatosis (fatty liver), pushing it to 50%.",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "c808a8f7-b5f7-41b7-bb54-93572079e36d",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.08,
        "w": 0.78,
        "x": 0.11,
        "y": 0.73
      },
      "kind": "list",
      "text": "High-volume TransMedics OCS Liver users report using the device for livers with warm ischemic times far exceeding 30 minutes.",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "fbd56c11-9b51-4f28-8684-6919faef7a1c",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.08,
        "w": 0.78,
        "x": 0.11,
        "y": 0.55
      },
      "kind": "list",
      "text": "OCS Liver is only indicated for liver allografts which meet three specific criteria for viability: a) from donors ≤ 55 years of age; b) with ≤ 30 minutes of warm ischemic time; and c) with ≤ 15% macrosteatosis.",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "fc924cdb-8eab-431c-af0f-c960c01b4abb",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.25,
        "w": 0.78,
        "x": 0.11,
        "y": 0.11
      },
      "kind": "paragraph",
      "text": "3) The off-label use is promoted directly by TransMedics, as the company has an unusual, high-risk business model. Its own procurement surgeons retrieve the organ, and then its device technicians manage the organ while it is on the pump.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "13be5606-45c3-427d-b4d4-1ae5993644e8",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.06,
        "w": 0.78,
        "x": 0.11,
        "y": 0.41
      },
      "kind": "paragraph",
      "text": "4) We believe that TransMedics is engaging in alarming business practices which suggest to us an attempt to conceal safety issues from hospitals and the FDA, as documented in chapter 15 of Petitioner's report.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "682d6065-57fc-4c7d-8066-4969d61936fc",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.6,
        "x": 0.11,
        "y": 0.51
      },
      "kind": "title",
      "text": "Off-label usage (please refer to p155-192, p174-192 in particular, Exhibit A)",
      "attrs": null,
      "subkind": "headline",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "4de51176-929e-49a6-b5aa-b83fa92686ac",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [
    {
      "name": "Anadiplosis",
      "slug": "anadiplosis",
      "agent": "Storyteller",
      "layer": "slide",
      "matchId": "ada8031c-e48b-4cab-86fa-df8331dff1b3",
      "evidence": "The off-label use is promoted directly by TransMedics, as the company has an unusual, high-risk business model. Its own procurement surgeons retrieve the organ, and then its device technicians man",
      "confidence": 0.7
    },
    {
      "name": "List presentation",
      "slug": "list-presentation",
      "agent": null,
      "layer": "slide",
      "matchId": "0e8e0dee-f6c2-45b1-829d-f7d8176f606a",
      "evidence": "list/bullet: OCS Liver is only indicated for liver allografts which meet three specific criteria for viability: a) from donors ≤ 55 years of age; b) with ≤ 30 minutes of warm ischemic time; and c) with ≤ 15% macrosteatos",
      "confidence": 0.9
    }
  ],
  "frameworks": [],
  "arcBeats": [
    {
      "to": 2,
      "from": 2,
      "beatId": "effe5861-4729-4783-a69f-5dd3eb9d1cd5",
      "arcName": "Problem-Agitate-Solution",
      "arcSlug": "problem-agitate-solution",
      "beatName": "Problem & Complication",
      "beatSlug": "consultants-gambit-problem-complication",
      "evidence": "Preempt rebuttal",
      "position": 1,
      "confidence": 0.8,
      "parentBeatName": "Complication",
      "parentBeatSlug": "complication"
    }
  ],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}