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  "documentTitle": "Penumbra, Inc. (PEN)",
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  "authorName": "Spruce Point Capital Management",
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  "sourceTypeLabel": "Short seller",
  "presentationDate": "2019-07-31 00:00:00",
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      "kind": "callout",
      "text": "If the aspiration catheter is so low-tech that its role can be satisfied by cheaper existing products, why should Penumbra expect to maintain a premium price as neurovascular aspiration thrombectomies become more common-place?",
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      "kind": "callout",
      "text": "Why should Penumbra expect to maintain its historical market dominance as established med tech companies rapidly enter the \"on-label\" space without having to develop any new technology?",
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      "text": "Why would you invest in a (nearly) one-product company whose \"regulated\" headline product is exists in a vertical which the FDA has failed to effectively police - and which has now seen a flood of FDA-approved competitors in any case?",
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      "kind": "callout",
      "text": "If the aspiration catheter is so low-tech that its role can be satisfied by cheaper existing products, why should Penumbra expect to maintain a premium price as neurovascular aspiration thrombectomies become more commonplace?",
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      "text": "Mid growing interest in interventional stroke treatments, some questions aspiration thrombectomy that aren't approved for that purpose. But is it really a big deal clinically, or is it simply an issue generated by a battle over market share in this booming area?",
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      "text": "In its \"dear doctor\" letter, the FDA noted that it has received a \"small number of adverse event reports\" stemming from use of a guide catheter for removing a clot, including one case involving vessel perforation that ultimately led to death from a large subarachnoid hemorrhage.",
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      "text": "But some neurointerventionalists interviewed by TCTMD said that this is not really a clinical issue, as there is not much difference in performance between the catheters-regardless of labeled indication-when it comes to using them for aspiration either alone or in conjunction with stent retrievers. Instead, the issue is seen more as an attempt for Penumbra to protect its market share in an increasingly competitive stroke market.",
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      "kind": "paragraph",
      "text": "While Penumbra was until recently the only company to offer an aspiration catheter approved by the FDA for thrombus aspiration in cases of acute ischemic stroke, doctors report that many of their peers use guide catheters \"off-label\" for the same purpose.",
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      "text": "Jadhav acknowledged those potential complications, but said that he's not aware of any data showing that aspiration-related events are more frequent with catheters used in an off-label fashion. \"At least with the [catheters] that are commonly being used right now, there's been no data that they're unsafe in that scenario,\" he said. \"There are theoretical complications with any of these catheters whether they're indicated for aspiration or not.\"",
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      "kind": "paragraph",
      "text": "Catheter Kerfuffle: How Concerning Is Off-Label Use in Stroke Interventions? The FDA sent a reminder to doctors clarifying that not all catheters are cleared for aspiration. But experts say comfort and safety should be considered.",
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      "kind": "quote",
      "text": "\"Penumbra makes great catheters, and they're effective for intracranial work for doing thrombectomy as a standalone device or as an adjuvant device,\" — Donald Heck, MD (Novant Health, Winston-Salem, NC). \"In this space, people end up using what they're comfortable with,\" — Jadhav.",
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      "kind": "title",
      "text": "Don't Let The \"Med Tech\" Label Fool You: Aspiration Catheters Are Disposable Commodities",
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