contentSlug

type

ContentSlug_ContentQuery

slug

ContentPageContentQuery

content

trendingContent

query ContentSlug_ContentQuery(
  $contentSlug: String!
  $type: [ContentType!]
) {
  ...ContentPageContentQuery_13QmVO
}

fragment CompanyDetails_Content on Content {
  __isContent: __typename
  companies {
    name
    description
    pageUrl
    id
  }
}

fragment CompanyTagList on Company {
  pageUrl
  name
  viewerIsFollowing
}

fragment ContentBasicInfo on Content {
  __isContent: __typename
  id
  type
  title
  lang
  companies {
    ...CompanyTagList
    id
  }
  ...PublishingDetails
  ...Reactions
}

fragment ContentMetadata on Content {
  __isContent: __typename
  type
  title
  lang
  pageUrl
  alternatePageUrls {
    pageUrl
    lang
  }
  imgUrl
  description
  ... on Video {
    liveTime
    videoUrl
  }
  ... on Webcast {
    liveTime
    videoUrl
  }
}

fragment ContentPageContentQuery_13QmVO on Query {
  content(slug: $contentSlug, type: $type) {
    __typename
    id
    type
    title
    isPremium
    lang
    htmlBody
    companies {
      forum {
        latestPosts {
          ...ForumPosts
        }
      }
      defaultInstrument {
        isin
        id
      }
      id
    }
    slug
    ... on CompanyReport {
      reportUrl
    }
    ... on ThirdPartyCompanyReport {
      reportUrl
    }
    ... on StockExchangeRelease {
      reportUrl
    }
    ...ContentBasicInfo
    ...ContentMetadata
    ...PriceAndRecommendation_Content
    ...CompanyDetails_Content
    ...ReportLink_Content
    ...KeyFigures_Content
  }
  ...TrendingContent_1jQ2Cn
}

fragment ForumPosts on ForumPost {
  text
  likesCount
  url
  author
  postedAt
  authorImgUrl
}

fragment KeyFigures_Content on Content {
  __isContent: __typename
  companies {
    defaultInstrument {
      estimateData {
        modelType
        reportingCurrency
      }
      snapshot {
        transaction {
          date
          actualized {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
          }
          estimates {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
          }
        }
      }
      id
    }
    id
  }
}

fragment PriceAndRecommendation_Content on Content {
  __isContent: __typename
  createdAt
  companies {
    id
    name
    viewerIsFollowing
    defaultInstrument {
      snapshot {
        priceData {
          date
          lastPrice
          tradeCurrency
        }
        transaction {
          date
          recommendation
          targetPrice
        }
        prevTransaction {
          recommendation
        }
      }
      id
    }
  }
}

fragment PublishingDetails on Content {
  __isContent: __typename
  createdAt
  publishers {
    name
    imgUrl
  }
  authors {
    __typename
    id
    name
    slug
    imgUrl
    jobTitle
  }
  ... on Video {
    liveTime
  }
  ... on Webcast {
    liveTime
  }
}

fragment Reactions on Content {
  __isContent: __typename
  id
  reactionGroups {
    reactionType
    reactionsCount
    viewerReacted
  }
}

fragment ReportLink_Content on Content {
  __isContent: __typename
  type
  isPremium
  ... on CompanyReport {
    reportUrl
  }
  ... on ThirdPartyCompanyReport {
    reportUrl
  }
  ... on StockExchangeRelease {
    reportUrl
  }
}

fragment TrendingContent_1jQ2Cn on Query {
  trendingContent(type: ARTICLE) {
    __typename
    id
    title
    lang
    pageUrl
    createdAt
    type
    imgUrl
    companies {
      squareLogoUrl
      id
    }
    authors {
      __typename
      imgUrl
      id
    }
    publishers {
      imgUrl
    }
  }
}


realheartr-tah-receives-humanitarian-use-device-designation-by-the-us-food-and-drug-administration-fda

__typename

title

isPremium

lang

htmlBody

companies

createdAt

publishers

authors

reactionGroups

pageUrl

alternatePageUrls

imgUrl

description

Scandinavian Real Heart operates in medical technology. Today, the company's main focus is on research and development of heart pumps used among patients with severe heart conditions who are in the queue for transplant. The idea behind the heart pump is to use the product as a transitional solution before a final heart transplant is performed. The company is based in Västerås.

Scandinavian Real Heart

Västerås, Sweden, January 29, 2025 – Scandinavian Real Heart AB (publ) today announces that its total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation...

<div class="mfn-preamble"><p><strong>Västerås, Sweden, January 29, 2025 – Scandinavian Real Heart AB (publ) today announces that its total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation by the U.S. Food and Drug Administration (FDA). The HUD designation makes Realheart® TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product limited marketing rights.</strong></p></div><div class="mfn-body"><p>Realheart® TAH is a total artificial heart that mimics the structure and physiological function of the human heart. Following multiple rounds of communication with the FDA, the device has been granted Humanitarian Use Device status which paves the way for Realheart® TAH to treat patients with advanced biventricular heart failure who have few other options and need to be supported by a total artificial heart.</p><p>HDE is approved if the sponsor can demonstrate data indicating probable safety and benefit to the intended patient group.</p><p>Realheart will continue communications with the FDA to develop a clinical investigation strategy to support a Humanitarian Device Exemption premarket approval.</p><p>“We are extremely pleased that Realheart® TAH has been granted Humanitarian Use Device designation by the FDA. It is gratifying to look forward to our efforts culminating in such humanitarian benefit. We look forward to updating the market on further clinical and regulatory activities and meanwhile continue our preclinical development which will be important for a potential future full market approval,” says Ina Laura Perkins, CEO of Realheart.</p></div><div class="mfn-footer mfn-contacts mfn-ddde9c982a0b"><p><strong class="mfn-heading-1">For more information, please contact:</strong><br>Ina Laura Perkins, CEO<br>Phone: +46 (0) 70 406 49 21&nbsp;<br>E-mail: <a rel="noopener" href="mailto:inalaura.perkins@realheart.se">inalaura.perkins@realheart.se</a><br>Certified Adviser: Svensk Kapitalmarknadsgranskning AB, <a rel="noopener" href="http://www.skmg.se">www.skmg.se</a></p></div><div class="mfn-footer mfn-about mfn-0285b54ad9f5"><p><strong class="mfn-heading-1">About Us</strong><br>Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function, and blood flow pattern of the human heart. These unique product features provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with severe heart failure. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive preclinical trials ahead of a first clinical study in patients. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit <a rel="noopener" href="http://www.realheart.se">www.realheart.se</a></p></div><div class="mfn-footer mfn-regulatory mfn-regulatory-mar"><p><em>This information is information that Scandinavian Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-01-29 17:25 CET.</em></p></div><div class="mfn-footer mfn-attachment mfn-attachment-general"><p><strong class="mfn-heading-1">Attachments</strong><br><a rel="noopener" href="https://storage.mfn.se/3f23c628-1dca-43a6-ae2f-8ed1cea5c1c4/realheart-r-tah-receives-humanitarian-use-device-designation-by-the-u-s-food-and-drug-administration-fda.pdf" class="mfn-generated mfn-primary">Realheart® TAH Receives Humanitarian Use Device Designation by the U.S. Food and Drug Administration (FDA)</a></p></div>

Realheart® TAH Receives Humanitarian Use Device Designation by the U.S. Food and Drug Administration (FDA)