SkinCube

What is SkinTE?

SkinTE is a first-of-its-kind human cellular and tissue-based product derived from a patient’s own skin to regenerate skin with all its layers (epidermis, dermis and hypodermis) and appendages.

What are the intended uses of SkinTE?

SkinTE can be used by physicians and other medical providers to repair, reconstruct, replace or supplement a patient's damaged or missing skin tissue.

How is SkinTE used?

Medical providers take a small, full-thickness skin sample from the patient (autologous) and returns it to PolarityTE in the provided parcel.

PolarityTE manufactures SkinTE.

SkinTE is contained within a syringe and is returned to provider in all-inclusive Deployment Box as soon as same day, and typically within 48-72 hours based on providers’ requests.

Provider applies SkinTE to patient’s wound/defect, covers with dressings and cares for wound/defect similar to standard of care for skin grafts.

Medical providers have used SkinTE for the treatment of:

  • Wounds (acute & chronic)
  • Surgical reconstruction events
  • Burns (acute, subacute & burn reconstruction)
  • Scar revision
  • Traumatic injuries
  • Replacement of skin grafts or failed flap coverage

How to receive treatment with SkinTE?

Whether an individual patient’s particular condition may be appropriate for treatment with SkinTE is a medical decision to be determined in consultation with a licensed and trained medical provider. To pursue treatment with SkinTE, patients should see their medical provider who can contact PolarityTE to obtain approval to use SkinTE at their desired health facility or refer to a medical provider or facility already approved for SkinTE treatment according to the specific case. SkinTE is currently only being used in the United States.

How can medical providers access SkinTE for their patients?

Providers can contact PolarityTE directly at ClinScience@PolarityTE.com for more information about clinical use of SkinTE.

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About SkinTE™

SkinTE is a human cellular and tissue-based product derived from a patient’s own skin (autologous) intended for the repair, reconstruction, replacement or supplementation (i.e., homologous use) of skin tissue and the integumentary system. Aseptic surgical procedures and handling during skin harvest, wound preparation and SkinTE deployment are mandatory.

Important Safety Information

SkinTE is donated human tissue for autologous, single application use only. SkinTE has not been evaluated for infectious substances. SkinTE may contain trace amounts of antibiotics (e.g., gentamicin), which may potentially cause an adverse effect in patients who are hypersensitive or allergic to antibiotics. For patients sensitive to or allergic to gentamicin, alternative processing is available with prior notice. Patients with multiple comorbidities, or who have any condition that could compromise recipient site vascularity and wound healing, should be carefully evaluated prior to using SkinTE. Such conditions may prevent successful outcomes or lead to suboptimal results. Failure to ensure proper aseptic technique may result in contamination of the harvested skin, donor site, tissue product and/or wound bed, and could result in potential adverse events including local, regional, or systemic infection, failure of the graft to take upon deployment, failure of skin to heal and/or regenerate, deleterious effects on potential surrounding or adjacent reconstructions including infection, failure of adjacent grafted material to take and heal, the need for further surgical operations(s), and/or debridement or other serious injuries or death. Failure to follow instructions may lead to suboptimal outcomes, product failure and/or patient harm. Outcomes may vary. Risks also include those associated with skin grafting such as graft failure, infection, and/or effects on adjacent tissue or reconstructions.