3
ALL3
PolarityTEYear
3
ALL1
20251
20211
2020DEALS // DEV.
3
ALL3
DevelopmentsCountry
3
ALL3
U.S.A3
ALL3
InapplicableTherapeutic Area
3
ALL2
Dermatology1
PodiatryStudy Phase
3
ALL1
Phase III1
IND Enabling1
UndisclosedDeal Type
3
ALL3
InapplicableProduct Type
3
ALL3
Cell and Gene therapyDosage Form
3
ALL1
Topical2
UndisclosedLead Product
3
ALL3
SkinTETarget
3
ALL3
UndisclosedLead Product(s) : SkinTE
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
PolarityBio Receives FDA Breakthrough Therapy for Wagner Grade I DFU
Details : SkinTE is a human cellular tissue-based product derived from patient's own skin to regenerate full-thickness, functionally-polarized skin. Being investigated for wagner grade 1 diabetic foot ulcers.
Product Name : SkinTE
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
February 20, 2025
Lead Product(s) : SkinTE
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : SkinTE
Therapeutic Area : Dermatology
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
PolarityTE Provides Update on Investigational New Drug Application
Details : SkinTE® is the only FDA-registered product that is capable of regenerating full-thickness skin with all layers and appendage with a proposed indication for chronic cutaneous ulcers.
Product Name : SkinTE
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
July 10, 2021
Lead Product(s) : SkinTE
Therapeutic Area : Dermatology
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : SkinTE
Therapeutic Area : Podiatry
Study Phase : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The data show a statistically significant difference favoring PolarityTE’s autologous skin construct, SkinTE, in the primary endpoint of wounds closed at 12 weeks, and in percent area reduction of wounds at each time point measured.
Product Name : SkinTE
Product Type : Cell and Gene therapy
Upfront Cash : Inapplicable
July 24, 2020
Lead Product(s) : SkinTE
Therapeutic Area : Podiatry
Highest Development Status : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable