Drug Profile

Autologous cell therapy - PolarityBio

Alternative Names: SkinTE^®

Latest Information Update: 04 Dec 2025

Price :

$50 ^*

Note:

Adis is an information provider. We do not sell or distribute actual drugs.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

Originator PolarityTE
Developer PolarityBio
Class Cell therapies
Mechanism of Action Tissue replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Phase III Diabetic foot ulcer
Clinical Phase Unknown Leg ulcer
Preclinical Burns; Wounds

Most Recent Events

02 Dec 2025 PolarityBio announces intention to submit BLA for Diabetic foot ulcer in the first half of 2026
02 Dec 2025 PolarityBio completes the phase III COVER DFUS II trial in Diabetic foot ulcer in USA (Topical) (NCT06140303)
30 Oct 2025 PolarityTE terminates Expanded Access Program in Diabetic foot ulcer due to unknown reasons (NCT07222540)

You need to be a logged in or subscribed to view this content

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com