Expanded Access Program

for SkinTE®

At PolarityBio, we are committed to developing innovative treatments for patients with complex wounds. Our investigational therapies undergo rigorous clinical testing to ensure their safety and efficacy. While participation in clinical trials is the preferred method for accessing investigational medicines, we understand that some patients may not be eligible for a trial. In certain circumstances, we may provide access to our investigational therapies through our Expanded Access Program (EAP), also known as Compassionate Use.

Physicians who believe their patient may benefit from access to an investigational therapy should contact us at EAP@polaritybio.com. Each request is carefully evaluated on a case-by-case basis in accordance with regulatory requirements and company policies. Submissions can expect a response within 2 weeks of receipt.

We encourage patients and healthcare providers to explore participation in our ongoing clinical trials where possible. Information on our active clinical trials can be found at ClinicalTrials.gov.

While we strive to assist patients in need, Expanded Access is not guaranteed and remains at the discretion of PolarityBio. Decisions are based on scientific and medical considerations and supply constraints of the investigational product.

Doctor and patient in consultation in a medical office
A male doctor in a white coat and blue checkered shirt is checking a patient's blood pressure using a sphygmomanometer in a medical office.

Forward Looking Statements

This website may contain forward-looking statements regarding PolarityBio’s pipeline, clinical development programs, potential future indications, regulatory strategy, and business plans. These statements are subject to risks and uncertainties, including those inherent in clinical development, regulatory review, and commercialization. Actual results may differ materially. PolarityBio undertakes no obligation to update forward-looking statements except as required by law.

Publications and Clinical Research

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