Evolution of Healing via SkinTE®

The multicomponent biologic mix rapidly seeds, stabilizes, and initiates the healing process. SkinTE immediately alters the wound bed environment by providing healthy cells and chemokines. Multicellular segments engrafting post-application serve as a cellular source to the wound bed.

SkinTE® Innovation – Full Skin Barrier Reconstitution with an Autologous Heterogeneous Skin Construct (AHSC) 

An illustration of a skin barrier.
Number one.

Harvest

Skin harvest has all the layers of healthy skin that is needed to regenerate and heal.

An illustration of the manufactured "cell-like" structure.
Number two.

SkinTE

Manufactured to create “organoid-like,” multi-cellular structures of the cells and matrix needed to heal.

An illustration of the mixture being applied to a wound.
Number three.

Application

Cells are activated in the manufacturing process. The mixture is planted into the wound.

An illustration of a healing wound.
Number four.

Healing

SkinTE regenerates and activates the tissue surrounding the wound to heal the wound completely.

An image of before and after the application of SkinTE.

Multicomponent Biologic Mix Rapidly Seeds, Stabilizes and Initiates Healing Process

  1. SkinTE immediately alters environment by providing healthy cells and chemokines

  2. Multicellular segments engrafting post application serve as cellular source to wound bed

  3. Epithelialization is initiated from multicellular segments within and around the wound closing the wound from inside out and outside in

The cost of diabetes care

$53,779

is the average cost of
inpatient care for a major
amputation per patient¹

60%

of people with diabetes develop neuropathy that can lead to a DFU⁴

49%

of people with a DFU experience recurrence in the first year²

85%

of diabetes-related amputations are preceded by a DFU, and can be avoided³

Diabetes directly cost $237 billion in the U.S. with one-third of these direct costs due to foot disease.

1. Hicks CW, Selvarajah S, Mathioudakis N, et al. Trends and determinants of costs associated with the inpatient care of diabetic foot ulcers. Journal of Vascular Surgery https://doi.org/10.1016/j.jvs....

2. Oliver T and Mutluoglu M, Diabetic Foot Ulcer. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/b...

3. David G. Armstrong, D.P.M., M.D., Ph.D., Andrew J.M. Boulton, M.D., and Sicco A. Bus, Ph.D. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med 2017;376:2367-75.

4. APMA, Diabetic Wound Care. https://www.apma.org/diabeticw....

SkinTE Publications

2023

2022

2021

2020

2019

Pipeline

A photo of the pipeline for SkinTE.

Science and Medicine Driven Management

  • A photo of John Stetson.

    John Stetson

    CEO

    • CFO & Director of PolarityTE 2016-18

    • CFO & Director of Marathon (MARA) 2012-15

    • University of Pennsylvania 

  • A photo of Nikolai Sopko.

    Nikolai Sopko, MD, PhD

    COO & CSO

    • CSO of PolarityTE 2018-2023

    • Johns Hopkins Urologic Surgery

    • MD from Case Western 

    • PhD Stem Cell Biology – Case Western

  • A photo of Ned Swanson.

    Ned Swanson, MD

    President & CMO

    • Co-Founder & CMO PolarityTE 2016-2021

    • Johns Hopkins Plastic Surgery Resident

    • MD from Harvard Medical School 

    • Bioengineering University of Pennsylvania

  • A photo of Parker Scott.

    Parker Scott

    CFO

    • Former research analyst at a leading investment bank and portfolio analyst at a multi-billion dollar special situations hedge fund.

    • Experience leading public startups in the biotech, digital asset mining, and nuclear energy sectors

  • A photo of Marytheresa Ifediba.

    Marytheresa Ifediba, PhD

    VP of R&D

    • PhD from Harvard University in Bioengineering

    • Expertise in therapeutic nanoparticle development for treatment of neurological damage & cancer

  • A photo of Nicholas Baetz.

    Nicholas Baetz, PhD

    VP of Manufacturing

    • Research Associate, Epithelial and Stem Cell biology, Vanderbilt and Johns Hopkins

    • PhD, Cell Biology, University of Arizona

  • A photo of Ashlee Fishleigh.

    Ashlee Fishleigh

    VP of Clinical Ops

    • 20 years clinical trials management

    • Designed, implemented, and managed Phase I through Phase IV trials

    • Oversaw all seven of Polarity’s wound care trials

Contact Us

PolarityTE Headquarters
1960 South 4250 West
Salt Lake City, UT 84104

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Investor Relations
Parker Scott
IR@polaritybio.com

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Call Us
Corporate Main: 800-560-3983

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Expanded Access Program

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.