At PolarityTE, our research is designed to deepen our understanding of skin’s complex regenerative cellular biology and use this understanding to develop new therapies for treatment of the most complex wounds, in patients with limited treatment options. We leverage our highly skilled in-house R&D team to rapidly move these strategies and therapies from bench to bedside, with the goal of delivering treatments to the patients that need them the most.
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Utilizes a patient’s own viable (living and healthy) tissue, unlike other products made from allogeneic tissue (i.e., tissue from another human) or xenogeneic tissue (i.e., tissue from an animal), which carry risks of rejection.
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AHSC leverages multicellular segments that include varied cellular populations found within skin and regenerates functional tissue thereby closing wounds.
*Animal models are not necessarily predictive of clinical outcomes
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Multicellular segments which engraft in the wound bed, which is especially important in the most complex wounds and austere local wound environments.
PolarityTE is focused on creating and developing products that address critical unmet needs within wound care. Our lead investigational product in development, SkinTE®, was previously marketed and used in over 1,200 clinical cases, often for patients who suffered from chronic cutaneous ulcers and had no other alternative form of treatment.
PolarityTE has an accepted investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the SkinTE® product, and has commenced its first pivotal clinical study in diabetic foot ulcers (DFU) to generate the data that the FDA requires for submission of a biologics license application (BLA).
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Wagner One Diabetic Foot Ulcers — ClinicalTrials.gov Identifier: NCT03881254.
The trial met the primary endpoint of wound closure at 12 weeks with closure rates of 70% (35/50) of participants receiving SkinTE plus SOC versus 34% (17/50) of participants receiving SOC alone (p=0.00032). The secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was also met with significantly greater PAR for the SkinTE plus SOC treatment group vs SOC alone (p=0.009). 90% (45/50) of SkinTE plus SOC treated participants received a single application of SkinTE. Treatment with SkinTE plus SOC increased the odds of wound closure by 5.37 times versus SOC alone (p=0.001).
Interim analysis was published in the International Wound Journal “A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis”
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Venous Leg Ulcers—ClinicalTrials.gov Identifier: NCT03881267. The trial met the primary endpoint of wound closure at 12 weeks with closure rates of 71% (10/14) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 33% (5/15) of participants receiving SOC alone (p=0.046). The secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was also met with significantly greater PAR for the SkinTE plus SOC treatment group vs SOC alone (p=0.000035). 93% (13/14) of SkinTE plus SOC treated participants received a single application of SkinTE.
SkinTE was used to treat 10 patients (11 DFUs) in a pilot trial. Results of the trial include: 10 of 11 (90.9%) DFUs healed within eight weeks of a single application of SkinTE; median time to closure was 25 days; DFU sizes ranged from 1.0 to 21.7 cm²; no SkinTE-related adverse reactions were observed.
Complete Wound Closure Following a Single Topical Application of a Novel Autologous Homologous Skin Construct: First Evaluation in an Open-Label, Single-Arm Feasibility Study in Diabetic Foot Ulcers. Int Wound J 2020 Oct;17(5):1366-1375.
SkinTE was used to treat 10 patients in a pilot trial. Results of the trial include: 8 of 10 (80%) VLUs closed within 12 weeks of a single application of SkinTE; median time to closure was 21 days; and no SkinTE-related adverse reactions were observed.
Open-label Venous Leg Ulcer Pilot Study Using Novel Autologous Homologous Skin Construct. Plast Reconstr Surg Glob Open 2020 Jul 16;8(7):e2972.
Closure Obtained with Vascularized Epithelial Regeneration for DFUs With SkinTE®—ClinicalTrials.gov Identifier: NCT05372809
34 million Americans are currently diagnosed with type II diabetes and, due mainly to vascular and neuropathic complications, approximately 15% of them suffer from diabetic foot ulcer (DFU), an open wound commonly located on the bottom of the foot that can lead to hospitalization due to infection or other related complications (including amputation in 14-24% of patients). Additionally, in severe cases DFUs and related complications can lead to death. It has been noted that the five-year mortality and direct costs of care for people with diabetic foot ulcer complications are comparable to cancer. Even if the initial ulcer heals, DFUs can come back and about 40% of healed ulcers will recur in one year. DFUs are commonly classified using the Wagner wound classification system in which DFUs.
Pressure Injuries (PI), known previously as pressure sores or bed sores, are defined as localized damage to the skin and/or underlying tissue, and arise as a result of pressure in combination with shear. 2.5 million people a year are affected by pressure injuries in the US alone and 500,000 will suffer a stage III/IV PI annually. The International NPIAP/EPIAP Guidelines classify pressure injures numerically by the depth of the wound, determined by inspection and palpation. Stage IV PIs extend through the deep fascia exposing muscle, tendon, ligament, cartilage, or bone. Stage IV PIs are particularly challenging with healing rates for stage IV being reported as low as 13% at 6 months. Approximately 9.3% of acute care patients develop hospital acquired pressure injuries (HAPIs), which are the most common hospital acquired condition. The incremental cost of a HAPI is estimated to add an additional ~$43,180 to a hospital stay which equates to an estimated $26.8 billion annualized cost to the U.S. healthcare system.
Venous leg ulcer (VLU) is the most common type of leg ulcer, accounting for more than 90% of all cases. VLUs can develop after a minor injury, where persistently high pressure in the veins of the legs has damaged skin. It is estimated that VLUs affect anywhere from 0.19%-0.23% of the general population and approximately 1 in 50 people over the age of 80 has a VLU. Studies show that the amount of these wounds remaining open longer than 12 weeks and therefore defined as “chronic” can be as high as 47%, which results in approximately 300,000 patients in the United States with VLUs that fail to heal with conventional treatments.
Acute wounds are recent wounds that have not yet gone through the stages of healing and include traumatic wounds, non-healing surgical wounds and burns. Similar to chronic wounds, acute wounds present a challenge to the healthcare system accounting for 17.2 million hospital, ambulatory and outpatients visits annually². Non-healing surgical wounds and traumatic wounds are the second and third most common wounds in the Medicare population¹. Non-healing surgical wounds are wounds remaining unhealed after a surgical procedure and have reported prevalence in the Medicare population as high as 3%². Traumatic wounds include acute injuries such as abrasion, puncture wounds or crush injury. There are an estimated 84 thousand surgical procedures yearly for traumatic skin wounds³. Burn injury remains a challenge despite advances in protocols and treatment options. Roughly half a million burn patients are treated annually in the US and the length of stay in the hospital for these patients is nearly double that of non-burn related stay².
¹Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. Epub 2017 Sep 19. PMID: 29304937.
²Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026. PMID: 33733885; PMCID: PMC8024242.
³DiMaggio, Charles et al. “Traumatic injury in the United States: In-patient epidemiology 2000-2011.” Injury vol. 47,7 (2016): 1393-403. doi:10.1016/j.injury.2016.04.002
PolarityTE presents original research on its science and therapeutic development at scientific and medical conferences, as well as in published peer-reviewed scientific journals.
Please contact us if you would like to learn more about the research presented here.
International Wound Journal
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The International Journal of Lower Extremity Wounds (online ahead of print)
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Plastic and Reconstructive Surgery‐Global Open
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Plastic Surgery Case Studies
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Cureus
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Oxford Medical Case Reports
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Annals of Burns and Fire Disasters
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Clinical Case Reports
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