KeraStat Cream Cleared by FDA for Radiation Dermatitis

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Figure 13 from Radiation dermatitis: clinical presentation ...KeraNetics Inc. announces that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has been cleared by the US Food and Drug Administration for indications of radiation dermatitis.  This product is designed to reduce the painful ulceration and skin damage that occurs during radiation therapy.  The effectiveness of KeraStat Cream is backed by human data in patients with breast cancer, that shows that KeraStat Cream reduces the symptoms of radiation dermatitis and improves quality of life.  Large animal testing has shown that KeraStat Cream is also an appropriate countermeasure for Cutaneous Radiation Injury, a more significant skin condition that could result from an event such as nuclear terrorism.  KeraNetics is in the process of expanding the potential uses of the product by completing an additional human study in patients with head and neck cancer, conducted by Wake Forest Baptist Health and the Wake Forest Cancer Center.  This study is enrolling patients now (NCT04173247).

The initial work that led to the development of KeraStat Cream was funded under a Biomedical Advanced Research and Development Authority (BARDA) contract HHSO100201200007C.  Radiation dermatitis, a cutaneous radiation injury, is seen in 85% of patients undergoing radiation therapy to the head, neck, breast, chest wall, perineum, or vulva, and negatively affects the patients' quality of life. 

"The clearance of this product by the FDA today will help improve the lives of patients, particularly those with breast cancer who are struggling with radiation treatment," said Dr. Luke Burnett, the CEO and Chief Science Officer at KeraNetics.  "This product is the first step in finding an evidence-based solution to radiation dermatitis and an easily deployed medical countermeasure that could be included in the Strategic National Stockpile to protect US citizens." 

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KeraStat Cream Cleared by FDA for Radiation Dermatitis.  Appl Rad Oncol. 

By News Release| July 21, 2020

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