Global News: FDA clears hydrogel PuraStat-OM®, a treatment for oral mucosa wounds
3-D Matrix, Inc., the U.S. subsidiary of 3-D Matrix group, obtained 510(k) clearance the pre-market clearance of PuraStat-OM®, an oral hydrogel wound dressing product, from the Food and Drug Administration (FDA) in the US.
PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination, and to provide a moist wound environment for optimal wound healing. It is intended to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa (e.g., oral mucositis and stomatitis). Oral mucositis is said to occur in over 40% of cases of solid cancers (e.g., head and neck cancers) and hematopoietic malignancies as a side effect of chemotherapy and radiation.
Inflammation of the oral mucosa causes pain and secondary infection and has a significant impact on the patient's quality of life. Current standard of care is limited to treatment of symptoms. Although the site of occurrence for oral mucositis is the oral cavity, the inflammatory symptoms are understood to be similar to those of radiation proctitis. We expect that the clearance of PuraStat-OM would contribute to the development of a wound dressing material for radiation proctitis in the US.
For more details, please refer to the press release on the corporate website.