US Notice Regarding Marketing Approval for Radiation Proctitis Wound Healing Material
We are pleased to announce that the 510K submitted to the United States Food and Drug Administration (FDA) by our US subsidiary 3-D Matrix, Inc for the Company’s wound-healing material for radiation proctitis as a medical device (class II) has been approved.
In the US, the Company began sales of the anti-adhesion and haemostatic material "PuraSinus" (now rebranded to "PuraGel") and in June 2021, has received the marketing approval for its haemostatic agent, “PuraStat”, for the prevention of postoperative bleeding in gastrointestinal endoscopy, with sales set to start imminently.
In addition to these products, 3-D Matrix, Inc plans to further expand its product line-up in the next fiscal year by rapidly commercialising healing materials for oral mucositis, radiation proctitis, as well as inflammatory bowel disease.
There are still many unmet needs related to radiation proctitis which is a side effect of radiation therapy for treating prostate and uterine cancers. Patients suffer from chronic inflammation of the rectal mucosa which can impact their day to day life.
This approval represents an important milestone for our Company as the wound healing material for radiation proctitis could contribute to improving the quality of life for patients.
For more details, please refer to the press release on the corporate website [link].