FDA Approves Medafor Hemostasis Products

NEW YORK (Reuters Health) Jan 10 – Medafor Inc. said on Thursday that the US Food and Drug Administration (FDA) has approved the company's TraumaDEX product for use by medical personnel to temporarily control severe bleeding on trauma and post-surgical wounds.

The Minneapolis, Minnesota-based company also said that its Bleed-X treatment for cuts, lacerations and abrasions has been cleared by the FDA for over-the-counter use.

According to Medafor, both products are based on its Hemadex technology, which uses a biopolymeric, microporous powder to rapidly initiate coagulation and stop profuse bleeding.

The privately held company said that it intends to first direct the two products to emergency medical services, dermatology and over-the-counter first aid markets. Later, it will begin marketing the products for military field applications and post-surgical wound management.

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