Ethicon has submitted a biologic license application (BLA) to the US Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.
The Fibrin Pad is intended for use by surgeons as an adjunct to hemostasis when surgical methods are ineffective or impractical to control bleeding.
The BLA submission includes efficacy and safety data from a randomised, controlled clinical study, in which the Fibrin Pad was used as an adjunct to hemostasis in soft tissue bleeding.
The proposed indication is: as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.
Ethicon Medical Affairs vice president Jim Hart said that the Fibrin Pad product candidate is an excellent example of convergence within Johnson & Johnson, bringing together medical device and pharmaceutical expertise to bring true innovation to the market.
“The results observed in the clinical trial are very encouraging. This clinical trial is just the first chapter in a stepwise clinical development plan that is ongoing and is intended to evaluate the product candidate in a variety of tissue types and in increasing intensities of bleeding,” Hart said.
Ethicon, a Johnson & Johnson company, is a provider in wound closure, general surgery, wound management, women’s health and urology and aesthetic medicine.