A Medical Device Daily

Rocky Mountain Biosystems (RMBI; Denver) said it has successfully completed Phase I of a National Institutes of Health (NIH; Bethesda, Maryland) Small Business Innovation Research grant (SBIR). The grant helped RMBI to adapt its Biofusionary tissue sealing technology to seal punctures in the skin following a dialysis procedure.

The $99,949 SBIR grant was awarded by the National Heart, Lung and Blood Institute (NHLBI; also Bethesda).

During the study, RMBI used its activated sealing system with a prototype applicator and energy source. The technology, named Biofusionary, activates a specially formulated adhesive to bond tissue and achieve a uniform seal in seconds. In the study, a prototype device referred to as FastSeal successfully sealed punctures in skin samples and maintained the seal through significant pressure. The seal formed immediately, demonstrated significant mechanical (tensile) strength, and was not affected by the presence of moisture. In addition, there was no evidence of skin damage.

“Our experiments suggest that the activated adhesive may have great utility in closing a variety of tissues with a uniform, fluid tight seal in seconds. It has the potential to be applied to a variety of external skin applications, such as punctures, lacerations and even battlefield wounds. It may also be applied to a variety of internal surgical wound closure applications,“ said Kevin Marchitto, RMBI's CEO.

RMBI partnered with Rose Biomedical (also Denver) to secure the NIH grants. Rose Biomedical partners with companies, medical professionals and inventors to develop and commercialize medical products that improve the quality of healthcare while reducing the cost.

“Based on these successful results, RMBI and Rose Biomedical have submitted a one million dollar Phase II grant application to advance our research on tissue sealing and explore additional applications,“ said Ken Weil, Rose Biomedical's CEO.

Vascular Solutions (Minneapolis) and B. Braun Medical (Bethlehem, Pennsylvania) said that they have extended their agreement for a second contract year for the inclusion of Vascular Solutions' D-Stat Dry hemostatic bandage with B. Braun Medical's vena cava filters sold in the U.S.

The agreement provides for the purchase by B. Braun Medical of individual units of the D-Stat Dry hemostatic bandage from Vascular Solutions for inclusion with B. Braun Medical's vena cava filter systems. Following the physician's implantation of Braun's vena cava filter, the D-Stat Dry hemostatic bandage can be applied to the puncture site for assistance in rapidly achieving hemostasis. Under the terms of the extension, B. Braun Medical's purchases of the D-Stat Dry will continue through March 2006.

Howard Root, CEO of Vascular Solutions, said, “We appreciate B. Braun's continuation of this agreement to the benefit of both parties. In addition to the increased revenue to Vascular Solutions, over the last year we have benefited from the added visibility within the interventional radiology market generated by B. Braun Medical's product and sales force. We are pleased to continue these benefits into a second year.“

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