TAMPA, Fla., Aug. 17 /PRNewswire-FirstCall/ -- Biomed Research, Inc. (Biomed) reports successful completion of Good Laboratory Practices (GLP) animal testing of the refined MedClose(TM) Internal Puncture Closure Device (MedClose)(TM). The MedClose(TM) is a proprietary catheter-based system that uses Tisseel(R) VH Fibrin Sealant to rapidly seal arterial puncture sites following angiography and angioplasty. MedClose(TM) is not presently available for human use.
The Company previously reported completion of engineering refinements that were identified during testing of an earlier MedClose(TM) design. While the earlier design demonstrated that the MedClose(TM) system resulted in rapid hemostasis and excellent healing, the ergonomics of the device did not meet the expectations of a cardiologist focus group. The refined device addresses the user interface issues of the focus group, resulting in a product that is easily administered by a single operator, and provides excellent tactile feedback, re: vessel wall capture. The simplified, re-designed MedClose(TM) also improves efficiency of the tissue factor/biological glue "mixing" feature, and adds a fixed guidewire to ensure centering of the intra-lumenal balloon within the femoral artery.
The GLP animal testing demonstrated that MedClose(TM) results in hemostasis 78% faster (AVG 24 sec) than manual compression, and rapid ambulation without re-bleeding or oozing. Angiography showed widely patent arteries in all animals with no embolization in the toes. Histopathology confirmed earlier findings of excellent healing associated with Tisseel(R). Gross examination revealed no nodes or bumps on the artery to indicate where it had been catheterized, while exam under dissecting microscope showed healing so complete in some cases that it was not possible to identify the access site on the adventitia or within the lumen. This finding suggests that the same vessel location may be re-accessed after closure with MedClose(TM). With the successful completion of GLP testing, the Company intends to produce approximately 800 MedClose(TM) units for use in human studies, and to submit an application (IDE) to the Food and Drug Administration to begin a clinical trial.
Biomed Research, Inc. is a privately held corporation that provides product research, development, manufacturing and regulatory advisory services. MedClose(TM) is the proprietary property of Med Enclosure, LLC a subsidiary of CPC of America, Inc (BULLETIN BOARD: CPCF) of Sarasota, Florida. This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, and commercialization of new technologies. Tisseel(R) is a registered trademark of Baxter Healthcare Corporation.
Biomed Research, Inc.
CONTACT: Michael Dayton, Biomed Research, Inc., +1-813-949-6090