TAMPA, Fla., April 6 /PRNewswire/ -- Biomed Research, Inc. (Biomed) reports completion of ergonomic refinements to MedClose(TM) Internal Puncture Closure Device (MedClose)(TM). The MedClose(TM) (http://www.medenclosure.com/) is a catheter-based debridement and biological glue delivery system designed to rapidly seal arterial puncture sites following angiography and angioplasty. The Company previously completed a supply agreement with Baxter Healthcare Corporation for the use of Tisseel(R) VH Fibrin Sealant with the MedClose(TM). Tisseel(R) is approved by the U.S Food and Drug Administration (FDA) as an adjunct to hemostasis in cardiopulmonary bypass and splenic injuries, as well as and adjunct in colostomy closure.
The Company has completed refinements to the MedClose(TM) that were identified during animal testing of devices produced during the primary design phase. While testing of the prior design confirmed rapid wound closure and excellent healing associated with Tisseel(R), several user interface issues indicated the need for further refinement before human studies could begin. Design enhancements include further miniaturization to permit use with a broader range of introducer sizes, ease of use ergonomics permitting true "single-user" operation, distal guidewire for centering the intraluminal balloon, and refinement of the patented debridement feature to initiate release and interaction of the patient's tissue factor with Tisseel(R) for rapid activation and sealing. Assembly processes for the refined MedClose(TM) are presently being validated, and when completed, animal testing will be repeated to verify and validate the design changes. Following completion of the pre-clinical and animal testing of the refined MedClose(TM), an application for a human study (IDE) permit will be filed with the FDA. The MedClose(TM) device is not presently available for sale.
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.
Biomed Research, Inc.
CONTACT: Michael Dayton, Biomed Research, Inc., +1-813-949-6090