SOURCE: BioSurface Engineering Technologies, Inc.

February 01, 2007 06:00 ET

BioSET Reports Patent Issuance, Product Development Advances, and New Financing

ROCKVILLE, MD -- (MARKET WIRE) -- February 1, 2007 -- BioSET, Inc. announced today several key developments as the Company advances its synthetic peptide-based tissue repair programs.

BioSET has received notice that United States Patent No. 7,166,574, titled 'Synthetic Heparin-Binding Growth Factor Analogs,' was issued on January 23. This is the first in a series of patents describing fully synthetic peptide constructs that mimic the activity of human growth factors. The growth factor mimetics were developed by researchers at the Company and Brookhaven National Laboratory and are exclusively licensed to BioSET.

According to Dr. Paul Zamora, co-inventor and BioSET's Chief Scientific Officer, "Growth factors play key roles in guiding the body's development and repair processes. Synthetic mimetics of growth factors represent a significant advancement that can facilitate the introduction of regenerative medicine into the clinic. BioSET's lead program incorporates our novel bone repairing peptide B2A with a bioresorbable bone graft matrix, producing a combination medical device for use in treating musculoskeletal injuries and diseases, including those of the spine."

The novel mode of action of BioSET's B2A peptide was recently described in an article published in the Journal of Orthopaedic Research. B2A escalates the activity of bone morphogenetic protein -2, the body's main bone repair protein, resulting in enhanced and more rapid bone formation and repair. Bone grafts are critical to numerous orthopedic procedures; it is estimated that surgeons employed more than 900,000 bone grafts in the United States last year.

Additional data on the BioSET B2A peptide will be presented at the upcoming annual 2007 Orthopaedic Research Society in San Diego, CA. An experimental animal spinal fusion study conducted by University of Iowa researchers, Joseph D. Smucker, MD and Doug Fredericks, indicated that B2A enhanced spinal fusion when compared to the "gold standard" of autograft (i.e. bone that often is obtained by surgical removal from the patient's hip). The researchers observed further that "To our knowledge, this is the first report of a synthetic peptide demonstrating enhanced posterolateral spinal fusion in this model."

BioSET is completing its pre-clinical evaluation package, according to Brent Atkinson, the Company's VP of Product Development, who also stated, "Based on discussions with the FDA, the company expects to complete pivotal animal studies before mid-summer, and believes it is on track to file an Investigational Device Exemption ("IDE") early in the second half of 2007 to allow a controlled human study of the use of B2A-resorbable bone graft construct in instrumented lumbar spinal fusion applications."

Tom Roueche, President and CEO of BioSET, commented, "I am extremely pleased with the progress our team has made over the past year toward our goal of bringing a fully synthetic bone graft material to the clinic. The data being generated by these highly knowledgeable and skilled researchers evidence the progress of our technology, and we look forward to the results of a final panel of studies that will permit the filing of our IDE in the near future."

BioSET reported that the Company recently has secured commitments for at least $8 million in new equity financing, subject to the completion of diligence activities. This capital will be used to advance the company's current bone graft program through human safety studies, and to begin the evaluation of additional applications of B2A and other peptide growth factors in both bone and soft tissue repair. The company expects to close the round of financing in the first quarter of 2007.

About BioSurface Engineering Technologies, Inc.

BioSET is developing proprietary therapeutic peptides for incorporation into medical devices to improve bone and soft tissue repair. BioSET's synthetic peptides are bioactive mimetics of growth factors that continue to show promising results in studies for the treatment of musculoskeletal, vascular and chronic wound diseases. The company intends to capitalize on the growing interest in drug/device combination products and seeks to initiate studies of these combination products in human clinical trials. For more information, please visit BioSET's website at: www.biosetinc.com

Contact Information

  • Contact:

    Tom Roueche
    301.795.6010
    Email Contact

    9430 Key West Avenue
    Suite 220
    Rockville, MD 20850
    301.795.6000 Ph.
    301.340.7801 Fax