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BioSyntech reaches significant BST-CarGel(R) clinical milestone |
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15 Jun 2007 |
BioSyntech Inc. announced today that it has completed the enrolment of a 20 patient subset of its ongoing Canadian-European BST-CarGel(R) pivotal trial
LAVAL, Canada | June 14, 2007 | BioSyntech Inc. (TSX: BSY) announced today that it has completed the enrolment of a 20 patient subset of its ongoing Canadian-European BST-CarGel(R) pivotal trial. The data collected from these patients will be submitted to the U.S. Food and Drug Administration as a pilot study in support of an Investigational Device Exemption (IDE) for a US pivotal trial.
"We have reached an important milestone for the Company," said Claude Leduc, President and CEO of BioSyntech, "because this pilot study should permit us to advance directly to a US pivotal trial, and pave the way for commercialization."
BioSyntech's current Canadian-European multicenter clinical trial for BST-CarGel(R) is targeting 80 patients. The objective of the trial is to assess BST-CarGel(R) safety as well as its ability to repair focal articular cartilage damage in the knee, and is intended to support market approvals in Canada and Europe.
About BST-CarGel(R)
BST-CarGel(R) is a promising new therapeutic approach for repair of localized cartilage lesions. Applied during minimally-invasive surgery, it acts in situ as a 3-dimensional scaffold and may guide the repair of the damaged cartilage.
About BioSyntech
BioSyntech is a biotechnology company specializing in the discovery, development and manufacturing of innovative cost-effective and physician-friendly therapeutic thermogels for regenerative medicine and therapeutic delivery. BioSyntech's Quality Management System is registered to ISO 9001:2000 standards. For additional information, visit www.biosyntech.com.
This press release contains forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws, which reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise.
SOURCE: BioSyntech Inc |
