Dear Shareholders,
BioSyntech is dedicated to leading change
in the orthopedic landscape through innovation
and the eventual commercialization of BST-CarGel®,
a minimally invasive off-the-shelf surgical alternative
that has the potential to dramatically improve cartilage
repair and be cost effective. The end of this fiscal year
marked an important time for BioSyntech. The Company was
able to build up cash reserves and is now working diligently
towards reaching its pre-commercialization objectives.
Our number one priority in the next 12 months will be to
complete the Canadian-European pivotal trial for BST-CarGel®:
Encouraging results for our lead product
While we had hoped for a more aggressive enrollment
rate for our BST-CarGel® clinical trial, we are pleased that
patient enrollment to date is over 65% complete and that
the number of active sites has increased to 23, from 15
at the beginning of the year. We are also proud to report
that our adherence to stringent patient enrollment criteria
and the maintenance of the highest quality standards have
contributed to the positive interim results reported during
the fourth quarter. We showed preliminary evidence that
BST-CarGel® produces cartilage repair tissue of greater
quality than the current surgical standard of care with
comparable safety. These results are in-line with our
published animal studies demonstrating similar positive
outcomes, as well as anecdotal data in humans treated under
Health Canada's Special Access Program. Our plan is to submit
these findings along with other required analyses and data to
the U.S. FDA in preparation for a pre-IDE meeting and
eventual IDE submission.
We remain optimistic that the Canadian-European
trial will establish BST-CarGel® as a valuable option
for the repair of cartilage in the knee and position
BioSyntech as a leading innovator in the orthopedic space.
Securing resources to drive growth
The past year has been a challenging one for
BioSyntech. Efforts to negotiate a favourable revenue
generating licensing agreement did not result in a
partnership with acceptable terms. To increase its
negotiation leverage the Company decided to suspend
partnership discussions until interim clinical results
could be analysed and its financial position strengthened.
BioSyntech recently successfully improved its cash position
by securing, in an especially difficult market for biotech
companies, a $12.55 million convertible debenture financing
which will provide the Company with sufficient capital resources
to continue driving its near-term pre-commercialization objectives.
Specifically, the proceeds of this financing will be
used to: complete the ongoing BST-CarGel® clinical trial
and to obtain clarity regarding the U.S. regulatory
pathway; implement a streamlined business plan focused on
maximizing value for all shareholders; involve a consultant
to enhance our management team in the exploration of strategic
alternatives, such as partnerships and M&A transactions; and
support working capital and general corporate purposes.
Focused approach for our compelling technology
As part of the implementation of the streamlined
business plan we will concentrate and focus our efforts
and resources on advancing BST-CarGel® through the clinic.
While we continue to believe strongly in the market
opportunity of our other programs, given the current
limited financial resources at BioSyntech, enrollment
for the BST-DermOnTM clinical trial and development
work on BST-InPodTM has been suspended at this time.
We continue to appreciate your support
and we look forward to updating you on our progress
as we strive towards building value for our shareholders,
employees and stakeholders.
Sincerely,
Claude LeDuc
President and CEO
BioSyntech Inc.
July, 2008
This letter contains “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