Prourocare Medical Inc. - Additional Proxy Soliciting Materials (definitive) (DEFA14A)
July 21 2008 - 1:22PM
Edgar (US Regulatory)
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UNITED STATES
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SECURITIES AND
EXCHANGE COMMISSION
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Washington,
D.C. 20549
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SCHEDULE 14A INFORMATION
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Proxy
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Definitive Proxy Statement
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Definitive Additional Materials
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Soliciting Material Pursuant to
§240.14a-12
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ProUroCare Medical Inc.
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(Name
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July 16, 2008
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To our Shareholders:
Last year, we identified
three areas of primary importance to the success of ProUroCare: obtaining the
financing required to bring the system to market, repositioning our ProUroScan
TM
System and its business model and expanding our relationship with our
development partner Artann Laboratories.
These areas have been the focus of our efforts during the past year and
I am happy to report that we have made significant progress on all fronts.
Financing
In early 2007, we
significantly reduced operating expenses and raised $0.5 million to ensure the
survival of the Company and begin laying the groundwork necessary to support
subsequent financing efforts. Since
then, we have succeeded in selling approximately $1.9 million of convertible
notes in a private placement to investors who have heard our story and believe
in the potential that the ProUroScan System holds. Working with our existing debt guarantors and
our bank, we were able to extend the maturity date of $2.2 million of debt by
one year, and changed the terms of our existing convertible debentures and
related interest to provide for automatic conversion to equity upon the closing
of a public offering. Our goal and our
challenge for the remainder of this year is to close on at least four million
dollars in additional funding on acceptable terms, to allow us to complete the
development of the ProUroScan System and obtain regulatory clearances.
Positioning
of the ProUroScan System
The investors in our
company believe that our product meets a major unmet need in the market. There is an obvious need to augment the
abilities of digital rectal examinations (DRE) and prostate specific antigen
(PSA) tests in the identification and characterization of prostate cancer. These tools often miss or incorrectly
diagnose the patients condition; clinical data suggests that a large
proportion of patients that have a positive result from these tests do not have
cancer. We plan to position the
ProUroScan system as an adjunct to DRE and PSA that provides a physical record
or map of where an abnormality exists and the ability to compare maps over
time. This latter capability allows
patients to follow the progression of their disease over time and only elect
aggressive treatment when there is a clear record of advancement. The goals are to reduce the number of
unnecessary biopsies, make necessary biopsies more effective by identifying
target areas within the prostate and provide a non-invasive method of
monitoring the disease for those undergoing active surveillance.
Once completed and in the
market, the ProUroScan system will benefit all stakeholder groups. Patients benefit by having access to a new
tool that can physically document and provide comparisons of their condition over
time. Physicians benefit by being able
to more effectively monitor a patients status and to prescribe treatments that
are consistent with the patients diagnosis, medical condition and family
situation. Insurance companies and other
third-party payors benefit by reducing the number of unnecessary biopsies and
surgery. We believe that the significant
benefit our system provides to all stakeholder groups will generate attractive
profit margins and returns to our shareholders.
Collaboration
with Artann Laboratories
Our collaboration with
Artann Laboratories of Trenton, New Jersey (Artann) is an important element in
completing the ProUroScan System. We are
currently in the process of negotiating new licensing, development and commercialization
agreements with Artann designed to bring the ProUroScan system and related
product improvements to market.
Artann is the inventor of
the ProUroScan technology and has been instrumental in advancing development of
the system. A major portion of Artanns
development effort to date has been funded by grants from the National
Institutes of Health (NIH), including a $3 million SBIR Phase II Continuation
grant that was awarded in September
2
2006 in which ProUroCare
is named as the prospective commercial partner.
Funding from this grant, which runs through September of 2009, will
be instrumental in moving this technology through the remaining stages of
development and clinical testing required for regulatory approval.
Among Artanns
achievements is the testing of more than 200 patients using the ProUroScan
System at the Robert Wood Johnson Hospital in New Brunswick, New Jersey. Artann has published five journal articles
based on its clinical efforts, including recent articles in the prominent
scientific journals
Urology
and
Nature Clinical Practice Urology
,
and has generated significant laboratory testing data that demonstrates the
accuracy of the system in detecting tissue abnormalities.
Artann has developed a
clinical protocol for the ProUroScan System that was presented to Food and Drug
Administration (FDA) reviewers in April 2008. Assuming we complete the agreements with
Artann and our financing on schedule, we expect to finalize development of the
system and obtain FDA clearance in 2009.
Strengthening
Our Intellectual Property Position
A major achievement for
us in April of this year was our purchase of the patents relating to
ProUroScans mechanical imaging technology.
Previously, we licensed the rights to these patents for use in the
prostate imaging field. This purchase ensures our rights in our current field
of use, allows us the opportunity to pursue other potential soft tissue
applications, and eliminates significant future royalty payments. We anticipate that our relationship with
Artann will lead to the licensing of additional intellectual property rights
covering enhancements and future innovations in mechanical imaging.
Moving
Forward
There are important tasks
still on our agenda, but a great deal has been accomplished this year. We are in position to successfully move the
ProUroScan system and the business forward.
Obtaining adequate funding is essential to meeting these goals, and I am
optimistic that we will be successful in doing so this year.
Prostate cancer is the
second leading cause of cancer-related death in American men. Our mission is to join the fight against
prostate cancer. Our milestones for 2009
are to complete the FDA clearance process and start commercial distribution.
Sincerely,
/s/ Richard Carlson
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Richard Carlson
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Chief Executive Officer
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3
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