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January 16, 2008
Dear Biophan Shareholder:
As we begin a new year, let me take the opportunity to review the
important steps we have taken during the latter part of 2007 to
position our company to meet critical challenges and to take
advantage of significant opportunities, particularly for the
treatment of acute heart failure.
More importantly, I want to provide a roadmap for our investors to
understand the strategic direction we have charted for Biophan and to
gage our progress as we reach some critical milestones for the
company in the coming year.
Since I was named CEO in September, we have taken a number of
initiatives to strengthen the focus and financials of Biophan, and
allow the company to pursue a clear and consistent direction.
Central to that direction, we completed the sale of a portion of our
patents to Medtronic for $11 million, which brought much needed
capital into the Company.
We now have the opportunity to develop, with an eye toward
commercializing, a number of technologies covered by Biophan's
existing 45 issued patents, as well as numerous pending patent
applications. In addition, Biophan has become the majority
shareholder in Myotech, which is developing the Myotech Circulatory
Support System (CSS) - a novel medical device designed to quickly
restore full cardiac output to an arrested heart.
Biophan is seeking to develop its emerging technologies through
grants and strategic partnerships. As an example, the biothermal
power supply is being co-developed with the NASA Ames Research Center
and has already received two grants totaling $200,000 to support
projects for the Departments of Energy and Homeland Security. In
addition, the company is working on developing some of its other
early stage technologies, such as pulsewidth modulation for tissue
stimulation, which can be used to excite nerve tissues in a manner
that is far more energy efficient than any existing stimulation
device. This technology may have the capability to take the
efficiency of pacemakers, ICDs, and neurostimulators to a new level,
and we are seeking grant funding to support further development.
In terms of the Myotech CSS, it is important to fully understand the
scope of this unmet medical need and the large market opportunity
that is crying for a solution.
Over 260,000 patients suffer in-hospital cardiac arrest every year,
and about 80% of those patients do not survive. The Myotech CSS is
capable of returning full cardiac output to an arrested heart in
under three minutes, doing so without any contact with circulating
blood. We believe this approach is superior and will dramatically
improve outcomes for this patient population.
In addition to prioritizing our product development pipeline, Biophan
also put in place a disciplined spending plan for the company. The
road toward regulatory approval and product introduction is a marathon, not a sprint. And at the early stages of the race, Biophan
must be prudent yet inventive with its resources.
On November 1, 2007, we named a number of seasoned professionals to
the Myotech Board of Directors, whose experience in and understanding
of our industry can provide solid counsel and direction as we move
down the regulatory path toward approval.
On December 18th, James Goldberg, a respected executive with vast
experience in all areas of running early- and mid-stage healthcare
companies, agreed to become President of Myotech. His experience and
contacts within the industry will provide steady leadership.
In a few short months we have sharpened our focus, strengthened our
financial position, and named a solid leader and a strong Board of
Directors for Myotech. Our goal is to begin clinical trials in
Europe for the Myotech CSS in 2009.
What can our shareholders look for in 2008 to indicate we are making
solid progress and gaining traction in reaching that goal?
We will continue to build an operational team at Myotech with the
requisite experience and expertise to navigate the various clinical
and regulatory hurdles. We should be making a number of
organizational announcements in the first half of 2008.
This team will undertake a number of important steps in moving toward
our goal to initiate clinical trials in 2009. We will be laying out
a detailed plan and milestones, including timelines for further
animal testing for the Myotech CSS, initial meetings with the FDA
regarding the regulatory pathway for the device, plans for engaging
with development partners to finalize and enhance the design of the
Myotech CSS, and ultimately for filing for regulatory approval.
Our 2008 progress can be measured as we grow and strengthen our
operational team, prudently manage our costs-including funding our
emerging technologies through grants and partnerships-and most
importantly, reach critical milestones in the development of the
Myotech CSS.
Strengthened by a focused strategic direction and more solid
financial footing, Biophan has a renewed purpose and vitality. 2008
should prove to be an eventful and productive year for our company.
Sincerely,
John Lanzafame
Chief Executive Officer
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OTC:BIPH
www.biophan.com
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Biophan Technologies, Inc.
15 Schoen Place
Pittsford, NY 14534
Tel +1.585.267.4800
Fax +1.585.267.4830 |
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