...The complete letter gives greater detail on the strategic positioning of the company and the milestones management has set by which shareholders can gauge Biophan’s progress during the year.
The letter can be viewed in its entirety at the Biophan website at www.biophan.com under “Items of Interest.”
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.
Chief Executive Officer
Biophan Technologies, Inc.
15 Schoen Place
Pittsford, NY 14534