Session 8-5: A Novel MRI Marker For Prostate Brachytherapy

M. D. Anderson Cancer Center
Date: April 2008
Duration: 0 / 06:05

Team 1: Steven Frank, presenter.

My name is Steven Frank. I actually here at this institution perform all the prostrate brachy therapy. And so over the last several years as I built the program up, and since 2005 I've identified several problems. The product that you're seeing right here is C4. C4 is the imaging marker that is like a beacon of light under MR. It its right here and its helped to identify the seeds under prostrate brachy therapy. Here's the current problem. The current standard imaging modality used for the planning and treatment of prostrate cancer is ultrasound. And as you can look right here, here is the prostrate. And these are the three images both at the base, midglen and apex. For evaluation and standard treatment, this is what is used. This is what the base of the prostrate looks like, this is what the midglen and this is what the apex. All of these are very difficult to identify the normal structures. The most superior imaging modality for prostrate cancer and its treatment is MRI. And we can see here that the imaging is much better identifiable, and if we earmark this place, here is where 70 thousand men are becoming incontinent each year. So the problem currently and the reason that MRI is not used for prostrate cancer treatment is because no marker has been able to identify the location of where the treatment is going. We have now solved that problem. We have identified and developed a novel marker that is like of beacon of light in MR imaging. Here we have now developed a somewhat of a prototype, which shows the three radioactive isotopes with the marker in between them. And here you can see the titanium seed is not identifiable under MR but the C4 agent identifies a location of that marker. So the highlights. Our company was designed to manufacture and distribute C4. It's a contrast marker again like a beacon of light in MR imaging. We would target the prostrate brachy therapy market because they are natural channels of distribution in place to capitalize on this emerging market. We project sales to go approximately 50% in 2010 another 30% in 2011 and reach production capacity in 2012. Where we hope to have everyone of the seeds implanted in the market. A hundred and sixty five thousand will be required to bring the product initially to market. Our net will grow approximately 2.7 million to 120 million by the end of the plan period. We require 1.5 million at the time of startup to cover overhead expenses and to permit enough cash on hand for up to two years of operations. Our exit strategy is to be acquired by an imaging based company within five years to generalize the C4 agent to additional markets. Here is the highlights characterizing the sales, gross margin and net profit over the first three years. The market that we are targeting are urologists, radiation oncologists, strand and seed manufacturers, hospitals and health care providers. Each one has to gain for this procedure. For the market need the seed manufacturers, they can sell the seeds and can be the industry's best advocate. They can market the product which will increase the usage of these seeds. For strand manufacturers they put the seeds in strands and the markers also in the strands. They can also market the product will also increase the use of strands. Any men over the age of 50 would demand that the marker be used during the course of their treatment and physicians need to be educated as well from the urologist and radiation oncologist to show that this will improve the outcomes both from a cure and to minimize morbidity. The competitive advantage is the first MRI marker to market. Its developed here at M. D. Anderson, the number one cancer center and the C4 agent will turn prostrate brachy therapy from an art to a science. Again here's a particular sales forecast for the C4 agent. The C4 marker and eventually an MRI visible C4 seed. A management team as it consists right now which is not much of a management team, but we are looking to develop a management team.

[ Laughter ]

Financial plan. Sort of funny. We come from debt from the following. 200 thousand dollars from M. D. Anderson, potentially 250 thousand from the Texas [inaudible] fund. Potential bank loans, personal investments and credit card debt. This funding will be necessary develop the following. A prototype, obtain a lease of a license from M. D. Anderson, 510K clearance and salaries. Our break even point will be to develop a 70 thousand dollars in average percent variable cost at 38% with estimated monthly [inaudible] cost at 43 thousand dollars. First year production we anticipate 12 million dollars in sales and we want to increase our sales to more than 40 million dollars in the second year and 100 million in the third year. The way we derive those numbers is that each patient it will be approximately $4000, and there's three thousand patients in the first year, which will be approximately 12 million, the second year increase to 10 thousand, in the third year 25 thousand. Our specific objective is to get C4 agents to the market by March of 2009. Incorporate the C4 market with seven million seeds implanted annually by 2012 and have the first sale of MRI visible seed by January of 2011. Our milestones include a prototype, pre-clinical studies, FDA 510K clearance, clinical trials and licensing of technology. Our investment now shows start up expenses will be 190 thousand dollars with total funding 1.4 million dollars including liabilities and capital. Our keys to success are quality control for manufacturing, channels of distribution and education of patients and providers. Our next step is to complete our prototype, develop a management team and to identify funding resources. Thank you for your attention.

[Applause]