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Company & product description
SONOMEDIX, INC [email protected] Company & Product Description SonoMedix is an early-stage, privately held medical device company located near Philadelphia, PA. SonoMedix’s initial product, EZ- INR, is an easy to use blood coagulation monitoring system for use by patients and healthcare professionals in the management of warfarin therapy. Warfarin, also sold as Coumadin, is an oral anticoagulation, or blood thinning drug given to patients to prevent the formation of blood clots. An estimated three million people in the US take warfarin daily and while it is the most prescribed anticoagulant next to aspirin, the consequences to the patient of being outside the safe therapeutic range can be severe and life threatening. The EZ-INR System consists of a handheld meter and disposable test strip with a nanoacoustic sensor built into the disposable test strip. This is a “razor and blades” business model. Communication capabilities of the meter enable it to store and transmit test results directly to the patient’s physician and a secure server. Clinical Need & Market Opportunity The clinical need for self testing of PT/INR values for patients on long term Coumadin therapy is critical and immediate. Coumadin is second only to Insulin with respect to dosing errors. Incorrect dosing of Coumadin is responsible for 43,000 ER visits and 17,000 strokes per year in the US. The direct hard costs of complications are in excess of $1.1B annually. The growth in Coumadin prescriptions, which is rapidly approaching 40 million per year in the US, is driven by demographic trends which continue to increase the size of the Afib, MHV and VTE patient populations. The target market for the EZ-INR includes those patients who are on long-term Coumadin therapy and are capable of self testing and the physicians who manage these patients. This market is divided into three distinct segments: patients with Atrial Fibrillation (Afib), Venous Thromboembolic disease (VTE) and patients with Mechanical Heart Valve (MHV) Major Market Changes – CMS National Total Available Market ($) Coverage Decision (Thousands)
On March 19, 2008 CMS issued a National Coverage
Decision to expand reimbursement of weekly patient self testing for PT/INR monitoring to cover patients with
Afib and VTE. This coverage decision impacts over
2.5M patients and increases the reimbursed market size
by over five fold. The significance of this decision
cannot be overstated: it has created a new market for
PT/INR patient self testing with a reimbursed market value of over $3.5 billion. This market along with the
already reimbursed MHV market of 600,000 patients creates a reimbursable market for this application worth
over $4.5B. Further, this market is in its infancy with
1 Budnitz DS, et al., “National Surveillance of ER Visits for Outpatient Adverse Drug Events.” JAMA 2006; 296: 1858-1866 Competition Currently, there are three visible competitors in the market. Roche is the market leader with strength in distribution network and relationships with several leading Independent Diagnostic Testing Facilities (IDTF). Hemosense Inc’s INRatio is the most user friendly system on the market. Hemosense has been aggressive in building out their distribution network and developing web based training programs. While Hemosense is not yet profitable, they have been able to grow revenues consistently on a quarter over quarter basis and was recently acquired by Inverness Medical, large diagnostic player. Inverness Medical acquired Hemosense for $167M, representing a 37% premium to their stock price and seven times trailing 12 months revenue. International Technidyne Corporation (ITC) markets the ProTime® patient self-test system which is the least competitive of the three players due to slow test time and large blood sample requirement. Competitive Matrix Key Management: Mike Dugery, Co-founder & CEO
• 20 years in med-tech w/ Engrng, Sales & Marketing experience in start-ups and multi-nationals
• Co-founder: SonoMedix, Vasculab, AVS & Bioconnect Systems Inc
• J&J Cordis, Senior Sales & Product Management Executive Positions
• Wharton/Penn Eng M&T Masters, Penn State BSME Mark Schafer, Ph.D., CTO (consulting)
• 20+ years of medical ultrasound product development experience
• Founded and sold start-up to Perceptron (NASQAQ: PRCP)
• Drexel Ph.D. (Biomedical), M.I.T. S.B.EE
Five-Year Financial Projection 2008 2009 2010 2011 EBITDA
(230,000) (275,000) ($1,989,550) ($3,170,000) ($2,311,000)
Pre-Tax Income
(230,000) (275,000) ($1,989,550) ($3,170,000)
Net Income
(230,000) (275,000) ($1,989,550) ($3,170,000)
Financing SonoMedix has secured seed financing of $500,000 in the form of convertible debt from an institutional investor. The company is now pursuing Series A financing of $6 million to complete product development and commercialize the EZ-INR System. From the close of the series A funding it is estimated to take twenty four months to commercialize the product in the PT/INR market.
VICTORIAN BRITAIN When we describe Great Britain in the Victorian period, words like stability,progress, prosperity, reform, and Imperialism come to mind. The British had grounds forsome satisfaction because evidence of great economic growth and technical progressseemed to abound. Despite the continued existence of widespread poverty, teeming,miserable slums and poor working conditions in many i
Dott. Damiano Angoli Researcher, Lab Manager email: [email protected] Citizenship: Canadian, Italian. Education and Languages: * 1988-94 Laurea (Doctor in Biological Sciences) with honor (110/110) in Biology at Dept. of Biochemistry and General Physiology, Electrophysiology Laboratory, University of Milan, Italy. “Regulation of intracellular pH in human promyelocytic leukemia cells�