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Company & product description

SONOMEDIX,
INC
mdugery@sonomedix.com
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.

Source: https://www.lifescienceintelligence.com/media/sample/example-execsum2.pdf

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