MARKET-THE EPINEX SIMPLYSURE PT-INR BLOOD COAGULATION TEST
THE EPINEX SIMPLYSURE PT-INR COAGULATION TEST
Atrial Fibrillation and Stroke in the United States
3 million cases/year (Mayo Clinic)
~800,000 per year
15%-20% attribute to AF
6.4 million total adult stroke cases
Receiving a stent
~600,000 per year
(patients receiving a stent
must have anti-coagulation
People taking blood-thinning medicines such as Warfarin need regular blood tests to check how well the medicines are working. The most common test is the PT/INR test (Prothrombin Time/International Normalized Ratio). People taking Warfarin must have the effect of drug monitored regularly, as often as once a week.
At present, all PT/INR testing, whether Point-of-Care or self-testing, requires an expensive reader device in addition to the actual test strips. Even though medical authorities are calling for increased self-testing, in 2011 only 13% of coagulation testing performed worldwide was self-testing.
The Self-Testing Market Opportunity:
20 million existing Warfarin users in the United States.
–Estimated 2 million new users each year
Recommended weekly testing.
–Equates to a potential 1 billion tests each year.
Epinex SimplySure PT-INR Advantage Over the Competition:
SimplySure PT-INR does not require complex and costly instrumentation for testing.
All competition requires upfront instrument/device cost >$900.
Simplicity and cost effectiveness of SimplySure PT-INR enables easy physician office or self-testing without need for additional infrastructure or patient assistance.
Disposable test design facilitates INR monitoring at any time any place.
• Specialty Healthcare Providers
• Home Healthcare
• Home Testing Supplies
• Retail Organizations
• Physician office Labs
• Emergency Rooms
• Home Healthcare
• Nursing Homes
• Small Reference Lab
• Stat Locations
• Research & Biotechnology
•Defense & other Government Agencies
* This product is under development and is intended for information and evaluation purposes only. It is NOT APPROVED by the USFDA.