MARKET-THE EPINEX SIMPLYSURE PT-INR BLOOD COAGULATION TEST

THE EPINEX SIMPLYSURE PT-INR COAGULATION TEST

Market Size

 

                                     

                                  Atrial Fibrillation and Stroke in the United States

 

 

 

 

 

 

 

Condition

Prevalence

Atrial Fibrillation

3 million cases/year (Mayo Clinic)

Stroke

~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

therapy)

 

 

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.

     

     

     

     

     

     

     

     

     

Target Users

 

Professional                                                                 Consumers        

• Pharmacies

• Specialty Healthcare Providers

• Home Healthcare

• Home Testing Supplies

• Retail Organizations

• Physician office Labs

• Emergency Rooms

• Home Healthcare

• Nursing Homes

• Hospitals

• 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.