A large unmet patient need worldwide

Novostia technology aims at improving the quality of life of all operable patients who need of a heart valve replacement, especially:

Young patients

Aortic valve narrowing and/or deficiency may occur in young patients because of a congenital defect.

The most common cause of aortic valve stenosis in young people is a birth defect where only two cups grow instead of the normal three (called a “bicuspid valve”). This disease affects 1.3% of the world population, comprising more than 90 million patients⁸.

The Triflo valve could meet the expectations of these young patients as it is made to last a lifetime without potentially dangerous anticoagulation therapy. Moreover, it will be available in a wide range of sizes, including small 16 mm size for children.

Patients in emerging economies

Rheumatic heart disease affects more than 33 million people worldwide and kills 320'000 people annually ^{3, 33, 58}. 

While rheumatic fever is rare in western countries, it is a common disease in emerging economies, where valvular disease represents a severe public-health problem.

Tissue valves are generally not considered the option of choice in emerging economies, where patients are young, because valve durability is greatly reduced in that population^13, 21, 39. On the other hand, current mechanical valves would also represent a suboptimal solution as they require anticoagulation therapy, which is generally difficult to control in emerging economies.

With its unique performances, the Triflo valve is expected to meet the requirements of these patients in emerging economies.

Patients unable to tolerate anticoagulation therapy

Many patients cannot tolerate the anticoagulation therapy required by current mechanical heart valves.

This is especially true for women who are pregnant or who may become pregnant as anticoagulation drugs can cause birth defects.

Certain medical conditions may also make anticoagulation therapy undesirable. This may be the case for patients with a history of bleeding ulcers, high blood pressure, diabetes, kidney or liver disease, stroke or alcohol abuse.

The Triflo valve should be appropriate for all these patients.

Adult patients suffering from Aortic Valve Stenosis 

Aortic stenosis is one of the most common and serious valve disease problems in industrialized countries. 

In the U.S. alone more than 5 million Americans are diagnosed with heart valve disease and the prevalence is estimated to be around 1.5% in people above 18 years old and more than 10% in individuals aged older than 65 years².  

This disease more commonly develops during aging as calcium, which amasses in the heart over the course of a lifetime, damages the valve and restricts blood flow through the valve. 

The currently widely recommended therapy for patients in the ages 65–75 is surgical valve replacement with a tissue valve that avoids anticoagulation therapy.

However, while surgical valve replacements performed promptly in these patients halts the disease progression, when patients present symptoms of heart failure, the median patients’ life survival generally does not exceed three years²⁵. This strongly supports systematic testing for the disease, which could be done today in a few minutes and at a low cost⁵⁵.

Preemptive treatment earlier in the disease course would render even more necessary the use of the Triflo valve.

Adult patients suffering from Mitral or Aortic Valve Regurgitation

Valve regurgitation may appear suddenly or may develop gradually over decades due to a variety of causes. 

While aortic regurgitation is less common, mitral valve regurgitation remains one of the most frequent forms of heart valve disease⁶.

Once mitral valve regurgitation becomes severe, it is generally repaired. If not possible, it is generally replaced by a standard prosthetic tissue valve. However, a tissue valve tends to deteriorate faster on mitral position than on aortic position due to higher mechanical stress during valve closing³⁹.

The lifelong durability of the Triflo valve and its anticoagulant-free property, could be a good answer for operable patients who need to have their mitral valve replaced.

Novostia technology is intended to address a major and growing public health problem:

• More than 100 million people worldwide suffer from heart valve disease^35,57
• Every year hundreds of thousands of patients undergo a heart valve replacement^a
• The demand is estimated to skyrocket over the course of the next decades, especially for young patients^3, 31

Novostia heart valve should significantly reduce the healthcare costs, avoiding lifelong anticoagulant medication or repeated replacements procedures