Hyblate Medical

The market seeks more effective solutions for ablation that reduce the need for repeat procedures and improve patient outcomes.

Hyblate Medical is developing a hybrid catheter with a proprietary anchoring system that combines the advantages of RF ablation and balloon catheters. The Company’s ablation system consists of numerous RF electrodes placed on a balloon catheter with an additional fixation balloon for improved anchoring and better stabilization.

Hyblate’s unique atrial fibrillation (AFib) catheter —

• improves contact with tissue for more effective and safer ablation
• produces circumferential and focal RF ablation for better, more complete lesions
• deploys balloon catheter easily for smoother operation and shorter procedure time

Hyblate provides an effective treatment that is expected to lead to higher success rates, reduced repeat ablation procedures, and improved patient outcomes.

Atrial fibrillation (AFib) is a condition that causes an irregular heart beat (arrhythmia) due to a malfunction in the heart’s electrical system. For people with AFib, the heart’s upper chambers beat irregularly and out of sync with the lower chambers.

The first line of treatment is most often drugs. For those who do not respond to, or cannot tolerate, drugs, ablation is recommended. This is a surgical procedure to scar the heart tissue around the area producing the faulty signal.

Scarring produces lesions that isolate the pathways of the abnormal electrical signals and allows normal heart rhythm to return.

• RF ablation (“point-by-point” lesions created with radiofrequency), a lengthy procedure, requires a high level of expertise. It may result in complications such as blood clots and punctures.
• With cryoballoons (lesions created in a single-shot, circular fashion with cryotherapy), ablation may be less focused, which could result in extensive tissue damage.

Recent studies report that existing AFib ablation solutions are associated with a one-year failure rate of up to 30%. The result: recurrent AFib and repeat ablation procedures.

Market

According to a study published in Circulation (December 2013), there are over 33 million people worldwide with AFib. In the United States, AFib affects approximately 6 million people, and this number is projected to reach nearly 12 million in 2030 (Cleveland Clinic).

Only 10% of patients with AFib receive device therapy (Medtech Strategist, August 2018), which leaves tremendous room for growth in this large market. Moreover, AFib is a disease that warrants treatment as it may reduce quality of life (shortness of breath, fatigue) and presents a fivefold risk of stroke.

It is estimated that AFib accounts for more than 750,000 hospitalizations and 130,000 deaths per year (Centers for Disease Control and Prevention). Treating patients with AFib adds $26 billion to the U.S. health care bill (American College of Cardiology).