Solution

_ HFpEF BY THE NUMBERS _

Patients with HFpEF Experience Worsening Symptoms and Decreased
Quality of Life 1,2

Million
Patients living with HFpEF in the U.S.
1 %
patients Are 60 years of age when diagnosed
1 %
patients are female
< 1 Years
Life expectancy once diagnosed
$ 1 Billion
total expected cost to the health care system by 2030

_ CONSEQUENCES OF HFpEF _

HFpEF is Characterized by a Stiffened Left Ventricle and
Impaired Relaxation

The left ventricle is the chamber of the heart that is responsible to push blood out the body. When it becomes stiff and can’t relax it leads to multiple problems.

As a result patients with HFpEF experience:

_ TODAY, HFpEF PATIENTS ARE POOR CANDIDATES OR NOT CANDIDATES FOR ADVANCED THERAPIES _

New Procedure Could Offer Hope For Patients with HFpEF

One way to reduce the strain on the left ventricle is to possibly modify the pericardium. The pericardium is the sac the heart sits in and in patients with HFpEF it can further contribute to the increasing demands put on the left ventricle. Surgery to modify the pericardium is not typically offered to patients because the risks associated with the surgical procedure are too high.

Heart Failure Solutions is developing a novel approach for pericardial modification to allow the LV to better fill and enhance the cardiac output. This minimally invasive approach is designed to minimize the risks compared to conventional surgery;
allowing patients with HFpEF to benefit.

_ Animal studies have been completed with evidence of improved LV pressures. _

Pre-Clinical Evidence is Promising

Over 36 animal studies have been conducted to date, focused on hemodynamic assessment pre and post pericardial modification as well as device design improvements. Results revealed an improvement in LV pressure sustained at 4 weeks.

Following the successful acute and chronic animal studies, Heart Failure Solutions will be looking forward to initiating an IDE early feasibility study.

References:

1.Virani, S. et al. Heart Disease and Stroke Statstitics – 2021 Update. Circulation. 2021; 143:e254-e743
2.https://www.healthline.com/health/heart-failure/heart-failure-preserved-ejection-fraction#life-expectancy