LAUD - A Superior Solution
Better Quality of Life for patients.
Minimally invasive surgery with superior prognosis for Cardiac Surgeons.
Lower costs for Insurance Providers.
Better care becomes standard of care for Hospitals
Market Opportunity
7.8 million people in the US suffers from HF
The nEW yORK hEART aSSOCIATION (NYHA) Functional Classification system places them in 1 of 4 categories according to severity of symptoms.
TOTAL ADDRESSABLE MARKET = 580,000 patients
HF patients classified as NYHA Class IIIB and IV
sERVICEABLE aDDRESSABLE mARKET = 115,000 PATIENTS
NYHA Class IIIB and IV patients who have an ejection fraction (EF) < 25% each year
Serviceable Obtainable Market = 60,000 patients/year
Heart Failure patients appropriate for VAD therapy each year
4,000 - 5,000 LVAD implants per year
(~6% - 8% of VAD appropriate patients)
Gap in treatment is more than 90%
HEart failure with preserved ejection fraction at a GLance
Reduced left ventricle cavity accounts for 50% of all cases of HF
with more than 3 million Americans currently affected by it.HFpEF mortality is 75% at one year for sickest patients.
Cost-per-QALY = $200K/year – anything above $180K for each QALY is considered low value by industry standards.
Quality of Life (QoL) severely impaired according to The Kansas City Cardiomyopathy Questionnaire (KCCQ) – restricted physical function, worsened symptoms, social limitations, depression.
To date, most of the pharmacologic agents investigated in clinical trials have generated limited results.
No FDA approval for any device-based treatment
COllaboration Efforts & Commercialization Partners
Partnered with the DU’s Cardiovascular Biomechanics Lab led by Dr. Ali Azadani, PhD to conduct Computational Fluid Dynamics (CFD) Simulations as well as an In-Vitro Experiment seeking proof of concept. Matching of funds for state grant was offered by DU to continue R&D efforts.
Partnered CSSI Lifesciences to help us strategize and navigate the regulatory path from animal studies to PMA submission for FDA clearance to market.
Accepted into Innosphere Ventures September 2021 Cohort for life sciences advice and fundraising purposes.
Hired Dorsey & Whitney LLP for IP development and strategy.
One patent granted
Two pending
Accepted into CSU Ventures’ Research-to-Market (R2M) Workshop, a 5-week program intended to ensure product-market fit for each participating team.
Cardiost mission is Improve the length and quality of life
for patients suffering from Heart Failure.
The Challenge is from Within.
