The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
Cardiost's mission is to improve the length and quality of life for patients suffering from Heart Failure with preserved Ejection Fraction (HFpEF). We are developing a fully implantable heart assist pump to treat patients with late-stage HFpEF, a chronic condition affecting 3.1M Americans and responsible for over 450K hospitalizations/year.
Affiliated Institution: University of Colorado Denver
Have we formed a company? Yes
Funding: Direct/Indirect University Support, Angel Funding (including Self or Friends/Family)
Our Company and the Problem We Are Trying To Solve
HFpEF is a chronic condition described as the heart not being able to fill up properly with blood coming from the lungs, rendering it unable to keep up with its workload. This translates into the body not receiving enough oxygenated blood flow. Cardiost’s Left Atrium Unloading Device (LAUD) is a fully implantable (thoracotomy) mechanical circulatory support (MCS) device targeting two key elements to improve the patient’s prognosis and Quality of Life (QoL) - it reduces left atrial pressure while increasing cardiac output. The concept behind the LAUD is simple - a partial derivation (0.5 - 1.5 Liters/min) of the Left Atrium (LA) into the Descending Aorta (DA) by means of a heart assist pump lessens the workload on a sick and hypertrophic Left Ventricle (LV), increasing much needed cardiac output while keeping the latter fully functional in case of malfunction. The conduit transferring blood into the DA is connected to a percutaneously inserted ‘Venturi stent’, whose function is to minimize the pressure differential between a LA (low-pressure chamber) and the DA (high-pressure chamber). The reduced amount of blood needed to be pumped and the pressure differential minimization allows the pump to be powered using a Transcutaneous Energy Transfer (TET) system (i.e., induction), liberating the patient from powering cables protruding through the skin, reducing the risk of infection. Increasing cardiac output and reducing LA pressure will lower patient readmissions, currently at 450K/year. The technology has not been tested yet, just simulated. Cardiost owns 100% of the IP pertaining to its solution.
Our Go-to-Market Strategy
Cardiost's go-to-market strategy is to complete early feasibility studies in humans showing efficacy, safety, reduced pressure in LA, and increased cardiac output without adverse effects. When successful, we would be in a strategic position to negotiate an acquisition by one of the leading companies in the long-term MCS field (e.g., Abbott, Medtronic, Abiomed, Edward Lifesciences). The current market is clinically defined by the New York Heart Association (NYHA) in four functional classes (I - IV) according to the patient's symptomatology. The TAM is 3.1M Americans. We have identified the SAM as being about 22% of the entire HFpEF population classified, or close to 650K patients. Last but not least, by some conservative estimates we believe the SOM is about 65,000 patients. At $75,000 per unit, the dollar figures for each market would be $233B, $51B, and $4.8B, respectively. With an estimated annual medical cost of $20 - 30 billion (2020), total HFpEF costs in the US are expected to exceed $53 billion by 2030, with the majority (80%) being attributed to hospitalization. Amongst Medicare patients the prevalence of HFpEF is 20%, with hospitalizations averaging $11K per patient per episode and 3.6 episodes per patient per year. HFpEF has the highest 30-day readmission rate of any condition in the healthcare system at 23%. By 2030 it is estimated 4.1M Americans will suffer from HFpEF. There are NO device-based therapies for HFpEF patients. The LAUD is less invasive, reduces LA pressure, increases cardiac output, and has no cables protruding the skin.
How We Will Generate Revenue
Cardiost's LAUD is a class III medical device, requiring Pre-Market Approval (PMA) by the FDA. It will take between 5 and 8 years to receive clearance to market. If the device is approved the market is vast and expanding. The American Heart Association estimates that about 200K patients could benefit from such a device. Our plan is to spend between $30M and $50M to get to early feasibility studies in humans. By then we should be able to assess the potential of Cardiost's LAUD on patients and have a clear exit opportunity. No revenue from the sale of the device itself would be generated by then. The potential acquirer would have to complete the clinical studies and go through the last steps of FDA clearance to market. According to some recent comps in the market, we could be looking at a $250M to $500M exit given that the condition has no device-based therapies approved by the FDA, the pharmacological treatments available have proven ineffective, and our competitors are at similar stages (i.e., early) than us. In short, it is anybody's game right now. We have a solid concept (partial derivation of the LA into the DA) that has been successfully proved by other companies in the past. With the backing from academic institutions and expert cardiologists in the field we feel confident we will be able to help hundreds of thousands patients experience a better QoL and extend their lifespan significantly.
How We Will Benefit From Destination Startup®
We are a small team with limited resources at our disposal but eager to bring this device to patients that would experience a game-changing situation in their lives. We think we would benefit immensely from exposure to investors, doctors, hospitals and patients (all within the CU community) that can give us a hand in bringing this project to fruition. We are seeking angel or corporate capital that can help us as well with the necessary know-how and connections to bring this device to patients. Right now we are looking for a $1M SAFE note that will be spent towards building a prototype ready to be installed in animals. We are also looking for Colorado-based physicians interested in the HFpEF field - Dr. Natasha Altman comes to mind as she's part of the CU Anschutz community (https://www.cumedicine.us/providers/medicine/natasha-altman#/). Passionate mechanical as well as bioengineers that can contribute to the team and our goal is also high up on the list of our goals. Having access to a wealth of individuals, industry, professors, and investors will improve the chances of recruiting the right team and partnering with the right investors for the sake of more than 30 million patients across the world suffering from this deadly condition.
Dr. Fernando Anzellini, MD (cardiologist and internist) is the inventor behind Cardiost's LAUD. He has been dealing with HFPEF patients for decades and had an idea (i.e., eureka moment) on how to create a "better mousetrap". He's currently living in Colombia and serves as Chief Medical Officer at Cardiost. Nicolas Anzellini is an engineer by trade and holds an MBA from the University of Denver (2012). He founded an e-commerce company in 2015 and exited in 2020. He has invested in a couple of startups and would like to call himself an entrepreneur. He's currently serving as Cardiost's CEO. Dr. Victor Caicedo, MD has been the Chief Cardiovascular Surgeon at Shaio Clinic Foundation (Bogota, Colombia) for more than 15 years. His cardiovascular experience is unparalleled (50+ years) and has joined the team as a top-notch Scientific Advisor. Professor Ali N. Azadani is the director of DU's Cardiovascular Biomechanics Lab and an expert in heart valves. Cardiost and DU signed a Master Research Agreement (MRA) to conduct CFD Simulations to assess the hemodynamic impact of the LAUD in patients' cardiovascular systems. Cardiost has hired CU Boulder Alum (J.D. 2011) and Dorsey and Whitney partner, Angela Morrison as their IP attorney. She has been essential in the building of Cardiost's IP portfolio. Mike Weiner at Dorsey and Whitney is also helping Cardiost on the transactional side. Cardiost has also hired CSSi Lifesciences, a regulatory strategy consulting company focused on managing their path towards FDA approval.