Cardiost - A Durable VAD for Heart Failure patients

Cardiost, Inc. (DE) recently relocated to Houston, TX to take advantage of its medical community and focus on cardiovascular medicine. Cardiost is a recent resident company of Johnson & Johnson Innovation, JLABS, a premier life science incubator program. JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers. More information: http://jlabs.jnjinnovation.com/

Founded and currently led by Nicolás Anzellini (Engineer, MBA) and his father Dr. Fernando J. Anzellini (Cardiologist and Internist), Cardiost is focused on developing Intellectual Property in the cardiovascular field as well as commercializing medical devices stemming from its R&D.

At the moment Cardiost is working on a durable mechanical circulatory support (MCS) device to treat advanced-stage Heart Failure patients , a chronic condition that currently affecting 7.8 million Americans and more than 32 million worldwide. Below are a a few stats and facts to highlight the dimension of the challenge ahead:

• Demographics - HFpEF’s patients are more likely to be older, obese, more often females, and have higher rates of hypertension and atrial fibrillation. Noncardiac comorbidities are highly prevalent in HF. The most prevalent are overweight/obesity, hypertension, diabetes mellitus (DM), chronic obstructive pulmonary disease, anemia, and chronic kidney disease.

• Prevalence and incidence - There are currently 7.8 million HF patients in America, and the figure is projected to reach 10 million by 2030. Prevalence increases with age. HF prevalence is 2% of persons age 40 to 59, more than 5% of persons age 60 to 69 have, reaching 10% in those age 80 or older. Annual incidence approaches 20 per 1,000 population after 65 years of age,

• Burden to the healthcare system - HF is the leading hospitalization cause in patients over 65, with almost ONE MILLION hospitalizations per year. The American healthcare system is becoming increasingly burdened with juggling between optimizing patient care and preventing readmissions, with direct medical costs exploding to $70B by 2030 in the US alone. This equals ≈ $200/year for every US adult, with $55B expected to be spent on hospitalizations alone.

• Current treatments are not quite effective - The current standard of care, pharmacological therapies, have proven difficult to implement because of cost, complexity, patient tolerance, and system/payer-related factors, which contributes to a rehospitalization rate of 29% within 60 of discharge. Durable mechanical circulatory support (MCS) devices improve the survival and quality of life of end stage heart failure patients, both as bridges to transplantation or as destination therapy. However, few of the 60K patients per year that would benefit from MCS receive such treatment (about 3000-3500/year). Limitations of more widespread use include the invasiveness of the procedure (i.e., sternotomy), the mandatory presence of a transcutaneous driveline, the ongoing burden of complications related to current technology, and a lack of FDA-approved MCS device-based treatment for heart failure with preserved ejection fraction (HFpEF) patients. There exists a clear need for the development of technologies that fill this gap in care for HF patients. HF’s readmission rates stand at:

  • 30-day = 22%

  • 90-day = 41%

  • 6-months = 54%

  • 1-year = 68%

• Compromised Quality of Life (QoL) - Late-stage patients with HF have poor QoL, similar to patients with end-stage renal disease, and they require frequent hospitalizations. Combined with high rates of depression, low levels of activity, and significant time spent away from home in hospitals and healthcare facilities, these collective data paint a bleak picture for the daily life and clinical course of a typical HF patient.

• High Mortality - Survival of patients with HF is poor, and it is associated with high inhospital, short-term, and long-term mortality rates. The one-year mortality rate for HF mortality is 25%, increasing to 75% at the five-year mark.

• Market opportunity - Approximately 250,000 Americans die of HF each year, and the number is growing as our population gets older.

The Left Atrium Unloading Device, or LAUD, which partially unloads the left atrium into the descending aorta by mechanical means, is Cardiost’s proposal to treat late-stage HF patients. The concept stems from Dr. Anzellini’s original U.S. Patent 7,384,389. It is a fully implantable, durable Mechanical Circulatory Support (MCS) device that supplements cardiac output, partially bypassing an hypertrophic and ineffective Left Ventricle. The simplicity of the premise is compelling: lessen the workload on a sick organ by partially bypassing it, preventing further deterioration while reducing left atrium (LA) pressure and increasing cardiac output (CO).

Cardiost has been actively filing new, additional IP since its inception as a company in March 2021 to protect its signature and novel approach to solving this condition. More intellectual property will be filed in the coming months and years, surrounding the area of interest the company would like to operate in - 100% of the company's IP is owned by Cardiost, Inc., a DE corporation.

The Cardiost team has been working with the University of Denver’s Cardiovascular Biomechanics Lab led by Dr. Ali N. Azadani since August 2021, building upon its original LA-to-DA. The second phase of our work has been focused on CFD simulations as well as in-vitro experiments, adding an additional pillar to our R&D efforts while strenghtening our IP portfolio. Published papers by reputable experts in the field have laid the foundations in the LA-Ao field when it comes to durable MCS devices, a reassuring sign despite the lack of progress by other competitors.