Second Heart Technology

Second Heart Assist objectives are to improve the quality of life by reducing the heart’s work-load and improve perfusion. The enhancement of renal function reduces risks associated with toxic contrasts used in percutaneous catheterization interventions (High Risk PCI). Additionally, the product helps patients recover from cardiogenic shock and get acute decompensating heart failure patients back to normal hemodynamics.

Two advanced device platforms for three distinct cardiovascular clinical endpoints and markets: (PCI, CRS, Class III HF).

The two platforms are:
• Catheter based device:
o Percutaneous Coronary Intervention (PCI) /angioplasty
o Cardio Renal Syndrome (CRS) for applicational therapy 12-72hrs

• Wireless Power Chronic Device
o Bridges the gap for unmet Class 3 Heart Failure, through destination therapy
o Aids in continuous off-loading of the heart for improved cardiac response

Both platforms utilize our proven pulsatile-conforming aortic radial stent with these expected advantages over other devices:

• Easy femoral insertion and aortic positioning (under 2 min)
• Greater position stability attributed to our high radial force aortic stent (migration is one of the chief complaints on other devices).
• SHA device does not cross heart valves and is a true percutaneously placed device
• Stable positioning in both our percutaneous catheter or chronic implant configurations.
• 22mm (expanded) Nitinol stent cage offers unique aortic wall protection from pump impellers.
• 33-50% Lower RPMs than competition: less mechanical wear, less heat, lower power and less hemolysis.
• SHA Catheter device is poised to be the first CRS device on the market.
• Chronic wireless device to be first and only percutaneous wireless powered system to address Class III HF
• Our radial force stent safely distends the aorta 1-2mm providing flow improvement with gentle non-invasive fixation.
• SHA Device does not use ‘hooks”, “paddles”, or other forms of unreliable or invasive anchoring
• SHA Catheter device has the motor external to patient
• No bearings in the implanted portion of SHA devices to potentially overheat or fail.
• Effective cam action to open and close impellers with no springs that typically fail.
• Our aortic stent design is only one known that combines high security of fixation stability and still maintains pulsatile aortic wall movement (which is deemed essential for long term chronic implant success).
• Highest flow generating 4-6L of truly augmented blood flow in addition to native flow

Problem

Currently available circulatory assist devices face a number of significant limitations and drawbacks, including: Low flow rates that do not provide the full assistance patients need. Device-associated thrombosis that can block blood flow to vital organs, potentially resulting in a stroke, myocardial infarction, etc. High impeller speeds that can cause hemolysis and pump migration. Risks and complications associated with invasive implantation procedures that are required to deploy many circulatory assist devices. External equipment can decrease patient comfort and quality of life while limiting the range of activities a patient can participate in (swimming, etc.).

Solutions

Second Heart’s technology is a minimally invasive solution that provides circulatory assistance to patients while overcoming many of the limitations of current options: Collapsible stent pump design allows for low profile catheter-based introduction for easy and secure placement in the aorta. Mechanical design provides high flow rates (over 7 liters per minute) while minimizing the risk of mechanical breakdown and reduces damage to blood cells (hemolysis). Thrombosis-resistant material, harmonic vibrational energy technology, and pulsatile flow all help to prevent blood clotting that can lead to stroke or myocardial infarction. Our patent-pending removable (and wirelessly powered) pulsating cuff stent is situated above the impeller pump providing a two pump “in-series” system. This wireless power source eliminates the need for percutaneous equipment that can serve as a site of infection and limit a patient’s quality of life.

Physiologically Accurate Mock Circulation Loop To Test Second Heart Assist Devices @ Cardiovacular Innovation Institute Louisville, KY

Market

The target markets for Second Heart’s temporary circulatory assist pump include:

  • Acute decompensated heart failure ― Of the estimated 1 million annual hospitalizations for decompensated heart failure, roughly 10% are complicated by reduced kidney function. Due to its placement, just above the renal arteries, patients with reduced kidney function stand to significantly benefit and represent 100,000 potential patients per year.
  • High-risk PCI ― The estimated number of PCIs that occur each year in the U.S. ranges from 650,000 to 1.2 million (based on the specific source). Current estimates are that at least 10% of PCIs are considered high risk and could potentially benefit from a support device such as Second Heart’s. As a result, this market segment includes 65,000 to 120,000 patients.

Combined, these segments encompass 165,000 to 220,000 heart failure patients every year and result in an annual projected market of over $4.6 billion. A comparable that confirms the market potential is Abiomed, a manufacturer of catheter-based temporary circulatory assist devices indicated for high-risk PCI and cardiogenic shock. Over the past 5 years they have seen 30% annual growth with Impella sales generating $310 million of revenue in 2016. Even with less than 10% of their projected market, Abiomed has achieved a market capitalization of over $5 billion.

The market for Second Heart’s chronic aortic implant will be heart failure patients who require long-term circulatory support. Since many of these patients are unable to receive a heart transplant (due to organ shortage, contraindications, etc.), they currently rely on cardiac assist devices such as ventricular assist devices (VADs). The LVAD market is expected to grow at 7.9% annually over the next 5 years to reach a total revenue of roughly $900 million in 2021.

CalTech tests pulsatile

Pulsatile computational fluid dynamics

Warning:

Investigational Use Only:  Not Available for Sale.  Product not yet tested to support any clinical claims. Early stage development.

WARNING:  Early stage development.  NOT AVAILABLE FOR SALE.  INVESTIGATIONAL USE ONLY WITH PROPER REGULATORY CLEARANCES ONLY.  Animal use only at this time.  Prospective, randomized, multi-center, double blinded, placebo controlled clinical evaluations of Second Heart circulatory assist pumps to assess safety in supporting cardiovascular haemodynamics in patients have yet to be completed.  No clinical claims for these devices are supported at this time.