Second Heart Assist, Inc.
Update on Progress
Designed to be first stable secure positioned aortic stent based circulatory assist pump which is percutaneously delivered. Company is developing both a temporary use catheter based device and a wireless powered chronic implant. 2nd generation device includes option to maintain true pulsaltility and harmonic resonant vibration energy technology to minimize risk of blood clot formations.
On Monday April 29th Second Heart Assist, Inc. reported successful results in up to 33 hours of durability testing at Vivitro Labs Canada in a physiological correct mock loop model. The device achieved flow rates of 1.5 to 2.3 liters per minute at 14,000 to 25,000 RPMS in this model and aortic pressure differentials of 10mm Hg to 20mm Hg at the same RPMS. At 30,000 RPMs an aortic pressure differential of 30mm Hg was reached. The team completed previously tests in 5 large animals in Boston and at Q Test Labs in Ohio and has scheduled another set of large animal studies for May 9th and 10th at American Pre-Clinical Sciences in Minneapolis. The team previously completed over 100 million performance characterization data points in a sophisticated mock loop system at the University of Louisville and 2 rounds of Computation Fluid Dynamics testing runs at EnModes in Berlin, Germany. Numerous lab challenge tests have also been completed at Biomerics in Minneapolis. Last month the Second Heart Assist team reported a successful lab demonstration of their patented technology for a wireless powered aortic stent pump delivered percutaneously.
Over 200 issued and pending U.S.P.T.O. patent claims covering… stability of position, conformance to aorta wall, minimizing RPMs, minimizing hemolysis, minimizing risk of blood clots, reducing power needs, special shaped impeller, for high performance and safety, minimization of bearings, minimization of power needs, aorta protein expression controls, auto management, two stent pumps in series in aorta, maintaining pulsaltility, true percutaneous delivery and wireless power. 6 patents option licensed from CalTech. 1 patent licensed from Vascor Pittsburgh. Multiple patents filed by core internal team.
- Early data shows highest renal artery improvement flow rates at lowest RPMS.
- Early data shows greatest position stability due to high radial force share conforming aortic stent – all other systems have migration issues.
- Predicted based on pre-clinical data to return cardio-renal dysfunction patients to normal hemodyamics and water retention levels.
- Multiple issued and pending patents for wireless power. Earliest issued wireless power patent claims in field.
Expected Advantages Over Other Devices – Designed To Intended To (confirmation pending full scale controlled studies)
- Greater stability of position due to high radial force aortic stent. Less risk of migration.
- Compared to Abiomed and Thoratec does not have to cross heart valves. =
- Only device designed to be stable in position in either percutaneous catheter configuration or chronic implant due to true aortic stent.
- Cardiobridge depends on catheter for position stability. Procyrion depends on hooks and a low radial force stent with minimal wall contact surface area for position stability. Neither is a good design for conversion to wireless power.
- Lower RPMs which should mean less mechanical wear, less heat, less power needs and lower hemolysis.
- 2nd gen. to be first percutaneous wireless powered system.
- 2nd gen. design offers option choice to maintain true pulsaltility.
- Distends aorta 2mms providing larger area to perform flow improvement with lower RPMs. Lessens risk of 14.5mm impeller hitting protective cage aortic stent or aorta wall.
- Minimization of bearings which can fail.
- Minimization of springs which can fail.
- Phase I Study IRB approval received in Paraguay.
- Phase Study IRB conditional approval in Australia.
- Engaged in Early Feasibility Study interactive review with FDA for U.S. study launch at Ohio State University under the supervision of Dr. William Abraham a heart failure leader.
- Completed 4 large animals in study in Boston.
- Completed sheep study at Q Test Ohio.
- Completed 2 rounds of Computation Fluid Dynamics studies at EnModes Berlin.
- Completed mock loop study at University of Louisville.
- Developed and tested combination alarm box and motor controller at DeviceLab California.
- Developed full Quality Management System up to EFS level.
- Completed transport testing.
- Completed Risk Analysis and Mitigation.
- Completed multiple rounds of challenge tests at Biomerics Minneapolis.
- Completed wireless power test Queensland University of Technology Australia.
- Completed mock loop study at Vivitro Labs Canada.
Expected Upcoming Milestones (Subject to Change)
- Large animal study May 9th and 10th at American Pre-Clinical Sciences Minneapolis.
- Final large animal study before clinical studies – late May
- New round of electrical safety testing at DeviceLab Tustin, California – late May or early June
- Sterility, packaging, biocompatibility assessment at BlueLine Novato, California – late May or early June.
- First in Man Studies Italian Hospital Paraguay – June.
- USA Early Feasibility Study @ Ohio State University – August
Howard J. Leonhardt
Executive Chairman & CEO
*Has brought multiple cardiovascular products to leadership since 1986.
Dr. Leslie Miller
Chief Medical Officer
*241 peer reviewed publications, 80+ clinical trials, former Chairman Cardiovascular Medicine U of Minnesota for over a decade.
*Helped launch Cardiac Assist in USA.
Chief Clinical & Regulatory Affairs Advisor
*Helped launch Thoratec and Heartware clinical studies.
Chief FDA Regulatory Compliance Advisor
*Over 20 years FDA Examiner device section.
Vice President Engineering & Product Development
*Over 30 years experience developing medical devices many serving Alfred Mann Cos.
Vice President Corporate Development & Physician Relations
*Over 30 years medical device launch experience.
Dr. Brett Burton
*PhD. Bioengineering, 7 years experience.
$10 billion +
- Cardio-renal dysfunction
- High risk PCI
- Cardiogenic shock
- Bridge to heart regeneration
- Bridge to transplant
- Bridge to LVAD
- Limb salvage
Valuation Comparables – Competition
- Abiomed = $12 billion.
- Procyrion = $96 million
- Thoratec PHP = $3.4 billion
- Cariobridge = $56 million+
Risk to Investment
An investment in Second Heart Assist, Inc. must be considered to be a high-risk investment. Second Heart Assist, Inc. is a development stage company and currently has no FDA approved products in its portfolio. Early indications of efficacy in pre-clinical studies may not necessarily translate into positive clinical results. As with any company, they may be unable to obtain sufficient capital to fund planned development programs. There are regulatory risks associated with the development of any device and Second Heart Assist, Inc. may not receive FDA approval for its two product candidates despite significant time and financial investments. Regulatory approval to market and sell a medical device does not guarantee that the device will penetrate the market, and sales may not meet expectations. Patents issued, licensed, optioned or pending may not be maintained or may be found to be invalid due to prior art. The company may be found to be infringing patent of others.The company is highly dependent on outside suppliers, which are not under control of the company, which may not meet timelines or other needed requirements for product development or regulatory compliance.
For more information visit www.secondheartinc.com
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