| By Api Podder
- Invention provides auto adjustment of impeller speed and pulsating cuff pulsations based on real time pressure differentials and other data from implanted sensors placed in strategic positions.
- This invention is designed to optimize flow by also timing pulsations and impeller speed with patient conditions and needs including synchronizing with real time pulsatile flow.
- Second Heart Assist, Inc. has completed pre-clinical studies at a number of leading universities and test centers in the USA and Europe and is planning to initiate clinical trials OUS in Australia this summer and in the USA later in the year.
- IP is solely owned by Second Heart Assist, Inc. a private company based in Salt Lake City, Utah with operations also in Los Angeles, California.
Press Release – SALT LAKE CITY, UTAH – 06/08/2018 (PRESS RELEASE JET): Second Heart Assist, Inc. is pleased to announce it has filed a continuation in part patent application on an improvement to their previously developed temporary and chronic circulatory assist pump systems based on implantable wireless pressure sensors placed in strategic positions to permit real time auto adjust management of circulatory assist support.
This new IP, which is solely owned by Second Heart Assist, Inc., was developed by their Executive Chairman and CEO Howard J. Leonhardt and is to be tested initially at the company’s research labs in Utah and California and later this summer at Queensland University in Brisbane, Australia as integral part of Second Heart Assist’s wireless powered chronic circulatory assist pump.
“Balancing hemolysis, pump efficiency, kidney over load, dehydration, edema, coronary steal, brain steal, thrombosis, mechanical fatigue, power needs, heat give off, pulsatile versus continuous flow and hemodynamic pressures in the setting of changing conditions of advanced heart failure patients is challenging. These needs and demands are even greater for chronic implant wireless powered devices like the 2nd generation device our team is developing. This new technology is designed to make patient circulatory assist management easier for the caring physician.” stated Alex Richardson, Vice President of Engineering and Product Development at Second Heart Assist, Inc. “If we can manage power usage well we can better serve patients with wireless power systems” Richardson further added.
“This technology breakthrough should permit patient treatment to be customized on a real time personalized basis which we believe will be proven out in future clinical trials to provide superior outcomes for patients especially those suffering of cardio-renal dysfunction in the advanced stages of heart failure. Our team is committed to being the innovation leader in this space and will continue to bring forward new improvements to our technology platform on a steady continuous basis.”stated inventor Howard J. Leonhardt, Executive Chairman and CEO of Second Heart Assist, Inc.
Second Heart Assist, Inc. previously announced these related product innovations with patents either issued or pending with the U.S. PTO.
- Conforming high radial force aortic stent for firm stability of fixation of position without need for hooks. Distends aorta diameter by 2mms on average which provides more space available for safe impeller use.
- Aortic stent protective cage with high flow through areas and rounded elements to balance stability strength with low hemolysis and highest flow.
- Low RPM impeller system with higher flow, less heat, less hemolysis risk
- Two aortic stent based circulatory assist pumps in series in the aorta, one upper and one lower, the upper being pulsatile.
- Optimization of flow and energy use via timing of pulsations and impeller turn speeds with natural heart pulsatile flow.
- Harmonic tuned resonant vibrational energy technology to prevent blood clot formations.
- Wireless powered and programmed micro coils to control aortic tissue protein expressions to increase smooth muscle mass and to control pulsations of natural aortic muscle a cellular muscle based “Second Heart”.
- Wireless powered and programmed micro coils to control chronic inflammation and blood pressure with real time reads and adjustments.
- Impeller shape and design to maximize safety, flow and reduction of hemolysis risk.
“Our team is committed to implementing carefully designed pre-clinical and clinical studies to prove out this technology platform in steps over time with patient safety always placed first. This real time auto adjustment technology may serve patients best that have physiologic hemodynamic changes due to things as simple as sleep and exercise. This real time monitoring technology is likely to be most useful in managing the balance between minimizing hemolysis and maximizing flow.” stated Dr. Leslie Miller, Chief Medical Officer for Second Heart Assist, Inc.
“By enabling real time auto adjustments of circulatory assist pump controls we are working like an airplane that auto adjusts airplane controls, direction and propeller speed based on changing wind and weather conditions to maintain a desired flight route, speed and altitude to remain safe. The principles apply the same here in adjusting to the constant turbulent changes in hemodynamic and edema conditions that occur on an on going basis in advanced heart failure patients.” stated Dr. Brett Burton, Director of R&D for Second Heart Assist, Inc.
“Our R&D team continues to place us in a leadership position in circulatory assist support innovation. A number of additional new developments are in the works which we look forward to share with you soon. We also look forward to sharing at upcoming conferences by the end of the year data from our numerous pre-clinical studies and anticipated first-in-man clinical results.” stated Jeff Donofrio, President, Second Heart Assist, Inc.
It is the long term future plan of Second Heart Assist, Inc. to combine its wireless powered chronic implant product with the investigational BioLeonhardt www.bioleonhardt.com bioelectric stimulator + micro infusion pump + fifteen component stem cell based heart regeneration composition to help off load the work load of the heart during a full heart regeneration procedure over time.
About Second Heart Assist, Inc:
Formed in Salt Lake City, Utah in late 2015 Second Heart Assist, Inc. is focused on the development of circulatory assist pump systems utilizing conforming strong radial force fixation aortic stents and pulsating stent grafts. The firm’s 2nd generation product is wireless powered and includes harmonic vibrational tuned resonance technology designed to reduce risk of thrombosis with chronic implants. See www.secondheartinc.com ;
About Leonhardt’s Launchpads:
The innovation and startup accelerator arm of Leonhardt Ventures and inventor Howard J. Leonhardt (21 U.S. patents issued and dozens of new patent claims pending with U.S. PTO). Opened originally in 2008 on the campus of the University of Northern California and incorporated in Santa Monica/Los Angeles in 2013 as Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. The company operates dually out of California and Utah. Leonhardt’s Launchpads Utah, Inc. was formed in 2015 in incorporated in 2016 and has research lab space at BioInnovations Gateway in Salt Lake City, Utah with a number of bioengineers engaged in daily research. The focus of the organization is on organ regeneration and recovery technologies. 30 startups including Second Heart Assist, Inc. are in the 2018 portfolio class. The accelerator business model is to accelerate each organ specific innovation or startup through first–in-man clinical results and then seek out a strategic partner to continue the development forward. See www.lventuresnestg.wpenginepowered.com and www.calxstars.com
Cautionary Note Regarding Forward-Looking Statements
Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, and “intend”, statements that an action or event “may”, “might”, “could”, “should”, or “will” be taken or occur, or other similar expressions. All statements, other than statements of historical fact, included herein including, without limitation; statements about the Company’s future plans, its goals and expectations, and the potential applications of its product platforms are forward-looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the risks identified in the management discussion and analysis section of Second Heart Assist’s and Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. interim and most recent newsletters, Annual Reports, news releases and other reports and filings with and applicable to securities regulators. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements. Second Heart Assist, Inc. is an unproven early stage development. The company lacks sufficient resources of cash and personnel typically needed to get a product of this type to market. Patents licensed or issued may not be maintained. Patents pending may not be issued. Key personnel and suppliers may not remain engaged. The company is highly dependent on a few key suppliers which leaves them vulnerable to uncontrolled delays in development.