Salt Lake City, Utah and Irvine, CA Nov. 17th, 2020 (PR Distribution) — Second Heart Assist, Inc. has filed a patent application with the United States Patent and Trademark Office (USPTO) covering numerous claims for the utilization of electro-active polymers and shape-memory nitinol in combination or on a stand alone basis to control, with electro-magnetic energy on demand, the shape and length of the impeller blade(s) within its aortic stent based circulatory assist pump.
The patent application covers, among other things, the ability to establish a twist in the impeller blade on demand which can increase efficiency of flow while minimizing turbulence, hemolysis and thrombosis risk. Without this feature of post deployment, on demand shape changing, to achieve a similar pitch of the impeller blade would require a housing catheter as large as 22 FR size. This shape memory twist allows the device to be deployed through a considerably smaller, 13.8FR catheter. This new patent pending “on-demand”, shape changing technology permits the benefits coming from a twist shape to the impeller without increasing the percutaneous introduction diameter and thus eliminating the need for a vascular surgeon to do a surgical cutdown to introduce the device.
“Second Heart Assist, Inc. seeks to be an innovation leader in the development of percutaneous (non-surgical) placed aortic stent based circulatory assist pumps and this new patent-pending technology, unique in the field, further establishes our emerging leadership position in the industry.” stated Jeff Donofrio, President
Howard J. Leonhardt, Executive Chairman & CEO, and inventor of this patent pending, further commented: “The invention covered by this exciting patent filing holds great promise for patients in improving further treatment and recovery of a range of cardiovascular disorders including cardio-renal syndrome where patients have both a failing heart and a failing kidney and have excess fluid buildup. Being able to change the shape, curvature, twist and length of impeller blades on demand will offer the treating physician a truly unique tool to customize the management of patients to optimally address their specific needs and thus improve outcomes”.
The patent filing also covers a simplified design for deploying and retrieving the impeller and aortic stent components of the circulatory assist pump.
Second Heart Assist, Inc.
Second Heart Assist, Inc. is focused on the development of two models of percutaneously placed aortic stent-based circulatory assist pumps primarily for use in cardio-renal syndrome heart failure patients to relieve excess fluid overload and for other potential purposes. The 1st generation product is catheter-based with the impeller powered by an external motor. The 2nd generation chronic implant product is powered wirelessly, or transcutaneously. Second Heart Assist previously filed patents covering vibrational harmonic energy reduction of blood clotting, auto controls of impeller speed and deflection angles, two or more aortic stent pump in series in the aorta including those that are fully pulsatile with no impeller blades. Second Heart Assist, Inc. has also licensed, on an exclusive basis, from CalTech, a full estate of circulatory assist pump related patents primarily focused on reduction of hemolysis risk and improvement of flow rates while maintaining natural blood flow and aortic wall pulsaltility. Second Heart Assist, Inc. previously completed large animal studies in Boston, Columbus, Minneapolis and Houston and mock loop studies in Louisville, Victoria, BC and Minneapolis as well as 2 round of computational fluid dynamics testing in Berlin, Germany. A pilot OUS clinical study was completed in 2019 and the team has recently launched a cardio-renal syndrome study now enrolling in Europe. See www.secondheartinc.com for more information
On Behalf of the Board of Directors
Howard J. Leonhardt
Chief Executive Officer
Jeff Donofrio
President
Dr. Leslie Miller
Chief Medical Officer
Public Relations:
Brian Hardy, Director of Marketing
This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer of securities or products for sale in the United States or anywhere else. We make no claims that the products mention have been proven to be safe or effective. Patents pending may not be issued. Patents licensed of issued mentioned may not be maintained for a variety of reasons. The company lacks sufficient capital to bring these products through all studies and to market and will very likely need to raise more capital or will have to partner with another well financed company to bring these products fully to commercialization. The company intends to find such a partner to complete a commercialization pathway but there are not assurances that it will succeed in this pursuit.