SECOND HEART ASSIST, INC. TO TEST WIRELESS POWERED CIRCULATORY ASSIST PUMP IN AUSTRALIA

SALT LAKE CITY, UTAH - 04/09/2018 (PRESS RELEASE JET)

Salt Lake City, Utah, Playa Vista, CA and Brisbane, Australia – Circulatory assist pump developer Second Heart Assist, Inc. announced today that they are working with a team in Brisbane, Australia led by Dr. Mahinda Vilathgamuwa, Professor of Power Engineering, Queensland University of Technology to test non-invasive wireless power technology with Second Heart Assist's device.

The same team in Australia published successful results for wireless power of a much larger power demand left ventricle assist device May of 2017 - https://medium.com/thelabs/wireless-powered-heart-pumps-to-save-lives-by-preventing-infection-dd16bdb53049

Second Heart Assist, Inc. has licensed a series of patents from Caltech and has filed its own for a wireless powered circulatory assist device having these unique components:

1. Two aortic stent pumps in series, one in mid to upper aorta and one in lower aorta just above the renal arteries.

2. Upper stent graft pump has pulsation capability with three pulsating bands with pulsations optimally timed with natural blood flow from heart.

3. Lower aortic stent is bare metal and fixated firmly in position with an impeller in the center.

4. Harmonic precision tuned resonant vibration technology to prevent blood clots on chronic implant

5. Electrical surface charge treatments to all metals to reduce blood clotting and calcification risk.

6. Aortic stents have radial force to not only fixate strongly to aortic wall but to distend slightly aortic diameter by 2mms increasing flow area inner diameter.

7. Bioelectric protein expression coils on aortic stents.

The Second Heart Assist, Inc. engineering team designed this in series aortic circulatory assist pump with these design criteria in mind:

a. Two aortic stent pumps in series in the aorta require less power each to achieve the same amount of flow improvement compared to one.

b. A optimally timed pulsating device in the mid to upper aorta can maintain and amplifying pulsaltility which helps the aorta release proteins beneficial to healthy organs.

c. The RPM turns of the lower impeller aortic stent can be reduced from 4500 to 7000 rpms to 1500 to 2500 RPMs and achieve > 4.5 liters per minute flow at the level of renal arteries.

d. Lower RPM turns should mean less hemolysis, less heat, less mechanical breakdown risk.

e. Wireless power should reduce infection risk and should improve patient quality of life compared to drive shaft systems with external motors.

Note - Further testing is required to confirm design criteria translates to actual expected results. The team has completed 4 large animals to date, is completing mock loop and hemolysis testing this week, has completed one round of computational fluid dynamics testing (for pulsating stent graft) and is embarking on a new set of CFD tests for the two pumps in series, has completed extensive lab flow and durability testing and has scheduled 5 additional large animal studies to take place this spring.

"The successful experience of Dr. Vilathgamuwa's team in achieving wireless power solutions for devices with much higher power demands led us to work with his team. Our device requires a fraction of the power of the device they previously tested." stated Alex Richardson, VP of Engineering and Product Development Second Heart Assist, Inc.

The Second Heart Assist team announced in the spring of 2017 the licensing of a series of patents from the California Institute of Technology (Caltech) in Pasadena, CA - https://www.biospace.com/article/releases/-b-leonhardt-b-s-launchpads-expands-patent-estate-with-option-to-exclusive-license-agreement-with-b-caltech-b-/. and the first of the series of their own filed patents June of 2017 - https://leonhardtventures.com/leonhardt-announces-vibrational-energy-device-preventing-blood-clots-provisional-patent-application-license-agreements/

"Physicians and patients have been calling for a device like this one, a chronic implant powered wirelessly with reduced risk of hemolysis, infection and blood clot formations, and we are excited to be embarking on this testing with this experienced team in Australia" stated Dr. Leslie Miller, Chief Medical Officer, Second Heart Assist, Inc.

"We are excited to be working with the Leonhardt team on this first project with Second Heart Assist and look forward to continuing a long relationship leading to the shared goal of total heart regeneration" stated Dr. Mahinda Vilathgamuwa, Professor of Power Engineering, School of Electrical Engineering and Computer Science, Queensland University of Technology

"We developed the Second Heart Assist circulatory assist system originally to support our flagship BioLeonhardt www.bioleonhardt.com product for total heart regeneration but physicians recommended to us to separate it out into a stand alone product to help patients in cardio-renal dysfunction in need in particular. We now are moving carefully through all steps to bring this product into the clinic with a great experienced team assembled. Working with Dr. Vilathgamuwa's group is a great example of the growing team of professionals we have assembled to develop and test this product." stated Howard J. Leonhardt, Executive Chairman and CEO

ABOUT SECOND HEART ASSIST, INC.

Formed in 2015 in Salt Lake City, Utah, within the Leonhardt's Launchpads Utah, Inc. innovation accelerator and USTAR's BioInnovations Gateway Utah, Second Heart Assist, Inc. is focused on developing advanced circulatory assist devices. The Leonhardt team previously patented and developed the leading aortic stent graft system for repairing aortic aneurysms without surgery and the first percutaneous heart valve system in the 1990s. In 2001 a team led by Leonhardt completed the landmark first non-surgical stem cell repair of a human heart in The Netherlands. The concept of putting a circulatory assist pump within an aortic stent was first explored by the Leonhardt team in the mid 1990s at the same time they developed a heart valve within an hour glass shaped aortic stent. The Second Heart Assist device project was re-surrected as a support device to the BioLeonhardt www.bioleonhardt.com heart regeneration platform (bioelectric stimulator + micro infusion pump + fifteen component composition) in 2008 with the concept that by off loading the workload of the heart and increasing perfusion it would be easier to regenerate a heart over a course of time. After showing the prototype design to over 20 heart failure department chairs across the USA the consensus was to spin out this product into a stand alone product for circulation support especially for cardio-renal dysfunction patients. The spin out process began in 2015 and Second Heart Assist fully launched with a dedicated team of experienced engineers, clinicians and scientists in 2016. The team has completed a series of large animals in the USA and has five more scheduled for the spring of 2018 in addition to mock loop, durability, biocompatibility, sterility, packaging, transport, electrical safety, risk analysis, computerized fluid dynamics, design controls and electrical safety testing including essential alarms. The Second Heart Assist, Inc. team had a Pre-Submission Early Feasibility Study meeting with the FDA in January which resulted in a clear plan for testing prior to entering clinical trials for both our 1st and 2nd generation designs, Hopefully later this year 2018 for our 1st. generation product and in 2019 for 2nd generation. Our team is also working with a team in Australia to develop a clinical protocol there as well to seek TGA authorization for studies of our 1st and 2nd generation designs after proper pre-clinical testing is completed.

ABOUT QUEENSLAND UNIVERSITY OF TECHNOLOGY

The Queensland University of Technology (QUT) is a public research university located in the urban coastal city of Brisbane, Queensland, Australia. QUT is located on two campuses in the Brisbane area: Gardens Point and Kelvin Grove. The university in its current form was founded in 1989, when the then Queensland Institute of Technology (QIT) was granted university status by the 'Queensland University of Technology Act' passed in 1988.

In 2015, QUT had enrolled 48,503 students, including 8,218 international students from more than 100 countries, 35,304 undergraduate students, 12,035 postgraduate students and 1,164 non-award students. The university had a total of 4,872 Full-time equivalent (FTE) staff members (academic, professional, full-time or fractional full-time and casual) in 2015, and an annual budget of over $900 million.

QUT ranks within the top 10 Australian universities by the Excellence in Research for Australia and the Times Higher Education World University Rankings. The university is consistently ranked in the top 12 universities of Australia and among the top 2% universities worldwide by the Times Higher Education World University Rankings, QS World University Rankings and the Academic Ranking of World Universities.

Queensland University of Technology Contact:

Mahinda Vilathgamuwa BSc, PhD, SrMIEEE

Professor of Power Engineering

School of Electrical Engineering and Computer Science | Queensland University of Technology

S Block, Level 8, Room 807, Gardens Point Campus, GPO Box 2434, Brisbane 4001, Australia

ph +61 7 3138 2459 | e-mail mahinda.vilathgamuwa@qut.edu.au

Web http://staff.qut.edu.au/staff/vilathga/

Second Heart Assist, Inc. Media Contact:
Brian Hardy, Director of Marketing
bhardy@secondheartinc.com

Web Sites:

www.secondheartinc.com

www.leonhardtventures.com