4Q 2021 Stakeholder Update
Progress Update
December 27th, 2021
Year End Summary
2021 was a great year of progress for Second Heart Assist, Inc. We completed a large series of large animals with long duration use at Texas Heart Institute with great success. We believe we are set now to begin a cardio-renal syndrome clinical study with 24 hours circulatory assist support time in 1Q 2022. Our team believes we are in the front leadership position in the industry in transitioning to wireless power with tremendous progress made in building and testing wireless powered prototypes achieved in 2021. Our team has had over 50 meetings with a dozen potential strategic partner/acquirers and nearly all we have met with wish to meet again immediately following the completion of the cardio-renal syndrome heart failure clinical study which is expected to be completed in 2Q 2021.
Senior Leadership
Howard J. Leonhardt
Executive Chairman and CEO
Jeff Donofrio
President
Dr. Leslie Miller
Chief Medical Officer
Alex Richardson
Chief Technology Officer, VP Engineering and Product Development
Summary of Key Differentiating Performance Features of Our Device Pipeline
Best stability of positioning due to strong radial force aortic stent.
Able to maintain pulatility of both blood flow and aortic wall movement.
Easiest to place of all systems – usually in under 2 minutes.
Highest flow rate of any system.
Lowest operating RPMs of any system.
Most ready for transition to wireless power.
Dr. Leslie Miller presented Second Heart Assist, Inc. this month at the Annual Devices for Heart Failure Meeting – here is a video link to his presentation –
Second Heart Assist – Devices for Heart Failure December 2021 Presentation –
video link > https://www.youtube.com/watch?v=j0LboEkrrb0
Second Heart Assist was featured on the Cover of Medtech Outlook Magazine as one of the top MedTech innovations of 2021 with a full article within the issue – https://www.medicaltechoutlook.com/magazines/July2021/Cardio_Vascular_Device/
Second Heart Assist, Inc. 2021 Year Highlights
“Results from our previous first in human clinical study, multiple sophisticated mock loop studies and over 17 large animals demonstrate clearly that this device warrants going into well controlled clinical trials, especially for the unmet need of helping cardio-renal syndrome heart failure patients. In sharing our data, design features and study plan with leading heart failure department chairs from around the world we have received an enthusiastic response with over 20 centers indicating to us that they would like to be in our planned Phase II pivotal trial if the Early Feasibility Study results come to match the results we have obtained in large animals and our previous pilot clinical study.” stated Dr. Leslie Miller Chief Medical Officer
Link to animation video of our wireless power device > https://vimeo.com/415533842
2021 Progress Highlights
• Highly successful Heart Failure Society of America Annual Meeting in Denver, Colorado – Expert Panel meeting with over 20 leading heart failure department chairs. Great response received.
• Attendees at HFSA almost universally commented that the Second Heart Assist wireless device will revolutionize the care of their patients with a needed alternative not currently available. They also commented that they believe our applicable patient population estimates are too conservative.
• Transparent demo model developed for wireless powered device featured in exhibit booth and meetings.
• Second Heart Assist, Inc. has officially engaged Truist https://www.truistsecurities.com/solutions/capital-solutions as an investment banking firm to represent the sale of our assets or company.
• Wilsoni Sonsini Goodrich has been engaged as our official Mergers and Acquisitions Counsel.
• Completed our 9th successful large animal at Texas Heart Institute testing out long duration circulatory assist support. We have completed over 17 animals all together, 3 formal mock loop studies, 2 computational fluid dynamics studies and 4 humans to date. We have over 100 million product performance characterization data points gathered on our device to date.
• New simplified handle design implemented and tested with success.
• Additional patent claims files for improvements to wireless power and potential use of multiple impellers. .
• The FDA had some questions on our 1250 page EFS application filed last quarter and we have met with them a number of times to provide clarifications and we are preparing now our final submission including the new data from the latest Texas Heart Institute long duration large animal studies.
• We had a great number of meetings at TCT Transcatheter Therapeutics Annual Meeting November 4th to 9th in Orlando, Florida with Truist arranging meetings with many potential strategic acquirers/investors/partners.
• Dr. Leslie Miller presented Second Heart Assist at Devices for Heart Failure Annual Meeting this month.
• We have surpassed over $13.00 million in capital raised to date.
• We have initiated efforts to have our own universal ASIC for our wireless power system.
• We have initiated development of a 2nd generation motor controller alarm box intended to be used in our pivotal study in the USA.
• We have filed patent claims for a 3rd generation simplified design with a flexible kink resistant nitinol drive draft within a ePTFE lined catheter and and auto pop open impeller blade system with the V elements pointed downwards for greater ease and reliability of removal.
• Commercial launch packaging has been designed. See below.
Market Size
$10 billion +
Markets
Cardio-renal dysfunction
High risk PCI
Cardiogenic shock
Bridge to heart regeneration
Bridge to transplant
Bridge to LVAD
Limb salvage
Published Patents and Patents Pending
1. Circulatory Assist Pump https://patents.justia.com/patent/20210077687
2. Circulatory Assist Pump https://patents.justia.com/patent/20210008263
3. Thrombosis Prevention https://patents.justia.com/patent/20190125932
4. Wireless power https://patents.google.com/patent/US9308303B2/en?q=wireless&inventor=heilman&assignee=Vascor&oq=Vascor+heilman+wireless+
5. Intravascular Miniature Stent Pump https://patents.google.com/patent/US7998190B2/en
6. Hydroimpedence Pump https://patents.google.com/patent/US7163385B2/en
7. Resonant Multilayer Impedence Pump https://patents.google.com/patent/US8092365B2/en
8. In-Line Actuator for Electromagnetic Operation https://patents.google.com/patent/US8197234B2/en
In addition to the above published patents and patents pending we have dozens of additional patent claims filed or in process but not published yet and we have some new license agreements in process as well, which will be disclosed later. New patent filings already made but not published include improvements to wireless power systems including miniaturization methods and design and also a 3rd generation simplified drive shaft and impeller design for greater reliability.
We believe our July 11, 2011 filed wireless power USPTO ISSUED patent U.S. 9,308,303 B2 to be pioneering providing broad patent protection and may possibly be recognized as the earliest filing in this scope in the field.
Our patent estate pending and issued in brief summary is meant to cover…
1. Open architecture aortic stent design to balance stability with minimizes disruption to blood flow.
2. Aortic stent design that balances stability with ability maintain aortic wall pulsatility.
3. High flows at low RPMs with less risk of hemolysis,
4. Minimization of thrombosis risk.
5. Minimization of mechanical wear risk.
6. Ease of percutaneous placement.
7. Wireless power.
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.