March, 5th, 2019 – Second Heart Assist, Inc. announced today that its Annual Shareholder meeting will be held 1pm to 2:30 pm MT at the Salt Mine Productive Workspace : 7984 1300 E, Sandy, UT 84094 on March 18th, 2019. The shareholders will elect the 2019 Board of Directors at this meeting and will approve compensation plans for executives, board members and advisors. Progress towards goals will be reviewed as well as company financials and our 2019 strategic plan and goals.
Conference Call Line 712-775-7031 Access Code 405-822-417
Accomplishments Progress To Date
· Completed 5 large animals – 2 more are scheduled for this month.
· Completed 100 million characterization data points in mock loop model at U of Louisville.
· Completed 2 rounds of Computational Fluid Dynamics tests at Enmodes Germany.
· Completed multiple rounds of durability challenge tests.
· Raised over $2.0 million in capital.
· Held three expert panel meetings with heart failure department chairs (20) from leading U.S. centers.
· Option licensed 5 patents from the California Institute of Technology (Caltech).
· Exclusively licensed for aorta Vascor pioneering wireless power patent.
· Filed patent pending for harmonic vibration energy protection against blood clots.
· Filed patent pending on 1st. gen. design of pump within conforming firm fixation aortic stent.
· Filed patent pending for auto adjustment pulsating two pumps within aorta in series.
· IRB approval gained to begin clinical studies in Paraguay.
· Conditional IRB approved gained to being clinical studies in Australia.
· Made it to finalist in ACC AngelMD National Innovation Challenge.
· Made it to finalist in CRT Cardiovascular Innovation Challenge.
· 2 Early Feasibility Meetings and interactive review with the FDA with intent to begin U.S.A. studies.
. Developed motor controller alarm box following design controls working with DeviceLab California.
· Developed internal full Quality Management System including Design Controls.
· Completed full Risk Analysis including mitigation of over 100 potential associated risks.
· Arranged for 44% R&D tax rebate on all research and development expenditures in Australia.
· Arranged potential pathway for up to approximately $150,000 in USA R&D tax credits.
· Completed successful demo of wireless power at Queensland University of Technology Australia – https://youtu.be/O5ROYnN8pFU
2019 Key Objectives
· Complete clinical studies in Paraguay for High Risk PCI and cardio renal dysfunction.
· Complete clinical studies in Australia or other OUS location for High Risk PCI and cardio renal dysfunction.
· Complete clinical studies at Ohio State University USA for High Risk PCI and cardio renal dysfunction.
· Add to patent estate for 1st and 2nd generation designs.
· Complete large animal studies for 2nd generation VibroCell and wireless power designs.
· Secure strategic partner/buyer to advance development to commercialization.
Agenda Second Heart Assist, Inc.
Shareholder Meeting Agenda
Meeting Will Be Called to Order @ 1pm March 18th, 2019 Sandy, Utah
Agenda
- Introductions
- Instructions on Rules of Conduct and Procedures
- Proof of Notice of Meeting Given
- Announcement of Existence of Quorum
Official Voting Business Agenda
Presentation of Proposals and Discussion
- Proposal #1 – Election of Directors
Howard J. Leonhardt – Executive Chairman & CEO
Jeff Donofrio – President
Dr. Leslie Miller – Chief Medical Officer
Dr. Dinesh Patel – Investor and Advisor
Ken Evans – VP Corporate Development
Dr. Mark Cunningham – Chief Circulatory Assist Advisor, USC Keck Cardiac Surgeon
Alex Richardson – VP of Engineering & Product Development.
Brittany Brown – CPA
- Proposal #2 – Ratification of Accountants, Legal Counsel, Tax Preparation, Audit Rules, Key Consultant
Brittany Brown CPA, Ledger Gurus working with Kim Medina – Accountant
Bruce Methven – Securities Counsel
Allen Turner – Patent Counsel
Mina Vallabh – Tax return specialist.
ADP – R&D tax credit specialists
Larry Stevens – FDA Regulatory Consultant
Todd Seiger – Reimbursement Consultant
Jane Reedy – Clinical, Regulatory, Quality Consultant
Dr. William Abraham – Chairman of Scientific and Medical Advisory Board
Michael Williams – Engineering Consultant
DeviceLab – Product developments and Quality Systems Consultants
BlueLine ETO – Sterility and Biocompatibility Consultants
Biomerics – Manufacturing consultants
Ryan Stanfield – Design Controls Consultant
Jon Teal – Design Controls Consultant
Michael Williams – Engineering Consultant
- Other Proposals from Management, Board or Shareholders.
Voting
- Opening of Polls
- Voting on Proposals
- Closing of Polls
Results of Voting
Adjournment Voting Business Official Meeting Portion
1. Management Presentation Regarding Company
a. Review of financials.
b. Review of data gathered to date.
c. Review of patents.
d. Review of facilities.
e. Review of 2019 goals.
2. Question and Answers from Shareholders Regarding Company
Web site: www.seconheartinc.com
Warning Disclaimers: Forward looking statements may be changed without notice. Company may not maintain all patent claims mentioned. It is possible that the company may be found to be infringing patents of others. Company relies on outside suppliers which may affect intended timelines. Company has less capital, staff and other resources normally required to bring a product like this to commercialization. For a number of reasons any quoted timelines may take longer, substantially longer. Product is early stage development that is not yet proven to be either safe or effective. By the nature of being early stage, under capitalized and under staffed any investment in Second Heart Assist, Inc. must be regarded as very high risk of loss.
Second Heart Assist, Inc., 370 S, 300 E, Salt Lake City, Utah 84111
Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc, 12655 W Jefferson Blvd, Los Angeles, CA 90066
Leonhardt’s Launchpads Utah, Inc. 370 S, 300 E, Salt Lake City, UT 84111
Research Lab @ 2500 S State St. #224, Salt Lake City, UT 84115
Research Lab @ 2500 S State St. #224, Salt Lake City, UT 84115
Leonhardt’s Launchpads Pittsburgh, Inc., 2730 Sidney Street, Suite 300, Pittsburgh, PA 15203
Office: (424) 291-2133