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ElevatedCPR Therapy: A Game-Changer in Resuscitation with AdvancedCPR Solutions, Study notes of Public Health

AdvancedCPR Solutions, founded in 2015, is pioneering ElevatedCPR Therapy, an evidence-based resuscitation method that could potentially improve survival from sudden cardiac arrest. This therapy, also known as head up or gravity-assisted CPR, focuses on patient positioning to improve intracranial, cerebral perfusion, and coronary perfusion pressures. The company's initial device, the EleGARD Patient Positioning System, delivers precise and safe ElevatedCPR therapy positioning in pre-hospital and hospital settings. Sudden cardiac arrest, a leading cause of death, claims a life every 90 seconds, and ElevatedCPR therapy may be an essential part of the improved bundle of care to address this crisis.

What you will learn

  • What are the potential benefits of ElevatedCPR Therapy for sudden cardiac arrest patients?
  • What is ElevatedCPR Therapy and how does it differ from traditional CPR?
  • How does the EleGARD Patient Positioning System deliver precise and safe ElevatedCPR Therapy positioning?

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2021/2022

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CORPORATE PROFILE
Founded in Minneapolis, Minnesota as Minnesota Resuscitation Solutions in 2015,
AdvancedCPR Solutions is the pioneer of ElevatedCPRTM therapy, an evidence-based
resuscitation therapy (also known as head up or gravity assisted CPR) centered on
patient positioning that could potentially improve survival from sudden cardiac
arrest. ElevatedCPR therapy is a broad, patent-protected method for performing
cardiopulmonary resuscitation (CPR) that incorporates lifting the head, heart, and
shoulders in a multi-angled incline. The early stage medical device firm is focused on
the development and commercialization of ElevatedCPR therapy delivery
mechanisms, methods and devices starting with the company’s initial device, the
EleGARDTM Patient Positioning System. The EleGARD delivers precise, rapid, secure
and safe ElevatedCPR therapy positioning for sudden cardiac arrest patients in the
pre-hospital and hospital settings.
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CORPORATE PROFILE

Founded in Minneapolis, Minnesota as Minnesota Resuscitation Solutions in 2015, AdvancedCPR Solutions is the pioneer of ElevatedCPR TM^ therapy, an evidence-based resuscitation therapy (also known as head up or gravity assisted CPR) centered on patient positioning that could potentially improve survival from sudden cardiac arrest. ElevatedCPR therapy is a broad, patent-protected method for performing cardiopulmonary resuscitation (CPR) that incorporates lifting the head, heart, and shoulders in a multi-angled incline. The early stage medical device firm is focused on the development and commercialization of ElevatedCPR therapy delivery mechanisms, methods and devices starting with the company’s initial device, the EleGARD TM^ Patient Positioning System. The EleGARD delivers precise, rapid, secure and safe ElevatedCPR therapy positioning for sudden cardiac arrest patients in the pre-hospital and hospital settings.

ABOUT SUDDEN CARDIAC ARREST (SCA)

Sudden cardiac arrest, the abrupt loss of heart function that occurs when the heart’s electrical system malfunctions, is a leading cause of death globally, claiming a life every 90 seconds and taking more lives annually than breast cancer, lung cancer and HIV/AIDs combined. 1

In the US alone, there are approximately 350,000 out-of-hospital cardiac arrests (OHCA) annually, and another 209,000 in-hospital cardiac arrests (IHCA). Overall survival rates are dismal, with approximately 8 percent of OHCA and 24 percent of IHCA^2 cardiac arrest patients surviving with neurological function intact.

There have been relatively few standard of care updates to improve outcomes of cardiac arrest over the last 50 years. While we have begun to address SCA as a public health crisis with continued education about bystander CPR and the growing placement of automated external defibrillators (AEDs), there remains a need to implement new technologies and protocols within the pre-hospital and hospital settings as a bundle of care to better improve the potential for survival. Evidence is growing that head up or ElevatedCPR TM^ therapy could be an important part of this improved bundle of care.

(^1) https://www.hrsonline.org/Patient-Resources/Heart-Diseases-Disorders/Sudden-Cardiac-Arrest-SCA (^2) American Heart Association Statistics, Update 2018

ORIGIN OF ELEVATEDCPR THERAPY

In the early 2010’s, Korean clinicians faced the challenge of extracting cardiac arrest victims from the small elevators pervasive in Asian apartment complexes, and determined that a change in patient positioning might provide a solution. The physicians were working with a patient stretcher that could be tilted to fit into the elevator without stopping CPR and recommended tilting the head of the patient down during extrication, based on a theory that blood draining from the lower trunk and legs from the force of gravity would increase blood flow to the heart and brain and produce better outcomes.

In 2014, Keith Lurie, MD, AdvancedCPR’s founder and a globally-respected expert and researcher in resuscitation, and his team analyzed the impact of head down positioning on patient physiology and hemodynamics. Dr. Lurie and his team used their proven cardiac arrest animal model, monitoring systems and an automated CPR device with a tilt table that could tilt the entire body up or down.

They first replicated the Korean recommendation for head down CPR and saw an immediate, profound and dangerous increase in intracranial pressure and a corresponding decrease in cerebral perfusion pressure – exactly the opposite of what was expected and needed.

The team decided to investigate what would happen if the patient were tilted the other direction – into a head up or elevated position. Surprisingly, the exact opposite of what was expected occurred – both the intracranial pressure fell and cerebral perfusion pressure increased by statistically significant levels.

Their research into head up positioning continued forward and is the basis for AdvancedCPR Solutions’ ElevatedCPR therapy. Lurie and his team have published a number of scientific papers about ElevatedCPR therapy and its potential benefits as an additional recommendation to a forward-thinking bundle of care to address sudden cardiac arrest.

EVIDENCE-BASED BENEFITS OF ELEVATEDCPR THERAPY

ElevatedCPR therapy is the first major CPR breakthrough in decades and may offer a significant opportunity to improve the chances for neurologically-intact survival of cardiac arrest when implemented with the proper bundle of devices.

  • Initial studies exploring ElevatedCPR therapy have shown doubled blood flow to and through the brain and other vital organs compared to today’s best-of- class CPR techniques and devices.^5
  • When compared to circulation from hands-only CPR with the patient supine or head flat, the increase in cerebral circulation is profound, nearly 4-fold after 15 minutes of CPR.^6
  • ElevatedCPR therapy produces an immediate and significant reduction in intracranial pressure,^7 mitigating the “brain concussion with every compression” seen in CPR. “Head flat” (conventional) CPR increases ICP– effectively causing a concussion with every compression.
  • (^) Human cadaver studies with Active Compression Decompression CPR with an ITD and with the Lucas Automated CPR device with an ITD show physiologic results consistent with the animal studies. 7 Research into the many potential benefits of ElevatedCPR therapy continues, with a number of publications and presentations in the process of being finalized for publication.

(^5) Moore J, Segal N, Lick M, Dodd K, et al. Head and thorax elevation during active compression decompression cardiopulmonary resuscitation with an impedance threshold device improves cerebral perfusion in a swine model of prolonged cardiac arrest. Resuscitation. 2017;2017(121):195-200. doi: http://dx.doi.org/10.1016/j.resuscitation.2017.07.033.

(^6) Moore J, Holley J, Segal N, Lick M. et al. Consistent head up cardiopulmonary resuscitation haemodynamics are observed across porcine and human cadaver translational models. Resuscitation. 2018; https://doi.org/10.1016/j.resuscitation.2018.04. (^7) Debaty G, Shin S, Metzger A, Kim T, Ryu HH, Rees J, et al. Tilting for perfusion: head-up position during cardiopulmonary resuscitation improves brain flow in a porcine model of cardiac arrest. Resuscitation. 2015;87(2015):38-43.

MILESTONES

  • 2015 - Founded as Minnesota Resuscitation Solutions.
  • 2015 – EleGARD (formerly known as MRS 525) received clearance from US FDA under a 513(g) Regulatory Requirements Review as Class 1, 510(k) exempt device which allows for immediate marketing.
  • 2017 - First patent issued by US PTO.
  • 2017 - Company received $225,000 grant from the National Institutes of Health Small Business Innovation Research (SBIR) Program.
  • 2018 – Broad method patent issued by USPTO.
  • 2018 – Design and development of First Generation EleGARD Commercial Device completed.
  • 2018 – Global headquarters established in Edina, Minnesota.

OFFICERS AND DIRECTORS

Phil Faris - Founder & CEO

A serial entrepreneur with over 35 years of successful CEO and Board experience. He has led over 30 major novel medical product introductions in the Pharma, MedTech, Clinical Informatics spaces. Currently Managing Director ProSavant International, LLC. Previously, Chairman, Flashback Technologies, Inc., Executive Chairman, Innovative Trauma Care, CEO, President and Director Vidacare Corporation (sold to Teleflex), Lead Director Advanced Circulatory Systems, Inc. (sold to ZOLL Medical).

Keith Lurie, MD - Founder, Chief Medical Officer

A prolific inventor, successful entrepreneur, electro-physiologist and world- renowned expert in the resuscitation of patients suffering Sudden Cardiac Arrest. Dr. Lurie founded Advanced Circulatory Systems, Inc. (ACSI) in 1997 to make Perfusion on Demand a standard of care. ACSI was sold to ZOLL Medical in January 2015. He is also Professor of Emergency Medicine at the University of Minnesota School of Medicine and director of a NIH funded research laboratory at Hennepin County Medical Center, Minneapolis MN.

Glen Robinson - Chief Financial Officer

A skilled Financial Executive with over 35 years’ experience in corporate and public accounting and financial management. Currently Leader of Financial Management Practice, ProSavant International, LLC, Partner and CFO Regent Coach Line, LTD. Formerly VP Finance Innovative Trauma Care, Inc.

Barbara Gold, MD, Founder, Director

Executive Vice President of Medical Affairs and Professor of Anesthesiology of Minnesota Health (M-Health), Professor of Anesthesiology at the University of Minnesota. She is a founding member of AdvancedCPR Solutions and co- inventor of a number of important devices and methods to improve outcomes from cardiopulmonary resuscitation. Dr. Gold’s special interests are focused on improving clinical performance and patient outcomes using systems-based approaches.

SCIENTIFIC ADVISORY BOARD

  • Michael Levy, MD – Anchorage EMS, State of Alaska Medical Director, Anchorage AK
  • R. J. Frascone, MD – Regions EMS, Twin Cities, MN
  • Charles Lick, MD – Allina EMS, Twin Cities, MN
  • Guillaume Debaty, MD – Centre Hospitalier Universitaire de Grenoble France
  • Demetris Yannopoulos, MD – University of Minnesota, Minneapolis, MN
  • Jeffrey Goodloe, MD – EMSA OK, Oklahoma City and Tulsa, OK
  • Joe Holley, MD – Memphis EMS, Tennessee State Medical Director
  • Kenneth Scheppke, MD – Palm Beach County Florida EMS
  • Peter Antevy, MD – Broward County Florida EMS
  • Johanna Moore, MD – Hennepin County Department of Emergency Medicine, Minneapolis, MN
  • Nicolas Segal, MD – University of New Mexico, Albuquerque, NM
  • Michael Jacobs – Alameda County CA, EMS and Public Health
  • Marvin Wayne, MD – Whatcom / Bellingham Washington EMS