MyoStrain® History

Translating the Gold Standard of Care in Research to the Clinical-Commercial Setting

The MESA Study

In 2000, Johns Hopkins University (JHU) initiated the MESA study, a long-term, multi-generational study to observe the progression of heart disease. To perform the study, researchers would need a way to monitor the subjects’ heart health over time. Professor of radiology and founder of Myocardial Solutions (MSI) Dr. Nael Osman created a new technology that would allow researchers to quantify the subtle changes in patient heart health reliably and in granular detail over time.

Harmonic Phasing (HARP)

To support the MESA study, Dr. Osman had invented early MyoStrain predecessor HARP, a medical image analysis technique that used tagging-based magnetic resonance image (MRI) sequences to extract and process information about the heart.

Strain-encoding (SENC)

Later, in 2006, the SENC pulse sequence was created as an improvement to the HARP analysis and traditional tagging-based MRI. SENC produced faster imaging results and enhanced post-processing capabilities to show the physiologic contraction of the heart.

Becoming the Gold Standard of Care in Research

HARP and SENC had become widely recognized as the “gold standard of strain in research” and played key roles in pivotal trials including the MESA Study, which became the largest cardiac study ever conducted at JHU.

Over the course of following ten years, these MyoStrain technologies had become rigorously validated in more than 400 peer-reviewed publications, including 50 in JACC and Circulation. Representing more than 70,000 patient scans to date, MyoStrain had demonstrated immense research support as a highly sensitive and reproducible marker for the early assessment of heart dysfunction.

MyoStrain (fast-SENC): Optimizing for Clinical/Commercial Use

To move the technology away from research and into the clinical setting, MSI developed MyoStrain (fast-SENC), which combined gold-standard strain assessment with high-speed, non-invasive imaging to bring testing time down to 10 minutes without the need for radiation exposure, contrast injection or breath-holding.

This, together with the standardized MyoHealth™ Score, has optimized MyoStrain for widespread clinical adoption across multiple unmet cardiac and cancer markets, bringing a holistic, patient-centric solution to hospitals and centers in the US and EU.

John Funkhouser

Chairman, Chief Executive Officer
John Funkhouser has extensive experience in healthcare as CEO of four cardiac life sciences companies including CoeurLabs, PharmaNetics, nContact and now, Myocardial Solutions. Before working in healthcare, Mr. Funkhouser worked in banking and venture capital at Chemical Bank Of New York, Wheat First Securities, Crestar Capital and Hillcrest Group. He is a graduate of Princeton University and the Darden School of Business at the University of Virginia.

Nael Osman, PhD

‍Founder, Chief Science Officer
Nael Osman founded Myocardial Solutions after developing MyoStrain’s technology as a professor at Johns Hopkins University. As a known leader in cardiac MRI technology, Nael has pushed the frontiers of measuring regional function of the heart using MRI. Nael is an accomplished researcher and academician with a track record of academic publications (60+ scientific papers, 100+ conference presentations and abstracts), research contribution, teaching and life science innovation.

Rafael Rivero, MD

Chief Medical Officer, Global Head of Medical Affairs
With over 18 years of global experience leading and transforming teams across Biotech, Pharma and Medical Devices, Rafael Rivero, MD leads the initiative in expanding MyoStrain clinical utilization and advocacy within the medical community. Dr. Rivero received his MD at the Superior School of Medicine in Cuba in 1992 and his professional experience includes Monogram Biosciences, Gilead Sciences, Abbott Laboratories, Stereotaxis and Ortho Clinical Diagnostics.

Jim Whayne

Chief Clinical Officer
Jim Whayne joined Myocardial Solutions to direct clinical initiatives. He has 25 years of medical device and entrepreneurial experience, having cofounded 3 device companies – nContact, Cayenne Medical and Converge Medical. Mr. Whayne holds a Master of Science in Biomedical Engineering from the University of Virginia and a Bachelor Degree in Biomedical and Electrical Engineering from Duke University. He is also an inventor on over 200 issued US patents.

Sid Fleischman

Vice President, Engineering and Operations
Sidney Fleischman has 25 years of experience in bringing medical devices from concept to commercialization. He has cofounded several successful medical device companies, including nContact, Cayenne Medical, and Converge Medical. He holds a BS in Mechanical Engineering from UC Santa Barbara and is an inventor of more than 100 issued patents in the medical device area.

Denise McKenzie

Vice President, Finance
Denise McKenzie has extensive experience in finance and accounting with a variety of start-up companies, primarily in the healthcare industry. She has led diverse financing projects including IPOs, commercial bank financing, PIPEs, private placements, venture rounds, and acquisitions. McKenzie is a graduate of Virginia Commonwealth University with both a Bachelor’s and Master’s degree in finance with a concentration in accounting.

Translating the Gold Standard of Care in Research to the Clinical-Commercial Setting

John Funkhouser

Chairman, Chief Executive Officer

John Funkhouser has extensive experience in healthcare as Chief Executive Officer of four cardiac life sciences companies including CoeurLabs, PharmaNetics, nContact and now, MSI. Before working in healthcare, Mr. Funkhouser worked in banking and venture capital at Chemical Bank Of New York, Wheat First Securities, Crestar Capital and Hillcrest Group. He is a graduate of Princeton University and the Darden School of Business at the University of Virginia.

Dane Carl Andreeff

Dane Carl Andreeff is the current President, Chief Executive Officer and Director at Helius Medical Technologies, Inc., an advanced medical device company focused on improving neurological health and wellness. He is also the founder of Maple Leaf Partners, LLC and Andreeff Equity Advisors, LLC.

In addition to his role as Director at MSI, Andreeff is Director at HDL Therapeutics, a highly innovative medical company that has developed the first therapy of its kind to rapidly reverse coronary atherosclerosis in patients with Homozygous Familial Hypercholesterolemia (HoFH). He is also on the board at TraceSecurity, LLC, a security company helping to protect and eliminate risk for companies ranging local and community financial institutions to global enterprises.

William W. Burke

William Burke is currently President at Austin Highlands Advisors, L.L.C., and in addition to MSI, is Director of Adtalem Global Education and Tactile Systems Technology, Inc. Burke’s strong experience in strategy development, mergers and acquisitions, and debt and equity financing. Previously, Burke served as Executive Vice President and Chief Financial Officer at IDEV Technologies, Inc., a subsidiary of Abbott, Inc. providing next-generation medical devices for use in interventional radiology, vascular surgery and cardiology.

Burke also notably served as Executive Vice President and Chief Financial Officer at ReAble Therapeutics, Inc. for over three years, a diversified orthopedic device company, where he increased annual revenues from $100 million to $450 million through means of both acquisitions and organic growth.

Nelson Randy Hill

Randy Hill currently serves as a key business advisor to United Imaging in North America and specializes in consulting innovative companies across the healthcare imaging sector. Hill brings extensive experience in the medical imaging industry and a background in sales in marketing to help position MSI at the forefront of imaging innovation.

Hill has also served as Chief Executive Officer at Siemens Medical, and previously as Chief Operations Officer and VP of Service at Siemens for more than eight years. Prior to that, Hill served six years as Chief Executive Officer and Director at VasoMedical subsidiary, Vaso Diagnostics, a medical technology company ranging a diverse product and service selection, including several diagnostic imaging solutions as well as non-invasive monitoring and therapeutic devices.

Todd Ames Robinson

Todd Robinson currently serves as CEO/Principal at Southwood Group, L.L.C., with approximately $45 million in revenue and 200 employees. Robinson also serves as Managing Partner for Hanover Ventures, L.L.C., a venture partnership currently holding three primary investments, including Myocardial Solutions, Inc., VazTec, L.L.C. American Nano, L.L.C. Robinson brings in a diverse background and significant operating experience as both a manager and director.

Translating the Gold Standard of Care in Research to the Clinical-Commercial Setting

United Imaging Healthcare Solutions

United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, has partnered with Myocardial Solutions Inc. to bring rapid cardiac MR imaging to unmet cancer care and cardiology markets, helping enable physicians to protect and manage patient heart health during and after cancer treatment.

United Imaging is the preferred provider for MyoStrain®, and the two companies have joined together to deliver this dedicated solution to cancer centers and hospitals. The FDA’s 510(k) pre-market clearance of MyoStrain for United Imaging MRI machines marks the availability of this novel, proprietary technology in the U.S. market.

Learn more about the uMR® 570 MyoStrain® Edition

“With this joint solution from Myocardial Solutions and United Imaging, oncologists and cardiologists will be able to monitor patient heart health before, during, and after cancer treatment. Together, United Imaging and Myocardial Solutions will deliver the diagnostic testing using MyoStrain software on a dedicated MR scanner for both cancer centers and cardiologists. The fast, MR based technique is highly automated to deliver reproducible results.”
Abram Voorhes, Ph.D
Vice President of MR Imaging at United Imaging

Translating the Gold Standard of Care in Research to the Clinical-Commercial Setting

The MESA Study

In 2000, Johns Hopkins University (JHU) initiated the MESA study, a long-term, multi-generational study to observe the progression of heart disease. To perform the study, researchers would need a way to monitor the subjects’ heart health over time. Professor of radiology and founder of Myocardial Solutions (MSI) Dr. Nael Osman created a new technology that would allow researchers to quantify the subtle changes in patient heart health reliably and in granular detail over time.

Harmonic Phasing (HARP)

To support the MESA study, Dr. Osman had invented early MyoStrain predecessor HARP, a medical image analysis technique that used tagging-based magnetic resonance image (MRI) sequences to extract and process information about the heart.

Strain-encoding (SENC)

Later, in 2006, the SENC pulse sequence was created as an improvement to the HARP analysis and traditional tagging-based MRI. SENC produced faster imaging results and enhanced post-processing capabilities to show the physiologic contraction of the heart.

Becoming the Gold Standard of Care in Research

HARP and SENC had become widely recognized as the “gold standard of strain in research” and played key roles in pivotal trials including the MESA Study, which became the largest cardiac study ever conducted at JHU.

Over the course of following ten years, these MyoStrain technologies had become rigorously validated in more than 400 peer-reviewed publications, including 50 in JACC and Circulation. Representing more than 70,000 patient scans to date, MyoStrain had demonstrated immense research support as a highly sensitive and reproducible marker for the early assessment of heart dysfunction.

MyoStrain (fast-SENC): Optimizing for Clinical/Commercial Use

To move the technology away from research and into the clinical setting, MSI developed MyoStrain (fast-SENC), which combined gold-standard strain assessment with high-speed, non-invasive imaging to bring testing time down to 10 minutes without the need for radiation exposure, contrast injection or breath-holding.

This, together with the standardized MyoHealth™ Score, has optimized MyoStrain for widespread clinical adoption across multiple unmet cardiac and cancer markets, bringing a holistic, patient-centric solution to hospitals and centers in the US and EU.