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Not FDA cleared in the United States
Mr. Bent brings more than thirty-five years of experience in financial management and fifteen years of experience in financing, early stage investing and acquisitions to HeartSciences Board. Mr Bent has held a variety of executive positions at The Matthews Group including Controller, CFO and President of various Canadian companies. He was integral in Matthews completion of “The Bow” a $1.7 billion corporate headquarters for Encana. Mr Bent’s finance and operations experience at Matthews and other entities give him a breadth of knowledge in the both finance and fund raising which will be very helpful to HeartSciences in this phase of its development.
Mr. Bent is Chairman of Enerdynamic Hybrid Technologies Corp. a TSXV listed public company involved in the development of renewable energy products. In addition Mr Bent serves in the same capacity for Astro Aerospace Ltd an OTC listed public company focused on the EVTL space.
Mr. Bent graduated from the University of Manitoba with a Bachelor of Commerce (honours) and obtained his Chartered Professional Accounting designation from the Province of Ontario.
He became a partner in Davis & Ceriani, P.C. , in 2002. Mr. Kanouff‘s practice is a combination of complex commercial litigation and business counseling. Litigation Practice Mr. Kanouff’s litigation practice focuses on commercial disputes, corporate and securities litigation, insurance coverage, employment dispute and real estate litigation.
The Company has established a Board of Clinical Advisors, which is comprised of highly qualified physicians and healthcare industry professionals. The Board of Clinical Advisors will advise the management team in making decisions and taking action related to our clinical study efforts, product design and sales efforts. However, the Board of Clinical Advisors will not be responsible for management decisions and has no legal or fiduciary responsibility to the Company. Currently there are three members on the Board of Clinical Advisors:
Carol Krieger is an experienced Regulatory/Clinical professional with over 30 years of medical device experience in the clinical and regulatory areas. She has led and trained clinical and regulatory staff while holding strategic management positions in both large and small companies.
Her experience includes successfully developing and/or managing over 100 regulatory submissions to the FDA, including interacting with FDA product reviewers in two FDA divisions to facilitate approval of 510(k) and PMA submissions involving varied Class II and III products. Building clinical research/regulatory departments including the hiring, training and professional development of staff. She has substantial experience
She has designed and implemented multiple clinical protocols for the investigation of diagnostic medical devices for the purposes of FDA approval. Her experience includes reviewing product labeling, advertising and quality assurance documentation for compliance with FDA regulations.
Carol most recently served as the Director of Clinical Quality Assurance and Compliance at Becton Dickenson and Company. He previous experience also includes Boston Scientific Corp and Roche Diagnostic Systems, Inc..
Carol holds a Master of Science in Jurisprudence Degree from Seton Hall University School of Law, a Master of Business Administration Degree from Montclair State University, as well as a Bachelor of Science Degree in Medical Technology from Rutgers University.
Peter Macfarlane DSc eFESC FRSE, is an expert in the field of electrocardiology and has over 40 years’ experience in the development of computer-based systems for the interpretation of ECGs. He has authored over 300 publications and peer-reviewed papers, as well as numerous books on the subject. Professor Macfarlane is recognized as a pioneer in the use of computers in hospital-based ECG interpretation. He is now Emeritus Professor and Honorary Senior Research Fellow at Glasgow University He was one of the founding members of the Department of Medical Cardiology and was Professor in Medical Cardiology from 1991 – 1995 and Professor of Electrocardiology from 1995 – 2010.
His major interest throughout has been the application of computer techniques to ECG interpretation. The work of his team has been adopted commercially and the University of Glasgow ECG interpretation program developed in his laboratory is currently used worldwide. He is particularly interested in differences in ECG appearances due to age, gender and ethnicity. As a result, he has influenced international guidelines for the ECG definition of acute myocardial infarction. In addition, he has established an ECG Core Laboratory for handling ECGs recorded in national and international clinical studys and epidemiological studies.
Professor Macfarlane is a Fellow of many learned Societies. He was also President of the Board of Computing in Cardiology from 2008-2014 and is currently Treasurer of the International Society of Electrocardiology. In 2000, he was awarded a DSc on the basis of his contribution to research in his own field. He was also jointly awarded the 1998 Rijlant International Prize in Electrocardiology by the Belgian Royal Academy of Medicine. He first attended the Engineering Conference in Banff in 1983 and then chaired both the 1990 and 1993 ISCE meetings, the latter due to the untimely ill health of Professor Jos Willems. In January 2014, he was awarded a CBE for Services to Healthcare.
Dr. James Terry, past President of the Tarrant County Academy of Family Physicians (TCAFP) has been practicing medicine since 1987. He earned his M.D. from UT Southwestern in 1984, and has held numerous leadership roles throughout his career. Dr. Terry has served as the former President of Health Partners Medical Group, and Chief Quality Officer for Texas Health Physicians’ Group (THPG). Currently a member of Texas Academy of Family Physicians (TAFP), he also serves as diplomat of American Academy of Family Physicians (AAFP), in addition to caring for his patients at Mid-Cities Family Care in Bedford, Texas.
Drew is a cofounder of HTL and was its CEO during the development phase of the MyoVista. He has over twenty six years’ experience in the domestic and international medical device business. Drew is also the cofounder of Foundation I-4 which is dedicated to the advancement of cardiac imaging technology. He was Senior Vice President of Global Sales for Criticare Systems Inc., a US based manufacturer of anesthesia, cardiac and patient monitoring equipment. Drew also held positions with IBM, Pfizer, and DeRoyal Industries, and was the Managing Director and President of Medical Logistics GMbH, a medical device company in Germany. Drew has worked and lived in various countries and has experience in opening new markets and driving revenue via distribution networks, which will be an important part of the growth of HTL. Drew currently sits on the Board of Directors for Bone Solutions Inc., an orthopedic biologics technology company based in Dallas Texas.
Joe has over 30 years’ experience in medical device clinical studies, regulatory affairs and quality assurance with several companies, including firms ranging from large multinational to startups. The majority of his experience is with cardiovascular products, comprising an ideal fit with the product focus of Heart Test Laboratories. A brief summary of his company experience includes Pacesetter Systems, Inc (acquired by St. Jude Medical), Biotronik GmbH, CardiacAssist, Health Hero Network (acquired by Bosch Healthcare), Pharmaceutical Product Development (PPD) and Neuros Medical, Inc.
He has organized and completed 12 IDEs leading to market release of medical devices in the United States, European Union, and other major markets. During his career, Joe has secured FDA clearance of 75 510(k)s, 6 Original PMAs, 100+ PMA Supplements, as well as CE Marks (European Union), Canadian MDLs (Canada), and product approvals throughout Asia, Australia, Middle East, Eastern Europe and Russia. Joe is an active member of RAPS, SEMDA, and has participated on various AdvaMed committees in Washington, DC.
Aaron has 23 years of Engineering and Product Development experience, mostly in the Medical Device industry. Aaron has successfully productized multiple innovative technologies in the areas of Cardiac Rhythm Management, Neurostimulation and electrocardiography based devices. He was Director, R&D Systems Engineering for St. Jude Medical and was a Sr. Manager of Software Testing and Automation Tools Development for Boston Scientific (Advanced Bionics). Aaron is well versed in Design Controls and customizing product development processes to meet the needs of the business while remaining compliant with the standards and regulations in the medical device industry.
Tess has over 30 years’ experience in business development, training and sales in the medical device industry. She joined HeartSciences in 2008 as a member of its founding management team. Prior to that, she was Clinical Specialist and Regional Sales Manager for Criticare, where she oversaw sales and clinical training for the company’s state-of-the-art, non-invasive blood pressure and critical care monitors. Tess also has more than 15 successful years growing revenue as a front-line sales representative for critical care products including cardiology, anesthesia, respiratory, labor and delivery, surgery, ICU, emergency and telemetry.
With 20 plus years of medical device experience Brian brings an accomplished track record of multiple first-to-market disruptive innovations, developing go-to-market strategies, and building successful commercialization teams to earn mainstream market adoption. Brian served as Vice President of Sales and Commercial Marketing for OrthoSensor Inc., where he led global market expansion through distribution partnerships. Brian also led the company’s domestic commercial launch of VERASENSE; the orthopedic industry’s first Sensor-assisted-surgery technology for total knee replacements. Prior to OrthoSensor, Brian served as Director of Sales and Marketing for MAKO Surgical and was responsible for the commercial launch of the orthopedic industry’s first Robotic-assisted Surgery System. MAKO Surgical Corp was acquired by Stryker Inc. for $1.65B (2013). Earlier career positions include progressive sales roles at Medtronic, Zimmer Inc., and Burrows Inc. (now Owens and Minor, Inc.).
Paul has over 25 years’ experience as a senior operations executive enabling both public and privately held companies to rapidly maximize top-line growth and profitability by building scalable, efficient organizations that balance the pace of change while effectively managing risk. Paul has successfully built and operated complex, high-growth businesses across multiple industries and geographies, including, technology distribution, consumer products design, manufacturing and distribution, technology service logistics, and technology infrastructure consulting and managed services. Paul also serves on the board of directors for The Children’s Advocacy Center for Denton County.
Mr. Adams is a serial entrepreneur and has enjoyed a long career in the healthcare industry. In 1969, he founded Baylor Laboratories, Inc. which he sold to the Norwich Eaton Pharmaceutical division of Morton Norwich, Inc. in 1980. He then founded Allerderm, Inc. which was purchased by Vibrac, Inc. in 1985. In 1985, Mr. Adams founded Adams Laboratories, Inc. and sold it in 1992 to Medeva PLC, a listed company in the United Kingdom following which he served on Medeva’s Board of Directors until 1997 and as an Executive Director, holding various offices, until 1995. He later repurchased certain assets from Medeva to reform Adams Laboratories, Inc. in 1999 where he served as CEO until 2003. Adams Laboratories changed its name to Adams Respiratory Therapeutics, Inc. where Mr. Adams served as Chairman until October 2005 having led it through a highly successful IPO. Adams Respiratory developed prescription and non-prescription pharmaceuticals for the treatment of respiratory disorders and diseases, including Mucinex™, and was subsequently acquired by Reckitt Benckiser Group in late 2007.
Mr. Adams continues to be an active investor in healthcare companies and retains memberships and board positions in several professional and philanthropic organizations, including the American College of Allergy and the Vanderbilt University Voice Center. In July 2007, he was elected to the Board of Trustees for Heidelberg College in Tiffin, Ohio, and in April 2009 he was inducted into the Hall of Excellence of the Ohio Foundation of Independent Colleges. He is also an Honorary Fellow of the American Academy of Otolaryngology-Head and Neck Surgery. Mr. Adams holds a degree in Biology from Heidelberg College.
John Owen has been a full-time private investor with particular focus on medical devices and clean technology since 2012. He has been an investor in HeartSciences since 2014. Mr. Owen served from 1984 to 1998 as Treasurer of Southwest Airlines, where he was responsible for, among other things, all of the company’s debt, equity and lease financing, new and used aircraft acquisition and property and liability insurance. He later served as Vice President for Operations Planning and Analysis. In 1999, Mr. Owen became one of the co-founders of JetBlue Airways, serving from its inception as Executive Vice President and Chief Financial Officer. He later added responsibility for overseeing supply chain and IT. After leaving JetBlue in 2007 he served as Chief Financial Officer of Volotea Airlines (Spain) from 2009 to 2011 during its preoperational years, assisting in developing the company’s business plan and financial projection model and in raising 65 million Euros of equity capital.
Mr. Owen has a Bachelors Degree in Economics summa cum laude and Phi Beta Kappa from Southern Methodist University and an MBA in Finance from the Wharton School at the University of Pennsylvania, where he was a Mayer Fellow.
Brian Szymczak is the lead attorney for Apollo Endosurgery, Inc. in Austin, Texas where he serves as Director of Legal Services. In this role Mr. Szymczak manages legal disputes and litigation matters and provides general legal counsel to the company’s leadership, sales, operations, R&D and human resources groups. Prior to working at Apollo, Mr. Szymczak served as Associate General Counsel and Director of Legal Affairs for a large surgical device manufacturer and previously worked as an associate at the law firm of Baker Botts, LLP where he counseled clients on patent and other intellectual property matters in a variety of technological fields. Mr. Szymczak is a 1999 graduate of Duke University School of Law and holds a Bachelor of Science in Mechanical Engineering from Texas A&M University.
Dr. Gray is a leading U.S. cardiologist. He is currently Director of the Tyler Heart Institute at Community Hospital of the Monterey Peninsula.
Dr. Gray has been the Medical Director of Sutter Pacific Heart Centers at California Pacific Medical Center in San Francisco. He also held appointments as Professor of Medicine at the University of California in Los Angeles, University of Minnesota and at the University of North Dakota School of Medicine. Dr. Gray became a cardiologist in 1975 and since then has been active with the American Heart Association. Dr. Gray recently served as President of the American Heart Association Western States Affiliate and previously was President of the former Greater Los Angeles Affiliate. He also has served in various leadership roles at the former Dakota Affiliate, Northland Affiliate, and the San Francisco Division Board.
Mark has over 30 years’ experience as a President/CEO of multiple successful startup companies.
He was previously CEO of INX, a company that he was asked to start as a subsidiary for a public company. The technology infrastructure consulting company was started in 2000 and grew to $400M in revenue with 15 offices, 2,000 customers, and 500 employees. The Company was traded on the NASDAQ, completed multiple offerings and was successfully sold to private equity in December of 2011.
Prior to that Mr. Hilz founded and ran as CEO a technology logistics outsourcing firm, PC Service Source, that grew to over $160 million in revenue with 1,100 employees in an 8-year span. Mr. Hilz raised the startup capital from traditional venture capital sources and after 4 years of operations was successful in taking the Company public in an IPO as a NASDAQ global listed company as well as a successful follow on public offering.
Mark’s experience includes raising venture capital as well as multiple successful public offerings and numerous M&A transactions as both a buyer and a seller.
Andrew has almost 30 years’ experience across a wide variety of business sectors and sizes from small entrepreneurial to large corporate and public companies. He was Group CEO of the Peel
Group from 2006 to 2010.
Peel Group is a large private company in the U.K. with approximately
$8 billion of businesses assets across the real estate, ports, airports, energy, media, telecoms and the environmental sectors. He left after achieving the strategic restructuring of the group by strengthening and creating key divisional teams; introducing key partners into several divisions (including the sale of stakes in its £1.6 billion ports business and £200 million airport business); materially increasing liquid assets by approx. £500 million; divesting non-core assets; and successfully managing £3 billion of debt funding across multiple facilities.
He was a main board director of Speedy Hire plc. (which became a FTSE 250 company) from 2003 to 2006 and was responsible for its development and expansion. This included seventeen acquisitions and several non-core divestments which saw the share price quadruple in value.
Andrew qualified as a Chartered Accountant with Price Waterhouse and spent eight years working in investment banking at Rothschild, advising on a wide variety of M&A transactions, debt and equity fundraisings, IPO’s and shareholder value issues. Andrew graduated first-class honors B.A. (Hons) in Accounting and Management.