Heart Test Labs Further Strengthens Board of Directors

April 25, 2017- Westlake, TX—Heart Test Laboratories, Inc. announces today the recent additions of Mr. John Q. Adams, Sr. and Mr. John D. Owen to further strengthen its Board of Directors.

“We are delighted to welcome two highly successful and experienced executives as Independent Members of Heart Test Labs’ Board of Directors. Their appointments come as product launch is imminent, and we position for an IPO or institutional capital in the coming months.” said Mr. Andrew Simpson, Chairman. “Their experience and track records of success in healthcare and strategic business management will help guide HTL in scaling around the world and to maximize the opportunity for the MyoVista®, a breakthrough in the early detection of heart disease.”

John Quincy Adams Sr.

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
Mr. Owen was a co-founder of Jet Blue Airways and was its CFO for many years. During his tenure Jet Blue went from a start-up to a successful NASDAQ listed company with over $2 billion in revenue. John managed multiple public and private funding rounds as well as its IPO. Prior to JetBlue, Mr. Owen served as Treasurer for Southwest Airlines from 1984 to 1998. Subsequently, he served as CFO for Volotea Airlines during its start-up which included raising €65 million in equity financing before its commencement of flight operations in 2012. He holds a BA in Economics from SMU, summa cum laude and Phi Beta Kappa, and an MBA in Finance from the Wharton School where he was a Mayer Fellow. Mr. Owen is currently a full time private investor with a particular interest in the medical sector. Mr. Owen also chairs the Audit Committee of HTL.

About Heart Test Laboratories, Inc. (“HTL”)

HTL uses patented proprietary technology to develop medical devices that focus on the early detection of heart disease. Its first product, MyoVista®, represents a major clinical breakthrough in diagnostic electrocardiography. It significantly improves clinical efficacy, compared to conventional ECGs, in the early identification of ischemic and other cardiac dysfunctions.

MyoVista® applies advanced digital signal processing to create a high-sensitivity ECG with new proprietary informatics. It is ideally suited to both primary care and clinical environments in hospitals and outpatient care centers. MyoVista® uses standard 12-lead resting ECG protocols to characterize cardiac dysfunction with high accuracy, including for asymptomatic patients. It also displays standard 12-lead ECG information, including traditional interpretive analysis. MyoVista® promises to bridge the “diagnostic gap” found in heart disease today, namely the identification of “at risk” patients before suffering an adverse cardiac event, such as myocardial infarction.

The device has a 15.6-inch high-resolution touchscreen display and incorporates many features commonly associated with a tablet device requiring minimal user training as well as easy and intuitive use.

Heart Disease results in 7 million deaths per year worldwide, more than all cancers combined; it represents the largest healthcare expenditure of any disease. Heart Test Laboratories is a privately held U.S. corporation. For more information, please visit www.hearttestlabs.com

Contact: Andrew Simpson, Chairman or
Mark Hilz, CEO
+1 682-237-7781
contact@htlabs.com

Heart Test Labs Announces the Appointment of Mr. Joe Schwoebel as Vice President, Clinical and Regulatory Affairs

Heart Test Labs Announces the Appointment of Mr. Joe Schwoebel as Vice President, Clinical and Regulatory Affairs

 

April 19, 2017- Westlake, TX—Heart Test Laboratories Inc., announced today the appointment of Mr. Joe Schwoebel as Vice President of Clinical and Regulatory Affairs.  Mr. Schwoebel has over 30 years’ experience in medical device clinical studies, regulatory affairs and quality assurance with several companies, including firms that range from large multinational to startups.

 

“We are very fortunate to have someone with Joe’s experience, capability and track record of success in this key role at Heart Test Labs," said Mark Hilz, President and CEO. "Joe is a key addition to our team and will play a pivotal role in advancing our innovative product, The MyoVista®, through clinical and regulatory processes.”

 

Mr. Schwoebel has substantial experience with cardiovascular products, comprising an ideal fit with the product focus of Heart Test Laboratories. He has previously worked at 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.

 

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. He has also organized and completed 12 IDEs leading to market release of medical devices in the United States, European Union, and other major markets.

 

Joe is an active member of RAPS, SEMDA, and has participated on various committees of AdvaMed located in Washington, DC.

 

 

About Heart Test Laboratories, Inc. (“HTL”)

Using patented proprietary technology, HTL develops medical devices that focus on the early detection of heart disease. MyoVista’s innovative technology facilitates the early identification of ischemic and other heart myocardial dysfunctions, which can enable improved screening for coronary arterial disease and other cardiac abnormalities. MyoVista® uses standard 12-lead resting ECG protocols to provide a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics to assist a physician in identifying the presence of heart disease. MyoVista® is ideally suited for use in both primary care and hospital environments, and has a 15.6-inch high-resolution touchscreen and incorporates many user features and functionality commonly associated with a tablet device, which makes it intuitive and easy to use, thereby reducing training time.
Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. MyoVista® helps to bridge the “diagnostic gap” in heart disease today, which is the identification of patients prior to an adverse cardiac event, such as a heart attack.

Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information, visit www.hearttestlabs.com

 

Contact: Mark Hilz, CEO
+1 682-237-7781
contact@hearttestlabs.com

 

Heart Test Laboratories Completes $12 Million Private Placement Funding

January 25, 2017 - WESTLAKE, Texas -- Heart Test Laboratories, Inc. (“HTL”) has successfully raised $12 million by way of a Common Stock private placement offering. The offering was significantly over-subscribed and provides HTL with a strong financial base entering into 2017. The company expects to commence the international launch of its MyoVista product in the first quarter. Prior to this latest funding round, HTL had previously raised over $21 million in funding. The latest round will fund sales launch, operations and further clinical work. HTL is in the process of hiring sales staff as it prepares for the launch of its MyoVista product.

The MyoVista is a technologically advanced medical (electrocardiography) device that uses proprietary technology to assist in the early detection of heart disease. It uses standard 12-lead resting ECG protocols to provide both a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics that facilitate the early identification of ischemic and other myocardial dysfunctions.

About Heart Test Laboratories, Inc. (“HTL”)
HTL develops medical devices using patented proprietary technology that focus on the early detection of heart disease. MyoVista’s innovative technology facilitates the early identification of ischemic and other heart myocardial dysfunctions, which can enable improved screening for coronary arterial disease and other cardiac abnormalities. MyoVista® uses standard 12-lead resting ECG protocols to provide both a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics to assist a physician in identifying the presence of heart disease. MyoVista® is ideally suited for use in both primary care and hospital environments, and has a 15.6-inch high-resolution touchscreen and incorporates many user features and functionality commonly associated with a tablet device, which makes it intuitive and easy to use, thereby reducing training time.

Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. MyoVista® helps to bridge the “diagnostic gap” in heart disease today, which is the identification of patients prior to an adverse cardiac event, such as a heart attack.

Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information, visit www.hearttestlabs.com

Contacts
Heart Test Laboratories, Inc.
Andrew Simpson, +1 682-237-7781
Executive Chairman
asimpson@htlabs.com
or
Mark Hilz, +1 682-237-7781
CEO
mhilz@htlabs.com

Heart Test Labs Appoints Industry Veteran Brian Allen as it Prepares for Commercial Launch of its MyoVista Medical Device

October 27, 2016- Westlake, TX—Heart Test Laboratories Inc., announced today the appointment of Brian L. Allen as Senior Vice President of Business Development. In this role, Mr. Allen will lead the company’s commercial launch of its MyoVista electrocardiographic device. He will be responsible for building the sales team and distribution partners on a global basis. Mr. Allen joins the senior executive team and will report directly to Mark Hilz, Heart Test Laboratories’ Chief Executive Officer.

Mr. Allen has 20 plus years of medical device experience that includes an accomplished track record of multiple first-to-market medical device innovations by developing strategies and building successful sales teams that achieved successful market adoption. Mr. Allen joins Heart Test Laboratories as it is preparing for commercialization after having recently submitted a 510k application to the FDA and CE Mark technical file for approval. “We are excited to have an executive of Brian’s caliber and experience leading our commercialization efforts. Brian brings to Heart Test Laboratories a strong track record of developing and executing multiple successful commercialization efforts in the medical device market.” said Hilz.

Recently, Mr. Allen served as Vice President of Sales and Commercial Marketing for OrthoSensor Inc., where he led the planning and successful launch of their global sales and market expansion through distribution partners. Prior to that, he led the company’s domestic sales strategy, and was responsible for launch which included sales, marketing and market education of VERASENSE; the orthopedic industry’s first Sensor-assisted technology used in Total Knee Replacement Surgery

Before joining OrthoSensor, Brian served as Director of Sales and Marketing for MAKO Surgical Corp. responsible for planning and executing the commercial market launch and sustainable growth of the orthopedic industry’s first Robotic-assisted Surgery system and novel implants. MAKO Surgical Corp. was acquired by Stryker Inc. for $1.65B (2013)

Early in his career, Brian held various progressive sales and leadership roles at Medtronic Neurological and Coronary Vascular business units, Zimmer Inc. and Burrows Inc., which subsequently was acquired by Owens and Minor, Inc.

“Meaningful innovation that has the potential to improve clinical care, reduce care-pathway costs and significantly enhance and extend the quality of life of patients, inspires and excites me. MyoVista® is poised to transform the early detection of heart disease and establish a new benchmark for heart disease screening.” stated Mr. Allen

The search was conducted for Heart Test Labs by Paula Rutledge of Legacy MedSearch.

About Heart Test Laboratories, Inc. (“HTL”)

HTL develops medical devices using patented proprietary technology that focus on the early detection of heart disease. MyoVista’s innovative technology facilitates the early identification of ischemic and other heart myocardial dysfunctions, which can enable improved screening for coronary arterial disease and other cardiac abnormalities. MyoVista® uses standard 12-lead resting ECG protocols to provide a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics to assist a physician in identifying the presence of heart disease. MyoVista® is ideally suited for use in both primary care and hospital environments, and has a 15.6-inch high-resolution touchscreen and incorporates many user features and functionality commonly associated with a tablet device, which makes it intuitive and easy to use, thereby reducing training time.

Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. MyoVista® helps to bridge the “diagnostic gap” in heart disease today, which is the identification of patients prior to an adverse cardiac event, such as a heart attack.
Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information, visit www.hearttestlabs.com

Contact: Mark Hilz, CEO
+1 682-237-7781
markhilz@hearttestlabs.com

Heart Test Labs Achieves ISO 13485 Certification

Westlake, TX. – Heart Test Laboratories, Inc. has achieved ISO 13485:2003/NS- EN ISO 13485:2012 certification for its quality management systems. The certification includes activities related to the design and development, manufacturing, distribution and servicing of active non-invasive electrocardiographic devices for screening for a variety of cardiac abnormalities and disease.

Click to learn more HERE

LA BioMed to Begin Clinical Study to Evaluate Heart Test Laboratories’ MyoVista® Heart Screening Device.

Clinical study will evaluate HTL’s Next Generation ECG technology designed to enable low cost screening for Heart Disease

Westlake, TX, December 10, 2015 – Heart Test Laboratories, Inc. (HTL) announces the start of a clinical study of its MyoVista device by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed). This study will compare the results of the MyoVista test to an established testing method, Cardiac Computed Tomography Angiography (CCTA). Dr. Matthew Budoff is the principal investigator. The study will compare MyoVista results to subclinical measures of atherosclerosis (CAC and CT angiography) in 200 subjects at risk for coronary disease.  Correlations between the MyoVista reading and the presence of calcified plaque, soft plaque, and CTA stenosis will be determined.  The study is expected to last between 6 months to 1 year.

This study has the potential to confirm MyoVista as a reliable and sensitive marker of atherosclerosis. Findings may provide a strong indication for the value of a MyoVista test to confirm Coronary Artery Disease (CAD) in clinical practice, and for the clinical application of MyoVista in management of coronary disease and atherosclerosis.

Background

In 2010, nearly 800,000 Americans died of cardiovascular, cerebrovascular, or renal disease. Over 120 million Americans are affected by some type of circulatory disease whether heart disease, hypertension, or stroke. However, in the USA, there are few validated commercially available, non-invasive, and accurate techniques to assess cardiac disease. With the exception of blood pressure and Framingham risk markers, all other measurements currently require costly and specialized equipment. However, the MyoVista a new non-invasive device, is now available for clinical study.

Furthermore, and importantly, in addition to identifying which patients might progress to later stages of disease, the earlier detection may also allow the device to be used to assess therapeutic progress.

A novel electrocardiographic recording method, the MyoVista obtains and processes signal information in a way that permits high resolution of the electrical activity associated with the myocardium. The clinical set up of this technique is identical to traditional 12-lead ECG, however, the recording is focused on the early detection of myocardial abnormalities by non-linear analysis of electrophysiological phenomenon propagated by changes of cellular metabolism level in the cardiac muscle, and the direction, timing and velocity of ion flow. This novel assessment may be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases, and may be especially of value in patients at risk for coronary artery disease.

About LA BioMed

Founded in 1952, LA BioMed is one of the country's leading nonprofit independent biomedical research institutes. It has approximately 100 principal researchers conducting studies into improved diagnostics and treatments for cancer, inherited diseases, infectious diseases, illnesses caused by environmental factors and more. It also educates young scientists and provides community services, including prenatal counseling and childhood nutrition programs. LA BioMed is academically affiliated with the David Geffen School of Medicine at UCLA and located on the campus of Harbor-UCLA Medical Center. For more information, please visit www.LABioMed.org

About Dr. Budoff

Dr. Matthew Budoff is a fellow of the American College of Cardiology and the American Heart Association, the president of the Society of Cardiovascular Computed Tomography, the principal investigator at the Los Angeles Biomedical Research Institute at Harbor- UCLA Medical Center and the author of more than 300 articles and four textbooks.

About Heart Test Laboratories, Inc. (“HTL”)

HTL develops medical devices using patented technology that focus on the early detection of heart disease. The MyoVista’s innovative technology facilitates the early identification of ischemic and other heart abnormalities which can enable improved screening for coronary arterial disease and other cardiac abnormalities.

The MyoVista provides two tests in one and is easy for physicians to administer and interpret. By using standard 12-lead resting ECG protocols, the MyoVista provides an ECG test incorporating interpretive analysis, plus easy to understand proprietary informatics that assist a physician in identifying heart disease at an early stage.  The MyoVista provides additional information to physicians in their decision process to refer patients to a cardiologist for further diagnostic testing and treatment.

The MyoVista has a 15.6 inch high resolution touchscreen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use thereby reducing training time. Its proprietary informatics provide information to physicians that suggest ischemic and certain types of structural heart abnormalities. The MyoVista is ideally suited for use in both primary care and hospital environments.

Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. The MyoVista helps to address the “diagnostic gap” in heart disease today, which is the identification of asymptomatic patients prior to an adverse cardiac event, such as a heart attack.

HTL expects to seek FDA clearance for the MyoVista in the near future. Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information visit hearttestlabs.com.

 

 

Contact:           Mark Hilz, CEO

+1 682-237-7781

markhilz@hearttestlabs.com

Mount Sinai Initiates Clinical Study to Evaluate Heart Test Laboratories’ MyoVista® Heart Screening Device

Clinical study will evaluate HTL’s innovative technology that enables low cost screening for Heart Disease

Westlake, TX, December 3, 2015 – Heart Test Laboratories, Inc. (HTL) announces that a clinical study initiated by Mount Sinai Medical Center, New York examining the MyoVista heart screening device has commenced.  The clinical study is designed to further evaluate the MyoVista, which incorporates HTL’s patented technology for the early detection of heart disease.  The study will assess the MyoVista indications for the identification of coronary arterial disease (CAD) as compared to computed tomographic coronary angiography (CTA) and myocardial dysfunction in patients without CAD as compared to echocardiography.

The lead investigator is Dr. Partho Sengupta, the Director of Cardiac Ultrasound Research and Core Lab, and an Associate Professor of Medicine in Cardiology at Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health. The clinical study is expected to enroll 200 patients and take between 12-24 months to complete.  Mount Sinai is ranked as a top 10 hospital for cardiology by U.S. News’ 2015 annual survey.

Heart Disease is the leading cause of death in the U.S., being responsible for 1 in every 4 deaths (approx. 600,000 per year U.S.). It is the leading cause of deaths worldwide, more than all cancers combined and is the largest spend area in healthcare.  Heart disease is known as the silent killer, because most affected people do not know they have it (i.e. they are asymptomatic), more than half of patients find out through an adverse event (angina, heart attack or even death).

The “diagnostic gap” in heart disease today is non-invasive, low cost screening to identify asymptomatic patients before an adverse event occurs.  Existing ECG technology is generally not considered effective for use on asymptomatic patients. The U.S. Preventive Services Taskforce and other healthcare bodies around the world recommend against screening with resting or exercise electrocardiography (ECG) for the prediction of coronary heart disease (CHD) events in asymptomatic adults at low risk for CHD events.

HTL believes the MyoVista will provide the opportunity for effective, low cost testing for heart disease in primary care. This would enable physicians to have a valuable additional tool to assist in the process of determining referrals to a cardiologist.

“We are excited that Mount Sinai has decided to initiate an important clinical study of the MyoVista. Mount Sinai is one of the most respected medical institutions in the world and has a strong reputation for research along with being recognized as a center of excellence in cardiology.  Our goal is to save lives and save healthcare dollars by both finding people with heart disease much earlier, and reducing expensive cardiac testing on people that do not require treatment.” stated Mark Hilz, Heart Test Laboratories' CEO.

About Heart Test Laboratories, Inc. (“HTL”)

HTL develops medical devices using patented technology that focus on the early detection of heart disease. The MyoVista’s innovative technology facilitates the early identification of ischemic and other heart abnormalities which can enable improved screening for coronary arterial disease and other cardiac abnormalities.

The MyoVista provides two tests in one and is easy for physicians to use. By using standard 12-lead resting ECG protocols, the MyoVista provides an ECG test incorporating interpretive analysis, as well as easy to understand proprietary informatics that assist a physician in identifying heart disease at an early stage.  The MyoVista provides additional information to physicians in their decision process to refer patients to a cardiologist for further diagnostic testing and treatment.

The MyoVista has a 15.6 inch high resolution touchscreen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use, thereby reducing training time. Its proprietary informatics provide information to physicians that suggest ischemic and certain types of structural heart abnormalities. The MyoVista is ideally suited for use in both primary care and hospital environments.

Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. The MyoVista helps to address the “diagnostic gap” in heart disease today, which is the identification of asymptomatic patients prior to an adverse cardiac event, such as a heart attack.

HTL expects to seek FDA clearance for the MyoVista in the near future. Heart Test Laboratories is a privately held U.S. corporation which to date has been funded by private investors. For more information visit hearttestlabs.com.

Contact:       Mark Hilz, CEO

+1 682-237-7781

markhilz@hearttestlabs.com

Heart Test Laboratories Stock Offering to Close December 12, 2014

Dallas --Heart Test Laboratories, Inc. (HTL), confirms that its Private Placement Stock Offering (“Offering”) will close on Friday December 12, 2014 as scheduled in its Offering document. The Offering will remain open to investors until that time.

The Offering is available to accredited and institutional investors. A number of investors have already subscribed to and funded the Offering. Remaining subscriptions must be made prior to the last dates set out in the timetable below. The Company does not intend to extend the Offering beyond December 12, 2014. All funds are held in an independent bank administered escrow account in accordance with the terms set out in the Offering document.

The Company continues to make strong progress and is on track to commence sale of the MyoVista™ in September, 2015 in accordance with its forecasts. The MyoVista™ is HTL’s proprietary medical device which enables the early detection of heart disease at low cost in a 10 minute non-invasive test.

Timetable for further subscriptions

5.00p.m (US Central Time) Thursday December 11th, 2014:
Latest time for completed subscriptions documents to be received by HTL
3.00p.m (US Central Time) Friday December 12th, 2014: Latest time for funds to be received into the bank escrow account

Contact information to participate in the Offering

Copies of the Offering document and subscriptions documents are available on request from Paul Klotz at HTL (paulklotz@hearttestlabs.com) or telephone +1 682 237 7781.

About Heart Test Laboratories

HTL is a US based medical technology company founded in 2008 to develop and exploit the MyoVista™ which for the first time will enable effective wide scale screening for heart disease.

The MyoVista™ is a patented technology breakthrough medical device that offers significant advantages in the early identification of ischemic and other heart abnormalities. It is a portable, affordable, device that is simple to use and very easy for a primary care physician to interpret. The MyoVista™ provides a 10 minute, at rest, noninvasive electrophysiology based device and is therefore significantly more cost-effective than other tests such as a CT scan, Nuclear Stress Test or Coronary Angiogram. It identifies myocardial abnormalities, ischemia and heart disease at an early stage.

HTL has benefited from 10 years and $10 million of R&D including clinical studies and field testing. The MyoVista is now fully developed and funding under the Offering is for sales and manufacture of the device and to expand the Company. Heart Disease is the biggest killer in the world. The MyoVista sits at the forefront of technology change. Its technology dramatically improves the sensitivity and accuracy of information about the heart using electrophysiology. Such technology will be highly sought after and become a global standard of care in non-invasive testing for heart disease at an early stage.

Contact:
Paul Klotz
paulklotz@hearttestlabs.com
682-237-7781
www.hearttestlabs.com