Myocardial Solutions Raises $6.7M to Advance Cardiac MRI Analysis Software MyoStrain

On December 29, 2018, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Myocardial Solutions, a software development company specializing in cardiology, had raised $6.7 million from 22 investors through a stock offering launched in mid-December.

Myocardial Solutions, founded in 2002, aims to drive the future of preventive and personalized cardiac care through innovative diagnostic technologies. The company states that its core MRI technology was co-developed with Johns Hopkins University in the United States. Through continuous technological advancement, Myocardial Solutions has produced innovative healthcare software focused on cardiac magnetic resonance image analysis.

The software, named MyoStrain, primarily provides physicians with a window into patient cardiac function by measuring myocardial strain. MyoStrain generates reports based on magnetic resonance imaging (MRI), providing measurements of ejection fraction, mass, and volume. Additionally, MyoStrain identifies regions for strain measurement, assessing 37 segments of left ventricular function.

It is understood that MyoStrain is primarily used to help identify patients with asymptomatic manifestations of cardiac dysfunction. It mainly includes the following three aspects:

MyoStrain typically detects cardiac dysfunction before a decline in ejection fraction. Strain measurement is a superior marker of cardiac dysfunction compared to ejection fraction, enabling proactive intervention through early detection and identification of potential problem areas for aggressive treatment, thereby improving outcomes.

Conventional cardiac monitoring and treatment fail to detect subtle changes in cardiac function. MyoStrain provides quantitative feedback for personalized therapy by measuring temporal variations in cardiac performance. Furthermore, the actionable data delivered by MyoStrain over time enables clinicians to assess these changes and enhances their ability to make optimal treatment decisions.

Most cardiac catheterizations performed due to poor diagnosis are unnecessary. MyoStrain, characterized by its high speed, accuracy, safety, and ease of use, leverages its diagnostic precision and efficiency to improve decision-making and patient experience, reduce unnecessary procedures, and ultimately lower healthcare costs. Notably, through near real-time processing, MyoStrain generates comprehensive, quantifiable stress test reports that display changes in cardiac function, enabling the identification of potential ischemia and other conditions.

MyoStrain’s technology is used in over 70 major medical research centers worldwide and has been established as the “gold standard” for strain measurement. Studies utilizing this technology have resulted in more than 250 publications in peer-reviewed journals, including 50 articles in Circulation and JACC alone. MyoStrain’s predecessor software (HARP & VIRTUE) holds FDA 510(k) clearance and European CE marking certification.

Currently, MyoStrain has obtained CE marking certification in the European Union, and the company is working towards securing FDA 510(k) clearance.

The FDA, short for the Food and Drug Administration, is authorized by the U.S. Congress (the federal government) and falls under the jurisdiction of the Department of Health and Human Services. It is a government regulatory agency tasked with protecting, promoting, and advancing public health, with its headquarters located in Rockville, Maryland.

To market medical devices in the United States, manufacturers must undergo one of two evaluation processes: the 510(k) premarket notification or Premarket Approval (PMA). Most medical devices commercially distributed in the United States are cleared through the 510(k) premarket notification pathway.

The CE mark is a safety certification mark regarded as the passport for manufacturers to access and enter the European market. CE stands for Conformité Européenne (European Conformity). In the EU market, the CE mark is a mandatory certification mark. Whether products are manufactured by companies within the EU or in other countries, they must bear the CE mark to circulate freely in the EU market, indicating that the products comply with the essential requirements of the EU’s New Approach to Technical Harmonization and Standardization directives. This constitutes a mandatory legal requirement imposed by the EU on products.