Mr. Hugh MacNaught reports
VENTRIPOINT'S VMS+ 4.0 SUBMITTED FOR REGULATORY APPROVAL IN CHINA BY LISHMAN GLOBAL INC.
Ventripoint Diagnostics Ltd.'s strategic partner, Lishman Global Inc., has formally submitted Ventripoint's VMS+ 4.0 system to China's National Medical Products Administration, commonly referred to as the Chinese Food and Drug Administration, for regulatory approval.
Importantly, Lishman Global has qualified for the NMPA's green channel pathway, an expedited review process designed to accelerate the approval of innovative medical technologies that address significant clinical needs. This designation is expected to streamline the regulatory timeline and facilitate faster access to the Chinese market.
This submission represents a significant milestone in Ventripoint's global expansion strategy and reflects growing demand for advanced, accessible cardiac imaging solutions in one of the world's largest health care markets.
China represents a substantial and rapidly growing opportunity in cardiology. Cardiovascular disease remains the leading cause of mortality in the country, with an estimated 330 million patients affected. At the same time, echocardiography is the most widely used cardiac imaging modality in China due to its cost-effectiveness, portability and scalability across urban and rural health care settings. However, variability in image interpretation and limited access to advanced imaging modalities such as MRI have created a strong need for artificial-intelligence-driven tools that can improve diagnostic accuracy and workflow efficiency.
Ventripoint's VMS+ 4.0 addresses this need by providing MRI-equivalent volumetric measurements using standard 2-D echocardiography. Powered by the company's proprietary knowledge-based reconstruction technology, the platform enables clinicians to assess all four chambers of the heart with high accuracy, supporting diagnosis and management of conditions such as congenital heart defects, heart failure, pulmonary hypertension, cardiotoxicity and valvular disease.
"We are excited to take this important step toward bringing VMS+ 4.0 to the Chinese market," said Paul Gibson, chief technology officer of Lishman Global. "Qualification for the NMPA's green channel underscores the clinical relevance and innovation of VMS+ 4.0 and provides a clear pathway to accelerated adoption. China's scale, combined with its increasing focus on improving cardiovascular outcomes, makes it an ideal environment for this technology."
"Hitting this regulatory milestone with Lishman Global is a key validation of both our technology and our international strategy," said Hugh MacNaught, president and chief executive officer of Ventripoint Diagnostics. "China is one of the most important cardiac care markets in the world. With the benefit of an expedited review pathway, we are well positioned to bring VMS+ 4.0 to clinicians and patients more quickly. By enabling more accurate and reproducible cardiac measurements using existing ultrasound infrastructure, VMS+ has the potential to significantly expand access to high-quality cardiac care."
The company will provide further updates as the regulatory review process progresses.
About Ventripoint Diagnostics Ltd.
Ventripoint is an industry leader in the application of artificial intelligence to echocardiography. Ventripoint's VMS+ products are powered by its proprietary knowledge-based reconstruction technology, which is the result of a decade of development and provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold standard alternative allows cardiologists greater confidence in the management of their patients. Providing better care to patients serves as a springboard and basic standard for all of Ventripoint's products that guide its future developments. In addition, VMS+ is versatile and can be used with all ultrasound systems from any vendor supported by regulatory market approvals in the United States, Europe and Canada.
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