Ventripoint Diagnostics Ltd. (TSX-V:VPT, OTC:VPTDF) announced that its strategic partner, Lishman Global Inc., has formally submitted the company's VMS+™ 4.0 system to China's National Medical Products Administration (NMPA) for regulatory approval. The submission has qualified for the NMPA's green channel pathway, an expedited review process designed for innovative medical technologies addressing significant clinical needs.
This development represents a major step in Ventripoint's global expansion strategy. China, with an estimated 330 million patients affected by cardiovascular disease, is one of the world's largest and fastest-growing cardiology markets. Echocardiography is the most widely used cardiac imaging modality in the country due to its cost-effectiveness and scalability, but variability in image interpretation and limited access to advanced modalities like MRI have created a strong demand for AI-driven solutions.
Ventripoint's VMS+™ 4.0 addresses this need by providing MRI-equivalent volumetric measurements using standard 2D 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 Inc. "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."
Hugh MacNaught, President and CEO of Ventripoint Diagnostics, added, "Hitting this regulatory milestone with Lishman Global is a key validation of both our technology and our international strategy. 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."
The green channel pathway is expected to streamline the regulatory timeline and facilitate faster access to the Chinese market. Ventripoint's VMS+™ products are already supported by regulatory approvals in the U.S., Europe, and Canada, and are compatible with all ultrasound systems from any vendor.
Lishman Global, established in 2012, assists foreign companies in navigating China's complex regulatory approvals and distribution channels. The partnership model allows Ventripoint to leverage Lishman's expertise in the Chinese medical device market.
The company will provide further updates as the regulatory review process progresses.
