HANGZHOU, China, Dec. 16, 2025 -- Enginprime Medical Inc ("Enginprime"), an emerging leader in percutaneous ventricular assist device (pVAD) technologies and a Voyagers Capital portfolio company, today announced that its industry leading pVAD, OpusOne™, has entered its first-in-human clinical study at The Second Affiliated Hospital, School of Medicine, Zhejiang University ("SAHZU"). This milestone marks the first clinical evaluation of the device's safety and performance in patients.

PVAD supports the cardiac output via a percutaneously implanted pump, reduces the load of left ventricle, relieves heart failure symptoms, and bridges to transplantation or recovery. It also delivers temporary hemodynamic support during Complex Higher-risk Indicated Patients Percutaneous Coronary Intervention (CHIP PCI) procedures by augmenting cardiac output, preserving organ perfusion, and stabilizing hemodynamics for safe intervention. While over 60,000 pVAD procedures are performed globally each year, no pVAD product has been approved in China yet, underscoring the significant unmet medical need.

OpusOne™ features an ultra-low profile down to 8F, external durable motor placement, and an all-new design of foldable, self-expanding impeller, capable of delivering 4–5 L/min of average flow with peak flows exceeding 7 L/min. Notably, this ultra-compact device integrates invasive blood pressure monitoring and patented perfusion purification system, enabling migration detection alerts while preventing wear particles from entering the patient's body. With high durability, enhanced reliability, OpusOne™ simplifies clinical procedures, improves patient accessibility, and emerges as a highly competitive pVAD - rivaling Abiomed's Impella, Magenta's Elevate, and Supira's pVAD systems.

"Enginprime's OpusOne^TM exemplified a promising approach to temporary ventricular support—especially for high-risk patients who can benefit from enhanced hemodynamic stability. Co-developed by the interventional cardiologists and Enginprime, this promising solution is tailored to address unmet clinical needs." said the study's lead investigator Jian'an Wang, MD,PhD, Director of the Cardiac Center at SAHZU. "I am impressed by its ability to achieve high flow with such a low-profile design. OpusOne^TM's optimization of access and positioning options increases procedural safety."

Co-investigator of the study, Jun Jiang, MD, PhD, Executive Associate Director of the Department of Cardiology at SAHZU added, "We are pleased to perform the first procedure with OpusOne^TM, seeing the patient's chest tightness was significantly alleviated. Its robust initial performance marks a meaningful advancement in circulatory support and great potential for expanding patient eligibility."

"The development of OpusOne^TM reflects our mission to bring globally competitive, exceptional performance and high reliability, cost-effective next-generation circulatory support products to patients who need them most," said the CEO of Enginprime. "We look forward to advancing this innovative device rapidly through further clinical validations."

About Enginprime Medical Inc.

Enginprime was established in 2023 and incubated under majority ownership by Voyagers Capital, leveraging cross-disciplinary engineering capabilities, systems integration expertise, and advanced manufacturing methodologies. OpusOne™ is the company's first flagship medical device platform and reflects Voyagers' long-term commitment to supporting breakthrough healthcare technologies.

About Voyagers Capital

Voyagers Capital is a leading healthcare venture capital firm focused on investing in groundbreaking biotech and medtech innovation. By leveraging our expertise and network, we partner with visionary entrepreneurs to bring transformative solutions to the global market.

OpusOne™ is an investigational device, not yet approved for commercial use.

For more information, please contact:
media@enginprime.com; info@voyagerscap.com.