Mendaera Announces World’s First Procedures with Focalist™ Handheld Robotic System

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SAN MATEO, Calif.--(BUSINESS WIRE)--Sep 11, 2025--

Mendaera™, Inc., a healthcare technology company developing next-generation robotics technology to simplify ultrasound-guided needle procedures, today announced the world’s first procedures performed with the Focalist™ handheld robotic system. Urologist Karen Stern, M.D., (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Dr. Stern presented the milestone procedures at the World Conference on Endourology and Uro-Technology (WCET), a prestigious global meeting for surgeons advancing minimally invasive kidney stone treatment.

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Focalist™ Handheld Robotic System

PCNL begins with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This critical first step requires extreme precision to avoid surrounding organs and to enable optimal and effective stone clearance. Using Focalist, Dr. Stern and her team achieved rapid, efficient, and precise first-pass needle placement into the ideal kidney location.

“I was thrilled to be the first in the world to use the Focalist System,” said Dr. Stern. “I found it intuitive to learn and easy to integrate into my workflow. Focalist enhances needle control and simplifies precise placement under ultrasound, particularly for operators with less experience. It has the potential to build confidence in ultrasound-guided access and lower the barrier to proficiency across providers with varying levels of experience.”

The Focalist™ System combines handheld robotics, real-time ultrasound, and advanced software to enable precise, repeatable instrument placement. These first-in-the-world procedures mark the beginning of the limited U.S. launch of Focalist in urology, with expansion to additional specialties planned in 2026.

“These first procedures underscore Focalist’s ability to deliver highly precise, consistent needle placement - a foundational requirement across all of medicine,” said Josh DeFonzo, co-founder and CEO of Mendaera. “We’re proud to partner with Dr. Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more healthcare providers to perform procedures with confidence. This milestone brings us closer to our mission of broadening access to minimally invasive procedures and elevating standards across the healthcare system.”

The recorded case presentation by Dr. Stern will be available in the coming weeks on the WCET website.

About Mendaera

Mendaera is building a new category of handheld robotics designed to make precision more accessible across healthcare. With its Focalist™ System, combining real-time imaging with intuitive handheld robotic control, Mendaera supports clinicians in delivering consistent, high-quality care across a broad range of minimally invasive procedures and settings. Based in Silicon Valley, CA, the company is backed by leading investors and a leadership team with a track record of successful outcomes, including Auris Health.

Mendaera’s Focalist™ System has FDA clearance in the U.S. to provide guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and resulting image during diagnostic or therapeutic procedures. The system is intended for use with pediatric and adult patients. Learn more at Mendaera.com.

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CONTACT: Michelle Stevens

[email protected]

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: TECHNOLOGY MEDICAL DEVICES SURGERY HOSPITALS FDA HEALTH TECHNOLOGY SOFTWARE GENERAL HEALTH ROBOTICS HEALTH

SOURCE: Mendaera, Inc.

Copyright Business Wire 2025.

PUB: 09/11/2025 08:00 AM/DISC: 09/11/2025 07:59 AM

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