Protaryx Medical, an innovative medical device company developing differentiated access solutions for minimally invasive left-heart procedures, today announced the successful completion of the first U.S. commercial cases using its FDA-cleared Protaryx Transseptal Puncture Device.

The procedures were performed at UC Davis Health in Sacramento, California, by interventional cardiologist Gagan D. Singh, M.D. The first two commercial cases were performed during left atrial appendage closure (LAAC) procedures and successfully achieved transseptal crossing on the first attempt.

The milestone marks the beginning of U.S. commercial use of the Protaryx Transseptal Puncture Device following FDA 510(k) clearance earlier this year.

The Protaryx system was developed to provide physicians with a fundamentally different approach to transseptal access. Its highly echogenic, extendable atraumatic EchoTip is designed to enable direct visualization and precise positioning while reducing dependence on fluoroscopy. The system combines this highly echogenic positioning capability with RF-assisted crossing and a zero-exchange design intended to simplify and streamline left-heart access.

“These first commercial procedures provided an opportunity to evaluate the Protaryx device in routine clinical practice,” said Dr. Gagan Singh of UC Davis Health. “The device was clearly visible under echocardiography and allowed us to assess the fossa and perform transseptal access without rewiring. We successfully completed both procedures and will continue to evaluate the technology as we gain additional clinical experience.”

Protaryx expressed its appreciation to Dr. Singh and the entire physician, nursing, technologist and clinical staff at UC Davis Health whose preparation and support helped make the first commercial cases possible.

“Innovation isn’t another version of the same idea,” said David Mester, Chief Executive Officer of Protaryx Medical. “We didn’t build Protaryx to be a me-too device. We built it because we believed transseptal access deserved a fundamentally different approach. These first commercial cases allowed us to see that approach translate from design intent into real-world clinical use. Sometimes true innovation is difficult to appreciate in a drawing or specification; you have to see it in the hands of a physician. We believe Protaryx provides a meaningful difference in how physicians can approach left-heart access.”

Mester continued, “Reaching this milestone is also the culmination of years of work by the Protaryx team, our clinical collaborators and everyone who has supported the development of this technology. We are especially grateful to Dr. Singh and the entire team at UC Davis Health for their confidence, professionalism and commitment to advancing patient care.”

About the Protaryx Transseptal Puncture Device

The Protaryx Transseptal Puncture Device is a next-generation system designed to facilitate transseptal access to the left atrium for catheter-based cardiac procedures. The system incorporates a highly echogenic, extendable atraumatic EchoTip designed to facilitate visualization, septal navigation and site-specific positioning prior to puncture. RF-assisted crossing is performed using a guidewire compatible with commercially available electrosurgical generators, while the system’s zero-exchange design is intended to streamline the transition from transseptal puncture to left-heart intervention.

The Protaryx Transseptal Puncture Device received U.S. FDA 510(k) clearance in April 2026.

About Protaryx Medical

Protaryx Medical is a Baltimore-based medical device company dedicated to advancing transseptal access for minimally invasive cardiac interventions. The Company’s proprietary Transseptal Puncture Device was developed to provide physicians with a differentiated approach to left-heart access through enhanced visualization, atraumatic positioning, site-specific puncture and a streamlined procedural workflow.

For more information, please visit www.Protaryx.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding commercialization, clinical adoption and the potential benefits of the Protaryx Transseptal Puncture Device. Actual results may differ materially from those projected or implied. The Company undertakes no obligation to update forward-looking statements to reflect subsequent events or circumstances.

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