Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device.

This submission marks a major milestone in the Company’s mission to redefine safe, efficient and reproducible left-atrium access for structural heart interventions.

Key Highlights

• The Protaryx Transseptal Puncture Device is designed to provide zero-exchange delivery of left-atrial therapy devices, improving workflow efficiency.
• The technology features a highly echogenic, extendable atraumatic positioning probe combined with a standardized RF guidewire compatible with commercially available electrosurgical generators, enabling enhanced visualization, precision and operator ease-of-use.
• The Company’s first-in-human (FIH) study, conducted on December 3, 2024, in Asunción, Paraguay (five patients), achieved all procedural success endpoints, no adverse events, substantially reduced fluoroscopic exposure and rapid patient discharge.
• With the 510(k) submission, Protaryx is now advancing toward U.S. regulatory clearance and the commercial launch of its device, opening a pathway to broaden access to left-heart therapies and improve patient care.

Company Commentary

“Achieving 510(k) submission is a pivotal milestone for Protaryx,” said David Mester, Chief Executive Officer of Protaryx. “Our team has worked with laser focus to solve one of the core workflow and ease-of-use challenges in structural heart procedures: transseptal puncture and left-atrial access. This submission brings us one step closer to offering a solution that enables physicians of all experience levels to operate with greater precision, less fluoroscopy, and a faster learning curve.”

Protaryx co-founder and System Chief of Cardiac Surgery at Johns Hopkins Health System, Dr. James Gammie added: “The results from the FIH study show that this device not only meets unmet needs in transseptal access but has the potential to set a new standard for safety, ease-of-use, and efficiency in left-heart interventions.”

About Protaryx Medical

Protaryx Medical is a Baltimore-based medical device company committed to developing next-generation transseptal puncture device for structural heart interventions. The Company’s differentiated Transseptal Puncture Device is engineered to streamline left-atrial access with a zero-exchange delivery platform, high-visibility echogenic probe, and RF guidewire compatibility with existing electrosurgical systems.

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 Protaryx’s expectations for regulatory clearance by the U.S. Food & Drug Administration, the timing of commercialization, and the potential market impact of the Transseptal Puncture Device. Actual results may differ materially from those projected or implied. Readers are urged to carefully consider the risks, uncertainties and other factors. The Company undertakes no obligation to update forward-looking statements to reflect on subsequent events or circumstances.

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Protaryx Medical is a Baltimore-based medical device company committed to developing next-generation transseptal puncture devices for structural heart interventions.