The innovative cardiac device shows promise in enhancing patient safety and procedural efficiency. The five-patient trial of the Protaryx’s TSP device took place at Sanatorio Italiano hospital in Paraguay

ASUNCIÓN, PARAGUAY, December 4, 2024 -- Protaryx Medical, a leading innovator in cardiac intervention technologies, has completed its first-in-human trial of a revolutionary transseptal puncture device at Sanatorio Italiano hospital in Asunción, Paraguay. The five-patient study, conducted on December 3rd, marks a significant milestone in advancing cardiac care and solidifies Latin America's growing role as a hub for cutting-edge medical device trials.

Approved by the Research Ethics Committee of the Paraguayan Institute of Social Studies, the trial achieved all procedural success endpoints with zero reported adverse events. Dr. Adrian Ebner, head of the cardiovascular department at Sanatorio Italiano, performed the procedures with Dr. Gagan Singh, an interventional cardiologist from UC Davis Health in Sacramento.

"This successful trial represents a leap forward in transseptal puncture procedures," said Dr. Ebner. "The device's superior echogenicity allowed for rapid and targeted punctures while significantly reducing our reliance on fluoroscopy. This not only enhances precision but also improves safety for both patients and medical staff."

Key highlights of the Protaryx transseptal puncture device include:

• Enhanced echogenicity for improved visualization

• Reduced fluoroscopy exposure, minimizing radiation risks

• Simplified design, lowering the technical learning curve for practitioners

• Rapid patient recovery, with all participants discharged within 24 hours

The success of this trial in Latin America underscores the region's emerging prominence in medical device innovation. "Latin America is increasingly becoming a preferred destination for first-in-human medical device trials," commented Julio G. Martinez-Clark, CEO of bioaccess®, a leading contract research organization specializing in the medical technology sector. "The combination of regulatory advantages, diverse patient populations, and cost-effective, fast patient recruitment makes the region an attractive option for medtech companies looking to accelerate their clinical studies."

Protaryx Medical's achievement comes when the demand for minimally invasive cardiac procedures rises. The company's innovative approach to transseptal punctures has the potential to revolutionize treatments for a wide range of cardiac conditions, improving outcomes and reducing recovery times for patients worldwide.

"The device substantially lowers the technical learning curve for targeted TSP due to its simplistic design, rapid echo visualisation of septal contact, and ease of negotiating the septum until the desired target is acquired," said Dr Gagan Singh, an interventional cardiologist at UC Davis Health who supervised the TSP procedures undertaken in the trial.

The company remains committed to advancing patient care through innovation as Protaryx Medical moves forward with plans for broader clinical trials and regulatory submissions. The successful completion of this trial in Paraguay represents a significant step towards bringing this groundbreaking technology to cardiac patients around the globe.

In a world where medical advancements continuously reshape healthcare, the emergence of innovative technology can mean the difference between life and death. The Protaryx Medicals Transseptal Puncture Device, now making waves in Latin America, is poised to revolutionize cardiac procedure approaches across the globe. This cutting-edge device promises to enhance surgical precision and improve patient outcomes in ways previously thought unattainable.

The first human trials of this groundbreaking technology mark a significant milestone in medical innovation, demonstrating the commitment to advancing personalized patient care. Researchers are uncovering critical insights into its potential applications by meticulously assessing the device's efficacy and safety. As the trial unfolds, diverse participants will contribute to a body of knowledge that could redefine cardiac treatment strategies forever.

About Protaryx Medical: Protaryx Medical is a pioneering medical device company dedicated to improving cardiac care through innovative technologies. With a focus on enhancing safety, efficiency, and outcomes in cardiac procedures, Protaryx is at the forefront of developing next-generation solutions for interventional cardiology.