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Implantica's Groundbreaking RefluxStop® Clinical Study Results

Implantica AG, a pioneering company in medical technology, recently announced the release of a peer-reviewed publication detailing the impressive five-year outcomes of its RefluxStop® clinical study. This innovative device aims to treat gastroesophageal reflux disease (GERD), which affects over 1 billion individuals globally. The second installment of this groundbreaking study reflects a commitment to advancing treatment options for patients battling acid reflux.

Long-Term Safety and Effectiveness

The publication is centered on long-term safety and effectiveness outcomes of the RefluxStop® device, which complements earlier findings regarding specific food passageway results. Both studies were published in the well-respected journal, Surgical Endoscopy, marking a significant moment for Implantica's endeavor in the field of gastroenterology.
The newly released data point out some remarkable achievements:

• - Medication Dependency: An astonishing 97.9% of patients were no longer reliant on proton pump inhibitors (PPIs) after five years, as opposed to 100% who needed them pre-surgery.
• - Safety Profile: Over the five-year period, no adverse device-related events were reported, indicating a robust safety profile for RefluxStop®.
• - Quality of Life Improvement: The quality of life, measured using GERD-HRQL scores, witnessed a median improvement of 90% (IQR), p<0.001.
• - Acid Exposure Reduction: The acid exposure time in the lower esophagus, tracked via 24-hour pH monitoring, demonstrated a remarkable improvement of 90.4%, p<0.001.

Insights from Leading Surgeons

Dr. Joerg Zehetner from Klinik Beau-Site in Bern, Switzerland, who presented these findings at the SAGES Scientific Conference in California, remarked on the stellar results of RefluxStop®. He affirmed that the device significantly enhances the quality of life for patients dealing with GERD. Emphasizing safety, he highlighted how the study confirms RefluxStop® as both the safest and most effective surgical option available today for acid reflux patients. Notably, there were zero complications reported over five years, a rarity in surgical procedures.

Dr. Zehetner also noted, "It is very encouraging to see that RefluxStop has maintained its crucial anatomical position over time, resulting in excellent sustained long-term patient outcomes. Importantly, RefluxStop® uniquely restores the body's natural anti-reflux barrier, offering unmatched long-term results and safety as demonstrated in this study."

He further pointed to the significant reduction in postoperative complications associated with swallowing, as no patients required esophageal dilation during the entire study, which is a major improvement compared to traditional GERD surgeries.

Future Prospects for Implantica

Dr. Peter Forsell, the founder and CEO of Implantica, expressed pride in the five-year findings, outlining the strong potential for RefluxStop® to redefine standards of care in GERD surgery. With nearly 50 Centers of Excellence for RefluxStop® established throughout Europe, Implantica is positioned to expand rapidly, readying itself for entry into the U.S. market pending FDA approval.

"As we prepare for the U.S. launch, we believe RefluxStop® can set the gold standard in surgical treatment for GERD, providing superior patient outcomes, safety, and long-term cost-effectiveness," said Dr. Forsell.

With global ambitions on the horizon, alongside mounting clinical momentum, Implantica is dedicated to delivering exceptional value to patients, healthcare providers, and shareholders. This commitment is further evidenced by their innovative eHealth initiatives and a promising pipeline catering to a diverse array of health parameters.

For more information about Implantica and its transformative RefluxStop® device, visit implantica.com.