Implantica Unveils Significant 5-Year Study Results for RefluxStop

Implantica Reveals Landmark 5-Year Findings on RefluxStop
Implantica AG (publ), a leading medtech company in advanced medical technology, has recently announced the publication of the five-year results from its CE mark clinical study of RefluxStop, a groundbreaking device designed to treat acid reflux—a condition that affects over a billion individuals globally.
This second peer-reviewed publication emphasizes the long-term safety and effectiveness of the RefluxStop device, supplementing a previous report focusing on food passageway outcomes. Both findings were published in the esteemed journal Surgical Endoscopy, which is supported by notable medical organizations such as the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES).
Key Outcomes of the RefluxStop Study
Titled "Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: A prospective multicenter trial of safety and effectiveness," this publication provides conclusive evidence of RefluxStop's significant clinical performance. Here are some of the crucial findings:
- 97.9% of patients were able to discontinue proton pump inhibitor (PPI) medication after five years, up from 100% of those who were on PPIs pre-surgery.
- No device-related adverse events reported throughout the entire five-year duration.
- Quality of life (measured via GERD-HRQL scores) showed a median improvement of 90% (IQR), p<0.001.
- Measured acid exposure time in the lower esophagus (through 24h pH monitoring) improved by 90.4%, p<0.001.
Expert Endorsements from Leading Surgeons
Dr. Joerg Zehetner from Klinik Beau-Site, who presented these findings at the SAGES Scientific Conference, commented, "RefluxStop has demonstrated stellar results significantly improving patients' quality of life. The safety profile is crucial, and this study validates RefluxStop as the safest and most effective surgical option currently available for acid reflux sufferers. Throughout five years, no complications such as reherniations or migrations occurred, confirmed using contrast-swallow imaging."
Dr. Zehetner also highlighted the superior patient experience with RefluxStop. "It's encouraging to see how RefluxStop maintains its anatomical positioning long-term, resulting in excellent patient outcomes. Notably, the device virtually eliminated postoperative swallowing difficulties, with no need for esophageal dilatation, which is a considerable advantage over traditional GERD surgeries."
Future Directions for Implantica and RefluxStop
Dr. Peter Forsell, founder and CEO of Implantica, remarked, "The results from this five-year study reinforce RefluxStop's potential to redefine GERD surgical standards. With nearly 50 RefluxStop Centers of Excellence established across Europe, we are enhancing our clinical and commercial infrastructure for broader adoption. Our team is actively preparing for our U.S. market launch, pending FDA approval. As we endeavor into this new market, we believe RefluxStop is positioned to become the benchmark in surgical GERD treatment—offering outstanding patient outcomes, safety, and long-term cost-effectiveness."
As FDA approval is on the horizon, with global expansion in progress and increasing clinical momentum, Implantica aims to create significant value for patients and stakeholders alike.
For inquiries, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)79 335 09 49
About Implantica
Implantica is a MedTech company devoted to pioneering advanced technologies for implantation. The lead product, RefluxStop, is a CE-marked implant addressing gastroesophageal reflux, potentially revolutionizing anti-reflux treatment. Implantica also focuses on eHealth innovations and manages a wide range of patent-protected products, utilizing two primary technologies: an eHealth platform overarching health monitoring and a wireless energizing platform for remote-controlled implants. Implantica is traded on the Nasdaq First North Premier Growth Market (ticker: IMP A SDB).
About RefluxStop
This innovative treatment is set to initiate a paradigm shift in anti-reflux surgery. Unlike traditional methods, the RefluxStop device treats the root causes of acid reflux without constricting the food passageway. It restores the natural position of the lower esophageal sphincter, ensuring better anatomical physiology, allowing the body to heal from acid reflux effectively.
Frequently Asked Questions
What is the main focus of the RefluxStop study?
The study primarily focuses on the long-term safety and effectiveness outcomes of RefluxStop in treating acid reflux.
What were the key findings of the study?
Key findings include a 97.9% success rate in discontinuing PPI medications, zero adverse events reported, and significant improvements in quality of life and acid exposure time.
How does RefluxStop differ from traditional GERD surgeries?
RefluxStop uniquely addresses acid reflux without encircling the food passageway, allowing the sphincter to maintain its natural position.
Who presented the findings at the SAGES conference?
Dr. Joerg Zehetner presented the findings at the SAGES Scientific Conference, emphasizing RefluxStop's effectiveness and safety.
What are the future plans for Implantica?
Implantica plans to expand into the U.S. market pending FDA approval while continuing to grow its Centers of Excellence across Europe.
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