#United States #Pleasanton #diabetes treatment #Aqua Medical #PIMA

Aqua Medical's Breakthrough in Diabetes Treatment

Aqua Medical Inc., a pioneering company in the field of metabolic restoration, has made a significant advancement in diabetes treatment with the recent approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE). This breakthrough allows Aqua Medical to initiate a clinical trial for its innovative approach to treating type 2 diabetes using the Proximal Intestinal Mucosal Ablation (PIMA) procedure.

What is the PIMA Procedure?

The PIMA procedure represents a state-of-the-art technique that focuses on metabolic restoration through a minimally invasive endoscopic approach. Unlike traditional surgical methods, this outpatient procedure utilizes a proprietary radiofrequency vapor ablation (RFVA) system to perform circumferential ablation on 50–70 cm of the proximal intestine. Importantly, the procedure requires no incisions or fluoroscopy, making it much less invasive than gastric bypass surgery, while still aiming to deliver similar metabolic benefits.

Dr. Rehan Haidry from Cleveland Clinic London emphasizes the elegance and simplicity of the RFVA catheter used in this procedure, stating that it exemplifies a major leap in the field of metabolic endoscopy and the treatment of type 2 diabetes. The goal of the PIMA procedure is to provide patients with a more accessible treatment option that effectively manages their diabetes with enhanced quality of life.

The RESTORE-1 Clinical Trial

With the IDE approval secured, Aqua Medical is poised to begin patient enrollment in the U.S. RESTORE-1 pilot trial. This trial will evaluate the potential of the PIMA procedure in achieving durable metabolic control for those suffering from uncontrolled type 2 diabetes. Co-led by prominent figures such as Prof. Nicholas J. Shaheen and Prof. John Buse from the University of North Carolina School of Medicine, the RESTORE-1 trial aims to gather critical data that can support broader FDA approval.

Prof. Shaheen and Prof. Buse expressed their excitement about the prospect of a straightforward, outpatient endoscopic solution for metabolic control, underlining the trial’s potential to change the landscape of diabetes treatment.

Significance of FDA IDE Approval

This FDA IDE approval marks a pivotal milestone for Aqua Medical, validating several years of foundational research and international clinical experience. The announcement underlines Aqua Medical’s commitment to innovating the treatment landscape for diabetes, particularly for patients who struggle with conventional therapies. President and CEO Lloyd Mencinger described the approval as a defining moment for the company, highlighting its importance in opening doors for research and patient care in the U.S.

As Aqua Medical prepares for U.S. site activation and patient enrollment, the excitement surrounding the PIMA procedure continues to build. The company’s robust IDE submission was backed by international data showcasing safety and positive metabolic outcomes, reinforcing confidence in the PIMA approach.

Conclusion

As the healthcare industry continues to seek cutting-edge solutions for chronic conditions like type 2 diabetes, Aqua Medical's innovative approach and FDA recognition signify hope for many patients. The upcoming RESTORE-1 trial could very well set the stage for a novel treatment paradigm, enabling more individuals to achieve better metabolic control and improve their overall health outcomes.