Aqua Medical Achieves Milestone in Type 2 Diabetes Treatment with PIMA Procedure in California

Aqua Medical Implements PIMA Procedure in FDA-Approved Trial

Aqua Medical, Inc., a leading player in the field of clinical-stage medical technologies focused on endoscopic metabolic restoration, has recently made headlines with the successful treatment of a type 2 diabetes patient in California. This significant achievement marks the initiation of Aqua Medical's Investigational Device Exemption (IDE) trial, named RESTORE-I, which is approved by the FDA for evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure.

The procedure took place at Hoag Hospital in Newport Beach, California, led by Dr. Jennifer Phan, who notably becomes the first woman interventional endoscopist in the United States to perform this innovative treatment. Dr. Phan, in collaboration with her fellow co-investigators, including Dr. Kenneth Chang and Dr. David T. Ahn, aims to pioneer advancements in medical interventions for type 2 diabetes.

The PIMA procedure utilizes Aqua Medical's proprietary radiofrequency vapor ablation (RFVA) technology, which is delivered through a standard endoscope. This minimally invasive technique targets a specific segment of the proximal small intestine and aims to rectify abnormal metabolic signaling that contributes to insulin resistance. With the goal of promoting mucosal regeneration, the clinical trial seeks to evaluate the long-term effects of the procedure on patients’ metabolic control. This unique approach offers patients a low-burden option for treatment as it does not involve surgery, requires no fluoroscopy, and seamlessly integrates into existing endoscopy workflows.

In her statement, Dr. Phan expressed her excitement about participating in such a groundbreaking trial, emphasizing, "Starting this clinical trial allows us to provide state-of-the-art endoscopic metabolic therapies that may lead to enhanced outcomes for patients. We are delighted that Hoag Hospital is part of such a pivotal study, placing our clinical team at the forefront of transformative minimal-invasive treatments."

Raj Nihalani, Aqua Medical’s Chief Medical Officer, added that the potential impact of this technology could redefine treatment methodologies for metabolic diseases. The RFVA technology aims to extend accessibility for patients needing advanced metabolic therapies. He highlighted, "The early indications from clinical experiences have been promising, and the ongoing study is designed to rigorously assess these initial findings."

Bob Haggerty, CEO of Aqua Medical, articulated the importance of collaborating with premier institutions like Hoag Hospital, stating that their innovative private-academic model reinforces their position as a leading partner in clinical research. This collaboration not only accelerates Aqua Medical’s clinical program but also expands patient accessibility to vital treatments across the western United States.

Dr. Phan’s involvement in this trial reflects the growing recognition of women in advanced therapeutic roles within the medical field. The IDE clinical trial continues to evaluate the safety and effectiveness of the PIMA procedure in adults who struggle with inadequately controlled type 2 diabetes despite standard medical interventions. Patient recruitment is actively ongoing across various sites involved in the study.

Aqua Medical is dedicated to advancing minimally invasive technologies that target the underlying mechanisms of type 2 diabetes. Their RFVA system has received FDA clearance for specific gastrointestinal applications, while the utilization of this system for the PIMA procedure remains investigational. Consequently, the procedure's safety and effectiveness are yet to be firmly established, necessitating ongoing research to validate its therapeutic potential.

As the clinical landscape for diabetes management evolves, Aqua Medical aims to be at the forefront, leveraging technology-driven solutions to potentially reshape how metabolic diseases are treated, ensuring better patient outcomes and expanded accessibility to innovative care.