A 2.6% HbA1c reduction. What that number actually means for Type 2 Diabetes.
HbA1c reflects average blood sugar over 2 to 3 months. It's the standard marker used to diagnose and monitor Type 2 Diabetes.
At DDW 2026, Aqua Medical presented 12-month data on the investigational PIMA procedure. In the oral antidiabetic drug cohort (n=13), HbA1c fell 2.6% at 12 months.
It adds to the rationale for continued study of PIMA as a device-based approach delivered through a standard endoscopic workflow to target the proximal small intestine.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#EndoscopicMetabolicRestoration #PIMAProcedure #Type2Diabetes
From 12-month data at DDW to Aqua Medical's first U.S. patient treated in RESTORE-1.
Our 2026 midyear review covers DDW, ABE, LSI Asia, the TAG Award, PBS coverage, and the start of U.S. clinical evaluation.
Read more: https://t.co/RgHAXkAoSm
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational.
The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
The lining of the small intestine naturally renews itself.
Ablation is the targeting of the mucosal layer while leaving the underlying intestinal structure in place. PIMA is designed to resurface the lining of the proximal small intestine without making incisions or permanently changing the anatomy of the gastrointestinal tract.
The treated cells are shed, and new mucosal tissue forms during healing.
The metabolic effects of this process are still being studied.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#EndoscopicMetabolicRestoration #PIMAProcedure
A new milestone for RESTORE-I on the West Coast.
Aqua Medical has treated the first West Coast patient, and second U.S. patient overall, in our FDA-approved IDE trial evaluating the investigational PIMA procedure for type 2 diabetes.
The procedure was performed at Hoag, led by Dr. Jennifer Phan, who becomes the first woman endoscopist in the U.S. to perform PIMA.
We're grateful to Dr. Phan, Dr. Kenneth Chang, Dr. David Ahn, and the entire Hoag team for their collaboration as RESTORE-I continues across participating U.S. centers.
Read the full announcement to learn more:
https://t.co/SIVNAmEv88
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#AquaMedical #PIMA #ClinicalResearch #Type2Diabetes
The working channel is the built-in path physicians use to pass instruments through a standard endoscope.
With PIMA, the catheter travels inside that channel. It deploys at the target site, delivers RF-generated vapor, then retracts so the scope can advance from the duodenum into the jejunum.
No separate catheter alongside the scope. No fluoroscopy. One familiar endoscopic workflow, designed with ASC delivery in mind.
๐Follow Aqua Medical for updates on investigational research in metabolic endoscopy.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#EndoscopicMetabolicRestoration #PIMAProcedure #RFVAVapor
Aqua Medical was recently featured in the LSI Alumni Newsletter. We're pleased to welcome Robert "Bob" Haggerty as President and CEO, bringing more than 35 years of medical device leadership and over 30 years in gastroenterology.
#AquaMedical#MedTech
https://t.co/xByd0Sdgna
RESTORE-1 is being conducted at U.S. research sites.
At HonorHealth Research Institute, James Swain, MD, serves as Principal Investigator for the study of PIMA, Aqua Medicalโs investigational endoscopic procedure for type 2 diabetes.
The procedure is delivered through-the-working channel of a standard endoscope. RESTORE-1 is designed to evaluate its safety and performance.
Read more:
https://t.co/wf0a07CNk2
#ClinicalResearch #Type2Diabetes #PIMA #RFVA #AquaMedical
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established
Type 2 diabetes is not only a glucose problem.
Research into bariatric procedures has helped focus attention on the role of the proximal small intestine in metabolic signaling.
PIMA is designed to study that region without rerouting the digestive tract. The procedure uses RF-generated vapor to treat targeted mucosa across the duodenum and jejunum.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#EndoscopicMetabolicRestoration #PIMAProcedure
Excited to welcome Robert โBobโ Haggerty as President & CEO of Aqua Medical.
Bob brings 35+ years of MedTech leadership, 30+ years in GI, and a proven track record developing and commercializing important endoscopic technologies.
That experience matters as Aqua Medical advances PIMA, our investigational through-the-scope procedure for type 2 diabetes, into the next phase of U.S. clinical validation.
T2D remains one of the largest underserved needs in healthcare. Too many patients remain inadequately controlled despite todayโs options. With the first U.S. patient now treated in our FDA-authorized IDE clinical trial, Aqua Medical is focused on completing the U.S. pilot and preparing for the pivotal work ahead.
We also thank Lloyd Mencinger for nine years of leadership and for helping build the clinical, technical, and regulatory foundation for this next chapter.
Welcome, Bob.
Read the full announcement: https://t.co/6aRUzSBfMo
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational.
The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#AquaMedical #MedTech #PIMA #RFVA
@State Of Medtech featured Aqua Medicalโs first U.S. RESTORE-1 patient, treated under our FDA-approved IDE trial evaluating PIMA. Proving RFVA reaches the proximal jejunum was never the hard part. Building a through-the-working-channel procedure a GI team can run $317.6 million in 2025 to $650.7 million by 2032.
Read more: https://t.co/04Lr1QcPKk
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
Aqua Medical has treated the first U.S. patient in its FDA-approved IDE trial evaluating PIMA for type 2 diabetes. Performed at @UNC Health, led by Dr. Nicholas Shaheen and Dr. John Buse.
PIMA reaches the jejunum through the working channel of a standard endoscope. No fluoroscopy. Built for the ASC.
Thank you to the UNC Health and Aqua Medical teams who supported this milestone.
https://t.co/xy9v4yAA1n
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract.. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#EndoscopicMetabolicRestoration #PIMAProcedure #RFVAVapor #AquaMedical
Aqua Medical has treated the first U.S. patient in its FDA-approved IDE study evaluating the investigational PIMA procedure for type 2 diabetes.
The procedure was performed at @UNCHealth under the leadership of Dr. Nicholas Shaheen, National Principal Investigator, with Dr. John Buse serving as Co-Principal Investigator.
Thank you to the UNC Health and Aqua Medical teams who supported this milestone.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for PIMA is investigational. Safety and effectiveness for PIMA have not yet been established.
#ClinicalResearch #PIMA #Type2Diabetes
https://t.co/tKMN4jY61n
โIf you can scope it, you can treat it.โ
That line from Raj Nihalani captures Aqua Medicalโs design philosophy.
The endoscope is not only a tool for visualization. It can also become a platform for therapy.
That is the logic behind our through-the-scope approach.
#Endoscopy #Gastroenterology #MedTech
A medical technology can be clinically promising and still struggle to gain adoption.
Why?
Workflow.
Our investigational PIMA procedure was designed as a through-the-scope approach that fits within workflows GI physicians already know.
Innovation matters.
Adoption matters too.
#Endoscopy #Type2Diabetes #MetabolicHealth
Type 2 diabetes care is evolving.
For decades, treatment has largely centered on medication management and surgery.
As our understanding of metabolic disease grows, so does interest in new approaches.
Aqua Medical is helping build the field of Endoscopic Metabolic Restoration through its investigational PIMA procedure.
#Type2Diabetes #MetabolicHealth #Endoscopy
Great week at LSI Asia.
Our CEO, Lloyd Mencinger, presented Aqua Medical's vision for Endoscopic Metabolic Restoration and the work behind our investigational PIMA procedure.
The conversations reinforced something we're hearing more often: growing interest in new approaches to metabolic disease and the role of the GI tract in metabolic health.
#LSIAsia #MedTech #Type2Diabetes #MetabolicHealth
Our CEO Lloyd Mencinger shared a note on the past year and the category ahead.
Aqua Medical is building where GI, endoscopy, and metabolic disease are starting to come together.
That overlap matters. It may open a new way to think about type 2 diabetes care.
Worth a read.
https://t.co/DDIKGySXle
Type 2 diabetes was never only a glucose problem.
Glucose is the number we watch.
Metabolism is what is changing.
Aqua Medical is helping build a new conversation around T2D as a metabolic disease and the GI tract as a place we can intervene.
The RFVA system is FDA-cleared for marketing for its cleared indications. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
#Type2Diabetes #MetabolicHealth