Automated Suturing System for Weight Loss Debuts in Spain

CAESAREA, Israel – April 23, 2026 – A new chapter in the fight against obesity began in Spain this week with the first commercial use of the EndoZip™, an automated suturing system designed to streamline a minimally invasive weight-loss procedure. The milestone, announced by Israeli medical technology firm Nitinotes, marks a significant step in the European rollout of a device that promises to make endoscopic sleeve gastroplasty (ESG) more consistent, accessible, and efficient.

The inaugural procedures were performed by Professor Gontrand Lopez-Nava, a leading figure in bariatric endoscopy, at the Madrid Sanchinarro University Hospital. His involvement bridges the gap from early clinical trials to routine commercial use, signaling growing confidence in the technology's potential to reshape obesity care.

A Robotic Hand in Bariatric Procedures

Endoscopic sleeve gastroplasty is an increasingly popular, non-surgical procedure where a physician uses an endoscope—a flexible tube passed through the mouth—to place sutures in the stomach, reducing its size by about 70-80%. This restriction helps patients feel full sooner and consume less food, leading to significant weight loss. However, the procedure has traditionally required advanced endoscopic skills and, often, two operators, creating a steep learning curve and limiting its widespread adoption.

Nitinotes' EndoZip system is engineered to overcome these challenges. Described as the first fully automated, single-operator suturing platform for ESG, the device automates the complex task of placing and tightening sutures inside the stomach. This automation is intended to standardize the procedure, ensuring a higher degree of reproducibility regardless of the operator's experience level. By simplifying the workflow, the system allows the physician to focus on the endoscopic view and maintain tactile control, potentially reducing procedure time and enhancing safety.

"Having worked with EndoZip™ from its early clinical experience, it is encouraging to now use the system in routine practice," said Prof. Lopez-Nava in a statement. "Automation has the potential to simplify ESG workflow while maintaining procedural control, which may support broader clinical adoption and expanded access to minimally invasive metabolic interventions." This transition from an investigational tool to a commercial one under the guidance of its earliest adopter underscores a critical validation of its utility in a real-world clinical setting.

Strategic Launch in a High-Need Market

The choice of Spain for the first commercial procedures is a calculated move. The country faces a significant and growing obesity crisis, with projections indicating that by 2035, 37% of the adult population could be living with obesity. The current prevalence stands at 21.6%, contributing to an estimated healthcare cost that could surpass 3 billion euros by 2030. This public health challenge creates a strong demand for effective, safe, and scalable weight-loss solutions.

Nitinotes is entering a booming European obesity treatment market, which was valued at over USD 2.3 billion in 2024 and is projected to grow at a compound annual rate of 15.7% through 2030. Within this market, minimally invasive approaches like ESG are gaining traction as alternatives to more invasive traditional bariatric surgery or for patients who do not find success with pharmacological treatments like GLP-1 agonists.

"Expanding into Spain represents an important step in our measured European rollout," stated Lloyd Diamond, Chief Executive Officer of Nitinotes. The collaboration with a key opinion leader like Prof. Lopez-Nava is crucial for building credibility and driving adoption among the European bariatric community. By establishing a foothold in Spain, the company positions itself to address a clear clinical need while building a commercial foundation for further expansion across the continent.

Backed by Clinical Evidence, Eyeing Global Reach

The EndoZip system arrives on the European market with promising clinical data. A multi-center pilot study conducted in Spain, Italy, and Israel involving 45 patients demonstrated an average total body weight loss of 13.5% at the 12-month mark. The study also highlighted a high safety profile and excellent usability, noting a short learning curve for physicians. These results align with an earlier first-in-human study, also led by Prof. Lopez-Nava, which showed a 16.2% total body weight loss after six months.

While the device received its CE Mark in November 2025, clearing it for commercial sale across the European Union, Nitinotes has its sights set on the United States market. The company is currently conducting the "Endoscopic Automated Sleeve Evaluation (EASE)" trial, a pivotal, multi-center, randomized controlled study. This trial directly compares the automated EndoZip procedure against the established manual suturing system, the Apollo OverStitch. Enrolling up to 184 patients across Europe and the U.S., the EASE trial will assess not only weight loss and safety but also physician-reported outcomes related to ease of use and efficiency. The results will be crucial for the company's future submission to the U.S. Food and Drug Administration (FDA).

The Road Ahead: From Market Access to Reimbursement

Achieving CE Mark approval and completing the first commercial sales are critical milestones, but the path to widespread adoption involves another significant hurdle: reimbursement. In Europe's complex healthcare landscape, market access does not guarantee payment. Each country's national health system or private insurers make independent decisions based on health technology assessments (HTA), which weigh clinical efficacy against cost-effectiveness.

While Spain officially recognizes obesity as a disease, a comprehensive national strategy for its treatment and follow-up remains underdeveloped, which could complicate the reimbursement process. However, the economic case for automated ESG is compelling. By potentially transforming a complex procedure requiring two physicians into a faster, outpatient intervention performed by a single operator, the EndoZip system could significantly reduce hospital resource utilization and overall procedural costs compared to traditional surgery. This value proposition will be central to Nitinotes' discussions with payers across Europe.

As the technology becomes more established, it represents a significant shift for patients seeking durable weight-loss options without the risks and recovery time of surgery. The introduction of automation brings the promise of more consistent outcomes and broader access, empowering more physicians to offer this life-changing intervention and providing new hope for a growing patient population.