#Israel #Caesarea #Obesity Treatment #EndoZip #Nitinotes

Nitinotes Secures CE Mark Approval for EndoZip™ System

Nitinotes Ltd., a pioneering company in the medical device sector focused on obesity treatment, recently announced a significant milestone with the receipt of CE Mark approval for its innovative EndoZip™ system. This marks the introduction of the first fully automated suturing platform designed for endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure aimed at helping patients achieve weight loss.

What is EndoZip™?

The EndoZip™ system represents a major advancement in the treatment of obesity, which affects over 650 million adults globally. Traditionally, patients with a Body Mass Index (BMI) ranging from 30 to 40 kg/m² faced challenges in finding effective treatment options between conservative methods, like diet and medication, and invasive surgeries. ESG provides a middle ground, offering a less invasive alternative for those who have not had success with traditional weight management strategies.

By automating the suturing process, the EndoZip™ system simplifies ESG, making it a streamlined, single-physician procedure that can be performed on an outpatient basis. This automation reduces the learning curve required for physicians, distinguishing it from current manual suturing systems that necessitate multiple practitioners and extensive endoscopic expertise.

The Impact on Healthcare

Lloyd Diamond, CEO of Nitinotes, emphasized that the CE Mark's approval for EndoZip is a critical step towards making obesity treatment more accessible. “This achievement not only validates the safety and efficiency of our technology but also lays the groundwork for commercializing it within Europe,” Diamond stated. The EndoZip system intends to widen the reach of obesity treatment, enabling healthcare providers to deliver a safe and effective solution that is economically viable.

The new system is expected to set a benchmark in ESG, enhancing efficiency and reproducibility while potentially reshaping how bariatric surgery is performed. As Nitinotes prepares for the rollout in select European medical centers, the company aims to compile clinical data to further support its broader market entry.

Future Prospects

Alongside its European launch plans, Nitinotes is gearing up for a pivotal Investigational Device Exemption (IDE) trial in the United States. This trial will be vital for securing approval from the FDA, thereby entering the largest market for obesity treatment worldwide.

Nitinotes, founded with the mission to innovate healthcare solutions, continues to lead in the development of technologies that cater to urgent health challenges. The EndoZip™ system not only reflects the company's commitment to enhancing patient care but also demonstrates the potential impact of innovation in medical technology.

In conclusion, the approval of EndoZip™ marks an exciting advancement in the field of obesity treatment, promising to transform the landscape of minimally invasive surgical options, making them safer, quicker, and more accessible to a larger population. As the company moves forward, it aims to establish EndoZip as a key player in the fight against obesity, providing a beacon of hope for countless patients seeking lasting solutions.