Endostart has received FDA 510(k) clearance for its flagship product, Endorail. This marks a significant step forward in advancing gastrointestinal endoscopy and improving patient care.

Endostart的旗舰产品Endorail已获得FDA 510（k）许可。这标志着在推进胃肠内镜检查和改善患者护理方面迈出了重要的一步。

Endorail is commercially available in the US and it enhances the safety and efficiency of endoscopic procedures, serving as a solution to solve looping and facilitate prolonged colonoscopies. It is designed to streamline the colonoscopy process with its magnetic balloon solution and user-friendly features that empower physicians to overcome procedural challenges.  .

Endorail在美国上市，它提高了内镜手术的安全性和效率，是解决循环问题和促进长时间结肠镜检查的解决方案。它的设计目的是通过其磁气球解决方案和用户友好的功能来简化结肠镜检查过程，使医生能够克服程序上的挑战。（笑声）。。

Endorail helps physicians gain access to an on-demand tool that optimizes procedural outcomes and reduces healthcare costs associated with prolonged or incomplete procedures.

Endorail帮助医生获得按需工具，该工具可优化程序结果并降低与延长或不完整程序相关的医疗保健成本。

“We are thrilled to obtain FDA clearance for Endorail, marking a significant milestone in our journey to revolutionize gastrointestinal endoscopy,” said Dr. Alessandro Tozzi, Endostart co-founder and CEO. “This clearance underscores our commitment to innovation and our dedication to improving patient care.

Endostart联合创始人兼首席执行官亚历山德罗·托齐（AlessandroTozzi）博士表示：“我们很高兴获得FDA对Endorail的批准，这标志着我们彻底变革胃肠道内窥镜检查之旅的一个重要里程碑。”。“这一批准突显了我们对创新的承诺以及我们对改善患者护理的奉献精神。

We look forward to introducing Endorail to endoscopic centers across the United States, empowering physicians with the tools they need to deliver exceptional care.” .

我们期待着将Endorail引入美国各地的内镜中心，为医生提供提供提供特殊护理所需的工具。”。。

The company conducted a multicenter clinical trial in 2023, demonstrating the safety and efficiency profile of Endorail in completing difficult colonoscopies. Endostart will share these results at the Digestive Disease Week Congress in Washington DC on May 18-21, 2024.

该公司于2023年进行了一项多中心临床试验，证明了Endorail在完成困难的结肠镜检查方面的安全性和有效性。Endostart将于2024年5月18日至21日在华盛顿特区举行的消化疾病周大会上分享这些结果。

“Through this study, Endostart and our research partners have established that Endorail is safe and can be used effectively on demand in patients with prolonged colonoscopies. Future studies will be carried out to identify additional benefits, including cost advantages and time-saving with our device,” Dr.

“通过这项研究，Endostart和我们的研究合作伙伴已经确定Endorail是安全的，可以根据需要在长期结肠镜检查的患者中有效使用。未来的研究将进行，以确定额外的好处，包括成本优势和节省时间，”Dr。

Tozzi added. .

托齐补充道。。.

This FDA clearance positions the company to expand in the United States and offer its solutions to more healthcare providers and patients. In leveraging its magnetic balloon technology, Endostart intends to position itself as a leader in endoscopic solutions.

FDA的批准使该公司能够在美国扩张，并为更多的医疗保健提供者和患者提供解决方案。通过利用其磁气球技术，Endostart打算将自己定位为内窥镜解决方案的领导者。