Endo Tools Therapeutics has announced the completion of several first-in-human cases where Endo Tools' new Endomina™ triangulation platform has been used.
Endomina is a universal platform that adds triangulation to any endoscope and that can be used with any endoscopic tool available for gastro-enterologists. It allows the surgeons to perform complex movements and to use multiple tools.
Dr Vincent Huberty and Dr Mostafa Ibrahim, both from Erasme hospital in Brussels, Belgium, first used Endomina to perform complex tissue resection and anterior-posterior tissue apposition in various models.
The device was then used on four patients in April, May, July and September 2012. The first two patients showed the safety of the device and highlighted the differences between all models done previously and real patients.
For the two other patients, the team, led by Prof. Jacques Deviere, chairman of the department of gastroenterology, was able to perform a full-thickness suture in the stomach, showing its potential for pouch reduction.
It allowed the surgeons to perform all the acts and validate the functionality of the device. All patients were released after a maximum of two days.
Endomina is an innovative device that adds multiple degrees of freedom and therapeutic channels to a conventional endoscope, a device that allows surgeons to look inside the body.
It gives full freedom to gastro-enterologists to perform manipulations that were until now only possible through laparoscopic access, often referred to as "keyhole surgery".
The devices open new opportunities for advances in flexible endoscopy, and for treatment of major diseases such as obesity, type II diabetes or gastro-intestinal tract tumors.
For the patient, the use of Endomina induces reduced hospitalization and improved comfort, due to lower anesthesia requirement. For hospitals and social security systems, it means a reduced overall intervention cost.
"For years, therapeutic endoscopists have been one-armed surgeons. Endomina offers the opportunity to work with two hands and therefore to do simple things like lifting tissue or making a knot, which have not been possible up to now," said Prof. Jacques Deviere, chairman of the department of gastroenterology. "I think it is a first step towards real endoluminal surgery."
The Erasme clinical trial, focused on morbid obesity treatment, will soon be expanded to four other key centers in Europe with a target of 50 patients in 2013.
To treat morbid obesity, surgeons usually perform a restrictive surgery of the stomach. There are more than 200,000 such procedures per year in the EU, representing a market of EUR two billion.
"The initial feedback about Endomina has been outstanding and many key clinicians who have been introduced to our technology are excited about its potential for new endoluminal surgery," said Alexandre Chau CEO of Endo Tools Therapeutics.
Chau continued, "We are in the process of raising funds to get to the next step of our development and put the device on the market in the EU."