In 2016 more than 650 million adults worldwide were classified as obese with a body mass index (BMI) of 30 or higher, according to the World Health Organization, and a 2017 study found that in Israel as well, one in six women and one in four men were obese.
The existing surgical solutions to reduce stomach volume and curb obesity — including gastric bypass and sleeve gastrectomy, in which a large portion of the stomach is removed — are available for people with a BMI of 40 of higher (or 35 with additional diseases), but are generally inadvisable or not covered by insurance for class one (BMI of 30-35) or class two (BMI of 35-40) obesity patients. In addition, bariatric surgery, as these procedures are called, can be risky and irreversible while offering only temporary improvements.
An Israeli company, Nitinotes, is developing a solution to provide these two groups of patients with a minimally invasive and fully automated gastrointestinal suturing system, CEO Raz Bar-On told The Times of Israel in a phone interview.
The device, called Endozip, will be inserted into and removed from the stomach through the mouth and esophagus with no scalpel needed. The treatment is intended to take around 30 minutes; patients will require minimal anesthesia and be released home the same day.
On the end of the long shaft of the Endozip is a suturing device, with a needle enclosed inside a chamber, as well as a five-millimeter (one-fifth of an inch) endoscope that allows to surgeon to see what is being operated on.
After the device is positioned, suction pulls the walls of the stomach inside the Endozip’s chamber through special ports on its sides.
The surgeon then simply pushes a button to activate the motorized helical needle, which sutures up and ties, automatically and precisely, the walls’ tissues from within the chamber, — making the stomach volume smaller.
The needle is then removed, while the suture thread tightens and zips the tissue even further along the suturing line. The device is then finally extracted, following the same path, through the esophagus and the mouth.
Bar-On said that while standard bariatric surgery is effective, it also is a three-decade-old, aggressive and irreversible solution. Indeed, such an operation carries a mortality risk of 0.3% and a 2% risk of future leakages, he said.
According to Bar-On, these figures are the reason only 2% of the patients eligible for bariatric surgery employ this solution, a figure that he said demonstrates the need for new methods.
Other solutions like diet, medication, and change of habits are often noneffective, he said, while intra-gastric balloons are best suited for people with a low BMI and provide just only a one-year solution at most before being removed.
By contrast, Nitinotes’s single-use device should offer its patients weight reduction for at least a couple of years, Bar-On said.
Nitinotes recently conducted a trial involving 13 patients under the supervision of Dr. Doctor López-Nava, director of bariatric endoscopy at HM Sanchinarro University Hospital in Madrid, and “one of the world’s leaders in bariatric endoscopy,” Bar-On said.
In the March-November 2018 study, Bar-On said, no issues or side effects were witnessed during or after the trial and results look very promising, though at least six months of followup is needed to evaluate the real effectiveness of the treatment.
The company is looking at carrying out larger, pivotal studies in Europe and the United States. Only after obtaining FDA and CE approval will Nitinotes start selling its devices to hospitals and private clinics in the US and the EU, Bar-On said.
Meanwhile, the firm’s testing is conducted on ex-vivo human tissue provided thanks to its collaboration with Jerusalem’s Shaare Zedek Medical Center.
The firm was founded five years ago in Peregrine Ventures’ Incentive Incubator in Ariel. Now based in Caesarea, it has eight employees.
To date the startup has raised some NIS 2.5 million ($673,000) from the Israel Innovation Authority and NIS 1 million from the investment firm Accelmed. It has also raised $6.3 million for its Round A thanks to the contributions of Elron Electronic Industries, Accelmed, Peregrine, Swiss-based VC MTIP, and Italian participation holding company TechWald Holding.
“We believe we have found the right technology for minimally invasive endoscopic stomach intervention, which combines an unmet ease of use with the possibility and versatility to customize the procedural intervention according to patient conditions and therapeutical needs,” said Alessandro Piga, CEO of TechWald Holding.
There are competitors, however. Apollo Endosurgery makes the “OverStitch,” which is also inserted through the mouth, doesn’t require an invasive surgical procedure and leads to a total body weight loss of 15% after a year, Bar-On said. But, he said, that procedure is not automated and has a long learning curve.
Besides being easier to use than its competitors, safer than bariatric surgery and more effective than gastric balloons, the solution Nitinotes is developing will also be competitively priced, Bar-On said. At $6,000-$10,000, it comes in between bariatric surgery’s $15,000-$25,000 and the $3,000-$8,000 price tag of balloons.