The link between obesity and type 2 diabetes mellitus (T2DM) is well documented. Nearly all individuals who have had gastric bypass surgery show drastic improvement in their diabetic status. In most cases following the surgery, the patient’s blood sugar levels decrease shortly after the procedure, which leads to dosage reduction of medication needed with an associated improvement in diabetes-related health problems. Gastric bypass surgery is a good solution, however only for a limited group of patients. It is normally only recommended for individuals with a body mass index of at least 35 with accompanying disease, usually T2DM. Even then, many of the patients do not want to undergo such an irreversible invasive surgery with many associated side-effects. Simple to insert and effective in action “The NOBIX system is a polymeric sleeve placed in the duodenum with a unique patented anchor positioned in the stomach to prevent migration,” explains Ziv Kalfon, CEO of Allevetix Medical Ltd, GDS project coordinator. The sleeve’s main function is to change the circulating levels of gut hormones and to stabilise the hormonal balance until it comes to an equilibrium, the core reason for T2DM. The beauty of the NOBIX system is that its insertion takes only 30 minutes, doesn’t need to be done in a hospital, and also doesn’t need a big, highly trained team of surgeons for fitting. As an extra bonus, the sleeve also helps to prevent weight gain through malabsorption of calories and the anchor increases satiety. Market knowledge a must Another essential goal was to “identify and establish communication with leading physicians who could be our key opinion leaders in the gastro and endocrinology fields,” Kalfon points out. On commercialisation, these medical experts are crucial in influencing end-user choice when it comes to therapy. “Phase one of the project gave us a wide understanding of the market, the business opportunities and helped to set a penetration strategy that took into account various important parameters,” he says. These include market acceptance level of a new treatment and technology, prevalence of the disease, medical care reimbursement, and insurance coverage and regulation. Overcoming barriers to development “The main challenge in our project was the lack of a suitable model to assess and develop the system performance,” Kalfon explains. “Targeting the gastrointestinal system, there is no large animal model that has a similar system as the human where we can evaluate its safety, usability and performance,” he continues. The Allevetix team had to evaluate each function of the NOBIX implant and the delivery system in a separate bench or animal model and then assess the safety and performance in a human clinical study. Identifying materials and manufacturing processes that are also safe and functional in the harsh gastric environment for a long period of time was another potential problem. “For this, we developed a unique, one-step, titanium 3D printing process for a dynamic system,” Kalfon emphasises. Final steps before commercialisation Allevetix now needs to complete a regulatory clinical study demonstrating the effectiveness of the NOBIX system prior to its commercialisation. “We are seeking a global strategic partner with proven distributing capabilities to achieve, together with us, a regulatory approval for marketing the NOBIX and to engage the market for global commercialisation,” Kalfon concludes.
GDS, NOBIX, Allevetix, gastric, sleeve, type 2 diabetes, implant, obesity, hormones, titanium, 3D printing