Critically ill patients are often fed through nasogastric tubes. It is however hard for physicians to know if the stomach of these patients is working properly, which is important to know, as overfilling the patient’s stomach could lead to complications. The startup VIPUN Medical offers a solution.
Every year, 12 million patients enter the intensive care unit (ICU) in Europe and the US. More than 3 million of them stay in the ICU longer than 4 days. They are at risk of complications and longer length of stay caused by undiagnosed feeding intolerance. Feeding critically ill patients is complicated since it is estimated that stomach function is impaired in more than 50% of patients. Physicians currently have no accurate tools to assess stomach function and are left in the dark as to how much nutrition they can provide without inducing feeding intolerance and associated complications. BioVox spoke with Nico Van Tichelen, CEO, and Pieter Janssen, CTO, from VIPUN Medical.
We intend to support physicians in making smart decisions about the mode, timing and speed of medical nutrition." - Nico Van Tichelen
Nico Van Tichelen: “VIPUN Medical is a brand new spin-off incubation project from the KU Leuven. We have developed a system to continuously monitor stomach function and predict feeding intolerance. We intend to support physicians in making smart decisions about the mode, timing and speed of medical nutrition.”
“At this moment, there is no method readily available to accurately assess stomach function. The need to assess stomach function is most pressing in critically ill patients who are mechanically ventilated. As they cannot eat themselves, a liquid meal is pumped directly in the stomach through a nasogastric tube. However, if the stomach does not function normally, it can easily be overfilled, potentially causing the patient to vomit and develop complications. As a result, patients are often fed conservatively and the amount of food is determined via trial-and-error. We intend to fill-in this blind spot.”
Stomach contractions create pressure changes in the balloon which are measured and can be used by physicians to interpret stomach function." - Pieter Janssen
A balloon in your stomach
Pieter Janssen: “We have developed a method to assess stomach function, using a balloon that is attached to the feeding tube. We position it through the nose and inflate it in the stomach. Stomach contractions create pressure changes in the balloon which are measured and can be used by physicians to interpret stomach function.”
“It took us three years to develop the balloon catheter. Through profound basic research and clinical studies, we defined the optimal size, shape, pressure and material characteristics for a translation of stomach contractions into pressure changes, while maintaining comfort for the patient and medical staff.”
“The balloon is only one part of the device as it will be connected to a control unit which provides the read out. In co-operation with ESAT at KU Leuven, we have developed an algorithm that can differentiate real stomach contractions from breathing, heartbeat or other body movements, thus taking out all pressures that could confound the stomach contraction signal. We intend to offer physicians an easy and interpretable read out of stomach function.”
Getting the system ready to market
Nico Van Tichelen: “Within three years’ time, our product can be ready to go to the market. During this time, we will finalize and validate the development of the balloon, control unit and algorithm. We are currently enrolling critically ill patients in a ‘First In Patient’ pilot trial at the UZ Leuven and intend to start a multi-centre international clinical trial in 2019.”
“We are looking forward to complete a series A capital round by the end of this year to complete the final stages of our product development and conduct the required clinical trials before commercialization.”