Acute gastrointestinal bleeding is a potentially life-threatening condition affecting up to two million people a year worldwide. Currently, those suspected of bleeding often end up having an endoscopy which is expensive, invasive and not always immediately available. Now, a new diagnostic device from medtech startup EnteraSense is set to speed up and simplify how those with suspected gastrointestinal bleeding are treated.
The sensor-based device is called Sentinel and it is swallowed in a capsule by the patient. It then collects data (which is wirelessly transmitted to a PC, tablet or smart phone) to provide real-time detection of upper gastrointestinal bleeding. This allows the clinician to treat the patient faster and can also speed up emergency department triage procedures .
The founders of EnteraSense are entrepreneur Donal Devery, who has more than 20 years' experience of product development and technology commercialisation, and Dr Christopher Thompson, director of developmental endoscopy at Brigham and Women's Hospital in Boston and instructor in medicine at the Harvard Medical School. The partners have worked together on a number of projects in the past, including the setting-up of biomaterials company Vysera in Galway in 2005.
“The existing diagnostic methodology for identifying gastrointestinal bleeding is quite slow to set up and it can also take time for lab results to come back. By contrast, Sentinel is quick and easy to engage and it gives the clinician immediate results,” says Donal Devery. “There is also no other device on the market that can be used in the stomach to monitor what’s happening for up to three days. Monitoring of high-risk patients is really important, as re-bleeds are common and associated with an increase in the mortality rate.
“EnteraSense is changing a treatment paradigm using advanced engineering and technology to monitor what up until now could only be confirmed visually through a relatively invasive procedure,” he adds. “Ultimately this benefits the patient, the doctor and the health system with reduced costs and better management of endoscopic resources.”
The initial technology for the product was developed in the US by Partners Healthcare Innovation (which incorporates Harvard Medical School and Brigham and Women's Hospital) over a three-year period at a cost of around $1million. EnteraSense has licensed the technology and is working with Galway-based medtech company Anecto to further refine and test the technology, which is currently at prototype stage.
“The partnership with Anecto has been very important as they are providing engineering and technical resources and the other supports we need when we need them. This has allowed us to keep the start-up very lean,” says Devery. EnteraSense’s investment to date in Sentinel is in the region of €250,000 and the company is currently finishing out a fundraising round of €1m.
The main customers for the Sentinel device will be clinics and hospitals. The product will be made in Galway by Anecto and the company expects to get regulatory approval in the second half of 2017. Sentinel will be launched in the United States at the beginning of 2018. The company's commercialisation strategy is to use key partners to develop a route to market in the USA initially followed by the introduction of Sentinel in Europe and beyond.
EnteraSense is based at the National Digital Research Centre, where it has participated in the Launchpad accelerator programme. The company employs four people with a further six due to join the operation in the new year.
“The clinicians we have spoken to are very excited about this product and many will collaborate with us in studies to be performed with the device in the second half of 2017,” Devery says. “Our vision is to be an international medical devices company recognised as a global leader in real-time detection and time- based monitoring of internal bleeding.”
