Endostart, an ISO13485 certified endoscopy platform company targeting incomplete colonoscopies.
The startup has developed the Endorail System (ES) a medical device aimed at facilitating fast colonoscopy completion. Colonoscopy is the standard procedure for the prevention and diagnosis of colorectal cancer (50 M of colonoscopies per year), however 15% of the procedures are difficult or incomplete with significant consequences in terms of costs, diagnostic delay and workload.
ES obtained the CE mark in 2019 and has already been tested in a clinical setting. The CE mark, obtained in self-certification as it is a device classified with risk class I, has made it possible to carry out a post-market clinical study with consequent savings in time and costs. The device works thanks to a patented technology that exploits the properties of the ferrofluid.
It consists of a reusable magnetic handpiece (EMH) and a disposable kit including a balloon guide (EBG) and a ferrofluid pre-filled syringe (EFF). EBG can be inserted in the endoscope tool channel, filled with EFF and magnetically anchored with the EMH. At this point the user, can straighten the colonoscope by pulling it, and recover its pushability.
Thus, the tip of the scope can be pushed forward to complete the visualization of the colon. The main advantages of ES are the following: it can be used as needed if the procedure is difficult, is compatible with standard colonoscopes and does not require changes in clinical practice. Thanks to ES the endoscopists can shorten the mean duration of the procedure, save costs, and get full reimbursement. The company has an international board of directors and 3 employees (8 in 2021).
The company quality system, ISO 13485 certified, includes a network of specialized suppliers. The business model is based on the sale of disposable kits at a price of € 250. Endostart will start marketing the product in EU within 12 months with the help of specialized distributors. The global addressable market is over € 1.8B per year and a revenue of € 162M is expected within the 5th y of commercialization considering the EU and US markets.