Video Transcription
Alessandro Tozzi 00:01
I'm a medical doctor, specialist in digestive endoscopy, and since 2018, I have been the CEO and co-founder of Endostart. We develop a technology that is able to facilitate difficult endoscopic procedures, and first of all, colonoscopy, which is performed in more than 50 million people every year. In 10 to 15% of cases, colonoscopy is difficult or incomplete. When a colonoscopy is difficult, you lose time, and the procedure is more traumatic and painful. It is also stressful for the GI staff, and sometimes it is incomplete, necessitating a second procedure to complete the exploration of the colon. Usually, it is a virtual colonoscopy or a second-level colonoscopy with a senior endoscopist who is able to complete the exploration and eventually treat the lesions. So, you have a diagnostic therapeutic delay, and you have an increase in cost.
Our solution is called EndoRail, and it is based on magnetic balloon technology. Looping is the main cause of challenging colonoscopy; when you have looping, you lose pushability, and there is an increase in pain and trauma. In these cases, the endoscopist can decide to use the device on demand without the need to preload the device or to remove the endoscope from the colon. The EndoRail is composed of a balloon catheter, a syringe containing a ferromagnetic fluid, and a handpiece containing a strong magnet, which is stored inside a cart that is approached to the piston. The balloon catheter is inserted into the tool channel of the endoscope. Once the balloon exits from the tip of the endoscope, it is filled with ferromagnetic fluid, which is an iron powder with a water-based solution. Once the balloon is filled, the nurse takes the magnet from the cart and places it over the patient's abdomen to magnetically attract the balloon. At this point, the balloon is anchored, fixed in place, and stabilizes the tip of the endoscope. Thus, by just pulling back the endoscope, we are able to solve the loop with standard maneuvers and recover pushability. At this point, the balloon can be deflated, removed, and the endoscopy is completed with standard techniques.
This device is compatible with any colonoscope and is in line with clinical practice. The hospital doesn't have setup costs because the magnet is provided with a free loan for use agreement. The device is composed of a disposable kit, and the business model is mainly based on the sale of the disposable kit. The second generation of EndoRail has been CE marked in 2022, and we achieved FDA clearance in 2024. We started early adoption in Europe, in Italy, France, and the UK, and we are going to launch the product in the first semester of 2025. We have treated more than 100 patients, including in clinical trials and market adoption.
The addressable world market is above 1 billion euros, considering both difficult and incomplete colonoscopies. We conducted a multicenter clinical trial in Europe, in Italy, Germany, and Belgium, focused on difficult colonoscopies, and we stopped the trial at the interim analysis, as we had no adverse events. We completed all the difficult cases. We don't have direct competitors. In 99% of cases, the virtual colonoscopy or second-level colonoscopies are performed after a failed colonoscopy, and the other procedures need to be scheduled, so none can be used on demand like our EndoRail. We have a favorable reimbursement landscape, as there are some incentives to promote the completion of colonoscopy. In case of a failed colonoscopy, the hospital receives half of one quarter of the reimbursement.
We provide clinical benefits to patients. We save costs for payers, but we also increase profitability for hospitals. With minor changes in the product, we can use this technology for other GI applications, mainly therapeutics, and this is important not only for the market opportunity but also to boost market penetration and decrease company risk. By the end of this year, we will achieve CE marking for enteroscopy, which is a diagnostic therapeutic procedure for the small bowel. We aim to launch at least one new application every year.
This is the core team. We have 12 employees. Chris Roland is the Chairman of our Board of Directors. He comes from the US med tech industry. Peter Garcia is our advisor for the US market launch. He's an entrepreneur who already founded a company in the GI field that was acquired by Pentax a few years ago. We founded the company in 2018 with a seed round of 1 million euros. In 2021, we raised 8 million euros, and now we are looking for an additional 10 million euros to launch the product in the US market, conduct new trials, and also expand the portfolio of the company. We aim to reach the break-even point by the end of 2026 and achieve positive EBITDA in 2027. We are in contact with big players; some of them are following us. One of these made a deep assessment of our technology, and we expect that from the end of 2026, we can open an exit window. Thank you.
