The israeli clinical stage medical diagnostics start-up Check-Cap plans to build an in-house manufacturing line to produce the x-ray source for its C-Scan capsule, a patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer – as the CEO of the company, Alex Ovadia, announced last week in a letter to investors. In the letter, Ovadia also disclosed that Check-Cap was recently awarded a 750k dollar grant from the Israel Innovation Authority to support the transition from R&D to production, and the company will invest a similar sum in the project as well.
An x-ray source is a radioactive isotope with an extra neutron, which emits X radiation when the extra neutron is released from the atom’s nucleus. Check-Cap uses an isotope from the osmium element in their capsule. This isotope has a short half-life. As such, by the time the capsule exits the body, the source will have already been extinguished and thus does not require a complex evacuation procedure.
Ovadia told Techtime that the establishment of the local production line is a part of the company’s business and logistic strategy. “Since the half-life of the x-ray source is relatively short, we may need to build local production facilities in our future markets, in order to ensure availability. It is a model similar to that common in the nuclear medicine field.”
Currently, Check-Cap has a production line in the US that was established by GE. The production line in Israel will also be used for a widespread clinical trial that the company is planning to hold in Israel throughout the year. The trial will take place in 10 medical centers and will include 250 patients at an average risk for colon cancer. The company added that recruitment of patients was going slower than expected because of the Covid-19 pandemic, but the trial is set to begin soon. The aim of trial in Israel is to gather additional clinical data that will allow continued improvement of the system’s functionality.
The main goal the company is preparing for these days, is the Pivotal trial in the US, which will be the last clinical hurdle before seeking marketing approval from the FDA. In November, Check-Cap submitted a request to perform the trial (IDE) to the FDA, and they are now in the process of responding to comments that they’ve received from the FDA.
The company also announced that it was notified by Nasdaq that it regained compliance with the minimum $1.00 bid price rule. Over the last month, after a continuous trampling, Check-Cap’s stock jumped by about 370% and is now traded at a market value of 74.4 million dollars. Ovadia: “Many significant things are happening in the company, in all aspects, and we came to the conclusion that we should give periodical updates from time to time. It is important that people know what is happening in our interesting company.”
Check-Cap, located in Isfiya near Haifa, Israel, develops an ingestible capsule-based system for preparation-free colorectal cancer screening. The C-Scan utilizes ultra-low dose X-ray and an wireless communication sub-system. The capsule is used to create a 3D map of the inner lining of the colon, which allows physicians to look for polyps and other abnormalities. C-Scan is non-invasive and requires no preparation or sedation, allowing the patients to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.