Check-Cap

Check-Cap established full assembly line for its X-ray capsules

Posted on by Techtime

Medtech company Check-Cap had completed in the last year foundation of an independent production line for serial manufacturing and the assembly of its X-ray capsule, intended for detecting pre-cancerous polyps in the colon. The new facility, located in Isfiya and spreads over 550 meters, is designed for producing the number of kits required for the 1000-patients  pivotal study currently carried out in the U.S. According to the company, the line is expected to expand in order to support the company’s needs at the early stages of the commercialization phase, following the study conclusion and FDA approval.  

In a conversation with Techtime, CEO Alex Ovadia says: “The complete assembly of the system is carried out here, in Israel. With a large company foresight, we have established the foundation for moving towards the commercialization phase. We are long-distance runners; we plan for years ahead”. 

The X-Ray source, which is the isotope inside the capsule that emits the X radiation during the process, is also manufactured in Israel, in a designated production line established by the company in Petach-Tikva. 

The crucial clinical study has started 

In May 2022, Check-Cap announced the initiation of the pivotal clinical study, conducted in Israel and the U.S. The study was postponed by over a year as a result of the COVID-19 crisis and various logistic issues.  

The study will include approximately 1,000 subjects ages 50-75 and is composed of two phases; the first phase, already started and expected to end in the middle of 2023, is meant for further calibration of C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second phase consists of approximately 800 subjects, half of them in Israel, and will continue for about a year. In this phase, the performance of the system will be compared to a traditional colonoscopy. 

Sensitivity, prevalence, and adherence 

In the field of colorectal cancer detection, there are currently several accepted methods. Some are intended for detecting polyps, such as the traditional colonoscopy and the PillCam camera of the Israeli Given Imaging Company (currently owned by Medtronic). These tests both require preparation and cleaning of the colon in advance. On the other hand, there are  tests intended for diagnosing findings that may indicate a cancerous state. Among these Fecal Immunochemical Test (FIT), Cologuard from Exact Sciences Company, based on  detecting cancerous DNA in the stool, and Liquid Biopsy tests intended for detecting cancerous biological markers in the colon. Check-Cap’s capsule is designed to detect pre-cancerous polyps in the colon without cleaning the colon before the test. 

The efficiency of a test is derived from three aspects: Sensitivity – the accuracy level of the  test in detecting the presence or absence of suspicious findings. Prevalence – the frequency of the finding which is in the focus of this test. For instance, a liquid biopsy test is intended to detect biological markers that may indicate the presence of colorectal cancer, a finding whose prevalence in the population is relatively low (about 0.5% of the population at average risk). On the other hand, Check-Cap’s test and traditional Colonoscopy are intended for detecting pre-cancerous polyps – a finding whose prevalence in the population is about 25%, which is considerably greater.  

The third aspect, which is one of the most crucial in the field of early colorectal cancer detection is adherence – the willingness of the patient to take the test. In fact, this is the problem Check-Cap is striving to address: the low adherence among the high-risk population to take the traditional colonoscopy test, mainly because it is an unpleasant, invasive test that requires cleaning the colon in advance. 

Despite the delays in the clinical study, CEO Ovadia thinks the company’s competitive  advantage is preserved when compared to the alternative solutions: “Our advantage is reflected in the optimal integration of sensitivity, prevalence, and adherence. The combination of these three aspects is the determinant of the test’s “yield” – and is also the  key for decreasing mortality rates from colorectal cancer. In this manner, the advantage of our capsule, even when compared to colonoscopy, is in the extensive willingness to take it.  

A friendly alternative to colonoscopy 

Check-Cap has developed a user-friendly solution for detecting pre-cancerous polyps in the colon. The system is composed of an ingested capsule containing an X-Ray source and a control system attached to the back of the patient, which positions and manages the tests. In addition, the system includes software for processing the data and provides a 2D & 3D mapping of the colon’s interior wall. 

Unlike colonoscopy, this test is a non-invasive, prep-free test. In fact, the patient swallows the capsule and continues their daily routine with no discomfort. At the end of the process, the capsule is naturally emitted from the body. 

Check-Cap initiated pivotal clinical trial in the U.S.

Posted on by Techtime

The medical device start-up Check-Cap, which has developed an X-ray capsule which performs screening test to detect polyps in the colon, announced the initiation of U.S. pivotal trial. The trial was delayed for over a year due to the COVID-19 crisis. At the completeness of this trial and based on the result, the company will file a request to obtain FDA clearance for its innovative C-Scan® system, intended to be the first and only patient-friendly replacement for traditional Colonoscopy test.

The trial will be conducted at the Mayo Clinic Medical Center in Rochester Minnesota, as well as in other medical centers. Mayo Clinic is one of the most respected academic medical centers in the U.S. and around the world, and is in collaboration with Check-Cap for several years.

The trial will include approximately 1,000 subjects ages 50-75 and will be conducted at up to 15 clinical centers in the U.S. The trial is composed of two phases; the first phase will be served as additional calibration of C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second phase consists of a statistically powered, randomized study which will compare the performance of the system to traditional colonoscopy and will enroll approximately 800 subjects. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site. 

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.

“We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population,” said Alex Ovadia, chief executive officer of Check-Cap. “We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022.”

Mr. Ovadia continued, “Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting.”

Check-Cap to produce its own X-ray source

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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.

Check-Cap Reveals the Secrets of its X-ray Capsule

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Check-Cap from Osfiya in the Mount Carmel, Israel, is approaching a major Milestone: soon it will finalize Post-CE and Pilot clinical trials needed to start a pivotal trial in the US to receive FDA Marketing Approval for its revolutionary X-ray ingestible imaging capsule system for colorectal cancer screening. Soon after that, it  will enter the phase of massive marketing and high volume production. Starting with a “soft launch” Israel and Europe, where has is already approved for marketing, and then to enter the lucrative US market in 2021.

Check-Cap was founded in 2005 by Dr. Yoav Kimchi, after a family relative of him was diagnosed with colorectal cancer. He sought a solution to the biggest hindrance in colorectal cancer: Low readiness of men and women over the age of 50 (population at risk) to do colonoscopy. It is an unpleasant screening procedure, yet highly advised by experts to increase survival rates, but only 60% of the target population in the US do go through the colonoscopy test.

Dense Suite of Technologies

To answer the the problem, Check-Cap developed a complex miniature X-ray capsule, C-Scan. Utilizing ultra-low dose X-ray and wireless communication technologies, it generates information on the contours of the inside of the colon as it passes naturally. Thus, provides a preparation-free, colorectal cancer screening method. C-Scan is about 12 mm diameter and 34 mm length. It includes a rotating X-ray source, surrounded by six detectors, a bi-directional RF communication, a safety mechanism to contain the radiation in emergency cases, power management subsystem and unique analytics and modelling algorithm.

In a standard X-ray device, the x-rays emitted from the source penetrate through the body and are absorbed by a detector on the other side. Check-Cap’s detectors are different: they measure the back-scattered photons bouncing back from the intestinal tissue. Since the photons released by the interaction of the X-ray radiation with the share the same amount of energy, it utilizes a photon counter to get the data needed to build the computerized model of the tissue. The photons scattered from the intestinal content have a different amount of energy. The result is a clean image with perfect distinction between content and tissue, eliminating the unpleasant process of bowel cleansing required in a standard colonoscopy.

X-ray testing on the Road

The capsule’s data and location are recorded by 3-axis sensor located on the patient’s back. According to Check-Cap’s CEO,  Alex Ovadia (photo above) the screening process does not interfere with the with patient’s daily routine. “A very complex algorithm synchronize between the tracking device and the capsule inside the bowel. During the process, the patient can drive his car, and use electronic devices and move around. We identify the entry of the capsule into the colon, and by using learning algorithm, we can improve the results without having to repeat the test on the patient.”

Ovadia’s mission today is to bring the technology into the market. Previously a defense engineer working on Elbit’S sophisticated Helmet Mounted Systems (used by F-35 fighter pilots) and GM of Philips CT division, he joined the company a year ago to lead the next phase: “Adapting the test as much as possible to home care environment. Today we are re-shaping the X-ray source and moving from Tungsten isotope to Osmium isotope. Osmium life cycle is almost as long as the screening process itself, freeing the service provider from complicated evacuation process.”

The company also redesign the tracking device to make it much smaller and lighter and has entered into a development project of cloud based analytics platform. “The patient will be able to download the data through wireless connection, from the system directly into the cloud with no need to visit a clinic.” The potential market is huge. The company estimates that the Toal Available Market in the US alone consists of 89 million people. In Europe the willingness to do the screening test is even lower: C-Scan will address 220 million people in Europe and approximately 348 million in China.