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

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.”

The FDA approved Insightec system for the treatment of advanced Parkinson

The U.S. Food and Drug Administration (FDA) has approved Insightec’s system for treating advanced Parkinson Disease (PD) patients suffering from rigidity, mobility and dyskinesia symptoms. This is a significant expansion of Insightec’s system clinical indication, which until now was approved for treating PD patients experiencing essential tremor. Last month Insightec signed a merger agreement with a SPAC in order to list on Nasdaq with a company valuation of $2 billion. The new clinical indication extends the potential market for the company’s system. Currently, one million patients in the United States are coping with PD.

The system developed by Insightec is a minimally invasive surgery (MIS) technique, used for treating symptoms such as essential tremor and benign tumors in the uterus using focused ultrasound waves. Within the new clinical indication, Insightec’s system may be used as an incisionless method of performing a process called Pallidotomy, which is used to ablate a brain area called globus pallidus. Until now, the only method of performing Pallidotomy was to place a tiny electrical electrode in the globus pallidus, which is then heated and destroy a small area of brain cells. Using Insightec’s device, this process could be performed incisionlessly, by externally focusing the ultrasound waves to the target area. In many cases, this process reduces the severity of the patient’s symptoms.

Founded in 1999, Insightec developed the Exablate platform which provides non-invasive treatments for a variety of oncology and gynecology indications. Exablate Neuro uses focused ultrasound waves to target and ablate tissue deep in the brain with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring.

In May 2017, Insightec received FDA Approval for Exablate Neuro fo the treatment of essential tremor. Following the approval Insightec has decided to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication.

Parkinson’s disease afflicts millions of people worldwide, including approximately one million in the United States alone with 60,000 additional diagnoses each year. Treatment with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.