Check-Cap (NSDQ:CHEK) said it finalized a manufacturing line transfer implementation and qualification with the healthcare business at General Electric (NYSE:GE) for its C-Scan system, a preparation-free ingestible scanning capsule-based system designed to prevent colorectal cancer.
The C-Scan system is in the midst of a pilot clinical trial at the New York University School of Medicine and Mayo Clinic. Israel-based Check-Cap intends to continue the collection of clinical data ahead of a planned pivotal study. The system has received CE marking in Europe and approval from the Israeli Ministry of Health, the Medical Device Division. If positive results are obtained from the pilot trial, Check-Cap plans to file for FDA approval of a pivotal trial, to begin in 2020.
Check-Cap and GE Healthcare collaborated on C-Scan manufacturing for the U.S. clinical trials. Upon the successful completion of the current trial phase, the two companies plan to explore collaboration expansion opportunities.
“Our collaboration with GE Healthcare, a global leader in medical technology manufacturing, has established a solid manufacturing infrastructure for the C-Scan system,” Check-Cap CEO Alex Ovadia said in prepared remarks. “We are confident in GE’s ability to scale up production and intend to explore other possible collaboration opportunities, primarily in the U.S., while adhering to regulatory and safety standards in various markets worldwide, as we advance our pilot clinical trial in the U.S.”
“We have worked closely with the experienced Check-Cap team to transfer and qualify the manufacturing process of the C-Scan system to GE Healthcare,”added GE Healthcare general manager of Americas Pharmaceutical Diagnostics Marco Campione. “This partnership reflects our commitment to helping Check-Cap increase capacity, improve productivity and potentially leverage our global infrastructure to improve people’s lives.”
