On Tuesday’s most recent check, IceCure Medical Ltd. (NASDAQ: ICCM) increased 15.39% to $1.20 in current market value as the firm declared reaching a critical milestone.
What landmark has ICCM accomplished?
IceCure (ICCM) announced today that the Level 1 Breast/Lymphatic Surgery and Related Treatments ambulatory payment classification, 5091, has been awarded by the Centers for Medicare & Medicaid Services (“CMS”) to its ProSense breast cancer cryoablation procedures, with CPT Category III code 0581T. On January 1, 2023, this payment assignment for the treatment will take effect, allowing the possibility for facilities to be compensated, on a case-by-case basis, for these procedures, subject to IceCure receiving FDA marketing approval for ProSense for breast cancer.
For the first breakthrough indication of early-stage low-risk breast cancer patients at high risk for surgery in October 2022, a De Novo Classification Request for breast cancer marketing authorization was submitted to the FDA. Its ICE3 clinical trial interim analysis findings of ProSense support ICCM’s proposal, which is the first and only cryoablation technique for breast cancer to receive Medicare coverage approval.
How does the ICCM process differ?
ProSense considerably lowers the cost of therapy compared to current standard-of-care lumpectomy treatments by removing early-stage breast cancer tumors in a less invasive technique. The cost of the procedure for the ICCM is estimated to be $3,400 under the interim CPT Category III code, which the CMS will reimburse. The formation of the permanent CPT Category I code, which is dependent on a number of variables, including the Company receiving FDA marketing approval for ProSense for breast cancer, is likely to result in more coverage, including reimbursement for the doctor.
According to data, using ProSense cryoablation during breast treatments reduces the chance of re-excision (a second surgery), which occurs in 14% to 20% of breast cancer surgeries and is linked to higher morbidity, patient anxiety, inferior aesthetic results, and higher costs.
How does ICCM stand out?
Only IceCure (ICCM) has the clinical data required to advance cryoablation on both the regulatory and reimbursement fronts and to give breast cancer patients what they deserve: a cutting-edge optimized, minimally invasive technology that destroys tumors, allowing them to easily exit the procedure room and resume their lives free of the disease. When ICCM achieves FDA marketing permission, this Medicare Payment Group assignment will help it to commercialize ProSense for early-stage breast cancer.