ProSense Cryoablation Device Granted Breakthrough Device Designation

The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer, according to a press release by IceCure Medical Ltd.¹

ProSense uses a computerized tomography (CT) scan or ultrasound in order to guide a probe that delivers liquid nitrogen into the tumor. The sub-zero temperatures turn the tumor into an ice ball and a freeze-thaw-freeze cycle destroys the targeted tissue and leaves healthy tissue undamaged. The debris left the procedure is absorbed by the body.² 

The designation is based on the upcoming interim results of the ICE3 trial (NCT02200705), which will be presented at the upcoming American Society of Breast Surgeons Annual Meeting on April 30.¹

The study has an estimated enrollment of 200 participants. During the single-arm study, all patients were treated with the ProSense system. The study had a primary outcome of local in breast tumor recurrence (IBTR) rate with a time frame of up to 5 years. Secondary outcomes included complete ablation of primary tumor up to 60 months after cryoablation, improvement or maintenance of quality of life, breast cosmetics satisfaction, regional and distant invasive breast tumor recurrence rate, and disease-free survival.

In order to participate, patients must be female and 50 years old or older. Additionally, they must have a tumor size of less than 1.5 cm in diameter and breast size that is adequate for safe cryoablation. Patients with the presence of luminal B pathology or lobular carcinoma are not eligible to participate.

Three-year follow-up data were available on more than 75 patients. As of the first reported data in 2018, no serious adverse events have been reported. Additionally, only one patient reported disease recurrence, making the procedure 99.4% effective.³ According to IceCure, 95% of patients and doctors are happy with the cosmetic results and 76% of patients were able to resume their daily lives within 48 hours.⁴

“We are thrilled to receive the Breakthrough Device Designation from the FDA for our lead asset, ProSense®, based on promising clinical outcomes in multiple clinical studies to date. ProSense® has successfully demonstrated the potential to be an exceptionally safe and effective minimally-invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense® to become the new gold standard for cryoablation tumor therapy," said Eyal Shamir, chief executive officer of IceCure in a press release.¹

ProSense is being investigated in a number of different cancers. The phase 4 ICE-SECRET trial (NCT02399124) aims to determine the therapy’s effectiveness and safety in renal cell carcinoma. The single-arm study has an estimated enrollment of 120 patients and an estimated completion date of January 2025.

Primary outcomes of ICE-SECRET include success in creating an ice ball that engulfs the whole tumor with 5 mm margins and recurrence-free survival. The secondary outcome of the study is safety verification. In order to participate, patients must be 18 years old or older and has a mass 5 cm or less. Patients with any terminal illnesses, permanent coagulation disorders, or who are participating on other clinical trials using drugs or devices are not eligible to participate. 

_REFERENCE:

_{1. IceCure Medical Granted FDA Breakthrough Device designation for ProSense Cryoablation System. News Release. April 5, 2021. Accessed April 5, 2021. https://bit.ly/31LMZAi}

_{2.ProSense Next Generation Cryoablation Technology. IceCure. Accessed April 5, 2021. https://bit.ly/3fEVUff.}

_{3. RSNA 2018: preliminary results of primary cryoablation in treating low-risk breast cancers. ASCO Posts. December 12, 2018. Accessed April 5, 2021. https://bit.ly/3dzuODJ.}

_{4. Backed by clinical evidence: The ICE3 Trial. IceCure. Accessed April 5, 2021. https://bit.ly/39JjBiu.}