Pioneering Cryoablation Therapy for Breast Cancer in Japan
IceCure Medical, a leader in cryoablation technology, recently showcased its ProSense® system at the 33rd Annual Meeting of the Japanese Breast Cancer Society held in Tokyo. This conference highlighted updated clinical data revealing an impressive 99% recurrence-free rate following treatment with cryoablation, a minimally invasive procedure that freezes tumors, offering new hope for breast cancer patients.
Clinical Data Presented
During the conference, Professor Eisuke Fukuma, a renowned breast surgeon at Kameda Medical Center and a proficient user of ProSense®, presented findings from independent studies involving over 600 women from 2006 to 2023. Under his expertise, the procedures demonstrated a remarkably low rate of local recurrence.
Professor Fukuma's presentation covered the following key findings:
- - A total of 535 patients treated for tumors smaller than 15 mm recorded an ipsilateral breast tumor recurrence rate (IBTR) of just 0.98%, translating to a 99.02% efficacy in preventing recurrences spanning up to 17 years.
- - Among patients with a follow-up extending beyond ten years, including 51 with invasive ductal carcinoma and 20 with ductal carcinoma in situ, the recurrence rate was recorded at 2.8%, which still reflects a strong 97.2% success rate.
Award-winning Research
Additionally, Dr. Richard Fine, a leading breast surgeon from the West Cancer Center Research Institute in the U.S., contributed by sharing outcomes from IceCure’s ICE3 study, discussing further enhancements in cryoablation for breast cancer.
An independent study led by Professor Hisanori Kawamoto of St. Marianna University School of Medicine was honored with the Best of Breast Cancer award. This research, titled “Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan,” reported zero local recurrences within five years after utilizing ProSense®. Dr. Kawamoto emphasized the increasing breast cancer diagnosis rates among women in Japan, particularly those in their late 40s to early 60s, and highlighted the critical need for effective and minimally invasive treatment modalities.
Collaboration for Future Success
IceCure’s CEO, Eyal Shamir, expressed optimism about the potential of ProSense® in improving breast cancer outcomes in Japan. The company is collaborating with Terumo Corporation, Japan’s leading medical device firm, anticipating swift commercial adoption following regulatory approval for breast cancer treatments. Shamir referred to the conference as an invaluable opportunity to engage with leading surgeons and industry experts, aiming to promote the ProSense® system effectively.
Regulatory Path Ahead
Looking forward, Terumo Corporation is poised to submit an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) by the end of 2025, seeking regulatory clearance for ProSense® in breast cancer treatment.
About ProSense®
The ProSense® Cryoablation System represents a breakthrough in cancer treatment methodologies. By employing liquid nitrogen to achieve extensive, lethal tumor destruction zones, it serves as a therapeutic alternative to traditional surgical options, allowing for faster recovery, reduced pain, and minimized surgical risks. With its compact design and efficiency, ProSense® enables outpatient procedures, catering to the increasing demand for less invasive cancer treatments.
The Future of Cancer Treatment
IceCure Medical is at the forefront of developing innovative cryoablation systems that target not only breast cancer but also other malignancies such as kidney, lung, and bone cancer. By adopting such advanced technologies, the healthcare landscape may significantly shift, presenting patients with safer, more effective treatment options without the need for complicated surgical interventions.
This groundbreaking work could reshape how breast cancer is treated, especially for women in active phases of life who seek to minimize the disruptions hospitalization causes. As IceCure Medical continues to navigate regulatory frameworks and commercial avenues, the future of non-invasive cancer care looks promising.