Breast cancer remains the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012. In South Africa alone, 1 in 28 women will develop breast cancer in their lifetime. Surgery has remained the default treatment option for removing breast tumours, which although can be effective in preventing recurrence, is an invasive medical procedure that’s associated with a hefty price tag, long recovery time and cosmetic and emotional scarring.

The evolution of tumour ablation

Over the past three decades tumour ablation has become a preferred minimally invasive alternative to traditional surgery for treating solid cancers. During the process, a probe the size of a biopsy needle is guided by a U/S into the affected tissue area to destroy the tumour. While thermal, radio frequency, microwave and high intensity focus ultrasound are commonly used to burn the tumours away, an ablation technique using cryoablation freezing technology uses high pressure argon and helium gas to freeze tumours at -100°C. While this cryotherapy technique was a great milestone in cancer treatment, unfortunately it remained an expensive option because each canister of gas could cost up to $500 USD, and was only being applied to prostate, renal and kidney cancer, not breast cancer.

This all changed in 2006 when IceCure Medical, an Israeli-based medical device company, developed  an advanced form of cryoablation that uses liquid nitrogen, a cheap and commonly found alternative to argon and helium gas, which is capable of freezing benign and early-stage breast cancer tumours into obliteration at -170°C.

“Patients who have other forms of cancer, like kidney cancer, have a number of treatment options available to them over and above conventional surgery, such as robotic surgery or thermal ablation. Therefore IceCure’s initial focus was on benign breast tumours – fibroadenomas, because up until now treatment options have been limited to standardised invasive surgery that would remove a noticeable portion of breast tissue during a lumpectomy,” IceCure’s CEO, Eyal Shamir, told eHealthNews.

Innovative cryoablation technology

IceCure’s FDA and CE approved IceSense3™ cryoablation technology is a portable, customisable system that was designed specifically for outside theatre use, such as a doctor’s practice or even a small rural clinic. The system’s interface consists of a touch screen through which the doctor can customise the procedure for the individual patient, ensuring targeted treatment.

During the procedure, after the doctor administrates a local anaesthetic to the patient, a small probe is inserted into the breast and guided using ultrasound imaging into the fibroadenoma. During the cryoablation of the fibroadenoma the tumour cells are destroyed, which the patient’s body will reabsorb gradually over time. Vacuum insulation along length of probe ensures that the surrounding tissue and skin are protected against the cryoablation. From a cosmetic perspective, no breast tissue is removed so the breast keeps its original shape, size and volume.

“The whole cryoablation procedure takes less than 15 minutes and is virtually painless. The procedure is performed using a small incision that’s less than 3mm, so there’s no scarring and the patient will be able to return to her normal routine almost instantly,” said Shamir.

Although the IceSense3 cryoablation technology was developed as a safe and effective way to treat fibroadenomas, the system has also proven effective in treating early-stage breast cancer.

“Patients who have undergone the procedure have been extremely happy with the results; and as clinical studies have demonstrated, cryoablation is directly linked to a lower local recurrence rate,” said Shamir.

Clinically-backed evidence 

A recent US study carried out by the American Society of Breast Cancer Surgeons found that cryoablation shows promise as a non-surgical alternative treatment for early-stage breast cancer due to it successfully treating tumours up to 1cm.

“According to the aforementioned Society, 62% of all diagnosed breast tumours in the western world are up to 2cm solid and considered as early-stage. In this scenario, lumpectomy has become the go to option; with our technology lumpectomies can be avoided all together with the patient receiving no cosmetic damage. Also just as important, cryoablation is cheaper than surgery and is also associated with far lower local recurrence rates,” said Shamir.

IceSense3 was recently the focus of the ICE3 clinical trial which aimed to evaluate afficacy and safety of cryoablation without lumpectomy on low-risk early-stage breast cancer in women. The trial was carried out at 18 sites across the US – consisting of top breast treatment centres, which in total enrolled 156 female patients who were at least 50 years old and had a breast cancer tumour smaller than 1.5cm.

“During the study the average patient age was 76 and the tumour size was 7.5mm; and of the patient participants 152 were successfully treated. Out of the 104 patients followed for almost two years following the procedure, only one patient had a local recurrence,” said Shamir.

“Due to the study’s success, the American Society of Breast Cancer Surgeons is now considering adding our technology as part of the US breast cancer treatment guideline,” continued Shamir.

Borderless application

According to Shamir, there is a direct cost-saving associated with IceSense3 due to its portable nature and the quick, minimally invasive cryoablation procedure under local anaesthesia. “The procedure can be done in 20-30 minutes by a breast surgeon or a breast technologist; all they need is a bed for the patient, a CT scan and our machine. So the procedure can be done anywhere outside of an operating room setting – from a small private clinic to a rural clinic,” said Shamir.

“This means that overall the patient recovery, the payer cost and the cosmetic outcome is a million times better than conventional surgery,” continued Shamir.

To date 60 IceSense3 machines have been installed in clinics across the US, Europe and Asia, and talks are underway to bring the technology to South Africa. According to Shamir, IceCure is seeking a strategic partner to help bring IceSense3 to the local market, and they are also seeking approval from the National Department of Health for both the device and treatment.

“Our technology could greatly benefit South Africa and the African continent at large because liquid nitrogen is a readily available, cheap gas, meaning the cryoablation procedure could be done in even small isolated villages,” said Shamir

“However, what’s really important is for women to have regular screenings for breast cancer to ensure early detection, because that’s the only way cryoablation will be a plausible and successful treatment option,” concluded Shamir.

Although IceCure has been marketed solely as a breast tumour treatment option, the IceSense3 device has also been approved to treat kidney, lung, liver and bone cancer. According to Shamir, in 2019 they will also start treating prostate cancer.

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