HIHI launches new FemTech case study with CLISTEPROBE. Their novel diagnostic technology aims to reduce wait times for breast cancer biopsy results

CLISTEPROBE technology aims to decrease anxiety for women waiting for breast cancer results with a novel biopsy technology which will reduce result wait times

Read the full case study here https://hih.ie/downloads/case-studies/HIHI-case-study_ClisteProbe.pdf

October marks Breast Cancer Awareness Month internationally. CLISTEPROBE have devised a novel method for breast cancer diagnosis which will reduce delays in providing patients with results. The Cork team based at University College Cork (UCC) and supported by Health Innovation Hub Ireland (HIHI) offers new hope to women with their innovative breast cancer screening and detection technology. This will come as welcome news as each year in Ireland, more than 3,400 women and approximately 30 men are diagnosed with breast cancer. Globally, according the World Health Organisation (WHO) breast cancer caused 670, 000 deaths in 2022.

The new venture emerging from UCC and Tyndall National Institute is an Enterprise Ireland (EI) Commercialisation Fund programme and was awarded €753K by EI to continue technical and commercial development on a bioimpedance biopsy needle. CLISTEPROBE specialises in developing advanced biopsy devices which will improve the accuracy and efficiency of disease detection in breast cancer and prostate cancer.

What is the new technology and how will it improve the detection and treatment of breast cancer? The biopsy device provides real-time diagnostic data to empower clinicians to make informed decisions during biopsy sampling by identifying benign and cancerous tissue. Millions of women around the world undergo breast biopsies following suspicious mammograms, waiting days and even weeks to get results. This causes stress and anxiety and in some cases unnecessary worry as up to 80% of these breast biopsies are benign and not indicative of cancer. The gamechanger is separating benign and malignant cases at the time of biopsy leading to a reduction in turnaround times of the biopsy. For those with malignant results, it will allow patients to start treatment immediately.

CLISTEPROBE’s pioneering technology is designed to revolutionise breast cancer diagnosis during biopsy procedures. The device named CLISTEPROBE, enhances point-of-care capabilities by integrating sensors that provide real-time tissue assessment. Bioimpedance sensors are used to differentiate diseased from healthy breast tissue, which is based on the changes in the electrical properties of each tissue type. The sensors are fabricated on the bevelled needle surface. The technology allows for more targeted biopsies, reducing the number of benign samples sent for histopathology and potentially minimising the need for multiple biopsies. The benefits from a clinical perspective are: a reduction in the workload of radiologists, improvement in  the patient care model and most importantly providing quicker and more accurate biopsy results. This will go a long way towards accurate and timely diagnosis of breast cancer in Irish women.

According to Breast Cancer Ireland

• 1 in 7 women will be diagnosed in their lifetime
• 1 in 728 men will be diagnosed in their lifetime
• We have 3,700 new cases of breast cancer diagnosed each year.
• 23% of women are diagnosed between the ages of 20-50 years.
• 34% of women are diagnosed between the ages of 51-69 years.
• 43% of women are diagnosed over the age of 70 years.
• Only 5%-10% of breast cancer cases are hereditary.

Health Innovation Hub Ireland (HIHI) played a crucial role in the CLISTEPROBE project with Dr Michael Twomey (Senior Clinical Research Manager) and Ms Niamh Allen (HIHI Clinical Liaison, based at University College Cork & South Infirmary Victoria University Hospital) facilitating part of the evaluation phase of their innovation pathway in breast cancer diagnosis. HIHI organised a series of focus groups and interviews with relevant healthcare professionals, including breast surgeons, oncologists, radiologists, and nurses, to gather feedback on the CLISTEPROBE device. HIHI’s involvement ensured that the team received comprehensive insights that could be integrated into their research and development processes to optimise the device for clinical use.

This newly launched CLISTEPROBE pilot study is part of HIHI’s FemTech initiative which focuses on women’s health from birth to death and includes areas such as adolescent health, fertility, menstruation, menopause, gynaecological health, pregnancy, cancer, mental health, female wellness and health conditions that affect women disproportionally. Health Innovation Hub Ireland’s FemTech initiative, supports the development of high potential new products, services and start-ups aiming to improve the health and wellbeing of 50% of the Irish population, women. It also aims to create a geographical FemTech focus and build an ecosystem of experts and entrepreneurs supporting, driving and innovating.

Dr Justina Ugwah CEO, commented on Breast Cancer Awareness Month and the benefits of CLISTEPROBE

“The devastating impact of this disease through my father’s friends who lost their wives to breast cancer. The pain and anguish I saw left an indelible mark on me. What’s particularly striking – and heartbreaking – is that even today, women still endure the excruciating 10+ day wait for biopsy results, a wait filled with anxiety and uncertainty. This reality drove me to get involved with CLISTEPROBE. To me, this isn’t just about developing technology; it’s about transforming lives. Every day of waiting for results is a day of emotional turmoil for patients and their loved ones. By providing rapid, accurate diagnostic results, we’re not just saving time – we’re offering peace of mind, enabling faster treatment decisions, and ultimately, saving lives.

Breast cancer doesn’t just affect individuals; it impacts families, friends, and entire communities. During this Breast Cancer Awareness Month, I’m more determined than ever to ensure that the next generation of women won’t have to endure the same agonizing wait that countless others have faced. CLISTEPROBE represents hope – hope for quicker diagnoses, more effective treatments, and ultimately, better outcomes for breast cancer patients everywhere. This is personal for me. It’s about honoring those we’ve lost, supporting those who are fighting, and creating a future where breast cancer diagnosis and treatment are faster, more accurate, and less emotionally taxing for everyone involved”.

Dr Tanya Mulcahy, Director HIHI Ireland and founder of FemTech Ireland welcomed the launch of the CLISTEPROBE pilot.

“Supporting innovations in women’s health is the key driver of our FemTech programme, we are delighted to support CLISTEPROBE, through clinical engagement, in the development of their novel biopsy device. Supporting the translation of academic research to product drives better outcomes for patients and in this case has the potential to impact the millions of people who undergo breast biopsy globally”.