Healthtech Startup Niramai to Expand its Base to European Economic Area

Healthtech Startup Niramai to Expand its Base to European Economic Area
Niramai, a deep-tech Health Analytix based in Bengaluru, has obtained CE Mark approval, ISO 13485, and MDSAP (Medical Device Single Audit Program) International Certifications for its AI-based, radiation-free breast cancer screening test. This gives the startup the ability to market its product in the European Economic Area.
Breast cancer is the most common cancer in women and the leading cause of death. According to the World Health Organization, one in every eight women in the United States is at risk of developing a breast abnormality at some point in their lives. Early detection of cancer is well known to save a cancer patient's life.
In 2021, it is expected that 2,81,550 new cases of invasive breast cancer and 49,290 new cases of non-invasive (in situ) breast cancer will be diagnosed in women in the United States. In India, 1,62,468 new cases of breast cancer were reported in 2018, with 87,090 deaths reported. Cancer survival becomes more difficult as it progresses, and more than half of Indian women are diagnosed with stage 3 or 4 breast cancer.
Niramai, which was established in 2016, has created a novel breast cancer screening solution based on Thermalytix, which is machine intelligence applied to thermography images, and a cloud-hosted analytics solution that employs big data analytics, artificial intelligence, and machine learning algorithms for early and accurate breast cancer detection.
The solution is now in use in many hospitals and clinics across the world, including HCG Hospital, Apollo Clinics, and Healthspring Diagnostics, among others, and it has now been licensed to sell its product service internationally.
“We are delighted to receive the CE marking, ISO, and MDSAP certifications for our technology, further strengthening our resolve to detect breast cancer in early stages and save lives. These certifications enable us to expand our operations internationally and meet the strong global demand we are seeing for our novel solution,” said Dr. Geetha Manjunath, Founder & CEO, Niramai.
She also reported that the company plans to partner with National Health Service radiologists and other key opinion leaders for initial market research in Europe, Africa, and Asia.
“In addition, we are in the process of partnering with more Indian healthcare providers for pan-India adoption,” Dr. Geetha added.
The startup has so far raised a total of $7 million from investors such as pi Ventures, Dream Incubator, Axilor Ventures, Ankur Capital, BeeNext, and others.
Its solution has already been received ten US patents, three Indian patents, two Chinese patents, and two Singaporean patents. The startup has secured various awards, including the Gold prize at Hack Osaka 2019, the Aegis Grahambell Award, and the Frost and Sullivan Award.
Niramai received the National Startup Award in the Healthcare Diagnostic category in 2020.