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Niramai gets US FDA clearance for their first medical device, SMILE-100 System

US markets now open for the Innovative Indian Startup

Bengaluru, 14 March, 2022: Niramai Health Analytix, the deep-tech Bangalore-based healthcare company offering a novel radiation-free, non-touch, accurate, breast cancer screening solution in India, has now received US FDA clearance for their first device called SMILE-100 System. The SMILE-100 System is a breast thermography device that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It can be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region.  

The SMILE-100 System assists experts to visualize high thermal activity patterns clearly demarcated on thermal images as hotspots and can enable healthcare professionals to make better decisions in breast cancer screening and diagnosis.  Another unique feature of SMILE-100 is use of their patented artificial intelligence-based algorithms to check the quality of input thermal images, which can greatly reduce the errors in thermal image capture and enable low skilled health workers to confidently perform the imaging. 

Dr. Geetha Manjunath, CEO and Founder of Niramai, said, “We are super excited to announce the FDA 510(k) clearance of SMILE-100 System. A proud moment for the team. It was a great learning experience to go through the very rigorous US regulatory process. This win further validates the intrinsic power of NIRAMAI team and has given us the confidence that we can build many more such world-class medical devices of high quality and help reduce untimely deaths due to cancer.”

Niramai is a pioneer in the breast cancer screening with 26 granted international patents. An US FDA approved device is a marquee asset for any Indian health-tech company. In fact, Niramai is the first Indian company to get an US FDA clearance for a medical device used for women health. Last year, the company announced European CE approval for their Thermalytix™ Solution and have already started pilots in multiple European countries. This FDA approval will now give Niramai a tool to foray into the US market and beyond.

Dr Kiran Mazumdar Shaw, the global biotech business leader and Biocon chairperson appreciated this news and said “I congratulate Geetha and her team for this tremendous achievement. Niramai is one of the very few deeptech startups from India which has obtained both European and US clearance for their innovative medical device. Indian startups are solving important healthcare problems that is the need of the hour today. Such milestones of innovation showcase the power of Indian women-led companies to the rest of the world”.

Mr. Manish Singhal, Founding Partner of pi Ventures and the lead investor of Niramai who has been part of their journey since 2017, commented, “In the last five years, we have seen Niramai grow in every aspect – product innovation, team strength, clinical provenance, product adoption and international recognition. I congratulate the team for this exciting win of the FDA clearance for their SMILE-100 System. It’s a great feat for any Indian Startup to get US approval for their medical device. This can be the key inflection point for the company to take their product truly global saving lives all the world.”

NIRAMAI has now created its own reputed brand in India with their innovative breast health products.  Partnering with experienced radiologists and reputed hospital / diagnostic chains in India such as Apollo Clinics, HCG Cancer Hospitals, Rainbow Hospitals among others, Niramai provides breast screening services across 19 cities in India.  Niramai also conducts large scale screening camps in association with Karnataka Cancer Society, Rotary International and other socially concerned organizations. With the FDA cleared SMILE-100 System and CE approved Thermalytix products, the company is now taking their Made-in-India innovation to global scale.


About Niramai Health Analytix:

NIRAMAI Health Analytix is a deep-tech healthcare company offering a novel Artificial Intelligence-based devices. Their flagship product is Thermalytix which is radiation-free, non-touch, accurate, breast cancer screening test for women of all age groups. The solution is portable, automated and detects breast cancer at a much earlier stage than traditional screening methods. NIRAMAI was co-founded in July 2016 by Dr. Geetha Manjunath and Ms Nidhi Mathur. NIRAMAI has so far raised a total of $7M from institutional investors from India, Japan and Singapore. Investors include Dream Incubator, BeeNext, pi Ventures, Ankur Capital, Axilor Ventures, 500 Startups, and others.  NIRAMAI has won many international prestigious awards including World Bank instituted Global Women HealthTech Award 2022, National Startup Award 2020 in India, the Gold prize in Hack Osaka 2019 in Japan and and have received research funding from the Bill & Melinda Gates Foundation and CDC UK. Niramai also conducts regular free webinars and awareness talks on breast health and provides a free breast health helpline on Whatsapp number on +91-9483434444.

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Niramai receives CE Mark – Regulatory approval for Europe

Bengaluru-based healthtech startup Niramai Health Analytix’s patented, radiation-free breast cancer screening solution, Thermalytix™, has received CE mark approval, ISO 13485, and MDSAP (Medical Device Single Audit Programme) International Certifications.

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Different Types of Breast Cancer

There are several types of breast cancer. The type of cell affected in the breast determines the type of breast cancer.

  • Carcinoma- Majority of breast cancers are carcinomas which arise from epithelial cells. When the epithelial cells are from glandular tissue involving milk ducts and glands, such type of carcinoma is called as adenocarcinoma.
  • Sarcoma -Less common types of breast cancer include sarcomas which arise from cells of connective tissue of muscle, fat or blood vessels.

Depending on the extent of spread of cancer into surrounding tissues cancer can be categorized into two types

  1. Invasive (Infiltrating) breast cancer-where the breast cancer invades into the surrounding breast tissue by breaking through the duct and lobular wall. Invasive cancer becomes metastatic once it spreads to lymph nodes or distant organs.
  2. Non-invasive (In situ) breast cancer- where the breast cancer does not spread to surrounding fatty and connective tissue and remains in a particular location(ducts, lobules) of the breast.

Common types of breast cancer

  • Invasive/Infiltrating ductal carcinoma (IDC) not otherwise specified (NOS) is the most common invasive cancer accounting to about 80% of all breast cancers. It originates in the milk ducts of breast tissue and invades into the surrounding fatty tissue through the wall of the duct. It further metastasizes to distant organs through lymph nodes and blood stream. It is an aggressive invasive cancer and prognosis depends on the stage
  • Invasive/Infiltrating lobular carcinoma is second common invasive cancer accounting to about 5-15% of all breast cancers. It starts in the lobules of the breast and invades into the surrounding tissue with a tendency to metastasize.
  • Ductal carcinoma in situ (DCIS) is an early stage (stage 0) cancer which is non-invasive in nature. The tumor cells lining the duct do not spread to surrounding tissue and are confined to the lining of milk ducts. Most of the women in this stage can be treated. DCIS is rare in countries like India as most cases present at later stage.
  • Lobular carcinoma in situ (LCIS) begins typically in the lobules of the breast glands and doesn’t spread beyond the wall of lobules to the surrounding breast tissue. Women having this condition are more likely to develop invasive cancer in future.

Sub types of invasive breast cancer

There are some special subtypes of invasive breast cancer which are less common in occurrence. They are often named based on their microscopic appearance arising from the alignment of cancer cells. They have better prognosis than the common types of invasive ductal breast carcinoma and respond well to the treatment. These include

  •  Medullary carcinoma (3-5%) with soft, fleshy mass resembling the medulla of brain
  • Mucinous/Colloid carcinoma (1.1%) formed by mucous producing cancer cells appearing mucinous
  • Papillary carcinoma where cancer cells are arranged as finger like projections
  • Tubular carcinoma where cancer cells are arranged in tube like structures

Other rare types of breast cancer

  • Inflammatory breast cancer accounts to about 1-3% of all breast cancers. It is less common aggressive cancer that often affects the skin. Cancer cells often block lymph vessels of the breast giving rise to appearance of red, swollen and warm inflamed breasts. Other symptoms include dimpling of breast skin and pulling in of nipple.
  • Pagets disease of the nipple accounts to about 1-3% of cancers. It is rare form of breast cancer that starts from ducts of breast and spreads to the skin of nipple & areolar area.
  • Phyllodes is a rare tumor that can be benign, malignant or borderline. It develops from the connective tissue of breast that surrounds the ducts and lobules. It grows quickly but rarely spreads outside the breast.
  • Metastatic breast cancer is an advanced cancer (stage –IV) that spreads to distant organs like lung, liver, bone and brain
  • Male breast cancer accounts to about less than 1% of all breast cancers. Males have breast tissue that develops in the same way as in women. But it is uncommon in males as breasts in men have less developed ducts and are not exposed to growth promoting female hormones.
  • Metaplastic breast cancer is rare heterogeneous cancer which represents less than 1% of all breast cancers. It is characterized by presence of both epithelial and mesenchymal components and has poor prognosis compared to Invasive ductal carcinoma.
  • Angiosarcoma accounts to about less than 0.05% of all breast cancers. It arises from cells lining blood vessels or lymph vessels. It can either involve the breast tissue or skin of the breast. It is aggressive with poor prognosis compared to invasive ductal carcinoma.

Based on Hormone receptor status

All invasive and in situ cancers are tested for hormone receptors. Hormone receptor positive tumors contain many hormone receptors. Such tumors can be treated by hormone therapy. Majority of breast cancer cases are hormone receptor positive.

Triple negative breast cancer involves tumours where the cells are negative for progesterone, estrogen and HER2/neu receptors. These cancers do not respond to hormone therapy. They are aggressive high grade tumors common in younger women and often have a ductal origin.

Different types of breast cancers tend to have different outcomes requiring different treatments. Tests like Niramai which can detect cancer accurately in its early stages compared to other modalities would always be a big plus in improving treatment effectiveness.


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