The number of cancer cases in India is projected to rise from 14.6 lakh in 2022 to 15.7 lakh in 2025, according to the Indian Council of Medical Research-National Cancer Registry Programme (ICMR-NCRP).
India’s cancer problem is growing, as is the struggle in dealing with the cancer margin. When cancerous cells are surgically removed, a rim of normal tissue surrounding the tumour is also removed. This rim is called the margin, and reveals whether or not all the cancerous cells have been removed.
Negative margins are the goal of curative cancer surgery, but intraoperative margin assessment continues to challenge surgeons. Surgeons don’t have enough tools to effectively see the cancerous cells, and the current procedures are time consuming. Apart from this, in cases of cancer in organs like breast and oral/head and neck, the margin is extremely critical as the amount of extra tissue affects the recovery.
As per standard procedure, a pathologist examines the margin – commonly after surgical biopsy, lumpectomy, or mastectomy – to see if cancer cells are present. The margin is ‘negative or clean’ if there are no cancer cells at the border of the tissue – an indication that cancer has successfully been removed. A ‘positive’ result indicates the presence of cancer cells and the need for additional surgery or radiation, and carries significant financial and prognostic implications. The current procedures to examine the cancer margin are frozen section analysis and the gold standard technique, histopathology assessment. Both are time consuming and the patient is usually stitched up by the time the result comes in. The histopathology procedure is complex and takes around three to four days. In frozen section analysis, pathologists take a minimum of an hour to 45 minutes, a time span where the patient is kept under anaesthesia as the doctor awaits results. If a positive margin is detected, the surgeon has to operate on the patient again. As many as 30% cancer surgeries fail due to inaccurate margin detection, leading to a total of 2,64,000 repeat surgeries per year.
Dr Jyotirmayee Dash realised how big of a challenge cancer surgeries are when her close friend was diagnosed with breast cancer in her early 30s. Even though the tumour was small, the doctors decided to remove the entire breast to reduce room for error.
“People in the medical fraternity are scared of the cancer margin. There is no intraoperative device in the country that can tell doctors whether the cancer has been removed properly or not,” she says.
This realisation led her to launch TeraLumen Solutions Pvt Ltd, India’s first company that leverages terahertz technology for cancer margin detection, with a focus on breast and oral cancer.
Leveraging terahertz technology
As someone involved in setting up the first fully dedicated terahertz laboratory in India, working with the technology came easily to Dash. After completing her bachelor’s degree in engineering from a government college in Odisha, she went to Chennai for her master’s degree, followed by a stint at CSIR to complete her doctoral studies.
In 2017, she completed her PhD and joined SRM University in Chennai as an assistant professor, which is where her life changed. While working as a professor, Dash began to make plans for TeraLumen Solutions Pvt Ltd by brainstorming with her peers and mentors, building resources and raising funds.
In 2019, she finally embarked on her entrepreneurial journey.
While working with terahertz, which lies between the microwave and infrared regions of the electromagnetic spectrum, she realised that the technology offered industrial applications that no other frequency spectrum could cover. It could differentiate between cancerous and non-cancerous tissues, and reveal whether the cancer margin was clear or not.
“[We] are the first company to leverage this technology. Most state-of-the-art technology and devices in India are very expensive, close to a crore. The sector has to depend on importing these devices from other countries. We thought we could build a device, which will be indigenous, quick, and low cost, and take it to the general public and hospitals,” Dash says.
Dash decided to counter the prevalent methods with a device based on artificial intelligence-enabled terahertz technology. The device aims to let surgeons detect the cancer margin accurately and non-invasively during surgery, in about 10 minutes. It additionally focuses on reducing time and complications, while providing higher accuracy and reducing the number of repeat surgeries. The TeraLumen Device for Margin Assessment hopes to provide 95% accuracy, 95% sensitivity, and 90% specificity. Dash claims that the device is 5X faster than frozen section analysis, and 100X faster than histopathology assessment.
Since the device can be used during surgery in the operating room, it saves a lot of time by skipping the further involvement of a pathologist. “We do not need separate pathologies or pathology labs to be involved. The sample to be used in this process is completely reagent-free. The doctor can see the results through their mobile phone or on a laptop,” she says.
Scaling up
As a deeptech company in the medical field, it wasn’t easy for Dash to raise money at the beginning. “Each component cost me lakhs,” she reminisces. TeraLumen developed its first prototype from a big grant that they received. It is using the more recent Pfizer INDovation Grant to conduct clinical trials.
The long and complex regulatory lifecycles of new medical devices is certainly difficult to manoeuvre, but the founder is hopeful. “We have started our ISO certification. In another six months, we will finish most of the trials and ISO certification regulatory process,” she says.
The ongoing clinical trial focuses on breast cancer and oral cancer. Tumours in breast cancer cases are usually very small, and the technology helps for breast conservation surgery. In cases of oral cancer, the margin is critical because any extra removal affects the speech. TeraLumen is focusing on these two cancers for now, but Dash says the technology can be used for every kind of cancer.
She aims to reach more and more hospitals with her technology. Most health facilities today lack the infrastructure for quick, cost-effective and non-invasive tools, and the startup aims to bridge this gap with their technology.
The next steps
Going forward, Dash’s team is integrating artificial intelligence that will aid the surgeons with more accurate decision making.
The company’s vision for the product is that it could be used in the operation theatre for sample analyses to address the current limitations of frozen section analysis and histopathology, and further reduce the dependency on the pathologists.
TeraLumen is targeting the India market for now, and plans to expand their reach in Southeast Asia and other Asian countries. The company is also working on FDA approvals to launch in the US and the European countries.
The team is looking to raise funds, which Dash calls “challenging” as the medical device industry is highly capital intensive with a long gestation period. The industry is constantly seeing the introductions of various new technologies, which requires the healthcare industry and its professionals to adapt and learn, thereby increasing the adoption barriers and slower uptake of the new products and technologies. These factors are responsible for the hesitation of private investors, who are also unsure about the medical devices’ regulatory lifecycles. But despite these challenges, Dash is hopeful that her product will revolutionise and change the way cancer surgery is done.
TeraLumen is one of the winners of the Pfizer INDovation programme, which was launched by Pfizer and Social Alpha to accelerate the journey of promising medtech startups.
“The Pfizer INDovation programme really helped us grow; they helped us connect with various hospitals, surgeons, and key opinion leaders. The team also mentored us in various ways such as working with us on our business model, helping us with go-to-market strategies, talking to customers, and making our value proposition, etc,” Dash says.
