Unmet needs, value proposition, technical feasibility, team strength & commercialisation potential: Key parameters for funding support from BIRAC

Dr Manish Diwan, Head – Strategy Partnership & Entrepreneurship Development, BIRAC, Department of Biotechnology, Government of India in an interaction with Viveka Roychowdhury talks about BIRAC’s criteria for selecting and funding start-ups

What is BIRAC’s criteria for selecting start-ups and ideas for funding, when it comes to the healthcare space?

BIRAC focuses on start-ups that are working to address unmet needs through development of technology-based globally competent and affordable solutions with the potential for commercialisation. A start-up can receive funding support from BIRAC across the value chain from ideation to proof of concept, minimal viable protype to validation and pilot to manufacturing stage. Unmet needs, value proposition, technical feasibility, team strength and commercialisation potential are the key parameters used for competitive evaluation of an application for funding support from BIRAC.

Why was Cardea Biomedical Technologies’ handheld ECG device chosen? What are the gaps in our public health ecosystem that the device addresses, especially those accentuated by the COVID-19 pandemic?

This handheld ECG device by Cardea Biomedical Technologies can work in low resource settings, providing accessible, affordable and a high-quality solution, and therefore it was chosen for support by BIRAC. Cardiovascular Diseases (CVDs) are on rise in the country and ECG screening is clinically helpful for early diagnosis of CVDs. The device has been named by the founder as Accurate Tele-Electrocardiogram on Mobile (ATOM). The device can also be used routinely to check ECG and is especially relevant in the current COVID-19 situation.

ATOM ECG is a product for monitoring the heart health of COVID-19 patients and post COVID19 patients. A regular 12 lead ECG is mandatory to check for myocardial inflammation. For Covid19 patients, there is a high probability that the ECG paper may get contaminated with the virus when the ECG is conducted in the COVID ward and might become a carrier of the virus to the cardiologist and care giver. When using ATOM ECG, there is no paper requirement and the ECG can be safely sent to the cardiologist instantly, using applications such as WhatsApp and Email.

Walk us through how the device works and its USPs compared to handheld ECG devices in the market.

ATOM can potentially record a medical grade 12-lead simultaneous ECG on any low-cost smart phone. It is a low-cost, portable, and compact equipment. With Bluetooth connectivity between hardware and mobile, the transmission of the ECG PDF file recorded on ATOM app is easily done through messaging services such as WhatsApp, or emails to a cardiologist for immediate tele-consultation.

ATOM ECG comes with Machine Learning (ML) algorithm which runs instantly on the smartphone itself to identify several cardiac anomalies. This allows ATOM a differential advantage compared to its peers to provide the necessary information without having to send the data to cloud via internet services. The mobile application is being made extremely user-friendly while handling the most sophisticated algorithms, to get noise-free data with ease.

ATOM’s features also include Augmented Reality-based Electrode Placement Guidance System. This helps the user place the electrodes with desired clinical precision even without support from any trained personnel.

Such features enable this to be an affordable, accessible, and friendly solution for low resource settings, especially relevant for rural and tier 2 and 3 towns where skilled healthcare givers and access to expertise might not be available easily.

What was the funding received by Cardea and the terms of the funding?

Cardea Biomedical Technologies has won BIRAC’s BIG grant. Under BIG, INR 50 lakh grant-in-aid is given to innovative ideas. It allows access to incubation, high end instrumentation, hiring manpower, engaging experts, and other opportunities. ATOM was also supported (both funded and facilitated) under the BIRAC- WISH (Wadhwani Initiative for Sustainable Healthcare Foundation) partnership program, where the ATOM ECG device was field validated during the period August 2018 to March 2019 in Primary Healthcare (PHC) settings in Rajasthan.

How has the device performed during the pilot roll-out? What kind of public health settings was it trialled in?

Pilot studies were conducted in two phases in PHC at Rajasthan between Aug 2018 to Mar 2019. The white paper was submitted by WISH which summarizes the following:

• The first phase aimed to estimate sensitivity of ATOM in screening patients for CVDs: During the study period, a total of 463 patients underwent ECGs using both ATOM as well as conventional ECG machine at the PHCs. A total of 451 pairs of ECGs (one each from ATOM and conventional ECG) were analysed by a senior cardiologist. The cardiologist reviewed all the ECGs and reported pre-defined clinical outcomes for each ECG.
• The second phase aimed at investigating feasibility of ATOM as a screening tool in terms of cost, convenience, and quality in PHCs as well as in community outreach settings. Around 1000 patients went through tele-ECG (ATOM) at various PHCs.
• Pilot study shows that sensitivity of ATOM in screening patients of suspected cardiovascular diseases (normal/abnormal ECGs) is 92.71% in comparison to the gold standard conventional ECG machine.
• Pilot study shows that sensitivity of ATOM in screening patients at the last mile for referral to a cardiologist for consultation is 92.68% in comparison to the gold standard conventional ECG machine.

Give us an idea of other such innovations being supported by BIRAC which are close to pilot phase?

There are about 350+ products from BIRAC supported start-ups that have already reached the market. BIRAC’s dedicated biotech showcase e-portal www.biotech-solutions.com features 150+ such biotech solutions. About 20% of BIRAC supported solutions are currently in the validation stage.

Some of the BIRAC supported healthcare innovations, such as those listed below, shall be field validated under the BIRAC-GCI-NASSCOM Healthcare Innovation Challenge “JANCare”

JANCare is a nationwide Innovation Challenge to Discover, Design and Scale the health-tech innovations, which work in low resource-settings especially, in rural & semi urban environments. These innovations will be built on technologies such as artificial intelligence, IoT, machine learning, big-data, and analytics, making use of telehealth platforms to enhance the access, quality, and affordability of the delivery of healthcare at the last mile.

Some of the other such innovations being supported by BIRAC which are close to pilot phase are –

• CervAstra (AIndra Systems): A Computational Pathology based, affordable system for detection of Cervical Cancer
• Aum Voice Prosthesis (Innaumation Medical Devices Pvt. Ltd.): a simple, non-invasive, and cost-effective device made for laryngectomy patients. It allows the patient to speak even in the absence of a larynx.
• Keyar (Janitri Innovations Pvt. Ltd.): An affordable, wearable, and wireless intrapartum fetal heart rate, uterine contraction, and maternal heart rate monitoring device