BabyBeat - intermittent home fetal monitoring for Asphyxia

About 300,000 of the 3.6 million annual preterm babies in India die due to complications. Globally, 15 million premature babies are born annually, with 80% of these in Asia and Sub-Saharan Africa having shortages of obstetricians. Primary health systems that serve the bulk of pregnancies, lack an effective and scalable preterm birth identification tool. Existing methods need a laboratory (blood/cervical fluid tests), or have poor sensitivity (cardiotocography), or they are not portable, capital-intensive and require expertise (traditional electrohysterography [EHG]). The current convention to monitor fetal heart in well-equipped facilities is cardiotocography (CTG). The CTG machines available in India are non-indigenous, capital-intensive USD 5-10k (Philips, General Electric), requires consumables (Monica, Janitri, Sattva, Nuvo, HeraBeat), are not portable (Luckcome, Shenzhen) and requires the operator to have technical expertise.  

CareNX has developed, clinically-validated and commercialized a smartphone based, portable fetal heart monitoring solution Fetosense in 2019 (MIT Solver). Fetosense overcomes the CTG limitations through portability, remote monitoring, a validated automatic result interpretation algorithm, no consumable. There are 375+ gynecologists which have been equipped with Fetosense since last 20 months through direct sale, channel partners from 6 states, 4 low-income counrties and overall 200000+ fetal monitoring tests have been conducted. CareNX has generated total revenue of USD 300K in FY2021-22. Our controlled studies have shown that Fetosense has helped reduce ~52% of fetal complications due to asphyxia and prematurity. 

Next, CareNX has piloted BabyBeat - a home fetal monitoring wearable capable of performing clinical standard non-stress-test (NST) with early indications of asphyxia and preterm. BabyBeat is typically useful for patient under fetal distress who require frequent fetal monitoring. Patients save visit cost, time due to self test at home and hospitals/doctors save time without loss of revenue. Hospitals rent out BabyBeat with bi-weekly (USD 25) and monthly (USD 40) models - collect payment - and share with CareNX for providing end-to-end service delivery.  

1. 15 of private premium hospitals from Mumbai, Bangalore and Pune those facilities have already started home fetal monitoring program through BabyBeat with 300+ mothers have bought bi-weekly rental subscription and is still ongoing with 20-30 mothers per week. 
2. We have strong validation and testimonials from 50+ pregnant women on how it has helped them monitor from convenience of their home and supervision from the hospital. We also have worked out acceptable pricing model considering incentives of distribution, service, hospital, doctor and CareNX through initial 3 month pilots with 5 facilities before scaling up.
3. We have established exclusive annual distribution and service partnership with a pharmaceutical company Bharat Serum Vaccine for PAN India presence. A team of 50 regional sales managers have been activated to onboard 500+ B2B hospitals to facilitate home monitoring for patients in FY 2022-23.

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We have built and commercialised a fetal BabyBeat home fetal heart monitor that can accurate measure fetal heart rate anomalies non-invasively through the maternal abdomen. Similar to conventional fetal monitors, our device works by injecting carefully selected ultrasound wavelengths into the maternal abdomen, followed by careful detection of very weak back fetal movements/activities. The detected signal is processed to remove the contamination due to the maternal tissue layers, and to isolate the signal due to the fetal tissue. 

CareNX conducted commercial pilot with 15 premium hospitals (B2B2C) from Pune, Bangalore and Mumbai to provide home fetal monitoring to 300+ mothers on a rental basis. It costs USD 25 for bi-weekly rental and USD 40 for monthly rental to the pregnant mothers - which saves cost of their frequent trips and CTG testing at the hospital - helps hospital's time without loosing on the test revenue from the patient. We have received extreme positive testimonials from 50+ mothers and 10+ doctors from these facilities so far. CareNX wishes to scale up this model and expand service/support geography.  

In the developing world, the device can be used in form of an inexpensive self-contained wearable in the care centers to alert care givers to administer associated therapeutics to prevent birth asphyxia. In the developed setting, the device will interface with and will supplement existing electronic fetal monitors to improve their sensitivity for detection of fetal hypoxia. 

In both urban-remote settings, the device can be marketed as a wearable monitor for high-risk pregnancies that may benefit from longitudinal monitoring of the baby to defer delivery as long as it is safe (which will greatly reduce the likelihood of preterm neonatal mortality). 

Broadly speaking, our target population is 1) B2B: Maternity Hospitals/Gynecologists 2) expectant mothers (and their families). Birth asphyxia and preterm typically leads to C-section deliveries incurring 3x more expenses than normal delivery for each stakeholder. 

In the developed world or those in the developing world with access to a reasonable health facility, which has been our immediate focus, the target population includes expectant mothers who prefer to have a safe vaginal delivery. Since fetal health assessment and the recommendation to continue with natural birth or opt for a C-section comes from providers, we have been working with a team of obstetricians, fetal surgeons and neonatologists to better understand the associated decision making process, and focus the solution development efforts on the unmet clinical need. 

The other target population that can potentially benefit from our solution, though in the longer term, are expectant mothers with access to midwives or a low resource health facility, e.g., in parts of the developing world or remote regions of the developed countries. Such patients and their caregivers could benefit from our solution to objectively decide if continuing with the natural birth is safe, or the use of some relevant intervention (e.g., perineotomy) is justified.

Team:

Cofounders have left out of PhDs high paying jobs and built the company since last 7+ years just because of a high level of motivation for social impact. Rest is an interdisciplinary team of 6 product engineers, 2 biomedical & 2 public health experts and 9 sales/marketing personal. Team is mentored by professors from KEM Hospital Mumbai and IIT Bombay. The team has experience of developing and commercializing technology products related to maternal and child health since last 7+ years and has built a sustainable business with annual revenue of over USD 600K covering for over 700+ healthcare facilities, 200000+ pregnancies and 1500+ gynaecologists so far.

Learnings so far:

1. Partnerships is a key in delivering care. We have had worked with 30+ big inter country NGOs/Governments partners for home based antenatal care delivery program and learned that no single organisation can create end-to-end system for comprehensive care and management.
2. Repeated training and capacity building of partners is very essential.
3. Behavior change can't be underestimated for new innovations, particularly in healthcare sector.

Why we are positioned in a right manner to scale fetal home monitoring:

1. We have 3+ years of experience of scaling up fetosense fetal monitoring solution to 700+ B2B hospitals including government, NGO, private and premium settings. Top private maternity chain of hospitals Cloudnine group, Sahyadri group, O&P group, Rainbow group and reputed government medical hospitals AIIMS, KEM, Nanavati, GMCH, AFMC etc. have been using our solution since 2+ years and have performed over 70000+ tests. 
2. 15 of private premium hospitals from Mumbai, Bangalore and Pune those facilities have already started home fetal monitoring program through BabyBeat with 300+ mothers have bought bi-weekly rental subscription and is still ongoing with 20-30 mothers per week. 
3. We have strong validation and testimonials from 50+ pregnant women on how it has helped them monitor from convenience of their home and supervision from the hospital. We also have worked out acceptable pricing model considering incentives of distribution, service, hospital, doctor and CareNX through initial 3 month pilots with 5 facilities before scaling up.
4. We have established exclusive annual distribution and service partnership with a pharmaceutical company Bharat Serum Vaccine for PAN India presence. A team of 50 regional sales managers have been activated to onboard 500+ B2B hospitals to facilitate home monitoring for patients in FY 2022-23.

1. Need consultation on the right clinical/business advice to formulate a legal framework required for onboarding various stakeholders, aligning their incentives and sharing liabilities. 
2. Need financial support to scale the proven rental model from 15 existing facilities to 500 new facilities with help from Bharat Serum Vaccine in FY 2022-23. Most of the funds required are for on-field sales calls, marketing & promotion, getting hold of most influential gynaecologists etc.
3. Need business advice and connects for structuring external partnerships for scale. The same model could be replicated in a cross country scenario with proper adherence to regulatory aspects.

• Product innovation: Clinical standard NST at home is uncommon in India. We made it possible by creating a different product form of already proven B2B solution Fetosense for B2B2C market. 
• Business innovation: Through various iterations with existing customers, we tried, tested and derived an acceptable rental model. We have been seeing monthly traction in an organic way from these 15 facilities since last 8 months. It would be safe to consider that we reached at product-market fit stage. 
• Affordable: BabyBeat costs USD 25 for bi-weekly rental and USD 40 for monthly rental. This is typically 3x lower than the overall expense hospital and/or patient incurs for frequent weekly NST tests. BabyBeat makes overall healthcare delivery less expensive but brings significant comfort.
• Technical innovation: We have filed a process patent to auto-detect fetal movements while performing the test. 

We believe that BabyBeat goes well with health trends - improvement in health seeking behavior across patients, need of home monitoring solutions, close connect with gynecologists etc. for the emerging market. BabyBeat addresses a well known, very important problem in a clinical manner with better use of technology and tools. 

Since 2015, ‘CareMother’ program has registered 300,000+ pregnancies (120000+ high-risk) via 260 frontline workers across nine states of India, in rural, urban and tribal areas, with 15+ Government, non-profit and corporate partners. BabyBeat will be over-time integrated within CareMother, to focus on mothers reporting with preterm contractions. 

After successful home monitoring pilot with 15 urban facilities, CareNX also has established exclusive annual distribution and service partnership with a pharmaceutical company Bharat Serum Vaccine for PAN India presence. A team of 50 regional sales managers have been activated to onboard 500+ B2B hospitals to facilitate home monitoring for patients in FY 2022-23.

Considering both public and private channels and their growth rate

1.   Year 1
   1. BabyBeat with CareMother - rural - 100 front line staff - 3000 pregnancies
   2. BabyBeat with Fetosense - semi-urban - 500 facilities - 100000 pregnancies - partnership with Bharat Serum Vaccine
2. Year 5
   1. We aim to install BabyBeat at least 10% of maternity clinics (~5000), 1% of general physicians (~10000) and 5% of public healthcare facilities from urban and semi-urban areas (~7500)
   2. Considering adoption over time and monthly average coverage rate of 25 pregnancies per month - total beneficiaries will be around 6 million 
   3. We also intend to scale BabyBeat cross-countries, particularly south-south countries viz Bangladesh, Nepal, Kenya, Nigria and Tanzania. We already are working with partner organizations via CareMother in these countries and BabyBeat innovation will solidify those partnerships further.  

Impact indicators:

1. Number of pregnancies which have undergone the test
2. Number of identified fetal distress and asphyxia patients
3. % of complications reduced after timely identification
4. # of reduced preterm cases
5. # of healthcare staff trained 
6. Amount of expense saved for hospitals and patients 

Implementation of BabyBeat will involve the following 'Activities': a) community health workers (CHWs) screen the risk of preterm labour at homes or nearby centres; b) BabyBeat captures data that can quantify the risk of preterm birth; c) the data is uploaded via cloud and shared with remote obstetricians; d) the obstetrician takes prompt decisions on a case-by-case basis; e) Treatment is communicated to the CHW/nearby primary health centre (PHC) doctor, who either deliver the intervention (tocolytics to delay labour, steroids for fetal lung maturation in case a premature birth is inevitable) or offer conservative treatment/monitor mothers' vital parameters, or the obstetrician asks for mother's referral to a higher centre.

The corresponding 'Inputs' include CHW training on BabyBeat, device development with auto-interpretation capabilities, and a back-end analytics team.

The corrresponding outputs include an increased identification of high-risk conditions, greater access to quality medical care, decreased cost of seeking such care in view of the traditionally advanced assessments such as preterm risk identification, and creation of a technologically strengthened workforce.

The Logic Model provides reference data to support the linkages between outcomes and activities based on CareMother pilot studies: for example, we calculated a 33% greater identification of high-risk pregnancies after comparison with routine Government systems of surveillance in an urban slum, and a 50% decrease in healthcare costs in comparison with a medical van, based on program managers' interviews. A third-party evaluation of the CareMother program has deduced a 2x increase in access to 'quality antenatal care' at the door-step (due to the tests in the screening kit) compared to traditional Government antenatal contacts.

The corresponding outcomes include an increased incidence of identification of preterm birth and fetal distress risks and a decreased incidence of neonatal morbidity. We would need larger sample sizes (>10,000) of mothers to assess impact on neonatal mortality. 

The corresponding impact level indicators overlap with some of the aforesaid outcomes, but they are measured at the population level such as neonatal mortality rate, level of third-trimester careseeking, 'escape' of mothers' risk from an untreated premature birth, and improved community-level access to remote care.

BabyBeat wearable device works on the principle of ultrasonic Doppler. Response from fetal heart is received by the wearable device, amplified, filtered and processed. Further, heart beats are analyzed on software with an algorithm built with as per clinical standard* to understand beat-by-beat variability and thus interpret the fetal health condition. This knowledge is used to plot the FHR vs Time graph on the mobile screen. Finally, this graph can be shared in real-time with associated expert through mobile app. Comments and interpretations from expert received in real time. CareNX has started validation studies of BabyBeat at KEM Hospital in Mumbai to compare it with the existing gold standards. The device is also given to Nanavati hospital for collection of samples to improve and calibrate the accuracy of the software. BabyBeat has shown 99.93% peak detection accuracy with standard deviation of +/-2 bpm error margin over 140+ samples. 

Customer segment (B2B): 

1. Maternity Clinics
2. General Physicians
3. NGOs and Governments
4. Pharmaceutical companies

CareNX provide end-to-end dispatch, delivery, support and maintenance. 

Revenue share when B2B customer rents out BabyBeat to end consumer (patient B2C)

1. Bi-weekly rental to mother - USD 25 - CareNX share USD 15
2. Monthly rental to mother - USD 40 - CareNX share USD 25

1. CareNX will fund 50% of BabyBeat model expansion through revenue of Fetosense and AanandiMaa solution for next 12 months. 
2. Rest 50% matching amount would be made available through BabyBeat revenue + grants.
3. With current projected commercial model, each rented device shall generate break even revenue within 10 rounds of rental. This period would be around 18 months.

Total funding received for BabyBeat:

1. Millenium Alliance Award from UkAid and USAid - Grant - 2020 - USD 34000
2. COVID Innovation Challenge FICCI - Grant - 2021 - USD 35000
3. ZS prize - Grant - 2021 - USD 15000

Technology support in-kind opportunities:

1. Nvidia Inception program for development infrastructure of AI model
2. Google Accelerator program for technology development mentorship
3. MIT D-lab and Deepmind Uk for AI model development expertise