Invu by Nuvo Cares

1.    Nuvo is committed to shifting the focus of pregnancy care to the home setting through our FDA-approved Invu platform. Our goal is to make the pregnancy experience mother-centric, while providing high fidelity digital data.

2.    Our solution consists of a wearable monitoring device self-administered by the mother, which is coupled with a powerful cloud-computing environment. The platform is used to conduct fetal and maternal cardiac surveillance, and future iterations will include the ability to monitor uterine activity as well. Once interpreted, meaningful but non-actionable data is provided to the mother via a phone app, and detailed diagnostic data is sent to her healthcare providers via a web portal.

3.    Invu will dramatically change the pregnancy journey for women who fall into high-risk categories, by providing more consistent high-quality monitoring. It will also allow women in remote/rural locations better access to care by giving healthcare providers a novel Telehealth approach.

Pregnancy monitoring is antiquated and outdated. Under current standards, women are hooked up to immobile machines that are costly to use and require a medical professional to administer. Some of these devices may even still give analog readings. This system provides a number of hardships for pregnant women, especially those with high-risk pregnancies requiring more than the standard number of check-ups. If a woman is employed, has certain risk factors, or lives in a rural area, undergoing thorough pregnancy monitoring is difficult at best, and unattainable at worst.

As things stand now, the U.S. lags behind other wealthy countries in terms of maternal/infant mortality. There is also a massive care issue, as obstetricians become more rare throughout the country due to increased malpractice risks and costs (there is currently a shortage of about 8,000 OBs in the U.S.). There are currently ~4 million births in the U.S. annually, and a significant number of the mothers giving birth will fall into either a rural or high-risk category. In the U.S. in 2014, 50,000 women were affected by high-risk pregnancies.

Invu addresses these issues by increasing accessibility for mothers, and giving doctors greater ability to care for their patients, wherever they are.

1.    The pregnant woman wears the belt as directed by her obstetrician to conduct pre-natal visits, which measure maternal/fetal heart rate.

2.    Raw data is collected with acoustic and biofeedback sensors, and then transmitted through mom's phone to Nuvo's cloud environment.

3.    In the cloud, our proprietary algorithms isolate and interpret the relevant data, which is then processed and fed back to the mother and her doctors via the phone/web apps.

4.    The mother receives meaningful but not actionable data about herself and her baby on her phone.

5.    The doctor receives detailed diagnostic results that are digitally displayed via our web portal, and can be integrated into a larger electronic health records system. Future iterations of Invu will also be able to measure things like maternal uterine activity. Invu can be coupled with secondary tests as well to increase the ability to have at-home monitoring, such as a standard urinalysis kit or a blood pressure cuff.

Our key demographic which we wish to address are women with high-risk pregnancies. Approximately 25% of all pregnancies fall into the high risk category, and about 8% of them actually end up having a complication. These women require a higher standard of care with more consistent check-ups, and we aim to provide that through a convenient and mother-centric service. We want all pregnant women, but especially those at high-risk, to have access to the highest standard of care, whether they are at work or at home. We hope to eliminate limiting factors such as geographical boundaries, or the lack of access to a local obstetrician.

Nuvo has conducted a usability trial to ensure that the Invu device can be administered at home by a layperson. We are also active on social media, promoting advancements in the field of pregnancy care while connecting with important stakeholders along the way. Some examples include leading political and medical figures in the rural health and maternal-fetal-medicine spaces. Through our connections, we are striving to better understand the needs of the women whom we wish to serve, as well as tailoring our offering to make sure it provides the utmost best care available.

Nuvo seeks to level the playing field for pregnant women, regardless of their background. By demolishing traditional geographical and social boundaries by utilizing Telehealth, underserved populations that may not have had access to proper pregnancy care before can now enjoy these services. Having the ability to properly surveil a high-risk pregnancy is crucial for a better outcome for mother and baby. Through Invu, we hope to lower the barriers to care that exist in the current system. We want to empower mothers to feel that they are at the center of their pregnancy journey and aren't just a marginalized party.

Invu provides two dimensions of innovation, both from the technological side, and the social aspect.

Technologically, Invu is comprised of proprietary and advanced electronics and algorithms that allow us to collect and interpret extremely high-fidelity digital data. Our outputs have been clinically tested and proven to hold up to the current gold standard of pregnancy care, and can even exceed them through future iterations.

Socially, we aim to drive the paradigm shift of pregnancy care from clinic/doctor centric to mother centric. The focus of care should truly be on the mother and her child, as the entire journey revolves around them. By reimagining how, and more importantly where, this care takes place, Nuvo is able to trail blaze what we hope will be a new standard of care.

Invu consists of three distinct pillars: The wearable belt, our patient/doctor facing app, and our cloud computing environment.

The belt contains multiple acoustic and biofeedback sensors, so that once situated it doesn't need to be repositioned throughout the remote checkup. It captures real-time data, which is not stored in the belt but rather is transmitted to the cloud via the patient's phone, and stored/interpreted there.

The patient/doctor app was built in-house and features a state of the art display which allows doctors to safely store and call upon their patients' historical data.

The true heart of the technology lies with our cloud software. Through innovative algorithms, Nuvo has designed a program that can interpret raw acoustic and bioelectric signals into actionable diagnostic data. The program is already used in Invu for monitoring maternal/fetal heart rate, and the ability to detect uterine movement is being developed as well. As Invu evolves, we hope we will be able to use our big data capabilities to develop descriptive and prescriptive analytics. This means we will be able to help doctors make diagnoses, and potentially predict potential outcomes or complications thanks to large data trends.

Our Invu belt is already being successfully utilized with our first commercial partners. We also have several validation trials and publications which we have completed, including the following publication from The American Journal of Obstetrics and Gynecology:

https://www.ajog.org/article/S0002-9378(19)31747-8/fulltext

As of now, Invu is the only platform of its kind which truly allows for a full shift of pregnancy monitoring to the home setting. Since the service includes add-ons such as a blood pressure cuff or a weight scale, we are able to provide a more robust ecosphere of remote monitoring. In the short term, we will affect a positive change both on our patients, in terms of peace of mind and convenience, and for the doctors using Invu, by giving them access the better care options. Down the road, as our AI becomes more advanced, we will completely alter the field of pregnancy care and bring about a new era of predictive and prescriptive analytics.

In one year, our goal is to cover 5-10 thousand pregnancies. In five years, we are hoping to saturate into the global market to cover about 1,000,000 pregnancies annually, which is about 25% of the available market.

Within the next 5 years, we will lay the foundation towards moving the needle on big pregnancy care issues, such as addressing preterm births and reducing C-sections. We're doing that by parachuting into existing procedures and billing codes in order to start shifting the delivery of care to a home setting. Our overarching goal of building predictive/prescriptive analytics is also achieved through our collection of high-fidelity digital data, which will help us transform pregnancy care in the long run.

Next year- Healthcare systems are very hesitant and slow to adopt new technologies. In the obstetrics space especially, which very rarely experiences innovation, this is a hurdle which we must leap over.

Next five years- We need to identify exactly what data needs collecting in order to help us build our AI.

Next year- Targeting the right early adopters, who are key opinion leaders in the space. This is why we are not going direct to consumers, but are rather gaining momentum, validation and approval from within the system first.

Next five years- By bringing in the best minds with AI and working with clinical teams to identify the most important AI indicators. Our whole system is built around the long-term view of addressing our AI needs and building a robust service with a constant eye towards the future.

50 FTEs

Our team, board and advisory board are composed of a diverse and experienced array of both technology and medical professionals, many of whom are key opinion leaders in their fields. We have years of experience in pinpointing exactly what Invu requires to be successful, and our expertise is expanding as we receive our first FDA approvals and begin commercialization.

We have four letters of intent with leading healthcare systems around the U.S. We've worked with them for clinical validations to assist with our FDA submission. Now, they transitioned into being our early first adopter commercial partners.

Our business model operates as a Platform as a Service (PaaS). This means we provide our Invu devices as part of a larger bundle of services, including access to our app ,web portal (for doctors) and cloud computing environment. Our primary customers are healthcare systems, who pay us directly in order to cover a desired percentage of their pregnant patient population with Invu.

We are a big data company that gets paid to collect data, and this is our value offer out of the gate. Our primary revenue driver will be sales, backed by raising investment capital as needed.

The Solve Grant can provide us with a unique opportunity to connect with some stakeholders in the pregnancy care world that we may not have otherwise gotten access to. One of the key value drivers that Invu with bring to obstetrics is its ability to potentially reduce yearly malpractice premiums and settlement payouts. However, without years of real-world evidence to study retrospectively, reaching the insurance providers who cover OBs has been extremely difficult. It is our hope that through a grant such as Solve, we'll be able to break down some of these barriers and progress with exploring these opportunities.

We've worked very hard to develop this solution, and now we need to focus on expanding our company and scaling the business in an impactful way.

We would like to partner with leading payers (insurance companies) in order to develop our save-sharing capabilities and better understand how we can reduce payer costs, including for issues such as malpractice. This is the industry in which we have the least inroads and can use help in making connections.

Invu is the perfect solution to provide high-fidelity pregnancy monitoring to rural populations, without requiring a massive on-the-ground infrastructure. It is easy to use, can be refurbished, and can greatly reduce pregnancy monitoring pressure from communities that are sorely lacking in medical experts.

The core of Invu is our cloud computing environment, which is comprised of powerful algorithms used to analyze and interpret the raw data from Invu's pregnancy monitoring sessions. As this AI grows with real-world evidence, it will add more and more analytic functions. We see all pregnant mothers benefiting from this, as our AI can be used to predict health trends and assist OBs in delivering care.