CreatSense

Autosomal dominant polycystic kidney disease (ADPKD, also known as PKD) is considered to be a rare, genetic kidney disease (potentially fatal), as well as a leading cause of end-stage kidney disease. PKD is characterized by the progressive growth of kidney cysts (fluid-filled sacs) that destroy kidney function over time and can lead to kidney failure. In some cases, PKD kidneys can grow as big as American football. 

Symptoms including early-onset hypertension, abdominal discomfort and pain, hematuria (presence of blood in urine), and urinary tract infections (UTIs) are common manifestations of PKD. Because kidney cysts grow over time, Total Kidney Volume (TKV) is one of the best biomarkers in early disease progression in PKD. TKV can be monitored through magnetic resonance imaging (MRI) or estimated. 

Bloodwork is prescribed to monitor PKD progression, and most importantly, creatinine (a waste product of the body) is used to estimate Glomerular Filtration Rate (GFR) (a measure of blood passing through the glomeruli each minute and an index of kidney function). Genetics are also important to PKD progression, with great variability even within families. Genetic testing is only useful for diagnosis purposes and can't predict the progression rate of PKD. 

An infographic showing the landscape of ADPKD.

Although accurate, current scanning technologies and blood work are expensive and time-consuming, demanding patients to go to medical facilities periodically. Additionally, patients with PKD lack education about the disease progression since kidney functions are complex and difficult to comprehend for lay people. 

Our product, CreatSense is a low-cost, portable, patient-friendly platform that can replace the conventional weighing scale with advanced Bioelectrical Impedance Analysis (BIA), enabling the detection of body composition contents such as body fat, muscle, bone, and water. There is an increasing popularity of BIA in body-building and sports. CreatSense would be the first health technology product targeted for PKD and can offer hassle-free monitoring of renal parameters.

How it works: 

The underlying technology of CreatSense is Bioelectrical Impedance Analysis (BIA) that is a non-invasive method used to estimate various body composition parameters by measuring the impedance or resistance of electrical currents as they pass through the body. It is commonly used to estimate body fat percentage, lean body mass, and hydration status.

The basic principle behind BIA is that different tissues in the body conduct electrical currents differently. Lean tissues, such as muscle and organs that contain a large amount of water, conduct electrical currents more easily than fat tissues, which have a lower water content. By measuring the resistance encountered by an electrical current passing through the body, BIA can estimate the composition of different body compartments.

During a BIA measurement, a low-level electrical current is applied to the body using electrodes. Typically, the electrodes are placed on the hands and feet, although some devices may use different electrode placements. The electrical current is safe and generally not felt by the individual undergoing the test.

CreatSense Design:

CreatSense is envisioned as an advanced weighing scale product for people with PKD. Our product is around the same size of a home-based weight scales, except for two hand rests that are planted onto the side of the weighing scale. There are four electrical contact points for the limbs - two for the soles (on the weighing scale plate) and two for the palms (on the hand rests). An individual needs to stand on the CreatSense platform with bare feet and touch the hand rests with bare palms. BIA measurements are taken and displayed on the large display on the footplate. 

CreatSense can be a portable companion for patients during travel.  This is very important for people with PKD who always want to ensure that they know their body composition, which may impact the PKD progression. Note that PKD is progressive and irreversible. There is no going back once the kidney is injured due to the growth of cysts. 

Digital Health Features: 

In the next developments, we plan to design a digital health app connected to CreatSense so the BIA parameters relevant to renal functions can be tracked over time. In addition, the app will offer education related to PKD from the context curated from trusted sources such as PKD foundation.   

Note: Unfortunately, we cannot show the product demo due to ongoing activities on IP protection. 

Our team lead, Dr. Kunal Mankodiya, was diagnosed with PKD when he was 35. Dr. Mankodiya's mother died at age 58 in India due to PKD and kidney failure. Seeing his mom passing through various stages of PKD, Dr. Mankodiya has closely experienced the painful journey of living with PKD. Over the years, he found out that he is not alone. He volunteers for the PKD foundation, enabling him to connect with other patients with PKD. He is also a part of various PKD communities. For example, he has been a part of a Google Group called PKDDiet for many years. He is a member of the largest PKD support group on Facebook where he learns how PKD affects patients from different countries, ethnicities, and ages. 

Lifestyle is one of the most key aspects of PKD disease management since patients with PKD need to live with kidneys that are not generally functioning at their full capacity. Patients with PKD are recommended to adopt a lifestyle to reduce the burden on the kidneys and lower the disease progression. Lifestyle recommendations include managing blood pressure, a healthy diet, staying hydrated, regular exercise, avoiding tobacco, lowering alcohol intake, and managing stress. 

Let's take an example of diet for PKD. Consuming a diet rich in fruits, vegetables, whole grains, lean proteins, and low-fat dairy products is generally recommended. It is important to limit the intake of processed foods, saturated fats, and added sugars. Additionally, controlling sodium intake is crucial for managing blood pressure. Studies reported that a high-protein diet could increase cyst size. Therefore, many patients with PKD go vegan or plant-based diets to reduce the animal protein that may burden the kidneys more. This is just one example. Many other factors can impact cyst growth in PKD.    

Patients with PKD are strongly interested in knowing how their lifestyle impacts renal function. This is where CreatSense can play an important role, enabling patients to monitor their renal functions, directly or indirectly associated with the disease progression in daily life settings. Instead of waiting for yearly lab results, CreatSense offers patients fast and reliable methods to track renal functions. CreatSense is not designed to replace bloodwork or ultrasound scans that can still be prescribed as before for more clinically-accurate reports. With CreatSense, patients with PKD are empowered to take control of their own health. They can learn about their polycystic kidneys.  

In the development stages, Dr. Mankodiya plans to take advantage of his ongoing connections with PKD communities. Patients with PKD will be welcomed as co-designers in R&D and product development activities. 

As described before, Dr. Kunal Mankodiya, our team lead, was diagnosed with PKD at the age of 35. His mother's death from PKD and kidney failure inspired his involvement in PKD communities, such as the PKD foundation and support groups like PKDDiet and the largest PKD group on Facebook. These connections allow him to share experiences and learn from others worldwide.

Besides being a PKD patient, Dr. Kunal Mankodiya, Ph.D. is also an associate professor of Biomedical Engineering at the University of Rhode Island, USA. He is the director of the Wearable Biosensing Lab which explores the intersection of wearable devices, biosensors, and healthcare applications to monitor and improve human health and well-being. Throughout his research profession, Dr. Mankodiya has acquired unique interdisciplinary skills that enable him to build collaborations with medical and clinical experts in various domains. He has translated medical needs into a wide range of wearable medical technologies focusing on personalizing the sensing of brain, body, and behaviors. The Wearable Biosensing Lab is a transformative research program well-funded by the National Science Foundation, National Institutes for Health, and many other state and nonprofit agencies. 

Our team of CreatSense is made of highly energetic interdisciplinary scientists and engineers who are passionate to bring change in the world of people with PKD: 

• Dr. Dhaval Solanki, PhD is an experienced scientist in the areas of electrical and electronics engineering with a special focus on patient-centered medical devices. He leads the engineering team on the power electronics circuits for CreatSense. 
• Vignesh Ravichandran is a PhD researcher with expertise in biopotential monitoring technologies. He designs the prototypes and tests them on human participants. 
• Shehjar Sadhu is a PhD researcher with digital health app development expertise. She currently designs a user-friendly app, CreatSense connected to cloud. 
• Dean Lotito is the PKD CONNECT Ambassador and also the lead at the Boston Chapter of the PKD Foundation. He enjoys helping people cope with PKD, and raising money towards a treatment and cure.

Dr. Mankodiya and his team

The reason that makes our team unique and special is that we are all together with a common mission to impact the lives of people with PKD. Our product development practices are always inclusive, getting people with PKD, caregivers, and their family members to join as proactive participants in building the future of PKD tracking technologies. 

With the help of Dean Lolito, we have strong plans to work closely with PKD Foundation to connect with the large pool of communities with PKD across the US. We will take the product prototypes to the PKD Walks and other community events in various locations, allowing us to get meaningful feedback for the product features. Such community engagements will also enable in-home studies to validate CreatSense in real-world environments. 

We will submit grant applications to the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) for funding R&D and clinical studies. 

We have begun Prototyping CreatSense in early 2023. CreatSense is a complex engineering system that demands understanding of physiology, anatomy, biomedical engineering, electrical engineering, embedded systems, and software development. 

A simplified block diagram of CreatSense (Photo Credits: Mohan Wang)

 Currently, we have developed an electronics prototype that consists of a front-end analog circuit and microcontroller. At the moment, we have started with a lower limb BIA system that requires only lower limbs. Later, we plan to expand it to a four limb BIA system.   

Electronics Prototyping for CreatSense

We are a group of mission-focused engineers and solvers who have a strong passion to impact the lives of people with PKD. The personal experiences of Dr. Kunal Mankodiya is a driving force, offering us to dive deeper into the challenges faced by people with PKD and defining solutions that are not only simple but also useful in tracking their symptoms in daily life. 

The Horizon Prize is the perfect opportunity for us because CreatSense is in its beginning stages. The Prize will help us address the initial financial and technical barriers. For example, we will be able to validate the science of BIA for PKD before we can promise the PKD community with the benefits that can be potentially offered by CreatSense. 

In addition, the Prize will become a part of the first disruptive solution for PKD. People with PKD are looking for a solution that can help them know their own body better. For some patients, PKD progression is faster than their yearly check-ups. In such cases, we need reliable in-home solutions like CreatSense. 

At 35, our team lead, Dr. Kunal Mankodiya, received a PKD diagnosis. Sadly, his mother passed away in India at age 58 due to PKD and kidney failure. Witnessing his mother's journey through the different stages of PKD, Dr. Mankodiya intimately experienced the challenges of living with the condition. However, he discovered that he is not alone. Dr. Mankodiya actively volunteers for the PKD foundation, providing him with opportunities to connect with fellow PKD patients. He participates in various PKD communities, including the longstanding Google Group PKDDiet and the largest PKD support group on Facebook. Through these platforms, he learns about the diverse ways in which PKD affects individuals from different countries, ethnicities, and age groups.

Dr. Mankodiya with Dean Lolito at the Boston PKD Walk 2022

CreatSense would be the first of its kind Bio-Impedance Analysis (BIA) Technology that will be brought to homes outside of clinical laboratories. One of the reasons it has never been done is because the scientific communities have focused on understanding the relationship between the body impedance and body composition components such as fat, water, and muscle. The tinier version of such technologies such as skin impedance sensors are already a part of today’s smartwatches. Hence, we strongly believe that it is time for BIA to explore its applications in consumer health and wellness. 

CreatSense is conceived as a simple design similar to everyday use items such as a weighing machine or treadmill. We strongly believe that simplicity is an innovation. We want CreatSense to be accessible and easy to use that can only be achieved through a simple design. 

Tracking renal functions over time is crucial in PKD. Currently, patients track it through outdated portal charts that face challenges of medical terminologies that cannot be interpreted by lay people. Many times, patients google these terminologies and terms and may lead to misunderstanding from websites that are not trustworthy. CreatSense will come with an app that can offer education towards renal functions.

Our long-term goal is to design and validate CreatSense as a reliable monitoring platform for renal functions in PKD. In order to achieve this, we first want to design a functional prototype that can be used for feasibility study in Year 1. Later, we will design a refined sophisticated prototype for clinical studies in Year 2-3. In later years 4-5, we plan to conduct an implementation trial in the PKD community. 

We will start with non-dilutive funds for Year 1-3. We will go for seed investment funding in Year 3 for implementation trials.

Impact Goal: 

Empower patients with ADPKD to self-monitor their renal functions and make lifestyle changes to reduce disease progression

Target 1: 

Educate people with PKD on renal functions and lifestyle modifications 

Target 2: 

Provide access to self-monitoring devices (as simple as weighing machines) to people with PKD

Target 3:

Help people with PKD track their own health parameters 

Target 4: 

Offer advanced solutions such as CreatSense to people with PKD 

Target 5: 

Make the technology affordable for patients through insurance coverage or community funds

First and foremost, we will pursue ethnographic research on understanding the requirements in detail. For this, we will engage with people with PKD, caregivers, nephrologists, dietitians, and nutritional experts who will offer insights into struggles and challenges in managing PKD, especially from a monitoring standpoint. This will help us define the product design and cost that can meet the requirements. At the moment, we have several assumptions towards how the product will be used. The research will test these assumptions. 

Financial aspect of CreatSense is another key point that we want to figure out since we want the product to be financially viable for end-users.

If your solution is tech-based, describe the core technology that powers your solution.

The underlying technology of CreatSense is Bioelectrical Impedance Analysis (BIA) that is a non-invasive method used to estimate various body composition parameters by measuring the impedance or resistance of electrical currents as they pass through the body. It is commonly used to estimate body fat percentage, lean body mass, and hydration status.

The basic principle behind BIA is that different tissues in the body conduct electrical currents differently. Lean tissues, such as muscle and organs that contain a large amount of water, conduct electrical currents more easily than fat tissues, which have a lower water content. By measuring the resistance encountered by an electrical current passing through the body, BIA can estimate the composition of different body compartments.

During a BIA measurement, a low-level electrical current is applied to the body using electrodes. Typically, the electrodes are placed on the hands and feet, although some devices may use different electrode placements. The electrical current is safe and generally not felt by the individual undergoing the test.

The University of Rhode Island (URI) is where the Wearable Biosensing Lab is located. It is likely that IP protection will be performed by URI. Later, we will spin-off a startup that will license the CreatSense technology. At the moment, we will perform R&D at URI. 

Our current team size is four:

1. Kunal Mankodiya, PhD, Director, Wearable Biosensing Lab is the team lead. 
2. Dhaval Solanki, PhD, Co-Director, Wearable Biosensing Lab is the engineering lead. 
3. Vignesh Ravichandran is a PhD researcher with expertise in biopotential monitoring technologies. He designs the prototypes and tests them on human participants. 
4. Shehjar Sadhu is a PhD researcher with digital health app development expertise. She currently designs a user-friendly app, CreatSense connected to cloud. 

We have started developing the solution in Jan 2023.

The Wearable Biosensing Lab’s core philosophy is to grow innovation and talents through diversity in team, thoughts, culture, and mindset. The lab has hosted over 65+ students (including PhD, masters, and undergraduate students) in which 30% come from underrepresented minority groups (women, African American, Hispanic, and Native American). Diversity and equality have become essential components in our research lab since they enable thinking about problem-solving through different angles and perspectives. We have established and nurtured the environment such that each and everyone can voice their idea or thought while we are brainstorming for potential solutions. 

In Summer of 2018, our lab hosted 20 students originating from 10 different countries. During summer, we don’t only pursue research but also organize sports and recreational activities when students have the opportunity to mingle with individuals with diverse cultural backgrounds. This trend adds a great value to our team culture in the lab. Students not only grow respect for others but also learn about personality trends and capabilities. 

With this spirit, we will also work closely with the PKD Foundation, which has one of the goals of identifying and recognizing gaps in clinical care to improve ADPKD outcomes, encourage disease-specific management strategies, and improve health equity.

Dr. Kunal Mankodiya's team

Key customers and beneficiaries:

• People with PKD

• Caregivers

• Nephrologists

• Dietitians

Value Proposition: 

• Easy to use, inexpensive, in-home monitoring technology for renal functions

• No delays in making lifestyle changes

• Peace of mind for people with PKD on learning about the disease progression state

Product and Services: 

• CreatSense, a weighing scale-style monitoring platform offering measurements of body composition contents such as fat, water, and muscle mass and also surrogate biomarkers or eGFR and creatinine.

• Smartphone app for tracking the renal functions over time. Education services on the app for understanding the PKD

Channels:

• Community engagement with PKD Foundation for increased awareness

Revenue Model:

• B2C: One-time device purchase 

• B2C: App subscription for health data tracking and PKD education

Non-dilutive funds from federal agencies such as NIH and NSF will help us with R&D and clinical studies. We plan to target SBIR/STTR programs that provide support for initial product development and validation. 

Later, for community trials, we will go to seed funding from angel investors, accelerators, and mission-oriented nonprofit foundations such as PKD foundation. 

In the later stages for the commercialization and scaling, we will approach VC funds. 

In the future, we plan to generate revenues through product selling and app subscriptions.  

So far, Dr. Mankodiya has received $ 3.6 million in funds from NSF, NIH, and other state and nonprofit organizations. These funds support collaborative R&D activities for designing medical technologies. 

Dr. Mankodiya is also a co-founder of a startup called EchoWear that has raised $1 Million in non-dilutive funds from SBIR/STTR programs of NSF and NIH.