SnugLit

The first moments of a newborn's life are critical to the infant's development, but with jaundice affecting over 60% of all newborns born each year, many newborns become separated from their mother during their first moments. TheraB Medical’s mission is to change this current approach of jaundice phototherapy to a method that fosters maternal-infant bonding, breastfeeding, and family togetherness instead of products whose sole purpose is to treat the condition. Our product SnugLit is the first portable and wearable treatment for infant jaundice that eliminates separation between mother and baby. SnugLit is battery powered, covers 360 degrees of a baby’s body, and can be easily used by a parental caregiver. By scaling SnugLit globally, newborns’ early developmental outcomes can be dramatically impacted, hospital stays and exposure to disease can be greatly reduced, and access to inexpensive treatment can be provided without compromising quality care, even in remote areas globally.

Neonatal jaundice is a condition that affects over 60% of all newborns. It affects 2.4 million infants annually in the United States and is estimated to be as high as 20 million globally. Jaundice is caused by the overproduction of bilirubin and the inability of the newborn to excrete it due to an underdeveloped liver. If left untreated, jaundice can cause severe brain damage and cerebral palsy. Bilirubin-induced mortality is consistently in the top 15 causes of neonatal mortality in Sub-Saharan Africa, South, East, and Southeast Asia.

Current phototherapy devices interrupt the daily care and handling of an infant for mothers and caregivers and are cumbersome, outdated, and require a wall outlet- making it difficult for parents to bond with, and nurse their newborn. In many areas of the world, jaundice is not treated at all due to lack of equipment or the inability to use clunky technology in rural areas. In some areas, jaundice is only treated when it reaches dire levels and treatment can be performed in a regional NICU center. In these situation, it's commong for one device to be used on multiple infants at one time.

SnugLit is a phototherapy device that treats jaundice through a wearable infant swaddle. SnugLit is composed of a reusable light pad, which provides high intensity blue light phototherapy, and a disposable, breathable cotton swaddle that wraps snugly around the infant’s body. The swaddle places the lights 360-degrees around the infant’s torso, arms, and legs, providing almost 3 times more surface area coverage of traditional phototherapy devices. SnugLit's wearable design allwos for uninterupted daily newborn activities such as movement, diaper changing, breastfeeding, and infant transportation, without migration of the LED source from its optimal position. The close-form fitting design of the device does not permit light leakage, which alleviates the need for infant eye protection. Its size allows it to be easily mobile and transportable for worldwide shipment, even to rural areas where other large equipment isn't optimal. The low-profile battery pack permits continuous hours of treatment, allowing for phototherapy to take place in remote regions with unstable power supplies. SnugLit’s design promotes maternal-infant bonding during jaundice treatment, allowing for an easier transition from hospital to home during the first week of life.

SnugLit is built to help every family who experience infant jaundice throughout the world. When we began our company,  we completed 250 voice of customer interviews in the U.S. to inform product design. We spoke to nurses, physicians, and mothers to learn about common problems with current products, and build their suggestions into SnugLit. We also completed voice of customer activities in Hyderabad, India in 2019  to ensure our design also addresses the unique needs of different populations across the globe. We've worked with urban, rural, public and private hospitals in India to ensure SnugLit is the best jaundice treatment device for areas outside of the U.S. as well.

With SnugLit, babies no longer have to be separated from their parents during phototherapy, but instead can receive complete treatment in the arms of its caregivers. SnugLit is a more patient-friendly jaundice treatment because it: 

• Is designed to be worn by the infant
• Facilitates closeness and allows mother to freely breastfeed, hold, interact and bond with her baby
• Provides 360-degree coverage - triple the surface area of standard treatments- thus providing quicker treatment
• Simplifies treatment processes for healthcare providers and parents
• Is battery operated and portable for in-home or in-hospital use.

Jaundice affects newborns all over the globe yet there isn't equal access to high quality, efficient treatment. Current phototherapy devices are large and not easily accessible to all patients due to their cost and size.  With SnugLit, newborns can receive individual jaundice treatment using an affordable phototherapy device, either in a hospital or an at-home setting. SnugLit’s portable, wearable, 360-degree coverage provides hospital-grade treatment in virtually any setting. This innovative design supports the mental and emotional health of both mother and baby by allowing for breastfeeding and maternal-infant bonding during those crucial first days of life that impact future development.

Existing phototherapy products are primarily overhead light products and fiber optic products produced by companies like GE and Philips. These products require nursing supervision, are clunky and cumbersome and not easily mobile, cannot treat all parts of an infant’s body simultaneously, and prevent basic care activities and bonding during treatment. These devices provide effective phototherapy to treat jaundice, but don't focus on other aspects of care during the first week of life. There are other startups focusing on jaundice treatment with a global health perspective (BiliHut and NeoLight), but neither solution focuses on the overall experience of the mother and baby. These devices are not wearable and do not provide the maximum surface area coverage while eliminating separation.

Unlike current solutions, SnugLit prioritizes maternal-infant bonding alongside efficient treatment. Infants treated using SnugLit can be held and comforted without tubes, cords and overhead lighting, something not possible with existing phototherapy treatments. Furthermore, caregivers can carry infants freely without restriction of a power cord or fiber optic cables, as SnugLit relies on power from interchangeable, rechargeable battery packs. SnugLit doubles the surface area of traditional treatments and eliminates the need to use two devices simultaneously on one infant. We expect mothers to feel more connected to their infant while using the SnugLit and to have greater success breastfeeding. Since SnugLit covers a greater skin surface area than conventional treatments, we also anticipate a decrease in treatment time. SnugLit is easily mobile and transportable, making worldwide shipment, even to remote regions, more achievable.

SnugLit was designed to modernize the way traditional phototherapy methods are used to treat infant jaundice. Light therapy technology (phototherapy) has been used for decades across the globe to treat infant jaundice. Traditionally, over light banks or fiber-optic light pads are used to expose a small part of a baby's body to a specific wavelength and itensity of blue light. That blue light is capable of breaking down bilirubin into an excretable format. Over the years, studies have proven that there is direct coorelation between surface area coverage (of the babies skin) and the time it takes to treat jaundice. Also, there is a direct coorelation between the treatment effectiveness and the distance between the light source and the baby's body. SnugLit modernizes traditional jaundice treatment by using our patented LED array design in a swaddle-style device in a way that doubles the surface area coverage and deceases the distance between the light source and the baby's skin. 

Phototherapy has been widely accepted as a standard-of-care treatment for infant jaundice for decades. The more effective wavelengths and irradiance levels are well documented, and Standards testing protocols exist to prove effectiveness to the FDA. SnugLit uses high-intensity phototherapy technology in our patented swaddle phototherapy device. 

https://pediatrics.aappublications.org/content/114/1/297

https://med.stanford.edu/newborns/professional-education/jaundice-and-phototherapy/faqs-about-phototherapy.html

Neonatal jaundice is a condition that affects 60% of all babies. Even with this problem being so prevalent, the phototherapy market still has many unmet needs. TheraB’s overall goal is to create a jaundice treatment device that prioritizes maternal-infant bonding and efficient treatment worldwide.The primary need is efficacy. The therapy must treat the infant’s jaundice quickly and safely. Meeting this need is the principal goal of the physician, parents, and hospital staff. Since SnugLit covers a greater skin surface area than conventional phototherapy treatments, we anticipate the required treatment time to decrease significantly. The secondary needs are efficiency and ease of use, which are directed towards the infant and parents. The device must be easy to use and permit closeness between mother and child in order to keep the focus on the child’s overall health, not only her bilirubin level. While existing devices can be easy to use, the care aspect is not considered. SnugLit’s portable, wearable swaddle design promotes maternal-infant bonding during treatment, leading to better mental health and decreased stress for the mother and increased bonding for both mother and child. Past research has demonstrated the detrimental effects that delayed touch and maternal-infant bonding can have on neonatal well-being, including delaying an infant’s social-emotional development, increasing the likelihood of childhood asthma, and leading to sustained feelings of decreased bonding. SnugLit’s innovative design eliminates this separation, leading to an overall stronger feeling of bonding and healthy psychological development. 

Additionally, in some remote areas, jaundice is not treated at all until it reaches dire levels and treatment can be performed in a regional NICU.. SnugLit combats this issue by providing affordable, high quality treatment in an at home setting. This gives newborns a better chance at recovery before their condition becomes severe enough to lead to new problems such as cerebral palsy or brain damage. The option for at-home care also reduces the risk of exposure to disease for both mother and baby, decreasing the worldwide spread of disease and allowing newborns with jaundice to safely undergo treatment and gain health.

TheraB Medical is currently a pre-revenue company that operates in the United States. We are still undergoing product development, so our solution is not yet serving a market.

Currently serving- 0

By the end of 2021, we will be serving patients in the United States and in India through our existing partner, MedLeap. Through MedLeap we will scale over 6,000 units to over 630 Primary Healthcare Centers in the state of Telangana, India. 

Serving by end of 2021- 500,000 babies

Within the next 5 years, we will increase our distribution with MedLeap to over 100,000 units to be scaled throughout India. We will also have a scaled up business model in the US and Latin America, with over 20,000 units distributed in those regions.

Serving by end of 2025- 8M babies

As it is medically impossible to ensure all children are born jaundice-free, Snuglit would enable 50% of term and 80% of preterm American babies who develop jaundice in the first few days of life to experience a greater depth of maternal-infant bonding and have the chance to achieve their full potential for a healthy life sooner. We want to be able to provide this treatment to newborns in as many areas of the world as possible. 

Within the next year, it is our goal to have launched SnugLit on the market in the US and India, providing more effective jaundice treatment to 500,000 babies in both rural and urban areas. We will do this through our distribution partner in India, MedLeap, and through our US sales channels. Our partnership with MedLeap allows us to utilize the channels built from Dr. Reddy's Labs over decades of business throughout Asia. 

Within the next five years, it is our goal to have lauched SnugLit in over 10 countries globally. So far, we’ve had interest from distribution partners servicing Latin America, Europe, Africa, and the Middle East. We plan to use our early traction in the US and India to solidify these partnership to ensure we can scale SnugLit into the regions of the world that need us most by 2025. 

Our biggest immediate challenge is raising enough capital to finish product and manufacturing work, complete our FDA safety studies, and manufacture enough inventory to begin our first pilot study with MedLeap.

A longer term barrier we must overcome is ensuring SnugLit has product-market fit in every market we anticipate entering over the next 5 years. While we have done extensive voice of customer activities in the US and India, it's impossible to be certain that there won't be nuanced requirements for our patients and customers in other areas of the world. We must be flexible to be able to customize SnugLit to fit the needs of patients everywhere if we wish to reach our impact goals within 5 years. 

Additionally, we must continue to build a company that is able to fund and physically manufacture the volume of devices we are anticipating over the next 5 years. This includes being prepared to bring on larger vendors and manufacturing partners, managing partnerships, and ensuring on-time delivery of product to several distribution partners in differing cultures across the globe.

In order to raise enough capital to fund our most immediate needs, we are seeking both traditional investment capital as well as non-traditional funding, such as this program. We are also applying to a number of grant programs that could help fund specific parts of our business, such as specific pilot studies or engineering testing. 

We will overcome our potential product-market fit barrier by continuing to perform voice of customer activities in each new market we plan to enter. This could be in person directly with TheraB/SnugLit personnel, or it could be utilizing our distribution partners.

We are preparing for a potential manufacturing and scale-up barrier by fostering relationships today with companies who can be good partners for us in the future. We have already identified a US-based manufacturing partner, as well as an India-based solution for international manufacturing. We will continue to build on these relationships as we continue to scale.

NA

Full time staff- 1 (full time founder and CEO)

Part time staff- 4 

Contractors- 10 people from engineering, product design, regulatory, marketing, and manufacturing 

The company creating SnugLit, TheraB Medical, started as a student engineering project at Michigan State University 6 years ago. What began as a capstone has turned into a startup company revolutionizing the way our youngest patients experience their first week of life. 

Alexa Jones, Founder and CEO, is the inventor of SnugLit. She received a Biomedical Engineering degree from Michigan State University and is a former FX analyst at Goldman Sachs. Alexa is one of the original founders of TheraB and has been with the company since it's inception.

Brianna Goodale, PhD, is the Director of Clinical Development. She has over 12 years of clinical research experience, has led other healthcare start-ups to develop and submit regulatory applications.

Lyne Charron-Keller is the Director of Commercialization at TheraB. She worked 3 years as a NICU nurse specialist before transitioning to a wide variety of healthcare marketing and consulting positions for 20+ years. 

Sam Hansen is our Product Commercialization Associate. She is a recent graduate from Michigan State University who focuses on attaining Snuglit’s commercialization and marketing milestones.

John Dahler, CFO, is a senior financial executive with over 30 years experience providing financial, operational and managerial expertise for companies across several industries. 

Dinesh Reddy, International Market Advisor, has experience working with international sales and marketing, spanning across over 16 countries. Dinesh is currently the associate director of MedLeap at Dr. Reddy's Laboratories in Hyderabad, India. 

Tekna is TheraB’s selected development partner for SnugLit. Tekna is an ISO 13485 certified full-service product development firm and Class I/II medical device manufacturer based in Michigan. They provide wide range of services to TheraB, including research, business strategy, design, branding, engineering, and product design. 

MedLeap is an Indian company incorporated under the leadership of Mr. Satish Redy, Chairman of Dr. Reddy's Laboratories. Mr. Satish Reddy is driving MedLeap with a vision to create a Medical Device company with the scope and reach of his Pharma company, Dr. Reddy's Labs. MedLeap has partnered with TheraB to launch and commercialize SnugLit in the Indian market over the next 5 years and beyond.

SnugLit will launch using  B2B sales model, selling to hospitals/health centers and home care rental companies using the razor/razor blade sales model. The reusable light portion of our product is the "razor" and will be sold for $3500 in the US and $1250 in India. SnugLit's fabric swaddle is the disposable "razor blade". This disposable is the swaddle garment portion that encases the infant and treatment pad in a 360-degree soft and comfortable swaddle. The goal of the disposable is to provide a clean, dry, and sanitary treatment area.  The average baby will use at least one disposable swaddle per day throughout the duration of their treatment.

The below are our 2 main value propositions to customers:

For infants with jaundice who are currenty not receiiving any treatment due to cost, location, socioeconomic class or other barriers, SnugLit is an effective wearable phototherapy garment that allows for high-intensity yet cost-effective phototherapy that can take place in hospital or home.

For mothers and infants with jaundice who are separated and distressed during treatment, SnugLit is a comforting, wearable phototherapy garment that allows maternal-infant bonding and breastfeeding without interrupting treatment. 

For healthcare providers who spend significant time caring for infants with jaundice, SnugLit is a wearable, portable phototherapy garment that provides 360-degree light coverage and allows for the use of a phototherapy device in-room, without requiring the infant to be cared for in a separate nursery or be treated under a common overhead phototherapy lamp with other babies. 

We will primarily raise capital through Angel and venture capital. Additionally, we are applying for and hope to receive at least one federal SBIR grant to assist with our preliminary pilot studies. Once we launch in the US, our revenue stream from both components of SnugLit will sufficiently fund company operations after 2 years of sales. Until then, we may raise an additional round of institutional capital to fund scale-up manufacturing operations to support our growth.

We are interested in applying to Solve to help us validate our product-market fit in international markets and to help us increase our scope as a more global-health focused company. We are looking for a partner to help us identify which markets across the globe make the most sense for SnugLit, and help us figure out how to get there from where we are today.

We are looking for a partner to help us identify which business model will get SnugLit into the hands of the most customers globally. This includes assistance with distribution planning, as well as help identifying funding to get us to a point where we can make the most impact. We are also looking for key talent to help us launch and scale once our pilot programs are finished in early 2021. 

We woud love to partner with Solve community and MIT faculty members with experience with jaundice treatment or global health. We would also love to partner with UNICEF's Infant Health study research group and the Bill and Melinda Gates Foundation. 

SnugLit is a new phototherapy tool that will make the lives of healthcare staff easier. 

For healthcare providers who spend significant time and money caring for infants with jaundice, SnugLit is a wearable, portable phototherapy garment that provides 360-degree light coverage and requires less supervision during treatment. Nursing staff will spend less time consoling and managing distressed parents, as Snuglit provides a more pleasant and less intimidating form of phototherapy for all involved. SnugLit allows for the use of a phototherapy device in-room, without requiring the infant to be cared for in a separate nursery staffed by a dedicated nurse. Since over 60% of all infants have some form of jaundice, every hospital worker globally who cares for neonates can benefit from SnugLit. 

Neonatal jaundice is a condition that affects 60% of all babies in some form. Asian populations experience the highest rates of neonatal jaundice- in some countries, prevalence rates reach up to 90%. Though common, jaundice can cause irreversible brain damage, cerebral palsey, and death if not treated quickly within the first weeks of life. In resource scarce settings, many babies are not treated for jaundice simply because of lack of access. It's our goal to change that narrative by providing SnugLit- a low-cost, easy to use jaundice treatment swaddle that fosters maternal-infant bonding and breastfeeding. By doing this, we hope to treat millions of babies with jaundice who would have other wise gone untreated. It's for this reason that we are qualified for this prize.

We are currently raising a seed round to complete product development, perform third party standards testing, submit for regulatory approval, and have a complete product packaged and ready for sale. If granted the Bill and Melinda Gates Foundation Award, we will spend the capital scaling up our operations in India with our partner, MedLeap. We will focus on providing a larger number of SnugLit units at a faster rate to rural, low-income areas around Hyderabad in 2021.

The funding from this grant will be used to:

• 30 Unit Pilot in 3 Hospitals in Hyderabad, India in late 2020
• Manufacture 600 units for launch in rural public hospitals in India in Q1 2021
• Support training programs for nurses and mothers in our first Hyderabad hospital locations- ensure healthcare workers are properly trained on how to use SnugLit
• Create scalable training documents in local languages to ensure property training as we scale up throughout India 

Neonatal jaundice is a condition that affects 60% of all babies in some form. Asian populations experience the highest rates of neonatal jaundice- in some countries, prevalence rates reach up to 90%. Though common, jaundice can cause irreversible brain damage, cerebral palsey, and death if not treated quickly within the first weeks of life. In resource scarce settings, many babies are not treated for jaundice simply because of lack of access. It's our goal to change that narrative by providing SnugLit- a low-cost, easy to use jaundice treatment swaddle that fosters maternal-infant bonding and breastfeeding. By doing this, we hope to treat millions of babies with jaundice who would have other wise gone untreated. It's for this reason that we are qualified for this prize.

We are currently raising a seed round to complete product development, perform third party standards testing, submit for regulatory approval, and have a complete product packaged and ready for sale. If granted the Future Planet Capital Prize, we will spend the capital scaling up our operations in India with our partner, MedLeap. We will focus on providing a larger number of SnugLit units at a faster rate to rural, low-income areas around Hyderabad in 2021.

The funding from this grant will be used to:

• 30 Unit Pilot in 3 Hospitals in Hyderabad, India in late 2020
• Manufacture 600 units for launch in rural public hospitals in India in Q1 2021
• Support training programs for nurses and mothers in our first Hyderabad hospital locations- ensure healthcare workers are properly trained on how to use SnugLit
• Create scalable training documents in local languages to ensure property training as we scale up throughout India