Disposable Neonatal Intensive Care Incubator - NICI

A  highly innovative, low cost, portable, disposable IoT (Internet of Things) infant incubator that provides heat, humidity, phototherapy and ventilation.

According  to  the WHO,  Low  and  Middle  Income  Countries  (LMICs)  have  more  than  80  million*  underserved babies  annually  with  more  than  3.3  million  preventable  death.  One  clear factor in  neonatal  morbidity  and mortality  in  developing  countries  is  the  lack  of  functioning  infant  incubators. 

In  LMICs,  newborns  are  usually presented with multiple life threatening illness and conditions that can be treated with incubators. However, the delivery of affordable, quality healthcare is prevented by inadequate hospital NICU infrastructure, a scarcity of qualified healthcare providers, and fragmented care pathways.   
 
Preterm babies are prone to serious illnesses or death during the neonatal period. Without appropriate treatment, those who survive are at increased risk of lifelong disability and poor quality of life. Complications of prematurity are the single largest cause of neonatal death and the second leading cause of deaths among children under the  age  of  5  years.  Global  efforts  to  further  reduce  child  mortality  demand  urgent  action  to  address  preterm birth. This leads to billions of dollars in human and capital loses annually. Currently, there are no affordable, fully functional incubators for low-resource and emergency settings. Modern hospital incubators are stationary, large  and  heavy,  and  require  a  constant  110-240V electricity,  are  prohibitively  expensive  to purchase and complex to disinfect and to maintain. 
 
Our solution is the first state-of-the-art highly affordable Neonatal Intensive Care Incubator (NICI), which saves babies’  lives  by  tackling  multiple  medical  newborn  challenges  in  low  and  limited   resources  settings. Neonatal mortality  is  a  complex  problem  with  many  contributing  factors—a  lack  of  affordable  multi-functional incubators should not be one of them. Breegi Scientific, Inc. has the expertise and state-of the-art solutions that has been built from the ground up to meet the specific needs of hospitals in LMICs. Our NICI will be offered for under 1% of the cost of traditional incubators. 

We are developing an innovative, low cost disposable neonatal incubator that delivers the essential treatments and  physical  necessities  for  neonatal  critical  care:  heat,  humidity,  ventilation,  phototherapy  and  containment. With several disruptive innovative technologies, such as (1) lightweight, collapsible and disposable infant housing, (2) dual 12 volt heating systems  (convection  and conduction),  (3)  smart  control,  compact,  high  efficacy  and  portable phototherapy,  (4)  portable  and  stationary  incubator design  and  functions,  (5)  full  containment  to  prevent  cross-contamination and interventions, (6) wireless/Wi-Fi feedback for monitoring, data collection and control.  it is a practical user-friendly, efficient, low maintenance, incubator designed to significantly reduce neonatal mortality and morbidity. NICI consists of two main components: 1) a lightweight a consumable/disposable infant housing unit and 2) a durable/reusable  12V electronic  control  module with versatile electricity capabilities with rechargeable battery.  Our  X-ray  compatible  infant  housing  is  designed  for  one  week  maximum single use per infant to reduce nosocomial risks and cost of care and maintenance.  The NICI is designed to run on a versatile convertible power source, allowing the device to be used as a portable incubator, operable on site or in transport vehicle.

Our AC/DC multi electricity source, 12V rechargeable battery incubator differs from other solutions by uniquely providing low cost innovative life-saving MULTIPLE functions, such as heat, ventilation, humidity and phototherapy capabilities while also being purpose-built to conduct medical and surgical procedures. We differ from low-cost solutions like Embrace, MoM and FireFly, which are single-function innovations, and high cost ones like GE, because we are:

- low cost (no disinfecting), and easy to fix and maintain
- disposable (cross-contamination), lightweight, collapsible 
- integrated weight scale and WiFi-enabled (IoT) 
- dual 12V heating systems 
- used for transport and stationary cases

Our solution was built on novel, paradigm-shifting technologies with the aim of creating state-of-the art, human-centered designs and solutions to ensure that we exceed all expectations of functionality, safety and cost. This includes the use of disposable plastic housing to create sterile newborn containment, which cuts the cost of cleaning, disinfecting and maintenance. It is cheaper to transport and store.  We developed our own software with IoT connectivity and wireless data collection for mobile and long-distance care. It is ideal for low-resource settings. Usage of innovative phototherapy technology to treat jaundice. In addition, we developed a bactericidal ultrasound humidifier

- series A fundraising

- With the support of School of Medicine and School of Engineering at Boston University, we will build 60 machines to be tested for clinical assessment in 4 hospitals in Honduras in Tegucigalpa, Tocoa, La Ceiba and Batalla.
- We have met and discussed with the ministers of health of El Salvador and Guatemala to conduct additional clinical assessments in 2019.
- We will be working on finalizing our industrial design for the controller.
- Finalizing the software development of the controller.
- Negotiating with several manufacturing facilities and vendors low cost to build the controller and housing. 

Our vision and plan is to build on our early success to:

1- Raise investment capital and obtain grants to support manufacturing and global expansion.
2- Reach out to high level officials and decision makers in the global health arena 
3- Expand our manufacturing and distribution capabilities to lower the cost
4- Grow our team and hire more talented people.
5- We will gain market entry, first in Latin America, then India, Africa, and Asia, with the home of saving hundreds of thousand s of babies per year.

Our innovative and low cost technology coupled with the lack of a clear market solution will give us the appropriate entry to the market. We started a limited, but very successful campaign to introduce our technology to several high officials including several ministers of health in Central America, the Director General of WHO and several directors of the main hospitals in Honduras. This will help us to reach our business partners and customers directly. Developing a comprehensive distribution system in collaboration with ministry of health and municipalities will facilitate our access and to retain our customers.

None, currently, but in the late summer of 2018, we will be testing our solution  in Honduras at four hospitals. We expect that we will be directly responsible for saving and/or improving the lives of dozens of babies.

Our upcoming clinical assessment in collaboration with Boston University in Honduras will serve approximately 80 infant in 8 weeks period. As we develop and finalize our product, we expect to conduct two to three trials in the first year serving 240-300 infants. By the second yer we expect to enter the market commercially, and by the end of year three we expect to serve over 50,000 patients. NICI will treat and prevent hypothermia, jaundice, cross contamination, and other ailments of premature babies.

We are a highly professional diverse team in multidisciplinary field of Science, business and innovation. We have medical and global health expertise. In addition, we have broad engineering experience in software, hardware, mechanical and materials. Our team has seasoned members in business development and international relations and partnerships.

Breegi Scientific’s revenue model consists of "Razor-Razorblade" business Model.  We offer two components to our Neonatal Intensive Care Incubator (NICI), a re-usable controller “razor” and a one-time use disposable component “blade.” We are selling the controller, which has a four year projected life, for $225 and the one-time use (1 week) disposable component for $25.00 The gross margins of the combined NICI medical device has gross margins of 65%.

Our business case shows revenue of $7 million by year three (>$2.6M EBITDA) and $100M in revenue ($42M EBITDA) by Year 5. Using conservative market assumptions, our company will achieve break-even in year three and is positioned for long-term profitability. We expect growth rates of more than 100% years 3-5, then growth rates of more than 50% for years 6-10.

We will be selling our device through several channels, including to Governments, NGOs, and through distributors to hospitals and clinics in some markets. We expect the governments/NGOs/hospitals will pay for the device and pass on the costs to the patients.

Although we are a for-profit company, we are socially conscious and it’s very important to our mission to provide a low cost solution to a devastating global problem.

At Breegi Scientific we are aligned with Solve's mission to serve those of the bottom of the pyramid. We are committed to bringing advance innovative solutions to make healthcare more available, affordable, and effective for marginalized communities. We believe that our partnership with Solve and the support of their partners will accelerate and enhance our services and innovation to reach those of low resource settings.

We are seeking the knowledge, expertise and connections of Solve in the fields of:

Software programming and connectivity to hardware 

Contacts at the World Health Organization and in LMIC Governments. 

Marketing and distribution support in bringing NICI to market.

Connections to investors, grant funding agencies, and partners that may be interested in supporting our mission.