Solution Overview

Solution Name:

Breegi Scientific's Biocontainment

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One-line solution summary:

NPS is a single-use, EUA first line of defense patient biocontainment facilitating safe medical procedures and respiratory interventions.

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Pitch your solution.

With infectious respiratory diseases (COVID-19), the first line of defense is biocontainment to protect healthcare workers and to safely treat suspected and confirmed COVID cases throughout the continuum of care.

Our practical, FDA-EUA negative pressure SteriDome (NPS) can effectively contain and filter aerosolized particles at the patient site. It provides healthcare workers with ample contained working space to treat and conduct procedures safely. It is used to transport and treat patients without exposing the surrounding environment to infectious agents. Breathing and oxygen treatments can be provided safely while the patient head is contained.

Containment of suspected and positive COVID-19 cases is difficult to control and is the number one cause of spreading the disease. Most healthcare facilities around the world lack containment infrastructure. Our scalable, lightweight cost-effective device can save countless lives and billions of dollars by providing a safe environment for healthcare providers and treatment for COVID-19 patients.

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What specific problem are you solving?

Our mission is to stop COVID-19 at it's source with a robust and practical solution. We will equip last-mile primary healthcare providers with a easy to use and highly effective protective containment enclosure for patients. COVID-19 is spreading rapidly around the world and is highly concentrated in healthcare facilities which are quickly being overwhelmed with each surge, particularly in low-resource settings with tens of millions of patients and providers globally being exposed to COVID-19 every day.

PPE, when available, is for individual safety. The comprehensive solution in the new normal of medicine is to couple PPE with protective patient isolation to prevent the infectious particles from spreading. Current solutions such as biocontainment rooms are extremely expensive and not scalable. Other isolation solutions such as aerosol boxes have been deemed dangerous for patients and providers due to their rigidity, size and weight. 

Our solution will provide a safe, scalable, comfortable and cost-effective protective solution across the spectrum of care, from elderly patients to suspected patients simply waiting for a test. This means tens of millions of people globally across high-and low-resource settings alike can benefit from our device which was designed for ease of manufacturing, access and distribution. 

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What is your solution?

Negative Pressure SteriDome (NPS) is a single-use protective barrier enclosure deployed on patient's head and upper body to provide an important layer of protection for providers from airborne infectious diseases. The clear plastic dome is connected to hospital-provided vacuum source (portable or wall suction) and has a head portal for the patient's head and neck to gently and effectively contain aerosolized pathogen's such as COVID-19. 

NPS weighs less than 1kg and comes folded in a small package the size of a notebook, making it highly compact and available to ship and deliver easily to last-mile healthcare at scale. 

It supports a wide variety of procedures and treatments, such as high flow oxygen canula, CPAP or ventilator without allowing infectious particles to escape from the NPS. This makes the safest device approved thus far by the FDA.

The enclosure has a voluminous interior space to provide an airy and comfortable environment for the patient to rest in. The dome is supported by a flexible fiberglass rods which are easy to assemble, perform procedures in via sleeves and pass-through portals and remove quickly. 

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Who does your solution serve, and in what ways will the solution impact their lives?

Our solution protects frontline caregivers from getting infected and patients from spreading the aerosolized infections during and beyond this pandemic.

The grim reality is tens of thousands of healthcare providers have perished globally, potentially more, due to exposure while serving their community during this pandemic. The mental and physical toll of being hyper-aware of exposure has contributed to provider burnout, PTSD and a severe impact on morale. The less understood yet equally important death toll is that of other patients with healthcare-acquired COVID-19. Controlling and containing the spread at the source will fill a critically needed gap in protective equipment which is not available, cause a needless loss of life. 

We have gained tremendously positive feedback from clinicians and volunteers during validation for it's use and practicality and have been granted FDA Emergency Use Authorization with a leading authority emphasizing the safety of NPS:

"Thank you for your thorough research and testing on SteriDome NPS. You and your team set a great example on the importance of patient safety."

We owe our frontline the appropriate tools to manage the inevitable waves to come. They are the ones who bear the brunt of this pandemic and they deserve to be safe and have peace of mind.

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Which dimension of the Challenge does your solution most closely address?

Equip last-mile primary healthcare providers with the necessary tools and knowledge to detect disease outbreaks quickly and respond to them effectively.
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Explain how the problem you are addressing, the solution you have designed, and the population you are serving align with the Challenge.

NPS aligns with the Challenge by delivering a powerful tool to frontline caregivers while protecting vulnerable patient populations. The threat of infectious aerosolized diseases will continue to compromise healthcare facilities globally. NPS is designed to be used in any healthcare setting for immediate response. The WHO and CDC agree that the focus should be to contain the aerosols at the source to protect patients and frontline workers in the new normal of medicine, particularly in low resource settings where biocontainment solutions are scarce. NPS is the scalable, affordable and practical solution to meet global demand for safe and effective biocontainment.

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In what city, town, or region is your solution team headquartered?

Woburn, MA, USA
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What is your solution’s stage of development?

Prototype: A venture or organization building and testing its product, service, or business model.
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Explain why you selected this stage of development for your solution.

NPS is an EUA approved (NPS - EUA203100). We run an extensive clinical assessments for use and safety. It has been successfully used and tested by many clinicians from different disciplines.

For the past three years, we have been working with our manufacturer and suppliers in preparation for launch our product.

At this stage we ready to go to market with the appropriate funding to put it in the hands of the healthcare providers and facilities.

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Who is the Team Lead for your solution?

Dr. Wisam Breegi

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More About Your Solution

Which of the following categories best describes your solution?

A new application of an existing technology
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What makes your solution innovative?

The U.S. loses and globally countless lives and billions of dollars annually due to inadequate biocontainment and treatment solutions, from aerosolized infected patients. COVID-19 patients continue to spread viral aerosols to frontline workers and their surrounding environment. No single-use cost-effective platform yet exists in the market. Before the COVID-19 pandemic highlighted the extreme difficulty, cost, energy and resource intensiveness of infection control. Our safe and compact containment platform with its innovative airlock system goes far beyond hospital-acquired infections and pandemics: it is a scalable microenvironment for standard and novel treatments which significantly reduces logistics, resources, costs and risks associated with current containment and invasive treatments. This will enable any healthcare facility to provide negative pressure biocontainment environment for 1/10,000 of the cost of operating a hospital negative pressure room. This is a novel and a game changer on a large scale to halt an aerosolized infection from becoming a full blown pandemic.

NPS (EUA203100) consists of the single-use patient dome without any electronics and is deployed about the head and neck of a patient to contain and evacuate aerosols while connected hospital provided negative pressure while also facilitating treatments such as CPAP/BiPAP, intubations, noninvasive ventilation and more. 
One of the main threads to healthcare workers is cross contamination in healthcare facilities, transport and treatment.  Our patented, single-use NPS platform treats and contains patients by bringing biocontainment down to a practical, safe, and cost-effective size and functions.

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Please select the technologies currently used in your solution:

  • Biotechnology / Bioengineering
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Select the key characteristics of your target population.

  • Women & Girls
  • Pregnant Women
  • LGBTQ+
  • Infants
  • Children & Adolescents
  • Elderly
  • Rural
  • Peri-Urban
  • Urban
  • Poor
  • Low-Income
  • Middle-Income
  • Refugees & Internally Displaced Persons
  • Minorities & Previously Excluded Populations
  • Persons with Disabilities
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Which of the UN Sustainable Development Goals does your solution address?

  • 3. Good Health and Well-being
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In which countries do you currently operate?

  • Honduras
  • Turkey
  • United States
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In which countries will you be operating within the next year?

  • Honduras
  • India
  • Turkey
  • Uganda
  • United States
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How many people does your solution currently serve? How many will it serve in one year? In five years?

NPS in not in the market yet. 

We tested our device on few dozen volunteers.

We anticipate on year one to serve 15,000

In five years we plan to serve conservatively over 2,000,000

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How are you measuring your progress toward your impact goals?

Our goat is to improve the patient experience and outcome and providing safe and practical environment to our healthcare providers. Our effort is measured by our progress toward our final goals by improving the patient experience and outcome and providing safe and practical environment to our healthcare providers.

1- Regulatory pathway:
Medical device is a highly regulated industry. Our goal is to obtain FDA's 510 (k) status and EU approval. Patient safety, usability and outcome benefits, naming few, are on the top of the list to measure our progress and success. This complex and intertwine process will encompass many matrix to assess our progress, such as optimal engineering designs, through bench testing, extensive clinical testing and usability.

2- Product adoption: (Awareness, Interest, Evaluation and Conversion)
.Personal  (patient) biocontainment is newly adopted technology. Our progress and success is related directly to achieve product adoption. Our effort is focused not only on the end user and subject matter experts, but on executives with decision making and purchasing power, too. This includes Hospitals, ministries of health, including high level government officials and big governmental and non-governmental organizations.

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About Your Team

What type of organization is your solution team?

For-profit, including B-Corp or similar models

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How many people work on your solution team?

Full time: 2

Part time: 4

Contractors: 14

Interns and volunteers: 38

Expert matter subjects and advisors: 12

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How long have you been working on your solution?

Platform: 7 years, NPS: 2.5 years

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How are you and your team well-positioned to deliver this solution?

At Breegi Scientific, our team has over 200 years of multidisciplinary experiences in clinical, public health, medical devices, engineering, regulatory and business.

Dr. Wisam Breegi, CEO - 26y Clinical and research experience, Medical device, inventor, intrapreneur and researcher with business acumen. He is a human rights activist with an international recognition.

Danstan Bagenda, PHD - 18y Infectious disease & global health expert with focus on eat Africa, especially Uganda.

Rebecca Love, RN- 16y A successful entrepreneur, nurse leader, founding member – SONSIEL. She has hands on experience with startups and business strategy.

Anh Nguyen - 22y Biomedical engineer,  highly experienced with medical devices, project management and leadership

Jason Walsh - 20y of life science business 

Clair Strohl - 45y Mechanical engineer with regulatory and medical devices experience. Experienced in startups and business.

Danny Breegi - 10y of global health and medical access research. Experience in regulatory, FDA: EUA, 510(k). He leads several regulatory and business groups.

Dr. W. El Bermani - Prof. 45y medicine and surgery

External Clinical Advisors:

Nicole Lincoln, RN - Nursing expert and leader - Boston Medical Center

Dr. Davidson Hamer - Prof. Global health and infectious diseases expert. COVID-19 advisor - Boston University School of Medicine.

Dr. Karsten Lunze - Prof. Global health and infectious disease expert - Boston University School of Medicine.

Dr. Jonathan M. Davis - Professor. & Neonatal chair, FDA Neonatal Innovation - Tufts Children's Hospital. Tufts School of Medicine.

In addition, we have several regulatory, engineering and business teams of volunteers. 

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What is your approach to building a diverse, equitable, and inclusive leadership team?

Diversity is a key success formula for any team, specifically in global health. Our team is not only diverse by race, ethnicity, gender, physical limitations and age. Our team embodies the human experience, survival of wars, ethnic, religious and political persecutions. At BSI, we cherish human experiences, diversity and equality.

Our founder is a human rights activist from a small persecuted ethnoreligious minority from the Middle East called Mandaeans. He experienced first hand the meaning of diversity and prevented from opportunities to succeed that is based on merit not on inherited advantages and affiliations.

Our head engineers and Board member, Anh Nguyen, is from Vietnam and survived the brutal war and the journey to the Us to start a new life with his family. He went to school for the first time at the age of 10 years old.

Danny Breegi, a war survivor, he was born hypothermic in an Iraqi hospital in the middle of the first gulf war that lacked electricity and no functioning infant incubators. His family fled Iraq from religious persecution.

Rebecca Love, a nurse who had to fight hard to break the glass roof and build a great business with a successful exit strategy.

Our team 

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Your Business Model & Partnerships

Do you primarily provide products or services directly to individuals, to other organizations, or to the government?

Organizations (B2B)
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Partnership & Prize Funding Opportunities

Why are you applying to Solve?

Solve's network and resources to implement and broaden the horizons of our technology on the frontlines of the pandemic and beyond can make a real difference for the voiceless. The majority of the world will continue to suffer from pandemic and it is our responsibility to forge partnerships and bring the most effective solutions to where they are needed most. 

The global health and innovation network available to Solve will be a force multiplier and allow subject experts to help us bring a revolutionary protective barrier with our mutual networks of selfless leaders. It is imperative that we maximize our combined abilities as such and work with public and private entities to organize, strategize, and optimize our solution through to the last mile and into the post-pandemic and recovery phase.

Solve and Breegi together will make a lasting difference in the lives of clinicians and patients who have little to no resources and are dying with makeshift solutions or none at all. Together, Solve and Breegi will be part of a paradigm shift in protection and treatment while giving frontline workers and patients desperately needed peace of mind. after 18 months of fear, turmoil, and heartache with little advancement in their own personal safety. The urgency and scale of this opportunity to help humanity is profoundly meaningful and we kindly request your support.

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In which of the following areas do you most need partners or support?

  • Financial (e.g. improving accounting practices, pitching to investors)
  • Public Relations (e.g. branding/marketing strategy, social and global media)
  • Product / Service Distribution (e.g. expanding client base)
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Please explain in more detail here.

Our recent gain of the EUA, enabled us to market our NPS to healthcare facilities to protect the healthcare workers and prevent the spread of the virus. Such opportunity requires great effort to raise funds and organize our finances to be on a successful path to market and sale our product.

This will require a strong branding, media and marketing plan and execution, especially we are dealing here with a new approach to contain the virus, which might be unfamiliar to the healthcare providers and patients alike.

Due to the global nature of the NPS, it is vitally important to understand and plan to how to expand our client base and how to build our distribution channels. This can be achieved with public and private collaboration.

The last piece, is our need for support to optimize our software and hardware for the NPS respiratory support and data collection. 

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What organizations would you like to partner with, and how would you like to partner with them?

We have no specific affiliation or connections with MIT faculty, but we are looking forward work with individuals or teams to: 

- optimize and develop the engineering of the NPS and its future functions. This include mechanical engineering, design. In addition to the development of the vital controller software, hardware and data analyses.
- develop a business strategy working with governments in developing countries, NGO, and industry to connect to new markets, including the US.
- focus on mentorship for funding and business development as Breegi Scientific to scales its products to multiple geographies and markets.

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Do you qualify for and would you like to be considered for the Robert Wood Johnson Foundation Prize? If you select Yes, explain how you are qualified for the prize in the additional question that appears.

Yes, I wish to apply for this prize

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Explain how you are qualified for this prize. How will your team use Robert Wood Johnson Foundation Prize to advance your solution?

Our NPS was designed and tested in our hospitals, here in the US. With EUA in hand, NPS is ready to be put in the hands of our healthcare providers, especially in low resources areas that lacks the proper containment facilities. 

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Solution Team

 
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