2021 CNYBAC Medical Device Innovation Challenge Graduate Rubitection Wins 2022 Health Equity FlexGrant from The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP)
Courtesy of CTIP
LOS ANGELES, CALIFORNIA - March 17, 2022 – The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) announced the launch of its 2022 Health Equity FlexGrant, a limited grant opportunity with award amounts up to $15,000 to support pediatric medical device innovators who can apply or adapt their existing medical device to help address health inequities in pediatric care.
All companies who submitted a FlexGrant proposal must have met CTIP's existing requirements to receive support and were evaluated on the following criteria:
- Potential impact on health inequity in children
- Ability to address an unmet need by current available solutions
- Scientific and clinical merit
- Feasibility of achieving stated goals with requested funding
- Sustainability of the proposed solution
- Ability to enter the market in a timely manner
We were impressed by the response from medtech innovators developing pediatric devices that address systemic barriers in the healthcare system. Proposals included devices ranging from concept to commercial stage; the majority of submissions were in the advanced prototype stage with 56% of submissions identifying as a Class II device. 2022 FlexGrant submissions evenly targeted all pediatric sub-populations: Newborn/Neonate (birth to one month), Infant (one month - 2 years), Child ( > 2 - 12 years old) and adolescents ( > 12 through 21 years old) with diagnostic, neonatology and infection control ranking as the most common of the 15 different pediatric subspecialties reported.
Across the United States, many communities face health gaps that have only been magnified due to systemic and institutional barriers. Pediatric health in general is underfunded and under supported, which further exacerbates other inequities. Our Health Equity FlexGrants are one way that CTIP can incentivize, support, and amplify innovators who understand the importance of viewing healthcare through an equity lens, and in response, have designed technologies, partnerships, and business models that tackle these issues head on.
CTIP is proud to announce the four winners for the 2022 FlexGrants:
Hemex Health - Gazelle
The Gazelle device provides affordable, point of care testing for hemoglobin variants including sickle cell disease and trait. Its quantitative information can be used for both screening and treatment monitoring and it can help address the lack of tools available for sickle cell patients and their providers.
Why they were selected: While sickle cell disease has been designated a priority by global health organizations, the CDC acknowledges that patients continue to experience health disparities in the United States. An ongoing problem has been the lack of convenient testing tools. Hemex Health has developed an accurate, affordable diagnostic platform (Gazelle®) that brings powerful testing capabilities to the point of care. Gazelle supports an 8-minute test for sickle cell disease and beta thalassemia that can be easily used in clinics or emergency departments for screening and treatment monitoring. The test has been on the market in 13 countries with high prevalence rates, but where testing is often unavailable.This grant will support Hemex’s application for US FDA 510(k) Clearance for the Gazelle test in the US to enable greater access to care for sickle cell and beta thalassemia patients.
Facebook: @HemexHealth Twitter: @HemexHealth LinkedIn: Hemex Health, Inc
Sonavi Labs - Feelix
Sonavi Labs is on a mission to improve patient outcomes globally by harnessing the most advanced acoustic technology available coupled with clinically proven diagnostic AI software. Sonavi Labs was formed to deploy Feelix, a system that features patented hardware embedded with clinically validated diagnostic software capable of detecting respiratory diseases such as pneumonia in seconds. The Feelix system also features supportive apps and an integrated cloud platform to provide remote monitoring solutions for chronic disease patients with asthma, COPD and Cystic Fibrosis, along with being an ideal solution for enhancing telehealth visits. Feelix is the world's first digital stethoscope that can be used by clinicians and patients anywhere.
Why they were selected: Sonavi Labs has secured NIH funding through the Institute of Minority Health and Health Disparities (NIMHD) to support the development of a novel asthma management systems; children of color are 3 times more likely to die from an asthma attack and 5 times more likely to be hospitalized for an attack. Their existing study is recruiting patients in Baltimore, MD, and Washington, DC. This proposal expands their existing study to include children from communities of color in Orange County in a partnership with Children’s Health Orange County (CHOC). Patients seen for an asthma exacerbation will be sent home with Feelix devices for 30 days, which will allow care teams to evaluate treatment progress and the severity of their symptoms once the patient has been discharged. Data from this study will inform patient monitoring and management algorithms, Soonavi’s regulatory application, and reimbursement strategy.
Facebook: @SonaviLabs Instagram: @sonavilabs Twitter: @SonaviLabs LinkedIn: Sonavi Labs, Inc.
Lactation Lab - Breast Milk Nutritional Analysis Tests
Breast milk provides numerous health benefits for infants and mothers, but over 50% of breastfeeding women stop early because they think their milk supply is inadequate. Studies have shown that women who had their breast milk tested were less anxious and prolonged breastfeeding; unfortunately, breast milk testing is difficult to access. The Lactation Lab Breast Milk Nutritional Analysis Test takes the guesswork out of breastfeeding and allows mothers to know what their milk contains. For many mothers, seeing the nutritional value of their milk (e.g., see that it is in fact higher calories than formula) will encourage continued breastfeeding.
Why they were selected: In the US, women of color are more likely to discontinue breastfeeding early, due to a number of social, economic, and healthcare access barriers. Lactation Lab will work with communities of color to identify breastfeeding mothers, provide breast milk nutritional analysis, and gather feedback on how to improve Lactation Lab’s AI driven breastfeeding support companion app. Funds will be used to provide all materials at no cost and compensate participants.
Facebook: @LactationLounge Instagram: @lactationlab Twitter: @LactationLab LinkedIn: Lactation Lab
Rubitection - Skin Imaging Software for Wound Assessment & Management on All Skin Tones
Rubitection’s skin health and care management tool improves the detection, risk assessment, and care management of dermatological and vascular conditions with an initial application to bedsores for patients with limited mobility whether at home, in nursing homes, or in hospitals. Early detection is critical to prevention, but it's difficult as it relies on visual (e.g. detection of erythema) and manual inspection.
Why they were selected: Many clinicians are trained to recognize skin findings using images and textbooks that contain individuals with lighter skin tones. However, many of these findings and associated physical exam techniques present differently in individuals with darker skin tones. This, combined with existing bias and systemic barriers, leads to disparities in risk assessment, diagnosis, and management of skin conditions. For example, people of color are two times more likely to suffer from a higher incidence of later stage severe bedsores and associated complications. Rubitection’s technology provides an objective and reliable assessment of skin health, helping to address the problem of biased assessment and monitoring. Funds will be used for development and testing of their custom image processing software.
Facebook: @Rubitection Instagram: @rubitection Twitter: @Rubitection LinkedIn: Rubitection Inc.
For more updates from CTIP about pediatric MedTech follow us @westcoastctip on Twitter, Facebook & Instagram, Consortium for Technology & Innovation in Pediatrics on LinkedIn, and the web at www.westcoastctip.org
The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is an FDA-funded pediatric MedTech accelerator centered at Children's Hospital Los Angeles. Our goal is to facilitate the development, production, and distribution of pediatric medical devices by identifying companies working in the space and providing advice, networking, and direct and indirect financial support on the road to commercialization.
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