DreaMed Receives FDA Clearance for its Type 2 Diabetes AI-based Clinical Decision Support System

TEL AVIV, Israel--(BUSINESS WIRE)-- DreaMed Diabetes AI LTD. (“DreaMed” or the “Company”), a developer of the Advisor Pro Al Clinical Decision Support System expert-care platform for diabetes, announced today that it has received its 4^th U.S Food and Drug Administration (FDA) clearance that expands the platform’s target population to patients with both type 1 and type 2 diabetes. Advisor Pro is the first decision support system that has been cleared to assist healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using continuous glucose monitor and/or blood glucose meters. This clinical and technological advancement leverages the power of artificial intelligence to optimize insulin administration, in a streamlined and cost-effective manner. Advisor Pro aims to solve the massive worldwide shortage of endocrinologists by empowering primary care clinicians, such as PCPs and NPs, to be able to provide expert level endocrinological care to diabetes patients.

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DreaMed Receives FDA Clearance for its Type 2 Diabetes AI-based Clinical Decision Support System (Photo: DreaMed Diabetes)

DreaMed Advisor Pro previously received a CE Mark and was cleared by the FDA for people with type 1 diabetes using insulin pump therapy with continuous glucose sensors and/or blood glucose meters and is already deployed by leading diabetes treatment centers, including Yale New Haven Health, Texas Children’s Hospital, University of Florida and more.

Eran Atlas, DreaMed’s Founder & CEO commented: ”There are simply not enough endocrinologists to provide the expert level care that all people with diabetes require continuously. In the U.S. alone, there are over 41,000 adults per endocrinologist¹ which results in circa more than 50%² of all people with diabetes that are not well managed due to limited access to proper care. DreaMed empowers the medical staff to treat significantly more patients by providing access to expert endocrinological advice in primary care settings. We can potentially help avoid thousands of unnecessary hospitalizations and medical complications for the community of people with diabetes and change the overall standards of care in this sector. The FDA clearance puts us on a path to help millions of people with diabetes and our next step is to develop and extend our solution to cover all injectable or oral medications for diabetes.”

Prof. Moshe Phillip, DreaMed’s Chief Science Officer and the Director of the Endocrinology and Diabetes Institute at Schneider Children’s Medical Center in Israel commented: ”Chronic diseases require constant care by experts. DreaMed has done significant clinical research to achieve a strong AI-based clinical decision support system that has just received the necessary FDA clearance. DreaMed Advisor Pro greatly expands the access to the much-needed expert-level care to millions of people. We are proud of this achievement and committed to work hard on its expansion to additional capabilities and treatment methods.”

About Type 2 Diabetes³

An estimated 463 million adults currently live with diabetes (9.3% of the world’s adult population). The total number is predicted to rise to 578 million (10.2%) by 2030 and to 700 million (10.9%) by 2045. Annual global health expenditure on diabetes is estimated to be USD 760 billion. It is projected that expenditure will reach USD 825 billion by 2030 and USD 845 billion by 2045. 43% of the global diabetes-related health expenditure occurs in the North America and Caribbean Region. The health costs of treating the complications of diabetes account for over 50% of the direct health costs of diabetes. Diabetes complications, as frequent causes of disability, premature mortality and absence from work due to sickness, are important drivers of indirect costs.

Type 2 diabetes accounts for the vast majority (around 90%) of diabetes worldwide. The global prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by population aging, economic development and increasing urbanisation. Patients with type 2 diabetes require constant control of raised glucose levels. It is vital to manage blood pressure and blood lipid levels and to assess metabolic control on a regular basis. This will enable screening for the development of renal complications, retinopathy, neuropathy, peripheral arterial disease and foot ulceration

About DreaMed Diabetes:

DreaMed is a digital health solution, consisting of a group of top diabetes experts that came to solve the massive lack of endocrinologists in the world and to provide ongoing diabetes expert care. The company started with its artificial pancreas technology project between 2007 and 2014 at the Schneider Children’s Medical Center. Since then, DreaMed has dedicated its efforts to commercialize the FDA cleared DreaMed Advisor, a SaaS based AI platform that is clinically proven to provide endo expert care for diabetes at a similar level as a human endo expert. For more information, visit https://dreamed-diabetes.com/

¹https://www.aamc.org/what-we-do/mission-areas/health-care/workforce-studies/interactive-data/number-people-active-physician-specialty-2019

² https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

³ IDF DIABETES ATLAS, 9th edition 2019 (available at: https://www.diabetesatlas.org/en/)

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