Digital Diagnostics and Baxter Announce New Partnership to Advance Diabetic Retinopathy Detection

Digital Diagnostics and Baxter International Inc. announced a long-term strategic partnership to help front line care providers deliver high-quality care and improve care outcomes. The partnership includes plans to offer Digital Diagnostics’ industry-leading IDx-DR® autonomous AI software as a diagnostic service combined with the Welch Allyn® RetinaVue® 700 Imager. 

Digital Diagnostics created IDx-DR, the autonomous AI diagnostic system for the detection of diabetic retinopathy (including diabetic macular edema) at the point-of-care. Only 15% of people with diabetes receive the recommended annual diabetic eye exam.^1,2 Access to effective diagnostic services is an obstacle, especially in rural or underserved areas. It leaves many with undiagnosed and untreated levels of disease, and a higher risk of consequent visual loss and blindness, as is recognized by the strict HEDIS/MIPS requirements for the diabetic eye exam.^{3, 4, 5, 6, 7, 8, 9, 10}

"Primary care providers want access to the latest diagnostic tools so that testing can be offered during office visits and easily incorporated into existing workflows," said Giuseppe Accogli, executive vice president and chief operating officer, Baxter. "The combination of artificial intelligence and our devices can give providers a clear view of what's going on with their patients, uncovering information that is valuable for treatment plans. Our partnership with Digital Diagnostics is integral in expanding our connected care diagnostics portfolio."

"This partnership has the potential to dramatically increase the number of patients who benefit from point-of-care diagnosis," said Seth Rainford, President, COO and Co-founder of Digital Diagnostics. "We are on a mission to create greater access to healthcare by removing barriers to the process and are pleased that our technology may help save the eyesight of patients suffering from diabetes."

The RetinaVue 700 Imager, which is currently available for use in the U.S., offers primary care providers a simple and affordable way to administer retinal exams during office visits. Together with the RetinaVue Care Delivery Model, the RetinaVue 700 Imager has been used to test more than one million patients, with automated features that make it easy to capture high-quality images in office. The device can be seamlessly integrated into clinical workflows, including connecting to the practice's electronic medical record (EMR) system. Image transfers are protected with SOC-2 certified software.

FDA clearance of the use of IDx-DR with the RetinaVue 700 Imager is expected by early 2023. The agreement between Baxter and Digital Diagnostics is exclusive in the U.S. and non-exclusive outside the U.S.

The Welch Allyn product family is now a part of Baxter's global medical technology portfolio, following Baxter's acquisition of Hillrom in late 2021. 

About Baxter

Every day, millions of patients, caregivers, and healthcare providers rely on Baxter's leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For 90 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

About Digital Diagnostics Inc. 

Digital Diagnostics Inc. is a pioneering autonomous AI diagnostics company on a mission to transform the quality, accessibility, equity, and affordability of global healthcare through the application of technology in the medical diagnosis and treatment process. The company, originally founded by Michael Abramoff, MD, PhD, a neuroscientist, practicing fellowship-trained retina specialist, and computer engineer, is led in partnership with co-founders John Bertrand and Seth Rainford. Today, Digital Diagnostics platform includes one FDA cleared autonomous AI system, IDx-DR, offered on Topcon NW400. 

Digital Diagnostics is paving the way for autonomous AI diagnosis to become a new standard of care, contributing to democratizing healthcare and closing care gaps. The company works closely with patient advocacy groups, federal regulators, and other quality of care and ethics-focused stakeholders to enable adoption of autonomous AI. For more information and the latest news follow: https://digitaldiagnostics.com/ 

This release includes forward-looking statements concerning the RetinaVue 700 Imager, including potential benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter, RetinaVue and Hillrom are trademarks of Baxter International Inc.
 

¹ Benoit SR, Swenor B, Geiss LS, Gregg EW, Saaddine JB. Eye Care Utilization Among Insured People With Diabetes in the U.S., 2010-2014. Diabetes Care. 2019;42(3):427-433.

² Hatef, Vanderver, Fagan, Albert, Alexander. Annual Diabetic Eye Examinations in a Managed Care Medicaid Population. American Journal of Managed Care, 2015

³ Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr, 1994. 125(2): p. 177-88.

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⁷ Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology, 1987. 94(7): p. 761-774.

⁸ Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch.Ophthalmol., 1985. 103(12): p. 1796-1806.

⁹ Antoszyk, A.N., et al., Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA, 2020. 324(23): p. 2383-2395.

¹⁰ Beaulieu, W.T., et al., Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial. Am J Ophthalmol, 2016. 170: p. 206-213.