RenalytixAI Secures FDA’s Breakthrough Device Status on KidneyIntelX Tool

RenalytixAI has achieved an important milestone this month after receiving the FDA’s Breakthrough Device designation for their cutting-edge KidneyIntelX – a diagnostic tool that uses artificial-intelligence to help diagnose patients at risk of kidney disease progression and dialysis.

The Breakthrough Devices Program is a voluntary initiative for specific medical devices and device-led combination products that offer more effective identification or management of life-threatening or irreversibly incapacitating diseases or conditions. The program is designed to give healthcare providers and patients timely access to medical devices – such as the KidneyIntelX – by accelerating their development, examination and evaluation without compromising FDA’s clinical standards.

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The medical apparatus uses machine learning algorithms to analyze biomarkers found in blood and combines data with information stored in electronic health records to detect signs of progressive kidney disease. The tool is specifically designed to monitor those patients with Type II Diabetes and those with African ancestry to assist with clinical management for those at-risk or diagnosed with fast-progressing kidney disease.

According to the International Society of Nephrology, it’s estimated that more than 850 million people have some form of kidney disease but most remain unaware of their impaired kidney function. The expense of treating chronic and late-stage kidney disease is estimated to cost $114 billion a year and it’s hoped that KidneyIntelX will be able to lessen some of that impact to the United States healthcare system.

“We’re pleased RenalytixAI has received breakthrough designation for KidneyIntelX providing the opportunity to work hand-in-hand with the FDA towards the goal of FDA submission.,” Sally Bowden, COO of RenalytixAI, said in a statement. “Renal disease represents an increasing healthcare crisis globally, and early detection and intervention is essential in changing the course of this disease.”

The healthcare company signed a multi-year license and collaboration agreement with Mount Sinai in May 2018. The partnership grants RenalytixAI access to the health system’s data stores containing over 3 million patient records and 43,000 records in the BioME biobank repository. In exchange, Mount Sinai will have a stake in RenalytixAI’s product development and commercialization of an artificial intelligence-based learning system that flags and follows-up with at risk patients.

Hiddo Heerspink, Department of Clinical Pharmacy and Pharmacology of UMCG and lead investigator in the planned evaluation, also shared his perspective: “The ability of KidneyIntelX to discriminate fast-progressing kidney disease offers pharma the potential to enrich clinical trials with patients most likely to benefit most from novel drug therapies. Additionally, the potential to predict drug response in these patients is critically important to directing clinical use of new therapies.”

RenalytixAI raised $29 million in series A funding in November 2018 before they started trading on the London Stock Exchange AIM market. Mount Sinai is a shareholder in the company and has made additional investment through the company’s funding round.