Renalytix AI confident despite delay to new US Medicare rule

The AIM-traded firm said MCIT was intended to provide a coverage pathway for Medicare beneficiaries across the United States for innovative medical devices and diagnostic tests designated under the ‘Breakthrough Device’ review programme and with market authorization by the Food and Drug Administration (FDA).

It said the Centers for Medicare and Medicaid Services (CMS) was delaying the implementation date of the MCIT rule by 60 days, beginning a 30-day comment period to solicit additional public feedback on the rule.

Renalytix AI said it expected the MCIT rule, as is or amended, would become effective within the expected 2021 FDA review and clearance period for its ‘KidneyIntelX’ product, and would have “no material effect” on its business plan.

“Renalytix AI's lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019 and submitted its final FDA application in August 2020,” the board said in its statement.

“The MCIT rule has bipartisan support in Congress and is considered by many as a key programme to drive medical innovation and improve countless lives.”

At 0833 GMT, shares in Renalytix AI were down 5.79% at 1,008p.