Dive Brief:

• Baxter has received De Novo marketing authorization for its Theranova dialyzer, a type of membrane used in hemodialysis, the company said Monday. FDA listed Theranova 400 and 500 products in its database but has not yet posted the associated letter.
• The new class of dialyzer aims to expand hemodialysis by widening the range of molecules that get filtered from the blood during the therapy. In particular, the product looks to remove "conventional" and "large middle" molecules. The goal is for the membrane to help existing dialysis machines more closely mimic filtration by a natural kidney, the company added in its announcement.
• Baxter previously applied for a CMS Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies for Theranova. In the agency's End-Stage Renal Disease Prospective Payment System for calendar year 2021, issued last month, CMS said the dialyzers did not yet show adequate evidence of substantial clinical improvement for Medicare patients on dialysis, but said it was open to further evidence in the comment period.

Dive Insight:

Renal care is Baxter's largest business line and has become especially important during 2020 as acute kidney injury has proven to be a complication of COVID-19, raking in nearly $1.79 billion during the first six months of the year, up 5% year over year at constant currency. The need for dialysis therapies around the world is driving demand and FDA has issued a few emergency use authorizations for Baxter supplies.

Theranova, which given is considered a "medium cut-off" dialyzer as opposed to "high-flux," may represent an important addition to that mix. The product has been commercially available in Europe and other parts of the world since 2016 and Baxter has already opened orders in the U.S. with an expected turnaround time of about a week.

The dialyzers are designed for use with conventional hemodialysis, which can occur in a clinic or at home — the latter setting has piqued the Trump administration's interest as a way to reduce how much the government pays for costly in-center treatments. But the majority of clinical data available on Theranova is from in-center use, a spokesperson clarified.

The device was under review by FDA for almost a year. Baxter backed its FDA submission with findings from a randomized controlled trial of 172 hemodialysis patients, results of which were published in the Clinical Journal of the American Society of Nephrology this month. The trial, run across 21 U.S. sites between 2017 and 2018, compared outcomes in patients given the Theranova 400 dialyzer over 24 weeks to those given ELISIO-17H, a high-flux dialyzer from renal care product manufacturer Nipro. Patients receiving Theranova were found to have had superior removal of large middle molecules.

In early July, CMS proposed additional payment to providers for at-home dialysis treatment as part of changes to its ESRD PPS. Baxter, like fellow applicant and dialysis tech newcomer Outset Medical, is yet to be successful in obtaining the add-on payment. Baxter CEO Joe Almeida said on an earnings call weeks after the CMS decision that the company would submit comments and new information to the agency by Sept. 4, including the publication of the clinical trial used to support its FDA submission and findings from a randomized controlled trial with Medicare patients.