Dialysis player Outset Medical attracted a lot of media attention last month when it released an SEC filing for a $60 million equity financing. Now, it's ready to give a much more detailed account of the financing and the plans for its Tablo product, which it touts as the first consumer-friendly, all-in-one dialysis device to get through the FDA.
The company said that the recent financing was in fact for $91 million, contrary to the earlier filing, with a $51 million equity component and $40 million in debt.
The cash will go to back a launch of its Tablo System next year, which the FDA cleared in November, as well as toward executing an in-home use trial to gain an FDA nod specifically for that indication. Its existing clearance from the agency is specifically for acute and chronic care settings including dialysis clinics and hospitals.
The company expects to launch Tablo next year in the U.S., likely in the clinic setting that is dominated by Fresenius Medical Care and DaVita ($DVA). There are more than 6,500 U.S. hemodialysis clinics. Tablo is CE-marked, but the company has opted to hold out for a U.S. launch first.
Outset sees its first task as transforming the dialysis service model within the clinic. It expects Tablo could lower costs for the major dialysis clinics by enabling a "self-care" option for users that would obviate about half the costs associated with dialysis, which are tied up with staffing and infrastructure.
"What really interested me about this field is there's been so very little innovation in the space over the last 20 or 30 years, on technology and service," Outset Medical CEO Leslie Trigg said in an interview. "Clinics look similar to how they look in the '80s. How could you use technology to catalyze service innovation? When you strip it all away that's what we're trying to do--for cost reduction and to change the patient experience."
Read More: http://www.fiercemedicaldevices.com/story/outset-medical-rounds-91m-make-dialysis-options-more-attractive/2015-06-08
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