Managing Editor

Aksys looking to next 12-18 months ‘to shape our destiny’

Aksys (Lincolnshire, Illinois) in 2002 reported winning FDA clearance for the first home dialysis device, the Personal Hemodialysis (PHD) System – thus posting a “major breakthrough” (Medical Device Daily, 2002) – but the company is still very much in pre-profit mode.

At the time of the PHD system’s U.S. clearance, company president and CEO William Dow predicted sales of $40 million by the end of 2003, but that prediction has not matched performance.

Aksys this past May reported 1Q05 revenues of $534,000 and a net loss for the quarter of $9 million. It said it had 126 patients being treated with the PHD system and 45 “partnership agreements” as of the end of the quarter. It also could boast receiving the “Enabling Technology of the Year” award from Frost & Sullivan for 2005.

But its half-million-dollars in sales for the quarter were below the 1Q04 sales of $682,000, which the company said was a result of “fewer units sold and more units placed as rentals.”

In late May, Dow told stockholders at the firm’s annual meeting that “The next 12 to 18 months will likely shape our destiny, particularly if one or more market-shifting and growth-accelerating events occur.”

He said these events included “positive modifications to reimbursement . . . currently being considered, the adoption of the PHD System by a major provider [unnamed] as a significant patient offering, and the continuing accumulation of clinical data that confirms the failure of more frequent dialysis at home.”

For the year ended Dec. 31, 2004, Aksys reported revenues of somewhat more than $2.4 million vs. revenues just short of $1.5 million for 2003. For the full year, it reported a loss of $27.7 million, compared to a 2003 loss of $22.3 million.

With the report, Dow set the half-year goal for 2005 of “140 to 160 patients on the PHD system.”

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