Medical device startup gets European approval for vascular access device
Eden Prairie, Minnesota-based Hemosphere announced last week that the company has obtained European market clearance for the HeRO Graft, an alternative to central venous catheters that are used by hemodialysis patients.
People suffering from kidney failure require central venous catheters to get hemodialysis treatment, but those catheters have an external opening that can lead to infection and may sometimes result in death. The HeRO Graft, on the other hand, is placed completely under the skin, thereby reducing the chance for infection, Hemosphere officials believe. It is approved for sale in the U.S.
“CE Mark approval of the HeRO Graft allows us to build upon the already successful commercialization of the HeRO Graft in the U.S.,” said Patrick Wethington, Hemosphere president and CEO, in a news release.
Since the product was introduced, more than 4,000 patients in the U.S. have received the HeRO Graft.
Hemosphere is not the only Minnesota startup that has developed an alternative vascular access product for hemodialysis patients. A device being developed by Phraxis allows a “percutaneous insertion of a permanent dialysis device that will allow you to withdraw blood from a patient and dialyze it,” said CEO Michael Kallok, in an earlier interview.
Kallok believes Phraxis’s vascular access device is less invasive and requires a surgical procedure to implant, unlike the Phraxis product being developed. The company has raised $1.2 million in a seed round and is looking for an additional $5 million. By contrast, Hemosphere has raised $9.3 million, according to a 2010 regulatory filing.