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| Xlumena's Axios stent and delivery system--Courtesy of Xlumena |
The FDA has approved Xlumena's AXIOS stent and delivery system to treat pseudocysts of the pancreas. In its press release announcing the approval, the FDA noted the stent is the first pancreatic stent specifically designed to drain a pseudocyst.
The FDA approval followed hard upon Xlumena's announcement of new investors. Earlier this month, the Mountain View, CA, company announced a $25 million Series C round of financing led by Third Point LLC, the New York hedge fund run by Daniel Loeb.
It's not clear how large the U.S. market opportunity might be for AXIOS, which cleared EU regulators in 2011. Executives couldn't immediately be reached.
Pseudocysts form in the pancreas when gallstones or injuries block pancreatic ducts. Buildup of enzymes can form large pseudocysts, measuring 7 to more than 50 centimeters wide. Bacterial infections there can lead to life-threatening blood infections.
AXIOS stents are designed to drain fluids by establishing a temporary opening between the pancreas and the gastrointestinal tract.
Xlumena's investors also include Prism VentureWorks, Charter Life Sciences, Ascent Biomedical Ventures and Aperture Venture Partners.
- read the FDA press release