Cardica ($CRDC) suspended enrollment in its European clinical trial of the MicroCutter XPress 30 because the device didn't perform satisfactorily in thicker tissue. The company says it has identified the cause and will modify the product accordingly. The news sent the company's shares down 20% after the announcement, as Mass Device notes.
Redwood City, CA-based Cardica designs and manufactures stapling devices for surgical procedures. Its technology is designed to minimize operating time and to enable minimally invasive and robot-assisted surgeries, the company notes on its website.
In light of these recent study results, Cardica has reprioritized its activities to emphasize the development of the MicroCutter XChange 30. Cardica hopes to continue the trial with the XChange 30 by the end of the first quarter.
In a statement, Cardica also cited limited financial resources for now suspending development of other potential offerings in its planned microcutter product line as it concentrates on XChange 30. It hopes to attract additional financial resources.
"We are disappointed that the XPress 30 did not perform as well as we expected in the upper range of tissue thickness but understand and are confident we can make the changes needed to enhance performance," explained Bernard Hausen, Cardica's president and CEO, in a statement. "In the interim, the XChange 30 will allow us to resume trial enrollment in the near future while also providing Cardica with a readily marketable product that is substantially smaller with significantly enhanced articulation range."
- read Cardica's release
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