CryoLife Says It Faces SEC Probe
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ATLANTA (AP) _ A Georgia tissue bank whose products have been linked to a death and numerous serious infections is being investigated by the Securities and Exchange Commission.
CryoLife Inc. said Monday the SEC probe was related to the Food and Drug Administration’s order to recall tissue because of suspected contamination.
``We are trying to determine whether there have been any violations of the federal securities laws,″ the SEC letter states.
Officials from CryoLife, the nation’s largest supplier of living human tissue for implantation, did not immediately return calls to The Associated Press.
Shares of CryoLife plunged last week after the human tissue bank delayed a quarterly securities filing. The sharp sell-off occurred after federal regulators ordered the company to stop distributing human cadaver tissue Aug. 14.
FDA officials said the company, based in Kennesaw, Ga., has failed to adopt and follow safety procedures to keep fungus and bacteria from contaminating soft tissue.
The FDA ordered CryoLife to recall all soft tissue processed since Oct. 3, a month before a Minnesota man died from tainted tissue he received in a knee operation.
The death of Brian Lykins of Willmar, Minn., touched off an investigation by the Centers for Disease Control and Prevention that concluded infections from cadaver tissue used in orthopedic implants are more widespread than previously thought. The CDC so far has uncovered 54 infections associated with soft tissue grafts, 26 of them involving tissue from CryoLife.
CryoLife shares rose 6 cents to close at $3.05 on the New York Stock Exchange.
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