A small New Brighton company that has developed a unique device to treat patients who have heart failure said Wednesday that it has secured $22 million in financing.
Acorn Cardiovascular Inc. said in a news release that it will use the money to fund "product development, clinical and regulatory activities." The company declined further comment Wednesday.
Acorn has been trying for the past three years to gain U.S. Food and Drug Administration (FDA) approval for its CorCap cardiac support device. The mesh, sock-like device supports the heart, which often swells to three times its normal size as heart failure progresses.
Although CorCap received European regulatory approval in 2000, the company has had a rough go in gaining approval from U.S. regulators -- a required step before the device can be sold in this country.
On two occasions, panels advising the FDA voted against approval. But in May, Acorn officials said the company reached an agreement with regulators for a new 50-patient clinical trial testing the device to make sure it is safe and effective, and to confirm results of an earlier 300-patient study.
To date, the company has raised about $100 million from investors.
Lead investors in the latest round of financing were Cardinal Partners, a Princeton, N.J., venture capital firm specializing in health care investments; Fidelity Biosciences, a venture capital firm in Cambridge, Mass., that focuses on biopharmaceutical and medical technology companies; and Thoratec Corp. of Pleasanton, Calif. They join existing investors Credit Suisse, New Enterprise Associates and SightLine Partners as the principal participants in the financing.
As part of the financing, Charles Hadley of Cardinal Partners and Robert Weisskoff of Fidelity Biosciences will join Acorn's board of directors.
