Direct Flow raises $27 million

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25/07/2016

Direct Flow Medical raised raised $27.1 million in a new round of financing through the sales of select stock and warrants.

Money in the round came from 11 anonymous investors, with the company looking for another $5.2 million before closing the round, according to the filing.

The company said it raised the funds through the sale and issuance of Series A-1 preferred stock, Series AA preferred stock, convertible notes, warrants to purchase Series A-1 or preferred stock, Series A-1 or preferred stock upon exercise and the underlying common stock issuable upon conversion, according to an SEC filing.

The company has not yet released information on how it intends to spend funds raised in the round.

In April, Direct Flow Medical said that recent FDA approvals for transcatheter aortic valve replacements prompted it to make changes to the Salus trial of its own TAVR entry.

Salus, originally aimed at enrolling 1,262 patients, is now expected to enroll a little more than half that number, 648 subjects, the company said. Santa Rosa, Calif.-based Direct Flow is also adding best practices and comparisons to TAVRs that are already on the U.S. market, which include the Sapien line from market leader Edwards Lifesciences (NYSE:EW) and the Medtronic (NYSE:MDT) CoreValve device.

The 30-patient feasibility phase of for Salus in 2013 showed a 30-day survival rate of 97%, low procedural complications, no incidence of stroke, a 3% rate of permanent pacing and 100% of patients with mild or less aortic regurgitation. The primary endpoint is composite all-cause mortality and disabling stroke at 12 months.


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