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FDA green-lights expansion of HeartWare’s Advance trial

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The Food & Drug Administration approved a bid by HeartWare International Inc. (NSDQ:HTWR) to expand the Advance trial examining its ventricular assist device as a bridge to transplant in patients with end-stage heart failure.

The FDA granted an investigational device exemption supplement to allow the Framingham, Mass.-based firm to expand the trial by 54 patients. The study, aimed at evaluating the device’s suitability in patients who are waiting for a heart transplant, will measure survival rates after 180 days, the incidence of adverse events such as bleeding and infection, functional status, hospitalization, neuro-cognitive function and quality of life.

So far, 140 patients at 30 sites have been implanted with the HVAD device, a small implantable pump designed to assist the heart’s ventricles in pumping blood. The last of those subjects is expected to reach the 180-day mark by the end of August. The FDA nod means HeartWare can now begin enrolling the additional patients under a modified protocol, setting the company up for a possible pre-market approval application in December.

In October 2008, HeartWare won approval to expand the Advance study from 28 to 40 sites; at the time, 22 clinics were participating in the trial. Last month the ahead-of-schedule enrollment of the 140th patient triggered milestone bonuses for HeartWare executives, under performance rights plans adopted by the HeartWare board in 2007 and 2008. The executives received restricted stock awards worth between $100,000 and nearly $1.3 million, depending on their position on the corporate ladder.

The company closed 2009 on a high note, with soaring sales and slashed losses. HeartWare posted sales of $12.2 million during the three months ended Dec. 31, 2009, up a whopping 4,900 percent compared with $244,000 during the same period in 2009. Fourth-quarter net losses plunged 51.4 percent, to $1.9 million (or 176 cents per share) compared with $3.9 million (44 cents per share) during Q4 2008.

HeartWare’s top line fared even better during the full year, soaring 7,180 percent to $24.2 million compared with $332,000 in 2008. Annual net losses were down 12 percent to $20.9 million ($2.15 per share) in 2009, compared with $23.8 million ($3.00 per share) during the prior year.

And early in February the company pulled in $62.8 million from a public stock offering, selling nearly 1.8 millions shares for a net gain of $59 million.

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