HeartWare International Inc. (NSDQ:HTWR) leavened some good news with a minor spot of bad news: Positive clinical and commercial data for its ventricular assist device balanced against a repair program and partial recall of some of the device’s controllers.
The Framingham, Mass.-based medical device maker said data from an international clinical trial and from commercial use of its HVAD device showed a survival rate of 90 percent after six months and an actuarial survival rate of 86 percent after a year. The data came from a 50-patient international study and from the first 50 commercial patients, according to a press release.
The 100 patients carried the device for an average of 444 days in the clinical trial population and 203 days in the commercial group, with the longest implantation lasting 1,108 days. Seven patients were transplanted within 180 days in the clinical trial group, compared to four in the commercial group, according to the release.
The device is designed to support patients with end-stage heart failure until they receive a heart transplant. It’s managed by a small controller that sends power and operating instructions to the implanted pump and gives visual and audio feedback to patients and their doctors. HeartWare said it re-designed the controllers in July 2009 to make them waterproof, which inadvertently also made them airtight. When shipped via air, some of those controllers "may be quieter than expected," according to a press release, which prompted HeartWare to add a vent in December 2009 and begin repairing or replacing affected devices.
"The reduced speaker volume does not otherwise impede the operation of the HeartWare controller and there have been no patient deaths or adverse patient consequences reported to date," according to the release. "The aggregate cost of implementing this voluntary repair and replacement project is expected to be less than $400,000, inclusive of inventory, travel, freight and related costs, and this program is expected to be completed within 30-60 days."
Earlier this month, the Food & Drug Administration approved the company’s bid to expand the Advance trial examining the device as a bridge to transplant by 54 patients. HeartWare said it expects to file for pre-market approval from the FDA by the end of the year, after patient follow-up for the trial winds down in August.
On the financial front, the company closed out 2009 on the upswing, posting 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 in January, HeartWare pulled in $55 million in a public stock offering, selling 1,537,305 common shares for $35.50 apiece.
In addition to the clinical trial and commercial data the company announced at the annual meeting of the International Society for Heart and Lung Transplantation in Chicago, HeartWare presented data on a small study of a miniaturized version of the HVAD system it calls the MVAD. It’s about a third the size of the HVAD pump and is designed to be implanted via less-invasive surgery. The device was successfully implanted in 12 cows for 30 days with no complications, according to the study.
