Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line.
Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombosis could be due to software algorithms, HeartWare said.
“We were hoping to be able to state when we expect to re-initiate the MVAD system clinical program with certainty, but it is essential that we complete our analysis and work with trial investigators and regulatory authorities on the path forward that enhances the opportunity for the MVAD system to realize its considerable potential,” CEO Doug Godshall said in prepared remarks. “While the initial MVAD clinical experience has not fully met our expectations, we have made meaningful progress in our investigation and have identified some software algorithms that we plan to adjust to improve pump performance. As the MVAD system is performing well on most fronts, we remain optimistic that an improved MVAD system will emerge from this additional evaluation.”
Investors pared 30.0% from HTWR shares in early October 2015, after the company said it might not be able to resume the trial as soon as was expected. But later that month, Godshall said HeartWare was on track to resume the trial. Yesterday the company said its evaluation of the MVAD data could take several more months and that “the timetable for regulatory filings and restarting clinical implants cannot be precisely projected at this time.”
“In parallel, the company is evaluating various aspects of the system design to determine whether additional changes could be made to improve performance. Should design changes be identified that could enhance outcomes, initiation of a new trial would likely be required,” HeartWare said.
On the positive side, HeartWare reported progress toward winning FDA approval for a destination therapy indication for its HVAD pump, currently approved only for bridge-to-transplant patients. A pre-market approval application, based on its 465-patient Endurance2 trial and data from the original Endurance trial, is expected in mid-2016, the company said. Six-month follow-up data from the Endurance2 study is slated to be released next month, HeartWare said.
“HeartWare’s Endurance trials are by far the largest cohort of ventricular assist device patients ever prospectively studied, and it is extremely gratifying to see that our hypothesis in Endurance2 – that tighter patient management would meaningfully decrease the stroke rate among HVAD patients – appears to be valid based on the data trends to date,”Godshall said. “As the market in the U.S. shifts increasingly toward destination therapy, a positive outcome and earlier submission for the DT indication has the potential to be a significant catalyst for the company. By submitting these data for earlier review, we move 1 step closer toward access to the broader U.S. VAD market and, importantly, ensuring compliance with enhanced blood pressure monitoring for the benefit of all HVAD patients.”
Leerink Partners analyst Danielle Antalffy said the mid-year forecast for the HVAD PMA submission is about half a year ahead of expectations, but the MVAD news likely means a delay for the re-start of that trial.
“”In [the] worst-case scenario, the device might require a redesign – pushing restart of the trial or a completely new trial 18 months from the current timeline,” Antalffy wrote today in a note to investors.
Barclay’s analyst Matthew Taylor said it’s tough to figure the odds on the 3 potential scenarios for MVAD without more information.
“1) The best case is HTWR has a goal to submit a request to a restart after testing the qPulse waveform; 2) HTWR is also evaluating other algorithms that could reduce pump sensitivity and assessing more moderate pulsatility modes (could take months); 3) HTWR is now also incorporating an external pump designer to take a hard look at the design. If design changes are needed, a new trial would be required and we think a redesign could mean a 12-18 month delay,” Taylore wrote this morning in a note to investors.
HeartWare also said it named former Medtronic (NYSE:MDT) medicine & technology SVP Dr. Stephen Oesterle, now a partner at venture capital firm New Enterprise Associates, to its board.
HTWR shares were down -28.4% to $29.25 apiece today in early trading.