On Tuesday at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, Sunshine Heart (SSH) presented updated results from the ongoing OPTIONS-HF European trial testing the C-Pulse heart assist device in late-stage heart failure patients.Following the short presentation at the meeting on Monday, further updates were presented at a SSH investor event on Tuesday morning. Here’s what we wrote previously on SSH in consideration of this event.
Overall, we believe the updated results are positive for Sunshine Heart and the device, although the evidence is largely anecdotal and from a small test population, thus warrants caution. Most interesting, three more patients from the feasibility study have been weaned from the device, suggesting that patients’ hearts may be recovering as the C-Pulse reduces strain on the muscle. Bear in mind, these results are from a small population and all of the weaned patients came from the same trial site.
The first of 50 planned patients in the OPTIONS-HF trial was implanted with the device in May of this year. Data presented this week included 415 cumulative days of C-Pulse therapy across five individual patients, four of whom remain on C-Pulse therapy, and an additional two patients have been implanted although data for these patients were not included in the presentation. There have been no re-hospitalizations due to worsening heart failure or heart failure related death (not surprising given that patients have been on therapy for a relatively brief period of time) but re-hospitalization is the primary endpoint in the U.S. COUNTER-HF trial and important to monitor. Below are a few pertinent slides from the TCT presentation:
We were initially concerned by the exclusion of one of these five patients from analysis when we read today’s press release, however, tachychardia following chardiac surgery is not particularly uncommon. C-Pulse’s counter-pulsation mechanism would likely not have been productive for this patient, thus its replacement with a traditional LVAD (continuous flow) does not alarm us.
The above are results from the two German patients who have been on-therapy for more than 100 days as of the TCT presentation. It’s encouraging to see rapid improvements in RVEF and LVEF (Right/Left Ventricle Ejection Fracture, a measure of the blood pumped from these ventricles) in both patients, as well as a NYHA class improvement in Patient 3. According to the presenters, Patient 1 performed worse on the 6 MHW test due to muscle weakness and cancer diagnosis. Ultimately, the device seems to be well-tolerated and is producing, at least over a short timeframe, a noticeable benefit in these Class III and IV patients, and investors will receive more color on the company’s upcoming third quarter earnings call, November 11. (see the OPTIONS-HF slide deck)
Sunshine Heart had previously announced that two patients from the U.S. feasibility study had been weaned from the device. The company profiled on Tuesday three additional patients from the feasibility trial, two of whom have now been successfully weaned from the device following improvements in heart failure NYHA classification, ejection fractions, and heart failure related symptoms; and a third patient is in the weaning process (see the patient weaning slide deck). Thus, four of the 23 patients included in the previous feasibility study have now been weaned entirely from the device, a 17% weaning rate.
Finally, Sunshine Heart offered new details on plans for a fully implantable C-Pulse device (see the slide deck), set to begin animal studies before year-end. The device is unique in that it does not require an implantable battery pack, relying instead on a transcutaneous power source, depicted below. The benefit is two-fold: a smaller, less obtrusive unit and a much lower rate of exit site infections related to a percutaneous lead.
We expect more details from these presentations on the company’s upcoming earnings call, but the takeaway after a glance through the presentation materials is net positive for Sunshine Heart. Although we trimmed our position immediately following yesterday’s press release upon noticing the 4/5 patient shenanigans, ours was a knee-jerk reaction, and we’ve since become comfortable with the results. Although we expected SSH to provide some trading opportunities through this quarter, we’re now more focused on the long-term holding as data read-outs over the next two years (until completion of the COUNTER-HF trial) will be incremental.
In connection with SSH, PropThink has taken a long position.