Coverage launched on Sunshine Heart and Heartware


A fan of Sunshine Heart's (SSH -0.2%) technology, BTIG is concerned about the current pace of enrollment in the company's U.S. trial. "We think it could be several years before this trial is complete, pushing FDA approval to 2018 or beyond," writes analyst Sean Lavin, initiating coverage with a Neutral. "We believe the most meaningful thing to watch in 2014 is the pace of enrollment."

"Taking U.S. share has proven more difficult than we initially thought," he writes, also starting Heartware International (HTWR) with a Neutral. "A DT label, especially in light of the recent NCD change and Q4 miss will be more important to taking U.S. share than we would have predicted a year ago."

"We feel HTWR's pipeline is robust, but risky. HTWR is working on several products: MVAD, SYNERGY Surgical and Endovascular Systems, and Longhorn. MVAD is the most important. We believe MVAD offers greater technical advances than THOR’s HMIII but also greater risk as the devices are brought to market."

Comments (6)
  • scooby123
    , contributor
    Comments (181) | Send Message
     
    Before we sell off here let's let them report their numbers next month. Then we should get a true picture of how many enrollments are in
    20 Feb 2014, 11:15 PM Reply Like
  • oneotherfool
    , contributor
    Comments (432) | Send Message
     
    jppoczatek, new to $SSH here. Any specific date for the report next month?

     

    Thanks,
    21 Feb 2014, 11:48 AM Reply Like
  • oneotherfool
    , contributor
    Comments (432) | Send Message
     
    Did you mean the Q4 report date, which doesn't look like it has been announced yet?
    21 Feb 2014, 11:51 AM Reply Like
  • scooby123
    , contributor
    Comments (181) | Send Message
     
    Event Timing
    Results of fully implantable pump chronic trial Q1 2014
    COUNTER HF National Investigator meeting Q1 2014
    Initiation of pilot program PR/Awareness Campaign for COUNTER HF Trial Q1 2014
    Presentation / publication of paper on aortic impact after 2 years,
    OPTIONS HF trial clinical update(presentation), Paper/presentation on
    experience at center with greatest C-Pulse experience, C-Pulse Mode of
    operation paper/presentation
    Q1/Q2 2014
    Reimbursement Update February 2014
    Publication of Pilot trial manuscript Q2 2014
    European targeted commercialization initiated Q3 2014
    OPTIONS HF Trial data released Mid 2015
    US trial fully-enrolled Q4 2015/Q1 2016
    US trial data 2016
    As you can see there are two announcements in Q1 still to come. These should have the enrollment numbers as well.
    21 Feb 2014, 04:52 PM Reply Like
  • oneotherfool
    , contributor
    Comments (432) | Send Message
     
    Thank you jppoczatek. I appreciate it!
    21 Feb 2014, 05:03 PM Reply Like
  • scooby123
    , contributor
    Comments (181) | Send Message
     
    Anytime, I think this will be a 10 bagger with in 1.5 years. Hang tight and buy more if it drops below 8!
    23 Feb 2014, 08:35 PM Reply Like
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs