GlobeNewswire (Tue, 5:15AM)
GlobeNewswire (Feb 28, 2014)
GlobeNewswire (Feb 26, 2014)
GlobeNewswire (Feb 26, 2014)
GlobeNewswire (Feb 5, 2014)
GlobeNewswire (Jan 13, 2014)
at MarketWatch.com (Oct 1, 2012)
at MarketWatch.com (Aug 6, 2012)
Sunshine Heart, Inc. is an early-stage medical device company focused on developing, manufacturing and commercializing its C-Pulse Heart Assist System for treatment of Class III and ambulatory Class IV heart failure.
Tuesday, Mar 111:03 PM
Tuesday, Mar 111:03 PM| 1 Comment
- Investors take umbrage at Sunshine Heart (SSH) today in response to its earnings report published this morning. Shares are down 16% on seven times normal volume.
- Some investors perceive that the company's patient enrollment for the C-Pulse system is proceeding at too slow a pace.
- 36 mutual funds have positions, up from 12 a year ago.
Tuesday, Mar 1112:47 PM|Tuesday, Mar 1112:47 PM| Comment!
Tuesday, Mar 115:58 AM
Thursday, Feb 2011:07 AM
Thursday, Feb 2011:07 AM| 6 Comments
- 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."
Tuesday, Dec 312013, 4:05 PM
Tuesday, Dec 312013, 4:05 PM| 2 Comments
- Summer Street is out with its "Alpha List" for 2014. Below are some of the firm's recommendations in the healthcare space.
- NPS Pharmaceuticals (NPSP) and Rockwell Medical (RMTI) are top picks, with the former propelled by Gattex and the latter buoyed by SFP optimism.
- Sunshine Heart (SSH) is a top MedTech play while Abiomed (ABMD), Heartware (HTWR), and Thoratec (THOR) get positive mentions as well, although these names aren't in the firm's coverage universe.
Tuesday, Dec 172013, 8:12 AM
Tuesday, Dec 172013, 8:12 AM| 2 Comments
- Leerink is out with some commentary on the MedTech space.
- Investors should "focus on companies with growth acceleration and/or upside surprise potential independent of (or at least less dependent on) a macroeconomic recovery [or, alternatively,] a higher and increasing percentage of sales derived from end-markets exhibiting above-average growth," Leerink says.
- Not surprisingly, the LVAD device market gets a mention, with Heartware (HTWR) recommended by name (remember, they just snapped up CircuLite which some think can compete with SSH's C-Pulse).
- Other names mentioned by Leerink: Covidien (COV) for neurovascular and energy devices; Stryker (SYK) for neurovascular and robotics; St. Jude's Medical (STJ) and JNJ for atrial fibrillation; Intuitive Surgical (ISRG).
- Thoratec (THOR) gets an LVAD mention as well, which is interesting considering Leerink's recent commentary on the NEJM manuscript which discussed possible thrombus formation with the HeartMate II.
Monday, Dec 22013, 12:11 PM
Monday, Dec 22013, 12:11 PM| 5 Comments
- HeartWare (HTWR -0.7%) has acquired CircuLite, maker of the SYNERGY system which treats ambulatory chronic heart failure patients.
- The deal is for $30M ($18M in HTWR stock and $12M in cash).
- Here's HTWR CEO Doug Godshall: "The partial-support system developed by CircuLite represents the industry's most intriguing platform for the treatment of patients with earlier stage heart failure." (PR)
- This raises some rather obvious concerns for Sunshine Heart (SSH -0.7%) and the C-Pulse system.
- "Circulite, like SSH, focuses on circulatory support for patients that have failed resynchronization therapy but are not yet sick enough for LVAD. This is a large market which we detail extensively in our SSH reports. Circulite is slightly ahead of SSH in commercializing their products in CE-Mark countries but have also run into problems and have had to pull the product," Summer Street's Mark Landy says, reiterating a Buy rating on SSH.
- "The main differences between Circulite and SSH are that Circulite's products are pumps that 'touch the blood' whereas SSH product does not and that Circulite's products are implanted in hybrid cathlab whereas SSH products as of now require surgery procedure in OR," Landy adds. SSH price target reiterated at $16.
Friday, Nov 292013, 8:35 AM
Friday, Nov 292013, 8:35 AM| 1 Comment
- Sunshine Heart (SSH) moves 2.7% higher in premarket trading.
- Investors are likely reacting to the NEJM and JHLT manuscripts which warn of device exchanges linked to thrombus occurring with HeartMate II (THOR) devices.
- SSH's C-Pulse system treats clinical symptoms associated with Class III and ambulatory Class IV heart failure.
- THOR is now -10% premarket
- For more on the journal manuscripts, THOR, and HTWR, see here and here
Monday, Nov 112013, 4:42 PM
Monday, Nov 112013, 6:17 AM
Tuesday, Oct 292013, 3:36 PM
Tuesday, Oct 292013, 3:36 PM| Comment!
- Sunshine Heart (SSH +5.9%) rallies on double its average 10-day volume.
- The move looks to have been sparked by a PR from earlier today in which the company announced the presentation of initial patient data from an ongoing trial of the C-Pulse System.
- The study's primary endpoint is evaluation of the rate of re-hospitalization due to worsening heart failure and heart failure related death.
- Here, in essence, is what was said: "Surgical implantation without cardiopulmonary bypass was successful [and] there have been no re-hospitalizations due to worsening heart failure or heart failure related death, which is the primary endpoint." (PR)
- Here's SA contributor PropThink: "First read, update net positive ... really can't read into this that much."
Thursday, Sep 192013, 11:32 AM
Friday, Aug 232013, 12:56 PM|Friday, Aug 232013, 12:56 PM| Comment!
Friday, Aug 232013, 12:46 PM|Friday, Aug 232013, 12:46 PM| Comment!
Wednesday, Aug 212013, 12:45 PM|Wednesday, Aug 212013, 12:45 PM| 2 Comments
Monday, Aug 122013, 11:21 AM
Monday, Aug 122013, 11:21 AM| Comment!
- Sunshine Heart (SSH -1.8%) announces a collaboration with St. Paul-based Minnetronix for a transcutaneous energy transfer system to power its C-Pulse device now under development.
- The energy transfer system is used to power implanted devices - such as heart assist devices, artificial hearts and electrical stimulators - and enables power transfer across the skin using time varying magnetic fields without direct electrical connectivity.
- The agreement includes milestone payments due to Minnetronix prior to U.S. regulatory approval for the fully-implantable C-Pulse system.
- As previously announced, SSH intends to initiate animal studies for its fully-implantable pump in the fourth quarter of this year.
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