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Mar. 11, 2014, 1:03 PM
- 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.
Mar. 11, 2014, 12:47 PM
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Feb. 20, 2014, 11:07 AM
- 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."
Dec. 31, 2013, 4:05 PM
- 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.
Dec. 17, 2013, 8:12 AM
- 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.
Dec. 2, 2013, 12:11 PM
- 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.
Nov. 29, 2013, 8:35 AM
- 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
SSH vs. ETF Alternatives
Sunshine Heart, Inc., is an early stage medical device company. It is engaged in developing, manufacturing and commercializing its C-Pulse Heart System for treatment of Class III and ambulatory Class IV heart failure.
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