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Oct. 31, 2014, 1:26 PM| Comment!
Oct. 30, 2014, 7:40 AM
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Jun. 4, 2014, 8:37 AM
- The FDA sends HeartWare International (HTWR) a warning letter after it conducted an on-site inspection of the company's Miami Lakes manufacturing facility in January. The notification cites four deficiencies the company needs to address: procedures for validating device design, including labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations; validation of computer software used in production or quality systems.
- The letter does not require any action by physicians or patients. HTWR will respond to the FDA within the required 15 days.
- President & CEO Doug Godshall says, "HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our devices and we are dedicating the resources necessary to address the items discussed in the letter."
- FDA warning letter procedures
Feb. 27, 2014, 7:26 AM
- Heartware International, Inc. (HTWR): Q4 EPS of -$0.92 misses by $0.13.
- Revenue of $53.1M (+62.6% Y/Y) misses by $2.82M.
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."
Jan. 14, 2014, 5:39 PM
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, 9:17 AM
- Leerink's Danielle Antalffy is out with some commentary on the NEJM manuscript regarding Thoratec's (THOR) HeartMate II device.
- "Wednesday after market close, NEJM published a three-center study highlighting a meaningful increase in thrombus formation in HeartMate II implants performed after March 2011 -- to 8.4% at three months post-implant from 2.2% in the period of 2004- March 2011. This high thrombus rate compares to published HeartMate II clinical trials demonstrating a three-month thrombus rate in the 2%-4% range. While THOR shares could trade down temporarily in reaction to the NEJM article, we continue to believe mid-teens LVAD market growth is sustainable over the next few years, as the study sample is still relatively small and centers are unlikely to dramatically adjust clinical practice on this study alone," said Antalffy.
- "Conversely, HTWR shares could react positively to this study as it seemingly mitigates the concerns around high thrombus rates with LVADs and evens the playing field from a competitive perspective," he added.
- For more, see here.
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
Nov. 29, 2013, 8:00 AM
- Canaccord isn't overly concerned about the effect two manuscripts published in the NEJM and JHLT are likely to have on the outlook for shares of Thoratec (THOR) and HeartWare (HTWR).
- "Our initial thought is 'we are not surprised,'" writes analyst Jason Mills, who adds that Cannacord "reported on a perceived increase in HM2 device exchanges via thrombus approximately two years ago."
- Mills says he wouldn't be surprised to see near-term weakness in THOR and strength in HTWR but notes that "the totality of data on both of these devices suggest they are both excellent solutions for end-stage heart failure patients in need of LV support relative to the alternatives, of which there are virtually none."
- Finally, Canaccord thinks the manuscripts may help to "offset the negative view of HTWR in some investors’ minds as a result of the higher stroke rates reported in the IFUs for HTWR's HVAD upon the FDA approval in November 2012."
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