CircuLite Boosts HeartWare's Fundamentals But What About Profit?
Andy Batts • 14 Comments
Andy Batts • 14 Comments
HeartWare Vs. Thoratec In The Heart Pump Race
HeartWare Is Premium-Priced Growth, But Could Still Go Higher
Stephen Simpson, CFA
Stephen Simpson, CFA
Mon, Jun. 27, 12:51 PM
Mon, Jun. 27, 11:00 AM
Mon, Jun. 27, 9:13 AM
Fri, Jan. 15, 5:40 PM
Tue, Jan. 12, 12:41 PM
Tue, Jan. 12, 10:21 AM
- Thinly traded micro cap HeartWare International (HTWR -26.3%) slumps in early trading on increased volume in response to its progress report on its left ventricular assist device MVAD System released after yesterday's close.
- Patient recruitment in MVAD's CE Mark clinical trial, initiated in July, was suspended in September due to reported adverse events, including the occurrence of blood clots. In its investigation of the incidents, the company identified an issue related to the manufacture of the controller as well as the need to update the software.
- Yesterday, HeartWare stated that it has detected certain software algorithms that appear to increase the risk of pump-related blood clots. In parallel, it is assessing certain aspects of the pump's design to determine if changes can be made to improve performance. The efforts will take several months to complete. Any changes may require a new clinical trial so the potential restart of the current study or the time table for regulatory filings is uncertain at this point.
- Previously: Heartware investigating adverse events in MVAD CE Mark clinical trial; restart of enrollment likely delayed past November; shares off 16% premarket (Oct. 13, 2015)
- Previously: HeartWare MVAD trial underway in Europe (July 20, 2015)
Oct. 13, 2015, 12:45 PM
Oct. 13, 2015, 9:16 AM
Oct. 13, 2015, 8:27 AM
- In a regulatory filing, Heartware International (NASDAQ:HTWR) discloses that the re-initiation of patient enrollment in its MVAD Ventricular Assist System CE Mark clinical trial may not happen in November as previously planned due to its investigation into reported adverse events in certain trial participants. It says the events are typical of those seen on other studies of ventricular assist devices.
- On September 9, the company announced that it paused the study in order to address an MVAD controller manufacturing process issue. It is in the process of implementing manufacturing improvements as well as software updates.
- Management will provide additional commentary on the situation during its earnings call on October 29.
- Shares are off 16% premarket on light volume.
Sep. 2, 2015, 12:40 PM
Sep. 2, 2015, 9:17 AM
Sep. 2, 2015, 9:05 AM
- HeartWare International (NASDAQ:HTWR) acquires Israel-based privately-held Valtech Cardio for up to 5.9M shares of HTWR common stock or ~$425M based on a price of $72 per share. Valtech specializes in surgical and transcatheter valve repair and replacement devices for the treatment of mitral valve regurgitation and tricuspid valve regurgitation.
- Under the terns of the agreement, Valtech shareholders will receive 4.4M HTWR common shares upfront, 800K shares upon CE Mark clearance of Cardioband and 700K shares upon the earlier of first-in-patient implants of either Cardioband tricuspid or CardioValve. The deal also includes warrants to purchase 850K shares of HTWR common stock at $83.73 contingent on the achievement of $75M in net sales of Valtech products and a $375M earn-out payment upon the attainment of $450M in net sales of Valtech offerings. The earn-out can be in either stock or cash at HeartWare's discretion.
- HTWR is down 13% premarket on increased volume.
Jul. 21, 2015, 12:41 PM
Jan. 14, 2014, 5:39 PM
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
HeartWare International, Inc. is a medical device company that develops and manufactures miniaturized implantable heart pumps or ventricular assist devices to treat patients suffering from advanced heart failure. It offers Ventricular Assist Devices which provides circulatory support until a... More
Industry: Medical Instruments & Supplies
Country: United States
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