**D*A**
13 years ago
Hi PsD, I copied this from the last 10Q released in May. Our time is drawing nearer each day, IMO.
http://biz.yahoo.com/e/110513/whrt10-q.html
OVERVIEW
Our business is focused on the development and sale of VADs, particularly our Levacor VAD (Levacor VAD or Levacor). VADs are mechanical assist devices that supplement the circulatory function of the heart by re-routing blood flow through a mechanical pump allowing for the restoration of normal blood circulation. The Levacor VAD uses a magnetically levitated rotor resulting in no moving parts subject to wear, which is expected to provide multi-year support. In August 2009, we received conditional approval of our Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the Levacor VAD to begin a BTT clinical study. In January 2010, we received unconditional IDE approval from the FDA. In February 2011, the Company decided to pause enrollment in the BTT study while three refinements are made to its Levacor VAD based on initial clinical experience until certain device refinements could be made and the FDA reviews and approves the refinements. These refinements are the projection of the inflow cannula into the ventricle, the elimination of a false alarm that has led to controller exchanges and the optimization of surface finishing/coating manufacturing processes. To date, we have completed refinements related to the projection of the inflow cannula and the elimination of the controller false alarm. We expect the design modification related to the optimization of the surface finishing/coating manufacturing process will be complete in the next two months. However, in light of ongoing communications with the FDA, the timeline for implementation of these refinements is dependent on review and approval by the FDA which is uncertain. We do not expect to receive FDA approval to restart our BTT study any earlier than the end of the third quarter 2011. Due to this uncertainty, it is anticipated that enrollment will not begin any earlier than the end of the third quarter 2011.
VADs are used for treatment of patients with severe heart failure, including patients whose hearts are irreversibly damaged and cannot be treated effectively by medical or surgical means other than transplant. BTT therapy involves implanting a VAD in a transplant eligible patient to maintain or improve the patient's health until a donor heart becomes
available. DT is the implanting of a VAD to provide long-term support for a patient not currently eligible for a natural heart transplant. Bridge-to-Recovery involves the use of VADs to restore a patient's cardiac function helping the natural heart to recover and thereby allowing removal of the VAD.
In addition, we, in conjunction with a consortium consisting of the University of Pittsburgh, Children's Hospital of Pittsburgh, Carnegie Mellon University and LaunchPoint Technologies, Inc. (LaunchPoint) have been developing a small, magnetically levitated, rotary pediatric VAD (PediaFlow VAD). The PediaFlow VAD is intended for use in newborns and infants and has been primarily funded by the National Institutes of Health (NIH). In February 2011, the FDA granted Humanitarian Use Device (HUD) designation for the PediaFlow VAD. The HUD designation is given to devices that are intended to benefit patients with conditions that affect fewer than 4,000 patients per year. Under the HUD designation, manufacturers are required to demonstrate safety and the probable benefit of their device.
The technology embodied in the PediaFlow VAD also forms the basis for our small, minimally invasive VAD. The minimally invasive VAD is aimed at providing partial to full circulatory support in both early-stage and late-stage heart failure patients. We expect to be in an adult clinical trial with the minimally invasive VAD in 2014, contingent on our ability to obtain future financing and our ability to satisfactorily complete all regulatory requirements. We are exploring various strategic options to accelerate our development of the minimally invasive VAD.
DonShimoda
13 years ago
"Preliminary clinical data suggests that the Levacor VAD does not cause acquired von Willebrand Factor (vWF) deficiency, a condition that is linked to serious bleeding disorders(1) and that has been associated with the use of current VADs"
Although not directly compared to HTWR's device, I think it is important to note that it was recently reported that the incidence of stroke in the HTWR device "was higher than might have been expected with the smaller size of the device, both Aaronson & Yacoub said, and this is something that will require watching. "The trial is only 180 days: we await the longer-term results with extreme interest because if there is major advantage it's going to be seen later. We need to be really critical and look at the results as we go along and not just say 'Hurrah,' " says Yacoub. There are other issues, too, he added, "such as evidence of GI bleeding due to malformations in the gut, and they got that already by 180 days. Also you get changes in the blood itself, the von Willebrand factor, and that is because of the lack of pulsatility. But that doesn't prevent me from concluding that this is a landmark trial and this device is extremely promising."
So it appears that for those who have already declared HTWR the "winner", the race may not be over. Personally, I'm of the opinion that this is not a winner take all scenario and there will be a role for THOR, HTWR and WHRT in this market.
DonShimoda
14 years ago
Wedbush says Medicare decision positive for ventricular device makers
In a note to investors, Wedbush analysts Dr. Duane Nash and Akiva Felt wrote that weakness in providers of left ventricular assist devices - including Thoratec (THOR), HeartWare (HTWR), and WorldHeart (WHRT) - could create an attractive entry point for investors.
Wedbush notes that the CMS said last night it is not expanding left ventricular assist device, or LVAD, reimbursement to include to Class IIIB patients. However, the firm points out CMS did make positive changes to the objective criteria. Wedbush recommends using any weakness in shares of Thoratec (THOR), HeartWare (HTWR), and World Heart (WHTR) following the news as buying opportunities.
DonShimoda
14 years ago
4th center has now implanted World Heart's LVAD.
SALT LAKE CITY, July 6, 2010 (GLOBE NEWSWIRE) -- World Heart Corporation (WorldHeart) (Nasdaq:WHRT - News), a developer of mechanical circulatory systems, announced today that Jewish Hospital in Louisville, Kentucky, successfully implanted a Levacor(TM) Ventricular Assist Device (VAD) in the Bridge-to-Transplant (BTT) clinical study. This is the eighth implant of the Levacor VAD in the fourth implanting center in the study.
Dr. Mark Slaughter, Chief of the Division of Thoracic and Cardiovascular Surgery, Jewish Hospital/University of Louisville, and surgical co-Principal Investigator of the study at Jewish Hospital indicated, "I am excited by our initiation of patient enrollment in this study. We are pleased to provide a fully magnetically levitated VAD therapy to our late-stage heart failure patients. This is part of our ongoing efforts to find ways to reduce complications and improve outcomes."
Mr. J. Alex Martin, WorldHeart's President and Chief Executive Officer noted, "We are pleased to continue to expand the BTT clinical study at Jewish Hospital led by Dr. Mark Slaughter, a top thought leader in mechanical circulatory support therapy. "
DonShimoda
14 years ago
WHRT's market cap is roughly the same as it was when the current investors recapitalized the company approximately 2 years ago. Since then they've gotten the LVAD approved, started clinical trials, and begun generating revenue. Yet, you can buy in today at half of what insiders just paid in January.
When one considers that 100,000 patients need transplants each year but only 2,000 get them, I believe the market for LVAD's is going to grow significantly. Whether World Hearts device will be one of the winners remains to be seen but considering HTWR's market cap is over 800 million, I like the upside.
DonShimoda
14 years ago
It appears you've got some smart venture capitalists who've recently put in $$$ at over $5 a share.
26-Jan-10 NEW LEAF VENTURES II, L.P.
Beneficial Owner (10% or more) 388,350 Direct Purchase at $5.15 per share. $2,000,002
26-Jan-10 MARXE AUSTIN W & GREENHOUSE DAVID M
Beneficial Owner (10% or more) 388,350 Indirect Purchase at $5.15 per share. $2,000,002
21-Jan-10 VENROCK ASSOCIATES V LP
Beneficial Owner (10% or more) 388,350 Indirect Purchase at $5.15 per share. $2,000,002
For all practical purpose, these investors have essentially taken the company private and have only left enough float to maintain nasdaq's listing requirements. Of course the downside is that there is very little liquidity and a lot of volatility.
DonShimoda
14 years ago
Emerging ventricular assist devices for long-term cardiac support
Nature Reviews Cardiology (February 2010)
Rajan Krishnamani, David DeNofrio & Marvin A. Konstam
The evolution of mechanical cardiac support has been fueled by an increasing need to support patients with end-stage heart failure. More than 100,000 patients are estimated to have severe, refractory (AHA/ACC stage D) heart failure. The prognosis in this group of patients is dismal, with a 4-year mortality of more than 50%. Of patients admitted to hospital with acute heart failure, the 1-year mortality is 30–50%. The option of cardiac transplantation is limited by organ availability and, as wait times have increased, the need for mechanical cardiac support as a bridge-to-transplant has also increased.
Innovations in ventricular assist device (VAD) technology has provided an alternative therapeutic option for patients with advanced heart failure. Initiated as a mechanical option to 'bridge' critically ill patients awaiting transplantation, VADs are being increasingly deployed as 'destination' devices to provide long-term support. With technical advances resulting in improved mechanical reliability, reduced postoperative morbidity and greater likelihood of patient acceptance, there is interest in expanding the applicability for destination VAD treatment beyond the current indication of severely ill patients who are not candidates for transplant. This Review examines the newer, third-generation VADs for mechanical cardiac support.
http://www.nature.com/nrcardio/journal/v7/n2/full/nrcardio.2009.222.html
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