Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
HTWR Acquires CircuLite, “developer of the SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent.”
12-2-13: HeartWare Intl. Announces Acquisition Of CircuLite, Inc.
Acquisition expands HeartWare's technology platform into partial support for less sick patients
Investor Conference Call on Monday, December 2, 2013 at 8:00 a.m. U.S. EST -
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1880820
FRAMINGHAM, Mass. and TEANECK, N.J., Dec. 1, 2013 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has acquired CircuLite, Inc. [ http://www.circulite.net ] – developer of the SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent.
(Photo: http://photos.prnewswire.com/prnh/20131201/LA25652 )
According to the terms of the merger agreement, HeartWare has acquired all of the issued and outstanding equity interests of CircuLite for consideration of $30 million, consisting of approximately $18 million in HeartWare common stock and cash of approximately $12 million to settle CircuLite's debt and transaction expenses, plus certain contingent success payments due upon satisfaction of regulatory and commercial milestones not to exceed $320 million in the aggregate over a 10-year period.
"The partial-support system developed by CircuLite represents the industry's most intriguing platform for the treatment of patients with earlier stage heart failure," said Doug Godshall, President and CEO at HeartWare. "CircuLite has pioneered the partial-assist approach and demonstrated that this technique can significantly enhance the quality of life for this group of patients, which is believed to be a substantially larger population than the end-stage heart failure patients that HeartWare currently treats with our full-support Ventricular Assist Devices (VADs). CircuLite's next generation endovascular system, which will be implanted collaboratively by cardiologists and surgeons in a hybrid cath lab setting, offers an extremely compelling interventional approach to circulatory support. While our HVAD® and MVAD® Systems offer minimally invasive treatment to end-stage heart failure patients, the SYNERGY platform offers even less invasive and ultimately interventional options to earlier-stage heart failure patients."
The SYNERGY Surgical System, which received CE Marking in the European Union in 2012, is designed for long-term support and is intended to reduce the heart's workload while improving blood flow to vital organs. Approximately the size and weight of a AA battery, the CE marked SYNERGY Surgical System is implanted through a right, mini-thoracotomy procedure and does not require a sternotomy or cardiopulmonary bypass. With this approach, the inflow cannula is placed in the left atrium, and the outflow graft is attached to the subclavian artery. CircuLite's proprietary micro-pump is then placed in a pacemaker-like pocket and attached to the inflow cannula and outflow graft, which connects to a wearable, external controller and battery pack.
The system is currently undergoing an upgrade to resolve issues that arose post commercial release. Surgical System sales are expected to resume in a controlled fashion following regulatory approval to re-launch the system in Europe and will focus on building experience at a small number of centers of excellence, refining training techniques and implementing additional system upgrades in advance of a full rollout.
"The SYNERGY system is a novel entrant in the partial-support space for treating patients with earlier stage heart failure," said Dr. Martin Strueber, of the University Heart Center Leipzig in Leipzig, Germany. "To date, there is no viable option for those patients who have used biventricular pacemakers without success and who are not yet sick enough for a VAD or cardiac transplantation. Having implanted SYNERGY systems and witnessed the marked benefits to my patients and increased referrals I received for both full and partial mechanical support, I look forward to technological advancements to the system and a restored availability for patients. Longer-term, the endovascular approach, which we have explored extensively in Leipzig in partnership with our cardiology colleagues, is truly exciting and holds considerable promise."
"We are confident that HeartWare's technical, regulatory, sales and marketing capabilities will have a profound impact on enabling the SYNERGY system to reach its full potential," said Daniel Burkhoff, M.D., Ph.D., Chief Medical Officer at CircuLite. "There is considerable opportunity for the current SYNERGY system, and through continued investment and innovation, we believe we could expand the circulatory support market with the launch of a groundbreaking, endovascular treatment for patients with earlier stage heart failure."
"The team at CircuLite created the SYNERGY Endovascular System in collaboration with several leading cardiologists and received approval to commence a feasibility study earlier this year. We look forward to commencing an investigation of this elegant device, as we believe it has the potential to vastly expand the mechanical support market by bringing cardiologists into the implant procedure for the first time," Mr. Godshall added.
Under the terms of the merger agreement, CircuLite securityholders may be entitled to receive additional clinical and commercial success payments, upon achievement of specified regulatory and revenue-based milestones.
Potential regulatory milestone payments include:
• $20 million payable in HeartWare common stock upon full European re-launch of the SYNERGY Surgical System;
• Up to $75 million payable in cash or HeartWare common stock upon CE Mark of the SYNERGY Endovascular System; and
• $50 million payable in cash or HeartWare common stock upon U.S. FDA Pre-Market Application approval of the SYNERGY Endovascular System.
Potential revenue-based success payments include:
• Up to $15 million payable in cash or HeartWare common stock when the 12-month trailing sales of the SYNERGY Surgical System reach $30 million;
• $85 million payable in cash or HeartWare common stock upon achievement of the 12-month trailing sales of $250 million of SYNERGY Systems (surgical or endovascular); and
• Up to $75 million (subject to adjustment) in royalties on sales of surgical and endovascular CircuLite products payable in cash or HeartWare common stock.
The total upfront and earnout consideration is subject to certain performance criteria, and cannot exceed $350 million. All consideration may only be earned through the eighth anniversary of the closing of the transaction, with the exception of the milestone payment based on trailing sales of $250 million, which may be earned through the tenth anniversary. Any payments made in HeartWare common stock, including the upfront consideration, are calculated using a 60-day volume weighted average price.
This transaction was approved by the Board of Directors of HeartWare and Board of Directors and shareholders of CircuLite.
Perella Weinberg Partners acted as financial advisor to HeartWare. Credit Suisse served as financial advisor to CircuLite.
Investor and Analyst Conference Call and Webcast
HeartWare will hold a conference call with slide presentation to discuss the transaction on Monday, December 2, 2013 at 8 a.m. EST. The conference call may be accessed by dialing 1-877-941-4774 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial +1-480-629-9760. The slide presentation may be accessed by logging onto the live webcast through the weblink below.
A live webcast of the call may be accessed in the Investor section of HeartWare's website at http://ir.heartware.com . A replay of the webcast will be available through the above weblink immediately following completion of the call.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 37 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at http://www.heartware.com .
HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market.
About CircuLite
CircuLite is developing disruptive solutions to improve the treatment of heart failure. The Company –whose manufacturing operations are based in Aachen, Germany – focuses on technology that works in conjunction with the heart to enhance clinical outcomes and improve quality of life. SYNERGY, which received CE Mark in 2012, features the smallest surgically-implanted blood pump for long-term use in ambulatory chronic heart failure patients not responding to optimal medical treatment. The company is developing a portfolio of minimally-invasive systems based on its proprietary micro-pump platform, including an interventional cardiology system, a right-heart system and a pediatric system that have not yet been submitted for FDA clearance. For more information, visit our website at http://www.circulite.net .
CircuLite® and SYNERGY® are registered trademarks of CircuLite, Inc. in the United States.
CRT Capital initiates coverage on HTWR, Buy/PT=$109
http://www.streetinsider.com/New+Coverage/CRT+Capital+Starts+Heartware+(HTWR)+at+Buy/8925347.html
HeartWare at 25th Piper Jaffray Healthcare Conf. 12-3-13 2pmET - Webcast
FRAMINGHAM, Nov. 25, 2013: HeartWare International, Inc. (HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the 25th Annual Piper Jaffray Healthcare Conference at 2:00pm ET on Tuesday, December 3, 2013. The conference is being held December 3-4 at the Palace Hotel in New York City.
HTWR presenting at Canaccord Forum 11-14-13 1:30pmET WEBCAST
FRAMINGHAM, Nov. 8, 2013: HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Canaccord Genuity Medical Technology & Diagnostics Forum at 1:30pm ET on Thursday, November 14, 2013. The one-day conference is being held at the Westin Grand Central in New York City...
11-7-13: HTWR Reports $54.8mm Revs in Q3’13, +140% from Yr-ago. Cash=$225mm. “During Q3’13, the company generated positive cash flows from operations, a historic first-time milestone for the company.”
• Strong continued adoption of HeartWare® System within U.S. commercial launch results in domestic revenue of $28.2 million, up 12% sequentially from Second Quarter of 2013;
• International Revenue of $26.6 million, up 38% from Third Quarter of 2012; Bolstered by European Market Strength
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1873618
FRAMINGHAM, Nov. 7, 2013: HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $54.8 million for the third quarter ended September 30, 2013, a 140% increase compared to $22.9 million in revenue for the same period of 2012.
"During the third quarter, 549 HeartWare® Ventricular Assist Systems were sold globally, an increase from 256 units in the third quarter of 2012 and more than our previous high quarterly total of 523 units in the second quarter of 2013," said Doug Godshall, President and CEO. "Our results for the third quarter reflect continued positive trends in the commercial launch of the HeartWare® System in the U.S., following approval from FDA late last year, as well as continued strong support from our international customers."
During the third quarter of 2013, U.S. revenue, which reflects the company's third full quarter of U.S. commercialization, was $28.2 million, a significant increase from $3.6 million in the third quarter of 2012. Revenue from international markets, generated through the sale of 287 units, was $26.6 million, an increase of approximately 38% from $19.3 million in the third quarter of 2012.
"Our strong commercial growth was complemented by advances made in clinical development, as we received full protocol approval from FDA for a supplemental patient cohort to our destination therapy trial and commenced enrollment last month," added Mr. Godshall. "We also remain on track for initiation of first-in-human testing of our next generation MVAD pump, with Pal™ controller, early next year."
For the nine months ended September 30, 2013, revenue increased approximately 98% to $154.9 million, compared to $78.3 million in the first nine months of 2012. Currency fluctuations benefitted revenue growth by 5.7% and 1.7%, respectively, in the three and nine months ended September 30, 2013 compared to the same periods in 2012.
Total operating expenses for the third quarter of 2013 were $45.8 million, as compared to $35.2 million in the third quarter of 2012. Research and development expense was $25.9 million for the third quarter of 2013, as compared to $21.4 million in the same period of 2012. Development costs are primarily attributable to clinical trials and research and development related to advancing HeartWare's existing products and pipeline technologies. Selling, general and administrative expenses were $19.8 million in the third quarter of 2013, compared to $13.8 million in the third quarter of 2012. The increase in selling, general and administrative expenses reflects expansion of sales and marketing activities, particularly in the U.S., an overall increase in corporate infrastructure to support the company's significant growth, and the effect of the 2.3% excise tax on the U.S. sales of medical devices which became effective January 1, 2013.
Net loss for the third quarter of 2013 was $11.4 million, or a $0.69 loss per basic and diluted share, compared to a $25.0 million net loss, or a loss of $1.75 per basic and diluted share, in the third quarter of 2012. For the nine months ended September 30, 2013, the company recorded a net loss of $37.3 million, or a $2.34 loss per basic and diluted share, compared to a $66.6 million net loss, or a loss of $4.70 per basic and diluted share, in the first nine months of 2012.
At September 30, 2013, the company had $225.0 million of cash, cash equivalents and investments, reflecting a modest net cash increase from June 30, 2013, when the company had $222.4 million of cash, cash equivalents and investments. During the third quarter of 2013, the company generated positive cash flows from operations, a historic first-time milestone for the company.
HeartWare will host a conference call on Thursday, November 7, 2013 at 8:00 a.m., U.S. Eastern Standard Time to discuss the company's financial results, highlights from the third quarter and business outlook. The call may be accessed by dialing 1-877-941-8418 five minutes prior to the scheduled start time and referencing "HeartWare." Callers outside the U.S. should dial +1-480-629-9809.
A live webcast of the call will also be available in the Investor section of the company's website ( http://ir.heartware.com/ ). A replay of the conference call will be available through the above weblink immediately following completion of the call.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 36 international countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at http://www.heartware.com .
HTWR to Present at Credit-Suisse 11-12-13 12:30amET
HeartWare Presentation At The Credit Suisse Healthcare Conference To Be Webcast
FRAMINGHAM, Nov. 5, 2013: HeartWare International, Inc. (NASDAQ:HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Credit Suisse Healthcare Conference on Tuesday, November 12, 2013 at 10:30 a.m. MST. The conference will be held November 11-14 at the Phoenician Hotel in Scottsdale, Arizona.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
HTWR Q3'13 Earnings 11-7-13, webcast at 8amET
FRAMINGHAM, Mass., Oct. 25, 2013: HeartWare International, Inc. (HTWR) has scheduled a conference call to discuss its financial results for the 3 months ended Sept. 30, 2013, at 8:00amET on Thursday, Nov. 7, 2013. The Company plans to release the financial results prior to the conference call...
HTWR Website – “Patient Stories (HVAD)” (Video Interviews)….
“VAD recipients share their experience of life with advance heart failure and “getting back to life” with the HeartWare Ventricular Assist System."
• DaKeia Williamson-Wheeler
• Georgi Petkov
• Carlo Brunnori
http://www.heartware.com/patients-caregivers/patient-stories
Thanks, APR - here's the Link to that article...
8-19-13 TheHeart.org article on Endurance Trial status/plans…
8-19-13: “Who, what, when? Questions over Heartware ENDURANCE trial”
By Steve Stiles and Shelley Wood, Heartwire
http://www.theheart.org/article/1570043.do
8-19-2013 - Who, what, when? Questions over Heartware ENDURANCE trial
By Steve Stiles and Shelley Wood
Framingham, MA - One of the principal investigators for the pivotal ENDURANCE trial testing HeartWare International's ventricular-assist device (VAD) as destination therapy says he still plans to present the full results late next year.
Moreover, Dr Joseph Rogers (Duke University, Durham, NC) said his preference would be to compare the primary ENDURANCE results against those of a 360-patient "supplemental cohort," enrolled in a continued-access fashion with the same inclusion/exclusion criteria, but with "enhanced blood-pressure management."
Those aims, however, seems at odds with recent remarks made by the Heartware CEO Doug Godshall on calls with financial analysts. On an August 8 earnings call, Godshall said that the current plan is to have the ENDURANCE data set "comingled" with the supplemental cohort study that was approved by the FDA in June [1], before presenting the final numbers. That's despite the fact that patients in the latter will be tracked for just one year instead of two, will be followed for a different primary end point, and will undergo more intensive blood-pressure management over the course of the trial than patients did in ENDURANCE.
"Given that this trial is now an aggregated original cohort, additional cohort, with the submission of the data being comingled and sort of contingent on one another, it is not our expectation that we are going to be presenting any [destination-therapy] data next year," Godshall said on the call. He also declined to say whether the company would release top-line "pass/fail" data on the ENDURANCE primary end point next year, "because the performance in this additional cohort could influence the interpretation of that primary-end-point area."
Speaking with heartwire today, however, Rogers stressed that the original ENDURANCE cohort "is still planned exactly as outlined in the beginning of the trial" and "when the trial gets presented it will be the original cohort of patients that we originally asked for, and that should be available toward the end of '14."
ENDURING results
As previously noted by heartwire, ENDURANCE is a 450-patient, multicenter randomized comparison of the Heartware HVAD with the HeartMate II LVAD in the setting of destination therapy for patients with end-stage heart failure. The primary end point in ENDURANCE is stroke-free survival at two years. Enrollment has completed.
The "supplemental cohort" is enrolling up to 360 patients (240 to the Heartware VAD and 120 to a control device) for only one year, and according to remarks made by Godshall in a June financial call, the end point will be "stroke incidents or reduction in stroke at 12 months."
Asked about company comments regarding plans to combine the data sets, Rogers said, "If that's true, I don't know that. . . . I haven't spoken to [co-PI Dr Francis Pagani (University of Michigan Hospital, Ann Arbor)] about this, but I'm sure both of us would make a strong case to analyze this data as scientifically accurately as we possibly can."
Adding that he hasn't spoken with the FDA or the company about this either, Rogers said, "I think the most scientifically valid way to approach that would be to compare rates from the original cohort with the extended population."
Neurological events and BP control
At issue is a signal of higher adverse neurological events among Heartware patients in ENDURANCE. In an unusual move, the FDA actually asked to see interim results on a subset of patients in ENDURANCE as part of its review of the device as a bridge-to-transplant therapy in 2012. Those interim results are included in the instructions for use for the Heartware VAD in the approved bridge-to-transplant setting and indicate a numerically higher rate of ischemic and hemorrhagic strokes for the Heartware device (6.7% and 5.1% respectively) as compared with the control LVAD (with ischemic and hemorrhagic stroke rates of 4.3% and 0%, respectively).
"It was a very unusual request from the FDA [to look at the ongoing ENDURANCE data], I thought, but it is what it is," Rogers said. "There was a question of whether the adverse-event rate for neurological events was higher with Heartware, so that's what prompted the company to go back into the data set and identify factors that may be associated with that, and one of the factors that came out was high blood pressure."
Godshall made similar statements on the August 8 earnings call, noting that sites in ENDURANCE that had done a better job monitoring and managing patients' blood pressure "witnessed a notably lower incidence of neurologic events." Thus, in the supplemental cohort, patients with the same inclusion/exclusion criteria at the same 50 ENDURANCE sites will be enrolled in the same way but subject to more rigorous blood-pressure management during the trial.
Combining data sets
As often noted by heartwire, combination of data sets from populations managed according to a different protocol is unusual, typically frowned upon, and likely to complicate interpretation of results.
But, Godshall said, "We are confident that the results from this enhanced pressure-management strategy will have a positive impact on outcomes and further support [destination-therapy] approval."
Rogers, however, was clearly unaware of any discussions to fully "integrate" the data sets and acknowledged doing so would open the door to criticism that combining the two could potentially dilute the adverse-event rates acknowledged so far in ENDURANCE.
"I can't argue with that: whenever you change trial design in the middle of a study, you run that risk," he said. "On the other hand, it seems unwise to expose human subjects to potentially serious adverse events. If you think that that's an issue—that blood-pressure management is an important issue to prevent strokes—you have to implement that change to protect the safety of human subjects participating in a clinical trial."
He continued: "This field is still in its relative youth, and there are things we don't know about the pumps. . . . We were assuming that those two pumps we were testing in ENDURANCE are the same, and they are not, they are very different pumps. So it may be that BP management is more important with one than the other."
Rogers reiterated that his hope would be to compare the supplemental cohort with the original ENDURANCE cohort. "So you have the same trial design, the same pumps, and a background signal with neurological event rates, and then, in that new cohort, where you've hopefully got the blood pressure down, you can look at the delta for stroke rate."
Roger's intention, he told heartwire today, is to submit the ENDURANCE results for the AHA 2014 meeting, or possibly the following ACC meeting.
HeartWare spokesperson Christopher Taylor, speaking with heartwire last week, confirmed the information as stated in the earnings calls but said company officers declined to be interviewed for this story, pending what it anticipates to be the FDA's final go-ahead on the supplemental cohort.
The HVAD approval for bridge-to-transplantation was based primarily on the ADVANCE trial, which compared patients with the HVAD with those with other pumps who were in the Interagency Registry for Mechanical Assisted Circulatory Support.
Can't Beat HeartWare, Thoratec
Credit Suisse upgraded the ventricular-assist-devices firms to Outperform.
Credit Suisse
We are upgrading HeartWare International and Thoratec to Outperform from Neutral.
We are lowering our discounted-cash-flow-based target price on HeartWare (ticker: HTWR) to $96 from $105 based on slightly lower market growth assumptions and a slightly higher weighted average cost of capital (WACC).
We are raising our discounted-cash-flow-derived price target on Thoratec (THOR) to $43 from $35 based on the assumption of higher out-year estimates (due to lower assumed HeartWare share) and a lower assumed WACC.
Based on HeartWare's second-quarter results we estimate that the U.S. left ventricular assist device (LVAD) market grew roughly 21% this Q (ex-stocking but including paracorporeal/implantable ventricular assist device (PVAD/IVAD)), implying about 1% HeartWare sequential share gains (excluding stocking), which was light of our 2% estimate and likely light of consensus. HeartWare also pushed back expectations for its U.S. muscle-powered ventricular assist device (MVAD) trial/destination therapy (DT) extension trial enrollment by 12 months/one quarter.
Despite these challenges we see the move in HeartWare shares in the past three months as overdone. If HeartWare ventricular assist device (HVAD) stroke rates are tamed, consistent with our expectations (we expect data to this effect could be shown at HeartWare's bridge to transplantation (BTT) post-approval study (PAS) presentation April 2014), then the surgical versatility of the HVAD (thoracotomy approach, etc.) could confer some advantages over the HeartMate II (HMII) (despite the requirement for closer attention to blood pressure and International Normalized Ratio (INR) [a measurement of the blood thinness]), allowing the HVAD to achieve about 50% U.S. market share over time (consistent with our recent survey and with performance in Europe where HVAD sales exceed HMII with about 48% overall share) despite the sluggish second-quarter share gains.
We believe Thoratec can grow sales about 11% over the next three to four years despite encroachment from HeartWare on its U.S. market share. Our growth estimates assume steady LVAD share outside the U.S. excluding Japan and market growth of about 14%, with an incremental about $40 million per year in sales in Japan by 2017 (Japan adds about 2% to our 2013-2017 growth compounded annualized growth rate (CAGR)). Moreover, we forecast about $30M in percutaneous heart pump (PHP) sales by 2017, which adds another about 1% to our 2013-2017 sales CAGR, helping to offset the U.S. BTT share gains we forecast for HeartWare in 2013 and DT share gains in 2016-2017.
-- Bruce Nudell
-- Matthew Keeler
Barrons
Canaccord & Barclays reit HTWR BUY, PT’s $110 & $100 (Canaccord cuts PT 118 to $100)...
8-9-13: Equities researchers at CANACCORD GENUITY decreased their price objective on shares of HeartWare Intl. (HTWR) from $118 to $110 in a research report issued on Friday. The firm currently has a “Buy” rating on the stock.
8-9-13: HEARTWARE (NASDAQ: HTWR) reiterated to Overweight with price target $100 by BARCLAYS.
CEO D.Godshall presenting at Canaccord Conf. 8-14-13 3pmET (webcast)…
“HeartWare Presentation At The Canaccord Genuity 2013 Annual Growth Conference To Be Webcast [8-14-13 3pmET]”
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1846662
FRAMINGHAM & SYDNEY, Aug. 9, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Canaccord Genuity 2013 Annual Growth Conference at 3:00pm EDT on Wednesday, August 14, 2013. The conference is being held August 14-15 at the The InterContinental Boston.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
Credit Suisse Upgrades HTWR to Outperform based on valuation.
Price target lowered to $94 from $105.
8-8-13: HTWR Q2’13 financials = $50.8M in Q2’13 Revs (+75% vs. yr. ago)
HeartWare Reports $50.8M in Q2’13 Revenue; 75% Incr. vs. Q2’12
"During Q2’13, 523 HVAD pumps were sold globally, an increase from 318 units in the Q2’12 and more than our prev. high qtly total of 482 units in Q1’13."
CASH at 6-30-13 = $222.4M
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1846035
8-6-13: F/U article on Sacramento’s HVAD rec. Ron Walters
8-6-13: ”First Sacramento Area Patient Receives New (HVAD) Heart Pump As He Awaits Transplant”
By Cynthia H. Craft, Sacramento Bee
http://www.sacbee.com/2013/08/06/5625873/first-sacramento-area-patient.html
One year ago, heart patient Ron Walters, 66, thought he'd seen the last of his beloved fishing pole. His poor circulation had stripped him of any sensation in his extremities, and he feared that if he tried to bait a hook, he'd only injure himself. But not being able to go fishing was the least of Walters' troubles. His failing heart was killing him, robbing him of blood supply to all but a few crucial organs – the brain, the kidneys and the lungs.
"I didn't think I'd be here a year ago," Walters said Monday at Sutter Memorial Hospital. All that's changed, now that Sutter doctors have implanted a new mechanical heart pump in Walters' chest. He's the first patient in the Sacramento region to receive the FDA-approved device (Heartware HVAD) as he awaits a heart transplant.
PHOTO: ”Ron Walters of Santa Maria prepares for discharge Monday from Sutter Memorial Hospital in Sacramento.”
The device is smaller and easier to implant than previous heart pumps. Because it is metal, there is no risk of rejection, doctors said. Dr. Robert Kincade is the surgical director of the Sutter Heart Transplant Program and the surgeon who opened Walters' chest to fit him with the new pump (“HVAD”), known as a left ventricular assist device.
Sutter Memorial Hospital is the first in the region to offer the procedure, and Walters and his wife, Nancy, traveled all the way from Santa Maria in Southern California to seek the expertise. "He's been a really good patient," Kincade said. "He feels good now, but when he came in he was in bad straits. He was in a wheelchair, he couldn't walk. He had no quality of life. He was dying."
On Monday, Walters was beaming as he left the hospital for the first time in weeks. As he rose from his wheelchair to meet the press, Walters, at 6-foot-4, stood tall. "I'm standing here real sturdy," he said, "and before the surgery, I couldn't. I was wobbly." Walters attributes his heart failure to the stress and anxiety he felt after being pistol-whipped during a 1992 robbery of a Fresno supermarket he managed. That night, two men burst into the store brandishing guns and demanding cash. One man with an Uzi pistol lined up store employees, all young women, and another held a gun on Walters as he gathered the money. "I got a good look at the pistol but not at the guy," Walters said, referring to the beating he took before the robbers retreated. Years passed, but the aftermath of the violence did not. "It still upset me because I had no power over what happened," Walters said. "It made me so mad. That frustration probably triggered my heart attack because I was unable to do anything to stop them."
The heart attack came one night in 2002 when Walters was closing up the supermarket. At first, he felt severe nausea. Then, he said, "It hit me real fast. It felt like I was on fire, and the pain in my jaw and chest went nuts." One stent, 5 bypasses and several angiograms later, Walters finds himself at the forefront of a trailblazing procedure featuring the newest, smallest heart pump on the market (Heartware’s HVAD).
The pump was inserted in his diaphragm, tucked in below his heart during a two-hour surgery. A centrifuge mechanism pumps 5 liters per minute of blood through his heart – at the rate of an average healthy adult. "We hope it'll hold him several years," said Kincade – or until Walters can receive a heart transplant. Heart disease is the No. 1 killer of Americans, striking down men and women alike. And although the pumps are expensive, running around $60,000 to $70,000, demand is expected to grow, and competition among manufacturers may help bring down health care costs.
One benefit of the new pump (“HVAD”), made by HeartWare, is that insertion is easier – and a smoother operation means patients get to go home faster. Besides being able to resume fishing, Walters said he is looking forward to reuniting with their dogs. "I feel really fortunate that I get to go home and play with my dogs," Walters said. "I miss my puppies."
*end*
= = = = = =
8-5-13: ”Sutter Uses Smaller Heart Pump (HVAD) to Help Patient Waiting for Transplant”
Kathy Robertson, Sacramento Business Journal
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90702067
8-5-13: Sutter Mem’s 1st HVAD rec. Ron Walters – “Because of its [HVAD’s] small size, the pump is easier to install and the patient recovers faster.”…
8-5-13: ”Sutter Uses Smaller Heart Pump (HVAD) to Help Patient Waiting for Transplant”
Kathy Robertson, Sacramento Business Journal
http://www.bizjournals.com/sacramento/news/2013/08/05/sutter-health-uses-heart-pump-patient.html
Ron Walters, 67, is expected to head home later Monday with a small heart pump in his chest that eventually will allow him to resume normal activity while he waits for a transplant.
The new ventricular assist system by HeartWare [“HVAD”] was approved by the U.S. FDA in November 2012. Walters is the first patient to be implanted with the device at Sutter Memorial Hospital, which houses the only heart transplant program in the region.
PHOTO: ”Ron Walters, left, is expected to leave home Monday with a heart pump that will let him resume normal activity while waiting for a heart transplant. Walters is standing with Sutter doctors Robert Kincade and John Chin. This was Sutter's first use of the HeartWare ventricular assist system.”
Because of its [HVAD’s] small size — the device fits into the palm of the hand — the pump is easier to install and the patient recovers faster. This cuts hospital stays and costs. “The advantage is it is quite a bit smaller than previous pumps, so the operation is a little simpler and less invasive,” said Dr. Robert Kincade, surgical director of the Sutter heart transplant program.
The new pump is expensive. Kincade would not say how much; Sutter negotiated a packaged deal. But the higher cost up front is expected to balance over time, as hospital stays go down. Designed for patients with heart failure who are waiting for a transplant, the device also may give patients more time while they wait for a permanent solution, given a limited pool of donors. Kincade estimates 50 to 100 patients annually could benefit from the procedure. Many are going without treatment currently.
Life is not normal for heart failure patients, but the size of the new pump should allow patients to feel better and resume normal activity in a few months, Kincade said. All except swimming and getting into a bathtub, he added. The device has a battery pack and cord. Sutter Memorial is the only local hospital offering the procedure. In the Bay Area, it is available at Stanford and the University of California San Francisco. Sutter launched a ventricular assist device program in 2009 for patients who need therapy but do not qualify for a transplant. Walters is the first local recipient of the new, smaller pump.
*end*
8-2-13 CMS VAD proposal an incremental positive for Thoratec, says Leerink
Leerink said the CMS ventricular assist device, or VAD, national coverage determination was largely in line with Street expectations and is an incremental positive for Thoratec (THOR) given the Bridge-to-Transplant vs. Destination Therapy destination remains intact. The firm said the proposal could be a perceived negative for HeartWare (HTWR) given some investors hoped for elimination of the designation.
8-1-13 article on 16yo HVAD rec. Jake Paul (Charleston SC)…
8-1-13: ”Teen Paving Way for Heart Transplant Devices at MUSC”
http://www.wset.com/story/23023405/teen-paving-way-for-heart-transplant-devices-at-musc
**Includes 4 minute VIDEO report** (WSET/ABC, Charleston SC)
CHARLESTON,SC (WCIV) – A year ago, 3-year-old Morgan Porter was suffering from heart failure and depended on a massive machine called the Berlin Heart to keep her alive. Now, there's another child – 16-year-old Jake Paul – with the same problem, but the device keeping him alive is small enough for his heard to carry. Jake Paul is a shy boy, outdoorsy, and quiet around cameras and microphones. Even when the camera is his own, he lets Mother Nature do the talking; he just responds. His quietness is no indication of the weight he carries on his shoulder.
"We didn't find out he head heart failure until Nov. 2012," said Larenda Paul, Jake's mother. "His heart, it was so enlarged that the muscle had stretched so far out that it was barely squeezing." 8 months ago Jake was diagnosed with dilated cardiomyopathy. "He really didn't make a big deal out of it because he wasn't feeling any symptoms," his mother said.
Between doctor's appointments every 2 weeks, Jake tried to go fishing whenever he could. That lasted until April, when his heart took him off the pier. "He ended up needing to be put on a ventilator. His kidneys started shutting down. He started developing liver dysfunction," Larenda Paul said. It landed him in the Intensive Care Unit at Medical University Hospital. "There was no sleeping in ICU because he had to be on oxygen," she said. "And somebody had to be in there with him to make sure he had his oxygen back on." Jake's parents took turns by his side. "On my nights off, I would either stay in my truck or stay in a room when I had the money," said his mother. "I've lost about 20 pounds. So has Jake; he lost 24 pounds throughout all of this." While they waited, doctors considered their options.
"The devices that we had at our hospital, known as the Berlin Heart, required the patient to stay in-house potentially for up to 6 or 9 months," said Dr. Minoo Kavarana. Then there was an alternative – a palm-sized Heartware (“HVAD”) device. "All that comes out of his body is a 4 millimeter driveline connected to a battery pack he wears on his belt. And that's all it takes to drive his blood to the rest of his body," said Kavarana. For $250,000, doctors and the Pauls were able to keep Jake's heart pumping until a new heart is available.
"Initially, the hospital has to take a leap of faith. This is not a cheap device," said Larenda Paul. "This is also not a device that has been FDA approved for long." But the innovation was worth the time and the bill. Jake was in need so MUSC made an investment on his behalf. "Early, 4am, they did blood work and his organs were failing so they let me know at 6am they had to put him to sleep one day early," his mother said. "Next thing I know, they were having emergency surgery on him." 3 days later, Jake became the first patient in the state of S.C. with the Heartware “HVAD” device. "We can go do things now, whereas the older devices you would have to push a cart," said the teenaged Paul. With a pouch at his side, Jake is up and moving and the silence during lunch carries a different tune.
"I can't even describe because he was not able to eat for 2 months. He would get sick. And now to see him get his appetite back," Larenda Paul says, smiling at her son's recovery. While Jake's mother is getting her son back, his doctors are getting a patient capable of undergoing a heart transplant. "Physically, he's much stronger. He's put on a lot more weight. And he'll be able to tolerate his transplant a lot better," Kavarana said. A dose of shyness may be just what the doctor ordered. After all, Jake is paving the way for dozens of hearts just like his.
Jake is still on the waiting list for a heart transplant. While he can fish and move around with the heartware device, he cannot participate in things like contact sports.
*end*
8-2-13/MassDev: New Medicare Rules For Heart Pump Implants
“The Centers for Medicare & Medicaid Services issues new proposed rules for implantable heart pumps, sending Thoratec shares up slightly by prompting investors to rival HeartWare's shares down”
by Brad Perriello, MassDev
http://www.massdevice.com/news/thoratec-ticks-heartware-slides-new-medicare-rules-heart-pump-implants
The Centers for Medicare & Medicaid Services issued new proposed rules for left ventricular assist devices, the heart pump implants designed to help patients with end-stage heart disease either make the bridge to transplant or to assist their hearts until the end of life – so-called "destination therapy."
The new Medicare rules change how potential LVAD patients must be registered, requiring bridge-to-transplant patients to be registered as potential heart transplant recipients with their own hospitals, as before, but also requires them to be placed on the national organ transplant list.
The new proposed rules would also tighten the restrictions on so-called "bridge-to-decision" patients who use the pumps until a decision is made regarding a heart transplant. They also eliminate restrictions on the amount of time BTT patients can spend on the devices while they await a heart transplant.
8-1-13 article about 5 year-old HVAD Recipient – “youngest VAD patient in the world” – after 10mos. on HVAD, rec’d a heart transplant…
8-1-13: ”Stollery Patient Youngest In World To Receive Artificial Heart - Surgically Implanted Device (HVAD) Keeps Organ Pumping Until Match For 6 Year-Old Heart Transplant”
http://www.albertahealthservices.ca/8839.asp
EDMONTON — A 6 year-old girl has received a heart transplant 10 months after becoming the youngest patient in the world to have a revolutionary heart pump surgically implanted inside her chest at the Stollery Children’s Hospital.
In Sept. 2012, then 5 year-old Muskaan Grewal received a HeartWare pump, a ventricular assist device (VAD) which took over the pumping function of her heart. The (“HVAD”) VAD, roughly the size of a golf ball, was designed for adults but has been used in a small number of pediatric cases around the globe. “Unlike other artificial heart machines which require patients to stay in hospital, this device did allow Muskaan and her family to return home until a heart became available for transplant,” says Dr. Holger Buchholz, Director, Pediatric Artificial Heart Program, Stollery Children’s Hospital. “We believed this device would improve her quality of life and allow her to start Grade 1 at her own school in her community.”
The pump sits inside the chest and is connected directly to the patient’s heart. The pump is powered by a small controller, outside the body, which is connected to a small cable that passes through the skin of the upper abdomen. HeartWare’s external mechanisms, including the controller and battery, weigh less than 4 pounds, which made it easy for Muskaan to carry them over her shoulders in a backpack. Muskaan was only 10 days old when her parents, Harmon and Sukhjit Grewal, were informed their daughter had Dilated Cardiomyopathy with non compaction. With this rare condition, which occurs in one case per 100,000 live births each year, the heart becomes weakened and enlarged and cannot pump blood effectively, leading to heart failure. Over the years, as her health deteriorated, Muskaan was in and out of hospital and required multiple interventions and medications. In Feb. 2012, she was listed for a heart transplant.
“Before she got the VAD, Muskaan would get tired just from taking a few steps; she was so weak for such a long time. We used to have to carry her from the car to the house,” says Mr. Grewal. “With the device she could run around and play as a normal child.”
The external controller operates the pump and features a 2-line LCD screen to display parameters, alarms, and troubleshooting tips on operating the system. Muskaan’s parents received extensive training on the device prior to her discharge and were given a 24-hour hotline number to call in case of emergency. Selvi Sinnadurai, Edmonton VAD Program Coordinator, travelled to her community where she educated staff at Muskaan’s school. “Thanks to the training, support, and plans in case of emergencies that we received, we felt very confident about going home with this device,” adds Mr. Grewal. “Muskaan has grown up with a number of interventions and she became our little helper, making sure we were doing everything correctly.” After 10 months with the HeartWare pump, Muskaan developed an infection and required hospitalization. During her stay at the Stollery, a heart became available and she received a heart transplant in July 2013.
“We are so grateful for the care we have received, and to the donor parents and family who made the decision to have their child be an organ donor,” says Mr. Grewal. “They have given my daughter the gift of life. If you ask her, she says she is free now.” Muskaan’s cardiac care team expects her quality of life to steadily improve — and that she’ll be back in school to start Grade 2 in September.
The Stollery Children’s Hospital is a member of the Western Canadian Children’s Heart Network, a group of pediatric cardiac programs across Western Canada that work in collaboration to deliver the best possible care for pediatric cardiac patients. The Stollery is Western Canada's largest referral centre for pediatric cardiac surgery and a national leader in pediatric heart transplantation. “I think that Muskaan’s case is truly a success of the Western Canadian Children’s Heart Network to provide world-class care to patients from a vast geographical area,” says Dr. Buchholz. “This collaboration of pediatric cardiac specialists from across Western Canada gave us the opportunity to implant a new device into a young girl who became the smallest patient to ever go home with a VAD.”
The Pediatric Ventricular Assist Device (VAD) Program at the Stollery is one of the largest such pediatric programs in North America, and is at the forefront of mechanical circulatory assist device treatment. In 2005, the Stollery became the first site in Western Canada to implant a Berlin Heart Left Ventricular Assist Device (LVAD); and in 2011, the first in Canada to implant a HeartWare LVAD in a pediatric patient to be discharged home.
In the last year, the Stollery Children’s Hospital Foundation has provided more than $500,000 for specialized diagnostic equipment, research, education and family support — assisting families of children requiring transplantation, VAD and other specialized cardiac care. Thanks to the support of donors to the University Hospital Foundation, adult and pediatric patients at the Mazankowski Alberta Heart Institute are benefiting from the latest technology, research and specialized cardiac programs every day — this includes $400,000 to support the expansion of the VAD Program. Alberta Health Services is the provincial health authority responsible for planning and delivering health supports and services for more than 3.9 million adults and children living in Alberta. Its mission is to provide a patient-focused, quality health system that is accessible and sustainable for all Albertans. *end*
7-30-13: 1st Robotic Implant of an HVAD done at Univ. of Arizona. “I’ve never felt good about opening up people’s chests. That’s why I’ve done robotic heart surgery,” Dr. Robert Poston said…
7-30-13: “UA Surgeons Perform World's First Robotic Implantation of an HVAD”
By Mark Armao, Arizona Daily
http://www.wildcat.arizona.edu/article/2013/07/ua-surgeons-perform-worlds-first-robotic-implantation-hvad-073113
Two surgeons at the University of Arizona Medical Center have performed the world’s first robotic implantation of a ventricular assist device.
The Heartware Ventricular Assist Device, “HVAD”, is a small, mechanical device that is attached to the heart to help pump blood throughout the body. Unlike artificial hearts, which generally replace the heart altogether, VADs are intended to sustain the function of the heart while leaving the organ almost entirely intact.
Using robotic instrumentation, Dr. Zain Khalpey and Dr. Robert Poston have implanted the device in a total of four patients so far. “It’s very humbling,” said Khalpey, an associate professor of surgery and director of clinical and translational research for UA’s Dept. of Surgery. “But, it’s also very exciting because it really takes forward a field which is looking toward new generation ventricular assist devices.”
The device, which is about the size of a golf ball, Khalpey said, continuously sucks blood out of the left ventricle, the largest chamber of the heart, and propels it into the aorta, the artery that supplies blood to most of the body. The HVAD connects to a control unit and power source via a thin cable that exits the body near the waistline. “[The technology] has catapulted into being science fiction, but really, it’s not,” Khalpey said.
The HVAD allows patients to live a relatively normal life while awaiting a heart transplant. And, in some cases, the device is left in permanently. While VADs have been around for several years, one had never been robotically implanted before.
A professor of surgery and the medical director of the Adult & Robotic Cardiac Surgery Program at UA’s Department of Surgery, Poston specializes in robotic heart surgery, in which robotic arms and instrumentation are utilized to perform surgical procedures on the heart without splitting the breastbone. “I’ve never felt good about opening up people’s chests. That’s why I’ve done robotic heart surgery,” Poston said.
The robotic VAD procedure requires an incision on both the left and right side of the chest cavity, he said. The robotic instruments, including a scalpel, forceps and a tiny camera, go in through the right-side and insert the device in the left. Poston said he believes that robotically implanting VADs could be a safer, more cost-effective option when it comes to this type of surgery in the future. Of the 4 surgeries performed using this technique, the procedure has resulted in less bleeding and a decreased need for blood transfusions, as well as a shorter recovery time than in traditional surgeries, he added. “It’s not a Nobel Prize kind of thing,” Poston said. “But it is definitely something that is a substantial improvement on the way it was done.”
Terry Scott, 58, has endured heart problems for more than 20 years. He was the second patient to undergo the groundbreaking procedure. Scott said he is grateful that Khalpey & Poston were able to provide him with what they call a “bridge to transplant,” and that he is glad to be one of the first beneficiaries of a robotically implanted VAD.
“It feels pretty cool. Dr. Khalpey said I was famous,” he said. Khalpey said that he enjoys seeing patients leave with a new lease on life. “With these devices, it’s changing their lives,” he said. “They’re able to pick up their children, they’re able to drive, they’re able to have a normal life.”
*end*
7-27-13: Article on Detroit HVAD Recipient… “Other people in the heart & vascular area were jealous of his (HVAD) LVAD, because it is smaller, lighter and quieter than the previous generation of LVADs. Nurses were fascinated by it because it was new and they wanted to know how it worked… it is pumping my husband’s blood when everything else stopped working; a quiet soldier, giving my husband back his strength, his sense of taste, his ability to function and think sharply and clearly. He has blood flow. His skin and body are warm again. And the people at Henry Ford Health System who made this happen are heroes.”
7-27-13: ”Life with an LVAD (HVAD) Heart Pump”
By Julie Topping. CityMetro (Charlotte NC)
http://www.qcitymetro.com/health/articles/life_with_an_lvda_heart_pump120541279.cfm
Youtube Video on HVAD: “Compact Mechanical Heart (HVAD) Gives Better Quality Of Life” (2 minutes)
7-25-13:
HeartWare Q2 Conf. Call/webcast: 8-8-13 8amET
July 19, 2013: HeartWare Intl. has scheduled a conference call to discuss its financial results for the 3 mos. ended June 30, 2013, at 8:00amET Thursday, August 8, 2013. The Company plans to release the financial results prior to the conf. call. The conference call with management will discuss the Company's financial results, highlights from Q2, and business outlook.
http://www.heartware.com
6-17-13: J.P. Morgan Reits Overweight PT=$115 on HTWR
In a report published 6-17-13, J.P. Morgan analyst Michael Weinstein reiterated an Overweight rating (PT=$115) on HeartWare Intl. (NASDAQ: HTWR).
In the report, J.P. Morgan noted,
“Overall, we view the CAP approval as a positive that should help to alleviate investor concerns about the DT data set. Heartware has been in negotiations with the FDA for several months about the structure the CAP would take, principally due to the company's desire to amend the original trial protocol to include more rigorous blood pressure management. Retrospective analysis of earlier HVAD studies has shown that centers that more closely managed MAP experienced a lower incidence of neurological complications, particularly hemorrhagic stroke. By implementing these protocol changes, the company hopes to generate a data set that can supplement the pivotal ENDURANCE cohort and show that better patient management can also reduce event rates in the DT population. Recall that unadjudicated interim data included in the HVAD's IFU following its approval under a BTT indication appeared to show a higher stroke rate with the HVAD than Thoratec's HeartMate II.”
http://www.benzinga.com/analyst-ratings/analyst-color/13/06/3681583/j-p-morgan-reiterates-overweight-rating-on-heartware-int
= = = = = = = =Prior Overweight Reit:
3-13-13: J.P. Morgan analyst Michael Weinstein reiterated his Overweight rating and $115 price target on Heartware…
In the report, Weinstein noted, “We view Heartware as one of the most compelling growth stories in small-cap MedTech. With its unique pump design, Heartware is poised to be the first real challenger to Thoratec's near-monopoly position in the VAD market, which we view as one of the more promising growth segments in the cardiovascular universe over the next decade. The HVAD's small size means the pump can be implanted directly within the pericardial space, allowing for less invasive implant techniques and potentially reducing complications. Heartware also expects first-in-man implants using its miniaturized next-generation pump, the MVAD, by mid-2013.”
http://www.benzinga.com/analyst-ratings/analyst-color/13/03/3413609/j-p-morgan-reiterates-overweight-on-heartware-internatio
6-17-13: FDA Grants Supplemental Patient Cohort for HVAD/DT Trial (addl. 240 HVAD’s)
HeartWare Receives Conditional Approval From FDA to Enroll Supplemental Patient Cohort in Destination Therapy Trial
• Amended protocol includes enhanced blood pressure monitoring to ensure optimal patient management
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1830293
FRAMINGHAM & SYDNEY, June 17, 2013: HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. FDA has granted conditional approval to an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company's pivotal, Destination Therapy clinical study.
ENDURANCE is a randomized, controlled, unblinded, multi-center clinical trial to evaluate the use of the HeartWare® Ventricular Assist System as a Destination Therapy in advanced heart failure patients. The non-inferiority study completed enrollment of 450 patients with end-stage heart failure who had not responded to standard medical management and who were ineligible for cardiac transplantation. Patients were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative LVAD approved by the FDA for Destination Therapy, in a 2:1 ratio.
The primary endpoint of the trial is stroke-free (Modified Rankin Score > 4) survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life. The final implant was conducted in May 2012, which will result in the final patient reaching the two-year follow up point in May 2014.
SUPPLEMENTAL PATIENT COHORT
FDA granted conditional approval to a protocol designed to confirm observations from ENDURANCE that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events.
In this supplemental cohort, HeartWare will enroll up to an additional 240 HeartWare HVAD patients, as well as up to an additional 120 control patients using a randomization scheme consistent with the ENDURANCE protocol. Patients will be followed for 12 months after implant. HeartWare intends to incorporate the data from this new cohort into an anticipated Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for the Destination Therapy indication.
Patient enrollment in this supplemental cohort can commence at the 50 centers participating in the ENDURANCE clinical trial, following edits to the protocol as prescribed by FDA and Institutional Review Board approvals at each of the centers.
On November 20, 2012, FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication. Concurrent with approval, the Company commenced a post-approval study (PAS) to assess device performance in a real-world setting. HeartWare's PAS is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database. HeartWare expects enrollment for both arms of the PAS will be complete by year's end.
HTWR’s CEO D.Godshall at W.Fargo: 6-18-13 9:25amET webcast
”HeartWare Presentation at the Wells Fargo Securities 2013 Healthcare Conference to be Webcast” [6-18-13 9:25amET]
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1829586
FRAMINGHAM & SYDNEY, June 13, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Wells Fargo Securities Research & Economics 2013 Healthcare Conference at 9:25amET on Tuesday, June 18, 2013. The conference is being held June 18-19 at the The InterContinental Boston.
A live webcast of the Company's presentation at the conference will be available [at Heartware com]
6-12-13: HeartWare Announces Intention To Delist From ASX (Australian Securities Exchange)...
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1829148
FRAMINGHAM & SYDNEY, June 12, 2013: HeartWare International, Inc. (NASDAQ:HTWR - ASX:HIN), today announced that it has requested and received approval from ASX Limited for its removal from the official list of ASX. Trading in HeartWare's CHESS Depositary Interests (CDIs) will be suspended on ASX at the close of market on September 10, 2013.
HeartWare's shares of common stock are currently listed for trading on the NASDAQ Global Select Market (NASDAQ) under the symbol HTWR and HeartWare's CDIs are traded on the ASX under the code HIN. One share of HeartWare common stock is equivalent to 35 CDIs.
ASX has advised that in accordance with the Company's request, it will remove the Company from the official list of ASX with effect from the close of trading on September 17, 2013 subject to HeartWare providing a voluntary sale facility through which holders of CDIs may sell their shares of common stock on NASDAQ (as described below) and notifying CDI holders of the availability of the sale facility. HeartWare's common stock will continue to be listed on NASDAQ.
Background on decision to delist
HeartWare Limited was admitted to the official list of ASX in 2005 and was replaced as the ASX listed entity by HeartWare following its redomiciliation in the United States in 2008. Since HeartWare's listing on NASDAQ in 2009, there has been a substantial shift in the trading volume of its securities from ASX to NASDAQ, which has culminated in more than 99% of the total trading volume of HeartWare's securities occurring on NASDAQ and less than 1% of its trading volume occurring on ASX since January 1, 2013. In addition, CDIs now only represent approximately 5% of HeartWare's issued and outstanding capital with the vast majority of its capital being held as common stock traded on NASDAQ. As a result, HeartWare has determined that sustaining the administrative costs of an ASX listing, including the higher level of regulatory compliance costs associated with dual listings, is difficult to justify and, accordingly, has made the decision to delist from ASX.
Delisting process
Prior to suspension of trading in HeartWare's CDIs on ASX, HeartWare will send each CDI holder a letter which will provide an overview of the delisting process as well as details of the following options which will be available to CDI holders:
•the continued right to sell their CDIs on ASX until trading of CDIs is suspended from the official list of ASX (expected September 10, 2013);
•a Voluntary Sale Facility that will be established by the Company to enable CDI holders to sell the shares of common stock underlying their CDIs on NASDAQ for a period of three months following the date of HeartWare's removal from the official list of ASX (expected for the period between September 18, 2013 to December 18, 2013);
•the continued right to convert their CDIs into shares of common stock until the end of the Voluntary Sale Facility (expected on or around December 18, 2013); and
•the compulsory sale of remaining shares of common stock underlying the CDIs during the nine day period following the close of the Voluntary Sale Facility (expected to occur between December 19, 2013 and December 27, 2013).
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 30 international countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at www.heartware.com.
HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of HeartWare, Inc.
HTWR’s CEO D.Godshall at Goldman-Sachs 6-12-13 11amET webcast
HeartWare Presentation At The Goldman Sachs 34th Annual Global Healthcare Conference To Be Webcast
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1826921
FRAMINGHAM & SYDNEY, June 4, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Goldman Sachs 34th Annual Global Healthcare Conference at 8:00amPT (11:00amET) on Wednesday, June 12, 2013. The conference is being held June 11-13 at the Terranea Resort in Rancho Palos Verdes, CA.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
HTWR’s CEO D.Godshall at UBS 5-20-13 11amET
HeartWare Presentation At The 2013 UBS Global Healthcare Conference To Be Webcast [Webcast 5-20-13 11amET]
FRAMINGHAM, & SYDNEY, May 16, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the 2013 UBS Global Healthcare Conference at 11:00amET on Monday, May 20, 2013. The conference is being held May 20-22, 2013 at the Sheraton New York Hotel.
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1821217
Link to D.Godshall 5-16-13 BOA/ML presentation (Las Vegas)
http://www.veracast.com/webcasts/baml/healthcare2013/id75779800.cfm
$229mm cash on hand a/o 3-31-13
MVAD (with qPulse): First in Man 1H'13 - CE Mark to commence immediately thereafter
Going after Canada & Japan
HTWR’s CEO D.Godshall at BOA/ML 5-16-13 8amPT
HeartWare Presentation at the Bank of America Merrill Lynch 2013 Health Care Conference to be Webcast [on May 16 2013 11amET]
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1818270
HeartWare Intl., Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Bank of America Merrill Lynch 2013 Health Care Conference at 8:00amPT (11:00amET) on Thursday, May 16, 2013. The conference is being held May 14-16, 2013 at the Encore at Wynn in Las Vegas.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com .
5-6-13: Credit Suisse downgrades HTWR to Neutral due to valuation, but raises PT from $95 to $105…
5-6-13: “HeartWare downgraded to Neutral from Outperform at Credit Suisse
Credit Suisse downgrades Heartware due to valuation. Price target raised to $105 from $95.”
http://finance.yahoo.com/news/heartware-downgraded-neutral-outperform-credit-102029822.html
5-3-13/SA: ”Heartware Q1 Results: Good News For All LVAD Companies”
By: Robert Honeywill, SeekingAlpha => “Disclosure: I am long SSH”
http://seekingalpha.com/article/1398241-heartware-q1-results-good-news-for-all-lvad-companies
4-30-13: Leerink Swann Raises HTWR’s PT to $110 from $100
4-30-13: ”HeartWare Price Target Raised to $110 at Leerink Swann (HTWR)”
HeartWare Analysts at Leerink Swann increased their price target on shares of HeartWare (NASDAQ: HTWR) from $100 to $110 in a research report issued to clients and investors on Tuesday, ARN reports. The firm currently has an “OUTPERFORM” rating on the stock.
http://www.mideasttime.com/heartware-price-target-raised-to-110-00-at-leerink-swann-htwr/15104
4-30-13: Barclays Raises HTWR’s PT to $100 from $95
4-30-13: “HeartWare Price Target Raised to $100 at Barclays Capital (HTWR)”
HeartWare logoEquities researchers at Barclays Capital upped their target price on shares of HeartWare (NASDAQ: HTWR) from $95 to $100 in a report issued on Tuesday, Stock Ratings Network reports. The firm currently has an “OVERWEIGHT” rating on the stock.
http://localizedusa.com/2013/04/30/heartware-price-target-raised-to-100-00-at-barclays-capital-htwr
4-30-13: HeartWare: JP Morgan Raises Target Price to $125
4-30-13 (Reuters) HeartWare Intl. Inc:
”JP Morgan raises target price to $125 from $115; rating overweight”
http://www.cnbc.com/id/100688006
4-30-13: HeartWare Given $125 Price Target at Canaccord Genuity
4-30-13: Canaccord Genuity analyst Jason Mills said HeartWare's on the path to snag a huge share of the LVAD market, writing in a note to investors that the company's quarter "crushed even the most bullish prognostications."
”HeartWare's sales soar after HVAD launch” - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/heartwares-sales-soar-87-after-
http://utahpeoplespost.com/2013/04/heartware-given-a-125-00-price-target-at-canaccord-genuity-htwr
4-29-13 Earnings Call Transcript
4-29-13 HeartWare Intl. CEO Doug Godshall Discusses Q1 2013 Results - Earnings Call Transcript
http://seekingalpha.com/article/1383171-heartware-international-inc-ceo-discusses-q1-2013-results-earnings-call-transcript
DG: "As noted in our news release revenue for Q1 came in at 49.2 million, representing an 87% increase over Q1 2012. During the quarter we sold a record 482 HVADs, 40% more than the 345 units we sold during Q4 of 2012... We are truly grateful for the enthusiasm we have seen from surgeons, cardiologists and VAD co-coordinators alike as this is essential for both the early launch and to sustain momentum. And now I will turn the call over to Peter to discuss our Q1 financials..."
4-29-13: HTWR Q1/2013 Financials; Revs=$49.2mm, Up 87%; Cash=$228.9mm
HeartWare International Reports $49.2 Million In First Quarter 2013 Revenue; 87% Increase From First Quarter Of 2012
• U.S. Revenues of $26.2 million, from $6.4 million in First Quarter of 2012
• Reflecting First Complete Quarter of Commercialization in U.S.
• Conference call today at 5:00 p.m. U.S. E.T.
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1812562
FRAMINGHAM & SYDNEY, April 29, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $49.2 million for the first quarter ended March 31, 2013, an 87% increase compared to $26.4 million in revenue for the same period of 2012.
"Our results for the first quarter reflect positive initial trends in the commercial launch of the HeartWare® Ventricular Assist System in the U.S., following approval from the Food and Drug Administration (FDA) in November 2012, and continued strong support from our international customers," explained Doug Godshall, President and CEO. "During the first quarter of 2013, 482 HVAD® pumps were sold globally, an increase from 298 units in the first quarter of 2012 and more than our previous high quarterly total of 345 units in the fourth quarter of 2012."
During the first quarter of 2013, U.S. revenue, which reflects the Company's first full quarter of U.S. commercialization, was $26.2 million, an increase of approximately 300% from $6.4 million in the first quarter of 2012. Revenue from international markets, generated through the sale of 244 units, was $23.1 million, an increase of approximately 16% from $19.9 million in the first quarter of 2012. Currency fluctuations decreased revenue by approximately 25 basis points in the first quarter compared to the same period in 2012.
"It has been quite gratifying to see such strong interest from new hospital centers thus far in our commercial launch," added Mr. Godshall. "Our team has been working diligently to expedite the training of additional hospitals in the U.S., and in the five months since FDA approval, 27 new U.S. sites have been trained. In total, HeartWare now has more than 190 customers around the world."
Total operating expenses for the first quarter of 2013 were $38.6 million, as compared to $32.7 million in the first quarter of 2012.
Research and development expense was $22.1 million for the first quarter of 2013, as compared to $20.0 million in the same period of 2012. Development costs are primarily attributable to clinical trial costs and research and development costs related to advancing HeartWare's pipeline technologies, including the MVAD® platform and a fully implantable system, as well as other early research initiatives.
Selling, general and administrative expenses were $16.5 million in the first quarter of 2013, compared to $12.7 million in the first quarter of 2012. The increase in selling, general and administrative expenses reflects expansion of sales and marketing activities, particularly in the United States, an overall increase in corporate infrastructure to support the Company's rapid growth, and implementation of the 2.3% excise tax on the U.S. sales of certain medical devices which became effective January 1, 2013.
Net loss for the first quarter of 2013 was $13.0 million, or a $0.87 loss per basic and diluted share, compared to a $18.9 million net loss, or a loss of $1.33 per basic and diluted share, in the first quarter of 2012.
At March 31, 2013, the Company had $228.9 million of cash, cash equivalents and investments.
HeartWare will host a conference call on Monday, April 29, 2013 at 5:00 p.m., U.S. Eastern Daylight Time to discuss the Company's financial results, highlights from the first quarter and business outlook. The call may be accessed by dialing 1-877-941-4774 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial +1-480-629-9760.
A live webcast of the call will also be available at the Company's website ( http://www.heartware.com ) by selecting "HeartWare First Quarter 2013 Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.
ABOUT HEARTWARE INTERNATIONAL
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 30 international countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at http://www.heartware.com .
HTWR 1Q’13 Financials/C.Call on April29 5pmET
HeartWare Schedules First Quarter Conference Call And Webcast
FRAMINGHAM & SYDNEY, April 15, 2013: Heartware Intl. has scheduled a conference call to discuss its financial results for the 3 months ended March 31, 2013, at 5:00pmET on Monday, April 29, 2013. The Company plans to release the financial results prior to the conference call.
The conference call with management will discuss the Company's financial results, highlights from the first quarter and business outlook. The call may be accessed by dialing 1-877-941-4774 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial +1-480-629-9760.
A live webcast of the call will also be available at the Company's website (www.heartware.com) by selecting "HeartWare First Quarter 2013 Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.
A copy of the news release announcing results and related information will be available on the Company's website, http://www.heartware.com .
Looks like a new webpage for MVAD & TET...
http://www.heartware.com/products-technology
Drilling down to:
http://www.heartware.com/products-technology/technology-pipeline
Also, a new page for Meetings & Events: http://www.heartware.com/clinicians/meetings-events
Come to think of it, the whole site looks re-designed: http://www.heartware.com
9-5-13: MAUDE - Manufacturer and User Facility Device Experience
MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
Interesting reading.
4-5-13: Leerink Swann Calls HVAD Failure “One-Off Event”…
4-5-13: ”Analyst Calls Heartware (HTWR) Device Failure One-Off Event”
http://www.streetinsider.com/Analyst+Comments/Analyst+Calls+Heartware+(HTWR)+Device+Failure+One-Off+Event/8236273.html
This morning shares of Heartware Int'l (NASDAQ: HTWR) declined following reports from the FDA MUADE database that a Heartware HVAD patient passed away after the device suddenly stopped working.
Commenting on developments, analyst Danielle Antalffy of Leerink Swann said,
"While this is a serious event, we are inclined to view it as an isolated case given the HVAD's extensive use in Europe - where it has been commercially available since 2009 - without similar instances reported. And while a detailed EU adverse event database similar to MAUDE doesn't exist, we believe that any widespread instances of device failure would've been brought to light given that the community of VAD implanting surgeons is small and well-connected."
Leerink Swann has an Outperform rating on Heartware Int'l.
= = = = = = = = = = = =
4-5-13: HVAD Malfunction Led to Death, FDA Reports… “After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell…”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86505411
4-5-13: HVAD Malfunction Led to Death, FDA Reports… “After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell…”
4-5-13: ”HeartWare Device Malfunction Led to Death, FDA Reports”
By Michelle Fay Cortez & Catherine Larkin
http://www.bloomberg.com/news/2013-04-05/heartware-device-malfunction-led-to-death-fda-reports.html
A malfunction in a device from HeartWare International Inc. (HTWR) used to take over the heart’s beating action led to a patient death, U.S. regulators said. The company’s shares declined.
After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell, setting off a controller fault alarm, the report posted on the U.S. FDA’s website said. A family member found the woman unresponsive at her house, with the alarm blaring. The problem had persisted for at least 3 hours before it was addressed, according to a preliminary analysis.
The patient, who was unidentified in the FDA report, was taken to a local hospital, where she died. She had had the device for nearly 3 years before the malfunction, which occurred on Feb. 25, the FDA said. The death may increase safety concerns if the problem is shown to be a malfunction related to the actual device, Bloomberg Industries analyst Jason McGorman said in an interview. It’s not clear from the FDA report what caused the device to stop working correctly.
HeartWare fell 2.5% to $84.15 at 12:34 p.m. in New York, after decreasing as much as 5.8% for the biggest intraday drop since Nov. 27. Christopher Taylor, a HeartWare spokesman, didn’t return a phone call or e-mail seeking comment. The device was returned to HeartWare, based in Framingham, Massachusetts, the agency said. An autopsy was done, though the results haven’t been provided.
3-30-13: Followup article on 13yo HVAD recip. Kyah DeSimone, “the first child in the United States to return to school after having a heart pump implanted”…
3-30-13: ”Portable Heart Pump Gives Yarmouth Teen Time”
By CYNTHIA MCCORMICK, Cape Cod Times
http://www.seacoastonline.com/apps/pbcs.dll/article?AID=/20130330/NEWS/130339999
3-30-13: YARMOUTH, Mass. (AP) – 13-year-old Kyah DeSimone wanted to make cheerleading practice and good grades, not medical history. But after a frightening brush with heart failure, the 8th-grader became the first patient at Boston Children's Hospital to be implanted with a heart pump small and portable enough to restore her to normal life while she waits for a transplant.
After February school break, the eighth-grader was back in class part time at Dennis-Yarmouth Regional High School — making her the first child in the United States to return to school after having a heart pump implanted, officials at Children's Hospital said.
Kyah eventually should be able to attend high school full time as well as resume cheerleading and hip-hop dance lessons, said Dr. Christina VanderPluym, cardiologist at Children's Hospital. "We actually encourage them to be as active as possible," she said.
There are some limitations. Kyah can't go swimming or do chores that cause electrical static — such as vacuuming — as long as the titanium golf-ball-sized pump is plugged into her left ventricle, VanderPluym said. "Other than that, she can do anything," she said. "It is keeping her going until she can get a heart" transplant, Kyah's mother, Danielle DeSimone, said.
Kyah has cardiomyopathy, or disease of the heart muscle, as a result of a rare genetic condition, and she was undergoing tests every six months as a precaution. But Kyah ended up in the emergency room of Cape Cod Hospital in early October after she experienced trouble breathing and excessive thirstiness.
"She had just been at my house," Kyah's best friend, Tarah Mendes, 14, said.
"All of a sudden she was really, really sick."
Diagnosed with heart failure, Kyah was taken by ambulance to Children's Hospital, where doctors gave her medicine to try to combat the weakening of her left ventricle. After a month in the hospital, however, Kyah's right ventricle also went into failure. "She was so ill," said VanderPluym, who first met Kyah a few days before the surgery. Already thin, Kyah lost about 20 pounds and vomited for half an hour after having a cup of water because the heart condition wouldn't allow her digestive system to work, VanderPluym said. "She could barely even speak," her mother said. "They told me they'd be surprised if she made it through the night. She was actively dying."
The only option in lieu of a heart transplant — which could mean a wait of months or years — was to put Kyah on a motorized centrifugal pump that would suck blood from her left ventricle through a tube into her aorta — performing the function of her heart for her. Until that point the device used by Children's Hospital was the Berlin Heart, a clear plastic pump worn outside the body and attached to a heavy computer console. "You can't go upstairs with it. You can't go to school with it," VanderPluym said. "Really it was our only device for children" awaiting heart transplant.
The HeartWare implantable device [“HVAD”] had been approved for several years in the cardiologist's native Canada, but it didn't receive the Food and Drug Administration OK for adult use until Nov. 20 - 9 days after Kyah's surgery. Convinced the HeartWare pump would be the best option for Kyah, VanderPluym filled out a 26-page request for emergency FDA approval for a pediatric patient during the Veterans Day weekend.
By 10 a.m. Nov. 11, Children's Hospital had the approval, and Dr. Francis Fynn-Thompson of Children's Hospital and Dr. Duc Thinh Pham of Tufts Medical Center, who had experience with the device, were scrubbed and ready to operate. "It was a big team effort," VanderPluym said. After a 3-hour surgery, the device's rotarized pump not only had succeeded in pushing blood through the left ventricle but also had relieved the stress on the right ventricle so it was functioning again. And the team effort didn't stop in the OR - VanderPluym and Children's Hospital cardiology nurse coordinator Beth Millian traveled to Yarmouth to educate police, fire and school officials as well as members of a local nursing team about Kyah's heart device.
The continuous flow of the pump means the child doesn't have a regular pulse, so emergency officials needed to know they don't need to start CPR if Kyah is conscious, VanderPluym said. First responders came up with a plan to transport Kyah to Cape Cod Hospital in the event of a power failure — which they did during the February blizzard. VanderPluym also met with students in Kyah's STEM (science, technology, math and engineering) class and let them handle a model of the HeartWare device. It's important to dispel mystique around the device, she said. "I was kind of embarrassed and nervous, but it was fine afterward," Kyah said.
She wears the black bag that carries the device's controller and battery over her shoulder like a purse. The wire that powers the ventricular assist device goes from the controller, about the size of a cable box, into her body through a hole in her abdomen. At night the device is plugged into an electrical socket to save the juice in the batteries. And day or night Kyah makes sure her little brother, 6-year-old Jaedan, doesn't accidentally yank the device's drive line out. "Kyah honestly amazed us at how quickly she picked it up," Millian said. "She wanted to learn." Even when her daughter was deathly ill, she was determined to get better, Danielle DeSimone said. "She kept telling me to 'think positive, mom.'" "I just felt like God has plans for you," Kyah said. "I don't really remember a lot of things. But I felt like I would be OK." Carrying around the device sometimes "feels weird," Kyah said. "I'm glad I have it because it saved my life."
Created by a company in Framingham, the HeartWare ventricular assist device is associated with fewer heart attacks and strokes than the Berlin Heart, VanderPluym said. "There's no time limit on it," she said. She said in Europe people have lived on it for several years. But the goal, especially for a young person like Kyah, is ultimately a heart transplant, VanderPluym said. "This is the safest way to get them to transplant when their heart (condition) is so severe. We call it a bridge to transplant."
Nearly two dozen other children in the U.S. have been implanted with the device — including one other child at Children's Hospital since Kyah's surgery — but the West Yarmouth teen is the first to return to school, VanderPluym said. She said the other patients are too young, too sick or are being tutored at home. Kyah, who got A's and B's before she ended up in the hospital, hopes to get back to class full time soon. "I miss it a lot," said Kyah, who wore a heart pendant and heart bracelet during a checkup at Children's Hospital on Tuesday. "I like school."
3-15-13: HeartWare PT Cut to $106 from $107 by Wedbush
Wedbush lowered their price target on shares of HeartWare (NASDAQ: HTWR) from $107 to $106 in a research note issued on Friday. The firm currently has an “outperform” rating on the stock.
http://www.dailypolitical.com/finance/stock-market/heartware-price-target-cut-to-106-00-by-analysts-at-wedbush-htwr.htm
Heart Failure - Heartware Technical Analysis - On an Up
Heart failure is the leading cause of death in the U.S. So what is the best way to play it? I think the answer is Heartware (HTWR).
HTWR makes small implantable heart pumps for people with advanced heart failure. The company is earnings and operating cash flow negative, but earlier this week the company sold 1.5 million shares to raise capital.
This first chart is the daily. They keys here include the hold of the triangle's lower boundary, the great reaction to the secondary offering and the relative strength breakout.
This second chart is the multi-year view. We can see there is flat top resistance around 98, with higher lows forming over the last 2 years or so. From this view we have a stock that is in a relatively safe entry area. If you like the chart, but want to wait for more confirmation, you have a plethora of signals to wait for.
Will this stock ultimately reach the highest possible target at 145? Who knows, but the world's trends and the price history say this is an attractive buy right now. Good luck out there!
If you want to discuss this further you can tweet me @aro618 on stocktwits/twitter
http://atmcharts.blogspot.com.au/2013/03/heart-failure.html
HeartWare overweight rating reissued by JPMorgan Chase.
HeartWare had its overweight rating reissued by analysts at JPMorgan Chase. The analysts wrote, “We view Heartware as one of the most compelling growth stories in small-cap MedTech. With its unique pump design, Heartware is poised to be the first real challenger to Thoratec’s near-monopoly position in the VAD market, which we view as one of the more promising growth segments in the cardiovascular universe over the next decade. The HVAD’s small size means the pump can be implanted directly within the pericardial space, allowing for less invasive implant techniques and potentially reducing complications. Heartware also expects first-in-man implants using its miniaturized next-generation pump, the MVAD, by mid-2013.”
Followers
|
4
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
760
|
Created
|
02/24/09
|
Type
|
Free
|
Moderators |
Heartware International, Inc. (HTWR), Framingham, Mass. http://www.heartware.com
Yahoo Quote & Profile for HTWR: http://finance.yahoo.com/q?s=HTWR
"HeartWare is developing the world's smallest implantable pumps for the treatment of advanced heart failure."
M A J O R…N E W S . . . . M A J O R…N E W S . . . . M A J O R…N E W S . . . .
2-13-09: Thoratec to buy Heartware for $282mm* (112% prem.) - deal to close during 2H'09.
50% CASH ($14.30/sh.) + 50% THOR STOCK (.6054-THOR/sh.) = ~$30.19/sh.* a/o 2-12-09.
…*Stock calcs based on THOR at $26.25. Curr. THOR-QUOTE: http://finance.yahoo.com/q?s=THOR
THOR 2-12-09 PR: http://tinyurl.com/awue9d . . . HTWR 2-16-09 PR: http://tinyurl.com/d5vrck
Reuters 2-13-09: http://tinyurl.com/chwxhu . . . Thoratec's website: http://www.thoratec.com
==> 7-29-09 FTC REJECTS THOR-HTWR Merger!! = = > http://tinyurl.com/lsk475
==> 8-1-09 Form 8-K: THOR-HTWR JOINT TERM. of Proposed Merger == http://tinyurl.com/l5t38r
==> 8-11-09: Private Placement to Raise $55mm (2.5mm sh. @ $22) ==> http://tinyurl.com/lnathp
===> 12-24-09: HeartWare Files S-3 for $100mm Mixed Shelf ==> http://tinyurl.com/y9vm39v
====> 2-3-10: Heartware Nets ~$59mm via Public Offering @ $35.50/sh. ==> http://tinyurl.com/yd4r8g4
=====> *THOR offered $282mm; a/o 6-28-12, HTWR's MktCap was $1.22billion ($86.49 x 14.14mm shares)
ABOUT HEARTWARE INTERNATIONAL (from PR, 4-12-10):
"HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices (VAD's), to treat Class IV patients suffering from advanced heart failure. The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of a U.S. clinical trial for a bridge-to-transplant indication with enrollment completed in February 2010."
11-25-10 VIDEO: Nice description of how the Heartware HVAD pump works: http://www.youtube.com/watch?v=v8aIeoHXTMw (2:46)
4-15-11 VIDEO: "Heartware - Leading a Small Revolution" http://www.youtube.com/watch?v=Etas42f8PPE (2:31)
12-1-13: HTWR acquires Circulite’s SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent. http://tinyurl.com/kr3vwop
CEO Doug Godshall:
HVAD™ System - a "3rd generation" Heart Pump:
• The smallest 3rd gen. Left Ventricular Assist Device
• The only centrifugal pump designed to be implanted in the chest, directly adjacent to the heart
• Only 1 moving part (Hybrid magnetic/hydrodynamic suspension)
• Designed to produce up to 10 liters of flow
• Designed for long-term reliability & optimal blood compatibility
HVAD Animated Demo: http://www.heartware.com.au/IRM/content/usa/hvad_broadband.html
MVAD™ System - a "Next Generation" Heart Pump:
The MVAD Left Ventricular Assist Device is a development-stage axial flow VAD, approx. 1/3 the size of the HVAD.
Like the HVAD pump, the MVAD pump is designed to support the heart's full cardiac output.
From the 4-28-2012 S-4: "The MVAD is a miniaturized blood pump intended for chronic heart failure patients. The device is a full-output axial flow pump with a fully suspended rotor and a displacement volume approximately one-third that of the HVAD Pump. The pre-clinical Good Laboratory Practices (GLP) in-vivo studies completed in Sept. 2011 have shown the MVAD to have similar comparable blood flow characteristics to the HVAD Pump. The MVAD is designed for pericardial implantation and initial human clinical trials are expected to commence in summer 2012. We believe it is likely that more patients will be willing to undergo a shorter, less invasive surgical procedure that may result in quicker recoveries and hospital discharge. We have taken advantage of the versatility of the MVAD design with multiple configurations specific to less invasive implantation procedures. This development has been supported by over 100 in-vivo studies. These devices may expand the potential pool of chronic heart failure patients."
There are actually 3 MVAD Versions being considered.
The MVAD utilizes an axial flow design rather than the HVAD's rotary impeller, but it retains the hydrodynamic thrust bearings and other attributes of the wide-blade impeller.
Heartware has conducted multiple preclinical studies of its 3 MVAD designs and has settled on which design will proceed into development for first-in-man implants:
3 MVAD designs all proving effective in preclinical studies…
• "Trans-Apical" MVAD - left thoracotomy or sternotomy, 1/3 size of HVAD
• "VCAN" aka "Trans-Mitral" MVAD - right thoracotomy, 1 incision for implant & anastomosis
• "LONGHORN" - subcostal incision, NO anastomosis, up to 8L/min, "30Mins Skin to Skin", avg. M.D. reaction: WOW
1-9-2012: HTWR & Dualis MedTech partner on TETS: to dev. Fully Implantable VAD System, with "with wireless, transcutaneous energy transfer system (TETS) technology exclusively for HeartWare". http://tinyurl.com/72maba6
...Doug Godshall 1-9-12/JPM: "We're delighted & most fortunate to have found such an incredible technical powerhouse to collaborate with, and we envision a long & fruitful partnership with the team in Seefeld, Germany."
Heartware's website: http://www.heartware.com
• About Us: http://tinyurl.com/cazwsw
• Products & Technology: http://tinyurl.com/b3mauo
• Clinical Trials: http://tinyurl.com/aqo2hl
• About Heart Failure: http://tinyurl.com/awzfh8
• Media Center: http://tinyurl.com/cmn9cm
• Investor Center: http://tinyurl.com/aru9db
• Press Releases: http://tinyurl.com/c35sb7
• Videos & Webcasts: http://tinyurl.com/cspt6x
• Corp. Presentations: http://tinyurl.com/bg86sv
• Qtly HTWR Shareholder Updates from CEO Doug Godshall: http://tinyurl.com/c9vxqm
. . . 1-11-10: http://tinyurl.com/yewj4p7 . . .7-31-09: http://tinyurl.com/n8sdlo
• Signup for email alerts: http://tinyurl.com/dm4py3
7-2004 article on Heartware's genesis: http://tinyurl.com/8jc78z
2008 Redomiciliation AUS->USA: http://tinyurl.com/7xk6on & http://tinyurl.com/9owp3j
4-18-08 2007 Annual Report & 94-pg Glossy PDF Slideshow: http://tinyurl.com/bbo45d
7-30-09 Annual SHM - 27-pg Glossy PDF Slideshow: http://tinyurl.com/lx9zbq
2-24-11 2010 Annual Fin. Report (Form 10-K): http://tinyurl.com/4twjq5y
2-27-12 2011 Annual Fin. Report (Form 10-K): http://tinyurl.com/7nao9oy
Excellent site lists All Heartware-related Scientific Papers: http://pubget.com/search?q=heartware
U.S. INVESTOR RELATIONS: Allen & Caron, Inc. (New York) http://www.allencaron.com
…Matt Clawson: 949-474-4300, matt@allencaron.com
• Allen & Caron's main Heartware: http://tinyurl.com/nosca9
• HTWR Corp. Backgrounder: http://tinyurl.com/mh4qne
• HTWR News Releases: http://tinyurl.com/3eaw4k7
• HTWR Media Coverage: http://tinyurl.com/lxofqk
• HTWR SEC Filings: http://tinyurl.com/9g6qg7
Yahoo Quote: http://finance.yahoo.com/q?s=HTWR . . .Yahoo Profile: http://finance.yahoo.com/q/pr?s=HTWR
StreetInsider.com - All Analysts Ratings: http://tinyurl.com/yk2h9nh
AUX Exch. Quote of CDI's in AUS$ (1:35 of Nasdaq HTWR): http://finance.yahoo.com/q?s=HIN.AX
AUD => USD exch. rate: http://tinyurl.com/cgt22f
ALL SEC filings for HTWR: http://tinyurl.com/bqas3u . . . #Shares O/S as of 2-15-2012: 14,114,055
Insider-Trans: http://tinyurl.com/bcgv42
Inst. Holdings (Nasdaq.com, upd. 45-days after q/e): http://tinyurl.com/bk7b7k
Short Interest - rolling 12-mos., updated semi-monthly: http://tinyurl.com/bunre3
IRASIA History of HTWR PR's (2005-curr.): http://tinyurl.com/dd2kza
HVAD INTL. (EUR+AUS) BTT TRIAL DATA (N=50, IMPLANTS 3/2006-12/2008): http://tinyurl.com/ycadwtb
. . . 90% overall survival at 6 mos., 84% 2-year survival, shortest CBP time: 21 mins.
In Jan.2009, HeartWare received CE Marking for the HVAD in the Eur.Union, and in 2011 the TGA granted approval for the device in Australia.
5-23-12 HTWR receives CE-Mark Addendum for "Destination Therapy" indication in EUROPE: http://tinyurl.com/73ch762
HVAD U.S. BRIDGE-TO-TRANSPLANT TRIAL "ADVANCE" (140 PATIENTS at 30 CENTERS):
OVERALL P.I.: Dr. Mark Slaughter, MD, Director of the Div. of Thoracic & Cardiovascular Surgery at Jewish Hospital and the Univ. of Louisville, which is one of the leading transplant centers in the U.S. He is a world-renowned expert in heart transplantation, ventricular assist devices and the surgical mgt. of heart failure. As one of the leaders in the field of ventricular assist devices, he has given 65+ invited lectures, published 50+ peer-reviewed papers and book chapters and presented 85+ papers & abstracts at national & intl. conferences.
Dr. Slaughter: "My peers and I are constantly seeking better solutions for our heart failure patients and we have been looking forward to HeartWare's HVAD for some time, We feel that the HVAD's unique technology presents a meaningful step forward in the treatment of this challenging disease."
CO-P.I.: Dr. Keith Aaronson, MD, Medical Director of the Heart Transplant Program and Co-Director of the Heart Failure and Transplant Mgt. Program at the Univ. of Michigan Medical Center. A renowned heart failure cardiologist, Dr. Aaronson is a member of the editorial board of the American College of Cardiology Cardiosource Review Journal and a reviewer for the leading American and European journals of medicine and cardiology and for the annual sessions of the American College of Cardiology, the American Heart Association, the Intl. Society for Heart & Lung Transplantation and the Heart Failure Society of America. Dr. Aaronson has authored over 50 peer reviewed pubs. & 9 book chapters. He has held leadership positions in a number of clinical trials, has authored over 100 abstracts and has presented widely at national and intl. conferences.
Dr. Aaronson: "I'm excited to be part of this effort to expand the treatment options for patients with advanced heart failure. The HVAD's small size and intrapericardial implant location have the potential to substantially improve patient comfort, while the centrifugal flow characteristics and simple device design may provide performance and durability advantages."
• 1ST U.S. HVAD IMPLANT 8-21-08: The P.I. at Washington Hosp. Center is Dr. Leslie Miller, one of the world's most renowned cardiologists and a recognized leader in the use of mechanical circulatory support systems. The surgery was performed by Dr. Steven Boyce, MD, Surgical Director, Heart Failure Program at WHC and one of the most progressive & highest volume cardiac surgeons in the USA…
Drs. Miller & Boyce: "We at Washington Hospital Center are pleased to have been the first to implant this exciting new device. The surgery was quick and without incident and the patient is recovering well. The novel configuration of the HeartWare device together with its small size allow the pump to be implanted in the pericardial space, potentially reducing the risks associated with more extensive surgery. The pump has one moving part, an impeller that utilizes a passive suspension system designed to minimize mechanical wear & friction while pumping. We look forward to WHC's continued use of the device through the course of this trial."
• 10th U.S. HVAD IMPLANT 2-10-09: The implants were performed by Dr. Edwin C McGee, Surgical director (Advanced Heart Failure Program), Northwestern Mem. Hosp., Chicago. Dr. McGee is a renowned cardiothoracic surgeon with special interest in heart failure, transplantation, mechanical assistance, coronary surgery, valve repair and aortic surgery.
Dr. McGee: "After our first implants of the HeartWare System, it's clear to us why this device is generating such enthusiasm among the clinical community. The small size of the pump allows for a relatively quick and straightforward implantation. The elimination of the abdominal pump pocket typically required to implant larger devices should translate into important clinical benefits."
2-25-10: Final (140th) patient implanted in BTT trial - CEO D.Godshall 5-3-10, "Our current priorities include the ongoing followup of patients in our U.S. BTT study... we expect the followup for the BTT study to conclude in August, and we remain on track to file a PMA with the FDA by year end."
4-7-10: FDA Approves "Continued Access Protocol" (CAP) for BTT Trial: addl. 54 patients @ 30 centers. http://tinyurl.com/32mu3db
9-3-10: FDA Approves 2nd CAP for BTT Trial: addl. 54 patients. http://tinyurl.com/356j7cq
11-14-10: U.S. "Advance" BTT Trial Data presented at AHA'10: 92% Success, 94% Survival at 6mos. http://tinyurl.com/35asu7q
1-24-11: FDA Approves 3rd CAP for BTT Trial: addl. 94 patients. http://tinyurl.com/3l4wknb
4-15-11: BTT/Advance(n=140) & CAP(n=110) data update at ISHLT'11: maintaining 94% Survival at 6mos. http://tinyurl.com/68s9una
. . .4-15-11 Webcast & Dr. Mark Slaughter's ISHLT SLIDES: http://tinyurl.com/68t7up9
10-2-11/EACTS/Lisbon: Dr. Mark Slaughter updates HVAD BTT/CAP data (n=241) http://tinyurl.com/43wk92h & http://tinyurl.com/3gelu2y
…"6mos-survival=93%; overall adverse event rates remain low; pump-exch. for thrombus now <.03/patient-year after Mar'11 adjustment in anticoagulation (325/Aspirin)."
2-14-12: Heartware announces HVAD U.S. FDA BTT PMA Approval PANEL will convene Apr. 25, 2012 http://tinyurl.com/766c4l4
3-16-12: FDA Approves 4th CAP for BTT Trial: addl. 54 patients. http://tinyurl.com/7bfw629
4-25-12: FDA Advisory Panel Approves HVAD by 9-2 Vote - see http://tinyurl.com/7oteooc & http://tinyurl.com/747h2p8
…Panel member Dr. Ralph Brindis (Oakland Kaiser MC): "I think this device is of incredible benefit to patients who are very ill."
5-23-12: Final "Advance" HVAD BTT Data Pub. in AHA Journal, "CIRCULATION" http://tinyurl.com/7a6o7t3
…D.Godshall: "As we showed at our FDA panel meeting last month, some of the more challenging adverse events we observed in this initial study cohort have improved measurably in our CAP cohort by refining post-operative management techniques and by introducing sintered inflow cannulas which appear to be contributing to decreased thromboembolic complications. We never stop seeking ways to improve outcomes for our patients and believe that continued analysis, as well as our ongoing commitment to enhancing the performance of our system, will lead to a further reduction in certain adverse events."
11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!! http://tinyurl.com/axrcau4 & http://tinyurl.com/al3j3en & http://tinyurl.com/b6e3w5m
12-12-12: WISN/Milw's TV Report & must-see VIDEO on James Kropidlowski's new HVAD http://tinyurl.com/bemzlcr
…"the 1st patient in the country to receive the new, smaller HVAD device, made by the company HeartWare, since it was approved by the FDA."
HVAD U.S. DESTINATION THERAPY (DT) TRIAL "ENDURANCE" (450 PATIENTS, 50 CENTERS):
6-14-10 FDA IDE Approval: The U.S. DT trial is a randomized, controlled, unblinded, multi-center clinical trial to evaluate the use of the HeartWare HVAD as a DT in advanced heart failure patients. Patients will randomly receive either the HVAD, or, as part of a control group they will be implanted with any alternative LVAD approved by the FDA for destination therapy, in a 2:1 ratio. The primary endpoint of the trial is stroke-free survival at 2 years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
PI's:
• Joseph G. Rogers, MD, Medical Director, Cardiac Transplant & MCS Pgm., Duke Univ. (Dr. Rogers replaced Dr. Mariell Jessup, who became Pres-Elect. of AHA in 6-2012)
• Francis Pagani, MD, PhD, Surgical Director of the Adult Heart Transplant Program and Dir.of the Center of Circulatory Support, Univ. of Michigan MC
CEO Doug Godahall, "We are fortunate to welcome to the ENDURANCE study two of the most respected, progressive and widely published heart failure physicians in the U.S., Dr. Jessup & Dr. Pagani."
…More about U.S. DT trial at HTWR's Website: http://tinyurl.com/33qvwj2
...2-24-11/Barclays/D.Godshall, "Projecting 300 DT implants by 12-31-11, and all 450 by 6-30-12." http://tinyurl.com/43yfv6u
...5-8-12: Enrollment complete in 450-pt. U.S. DT Trial: http://tinyurl.com/7yub53d
...6-17-13: FDA grants 240 addl. HVAD implants under a CAP in the Endurance DT trial: http://tinyurl.com/luowr64
1-2011: 'REVIVE-IT' HVAD Trial To Examine Earlier Heart Device Use http://tinyurl.com/3fstudb
...Protocol: http://clinicaltrials.gov/ct2/show/NCT01369407
…NIH/NHLBI & Heartware award $13.9mm to U-Mich & U-Pitt to coordinate 100-pt. study at ~10 sites - see VIDEO: http://tinyurl.com/3laudmu
...10-15-12: HTWR to W/D from REVIVE-IT HVAD Study, as predicted in recent talks by Doug Godshall… http://tinyurl.com/9gr3e5b
HVAD biVAD - ex-OUS Approval & U.S. Clinical Pathway (2012 Goals) - see http://tinyurl.com/79hcdgx
HEARTWARE'S COMPETITORS:
Thoratec's Heartmate II - http://www.thoratec.com . . . http://finance.yahoo.com/q?s=thor
XXXVentractor's VentrAssist - http://www.ventracor.com (VCR.AX) http://www.saveventracor.com => Company Liquidated 7-2009.
XXXWorld Heart's Levacor - http://www.worldheart.com . . . http://finance.yahoo.com/q?s=WHRT => Levecor term. 7-29-2011.
...3-20-12: HeartWare buys World Heart's Patent Portfolio for $8mm http://tinyurl.com/7bynf5c
Sunshine Heart's C-Pulse - http://www.sunshineheart.com . . . http://www.asx.com.au/asx/research/companyInfo.do?by=asxCode&asxCode=SHC
Jarvik Heart's Jarvik 2000 - http://www.jarvikheart.com . . .private company.
Abiomed's AB5000 Ventricle - http://www.abiomed.com . . . http://finance.yahoo.com/q?s=ABMD
Terumo Heart's DuraHeart II LVAS - http://www.terumoheart.com (acq. by Thoratec 6-2013)
MicroMed's HeartAssist5 ( 92grams, CEmark since 4-2001) - http://www.micromedcv.com/us . . .private company
SynCardia's 'Temporary Total Artificial Heart' - http://www.syncardia.com . . .private company
Other Companies with heart pumps at varying stages of clinical trials: Duraheart, Incor.
8-2011 Animation Videos of HVAD Operation: http://youtu.be/19DSt4q6T68 & http://youtu.be/w8xCYS0KEH0
. . .compare to similar video of Thoratec Heartmate II: http://youtu.be/ev_01gQVWAM
. . . ."HMII, weighing only 400 grams…" (Heartware's HVAD weighs 140 grams)
DISCLAIMER: This message board is not affiliated with or endorsed by Heartware Intl. Inc.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |