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HeartWare International, Inc. (HTWR)

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Last Post: 6/27/2016 8:29:10 AM - Followers: 4 - Board type: Free - Posts Today: 0

Heartware International, Inc. (HTWR), Framingham, Mass.
Yahoo Quote & Profile for 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:
THOR 2-12-09 PR: . . . HTWR 2-16-09 PR:
Reuters 2-13-09: . . . Thoratec's website:
==> 7-29-09 FTC REJECTS  THOR-HTWR Merger!!  = = >
==> 8-1-09 Form 8-K: THOR-HTWR JOINT TERM. of Proposed Merger ==  
==> 8-11-09: Private Placement to Raise $55mm (2.5mm sh. @ $22) ==>  
===> 12-24-09: HeartWare Files S-3 for $100mm Mixed Shelf ==>
====> 2-3-10: Heartware Nets ~$59mm via Public Offering @ $35.50/sh. ==>
=====> *THOR offered $282mm;  a/o 6-28-12, HTWR's MktCap was $1.22billion ($86.49 x 14.14mm shares)

"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: (2:46) 
4-15-11 VIDEO: "Heartware - Leading a Small Revolution" (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.

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:

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".
...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: 
• About Us:
• Products & Technology:
• Clinical Trials:
• About Heart Failure:
• Media Center:
• Investor Center:
• Press Releases: 
• Videos & Webcasts:
• Corp. Presentations:
Qtly HTWR Shareholder Updates from CEO Doug Godshall: 
. . . 1-11-10:  . . .7-31-09:  
• Signup for email alerts:
7-2004 article on Heartware's genesis:
2008 Redomiciliation AUS->USA: &
4-18-08 2007 Annual Report & 94-pg Glossy PDF Slideshow:  
7-30-09 Annual SHM - 27-pg Glossy PDF Slideshow:
2-24-11 2010 Annual Fin. Report (Form 10-K):
2-27-12 2011 Annual Fin. Report (Form 10-K):  
Excellent site lists All Heartware-related Scientific Papers:    

U.S. INVESTOR RELATIONS: Allen & Caron, Inc. (New York)
Matt Clawson: 949-474-4300,
• Allen & Caron's main Heartware:
• HTWR Corp. Backgrounder:    
• HTWR News Releases:      
• HTWR Media Coverage:   
• HTWR SEC Filings:

Yahoo Quote: . . .Yahoo Profile: - All Analysts Ratings:  

AUX Exch. Quote of CDI's in AUS$ (1:35 of Nasdaq HTWR):
AUD => USD exch. rate:
ALL SEC filings for HTWR: . . . #Shares O/S as of 2-15-2012: 14,114,055
Inst. Holdings (, upd. 45-days after q/e):
Short Interest - rolling 12-mos., updated semi-monthly:
IRASIA History of HTWR PR's (2005-curr.):

. . . 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:

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.
9-3-10: FDA Approves 2nd CAP for BTT Trial: addl. 54 patients.

11-14-10: U.S. "Advance" BTT Trial Data presented at AHA'10: 92% Success, 94% Survival at 6mos.
1-24-11: FDA Approves 3rd CAP for BTT Trial: addl. 94 patients.
4-15-11: BTT/Advance(n=140) & CAP(n=110) data update at ISHLT'11: maintaining 94% Survival at 6mos.
. . .4-15-11 Webcast & Dr. Mark Slaughter's ISHLT SLIDES:  
10-2-11/EACTS/Lisbon: Dr. Mark Slaughter updates HVAD BTT/CAP data (n=241) &
…"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
3-16-12: FDA Approves 4th CAP for BTT Trial: addl. 54 patients.
4-25-12: FDA Advisory Panel Approves HVAD by 9-2 Vote - see &
…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"  
…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.!!!!!!! & &
12-12-12: WISN/Milw's TV Report & must-see VIDEO on James Kropidlowski's new HVAD 
…"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."

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.
• 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: 
...2-24-11/Barclays/D.Godshall, "Projecting 300 DT implants by 12-31-11, and all 450 by 6-30-12."
...5-8-12: Enrollment complete in 450-pt. U.S. DT Trial:
...6-17-13: FDA grants 240 addl. HVAD implants under a CAP in the Endurance DT trial: 
1-2011: 'REVIVE-IT' HVAD Trial To Examine Earlier Heart Device Use
…NIH/NHLBI & Heartware award $13.9mm to U-Mich & U-Pitt to coordinate 100-pt. study at ~10 sites - see VIDEO:
...10-15-12: HTWR to W/D from REVIVE-IT HVAD Study, as predicted in recent talks by Doug Godshall…  

HVAD biVAD - ex-OUS Approval & U.S. Clinical Pathway (2012 Goals) - see   

Thoratec's Heartmate II - . . .
XXXVentractor's VentrAssist -  (VCR.AX)  => Company Liquidated 7-2009.
XXXWorld Heart's Levacor - . . . => Levecor term. 7-29-2011.
...3-20-12: HeartWare buys World Heart's Patent Portfolio for $8mm  
Sunshine Heart's C-Pulse - . . .
Jarvik Heart's Jarvik 2000 - . . .private company.
Abiomed's AB5000 Ventricle -   . . .
Terumo Heart's DuraHeart II LVAS - (acq. by Thoratec 6-2013)
MicroMed's HeartAssist5 ( 92grams, CEmark since 4-2001) - . . .private company
SynCardia's 'Temporary Total Artificial Heart' - . . .private company
Other Companies with heart pumps at varying stages of clinical trials: Duraheart, Incor.

8-2011 Animation Videos of HVAD Operation:
. . .compare to similar video of Thoratec Heartmate II:
. . . ."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.

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#760   6-27-16: Medtronic to Acquire of HeartWare Intl. For $58/sh. cjgaddy 06/27/16 08:29:09 AM
#759   1-13-16: Heartware sees 35% stock-plunge on bad news@JPMorgan, cjgaddy 01/13/16 10:30:11 AM
#758   10-12-15: Heartware Updates on MVAD Trial; May Not cjgaddy 10/14/15 06:07:21 PM
#757   Out at 66/67 looks like blood ain't over Mean Weimaraner 09/03/15 11:30:15 AM
#756   10% 24 hours doesn't get much better than that.. Mean Weimaraner 09/03/15 10:38:39 AM
#755   lookin good today CJ Mean Weimaraner 09/03/15 10:31:27 AM
#754   CEO D.Godshall presenting 9-9-15/8:50ET at Wells-Fargo cjgaddy 09/03/15 10:15:15 AM
#753   Going back up. No selling Mean Weimaraner 09/03/15 10:08:50 AM
#752   That it is. Still picked some up at Mean Weimaraner 09/02/15 04:02:19 PM
#751   This thing is getting crushed gixxer11 09/02/15 03:09:08 PM
#750   7-30-15: HeartWare Reports $73.6mm in Q2’15 Revs, Driven cjgaddy 07/30/15 10:03:18 AM
#749   HTWR's Q2'15 Financials 7-30-15, CC @8amET cjgaddy 07/21/15 09:57:55 AM
#748   HTWR Webcast 6-11-15 8amPT at Goldman-Sachs Conf. cjgaddy 06/04/15 10:26:28 AM
#747   4-30-15: HTWR Q1/Fins q/e3-31-15 Revs=$70mm cjgaddy 04/30/15 09:06:18 AM
#746   HTWR Q1’2015 Fins & CC 4-30-15 8amET cjgaddy 04/22/15 01:50:53 PM
#745   2-26-15/HTWR Q4’14 Fins: Revs=$73.2mm +38% cjgaddy 02/26/15 03:45:05 PM
#744   HTWR Q4’14 Fins & Conf-Call: 2-26-15 8amET cjgaddy 02/13/15 11:13:23 AM
#743   CEO D.Godshall to present 2-12-15 10:20amET at Leerink Conf. cjgaddy 02/05/15 09:35:27 AM
#742   1-13-15 PR/Prelim-Revs: Q4’14=~$73mm; full’14=~$278mm cjgaddy 01/13/15 11:16:00 AM
#741   1-13-15: 1st Pt. Implanted in HVAD MEDIAN STERNOTOMY Trial cjgaddy 01/13/15 09:07:48 AM
#740   D.Godshall presenting at JP.Morgan 1-13-15 11amET Webcast cjgaddy 01/02/15 11:13:41 AM
#739   CEO D.Godshall presenting 11-20-14 at CANACORD, 10amET Webcast cjgaddy 11/13/14 02:00:38 PM
#738   HTWR’s CEO D.Godshall at Credit-Suisse 11-12-14/2pmET WEBCAST cjgaddy 11/07/14 09:38:25 AM
#737   HTWR reports Q3; revs=$68.3mm, +25% v. Q3’13; 675 cjgaddy 10/30/14 09:22:44 AM
#736   10-14-14: Piper-Jaffray upgrades HTWR Neut=>OverWgt PT=$91 cjgaddy 10/14/14 02:23:36 PM
#735   CEO D.Godshall at Canaccord Conf. 8-14-14 9amET WEBCAST cjgaddy 08/05/14 04:34:01 PM
#734   8-4-14: HeartWare’s hires new CMO: Dr. Katrin Leadley, MD cjgaddy 08/04/14 10:07:06 AM
#733   7-31-14: StrongQ2 Can't Buoy HTWR/PPS given Recall News cjgaddy 07/31/14 03:20:19 PM
#732   7-31-14: HeartWare Reports $70.1mm Q2’14 Revenue; +38% vs. Q2’13 cjgaddy 07/31/14 09:16:26 AM
#731   HTWR Qtly’s & CC Thur. 7-31-14 8am cjgaddy 07/17/14 09:19:18 AM
#730   New 7-13-14 VIDEO: “Heartware: Saving Kids Waiting for Transplants” cjgaddy 07/13/14 11:10:02 AM
#729   What is the name of the conference in thehornet 06/26/14 09:47:58 AM
#728   CEO D.Godshall presenting 6-17-14 WELLS-FARGO HC –Conf (4:40pmET cjgaddy 06/12/14 10:13:26 AM
#727   6-4-14 Leerink: “FDA warning letter to HeartWare is cjgaddy 06/06/14 10:09:58 AM
#726   CEO D.Godshall webcast: Goldman-Sachs 6-12-14 10amPT cjgaddy 06/06/14 09:59:40 AM
#725   CEO D.Godshall to present 6-10-14/5:10pmET at William Blair cjgaddy 06/03/14 04:58:44 PM
#724   HVAD Overview Youtube video added 5-9-14 by MyLVADvideos… cjgaddy 06/01/14 01:06:10 PM
#723   4-27-14: “HeartWare: Saving Kids Waiting For Transplants” (KFSN-TV) cjgaddy 05/13/14 08:14:05 AM
#722   5-5-14: Baron Funds Comments on HeartWare Intl. cjgaddy 05/13/14 08:06:43 AM
#721   Recall HWTR bought Circulite in Dec.2013… (SYNERGY Circulatory cjgaddy 05/02/14 04:29:04 PM
#720   Link to 5-1-14 Conf. Call (Nasdaq & Seeking Alpha) cjgaddy 05/02/14 04:23:04 PM
#719   5-1-14: HTWR’s Q1 Financials – revs=$66.5MM, 665 HVAD’s cjgaddy 05/02/14 04:17:06 PM
#718   HeartWare's Recall Receives FDA's highest-risk Class I label. gobigthenGoBigger 05/01/14 11:04:39 AM
#717   The FDA puts its highest-risk Class I label gobigthenGoBigger 05/01/14 10:46:12 AM
#715   HeartWare’s Q1’14 Financials 5-1-14, CC/8am cjgaddy 04/25/14 09:37:43 AM
#714   HTWR Q4 Results & CC Feb.27 8amET cjgaddy 02/04/14 06:17:46 PM
#713   CEO D.Godshall to present 2-13-14 at Leerink Conf. cjgaddy 02/04/14 03:29:08 PM
#712   01-31-2014 A Heartier Ventricular-Assist Market aproimos 02/01/14 03:19:09 AM
#711   CEO D.Godshall to present 1-14-14 at JP-Morgan HC cjgaddy 12/20/13 04:50:41 PM
#710   CEO D.Godshall at Oppenheimer 12-11-13/7:45amET (webcast) cjgaddy 12/06/13 03:51:48 PM