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, firstname.lastname@example.org
• 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
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.
• 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
…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
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)
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