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Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse(R) Heart Assist System
EDEN PRAIRIE, MN and SYDNEY, AUSTRALIA--(Marketwire - Oct 1, 2012) - Sunshine Heart, Inc. ( NASDAQ : SSH ) ( ASX : SHC ), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that it has received conditional approval from the FDA for an Investigational Device Exemption (IDE) for its flagship C-Pulse® Heart Assist System.
"We are thrilled to receive conditional approval from the FDA to move forward into a pivotal trial for C-Pulse," said Dave Rosa, CEO of Sunshine Heart. "Today's announcement represents another significant milestone for the Company, as well as for the C-Pulse System. I am especially pleased that we were able to receive this approval on our initial submission. The Company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year. These timely approvals continue to support the Company's market guidance and timelines."
With the receipt of conditional approval of the IDE, Sunshine Heart plans to initiate a pivotal trial in North America in the fourth quarter of 2012. The trial design will consist of 388-patients of which half will be implanted with the C-Pulse System. The other half will be randomized to optimal medical therapy across 30-40 clinical sites. Sunshine Heart expects to receive revenues from trial sites for device implants as the FDA has granted CMS Category B3 status. Because of this designation, it is also anticipated that participating trial centers will be reimbursed by CMS and most private insurance providers. The trial will utilize the Company's next-generation C-Pulse driver, which received approval for clinical trial use from the FDA in August, 2012, and has been in use in Canadian patients currently on the device. The new driver features a single unit, which is lighter, quieter, approximately half the size of its predecessor, and also includes numerous software updates.
The Company estimates enrollment for the event-driven trial will take approximately 2.5 years. The primary endpoint of the trial will be reduction in worsening heart failure events leading to hospitalization, advanced heart failure therapies and heart failure related mortality. A one year safety follow-up is expected. The lead investigator for the trial will be Dr. William T. Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.
"Having led the C-Pulse feasibility study last year and witnessed the potential impact the device had in patients suffering from heart failure, I am excited to return to play an integral role in C-Pulse's final stages of development," said Dr. Abraham. "With a large and growing population of C-Pulse eligible patients and hospitals facing financial penalties for high heart failure re-hospitalization rates beginning in 2013 under the Obama Health Reform Act, the C-Pulse pivotal trial will determine if it will be beneficial to both patients and hospitals alike to improve health outcomes."
In July, Sunshine Heart announced positive 12-month extended follow up data from its preliminary feasibility study. Extended data included further positive efficacy trends with continued improvements in NYHA Class reduction, MLWHF Quality of Life score, and six minute hall walk. There were no additional patients with device-related serious adverse events (SAEs) in this 12 month time frame. Dr. Abraham will be presenting 12 month results at the October 2012 TCT meeting in Miami, Florida. Also in July, the Company achieved CE Mark certification, allowing commercialization of the device in Europe. The Company has been targeting leading LVAD and transplant centers in the EU. Specific initial focus for the device has been within Germany and Italy, two countries that when combined, are believed to have the highest number of hospital bed days per year for heart failure in Europe.
chart for the stock with $1.5K in trading volume? lol
$ITNS 700,000,000 shares are freely available. good luck with it. lol
http://nvsos.gov/sosentitysearch/corpActions.aspx?lx8nvq=Hky1vdd%252bLTTX4XvvZBQ%252bag%253d%253d&CorpName=ITONIS+INC.
Action Type: Amendment
Document Number: 00003628764-66 # of Pages: 1
File Date: 8/10/2012
Previous Stock Value: Par Value Shares: 305,000,000 Value: $ 0.001 No Par Value Shares: 0 Total Authorized Capital: $ 305,000.00
New Stock Value: Par Value Shares: 1,000,000,000 Value: $ 0.001 No Par Value Shares: 0 Total Authorized Capital: $ 1,000,000.00
what's bullish about it? just curious...
$ALQA > broke 1month resistance; chart sets for up-trend...
sanp: sma got 150K only... will last a few days...
$ALQA > going up...
$SANP > SMA pick?
$ALQA > interesting move...
watching $LNET... volume is over the roof even with Mark Cuban's sells of 300K shares lately...
deal with a new lender is in progress... stock is going to fly on an announcement...
what's your point? they have not been compensated...
looks like they listen to me... lol
wrap > $10K in volume versus billion of posts. lmfao
Board Subject Author Date/Time
$STOCK UNDERGROUND$ WRAP Volume Nearing 400K On News!!! pennybuster 09/25/2012 09:54:07 AM
$TOCKTAMER $WRAP Breaking News!! - Goldman Small Cap Research jedijazz 09/25/2012 09:54:04 AM
$THE WAVE WRAP busting a wave off this bottom formation WhisperingEye 09/25/2012 09:53:56 AM
LOOKING FOR THE NEXT BIG RUNNER WRAP[/b The Dashboard (web-based Control Panel) comes geraldr 09/25/2012 09:53:51 AM
Wrapmail, Inc. here she goes $WRAP is hot .. pivotpoint1 09/25/2012 09:53:36 AM
MOMO'S BREAKOUT BOARD $WRAP - WrapMail, which boasts over 6,200 clients, ZipCash 09/25/2012 09:53:15 AM
MOMO'S BREAKOUT BOARD WRAP COMPANY INFORMATION cherrob 09/25/2012 09:53:09 AM
New Penny Order - N.P.O. WRAP seems to be holding here after the dip WhisperingEye 09/25/2012 09:52:59 AM
MOMO'S BREAKOUT BOARD $WRAP DD Rule # 2 , Once mrchipper 09/25/2012 09:52:44 AM
PSIONICMATRIX WRAP COMPANY INFORMATION cherrob 09/25/2012 09:52:37 AM
LOGI-COOL STOCK PLAYS WRAP Wrapmail, Inc. is publicly traded on the pivotpoint1 09/25/2012 09:52:35 AM
MOMO'S BREAKOUT BOARD WRAP ~ WRAPmail, Inc. pennybuster 09/25/2012 09:52:27 AM
BB's Stock Haven WRAP ~ Company Profile Video: budfoxhub 09/25/2012 09:52:13 AM
"JET LIFE" PENNY STOCK$ WRAP Wrapmail, Inc. is publicly traded on pivotpoint1 09/25/2012 09:52:03 AM
BB's Stock Haven WRAP ~ WRAPmail, Inc. pennybuster 09/25/2012 09:51:47 AM
10-Baggas Factory 10 WRAP ~ Goldman Small Cap Research, a stock ZipCash 09/25/2012 09:51:45 AM
Momentum Players LOVE THIS -> $WRAP WRAPmail CEO purchases 700,000 tommyboyboy 09/25/2012 09:51:34 AM
Penny Stock Millionaire WRAP holding nice WhisperingEye 09/25/2012 09:51:34 AM
$STOCK UNDERGROUND$ LOVE THIS -> $WRAP WRAPmail CEO purchases 700,000 tommyboyboy 09/25/2012 09:51:28 AM
BB's Stock Haven WRAP KEY STATISTICS cherrob 09/25/2012 09:51:19 AM
CASH COW WRAP Solutions geraldr 09/25/2012 09:51:08 AM
MOMO'S BREAKOUT BOARD To view a summary of the $WRAP report tommyboyboy 09/25/2012 09:51:00 AM
Pro Traders Forum WRAP getting a lot of attention today may WhisperingEye 09/25/2012 09:50:44 AM
"JET LIFE" PENNY STOCK$ To view a summary of the $WRAP report tommyboyboy 09/25/2012 09:50:44 AM
BB's Stock Haven WRAP NEWS- Goldman Small Cap Research Issues Research ZipCash 09/25/2012 09:50:38 AM
Beat The Street WRAP WRAPmail, which boasts over 6,200 clients, cherrob 09/25/2012 09:50:15 AM
10-Baggas Factory 10 http://ih.advfn.com/p.php?pid=nmona&article=54293575 WRAP News! budfoxhub 09/25/2012 09:50:14 AM
"JET LIFE" PENNY STOCK$ $WRAP News Out! Goldman Small Cap Research Issues ManicTrader 09/25/2012 09:50:08 AM
BB's Stock Haven WRAP Bollinger Bands are ready to pop. VIDAO 09/25/2012 09:50:03 AM
$TOCKTAMER WRAP Bollinger Bands are ready to pop. VIDAO 09/25/2012 09:49:51 AM
MOMO'S BREAKOUT BOARD WRAP - Solutions pennybuster 09/25/2012 09:49:33 AM
BB's Stock Haven $WRAP News Out! Goldman Small Cap Research Issues ManicTrader 09/25/2012 09:49:26 AM
BB's Stock Haven $WRAP ~ 209K Buys ~ 90K Sells zigzagman 09/25/2012 09:49:05 AM
MOMO'S BREAKOUT BOARD WRAP over 350k in volume! budfoxhub 09/25/2012 09:49:02 AM
BB's Stock Haven WRAP - Solutions pennybuster 09/25/2012 09:48:59 AM
THE ASK SMACKERS CLUB....BID SITTERS NEED NOT APPLY Going to watch WRAP seems to be forming WhisperingEye 09/25/2012 09:48:55 AM
"JET LIFE" PENNY STOCK$ WRAP over 350k in volume! budfoxhub 09/25/2012 09:48:39 AM
BB's Stock Haven WRAP holding solid green this am ZipCash 09/25/2012 09:48:39 AM
STOCKGOODIES PLAYS OF THE WEEK $WRAP ~ 209K Buys ~ 90K Sells zigzagman 09/25/2012 09:48:38 AM
Chart It, Trade It, Bank It! WRAP http://www.goldmanresearch.com/Popular/wrap-your-email-around-this.html cherrob 09/25/2012 09:48:29 AM
PSIONICMATRIX WRAP - "The innovative WRAP approach allows unique Hooka 09/25/2012 09:48:27 AM
MOMO'S BREAKOUT BOARD $WRAP holding +14% nicely Teaks1185 09/25/2012 09:48:24 AM
Wrapmail, Inc. not bad ramsy $WRAP looks like accumulation.. pivotpoint1 09/25/2012 09:48:24 AM
BB's Stock Haven $WRAP holding +14% nicely Teaks1185 09/25/2012 09:48:18 AM
THE ASK SMACKERS CLUB....BID SITTERS NEED NOT APPLY WRAP looking good from the get go WhisperingEye! jedijazz 09/25/2012 09:48:07 AM
PSIONICMATRIX Big moves happeing on WRAP today WhisperingEye 09/25/2012 09:48:07 AM
Sizzling Stock Picks WRAP - "The innovative WRAP approach allows unique Hooka 09/25/2012 09:47:56 AM
$treet Trader Lion''s Den WRAP http://www.goldmanresearch.com/Popular/wrap-your-email-around-this.html cherrob 09/25/2012 09:47:56 AM
MOMO'S BREAKOUT BOARD $WRAP issues news today on huge research mrchipper 09/25/2012 09:47:32 AM
$ZIP CASH TRAIN WRAP Volume Alert !! ZipCash 09/25/2012 09:47:13 AM
Sizzling Stock Picks WRAP - "The innovative WRAP approach allows unique Hooka 09/25/2012 09:47:56 AM
$treet Trader Lion''s Den WRAP http://www.goldmanresearch.com/Popular/wrap-your-email-around-this.html cherrob 09/25/2012 09:47:56 AM
MOMO'S BREAKOUT BOARD $WRAP issues news today on huge research mrchipper 09/25/2012 09:47:32 AM
$ZIP CASH TRAIN WRAP Volume Alert !! ZipCash 09/25/2012 09:47:13 AM
Wrapmail, Inc. WRAP getting ready for some .03 s IMO! Ramsey AC/DC 09/25/2012 09:47:10 AM
BB's Stock Haven WRAP killing it +14.78% Hooka 09/25/2012 09:47:05 AM
RUMORED NEWS, NEWS and STOCKS GOINGUP WRAP back to 14% this thing is amazing WhisperingEye 09/25/2012 09:46:59 AM
"JET LIFE" PENNY STOCK$ $WRAP American Greetings Announces Content Licensing Agreement with pennybuster 09/25/2012 09:46:58 AM
STOCKGOODIES PLAYS OF THE WEEK $WRAP heading back North!!! j$tops 09/25/2012 09:46:57 AM
STOCKGOODIES PLAYS OF THE WEEK WRAP killing it +14.78% Hooka 09/25/2012 09:46:47 AM
Billionaire Boys Club Member Forum (BBCMF) WRAP WRAPmail’s revenue models are Advertising geraldr 09/25/2012 09:46:40 AM
Pro Traders Forum WRAP The size of WrapMail’s addressable market is in cherrob 09/25/2012 09:46:34 AM
ALERTS, CHARTS, & HOT STOCKS $WRAP American Greetings Announces Content Licensing Agreement with pennybuster 09/25/2012 09:46:29 AM
STOCKGOODIES PLAYS OF THE WEEK $WRAP @ 14% and climbing... MACDgyver 09/25/2012 09:46:28 AM
BB's Stock Haven WRAP +14.7% budfoxhub 09/25/2012 09:46:04 AM
BB's Stock Haven WRAP - WrapMail, which boasts over 6,200 clients, Hooka 09/25/2012 09:45:54 AM
THE ASK SMACKERS CLUB....BID SITTERS NEED NOT APPLY WRAP is strating to build nicely here WhisperingEye 09/25/2012 09:45:44 AM
Penny $$ Tiny Float * Low(OS & AS) WRAP - WrapMail, which boasts over 6,200 clients, Hooka 09/25/2012 09:45:42 AM
MOMO'S BREAKOUT BOARD WRAP +14.7% budfoxhub 09/25/2012 09:45:40 AM
BB's Stock Haven WRAP WRAPmail is available for free (with 3rd party pennybuster 09/25/2012 09:45:30 AM
$TOCKTAMER Wrap early morning chart! jedijazz 09/25/2012 09:45:16 AM
$TOCKTAMER WRAP WRAPmail is available for free (with 3rd party pennybuster 09/25/2012 09:45:05 AM
MOMO'S BREAKOUT BOARD WRAP NEWS - Goldman Small Cap Research Issues Hooka 09/25/2012 09:45:02 AM
MOMO'S BREAKOUT BOARD $WRAP issues news today on huge research mrchipper 09/25/2012 09:45:02 AM
UNDERVALUED PENNY STOCKS WRAP formed a nice bottom here it seems WhisperingEye 09/25/2012 09:44:58 AM
BB's Stock Haven WRAP WRAPmail is available geraldr 09/25/2012 09:44:57 AM
BB's Stock Haven WRAP NEWS - Goldman Small Cap Research Issues Hooka 09/25/2012 09:44:50 AM
$ Young Money $ Wrap early morning chart! jedijazz 09/25/2012 09:44:48 AM
The Amazing Penny WRAP - b]PR Newswire ~ (August 27) ZipCash 09/25/2012 09:44:48 AM
Sizzling Stock Picks Sorry.. had to pile through old messages $DARA!! MACDgyver 09/25/2012 09:44:15 AM
$treet Trader Lion''s Den WRAP pennybuster 09/25/2012 09:44:15 AM
Sizzling Stock Picks $WRAP Lame attempt to cause a dip!!! j$tops 09/25/2012 09:44:06 AM
"JET LIFE" PENNY STOCK$ Click on "Download" via this link for the tommyboyboy 09/25/2012 09:44:05 AM
Penny Stock Millionaire WRAP ~ Company Profile Video ~cherrob 09/25/2012 09:44:01 AM
$STOCK UNDERGROUND$ WRAP pennybuster 09/25/2012 09:43:52 AM
WRATH OF KONGG ON PINKY,OTC,NAS,DOGJONES,HANGSENG WRAP up 15% today goign to catch it WhisperingEye 09/25/2012 09:43:49 AM
PSIONICMATRIX WRAP - PR Newswire ~ (September 5) ZipCash 09/25/2012 09:43:43 AM
Wrapmail, Inc. looks like we're ready to move here $WRAP... pivotpoint1 09/25/2012 09:43:22 AM
Wrapmail, Inc. WRAP liking it Mac ic3king 09/25/2012 09:43:09 AM
ALERTS, CHARTS, & HOT STOCKS WRAP The basic idea behind WRAPmail is geraldr 09/25/2012 09:43:06 AM
LOOKING FOR THE NEXT BIG RUNNER Looks like WRAP maybe the next big runner WhisperingEye 09/25/2012 09:42:45 AM
MOMO'S BREAKOUT BOARD WRAP - PR Newswire ~ (September 17) ZipCash 09/25/2012 09:42:43 AM
LOGI-COOL STOCK PLAYS WRAP Industry Leaders Team Up to Give Consumers pennybuster 09/25/2012 09:42:37 AM
Wrapmail, Inc. WRAP .03 break sends it! stockman69 09/25/2012 09:42:34 AM
Penny Stock General WRAP .03 break sends it! stockman69 09/25/2012 09:42:21 AM
Wrapmail, Inc. Im in..liking the action here! mrbizzard 09/25/2012 09:42:19 AM
Premium Stock Alerts WRAP on watch here too WhisperingEye 09/25/2012 09:42:17 AM
$STOCK UNDERGROUND$ About WRAPmail Pro+ from $WRAP zigzagman 09/25/2012 09:41:59 AM
BB's Stock Haven WRAP Industry Leaders Team Up to Give Consumers pennybuster 09/25/2012 09:41:54 AM
Billionaire Boys Club Member Forum (BBCMF) Click on "Download" via this link for the tommyboyboy 09/25/2012 09:41:54 AM
4 more trading sessions left in September...
$WPCS - lowest market capitalization in industry
http://finviz.com/screener.ashx?v=111&f=ind_diversifiedcommunicationservices&o=marketcap
WPCS International Incorporated:
Engineering for the Future
What will the world of tomorrow look like? WPCS envisions new energy sources, safer communities, affordable healthcare and broader educational opportunities. We see a world where people, communities, markets, businesses and industry are seamlessly connected to the information, services and resources needed to live, work, grow and learn.
WPCS sees it all because the future is our business. As a design-build engineering company, we specialize in creating and building the connections and infrastructure that will make the promises of tomorrow a reality.
Established in 2002, WPCS operates globally, providing a comprehensive range of capabilities in wireless communication, specialty construction and electrical power. We provide expertise in the design, project management, installation and maintenance of infrastructure, enabling the deployment of advanced technology, the delivery of information, and the expansion of global economies.
Committed to Growth
WPCS is committed to growth. We are continually expanding our capabilities in domestic and international markets, and are working to establish a leadership position in each market we serve. WPCS continues to balance its goals of profitable operations, return on investment and superior services. We conduct our business ethically and demonstrate leadership in satisfying our responsibilities to our customers, investors, employees and communities.
WPCS International Incorporated: International Operations
Taian AGS
East Pahne Street
Taian, Shandong, China 271000
86 538 626 2668
The Pride Group
1/40 Wilson Avenue
Woombye, QLD 4559 Australia
07 5442 1000
WPCS International Incorporated: Domestic Operations
Seattle Operations
15241 NE 90th Street
Redmond, WA 98072
425.483.2677
Suisun City Operations
521 Railroad Avenue
Suisun City, CA 94585
707.421.1300
Trenton Operations
1095 Cranbury South River Road
Suite 5
Monroe Township, NJ 08831
732.641.2283
WPCS International Incorporated
Corporate Headquarters
One East Uwchlan Avenue, Exton, PA 19341
610.903.0400
http://www.wpcs.com
do you have something good/bad/whatever relative to IMSC?
you're constantly spamming your site on tons of IHub boards with those tech charts nonsense...
most likely
just a few more pieces of the puzzle, and ...
$BCDH > crap may go to .003s ...
I have almost a bagger here... Just curious – why post a nonsense day-over-day instead of making money? jeez
I'm ready
7th GPEC in Leipzig closed yesterday. News could be on the way for Monday...
will be great to make it rollin' too. lol
weeeeeeeeeeeeeeeee
$RCFEF - too much noise for $1K in volume. lol
out of $SGOC from 1.13/1.14ssss weeeeeeeeeeeeee
market misread the morning PR. lol
$KIPS - low float, gonna boooooooom with a pushzzzzzzzzzzzzzzzz
Kips Bay Medical Announces the First Patient Enrollment in Its U.S. Clinical Feasibility Trial in Europe
Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (KIPS) announced that on August 31, 2012, the first patient was enrolled in the Kips Bay Medical eMESH I clinical feasibility trial at the Bern University Hospital, Bern, Switzerland, by Lars Englberger, MD, Senior Consultant Cardiac Surgeon who stated, “The patient had a smooth and uneventful implant of an eSVS® Mesh graft and is doing very well after quadruple bypass surgery. I am looking forward to the results of this well-designed, randomized, multicenter study of the eSVS Mesh.” Dr. Englberger further commented, “I think that the eSVS Mesh® will be a very valuable tool to increase mid- and long-term patency of saphenous vein grafts, further improving clinical outcomes of patients undergoing CABG surgery by lowering the need for coronary re-interventions.”
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medical’s eSVS Mesh in CABG Surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (“SVG”) support device during coronary artery bypass (“CABG”) procedures sufficient to allow the FDA to approve an IDE for a pivotal study in the U.S. The Company expects to enroll up to 120 patients at eight European sites.
Kips Bay Medical continues to pursue an approval from the U.S. FDA to include four U.S. hospitals in the eMESH I clinical feasibility trial. As previously announced, the Company is gathering additional information on the preclinical design testing of the eSVS Mesh requested by the FDA and will provide this information to the FDA in a soon-to-be filed amended IDE Application. If the FDA approves the amended IDE Application, U.S. physicians will then be allowed to begin enrolling patients. Kips Bay Medical has already contacted prominent U.S. heart centers that are taking steps to secure the internal approvals of their institutional review boards and administrations to participate in the study.
$KIPS AH news
http://finance.yahoo.com/news/kips-bay-medical-announces-first-203000754.html
Kips Bay Medical Announces the First Patient Enrollment in Its U.S. Clinical Feasibility Trial in Europe
Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (KIPS) announced that on August 31, 2012, the first patient was enrolled in the Kips Bay Medical eMESH I clinical feasibility trial at the Bern University Hospital, Bern, Switzerland, by Lars Englberger, MD, Senior Consultant Cardiac Surgeon who stated, “The patient had a smooth and uneventful implant of an eSVS® Mesh graft and is doing very well after quadruple bypass surgery. I am looking forward to the results of this well-designed, randomized, multicenter study of the eSVS Mesh.” Dr. Englberger further commented, “I think that the eSVS Mesh® will be a very valuable tool to increase mid- and long-term patency of saphenous vein grafts, further improving clinical outcomes of patients undergoing CABG surgery by lowering the need for coronary re-interventions.”
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medical’s eSVS Mesh in CABG Surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (“SVG”) support device during coronary artery bypass (“CABG”) procedures sufficient to allow the FDA to approve an IDE for a pivotal study in the U.S. The Company expects to enroll up to 120 patients at eight European sites.
Kips Bay Medical continues to pursue an approval from the U.S. FDA to include four U.S. hospitals in the eMESH I clinical feasibility trial. As previously announced, the Company is gathering additional information on the preclinical design testing of the eSVS Mesh requested by the FDA and will provide this information to the FDA in a soon-to-be filed amended IDE Application. If the FDA approves the amended IDE Application, U.S. physicians will then be allowed to begin enrolling patients. Kips Bay Medical has already contacted prominent U.S. heart centers that are taking steps to secure the internal approvals of their institutional review boards and administrations to participate in the study.
smart trade
one more "educated" guess:
TWWI buddy