Navigation Links
Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
Date:5/12/2008

WALTHAM, Mass., May 12 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced today that the Company has received approval from the U.S. Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") to begin the pivotal clinical trial for SEPET(TM), Arbios' extracorporeal (outside the body) liver assist device for blood purification of acutely ill patients suffering from chronic liver disease.

"We are pleased to have received FDA approval to start the SEPET pivotal trial and to have fully satisfied the points addressed in the FDA's previously issued conditional approval," commented CEO and President Shawn Cain. "We were pleased with the compelling results from the SEPET feasibility trial, and we are excited to initiate the pivotal clinical phase of SEPET's development. The pivotal trial design includes adaptive measures to optimize our ability to achieve the trial's primary and secondary endpoints. We believe that the pivotal trial, if successful, should support our filing for approval of SEPET in the United States and marketing efforts in the United States and the European Union. Further, we believe that the design of this trial will enhance physician acceptance of SEPET as a much needed tool in sustaining patients through acute life threatening episodes of liver failure, a market which we believe exceeds a billion dollars annually."

Trial Design

There are three segments to the pivotal trial design. During the first segment of the trial, 5 non-randomized patients will be treated with SEPET to allow us to validate the patient selection criteria, clinical protocol, case report forms, and other trial related documents. During the second segment of the trial, we expect to enroll 116 patients in this randomized, controlled phase of the trial. This segment is targeted to achieve the co-primary endpoints, which are 1) the percentage of patients achieving improvement in hepatic encephalopathy ("
'/>"/>

SOURCE Arbios Systems, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
2. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
3. Strykers Biotech Division Receives FDA Warning Letter
4. Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging
5. Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch
6. Genta Receives Key Patent Related to Oral Gallium Compound G4544
7. QMed, Inc. Receives 2-Year Extension of Medicare Coordinated Care Demonstration Project by CMS
8. Thermo Fisher Scientific Receives FDA Clearance for MRSA Test Medium
9. Vical Receives NIH Grant for an Immunotherapeutic Herpes DNA Vaccine; Herpes Experts at University of Washington and University of Texas to Conduct Preclinical Development
10. DermaGen AB Receives Over 1 Million Euros From a New Share Issue
11. PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Fla. , Jan. 23, 2015  HyGreen, Inc., a ... agreement and partnership with RCA Medical, a subsidiary of ... . Each year, hundreds of millions ... care-associated infections as organisms are transmitted from patient to ...
(Date:1/23/2015)... Africa , Jan. 23, 2015   Leatt Corporation ... personal protective equipment for all forms of sports, including ... Leatt-Brace® neck brace, announced today that the UISP Lega ... now requires all riders to wear a neck brace ...
(Date:1/23/2015)... China , Jan. 23, 2015 Tianyin Pharmaceutical ... company that specializes in the development and sale of ... generics and active pharmaceutical ingredients (API) today announced the ... (JCM) API operation. 1. Following the September ...
Breaking Medicine Technology:HyGreen Partners with RCA Medical in Johannesburg, South Africa 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3TPI's JCM Updates on Import Registration for International Clients 2TPI's JCM Updates on Import Registration for International Clients 3TPI's JCM Updates on Import Registration for International Clients 4
... 19, 2007 - Abraxis BioScience,Inc. (NASDAQ:ABBI), ... from two pre-clinical studies that,provide evidence ... combining nab-paclitaxel (ABRAXANE(R) for Injectable,Suspension (paclitaxel ... VEGF inhibitor drugs like,bevacizumab (Avastin(R)) at ...
... WIRE)--Apr 19, 2007 - Abraxis BioScience,Inc. ... first-time data from a pre-clinical study,evaluating ... nab-rapamycin,(ABI-009), an albumin-bound mTOR kinase inhibitor, ... Research (AACR) Annual Meeting held,April 14-18, ...
Cached Medicine Technology:Abraxis BioScience Presents Data from Pre-Clinical Study That,Provide Evidence for Chemotherapy-Induced Angiogenesis and,Rationale for Combining nab-Paclitaxel (Abraxane) with,Anti-Angiogenic Agents to Increase Tumor Response 2Abraxis BioScience Presents Data from Pre-Clinical Study That,Provide Evidence for Chemotherapy-Induced Angiogenesis and,Rationale for Combining nab-Paclitaxel (Abraxane) with,Anti-Angiogenic Agents to Increase Tumor Response 3Abraxis BioScience Presents Data from Pre-Clinical Study That,Provide Evidence for Chemotherapy-Induced Angiogenesis and,Rationale for Combining nab-Paclitaxel (Abraxane) with,Anti-Angiogenic Agents to Increase Tumor Response 4Abraxis BioScience Presents Data from Pre-Clinical Study That,Provide Evidence for Chemotherapy-Induced Angiogenesis and,Rationale for Combining nab-Paclitaxel (Abraxane) with,Anti-Angiogenic Agents to Increase Tumor Response 5Abraxis BioScience Presents Results from Pre-Clinical Study That,Demonstrates nab-Rapamycin's Robust Antitumor Properties and,Ability to Target Intracellular Sites Such as the mTOR Pathway 2Abraxis BioScience Presents Results from Pre-Clinical Study That,Demonstrates nab-Rapamycin's Robust Antitumor Properties and,Ability to Target Intracellular Sites Such as the mTOR Pathway 3Abraxis BioScience Presents Results from Pre-Clinical Study That,Demonstrates nab-Rapamycin's Robust Antitumor Properties and,Ability to Target Intracellular Sites Such as the mTOR Pathway 4
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 As interest in ... health care gains momentum worldwide, Rev. Eric J. Hall ... Chaplaincy Network (HCCN), will be the keynote speaker on ... in Israel’s public health system. , The conference, “Hope and ...
(Date:1/22/2015)... Compare-autoinsurance.org has released a new blog post presenting a list ... policy . , Some types of vehicles cannot be covered ... released blog post to see if their vehicle qualifies for auto ... some of the cars that cannot be covered by a plan. ...
(Date:1/22/2015)... January 22, 2015 Step into a ... the Science Museum of Virginia. Wicked Plants, the Museum’s ... Plants unearths 75 poisonous, carnivorous and diabolical plants inside ... room to uncover the biochemical, physical and neurological processes ...
(Date:12/26/2014)... The US represents the largest market for CRC across the ... that sales of branded therapies were $2.23 billion. The US ... of the disease, high drug treatment rate, and higher drug ... of CRC therapies over the forecast period will be driven ...
Breaking Medicine News(10 mins):Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2Health News:Wicked Plants are taking over the Science Museum of Virginia 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... 2 copies of variant, puffing before age 17 boosted odds ... -- People with certain common genetic variations that affect their ... life-long nicotine addicts if they begin smoking before they turn ... people who begin smoking at a young age are more ...
... NEW YORK, July 17 Fresh Harvest Products,Inc. ... is expanding and,enhancing its long standing commitment to ... offerings, through a new initiative to,build natural and ... side the Fresh Harvest brands,through our network., ...
... A NEW SOUTH AFRICA TO PRODUCE, HACHETTE AUDIO TO ... PROGRAMS SERVING AFRICAN AIDS ORPHANS, LOS ANGELES, July ... week, Artists for a New South Africa (ANSA) announced ... African,Folktales, an award-winning book of legendary tales hand-picked by ...
... Uninsured Fail to Address the High Percentage of people with Mental ... ... July 17, 2008 -- New data indicates that more than one ... or addiction disorder, or both., , , , ,Many state healthcare ...
... France, July 17 - First-Half 2008 Revenue ... Constant Exchange Rates Essilor International, the ... EUR1,520.3 million for the six months,ended June 30, 2008, ... Like-for-like growth was 5.4%, in line with trend rates, ...
... a privately held medical device manufacturer focusing on ... today announced that the company has closed a ... leading venture capital firms active in medical technology. ... Foundation Medical Partners and were joined in the ...
Cached Medicine News:Health News:Gene Mutation Puts Some Kids at Risk for Tobacco Addiction 2Health News:Fresh Harvest Products, Inc. Announces New Brand Initiative 2Health News:Nelson Mandela's Favorite African Folktales to be Produced as Audiobook Featuring Archbishop Tutu, Gillian Anderson, America Ferrera, Whoopi Goldberg, Samuel L. Jackson, Alan Rickman and Jurnee Smollett, Directed by Alfre Woodard 2Health News:Nelson Mandela's Favorite African Folktales to be Produced as Audiobook Featuring Archbishop Tutu, Gillian Anderson, America Ferrera, Whoopi Goldberg, Samuel L. Jackson, Alan Rickman and Jurnee Smollett, Directed by Alfre Woodard 3Health News:Uninsured With Mental Illness and Addiction Disorders Not Covered by State Healthcare Initiatives 2Health News:Essilor - First-Half 2008 Revenue 2Health News:Essilor - First-Half 2008 Revenue 3Health News:Essilor - First-Half 2008 Revenue 4Health News:Essilor - First-Half 2008 Revenue 5Health News:Vertos Medical Inc. Completes Series C Financing 2Health News:Vertos Medical Inc. Completes Series C Financing 3Health News:Vertos Medical Inc. Completes Series C Financing 4
For monitoring vacuum pressure, suitable for use with all QIAvac manifolds;...
... Millex Filter Units,Filter units with ... hydrophobic Fluoropore membrane are ideal for ... venting of sterile containers, and for ... sterile 25 mm Millex filter units ...
... Undercounter refrigerator -4C. ... is reversible. Interior light. ... Two see-through drawers. Two ... large bottles. Adjustable thermostat. ...
Designed to meet the requirements of reagent grade water for routine analysis....
Medicine Products: