Navigation Links
Celleration, Inc. Announces First Patient Enrollment in In-Balance VLU Randomized Control Trial
Date:5/14/2012

EDEN PRAIRIE, Minn., May 14, 2012 /PRNewswire/ -- Celleration, Inc., a privately-held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies, announced the first patient enrollment in IN-BALANCE VLU (Inflammation, Bacteria, & Angiogenesis effects in Launching Venous Leg Ulcer healing: A Clinical Evaluation).  IN-BALANCE VLU is designed to expand on the vast body of evidence on MIST Therapy® that currently includes 12 peer-reviewed studies and a 444 patient meta-analysis supporting the clinical and economic benefits of the FDA cleared wound healing therapy.

IN-BALANCE VLU is a prospective, randomized, controlled, multi-center study of MIST Therapy in chronic lower extremity venous ulcers ("VLU").  The study will compare the effect of MIST Therapy on wound healing rates to traditional standard of care. The study will be performed at up to 20 study centers with an estimated 124 subjects enrolled in the study overall.  This study also includes sub-analyses of fluid and tissue samples to characterize cellular and molecular changes surrounding inflammation, angiogenesis and bio-burden impact of the treatments.

Venous leg ulcers are estimated to cost the U.S. healthcare system approximately $2-$3 billion annually and cause the loss of approximately two million working days per year. "With the significant economic and social cost of wound care rapidly rising, we must focus on conducting rigorous studies to fully understand both the biological mechanisms and healing outcomes of the many wound care treatment options to ensure we are selecting the most clinically efficacious and cost-effective treatment for each unique patient and wound," commented Gary Gibbons, MD, South Shore Hospital Center for Wound Care and Hyperbaric Medicine, Weymouth, MA.  "Celleration's IN-BALANCE VLU is a very well-designed study that will significantly add to the body of evidence surrounding venous leg ulcer prevention, education and management and in particular the role of advanced therapies like MIST."

"The design of IN-BALANCE VLU was based on input from the world's leading wound care clinicians and researchers," commented Mark Wagner, Celleration's president and CEO. "We believe the results from IN-BALANCE VLU will clearly differentiate MIST Therapy from the vast array of wound care options by providing compelling evidence of superior healing rates and a thorough understanding of the mechanism of actions of MIST Therapy."

About Celleration, Inc.:

Celleration, Inc. is a privately-held medical device company. Celleration develops and markets a proprietary technology that has been proven to accelerate healing in wounds by delivering therapeutic, low frequency ultrasound without direct contact of the delivery device to the wound surface.  Celleration's core product, the MIST Therapy System, has been clinically shown to positively impact all critical aspects of the wound healing process providing clinical and economic benefits to institutions treating non-healing wounds.   MIST Therapy has been performed more than 900,000 times on over 60,000 patients.

 

 

 


'/>"/>
SOURCE Celleration, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Celleration, Inc. Announces Close of $8 Million Series E Financing
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
8. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
9. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
10. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
11. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... , Jan. 24, 2017   Intrexon Corporation ... and industrialization of biology to improve the quality of life ... entered into a definitive agreement to acquire GenVec, Inc ... pioneer in the development of AdenoVerse™ gene delivery technology.  ... expertise in adenoviral vectors and cGMP drug product manufacturing to ...
(Date:1/24/2017)... 24, 2017   Keneric Healthcare , a ... effective patient care products, today announced their partnership ... the reach of both companies by leveraging their ... Angelini Pharma Inc . ... include Keneric Healthcare,s RTD™ Wound Dressing (antibacterial/antifungal).  RTD™ ...
(Date:1/24/2017)... 2017 Stock-Callers.com today has issued research ... ZTS ), Mallinckrodt PLC (NYSE: MNK ), ... Inc. (NYSE: DPLO ). According to pharmaceutical manufacturer ... 2017 for the Generic Drugs industry, including a possible reduction ... current growth, and a speedier FDA approval process that could ...
Breaking Medicine Technology:
(Date:1/24/2017)... New York (PRWEB) , ... January 24, 2017 , ... ... Brazilian butt lifts is on the rise. According to the American Society of ... since 2000. On average, these procedures are performed every 30 minutes of every day. ...
(Date:1/24/2017)... ... 24, 2017 , ... PeroxyChem Food and Beverage Safety announced ... at the International Production and Processing Expo (IPPE) in Atlanta, Georgia from Jan. ... that is used in poultry processing facilities to provide constant, real-time data that ...
(Date:1/24/2017)... ... January 24, 2017 , ... Twelve startups ... of the 2017 Cupid's Cup Entrepreneurship Competition. Chaired by Under Armour Founder and ... The entrepreneurs will showcase their businesses on February 6, 2017, at Under Armour’s ...
(Date:1/24/2017)... ... ... Bellus Medical, a leader in medical aesthetics, today announced that Marek Dobke, M.D., ... will provide physician oversight for in-house clinical studies and hands-on device training, among other ... Professor of Surgery at UC San Diego Health and is a board certified plastic ...
(Date:1/24/2017)... Boston, MA (PRWEB) , ... January 24, 2017 ... ... What They Really Need to Thrive , Well-meaning studies such as the Fordham ... and schools can better serve top students, such as including gifted or high-achieving ...
Breaking Medicine News(10 mins):