SANUWAVE
Completes Patient follow‐up in PHASE III Trial of dermaPACE for the Treatment of Diabetic Foot ULCERS
FDA Accepts Company's Modular Premarket Approval Shell Application
SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non‐invasive, biological response activating devices in regenerative medicine, announced the completion of patient follow‐up in the Company's pivotal Phase III, Investigational Device Ex‐ emption (IDE) clinical trial with dermaPACE™ for the treatment of diabetic foot ulcers.
A total of 206 patients were enrolled in the trial, which was conducted at 22 sites in the U.S. and two sites in Western Europe. Data entry will be completed in the coming weeks, followed by a final data review and then locking of the database in the fourth quarter of 2010. After the database is locked, the Company will unblind the data, conduct statistical analyses, announce top‐line results publicly and draft the clinical study report. This work will culminate in submission of the final Premarket Approval (PMA) module to the U.S. Food and Drug Administration (FDA) late in 2010 or early in 2011.
The dermaPACE™ is the Company's lead product candidate for the global wound care market. It incorporates the Company's PACE™ (Pulsed Acoustic Cellular Expression) technology platform, which delivers a proprietary form of extracorporeal shock wave therapy (ESWT) to treat a wide variety of chronic and acute soft tissue conditions. The U.S. diabetic foot ulcer market is estimated at approximately $2 billion annually.
In August 2010 the FDA accepted SANUWAVE's shell application for dermaPACE™ proposing a modular PMA submission plan containing three sections or “modules.” A modular submission divides the PMA document into modules filed at different times that together form the complete application. This modular approach allows the FDA to review each module separately as soon as it is received, making it possible for manufacturers to receive timely feedback during the review process, and perhaps shortening the time to a final regulatory determination.
The Company will submit the first two modules containing the preclinical data, prior clinical testing and a quality manufacturing system review to the FDA in October 2010. The Company plans to submit the third and final module containing the PMA application, clinical trial data, proposed product labeling and summary of safety and effectiveness late in 2010 or early in 2011.
KCI's LifeCell™ Corporation and Novadaq Technologies Enter North American Sales and Marketing Agreement for Exclusive Distribution of SPY® Imaging System
Kinetic Concepts, Inc. announced the U.S. launch of the Prevena™ Incision Management System, the latest addition to KCI's negative pressure technology platform.
The Prevena™ System leverages the clinically proven effectiveness of negative pressure wound therapy that KCI pioneered with the V.A.C.® Therapy System, which has been used to treat millions of complex open wounds since its introduction. The Prevena™ System is expected to be used most often for linear incisions associated with general surgery, OB/ GYN, orthopedic and cardiothoracic incisions.
“Surgeons know all too well that an operation cannot be deemed a success simply when the last suture or staple is made,” said Mike Genau, global president of KCI's Active Healing Solutions™ business. “An operation is a success when the incision heals without incident. The Prevena™ System is designed to promote that favorable healing environment.”
Examples of complications that can follow surgical incisions include dehiscence (reopening of the wound,) infection, hematoma and seroma. In addition to lengthening hospital stay and increasing cost of care, these complications can compromise patient quality‐of‐life.
The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by:
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Removing exudate and potentially infectious material
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Protecting the surgical site from external contamination
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Providing a clean, protected postoperative wound environment
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Helping draw the edges of the incision together
The Prevena™ System is designed for single‐patient use. Portable and discreet, it is designed to be applied as the last step of the surgical procedure and may accompany the patient during transition from the hospital to the home.
In addition to the Prevena™ System, KCI's negative pressure surgical management portfolio also includes the ABThera™ Open Abdomen Negative Pressure Therapy System, designed to manage the open abdomen.
Coloplast Staff Volunteer at Wheelchair Rugby World Championships
As the Wheelchair Rugby World Championships kickoff in Vancouver, Canada today, Coloplast is once again featured as a major sponsor. In addition to the sponsorship, Coloplast staff from Denmark, the United States and Canada will travel to Vancouver to volunteer at the event.
“We’ve been a major sponsor of wheelchair rugby for many years. Not only is it an extremely action‐packed and challenging sport, it also provides these athletes with the opportunity to have fun and to compete at the highest level. We are excited that some of our colleagues have decided to strengthen our involvement in wheelchair rugby by volunteering,” says Cheryl Carlson, Product Manager, Coloplast US.
Volunteering at this event is a great opportunity for local Coloplast staff to interact with the athletes, who in many cases use Coloplast products daily.
“Besides helping out with the logistics, I'm looking forward to interacting with some of the athletes and listening to their personal insights on our products,” says Melissa Paris, Marketing Director, Coloplast US.
The player's lounge is a new feature of this year's championships in Vancouver. Participants can visit the lounge between games to relax or to enjoy the activities provided. The lounge has been named The Coloplast Team Lounge and will be staffed by Coloplast employees.
“We’re really looking forward to working at The Coloplast Team Lounge, which will be equipped with both Playstation and Nintendo Wii consoles, coffee stations and a comfortable lounge environment,” says Brian Olson, Marketing Product Specialist, Coloplast US.
CONVATEC
New Laboratory Data Analyzes Physical Performance Characteristics Of Unique Bio‐Dome™ And Granufoam™ Negative Pressure Wound Therapy Dressings
Encouraging Results Obtained for Negative Pressure Wound Interface Products in the Engenex® Negative Pressure Wound Therapy System
ConvaTec, a world‐leading developer and marketer of innovative medical technologies for community and hospital care, announced new in vitro study results. The Engenex® Negative Pressure Wound Therapy (NPWT) system's Bio‐Dome™ wound interface showed superior tensile strength and lower simulated bioadhesion when compared with GranuFoam™ (polyurethane foam).1 This study was conducted by employees of ConvaTec's Global Development Center and was presented at The Annual Fall Symposium on Advanced Wound Care in Anaheim, California.
In addition to the superior tensile strength and lower simulated bioadhesion, the laboratory tests also showed that the Bio‐Dome™ wound interface provided broader contours of microstrain when compared to GranuFoam™. The Bio‐Dome™ wound interface also effectively transmitted sufficient levels of fluid to the canister from simulated highly exuding wounds.1 To better understand the physical performance attributes of wound interfaces, a range of in vitro physical testing and analytic studies using different levels of applied negative pressure were performed.
The analytic studies included finite element analysis (FEA) to predict strain forces applied to the wound bed; fluid handling testing to simulate exudate management capabilities; tensile strength of interface dressings to show their robustness during handling; and simulated bioadhesion testing.