• Echo Therapeutics (Franklin, Massachusetts) said that it has started the second clinical study of its current Symphony continuous transdermal glucose monitoring system (CTGM System) at the Tufts-New England Medical Center. The company said it expects to report the results of the study this quarter. Echo’s current generation Symphony CTGM system consists of the FDA-cleared SonoPrep skin permeation device that incorporates permeation control technology, together with wireless conductivity and proprietary transdermal sensor technologies. In addition to providing glucose monitoring benefits to diabetes patients, Symphony is designed to help patients and healthcare teams in hospital critical care settings to better control glucose levels with accurate, needle-free, continuous glucose readings. The skin permeation feature of Echo’s current generation of Symphony CTGM System involves SonoPrep, Echo’s FDA-cleared device using ultrasound-mediated skin poration technology. Echo Therapeutics is a platform-enabled specialty therapeutics and diagnostics company developing a broad pipeline of both advanced topical reformulations of FDA-approved products using its AzoneTS dermal penetration technology, and Symphony, a wireless, needle-free, CTGM system for the diabetes and hospital critical care markets.
• Innocoll (Ashburn, Virginia) said that the first of two Phase III clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections, has commenced dosing. The implant is a biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx, and (outside of the US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. The cardiac surgery trial will enroll diabetic and/or obese (BMI>30) patients known to be at a higher risk of sternal wound infections, a serious and potentially life-threatening complication of cardiac surgery.
• Three Palm Software (Los Gatos, California) reported receiving FDA clearance for its WorkstationOne Breast Imaging Workstation. WorkstationOne is intended for softcopy reading and interpretation of digital mammography images, and was developed with the goal of assisting radiologists to read digital mammograms efficiently. WorkstationOne incorporates viewing methodology, including Tabar’s systematic viewing technique for searching for subtle abnormalities on the mammograms. The workstation, supporting IHE integration profiles and the display of CAD markers, is a software system that can be installed on an off-the-shelf general purpose computer with one or two gray scale high resolution monitors and one color monitor. Three Palm Software specializes in development of medical imaging software.
• VGX Pharmaceuticals (Blue Bell, Pennsylvania) reported the completion of its first study to assess the tolerability of VGX’s Cellectra electroporation device in humans. Ten healthy adult volunteers were treated with Cellectra device and were asked to report the level of discomfort they experienced immediately after electroporation and at various times thereafter. The procedure was generally well tolerated. On average, the patients reported a moderate level of discomfort during the procedure. However, the discomfort was short-lived, with comfort levels approaching baseline levels within 30 minutes following the procedure. Other complaints were mild and did not require any treatment. VGX manufactures DNA plasmid-based vaccines and therapies.