Archive for August, 2010

Spectral Molecular Imaging, Inc. Announces Accelerated Timeline For Its Early Melanoma Detection Product SkinSpect(TM)

MelanomaCascade Technologies, Inc. announced that its wholly-owned subsidiary Spectral Molecular Imaging, Inc. will complete development of its new product SkinSpect™, aimed at early detection of melanoma by hyperspectral imaging, in mid-September 2010. The device incorporates new advances in component technologies, as well as experience derived from previous prototypes developed under federal funding and tested in the clinic. The spectral range covered is also extended, now ranging from 385 nm to 920 nm.

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FDA Warns Of Possible Dangers From Portable Foot-Tanning Device

ultraviolet radiationThe FDA is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device. Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure.

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BINDER BIOMEDICAL Announces Official Launch Of The NEWTON(TM) Intervertebral Body Fusion Spinal Spacer System

BINDER BIOMEDICALThe NEWTON™ Intervertebral Body Spacer System is comprised of a complete line of lumbar spinal spacers that allow anterior, posterior or lateral insertion angles to reach the intervertebral disc space. Each implant is designed with a large central window for optimum graft placement. Through the use of a minimal-exposure patent-pending tube system, the NEWTON™ devices are implanted into the intervertebral space to provide stabilization and facilitate fusion.

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Xenon Pharmaceuticals Initiates A Phase 2 Clinical Trial In Post Herpetic Neuralgia (PHN) For Topical XEN402

Xenon PharmaceuticalsXenon Pharmaceuticals Inc. announced that it has initiated a phase 2 clinical trial evaluating its novel topical XEN402 therapy for the treatment of PHN. XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability phase 1 study in normal human volunteers. The product was well tolerated and achieved good drug concentrations in the skin.

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STELARA(R) Three-Year Efficacy And Safety Data Presented On Patients With Moderate To Severe Plaque Psoriasis

psoriasisNew study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® sustained a clinical response for up to three years with continued treatment regardless of their weight. Investigators also presented findings from an integrated safety analysis that included data from clinical trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment.

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Healthpoint Initiates Double-Blind Study To Evaluate Effectiveness Of Collagenase SANTYL(R) Ointment On Healing Of Diabetic Foot Ulcers

HealthpointHealthpoint announced that it has initiated a clinical trial assessing the effectiveness of Collagenase SANTYL® Ointment, as compared to vehicle, on the change from baseline in wound area of diabetic foot ulcers (DFU) over four weeks. The trial will also follow subjects to determine the proportion that achieve complete wound closure within 12 weeks of initiating treatment. One of the long-term complications of diabetes is the development of foot ulcers primarily as a consequence of peripheral neuropathy due to prolonged serum glucose elevation.

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Excaliard Announces Positive Data From Phase 2 Clinical Trial Of Its Anti-Scarring Drug, EXC 001

Excaliard Pharmaceuticals, IncExcaliard Pharmaceuticals, Inc. has announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo. In the randomized, double-blind multicenter study conducted in the U.S., EXC 001 or placebo was administered intradermally adjacent to the surgical incision in patients who were undergoing elective abdominoplasty surgery.

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Bausch And Lomb Introduces The Stellaris(R) PC Vision Enhancement System

Bausch And LombBausch + Lomb has announced the worldwide launch of the Stellaris(R) PC (Procedural Choice) Vision Enhancement System. The new combined vitrectomy and phacoemulsification system allows surgeons to have true “procedural choice” by providing the most advanced technology for both vitreoretinal and cataract surgery in a single system. The new Stellaris PC provides a high-performance, combined experience that leverages Bausch + Lomb’s history in retinal innovation with the demonstrated excellence of the Stellaris phacoemulsification platform.

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Anesthesia misuse could lead to hepatitis virus transmission

anesthesiaA new study has revealed that hepatitis B virus (HBV) and hepatitis C virus (HBC) can be transmitted during intravenous administration of anesthesia. In the study, doctors found that anesthesia contamination, not endoscopy contamination, was the cause of infection. The study findings highlight the fact that many instances of health care-related HBV and HCV virus transmission probably go undetected. The true magnitude of this problem is therefore unknown.

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Topaz Pharmaceuticals Announces Positive Data From Topical Ivermectin Trials

Topaz PharmaceuticalsTopaz Pharmaceuticals Inc. has announced positive results of studies of topical ivermectin cream, which it is developing as a potential treatment of Pediculus humanus capitis (head lice). In a Phase 2 dose-ranging study presented at the annual meeting of the Society for Pediatric Dermatology in Portland, OR, this novel topical formulation produced a statistically significant eradication of live lice as compared to vehicle.

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