From the press release:

The HairDX (RxR) Genetic Test for Finasteride Response will help doctors predetermine if patients will have a subtle, moderate, or great treatment response to Finasteride, allowing the physician to provide patients with the best treatment regimen to save their hair...

[The test] provides doctors with a patient score, called the CAG repeat score. “A smaller CAG test score is associated with an increased response to Finasteride for treatment of Androgenetic Alopecia,” says Dr. Sharon Keene, HairDX Chief Medical Officer. “Scientists discovered that among men that had the best response to Finasteride approximately 70% had a CAG score below 22 while among men that had a subtle response to Finasteride approximately 70% had a CAG score above 22.”

Press release: HairDX Introduces Genetic Test For Finasteride Response (.pdf)...

Product page: HairDX...

NOTE: Please say big hello to our new editor. Sean Duffy is a graduate of Columbia in neuroscience, who is starting Harvard Medical School this August. For now he will be blogging with us. This is his first post.

From the University of Texas M. D. Anderson Cancer Center:

With hollow gold nanospheres inside melanoma cells, photothermal ablation destroyed tumors in mice with a laser light dose that was 12 percent of the dose required when the nanospheres aren't applied, Li [Chun Li, Ph.D., professor in M. D. Anderson's Department of Experimental Diagnostic Imaging] and colleagues report. Such a low dose is more likely to spare surrounding tissue.

Injected, untargeted nanoparticles accumulate in tumors because they are so small that they fit through the larger pores of abnormal blood vessels that nourish cancer, Li said. This "passive targeting" delivers a low dose of nanoparticles and concentrates them near the cell's vasculature.

The researchers packaged hollow, spherical gold nanospheres with a peptide - a small compound composed of amino acids - that binds to the melanocortin type 1 receptor, which is overly abundant in melanoma cells. They first treated melanoma cells in culture and later injected both targeted and untargeted nanospheres into mice with melanoma, then applied near-infrared light.

Fluorescent tagging of the targeted nanospheres showed that they were embedded in cultured melanoma cells, while hollow gold nanospheres without the targeting peptide were not. The targeted nanospheres were actively drawn into the cells through the cell membrane.

When the researchers beamed near-infrared light onto treated cultures, most cells with targeted nanospheres died, and almost all of those left were irreparably damaged. Only a small fraction of cells treated with untargeted nanospheres died. Cells treated only with near-infrared light or only with the nanospheres were undamaged.

Most of the targeted nanospheres in the treated mice gathered in the tumor, with smaller amounts found in the liver and spleen. Most of the untargeted nanospheres gathered in the spleen, then in the liver and then the tumor, demonstrating the selectivity and importance of targeting.

In another group of mice, near-infrared light beamed into tumors with targeted nanospheres destroyed 66 percent of the tumors, but only destroyed 7.9 percent of tumors treated with untargeted nanospheres.

The researchers used F-18-labeled glucose to monitor tumor activity by observing how much glucose it metabolized. This action "lights up" the tumor for positron emission tomography (PET) imaging. Tumors treated with targeted shells largely went dark.

Press release: Targeted Nanospheres Find, Penetrate, then Fuel Burning of Melanoma

Image: Gold nanoparticles from an unrelated project. Credit Annie Cavanagh, Wellcome Images

Here's a video report from Vanderbilt:

Press release: Diagnosing Skin Cancer Without Biopsy

From the press release:

President and CEO Richard Burtt commented, “The granting of this 510(k) approval is another significant milestone in Nomir’s regulatory process, which we have been pursuing rigorously, and paves the way for future 510(k) multi-site, disease-specific applications. The Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery. This new FDA clearance highlights the continued success of the Nomir team and its implementation of our regulatory plans for commercialization of our unique photo-biological, anti-infective Noveon system.”

Nomir’s Chief Scientific Officer, Dr. Eric Bornstein, added, “Noveon has also demonstrated its success in the clinic, eliminating MRSA infection in the nose, reversing microbial resistance to common antibiotics, and effecting complete photo-inactivation of toe nail fungus, all at safe energy densities and temperatures. We believe these positive results, combined with our successful regulatory strategy, will make Noveon a potentially attractive option in the future to clinicians treating an array of infections.”

Nomir has completed two IRB human studies with Noveon against methicillin-resistant Staphylococcus aureus (MRSA) carriage and infection in the nares (nose). Based on positive data from these studies, Nomir is initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.

After multiple IRB human pilot studies with Noveon against onychomycosis (toe nail fungus), Nomir initiated an FDA pivotal study of its Noveon device for this indication in May 2008, an integral step for FDA clearance of the application.

Press release: Nomir Medical Announces Second FDA 510(k) Clearance of its Noveon® Dual-Wavelength Device...

Nomir technology page...

Flashback: A Bright Light Against Dark Matter: A New Device to Fight Toe Nail Fungus

BAD has dubbed the rash "mobile phone dermatitis" but we think MedGadgetitis is not only easier to remember, but it's catchier and shamelessly promotes our website. We hope this catches on before the dermatologists lobby for "BAD Rash", as this could lead to all kinds of problems when trying to explain it to your partner.

Lionel Bercovitch, MD, and John Luo of Brown's Warren Alpert Medical School noticed a pattern with phones containing nickel and published their work in the January 2008 edition of the CMAJ (Canadian Medical Association Journal).

Picture and case from the CMAJ (January 1, 2008)

The case:

An 18-year-old male presented with pruritic lichenified dermatitis on his lower abdomen and eczematous dermatitis on his extremities, flanks and face that had lasted several weeks. We suspected his belt buckle had led to allergic contact dermatitis with subsequent autoeczematization. Patch testing using the expanded North American Contact Dermatitis Group allergen battery of 65 allergens1 disclosed an edematous and papulovesicular reaction to nickel at 72 hours. The patient had no other positive reactions, nor did he react to other metals tested, including gold, cobalt, chromium, copper and palladium.

The patient suspected that his recurrent facial dermatitis was related to contact with the headset of his cellphone. We spot tested both the antenna and the headset for free nickel. The test of the antenna, which was plastic coated with metallic paint, was negative. The test of the headset was strongly positive for free nickel. The patient began using a cellphone that contained no nickel, and his facial dermatitis cleared. He decided to resume using his old cellphone to confirm that it had caused his dermatitis and the eruption recurred.

CMAJ Article: Cellphone contact dermatitis with nickel allergy; CMAJ • January 1, 2008; 178 (1)

Press Release: British Association of Dermatologists

The following is from the press release:

The Pixel CO2 OMNIFIT is Alma’s newest offering in skin rejuvenation and it is an upgrade to physicians’ existing CO2 skin resurfacing lasers. It is designed to provide patients with impressive results with just a fraction of the downtime compared to current treatments, and for significantly less money than replacing their current laser.

The Pixel CO2 OMNIFIT handpiece fits onto most existing CO2 lasers and is designed to deliver a high degree of efficacy without the side effects or significant downtime associated with traditional CO2 resurfacing. By combining Alma’s proprietary and proven Pixel fractional technology with a standard CO2 resurfacing laser, the new Pixel CO2 OMNIFIT delivers a supremely effective treatment for aged, photo-damaged, and acne-scarred skin with minimal patient redness, irritation or downtime...

The Pixel CO2 OMNIFIT handpiece takes ablative patient downtime from 30 days to approximately three, making the procedure as appealing as many non-invasive approaches available to today’s busy patients.

And here's a product brochure:

Product page: Pixel C02 OMNIFIT Fractionated CO2 Adapter From Alma Lasers...

Press release: Alma Lasers Announces FDA Clearance of the Pixel® CO2 OMNIFIT Handpiece...

Flashback: HarmonyXL, Aesthetic Dermatologist's Multi-Tool

The HarmonyXL device is the most comprehensive and versatile platform to enter the medical and aesthetic industry, as it is the first to combine lasers, pulsed light, near-infrared, LED and UVB technologies with multiple exchangeable handpieces to ensure easy and effective singular and combined therapeutic treatment. The HarmonyXL also accommodates new versions of Alma’s unique Advanced Fluorescence Technology (AFT) and several different laser technologies. Compared to its successful predecessor, HarmonyXL delivers higher energy and is the first Harmony model to incorporate Alma’s proprietary IN-MotionTM technology, which delivers effective energy with virtually no discomfort over a range of applications. Additionally, the HarmonyXL exclusively offers high-power Pixel® 2940 technology – a breakthrough for fractionated skin resurfacing treatments.

Press release: Alma Lasers Announces FDA Clearance of the HarmonyXL

Product page: HarmonyXL

Product brochure (.pdf)...

More about technology:

Researchers at Georgia Tech have developed a narrowband filter mosaic that will expand the uses and functionality of multispectral imaging—a technology that enables subsurface characterization...

In addition to this application, the filter could potentially offer a reliabile, low-cost method to instantaneously classify military targets, sort produce, inspect product quality in manufacturing, detect contamination in foods, perform remote sensing in mining, monitor atmospheric composition in environmental engineering and diagnose early stage cancer and tumors.

The technology was developed in Georgia Tech’s Center for Assistive Technology and Environmental Access (CATEA) as part of a project to design a portable erythema and bruise-detection technology that will enhance early prevention and diagnosis of pressure ulcers, a secondary complication for people with impaired mobility and sensation.

Currently, clinical assessment of bruises is subjective and unreliable, especially when on persons with darkly pigmented skin. Improved imaging can lead to earlier intervention which is vital in cases of suspected physical abuse. Similarly, early detection of erythema can trigger preventive care that can stop progression into pressure ulcers.

Pressure ulcers are a serious secondary complication for people with impaired mobility and sensation. Annual Medicare spending is conservatively approximated at $1.34 billion for the treatment of pressure ulcers. Early detection of erythema can prevent progression into more serious Stage III or Stage IV pressure ulcers.

The filter mosaic can be conveniently laminated with imaging sensors used in digital cameras. With a patent pending, CATEA researchers are currently seeking collaborative or financial support to further develop and design the device.

“Although multispectral imaging has matured into a technology with applications in many fields, clinicians and practitioners in these fields have generally stayed away from it due to extremely high costs and lack of portability,” said Dr. Stephen Sprigle, director of CATEA and professor of industrial design and human physiology. “Now, the possibilities are plentiful.”

Press release: New Technology Puts Biomedical Imaging in Palm of Hands...

From the press release:

The primary objective of the trial is to test the efficacy and safety of Noveon in treating patients with onychomycosis (toenail fungus). The target population for this study is patients with toenail onychomycosis, as confirmed by culture, with the goal of gaining a new FDA approval to use the device for the treatment of onychomycosis.

“This pivotal trial initiation is a major step for Nomir, moving us closer to commercial launch of our first product utilizing our proprietary dual-wavelength optical energy technology,” stated Richard Burtt, CEO of Nomir Medical Technologies. “Noveon represents a novel treatment approach of using optical energy to address disease indications, such as onychomycosis, that are typically sub-optimally treated with traditional pharmaceutical drugs. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation.”

In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir’s regulatory strategy accelerates the review process for the FDA by de-coupling the device clearance from the application clearance.

Forty evaluable subjects will be enrolled in the prospective, randomized, multi-site U.S. trial. It is expected that this will provide at least 30 evaluable subjects, two-thirds of which will be treated with Noveon and the remaining serving as controls. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients will receive four treatments over a four-month period and will be followed up to one year following the initial treatment to assess clinical improvement and mycological response.

Press release (.pdf)...

Nomir Medical Technologies...

Using Bluetooth, wi-fi and cellular networks, a phone needs no modification itself. Capable of 50x magnification today, the devices could provide twice that. A smaller prototype features its own light source.

"This could be useful even at home," suggests Fletcher [Associate Professor of Bioengineering at Berkeley --ed.], "where, for example, early warnings of a change in the shape of a mole could be sent to your clinician on a regular basis to monitor."

In addition, cancer patients could conduct their own blood cell counts that today require larger microscopes and particle counters.

Dr. Lam, Pediatric Oncologist at UCSF, is one of the grad students working on CellScope. He adds, "By no means do we think this is going to replace those large particle counters. It's just a good adjunct for the patient to have at home."

More, with video, from ABC...

Project page: Telemicroscopy for Disease Diagnosis...