Imperial College London

Department of Materials

Research Associate

Micro-Raman Spectroscopy of Living Cells

Fixed Term post for 12 months in the first instance, with possibility of extension

Salary in the range £26,580 to £38,730 per annum

Applications are invited for a Research Associate to work on a project aimed at performing micro-Raman spectroscopy of living cells as a function of cell differentiation and drug exposure. The post will be held at the Department of Materials and the Institute of Biomedical Engineering at Imperial College London in the biomaterials and tissue engineering group led by Professor Molly Stevens (www3.imperial.ac.uk/people/m.stevens).

Raman spectroscopy of cells is rapidly growing in importance in biological science and can become an important tool in tissue engineering. Raman spectroscopy can further our understanding of the primary cellular process vital for developing functional tissue constructs, such as differentiation and maintenance of cell phenotype, in addition to non-invasively monitoring the cellular response to tissue scaffolds. Raman spectroscopy can potentially offer a non-invasive, information rich biochemical “snap-shot” of living human cells rapidly, without the need of labels or contrast enhancers. This project will involve performing micro-Raman spectroscopy of living cells as a function of cell differentiation and drug exposure. A range of multivariate statistical analyses will be employed and the experiments will be complemented with ongoing cell biology in the research group to understand how these spectral changes relate to cell genotype and phenotype.

You will be a conscientious, innovative experimental scientist who has successfully completed a PhD (or equivalent) in Raman spectroscopy of biological systems. Experience in the following areas is desirable: Raman spectroscopy as applied to cells, multivariate statistical analyses, SERS and cell biology. Previous Research Associate level experience is also desirable. You should have a proven publication record in well-ranked journals and you will work well within a team of dynamic students and Research Associates in newly refurbished laboratories on the South Kensington Campus. You will have extensive interaction with several academic collaborators and in addition to the state-of-the-art facilities within the department, you will also have access to the facilities at the new London Centre for Nanotechnology.

Excellent communication and organisational skills are necessary.

Please e-mail m.stevens@imperial.ac.uk asap with your resume and cover letter.  Please quote MAT\Raman in email subject. 

http://www.nanowerk.com/news/newsid=9376.php

http://www.medicaldesignonline.com/article.mvc/New-Identafi-3000-Identifies-Signs-Of-Silent-0001?VNETCOOKIE=NO

New Identafi 3000 Identifies Signs Of Silent Killer

February 25, 2009

Houston, TX - What the oral cancer detection market needs is a breakthrough medical device that is affordable and easy to use and, most important, immediately and reliably detects pre-cancer or cancer in the oral cavity.

Next-Generation Technology Introduced by Trimira

Houston-based Trimira LLC is now rolling out a next-generation oral cancer-screening device that will change the diagnostic landscape for doctors and dentists. Called Identafi 3000, the new device consists of a "multispectral" optical illumination and visualization system housed in a small cordless handheld unit specifically designed for use by dentists, periodontists, oral surgeons, otolaryngologists, and primary-care physicians.

"As they work to accurately and immediately screen for both pre-cancer and cancer, the medical community has a crying need for technology that not only will reliably deliver enhanced specificity, sensitivity, and efficacy, but is inexpensive enough that every doctor and dentist's office can carry it," Trimira VP Jerry S. Trzeciak said.

Unlike other methods, Trimira's Identafi™ 3000 enables doctors and dentists to locate biochemical and morphological changes in the cells of the mouth, throat, tongue, and tonsils, and to get real-time results.

"Oral cancer kills one person every hour of every day," Trzeciak said. "The way to stop it is through early detection, and that means getting every doctor and every dentist involved in that effort."

Having received FDA approval in recent months, Identafi™ 3000 will be unveiled at the 144th Midwinter Meeting of the Chicago Dental Society to be held at McCormick Place in Chicago Thursday, Feb. 26 to Sunday, Mar. 1.

Filling the Early-Detection Technology Vacuum

Identafi 3000 enables those on the front line of detection to catch early signs and stages of oral cancer and pre-cancer that are often missed by the naked eye — which is currently the 'default' means of early detection.

"Trimira's multispectral Identafi technology platform allowed for development of a device that combines three separate wavelengths to visualize both fluorescence and reflectance images in the oral cavity," Trzeciak said. "Trimira's oral cancer screening device can spot the location of pre-cancerous cells and determine the extent of the disease in the area being screened."

Trimira's Identafi technology includes multiple patents and seven patents pending that relate to the detection of pre-cancerous conditions (dysplasia) and cancers. Detection occurs through the processing of optical fluorescence and reflectance in body tissues. The core technologies are based on high-speed, high-resolution, multispectral capabilities from its optical processing technology. The device is able to read metabolic differences in diseased and healthy tissue.

Trimira will leverage the Identafi technology platform to develop diagnostic products that will be able to detect pre-cancerous cells and cancers in other body tissues, including, but not limited to, the cervix, bladder, esophagus, and colon.

$30 Million and 15 Years of Research

The research team that developed the breakthrough multispectral optical illumination system includes:

• Dr. Michele Follen, The University of Texas' M.D. Anderson Cancer Center;
• Dr. Rebecca Richards-Kortum, Rice University
• Dr. Calum Macaulay, British Columbia Cancer Research

The technology was developed by research scientists at The University of Texas' M.D. Anderson Cancer Center and British Columbia Cancer Research Centre.

Trzeciak noted that the research effort has cost some $40 million over 15 years.

Identafi 3000 uses white, violet, and amber wavelengths of light to excite oral tissue in distinct and unique ways. Biochemical changes can be monitored with fluorescence, while morphological changes can be monitored with reflectance. The combined system of fluorescence and reflectance uses the body's natural tissue properties as an adjunctive tool for oral mucosal examination. Conventional examination of tissue is performed using a highly concentrated white light.

A health professional wears reusable Identafi 3000 filtered eyewear to enhance visual effects and allow transmission of reflected light, then switches to violet for a second observation. The clinician's filtered glasses block the violet excitation light and allow the observance of the tissues natural fluorescence. Violet light enhances normal tissue's natural fluorescence; however, suspicious tissue appears dark because of its loss of fluorescence.

When suspect abnormalities are present the selector is switched to amber light, which enhances normal tissue's reflectance properties so the clinician may directly observe the difference between the normal and abnormal tissue's vasculature. This minimizes the impact of confounders when screening and diagnosing oral cancer.

Studies indicate abnormal tissue has a diffuse vasculature, while normal tissue vasculature is clearly defined. The combination of all three multispectral wavelengths provides the clinician with more visual information to differentiate between areas of normal and diseased tissue, and improve decision-making for the health professional in recommending biopsies. In delivering a new "highest standard of care" for patients, Identafi™ 3000 does away with the use of messy and bad-tasting dyes and solutions while ensuring a more thorough oral examination.

Accuracy Is Key to Lowering Oral Cancer Rates

Trzeciak noted that oral cancer has become epidemic due to the lack of effective, broad-based early detection programs. In fact, the oral cancer death rate now surpasses that from breast, cervical, or prostate cancers. The rise in oral cancer has occurred despite decreased use of tobacco products. The reason is thought to be the disease's link to the HPV 16 and 18 viruses.

One of the most common virus groups in the world, HPV (human papilloma virus) affects the skin and mucosal areas of the body. More than 100 types of HPV have been identified.

Oral cancer is often detected late in its development, when the possibility of metastasis is far greater. Like most cancers, cancer of the lip and oral cavity are best treated when found early.

Trzeciak added: "This new technology is huge, and has the potential to transform the landscape of early detection."

SOURCE: Trimira LLC

http://www.marketwatch.com/news/story/biggest-names-field-laser-medicine/story.aspx?guid={41374C9B-47A5-4090-8559-5F9DD9A73487}&dist=msr_2

PRESS RELEASE

The Biggest Names in the Field of Laser Medicine to Speak at Upcoming Annual Conference of the American Society for Laser Medicine and Surgery

Last update: 10:30 a.m. EST Feb. 25, 2009

WAUSAU, Wis., Feb 25, 2009 (BUSINESS WIRE) -- The world's top laser experts will gather in National Harbor, Maryland to share innovations in lasers and emerging technologies at the 29th ANNUAL SCIENTIFIC CONFERENCE OF THE AMERICAN SOCIETY FOR LASER MEDICINE AND SURGERY (ASLMS). "LASER 09" will be held on April 3-5, 2009, at the Gaylord National(TM) Resort and Convention Center.

Headlining the scientific program are acknowledged leaders in the field who will unveil the latest research developments and clinical studies in laser medicine and surgery, as well as present promising devices and technologies poised to enhance disease detection and management. As the ASLMS conference is traditionally regarded as the premier forum for the introduction of the newest breakthroughs in laser diagnostics and related therapies, some of the research and techniques are only in the early stages of development.

In addition to more than 1,500 laser specialists in aesthetics, dermatology, ophthalmology, oncology, laryngology, gynecology and dentistry, about 150 industry exhibitors will be on hand to showcase their latest products.

Scientific Highlights

This year's "hot topics" include, but are not limited to, the following talks:

-- Basic Science: Corneal Surface Reconstruction. A novel light-activated, sutureless technology called photochemical tissue bonding to secure the amniotic membrane over corneal defects will be introduced.

-- Pharmaco-Laser Therapy. Promising research findings will show how integrating dual photothermal and photochemical sensitizing agents into laser therapy can enhance tumor destruction and decrease the likelihood of tumor recurrence.

-- Cosmetic Laser Treatment. The ability of a pulsed dye laser to lighten periorbital dark circles primarily due to increased melanin versus increased vascularity will be evaluated based on data from a split-face study.

-- Photobiomodulation. The latest data on clinical applications of low level light irradiation as a potential treatment for reducing cholesterol and triglyceride serum levels; and the effects of light therapy on cancer cells will be discussed.

-- The Skinny on Fat Reduction - Leading researchers in fat removal, body contouring and cellulite reduction will critically assess non-invasive technologies and techniques.

-- Advanced Technologies in Head and Neck Cancers. Innovations in laser surgery for benign and malignant laryngeal disease will be presented.

Keynote Speaker

This year's keynote speaker is THOMAS GUNDERSON, a managing director and senior research analyst at Piper Jaffray following medical technology companies. Mr. Gunderson's lecture entitled "Aesthetic Technology and Wall Street: Looking Good in Tough Times" will be delivered on Saturday, April 4th.

About the ASLMS

The American Society for Laser Medicine and Surgery (ASLMS) is the world's preeminent resource for laser research, safety, education, and clinical knowledge. Founded in 1980, ASLMS promotes excellence in patient care by advancing clinical application of lasers and related technologies. For more information, please visit www.aslms.org.

For more information regarding press coverage, media registration or to schedule interviews with Society experts, please contact Nadine Tosk at 847.920.9858; nadinepr@gmail.com or Karen Sideris at 219.922.7537; kmssgs@msn.com.

SOURCE: American Society for Laser Medicine and Surgery

for ASLMS 

Nadine Tosk, 847.920.9858 

Karen Sideris, 219.922.7537

Laser Therapy Shows Efficacy in Moderate to Moderately Severe Acute Ischaemic Stroke: Presented at ISC

By Kristina Rebelo

SAN DIEGO -- February 24, 2009 -- The first major clinical trial testing the safety of transcranial laser therapy (TLT) did not significantly reduce stroke disability for the overall group of stroke patients, according to study results presented for the first time at the "Sample of the Best Science" session here at the International Stroke Conference (ISC) 2009.

TLT is a noninvasive technology that uses low-radiation, near-infrared laser energy to painlessly penetrate several centimetres into the skull and treat brain cells in patients with acute ischaemic stroke.

In this trial, the laser was used within 24 hours of stroke onset in patients who had not received tissue plasminogen activator (tPA) therapy, with an average time to laser treatment of 14.6 hours. The study failed to meet its endpoint, although patients experiencing moderate to moderately severe strokes did show an improvement in neurological deficits following the laser therapy.

"For a trial that 'failed,' we are quite encouraged," said principal investigator Justin A. Zivin MD, PhD, Veterans Affairs San Diego Healthcare System and University of California, San Diego, La Jolla, California.

"We saw no ill effects from the laser treatment and, in fact, there was a strong signal that this treatment actually offered some improvement in some patient groups, even in the presence of prior risk factors such as previous stroke, heart disease, and diabetes," Dr. Zivin explained.

"We're not mechanically injuring the brain at all," Dr. Zivin said. "We shave off the patient's hair and aim the laser at 20 points around the head so that the beam can cause a reaction in or around the damaged tissue. We're trying to radiate all sides of the lesion."

NeuroThera Effectiveness and Safety Trial-2 (NEST-2) was a prospective, double-blind, randomised, and sham-controlled study of the safety and effectiveness of the NeuroThera Laser system. NEST-2 was the largest human trial and the first phase 3 clinical trial of transcranial laser therapy to date, with 660 patients treated between January 2007 and April 2008 in 4 countries.

In the trial, the researchers measured laser effectiveness on stroke disability and neurological improvement 90 days after stroke using the modified Rankin Scale (mRS) and the National Institutes of Health Stroke Scale (NIHSS). A control group was included, in which patients received inactive laser therapy.

The primary endpoint was treatment success was defined as mRS scores of 0 to 2. The secondary efficacy endpoint was change in NIHSS score from baseline to 90 days. Tertiary efficacy endpoints included the binary NIHSS score at 30, 60, and 90 days, which defined success as (1) an improvement of 9 or more points on the NIHSS or (2) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analysed across the range of scores from 0 to 6 on the mRS scale; and mortality at 30, 60, and 90 days.

Safety endpoints included the number and percentage of device-related adverse events and procedure-related adverse events through 90 days.

Dr. Zivin noted that the precise mechanisms of laser therapy are unknown, but earlier animal studies indicated that spacing the laser therapy at 20 points around the skull was more effective than targeting 1 point. "That may be because the 20-point approach allows infrared beams to cover the area of brain damage from many different angles," he suggested.

Results showed that 36.3% of patients who received laser therapy improved to mild or no disability within 90 days compared with 30.9% of patients receiving inactive therapy. This difference, however, did not reach statistical significance.

Among patients with moderate to moderately severe impairment at baseline, 51.6% in the laser-treated group improved to mild or no impairment within 90 days compared with 41.9% of the control group. "The 9.7% absolute improvement in the treated patients was significant," Dr. Zivin said.

He added that in the future, researchers hope to explore combination treatment with tPA and laser therapy.

Funding for this study was provided by PhotoThera, Inc., the maker of the laser.


[Presentation Title: The Results of NEST-2: A Double-Blind, Randomized, Phase III Study Evaluating the Safety and Efficacy of Transcranial Laser Therapy for Acute Ischemic Stroke Within 24 Hours of Stroke Onset. Abstract 195]

Source: Hutchinson Technology Incorporated

Assistance Publique Hopitaux De Paris (AP-HP) Selects Hutchinson Technology to Provide Noninvasive Tissue Oxygenation Monitoring

HUTCHINSON, Minn., Feb. 24, 2009 (GLOBE NEWSWIRE) -- Hutchinson Technology Incorporated (Nasdaq:HTCH) announced today that it has signed a two-year tender authorizing it to sell its InSpectra(tm) StO2 Tissue Oxygenation Monitoring System to the 37 French hospitals belonging to the Assistance Publique Hopitaux De Paris (AP-HP). The AP-HP system admits more than 1,000,000 emergency patients per year.

"We are very pleased with the confidence that this multi-hospital system has shown in our InSpectra StO2 System," stated Rick Penn, President of Hutchinson Technology's BioMeasurement Division. "This agreement provides strong validation for the value of non-invasive tissue oxygenation monitoring of critically ill patients. We have put the resources in place to support this opportunity, and we hope to build a strong partnership moving forward."

About the InSpectra StO2 Monitoring System

InSpectra StO2 is a new vital sign with broad applications for critical care medicine. The InSpectra StO2 System for tissue oxygenation monitoring helps clinicians reduce risks and costs by enabling faster and more precise assessment of oxygen delivery to vital organs and tissue. The system provides continuous information using near infrared spectroscopy and a noninvasive, single-use sensor placed on the thenar eminence (thumb muscle).

During shock, the body reduces blood flow to peripheral muscles and core organs (liver, gut and kidneys) in order to preserve oxygenation of the brain and heart. Thus, by measuring tissue oxygenation (StO2) in peripheral thenar muscle, the InSpectra StO2 System uses the body's own response mechanism to provide valuable information on the adequacy of oxygen delivery to these vital organs.

About Hutchinson Technology

Hutchinson Technology is a global technology leader committed to creating value by developing solutions to critical customer problems. The company's BioMeasurement Division is focused on bringing to the market new technologies and products that provide information clinicians can use to improve the quality of health care and reduce costs.

About Assistance Publique Hopitaux De Paris

The AP-HP is made up of 37 hospitals organized into four university hospital groups (GHU): North, East, South and West. Within the AP-HP group 29 hospitals provide OR, ICU and ED services. In addition, AP-HP has developed a special pre-hospital network (SAMU Network) that services all hospitals within the group.

Cautionary Note Regarding Forward-Looking Statements

This announcement contains forward-looking statements regarding product commercialization and adoption. The company does not undertake to update its forward-looking statements. These statements involve risks and uncertainties. The company's actual results could differ materially from those anticipated in these forward-looking statements as a result of changes in market acceptance of the company's products and other factors described from time to time in the company's reports filed with the United States Securities and Exchange Commission.

CONTACT:  Hutchinson Technology Inc.

          Investor Contact:

          Chuck Ives

            320-587-1605

          Media Contacts:

          North America

          Scott Pries

             320-587-1893

          EU and Middle East

          Roberta Ranzo

            31 26 365 33 64

February 24, 2009 09:16 AM Eastern Time 

Imalux® Corporation and Preventive Oncology International®, Inc. Differentiate Grades of Pre-Invasive Cervical Dysplasia with Niris Optical Coherence Tomography Imaging System

http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090224005848&newsLang=en

Studies Yield Statistically Significant Results

CLEVELAND--(BUSINESS WIRE)--Imalux Corporation and Preventive Oncology International, Inc. (POI) conducted two studies to determine the diagnostic efficacy of “real time” Optical Coherence Tomography (OCT). The first study was held in December 2007 and the second in April 2008. Both IRB-approved studies took place in China in partnership with the Peking University Shenzhen Hospital and the Renmin Hospital in Buyi-Miao Autonomous District of Guizhou Province. Two thousand (2000) women participated in the studies and approximately two thousand eight hundred (2,800) OCT images were taken and were compared to diagnostic impression and pathologic findings to determine the accuracy of OCT. The studies yielded the statistically significant abilities of OCT to differentiate grades of pre-invasive cervical dysplasia prior to biopsy.

According to Dr. Nancy Tresser, VP and Chief Medical Officer at Imalux, “These studies showed that we could use Imalux’s Niris^® Imaging System in both high- and low-resource settings with the intent to improve women’s health care globally.”

Epidemiologist Dr. Suzanne Belinson (POI) will be presenting the statistical results of the study at the 25^th International Papillomavirus Conference in Malmo, Sweden this May. Her conclusions are based on the analysis of differences in the brightness of cervical epithelium images. She found that the mean brightness differed significantly between each histological grade (p-values 0.000) for the comparisons of two grades of precancerous dysplasia (CIN II, CIN III) and their comparisons to cancer, as well as squamous metaplasia to cancer.

Cervical cancer is the second greatest cause of cancer deaths in women world-wide and the greatest cause of cancer deaths in women under the age of 50. It is directly linked to the high-risk types of the Human Papillomavirus (HPV). While the current standard for cervical cancer diagnosis in the US is based upon the Pap test, the link between cervical cancer and HPV has made it possible to identify patients at high risk of cervical cancer by testing for the HPV virus.

“POI and Imalux are very encouraged that we have now identified several characteristics associated with pre-invasive and invasive cervical cancer. The Niris System may well be able to provide a rapid, accurate, and efficient method for a single episode of care (“see and treat”) for cervical dysplasia," stated Dr. Jerome Belinson, Founder and President of POI. “We are hoping to conduct similar studies in the near future with a second generation Niris System."

About Imalux

Imalux Corporation, Cleveland, Ohio, is positioned to be a worldwide leader in the development and commercialization of site of care tissue imaging systems utilizing harmless, near-infrared light. The Imalux technology platform, sold under the Niris trademark, is based on our proprietary application of optical coherence tomography using harmless, near-infrared light to provide real-time, high resolution, cross sectional imaging of tissue structures. Niris is a tool to aid in the diagnosis of disease, detection of cancer in its earliest stages, guidance of biopsy and surgery, and post-treatment surveillance in a multitude of clinical applications.

About Preventive Oncology International

Preventive Oncology International (POI) is an international non-profit organization that blends humanitarian work with scientific investigation. Since its founding in 1997, it has been the specific objective of POI to transplant as well as develop techniques of high quality cervical cancer screening, diagnosis and treatment, to the developing countries and other low resource areas. POI has already completed HPV and cervical cancer screening studies in Mexico and Dominican Republic, as well as both urban and rural sites in China. For more information on POI see http://www.poiinc.org/

Contacts

Imalux Corporation
Nancy Tresser, MD, MBA, 216-502-0755 x1002
ntresser@imalux.com

Postdoctoral Position in Optical Imaging

At Roswell Park Cancer Institute (RPCI) we are looking for candidates to take an active part in the research and development of state-of-the-art optical imaging instrumentation. We focus on noninvasive imaging/monitoring of tumors during therapies. RPCI, top ten cancer institute in US, is a cancer center established in 1898 on the principle of integrating clinical cancer care, cancer research and cancer education, making it the oldest “cancer institute” in the US. Photofrin, which was developed at RPCI as a PDT drug, is being used worldwide for treatment of a wide variety of solid tumors. RPCI offers a stimulating work environment integrating physics and engineering with chemistry, biology and medicine.

The candidate will have a unique opportunity in both basic laboratory and translational research by collaborating with scientists and medical doctors located in the same research environment. Several projects are available with a particular focus on CCD/(gated)ICCD based fluorescence tomography to investigate novel drugs in therapy monitoring and a hybrid, portable instrumentation for quantification of blood flow/oxygenation/fluorescence in small animals and in humans. For the details please visit us at:

http://www.roswellpark.org/BIL

Qualifications:

The qualified candidates should have a strong background in Electrical Engineering, Physics, Biomedical Engineering, Medical Physics, or related fields. The contract is offered for a period of one year but can be extended to three years.

Preferred particular skills are following:

• Previous hands-on experience in instrumentation development, hardware control, signal acquisition and processing,
• Experience with diffuse optical tomography, image reconstruction, numerical modeling of light propagation in tissue,
• Strong programming skills and experience with Matlab, Labview, C/C++.

To Apply:

Please send (via email) your CV with three names of reference with contact details and a cover letter describing your background, research experience, and research interests to:

Ulas Sunar, Ph.D.

E-Mail: ulas.sunarATroswellpark.org

Phone: 716-845-3311

BIL-PDT

Roswell Park Cancer Institute

Dept of Cell Stress Biology

Elm & Carlton Streets

Buffalo, NY 14263

Northwestern University invites exceptional candidates to apply for the position of the Associate Director of The Center for Photonics in Biology and Medicine, which is being formed by the University.

The mission of the Center is to develop novel optics technologies for the characterization and imaging of biological tissue. The focus is on the nanoscale, microscale and the molecular levels. The Center also utilizes biophotonics to gain new insights into biological systems and their response to disease. Furthermore, the Center aims to translate these technological and biological innovations into clinical practice. The Center will be supported in part by a recently awarded $7.5M grant from the NIH.

The Associate Director will work in close collaboration with the Center Director, Professor Vadim Backman. S/he will play a leadership role in the Center overseeing administration and ongoing research activities. In particular, the candidate will be responsible for identifying new research targets and help define the Center strategic development. The candidate is expected to help secure new research funding for the Center. The candidate will manage scientists involved in the Center projects, provide creative scientific input and coordinate the overall execution of the projects. The candidate will build relationships and coordinate external collaborations with academia and industry.

The successful candidate will have a Ph.D. and 4+ years of experience in biophotonics or a related field. The candidate will have demonstrated an outstanding record of research accomplishment and leadership documented by peer-reviewed publications and external reputation. The candidate is expected to have excellent interpersonal and writing skills.

Candidates should submit their Curriculum Vitae and the names of four referees by e-mail to the following address: m-proenca@northwestern.edu.

Questions of scientific nature should be addressed to Professor Vadim Backman at v-backman@northwestern.edu. Applications will be accepted until the position is filled.

------------------------------------------------------------------
Maria Jose Proenca

Backman's Lab

Biomedical Engineering Department

McCormick School of Engineering and Applied Sciences
Northwestern University
2145 Sheridan Rd Room NG41

Evanston IL 60208
Tel: 847-467-0395

Fax: 847-491-4928
E-mail: m-proenca@northwestern.edu

http://americanheart.mediaroom.com/index.php?s=43&item=667

Laser treatment clinical trial misses primary endpoint

Abstract 195

Study highlights:
• Low-radiation infrared laser therapy failed to significantly reduce stroke disability in a clinical trial.
• Patients with mild stroke did have improvement in neurological deficits after laser therapy.

SAN DIEGO, Feb. 20, 2009 – Using a laser to treat cells in the brain did not significantly reduce stroke disability, according to results of the first major clinical trial of laser therapy presented at the American Stroke Association’s International Stroke Conference 2009.

The full study will be simultaneously published in Stroke: Journal of the American Heart Association and is presented in the “Sample of the Best Science of the ISC” session during the conference.

Researchers said the laser’s impact on stroke disability did not reach statistical significance for the overall group of stroke patients. However, it appeared that laser therapy did provide some improvement in those experiencing moderate to moderately severe strokes.

“Although our primary endpoint of improvement for overall stroke disability missed reaching statistical significance, we saw no ill effects from the laser treatment. And, in fact, there was a strong signal that this treatment actually offered some improvement for patients with moderate to moderately severe strokes, even in the presence of prior risk factors such as previous stroke, heart disease and diabetes,” said Justin Zivin, M.D. Ph.D., principal investigator of the study and a professor of neurosciences at the University of California San Diego.

The NeuroThera Effectivess and Safety Trial (NEST-2) was a prospective, double-blind, randomized and sham (inactive procedure) controlled study of the safety and effectiveness of a device called the NeuroThera® Laser System. NEST-2, which included 660 patients and 53 researchers in four countries, is the largest human trial and the first Phase III (large randomized trial of effectiveness) of transcranial laser therapy to date. Researchers found:

• Overall, 36.3 percent of patients who received laser therapy improved to mild or none on a disability rating scale within 90 days compared to 30.9 percent of patients receiving (non-laser) inactive therapy. This difference of 5.4 percent did not reach statistical significance.

• However, of the patients considered to have moderate to moderately severe stroke impairment, 51.6 percent in the laser-treated group improved to mild or no disability range in 90 days compared to 41.9 percent of the control group. That represents a 9.7 percent absolute improvement in treated patients, which is statistically significant, Zivin said.

“For a trial that ‘failed,’ this one was reasonably encouraging,” Zivin said, a staff neurologist at the San Diego Veterans Administration (VA) Medical Center. “Laser therapy is unlike most treatments that have been tried for acute stroke.”

The only FDA-approved treatment for a stroke caused by a blood clot (an ischemic stroke) is an intravenous clot-busting drug called tissue plasminogen activator or tPA and it must be given within three hours of symptom onset. Other treatments include delivering clot-busters directly to the arteries and mechanical clot removal.

In this trial, the laser was used within 24 hours of stroke onset, with the average time to treatment being 14.6 hours. The device uses low-energy infrared radiation to painlessly penetrate several centimeters into the skull.

“We’re not mechanically injuring the brain at all,” Zivin said. “We shave off the patient’s hair and aim the laser at 20 points around the head so that the beam can cause a reaction in or around the damaged tissue.”

While the mechanisms of laser therapy are unknown, earlier animal studies indicated that spacing the laser therapy at 20 points around the skull was more effective that targeting one point. That may be because the 20-point approach allows infrared beams to cover the area of brain damage from many different angles, he said.

In the trial, researchers used two well-known scales to measure laser effectiveness on stroke disability and neurological improvement 90 days after stroke. The modified Rankin Scale (mRS) is a seven-point (0 to 6) scale of stroke disability and dependence in which “0” represents no disability; “1” refers to deficits so slight only a neurologist would notice them; “2” is slight disability such as the inability to conduct previous activities, but able to care for own affairs without assistance; and “6” is death. The mRS was used as the trial endpoint, which is the number of patients in each group who had improved to the 0-2 range on the mRS 90 days after the procedure or sham procedure, he said.

The 42-point National Institutes of Health Stroke Scale (NIHSS) is a simplified neurologic exam that measures stroke-related neurologic deficits such as extremity strength, sensory function, coordination and language ability. A higher number means more impairment.

Earlier studies have shown that stroke patients who score 7 or below on the NIHSS tend to recover to the range of 0 to 2 on the Rankin Scale on their own without any treatment. Here, researchers focused on patients who scored 7 to 22 on the NIHSS when they arrived at the hospital.

Although this study excluded stroke patients who received tPA, Zivin said he hopes to explore combination treatment with laser therapy and tPA in the future, he said.

Co-authors are Marc Fisher, M.D.; Greg Albers, M.D.; Natan Bornstein, M.D.; Werner Hacke, M.D., Ph.D.; Bjorn Dahlof, M.D., Ph.D.; Robert Lew, Ph.D.; Sanja Ilic, M.D. and Jackson Streeter, M.D. Individual author disclosures can be found on the abstract.

The study was funded by PhotoThera, Inc., the maker of the laser.

Statements and conclusions of study authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.  

###

Blue Light Kills MRSA

Blue Light -- Without UV -- Kills Drug-Resistant Staph Superbug

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Feb. 4, 2009 -- Blue light -- not including dangerous UV frequencies -- kills MRSA, the multidrug-resistant staph superbug.

The finding comes from Chukuka S. Enwemeka, PhD, and colleagues at New York Institute of Technology. Their study was funded by Dynatronics Corp., which makes the blue-light device used in the study.

In earlier studies, Enwemeka's team found that MRSA died when exposed to blue light that included part of the ultraviolet (UV) spectrum. Even though the total UV dose was less than that of a few minutes of sunlight, it would be safer not to expose humans to any more UV light than necessary.

So the researchers used a LED device that emits blue light not in the UV spectrum, and found it worked nearly as well.

"Irradiation with [blue] light energy may be a practical, inexpensive alternative to treatment with pharmacologic agents, particularly in cases involving cutaneous and subcutaneous MRSA infections," Enwemeka and colleagues conclude.

The researchers tested two MRSA strains: one typical of the strains that bedevil hospitals, and one typical of the strains found in the community. Both strains were susceptible to the blue light.

Relatively low doses of blue light -- about 100 seconds' worth -- killed off about 30% of MRSA in laboratory cultures. Longer doses were more effective, although with diminishing returns. It took about 10 times longer exposure to kill off 80% of the MRSA in culture dishes.

Exactly how blue light kills MRSA, or whether the bacteria can become blue-light resistant, isn't known.

The study will appear in the April 2009 issue of Photomedicine and Laser Surgery.

http://ca.sys-con.com/node/839698/print

New Identafi(TM) 3000 Identifies Signs of Silent Killer:

TRIMIRA(TM) LLC to Introduce First-of-Its-Kind Device To Aid Dentists & Doctors in Detecting Oral Cancer

Growing at Alarming 11% Rate, Oral Cancer is Overlooked, Yet More Deadly Than Breast, Cervical, or Prostate Cancers

HOUSTON, Feb. 11 /PRNewswire/ -- Without a truly effective and affordable device to aid in early detection, dentists, hygienists, and doctors have been fighting an uphill battle against a silent killer -- oral cancer, which has reached epidemic levels (11 percent annual growth rate) due in part to unsafe practices like oral sex.

Filling the Early-Detection Technology Vacuum

Houston-based TRIMIRA(TM) LLC is stepping into the technology breach with a next-generation cancer-screening device that will change the diagnostic landscape for doctors and dentists. The device will be unveiled at the 144th Midwinter Meeting of the Chicago Dental Society to be held at McCormick Place Thu.-Sun., Feb. 26-Mar. 1.

Called Identafi(TM) 3000, the new device consists of a three-wavelength optical illumination and visualization system housed in a small cordless handheld unit specifically designed for use by dentists, periodontists, oral surgeons, otolaryngologists, and primary-care physicians.

Identafi(TM) 3000 is unlike anything in the dental/doctor detection tool kit because it lets those on the front line of detection to catch early signs and stages of oral cancer and pre-cancer that are often missed by the naked eye -- which is currently the main (and ineffectual) means of early detection.

Identafi(TM) 3000 enables doctors and dentists to identify biochemical and morphological changes in the cells of the mouth, throat, tongue, and tonsils.

"As they work to accurately and immediately screen for both pre-cancer and cancer, the medical community has a crying need for technology that not only will reliably deliver enhanced specificity, sensitivity, and efficacy, but is inexpensive enough that every doctor and dentist's office can carry it," TRIMIRA(TM) VP Jerry S. Trzeciak explained.

"Oral cancer kills one person every hour of every day, " he said. "The way to stop it is through early detection, and that means getting every doctor and every dentist involved in that effort."

Accuracy Is Key to Lowering Oral Cancer Rates

Trzeciak noted that oral cancer has become a true epidemic due to the lack of effective, broad-based early detection programs. In fact, the oral cancer death rate now surpasses that from breast, cervical, or prostate cancers. The rise in oral cancer has occurred despite decreased use of tobacco products. The reason is the disease's link to the HPV 16 and 18 viruses.

One of the most common virus groups in the world, HPV (human papilloma virus) affects the skin and mucosal areas of the body. More than 100 types of HPV have been identified.

"Trimira's multispectral Identafi(TM) technology platform allowed for development of a device that combines three separate wavelengths to visualize both fluorescence and reflectance images in the oral cavity," he said. "Trimira's oral cancer screening device can spot the location of pre-cancerous cells and determine the extent of the disease in the area being screened."

Oral cancer is often detected late in its development, when the possibility of metastasis is far greater. Like most cancers, cancer of the lip and oral cavity are best treated when found early.

Metastasis is the spread of a disease from one organ or body part to another nonadjacent organ or body part. Only malignant tumor cells and infections have the capacity to metastasize. Cancer cells can break away or spill from a primary tumor and enter the bloodstream or lymphatic system, and thus circulate to and infect normal tissues.

Trzeciak added: "This new technology is huge, and has the potential to transform the landscape of early detection." He noted that Identafi(TM) 3000 recently received FDA approval.

Oral Cancer Strategy Hinges on Early Detection

Early detection of oral cancer translates into cure rates of greater than 80 percent, which is one reason why the American Cancer Society (ACS) and American Dental Association (ADA) both recommend opportunistic screening for oral cancer.

Yet the National Cancer Institute estimates that only 20 percent of the U.S. population receives an annual oral examination. In fact, the ADA estimates that while 60 percent of the U.S. population visits a dentist every year, fewer than 15 percent of those who regularly visit a dentist report actually having received an oral cancer screening.

Not surprisingly, 40 percent of those diagnosed with oral cancer will die within five years because the majority of those cases will be discovered only as a late-stage malignancy.

Oral cancer is so dangerous because so few patients notice symptoms of the disease in its early stages. It can progress without causing pain or obvious signs. As a result, oral cancer often goes undetected until it has metastasized and spread to another part of the body.

"The bottom line is that we need population-based screening programs to catch the disease as early as possible," Trzeciak said. "It's the only way we're going to beat oral cancer."

About TRIMIRA(TM) LLC

TRIMIRA(TM) LLC is a subsidiary of Remicalm LLC, a privately held medical diagnostic and imaging device company, and is its first subsidiary. Other subsidiaries are working on screening and diagnostic devices for skin, cervical, gastrointestinal, and bladder cancers. Remicalm targets certain female cancers with its optical processing technology for cancer of the cervix. Remicalm, as the parent company, has licensed exclusive use of certain of its patents and patents pending for use as a cervical cancer product to be later expanded to include additional epithelial based cancers. Remicalm's core technologies are based on high-speed, high-resolution capabilities from its patented optical processing technology platforms and include the ability to read metabolic and physiologic differences in diseased and healthy tissue in the human body.

Visit TRIMIRA(TM) at: http://www.trimira.net/

http://www.genengnews.com/news/bnitem_print.aspx?name=49860111

Human papillomavirus lesion identified at the dentist

EUREKALERT

Contact: Stefanie Schroeder
media@agd.org
312-440-4346
Academy of General Dentistry

Technology identifies cancerous oral tissue

CHICAGO (February 18, 2009) - Human papillomavirus (HPV) is a group of viruses that includes more than 100 different strains or types and is the most common sexually transmitted virus. The American Social Health Association (ASHA) reports that 75 percent or more of sexually active Americans will contract HPV sometime in their lives. HPV is most commonly attributed to causing cervical cancer and genital warts, but did you know HPV also causes oral cancer?

According to a study in General Dentistry, the clinical, peer-reviewed journal of the Academy of General Dentistry (AGD), oral HPV can be detected using a very familiar, conventional device that patients may already experience in your mouth during routine procedures. This device is the VELscope. It's the fun wand that emits a bright, indigo blue light. If you've ever had a cavity, your dentist may have used the VELscope to set/harden the material used to fill the cavity.

John C. Comisi, DDS, FAGD, author of the study, discovered that the blue light emitted from the VELscope also detects cancerous oral tissue. The study explains that when emitting a specific wavelength of light into the mouth, oral fluorescence occurs, which in turn causes the tissue to emit its own light (this is called natural fluorescence). The VELscope produces a blue light that excites the oral tissue cells. Healthy cells will fluoresce back and appear green in color, while damaged and unhealthy cells will not fluoresce and thus appear as black or dark maroon areas against the green surrounding tissue.

"Surgery can remove cancerous lesions, but typically if they are found at a late stage, the surgery can be extensive," says Dr. Comisi. "Only early detection can help to minimize the extent of surgery needed to eradicate the disease. The earlier a lesion is detected, the higher the rate of survival," he adds.

The Oral Cancer Foundation says that more than 34,000 Americans will be diagnosed with oral or pharyngeal cancer this year. Of those 34,000 newly diagnosed individuals, only half will be alive in 5 years. It will cause over 8,000 deathskilling roughly 1 person per hour, 24 hours per day. The Oral Cancer Foundation warns that oral cancer is typically hard to diagnose because in early stages, it may not be noticed by the patient. The next time you visit your dentist, ask about oral cancer screeningmost people receive one during their regular dental checkup but do not realize it. AGD spokesperson, Eugene Antenucci, DMD, FAGD, says, "Dentists have a unique ability to diagnose disease at an early stage. All dentists are trained to do comprehensive oral screening examinationseach individual practitioner decides on how to implement their training in their practices."

Numerous studies have shown a connection to oral and overall health. That is why it is important to disclose all health related problems to a dentistincluding STDs. "Web site educational information also proves helpful in informing and educating patients regarding diseases such as HPV, its mode of transmission, means of prevention, and the need for regular examinations utilizing technologies such as VELscope for early detection," says Dr. Antenucci.

###

Prevention and detection

• Maintain regular dental check-ups
• Ask your dentist to perform an oral cancer screening
• Disclose your medical history to your dentist including STDs
• Avoid tobacco and alcohol use
• If you notice abnormal growths, discoloration, tenderness, or bleeding contact your dentist right away.

Lasers and a century-old dye could supplant needles and thread.

By Lauren Gravitz

Despite medicine's inestimable progress over the past century, surgery can still leave scars that look more appropriate to Frankenstein's monster than to the beneficiary of a precise, modern operation. But in the Wellman Center for Photomedicine at Massachusetts General Hospital, Irene Kochevar and Robert Redmond have developed a method that has the potential to replace the surgeon's needle and thread. Using surgical lasers and a light-activated dye, the researchers are prompting tissue to heal itself.

Laser-bonded healing is not a new idea. For years, scientists have been trying to find ways to use the heat generated by lasers to weld skin back together. But they've had a difficult time finding the right balance. Too little heat and a wound won't heal; too much and the tissue dies. Eight years ago, one of Kochevar and Redmond's colleagues was examining pathology slides of cells killed by this kind of thermal healing when it occurred to him that it might be possible to use just the light of a laser, rather than its heat.

While the idea of skin weaving itself back together may sound more like superhero lore than surgical skill, the science is startlingly simple. The team took advantage of the fact that a number of dyes are activated in the presence of light. In the case of Rose Bengal--a stain used in just about every ophthalmologist's office to detect corneal lesions--the researchers believe that light helps transfer electrons between the dye molecule and collagen, the major structural component of tissue. This produces highly reactive free radicals that cause the molecular chains of collagen to chemically bond to each other, or "cross-link." Paint two sides of a wound with Rose Benga­l, illuminate it with intense light, and the sides will knit themselves back together. "We call this nano suturing," Kochevar says, "because what you're doing is linking together the little collagen fibers. It's way beyond anything that a thread of any kind can do."

The benefits of such nano suturing are manifold. In just about every case, it appears to result in faster procedures, less scarring, and possibly fewer infections, since it seals openings completely and leaves no gap through which bacteria can penetrate. This makes it particularly well suited for closing not only superficial skin incisions but also those made in eye and nerve operations. In eye surgeries, such as corneal replacement, stitches that can cause irritation and infection must sometimes be left in place for months, which can aggravate complications. In nerve surgeries, damage from scar tissue can decrease the conduction of neural impulses. "If you put a needle through skin, it's not a big deal," says Redmon­d. "But if you put it through a nerve it's a big deal, because you're destroying part of the nerve."

Light Work
The operations take place in a surgical suite of tile and stainless steel. Min Yao, a surgeon on Kochevar and Redmond's team, has carted a medical laser up from the lab downstairs. The instrument is already used for eye, ear, nose, and throat procedures, and its green light has just the right wavelength for maximum absorption by the pink Rose Bengal stain. The better the light is absorbed, the more it activates the dye and the more complete the collagen cross-linking. The box that generates the laser light is barely larger than a stere­o receiver; a thin fiber-optic cable snakes out of its side, and it gives off an appletini-green glow.

For this particular test surgery, on the skin of an anesthetized rabbit, surgeon Ying Wang measures and marks a patch of skin to be removed, an elliptical, leaf-shaped patch 1.5 centimeters wide by 3.5 centi­meters long. After removing the tissue, Wang begins closing the wound. Surgical cuts typically require two layers of suturing: buried, or subcutaneous, stitches to bring deep tissu­e together, and superficial ones to close up the skin itself. Wang moves her needle and thread through the subcutaneous layer, working her way deftly from one end of the incision to the other. Then she moves on to the epidermal layer.

Wang closes up the right half of the cut with three stitches, black thread standing out against the rabbit's pink skin. Then she takes a vial of Rose Bengal and drips the neon-pink dye onto either side of the unclosed portion of the wound. She threads the laser's fiber-optic cable into a metal stand, which maintains a set distance between laser and tissue while holding the light steady; a lens focuses the beam into a sharp, straight line that can be aligned with the incision. Wang positions the stand on the rabbit's flank, dons a pair of orange safety glasses, sets a timer, and steps down on the pedal that activates the laser. A green glow washes over the room.

Three minutes later, the timer beeps and Wang releases the pedal. She removes her safety glasses, moves the laser stand away, and inspects her handiwork. A small line is visible--a remnant of the Rose Benga­l stain and of the black marker used to trace the location of the incision prior to surgery. But when she tugs on the wound, using a pair of forceps in each hand to pull the skin apart, the skin holds taut, and there's little visible evidence of the cut itself.

A Bright Future
"It's a very interesting technology, which would be useful to anyone who does any kind of skin surgery--plastic surgeons, d­ermatologists," says Robert Stern, a professor of dermatology at Harvard Medical School and chief of dermatology at Beth Israel Deaconess Medical Center in Bosto­n. He notes that the technology must still prove itself, and he isn't yet convinced that the benefits will offset the costs of photochemical dyes and laser equipment, which are far pricier than a needle and thread. But, he says, the potential to minimize scarring and perhaps speed healing "could be nice for patients and improve outcomes [too]."

So far, use of the technique in humans has been limited to skin surgeries: in a clinical trial, 31 patients with skin cancers and suspicious moles had their three-to-five-centimeter excisions closed with sutures on one side and photo­chemical tissue bonding on the other. The dermatological procedure will be submitted to the U.S. Food and Drug Administration for approval, which the researchers are awaiting before beginning additional human trials. Animal experiments have already shown the technique to be useful in nerve, eye, and blood vessel surgeries, among others--so useful, in fact, that Kocheva­r and Redmond have surgeons ready and waiting to start human trials the moment the hospital approves them.

"Talk to just about any physician about this, and they have an idea for how it could be used," Kochevar says. The technology is limited by tissue depth: it works only where light will penetrate, so it could never replace subcutaneous sutures or be effective on dark or opaque tissue like liver and bone. The scientists have licensed the technology to a brand-new startup, still in stealth mode, which plans to commercialize the tech­nology once it receives FDA approval. The company has just begun seeking its first round of funding.

Copyright Technology Review 2009.

by Darren Murph, posted Feb 15th 2009 at 1:01AM

It sounds more like something you'd see in X-Men than on an actual operating table in real life, but a team at Massachusetts General Hospital has developed a way to heal surgical incisions with laser light. Christened laser-bonded healing, the methodology has been studied for years, but up until now, scientists have found it impossible to find the perfect balance of heat required to coax tissue into healing itself back together. Irene Kochevar described the process as "nano suturing," as diminutive collagen fibers are woven together in a way that the old-fashioned needle-and-thread method simply can't match. The benefits, as you can likely imagine, are numerous: less scarring, faster recovery, the potential for fewer infections and bragging rights that you were struck with lasers and survived. Still, the procedure is far from becoming commonplace in ORs, given that the dermatological procedure hasn't even been submitted to the FDA yet. 'Til then, it's up to you and Wolverine to figure things out.

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