Dementia, including Alzheimer's disease, is one of the most devastating conditions of older age. Currently affecting nearly 7 million individuals in the U.S. and 24 million worldwide, dementia leads to total loss of memory and the ability to function independently - making it one of people's greatest fears of aging.
Delirium is an acute confusional state, a common and serious complication in older individuals that often follows surgery or serious illness. Sometimes accompanied by disorientation, paranoia and hallucinations, delirium develops in 14 to 56 percent of all hospitalized seniors, complicating hospital stays for over 4 million older individuals in the U.S. each year.
For the most part, dementia and delirium have been viewed as separate and distinct conditions. But a special section of The Journal of Gerontology: Medical Sciences, appearing in January 2007, looks at their interface, asking: Can delirium itself lead to the development of a cognitive disorder? Do delirium and dementia represent opposite ends of the same spectrum of disease, rather than two separate conditions?
"I have been studying delirium for 20 years," says Sharon Inouye, MD, MPH, a geriatrician at Beth Israel Deaconess Medical Center and Director of the Aging Brain Center at the Institute for Aging Research, Hebrew SeniorLife. "And the more cases I encounter, the more linkages I see with dementia. For a large proportion of older patients, the problem [of delirium] is never resolved. I routinely hear from patients' families, 'They went into the hospital, they became very confused, and they never recovered.'"
Inouye, a professor of medicine at Harvard Medical School, together with Luigi Ferrucci, MD, PhD, Chief of the Longitudinal Studies Section of the National Institute on Aging and Editor-in-Chief of the journal, which is published by the Gerontological Society of America, examined the relationship between these two widespread conditions during the "Aging Brain Center Scientific Symposium: The Interface of Delirium and Dementia," held last spring.
"Better understanding of delirium may represent a new window of opportunity for the prevention of dementia," explains Ferrucci. "We, therefore, decided to approach the subject from a multidisciplinary perspective, exploring delirium and dementia from a number of vantage points." Findings spawned from the symposium make up the five articles featured in the special issue of the journal, including:
* Biomarkers. "There is currently no way of identifying delirium save for the observations of an astute clinician," notes Inouye. In this review article, BIDMC geriatrician Edward Marcantonio, MD, examines a number of promising biomarkers for delirium, including serum chemistries,genetic markers, serum anticholinergic activity, neurotransmitters, inflammatory markers and cortisol.
* Role of neuroimaging. Physicist David Alsop, PhD, of BIDMC's Department of Radiology, describes major advances in neuroimaging - including advanced methods using magnetic resonance (MR) imaging, positron emission tomography (PET) and single photo emission computed tomography (SPECT) -- which offer the possibility of using highly sensitive imaging techniques to detect changes in the brain following episodes of delirium and thereby investigate the mechanisms and networks involved in its onset and consequences.
* Use of SPECT scanning to assess cerebral perfusion changes in patients with delirium. Led by Tamara Fong, MD, of BIDMC's Department of Neurology, this paper describes the results of a study examining a group of hospitalized patients, which shows that frontal or parietal cerebral perfusion abnormalities occur in cases of delirium. These results suggest localized involvement in the brain's frontal and parietal lobes with delirium, which may correlate with the clinical findings and long-term outcomes.
* The link between anesthesia and development of long-term delirium. Zhongcong Xie, MD, together with senior author Rudolph Tanzi, MD, of the Genetics and Aging Research Unit, Massachusetts General Institute for Neurodegenerative Disease, demonstrate that the commonly used anesthetic isoflurane results in neuronal cell death, and enhancement of A-beta oligomerization, for the first time, providing a direct link between the acute effects of inhalational anesthetics (recognized risk factors for delirium) and the hallmark mechanisms of Alzheimer's disease neuropathogenesis.
* The potential role for cognitive reserve. Inouye, together with BIDMC gerontologist Richard Jones, ScD, an investigator in the Institute for Aging Research at Hebrew SeniorLife, report their findings showing that hospitalized older persons with lower levels of education may be at increased risk for delirium relative to older persons with more education. "People have varying degrees of cognitive reserve, the capability to withstand insults and stresses to their system [such as might occur in a hospital setting]," explains Inouye. "Our study shows that amount of education correlates with brain resiliency, perhaps by building greater numbers of neuronal pathways."
Delirium is a tremendous expense to the country's medical system, amounting to more than $7 billion per year in hospital expenses and more than $100 billion a year when rehabilitation, institutionalization and long-term care is factored in.
In a 1999 study in The New England Journal of Medicine, Inouye demonstrated that delirium can be decreased by 40 percent by implementing a number of straightforward interventions while patients are hospitalized. These include making sure that patients are oriented and hydrated, that they are up and walking, that they are using their hearing aids and vision aids, and that they avoid the use of sleep medications.
"Our goal now is to better understand the fundamental changes that cause delirium and determine whether they result in permanent injury to the brain, in order to better devise ways to intervene and prevent this injury," explains Inouye. "Knowing that our population is rapidly aging, these figures are only going to increase unless we do something now. We hope to eventually be able to identify at-risk individuals before they develop delirium, so that we can intervene before it escalates to a chronic condition."
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In addition to Inouye, coauthors include: BIDMC investigators Edward Marcantonio, MD, and David Alsop, PhD, and Brigham and Women's Hospital investigators James Rudolph, MD, Deborah Culley, MD, and Gregory Crosby, MD, for "Serum Biomarkers for Delirium."
David Alsop, Michael Fearing, PhD, of Hebrew SeniorLife, Keith Johnson, MD, of Massachusetts General Hospital, Reisa Sperling, MD, of Brigham and Women's Hospital, and Tamara Fong, MD, of BIDMC for "The Role of Neuroimaging in Elucidating Delirium Pathophysiology."
Tamara Fong, MD, Sidney Bogardus, Jr., MD, Linda Leo-Summers, Aditya Daftary, MD, and Hal Blumenfeld, MD, and John Seibyl, MD, of Yale University School of Medicine; Eliza Auerbach, MD, of Columbia School of Medicine; Sharada Modur of Ohio State University, for "Cerebral Perfusion Changes in Older Delirious Patients Using 99mTc HMPAO SPECT."
Zhongcong Xie, PhD, Yuanlin Dong, Uta Maeda, Robert Moir, and Rudolph Tanzi, PhD, of Mass General Institute for Neurodegenerative Disease, MGH; Deborah Culley, MD, and Gregory Crosby, MD, of Brigham and Women's Hospital for "Isofluorane-Induced Apoptosis: A Potential Pathogenic Link Between Delirium and Dementia."
Richard Jones, ScD, Frances Yang, PhD, Ying Zhang, MD, MPH, Dan Kiely, MPH, MA, and Edward Marcantonio, MD, of the Institute for Aging Research, Hebrew SeniorLife for "Does Educational Attainment Contribute to Risk for Delirium? A Potential Role for Cognitive Reserve."
Funding for the studies and article was provided, in part, by grants from the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, the Alzheimer's Association and the Donaghue Medical Research Foundation.
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and ranks third among independent hospitals nationwide in National Institutes of Health (NIH) funding. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu/.
The Aging Brain Center is housed within Hebrew SeniorLife's Institute for Aging Research, the country's largest geriatric research facility in an applied setting. It is located at Hebrew Rehabilitation Center in Boston, which is also a major teaching site for the Harvard Medical School Multi-Campus Fellowship in Geriatric Medicine. IFAR is distinguished by the multidisciplinary nature of its faculty, which includes both social and medical research scientists.
Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center
April 15, 2007
Low-Dose Aspirin Lowers Risk Of Asthma Diagnosis
In a large, randomized, placebo-controlled study of 22,071 healthy male physicians, taking a low-dose of aspirin every other day lowered the risk of receiving an initial asthma diagnosis by 22 percent.
These findings, based on data from the double-blind Physicians' Health Study, appear in the second issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Tobias Kurth, M.D., Sc.D., of the Division of Aging at Brigham and Women's Hospital in Massachusetts, and five associates studied physicians, ages 40 to 84, over a period of 4.9 years. Among the 11,037 individuals who took aspirin, 113 new cases of asthma were diagnosed, as contrasted to 145 in the placebo group.
Asthma is a chronic inflammatory disease that causes potentially reversible obstructive lung problems. Breathing difficulties from asthma usually occur during "attacks," which involve narrowing of the airways, swelling of the lining, tightening of respiratory muscles and an increased secretion of mucus. In 2004, more than 20 million Americans were estimated to have asthma.
"Aspirin reduced the risk by 22 percent of newly-diagnosed adult-onset asthma," said Dr. Kurth. "These results suggest that aspirin may reduce the development of asthma in adults. They do not imply that aspirin improves symptoms in patients with asthma."
"Indeed, asthma can cause severe bronchospasm in some patients who have asthma," he continued. "Because asthma was not the primary endpoint of the U. S. Public Health Service study, additional randomized trials would be helpful to confirm the apparent reduction in asthma incidence caused by aspirin."
The Physicians Health Study, which began in 1982, was terminated after 4.9 years when results showed a 44-percent reduction in the risk of a first heart attack among those randomly assigned to aspirin.
"Physicians could self-report an asthma diagnosis on questionnaires at baseline, at six months and annually thereafter," said Dr. Kurth. "Asthma was not the original deductive endpoint of the trial."
According to the authors, the 22-percent lower risk of newly-diagnosed asthma among those assigned to the low-dose aspirin group was not affected by participant characteristics like smoking, body mass index or age.
They noted that aspirin-intolerant asthma, a problem in which aspirin exacerbates the disease, affects only a small minority of asthma patients. In three large population-based studies, that difficulty affected only four to 11 percent of the groups. In children, however, the proportion affected by aspirin intolerant asthma was significantly smaller.
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Contact: Suzy Martin
American Thoracic Society
These findings, based on data from the double-blind Physicians' Health Study, appear in the second issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Tobias Kurth, M.D., Sc.D., of the Division of Aging at Brigham and Women's Hospital in Massachusetts, and five associates studied physicians, ages 40 to 84, over a period of 4.9 years. Among the 11,037 individuals who took aspirin, 113 new cases of asthma were diagnosed, as contrasted to 145 in the placebo group.
Asthma is a chronic inflammatory disease that causes potentially reversible obstructive lung problems. Breathing difficulties from asthma usually occur during "attacks," which involve narrowing of the airways, swelling of the lining, tightening of respiratory muscles and an increased secretion of mucus. In 2004, more than 20 million Americans were estimated to have asthma.
"Aspirin reduced the risk by 22 percent of newly-diagnosed adult-onset asthma," said Dr. Kurth. "These results suggest that aspirin may reduce the development of asthma in adults. They do not imply that aspirin improves symptoms in patients with asthma."
"Indeed, asthma can cause severe bronchospasm in some patients who have asthma," he continued. "Because asthma was not the primary endpoint of the U. S. Public Health Service study, additional randomized trials would be helpful to confirm the apparent reduction in asthma incidence caused by aspirin."
The Physicians Health Study, which began in 1982, was terminated after 4.9 years when results showed a 44-percent reduction in the risk of a first heart attack among those randomly assigned to aspirin.
"Physicians could self-report an asthma diagnosis on questionnaires at baseline, at six months and annually thereafter," said Dr. Kurth. "Asthma was not the original deductive endpoint of the trial."
According to the authors, the 22-percent lower risk of newly-diagnosed asthma among those assigned to the low-dose aspirin group was not affected by participant characteristics like smoking, body mass index or age.
They noted that aspirin-intolerant asthma, a problem in which aspirin exacerbates the disease, affects only a small minority of asthma patients. In three large population-based studies, that difficulty affected only four to 11 percent of the groups. In children, however, the proportion affected by aspirin intolerant asthma was significantly smaller.
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Contact: Suzy Martin
American Thoracic Society
Narcotics Often Prescribed For Back Pain But Efficacy Data Are Poor And Chances For Abuse High
A review of studies on use of narcotics for chronic back pain found that they are commonly prescribed and may help for short-term pain relief but that substance abuse disorders are common, occurring in up to 24 percent of cases (Review, p. 116). But many of the studies are of poor quality and none evaluated relief of pain lasting 16 weeks or longer.
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Tip sheet: Annals of Internal Medicine, Jan. 16, 2007, issue
NOTE: Annals of Internal Medicine is published by the American College of Physicians.
Contact: Susan Anderson
American College of Physicians
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Tip sheet: Annals of Internal Medicine, Jan. 16, 2007, issue
NOTE: Annals of Internal Medicine is published by the American College of Physicians.
Contact: Susan Anderson
American College of Physicians
Big Purses Can Cause Big Problems To Your Health
Was a big purse on your wish list this holiday season? It's one of the biggest fashion trends this season, but experts say those over-sized bags may leave you with back, neck and shoulder pain, headaches and possibly even arthritis.
"I see so many women with neck pains and headaches and what I usually do is look for their purse and pick it up," says Jane Sadler, M.D., family practice physician on the medical staff at Baylor Medical Center at Garland.
"We take it over to the scale and weigh it and usually they're anywhere from 7 to 10 pounds."
The new extra-large purses mean women are carrying more, causing an imbalance as they walk and stand.
"If you think about how you carry a bag, it's usually on one side and you kind of pull your neck to one side and lift your shoulder. It's a very unnatural position," says Dr. Sadler.
That kind of weight pulling down on you for several hours at a time can leave a lasting impression.
"It creates strain along the neck and into the nerves that exit the neck and down the shoulder so it can be very painful later on for many women," adds Dr. Sadler.
So how heavy is too heavy when it comes to your purse? Dr. Sadler says that if you're carrying your cell phone, makeup and wallet in your purse that's already too much. If your purse is uncomfortable when you put it on, if you can feel it pulling on your shoulder, or if it weighs more than just a few pounds, Dr. Sadler says it may be time to downsize your bag.
"We're really going to see women with more and more problems later on if we continue the big purse craze," Dr. Sadler says.
Here's a couple of tips to help you lighten your purse load: try downsizing your wallet only carry the credit cards and cash you need, leave the oversized makeup bags at home, and carry your cell phone with a clip on your body.
For more information about Baylor Medical Center at Garland, visit http://www.BaylorHealth.com.
Baylor Health Care System
2001 Bryan St., Ste. 2200
Dallas, TX 75201
United States
http://www.BaylorHealth.com
"I see so many women with neck pains and headaches and what I usually do is look for their purse and pick it up," says Jane Sadler, M.D., family practice physician on the medical staff at Baylor Medical Center at Garland.
"We take it over to the scale and weigh it and usually they're anywhere from 7 to 10 pounds."
The new extra-large purses mean women are carrying more, causing an imbalance as they walk and stand.
"If you think about how you carry a bag, it's usually on one side and you kind of pull your neck to one side and lift your shoulder. It's a very unnatural position," says Dr. Sadler.
That kind of weight pulling down on you for several hours at a time can leave a lasting impression.
"It creates strain along the neck and into the nerves that exit the neck and down the shoulder so it can be very painful later on for many women," adds Dr. Sadler.
So how heavy is too heavy when it comes to your purse? Dr. Sadler says that if you're carrying your cell phone, makeup and wallet in your purse that's already too much. If your purse is uncomfortable when you put it on, if you can feel it pulling on your shoulder, or if it weighs more than just a few pounds, Dr. Sadler says it may be time to downsize your bag.
"We're really going to see women with more and more problems later on if we continue the big purse craze," Dr. Sadler says.
Here's a couple of tips to help you lighten your purse load: try downsizing your wallet only carry the credit cards and cash you need, leave the oversized makeup bags at home, and carry your cell phone with a clip on your body.
For more information about Baylor Medical Center at Garland, visit http://www.BaylorHealth.com.
Baylor Health Care System
2001 Bryan St., Ste. 2200
Dallas, TX 75201
United States
http://www.BaylorHealth.com
Anesiva Announces Clinical Data From Phase 1 Trial Of 1207
Anesiva, Inc. (Nasdaq: ANSV) announced today clinical data from a Phase 1 safety study of product candidate 1207, which was being tested as a topical anesthetic for treatment of neuropathic patients. 1207 achieved the primary endpoint of the study of safety and tolerability. In the studied population of healthy volunteers, no clear anesthetic effect of 1207 was demonstrated.
"While we are disappointed that we did not see positive efficacy in this trial, our primary focus is on our two most advanced pain product candidates -- Zingo(TM), for which we recently filed a New Drug Application, and 4975, which is expected to enter pivotal trials later this year," stated John P. McLaughlin, chief executive officer of Anesiva. "Based on the results of the Phase 1 trial of 1207, we are no longer pursuing the clinical development of this drug."
The Phase 1 study enrolled a total of 24 adult healthy male volunteers in six dose-escalating cohorts at a single clinical center in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study measured sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been submitted for the most advanced product, Zingo(TM). The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com/.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended September 30, 2006.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Anesiva, Inc.
http://www.anesiva.com/
"While we are disappointed that we did not see positive efficacy in this trial, our primary focus is on our two most advanced pain product candidates -- Zingo(TM), for which we recently filed a New Drug Application, and 4975, which is expected to enter pivotal trials later this year," stated John P. McLaughlin, chief executive officer of Anesiva. "Based on the results of the Phase 1 trial of 1207, we are no longer pursuing the clinical development of this drug."
The Phase 1 study enrolled a total of 24 adult healthy male volunteers in six dose-escalating cohorts at a single clinical center in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study measured sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been submitted for the most advanced product, Zingo(TM). The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com/.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended September 30, 2006.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Anesiva, Inc.
http://www.anesiva.com/
Penwest Begins Next Study In Development Of Nalbuphine ER
Penwest Pharmaceuticals Co. (Nasdaq: PPCO) today announced that it has begun a Phase I safety study on a nalbuphine hydrochloride extended release tablet formulation (Nalbuphine ER) that the Company is developing for the treatment of pain.
Nalbuphine ER is a controlled release formulation of nalbuphine hydrochloride that Penwest is developing using its TIMERx(R) drug delivery technology. It is designed to be taken as a twice-daily tablet.
The primary objective of the Phase I safety study is to evaluate the safety and tolerability of the drug in healthy subjects of escalating dosage levels during multiple-dose steady-state administration. The secondary objective is to evaluate the pharmacokinetics of nalbuphine during steady-state administration and the effect of different nalbuphine ER dosage levels on typical opioid-related side effects.
Alan F. Joslyn, Ph.D., Penwest's Senior Vice President of Research and Development, said, "This next step in the clinical development of nalbuphine ER demonstrates our progress in building our own product portfolio. We are conducting the Phase I safety study to enhance our understanding of the safety and pharmacokinetics of multiple doses of nalbuphine ER over the projected clinical dose range. We believe that, combined with the single dose safety and efficacy data we already have, this study will give us the information necessary to advance to the Phase II program we intend to begin in the first half of this year."
The study will employ a randomized sequential dose-escalation design, with a planned total enrollment of 32 healthy adult subjects in two separate alternating cohorts. The study will examine a total of four dosage levels. Each subject will receive treatment at two different dose levels sequentially, with a number of days at each dosage level until steady state plasma concentrations are achieved.
The Company expects subject participation to be complete by the end of February, with data available in the second quarter.
About Penwest
Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for diseases of the nervous system. At the core of this strategy, Penwest applies drug delivery technologies, including its own proprietary technologies, to new and existing compounds to enhance their therapeutic profiles. The launch by Endo Pharmaceuticals of Opana(R) ER (oxymorphone hydrochloride extended-release tablets) in mid-2006 demonstrates the execution of this strategy and the value of Penwest's TIMERx(R) extended release delivery technology. Penwest is currently applying its expertise to a pipeline of potential products that are in various stages of development. The Company intends to commercialize these products independently and through third party alliances.
Forward-Looking Statement
The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," "potential," and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of our products; regulatory risks relating to drugs in development, including the timing and outcome of regulatory action; uncertainty of success of collaborations; the timing of clinical trials and whether the results of clinical trials will warrant further clinical trials or warrant submission of an application for regulatory approval of, or the regulatory approval of, the product that is the subject of the trial; actual and potential competition; the need for capital; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2006, which risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release speak only as of the date of the statement made. Penwest disclaims any intention or obligation to update any forward-looking statements.
TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.
Penwest Pharmaceuticals Co.
http://www.penw.com/
Nalbuphine ER is a controlled release formulation of nalbuphine hydrochloride that Penwest is developing using its TIMERx(R) drug delivery technology. It is designed to be taken as a twice-daily tablet.
The primary objective of the Phase I safety study is to evaluate the safety and tolerability of the drug in healthy subjects of escalating dosage levels during multiple-dose steady-state administration. The secondary objective is to evaluate the pharmacokinetics of nalbuphine during steady-state administration and the effect of different nalbuphine ER dosage levels on typical opioid-related side effects.
Alan F. Joslyn, Ph.D., Penwest's Senior Vice President of Research and Development, said, "This next step in the clinical development of nalbuphine ER demonstrates our progress in building our own product portfolio. We are conducting the Phase I safety study to enhance our understanding of the safety and pharmacokinetics of multiple doses of nalbuphine ER over the projected clinical dose range. We believe that, combined with the single dose safety and efficacy data we already have, this study will give us the information necessary to advance to the Phase II program we intend to begin in the first half of this year."
The study will employ a randomized sequential dose-escalation design, with a planned total enrollment of 32 healthy adult subjects in two separate alternating cohorts. The study will examine a total of four dosage levels. Each subject will receive treatment at two different dose levels sequentially, with a number of days at each dosage level until steady state plasma concentrations are achieved.
The Company expects subject participation to be complete by the end of February, with data available in the second quarter.
About Penwest
Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for diseases of the nervous system. At the core of this strategy, Penwest applies drug delivery technologies, including its own proprietary technologies, to new and existing compounds to enhance their therapeutic profiles. The launch by Endo Pharmaceuticals of Opana(R) ER (oxymorphone hydrochloride extended-release tablets) in mid-2006 demonstrates the execution of this strategy and the value of Penwest's TIMERx(R) extended release delivery technology. Penwest is currently applying its expertise to a pipeline of potential products that are in various stages of development. The Company intends to commercialize these products independently and through third party alliances.
Forward-Looking Statement
The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," "potential," and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of our products; regulatory risks relating to drugs in development, including the timing and outcome of regulatory action; uncertainty of success of collaborations; the timing of clinical trials and whether the results of clinical trials will warrant further clinical trials or warrant submission of an application for regulatory approval of, or the regulatory approval of, the product that is the subject of the trial; actual and potential competition; the need for capital; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2006, which risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release speak only as of the date of the statement made. Penwest disclaims any intention or obligation to update any forward-looking statements.
TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.
Penwest Pharmaceuticals Co.
http://www.penw.com/
Pharmos Announces Clinical Data From Phase 2a Trial Of Cannabinor For Capsaicin-induced Pain
Pharmos Corp. (Nasdaq: PARS) today announced preliminary results from its Phase 2a study evaluating intravenous (i.v.) cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model. The drug candidate did not meet the primary endpoint defined by analgesic effects compared to placebo, but confirmed safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.
The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia (pain resulting from a non- noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).
"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Dr. Haim Aviv, Chairman & CEO. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising." Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of Phase 1 testing.
The Company expects to complete its separate, ongoing Phase 2a clinical trial of cannabinor as a treatment for nociceptive pain in the first quarter of 2007. The single-center, randomized, double-blinded, single-administration study compares different i.v. doses of cannabinor with placebo. The completed study will involve 100 healthy male subjects experiencing pain following third molar dental extraction.
About Cannabinor and CB2-Selective Cannabinoids
Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in post-operative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin. In a number of models where duration of analgesia was measured, cannabinor remained effective at reducing pain significantly longer than morphine. Preliminary evidence from preclinical studies also suggests that tolerance to the therapeutic effect of cannabinor might not occur. A drug that remains effective without increasing dosage would be a valuable advance in treating severe pain.
Pharmos' cannabinoid research focus has been geared toward the development of selective and specific CB2 receptor agonists. Because they range from having little (CB2-selective) to barely detectable (CB2-specific) affinity for the central nervous system-located CB1 receptor, CB2-selective and -specific agonists lack the unwanted psychotropic side effects of many natural cannabinoids. CB2 agonists bind to CB2 receptors, which are located on immune and inflammatory cells. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders. Pharmos is developing its CB2 agonists as treatments for chronic pain and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Cannabinor is the first lead candidate to emerge from this body of Pharmos' proprietary technology.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (gastrointestinal/irritable bowel syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, with positive effect on the primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor and other CB2 agonist compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders. Pharmos is also working to commercialize its unique proprietary NanoEmulsion drug delivery system, which is in clinical stage development for topical application of analgesic and anti-inflammatory agents.
Pharmos Corp.
http://www.pharmoscorp.com
The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia (pain resulting from a non- noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).
"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Dr. Haim Aviv, Chairman & CEO. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising." Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of Phase 1 testing.
The Company expects to complete its separate, ongoing Phase 2a clinical trial of cannabinor as a treatment for nociceptive pain in the first quarter of 2007. The single-center, randomized, double-blinded, single-administration study compares different i.v. doses of cannabinor with placebo. The completed study will involve 100 healthy male subjects experiencing pain following third molar dental extraction.
About Cannabinor and CB2-Selective Cannabinoids
Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in post-operative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin. In a number of models where duration of analgesia was measured, cannabinor remained effective at reducing pain significantly longer than morphine. Preliminary evidence from preclinical studies also suggests that tolerance to the therapeutic effect of cannabinor might not occur. A drug that remains effective without increasing dosage would be a valuable advance in treating severe pain.
Pharmos' cannabinoid research focus has been geared toward the development of selective and specific CB2 receptor agonists. Because they range from having little (CB2-selective) to barely detectable (CB2-specific) affinity for the central nervous system-located CB1 receptor, CB2-selective and -specific agonists lack the unwanted psychotropic side effects of many natural cannabinoids. CB2 agonists bind to CB2 receptors, which are located on immune and inflammatory cells. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders. Pharmos is developing its CB2 agonists as treatments for chronic pain and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Cannabinor is the first lead candidate to emerge from this body of Pharmos' proprietary technology.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (gastrointestinal/irritable bowel syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, with positive effect on the primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor and other CB2 agonist compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders. Pharmos is also working to commercialize its unique proprietary NanoEmulsion drug delivery system, which is in clinical stage development for topical application of analgesic and anti-inflammatory agents.
Pharmos Corp.
http://www.pharmoscorp.com
Long-Term Narcotics Use For Back Pain May Be Ineffective And Lead To Abuse
Narcotic drugs (opioids) are commonly prescribed for short-term relief of chronic back pain, but their effectiveness long-term has been questioned in a review article by researchers at Yale School of Medicine, who also found that behaviors consistent with opioid abuse was reported in 24 percent of cases.
"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."
Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.
The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.
"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.
###
In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.
Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)
Yale News Releases are available via the World Wide Web at http://www.yale.edu/opa
For further information please go to:
Yale University
"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."
Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.
The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.
"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.
###
In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.
Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)
Yale News Releases are available via the World Wide Web at http://www.yale.edu/opa
For further information please go to:
Yale University
Childhood Obesity Linked To Foot Pain
January 17, 2007) Doctors with the American College of Foot and Ankle Surgeons (ACFAS) say they're noticing more and more overweight and obese children with foot and ankle pain in their examining rooms, mirroring a national epidemic of childhood obesity.
An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.
"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.
The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.
Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to FootPhysicians.com, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.
Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.
"The numbers are definitely increasing. I treat four to five overweight children a week," he says.
Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.
Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.
"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.
For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site, http://FootPhysicians.com.
The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website, http://www.footphysicians.com.
American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States
http://www.acfas.org
An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.
"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.
The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.
Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to FootPhysicians.com, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.
Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.
"The numbers are definitely increasing. I treat four to five overweight children a week," he says.
Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.
Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.
"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.
For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site, http://FootPhysicians.com.
The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website, http://www.footphysicians.com.
American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States
http://www.acfas.org
Leading Radiofrequency Manufacturer Introduces A New Product For Treating Heel Pain
NeuroTherm, Inc., a global leader in radiofrequency generators for chronic pain management, announces the introduction of an RF product specifically for the podiatric market: The PodiaTherm RF Generator, designed to treat chronic heel pain, which often is associated with plantar fasciitis.
Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.
"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."
The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.
"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.
"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.
According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.
Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.
NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.
NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at http://www.neurotherm.com.
Additional information about the PodiaTherm RF Generator can be found on the Internet at http://www.podiatherm.com.
NeuroTherm, Inc.
http://www.neurotherm.com
Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.
"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."
The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.
"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.
"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.
According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.
Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.
NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.
NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at http://www.neurotherm.com.
Additional information about the PodiaTherm RF Generator can be found on the Internet at http://www.podiatherm.com.
NeuroTherm, Inc.
http://www.neurotherm.com
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