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| Microendoscope Provides An Alternative To Painful Muscle Biopsy |
| 07.25.08 (1:15 pm) [edit] |
Using an unusual microscope with a tip the size of a needle, Stanford researchers are now able to look at tiny fibers of working muscles in live humans, with minimum discomfort to the patient - a development patients are sure to welcome.
This microendoscopy technique for viewing sarcomeres - microscopic lengths of muscle fiber about 3 millionths of a meter long - has advantages over the uncomfortable alternative, a muscle biopsy in which a portion of the muscle is removed for examination.
Sarcomeres are the basic contracting engines of muscle. They generally pull in a coordinated fashion, allowing us to walk down the sidewalk or throw a sinking curveball from the pitcher's mound. But out-of-sync sarcomeres are implicated in muscular dystrophy and other diseases of diminished muscular control. It is thought that disease may change the length of sarcomeres and cause havoc with muscle control because the force exerted by muscle is critically dependent on length.
To observe sarcomeres in action, researchers from Stanford's Bio-X program have devised a needle-thin probe, which is inserted through the skin into muscle. When a flash of finely tuned laser light is sent through the probe, the sarcomeres respond with light of their own to form a snapshot of muscle in action.
The researchers see the images in real time on a display screen. A change in the depth of focus of the rapidly scanning device can provide a three-dimensional movie.
"This is a method that does not require any operative procedures," said Mark Schnitzer, an assistant professor of biology and of applied physics. For the first time, "it allows us to view individual sarcomeres in live humans."
The breakthrough was reported online in the journal Nature on July 6.
The technology could prove useful in understanding how muscles are altered by spinal cord injuries or strokes as well as muscular diseases, according to another of the researchers, Scott Delp, a professor of bioengineering and of mechanical engineering and, by courtesy, of orthopedic surgery.
Other areas of interest include biomechanics, orthopedic reconstructions, prosthetic devices and tendon transfers, in which tension adjustments are a crucial element for patients relearning how to walk or grasp. "If you measure the length of the sarcomeres during surgery, then you can adjust them to work at their optimal length, giving maximum muscle strength," Delp said.
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Article adapted by Medical News Today from original press release.
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Research funding came in part from the Wallace H. Coulter Foundation and involved co-investigators from the Department of Bioengineering and the School of Medicine. Additional funding was provided by a Stanford Bio-X Interdisciplinary Initiatives award. The authors of the research paper, in addition to Schnitzer and Delp, are graduate students Michael Llewellyn, bioengineering and medicine, and Robert Barretto, biophysics.
Related information: Source: Dan Stober
Stanford University
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| Physician Owned Hospitals Linked To Shifts In Care |
| 07.25.08 (1:15 pm) [edit] |
After physicians become part-owners of specialty hospitals, referrals for surgery and other hospital tests and treatments increase significantly, suggests a study in the July issue of Medical Care. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.
"Given the growth in physician-owned hospitals, these findings suggest that health care expenditures will be substantially greater for patients treated at these institutions relative to persons who obtain care from non self-referral hospitals," writes Jean M. Mitchell, Ph.D., of Georgetown University, Washington, D.C.
Dr. Mitchell analyzed patterns in the care of Oklahoma workers compensation patients treated for back and spine problems from 2001 to 2004. Her focus was on how physicians' practice patterns changed after they became part-owners of specialty hospitals. Recent years have seen a growing number of physician-owned specialty hospitals, which are limited to providing specialized, relatively profitable services such as spine, orthopedic, or heart surgery.
During the period studied, two new physician-owned specialty hospitals an orthopedic hospital and a spine hospital opened in the Tulsa area. Dr. Mitchell compared changes in practice patterns for doctors who did and did not become part-owners of one of these two hospitals.
Referrals for complex spinal surgery jumped 650 percent
The results showed a significant increase in referrals for certain treatments and tests after physicians gained ownership interest. The most dramatic change was a 650 percent increase in patients referred for "complex" spinal fusion surgery: from 0.1 percent before ownership to 6.51 percent after ownership. In contrast, for non-owner physicians, referrals for complex spinal fusion surgery remained stable at less than one percent.
At the same time, physician-owners became less likely to refer patients for less-costly "simple" spinal fusion surgery, compared to an increase in such referrals for non-owners. Physicians who became owners also became more likely to refer patients for ancillary services performed at specialty hospitals, including physical therapy and diagnostic tests such as MRI scans.
Specialty hospitals are generally exempted from federal and state laws banning physicians from referring patients to facilities where they have an investment interest. Proponents of specialty hospitals contend that, by concentrating on a single area, these facilities can lower costs while potentially enhancing quality. However, critics suggest that financial incentives create an inherent conflict of interest for physician owners.
The new results suggest that physicians' behavior changes after they become owners of specialty hospitals, including a dramatic increase in referrals for complex and costly spinal operations. As the market share of physician-owned specialty hospitals continues to rise, health care costs may be higher for patients treated at these centers than for patients treated by physicians who do not profit from self-referrals, Dr. Mitchell believes. She concludes, "These findings should be of interest to policymakers and third party insurers who are concerned about increased utilization associated with physician self-referral arrangements and its subsequent contribution to escalating health care expenditures for individuals with good insurance coverage."
About Medical Care
Rated as one of the top ten journals in healthcare administration, Medical Care is devoted to all aspects of the administration and delivery of healthcare. This scholarly journal publishes original, peer-reviewed papers documenting the most current developments in the rapidly changing field of healthcare. Medical Care provides timely reports on the findings of original investigations into issues related to the research, planning, organization, financing, provision, and evaluation of health services. In addition, numerous special supplementary issues that focus on specialized topics are produced with each volume. Medical Care is the official journal of the Medical Care Section of the American Public Health Association. Visit the journal website at http://www.lww-medicalcare.com" title="http://www.lww-medicalcare.com" target="_blank"http://www.lww-medicalcare.co....
About Lippincott Williams & Wilkins
Lippincott Williams & Wilkins (http://www.LWW.com" title="http://www.LWW.com" target="_blank"http://www.LWW.com) is a leading international publisher for healthcare professionals and students with nearly 300 periodicals and 1,500 books in more than 100 disciplines publishing under the LWW brand, as well as content-based sites and online corporate and customer services. LWW is part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.
Wolters Kluwer Health is a division of Wolters Kluwer, a leading global information services and publishing company with annual revenues (2007) of €3.4 billion ($4.8 billion), maintains operations in over 33 countries across Europe, North America, and Asia Pacific and employs approximately 19,500 people worldwide. Visit http://www.wolterskluwer.com" title="http://www.wolterskluwer.com" target="_blank"http://www.wolterskluwer.com for information about our market positions, customers, brands, and organization.
Lippincott Williams & Wilkins
530 Walnut St.
Philadelphia, PA 19106
United States
http://www.lww.com" title="http://www.lww.com" target="_blank"http://www.lww.com
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| Published Study Demonstrates Effectiveness Of Vitalstim Therapy For Patients Suffering With Dysphagia |
| 07.25.08 (1:14 pm) [edit] |
A recent study published in the April 2008 issue of the Annals of Otology, Rhinology & Laryngology has revealed the positive clinical effect of the adjunctive use of VitalStim® Therapy. A leading brand within the Empi Recovery Sciences line of pain management and rehabilitation products, VitalStim is a non-invasive neuromuscular electrical stimulation (NMES) device for the treatment of dysphagia. Results of the study were also originally presented at the American Association of Speech-Language Pathology Conference in Miami, Fla. in November 2006.
Dysphagia, or difficulty swallowing, is a sorely neglected medical condition which affects 15 million Americans and is generally caused by a neurological disorder or event, such as a stroke, degenerative neurological diseases and head and neck cancer. Without proper management, dysphagia can lead to aspiration, pneumonia, choking, chronic malnutrition, severe life-threatening dehydration, an increased rate of infection, longer hospital stays, long-term institutional care and even death.
VitalStim Therapy is a non-invasive external electrical stimulation therapy that was cleared to market by the FDA in December 2002. VitalStim is a portable, dual-channel electrotherapy system that is used with electrodes specifically designed for application to the muscles of the throat to promote swallowing.
Entitled "Adjunctive Neuromuscular Electrical Stimulation for Treatment-Refractory Dysphagia," the study details the measured clinical effect of the VitalStim program on six patients with chronic, treatment-refractive dysphagia. The study describes a prospective case series using validated outcome measures to represent different domains and a standard program of dysphagia therapy, which includes a consistent application of NMES following VitalStim Therapy protocol.
Patients received an average of 12 treatment sessions throughout the study. Following the treatment, patient measurements demonstrated key findings, including:
- 80 percent of patients reached the defined primary end-point of clinical improvement in swallowing ability, with significant Mann Assessment of Swallowing Ability (MASA) score improvements;
- All patients in the study significantly increased the range and amount of materials consumed orally - 83 percent of the patients increased their Functional Oral Intake (FOIS) score by at least two scale points, with most of the patients progressing from a restricted, single-consistency diet to a full oral diet;
- The average weight gain for the group over the three-week treatment period was two pounds;
- Patients involved in the study perceived significant improvement in their ability to swallow after treatment - no patient rated their post-therapy swallowing ability as lower than their baseline score;
- No patient experienced any swallowing-related medical complication over the treatment period.
The study was led by Giselle D. Carnaby-Mann, MPH, Ph.D., associate research scientist in the Department of Behavioral Science and Community Health at the University of Florida, and Michael A. Crary, Ph.D., professor in the Department of Communicative Disorders at the University of Florida. In addition, both are co-directors of the Swallowing Research Laboratory at the University of Florida.
Six months following completion of the treatment period, four of the patients completing the protocol returned for a medical review. Post-treatment examinations showed no statistically significant changes in clinical outcome measures, showing sustained efficacy after cessation of treatment.
For more information, please visit http://www.vitalstimtherapy.com/research" title="http://www.vitalstimtherapy.com/research" target="_blank"http://www.vitalstimtherapy.c....
About Empi, Inc.
Headquartered in St. Paul, Minnesota, Empi is a leading manufacturer and provider of non-invasive medical products for pain management and physical rehabilitation. Empi is committed to delivering positive patient outcomes and providing innovative products specifically designed to meet the needs of the patient, medical professional, and payor. For additional information on the company, please visit http://www.empi.com" title="http://www.empi.com" target="_blank"http://www.empi.com. Empi is a DJO company.
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| MAKO Uses SolidWorks Software To Design Robotics And Implants For Minimally Invasive Surgery Alternative |
| 07.25.08 (1:13 pm) [edit] |
More than 1,000,000 stiff and aching knees worldwide get replaced every year, many of which are now candidates for a breakthrough, minimally invasive knee surgery option called MAKOplasty®. All of the procedure's key components - including a robotic arm and minimally-invasive resurfacing knee implants - were designed in SolidWorks® 3D CAD software.
Based on more than 200 licensed or owned patent applications and patents, MAKOplasty enables orthopedic surgeons to treat patient-specific, early- to mid-stage osteoarthritic knee disease with consistent, reproducible precision. The procedure employs the MAKO Tactile Guidance System™ (TGS™), a proprietary, FDA-cleared surgeon-interactive robotic arm system that controls surgeons' movements through the use of tactile resistance technology. Computer-generated virtual surfaces guide surgeons and the robotic arm along their planned path and focus cutting on patient-specific 3D visualizations, based on pre-operative imaging. The surgeon can confidently make complex tissue-sparing and bone-conserving cuts. Any necessary adjustments can be made during the operation, and patients stand to recover faster.
The Fort Lauderdale, Fla., MAKO Surgical Corp. used SolidWorks software to design the TGS, which uses proprietary cable-drives instead of gears to make the robotic arm extremely human-interactive, enabling very high-fidelity tactile response. Knee replacement doesn't have to be 'total'
"The implants and instruments benefit from SolidWorks' rapidly improving surfacing capabilities, and the TGS design benefits from SolidWorks' large assembly and motion simulation capabilities," said MAKO CTO, Senior Vice-President and Co-founder Rony Abovitz. "We also use SolidWorks to design the virtual volumes - the safe cutting zones, if you will - that guide the surgeon in reshaping patients' bone surfaces prior to implanting. SolidWorks handles all of these jobs well, and the software is easy for our engineers to learn no matter what platform they've learned on."
The MAKOplasty design effort has been under way since 1997, tracing its surgical navigation and medical robotics roots to a wide range of licensed and internally developed technologies, notably the MIT Artificial Intelligence (AI) Lab, Northwestern University's Lab for Intelligent Machines, and The Cleveland Clinic. One of the original seats of SolidWorks was used by William Townsend, CEO of Barrett Technology and the co-inventor of core cable-drive robot technologies (WAM™ arm) at the MIT AI Lab.
"Bill Townsend introduced me to SolidWorks co-founder Jon Hirschtick in the late 1990's - the two had been friends for some time. Since the introduction, we have had a long connection and affinity with SolidWorks - the karma is good, and the results we have produced to date with it have been great," said Abovitz.
SolidWorks Corporation Vice President of Worldwide Marketing and Strategy Rainer Gawlick said, "MAKOplasty represents a substantial leap in the state of the art, one that stands to benefit a vast and rapidly growing population. It will be interesting to see patients benefit and the company gradually expand its range of robotic arm-assisted procedures."
MAKO Surgical relies on authorized SolidWorks reseller The SolidExperts for ongoing software training, implementation, and support.
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| Increased Risk Of Developing Rheumatoid Arthritis When Birth Weight Exceeds 10 Pounds |
| 07.25.08 (1:12 pm) [edit] |
People who have a birthweight over 10 pounds are twice as likely to develop rheumatoid arthritis when they are adults compared to individuals born with an average birthweight, according to a study published by researchers from Hospital for Special Surgery online in advance of print in the Annals of the Rheumatic Diseases. While the mechanism for this association is unclear, the study identifies a potentially modifiable risk factor and highlights a potential way to decrease the incidence of the disease.
"There may be a relationship between being born over 10 pounds and getting rheumatoid arthritis later in life," said Lisa Mandl, M.D., MPH, who led the study and is an attending rheumatologist at Hospital for Special Surgery (HSS) in New York City. "If there was some way that you could prevent someone from getting rheumatoid arthritis by making sure their birth weight wasn't over 10 pounds, this is a risk factor that could be modifiable. You can't change someone's age. You can't change someone's gender, but potentially you could change someone's birth weight. This is however only speculative at this point."
Previously, investigators have demonstrated that an increased risk of adult onset chronic disease can be a function of the fetal environment. Strong associations between low birth weight and an increased risk of type 2 diabetes mellitus, coronary heart disease and hypertension have been documented in a number of different populations. Published in 2003, a case-control study of roughly 400 individuals in Sweden identified an association between high birthweight and rheumatoid arthritis.
To see if this association played out in a larger population, Dr. Mandl and colleagues turned to a study of 87,077 women in the Nurses' Health Study. In 1976, nurses were invited to participate in this study that involved a baseline survey and then a biennial questionnaire regarding health status, lifestyle, family medical history and health practices. The investigators excluded women who had cancer or any type of connective tissue disease at baseline or follow-up because these can cause joint swelling, symptoms that can be confused with rheumatoid arthritis. Also excluded were women who reported having rheumatoid arthritis or connective tissue disease during follow-up, but in whom the diagnosis could not be confirmed by review of their medical record. The study population included only women who answered a 1992 survey that collected information about birthweight. After these exclusions, 87,077 individuals were included in the study and 619 of them developed rheumatoid arthritis.
Through statistical analysis, the investigators discovered that a birthweight of greater than 4.54 kg doubled the risk that a person would develop rheumatoid arthritis as an adult compared with individuals who had an average birthweight.
"In utero, the fetus will react appropriately to different stressors. However, this may preprogram the fetus so that when it gets out into the world, this preprogramming is not helpful out in the 'real world'," said Dr. Mandl. In other words, the fetal environment may be preprogramming people's brains or endocrine systems to be maladapted in later life.
"There have now been two different groups, in different countries with different patients born at different times, that both suggest a similar relationship between birthweight and rheumatoid arthritis," said Dr. Mandl. "I hope that other people will think about looking for this association in other populations."
Dr. Mandl says that patients with rheumatoid arthritis are known to have a dysregulated hypothalamic-pituitary-ad renal (HPA) axis, and this axis may be affected in utero. The HPA axis is the body's neuroendocrine system that involves the hypothalamus, pituitary and adrenal glands; this system is responsible for handling stress by regulating the production of cortisol, neurotransmitters and key hormones.
"If you look at this as a theoretic biologic underpinning for why this might be true, it might give basic scientists interesting ideas to think about regarding what causes rheumatoid arthritis, and provide support for a new hypothesis," Dr. Mandl said.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, about 2.1 million people, or between 0.5 and 1 percent of the U.S. adult population, have rheumatoid arthritis, an autoimmune disease that causes chronic inflammation of the joints. The disease is more common in women and has no cure, but can be managed in a way that allows individuals to live productive lives.
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Article adapted by Medical News Today from original press release.
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In addition to researchers from Hospital for Special Surgery and Weill Cornell Medical College, investigators from the Brigham and Women's Hospital, Harvard Medical School contributed to the study. This research was supported by grants from the National Institutes of Health.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2007), and has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center. In 2008 and 2007, HSS was a recipient of the HealthGrades Joint Replacement Excellence Award. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weill Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at http://www.hss.edu/" title="http://www.hss.edu/" target="_blank"http://www.hss.edu/.
Source: Phyllis Fisher
Hospital for Special Surgery
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| New Drug Prevents Dangerous Complications Of Hip And Knee Surgery, Says McMaster Professor |
| 07.25.08 (1:10 pm) [edit] |
A McMaster University researcher predicts a new oral blood thinner will revolutionize treatment for preventing dangerous blood clots in patients undergoing hip and knee surgery.
Dr. Alexander Turpie, professor of medicine in the Michael G. DeGroote School of Medicine, oversaw four major international studies on the drug rivaroxaban (Xarelto). All studies found the drug was significantly more effective than the current standard enoxaparin (low molecular weight heparin) in preventing venous thrombosis (VTE).
VTE begins with a blood clot in a vein and is a serious, frequent and potentially fatal complication of major orthopedic surgery.
Heparin and warfarin are the anticoagulants commonly used to treat this condition but warfarin, in particular, is difficult to monitor because it changes with diet, other drugs and alcohol. "Much of that will be overcome with this new drug," Turpie said.
Turpie chairs the executive committee for the RECORD clinical program (Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE), a global program of four clinical trials (RECORDS1, 2, 3 and 4) involving more than 12,500 patients which is comparing oral rivaroxaban with injectable enoxaparin.
He is presenting a meta-analysis of the four studies today (Thursday, June 26) at the 20th International Congress on Thrombosis in Athens, Greece. "It will be the first time people will see the dramatic benefits," he said. "When you put it all together, you can see the growth and potential for this drug."
Results of the RECORD3 clinical trial, of which Turpie is the senior author, appear today (Thursday, June 26) in the New England Journal of Medicine (NEJM).
RECORD3 is a randomized, double-blind trial of 2,531 patients undergoing total knee replacement surgery. Patients received either oral rivaroxaban, 10 mg once daily, beginning six to eight hours after surgery, or a 40 mg injection of enoxaparin once a day, beginning 12 hours before surgery.
Both treatments continued for 10 - 14 days.
For patients treated with rivaroxaban, there was a 49 per cent relative risk reduction (RRR) in total VTE and a 62 per cent RRR in major VTE compared with those treated with enoxaparin. Both drugs showed a low rate of bleeding.
In the same NEJM issues, other researchers reported on the RECORD1 study which also found rivaroxaban was "significantly more effective" than enoxaparin.
An accompanying editorial in the NEJM suggested the positive reports from the two RECORD studies raises questions that reach far beyond individual drugs to the overall process of drug development, such as: What are the guiding principles for developing safe, effective and widely applicable anticoagulants?
Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a wide range of indications to prevent and treat blood clots. It works at a pivotal stage in the complex coagulation process to directly inhibit the enzyme Factor Xa. Based on extensive studies, the drug has been shown to have a wide therapeutic window without the need for routine monitoring.
The drug is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
It is not licensed for sale in Canada. Bayer Inc. has submitted a regulatory filing to Health Canada for approval to market rivaroxaban.
The number of total knee and total hip replacements is rising in Canada, with the majority of procedures being performed on people aged 55 and older.
From 2004 to 2005, close to 60,000 people underwent hip and knee replacement surgeries in Canada. Among these patients, blood clots are the most common cause of re-hospitalization. VTE is considered the most frequent preventable serious and potentially fatal complication following major orthopedic surgery.
The threat of blood clots goes far beyond orthopedic surgeries: Blood clots are one of the leading causes of global disease and death in many patients, including those with atrial fibrillation, heart attack, acutely ill hospitalized patients, such as those with cancer.
McMaster University
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| Anesiva Commences Phase 2 Trial Of Adlea(TM) In Arthroscopic Shoulder Surgery |
| 07.25.08 (1:09 pm) [edit] |
Anesiva, Inc. (Nasdaq: ANSV) announced that it has begun a Phase 2 clinical trial of Adlea(TM), the company's long-acting, site specific, non-opioid drug candidate for the management of acute pain in patients undergoing arthroscopic shoulder surgery involving rotator cuff repair.
Adlea is currently in two pivotal Phase 3 trials in the U.S.: one in total knee replacement surgeries and one in bunionectomy surgeries. An additional Phase 2 Adlea trial is in progress in total hip replacement surgeries. These trials are among those intended to support an Adlea label indication for the management of acute pain following orthopedic surgery.
The Phase 2 arthroscopic shoulder surgery trial is being conducted in South Korea. Unlike the United States, where the procedure is often conducted on an outpatient basis, arthroscopic shoulder surgery patients in South Korea are routinely hospitalized for up to two days, thus allowing more extensive near-term follow-up.
"We believe Adlea holds promise for treating pain associated with a number of orthopedic surgical indications, and may reduce the need for other pain treatments such as opioids," said Michael L. Kranda, Anesiva's president and chief executive officer. "As we pursue a broad indication of management of post-surgical pain following orthopedic procedures, each specific procedure that we can evaluate will add to the breadth of available data for Adlea."
Arthroscopic surgery is performed through small incisions using an arthroscope, or camera, to visualize the inside of a joint. Through the incisions, a surgeon inserts a camera and small instruments to perform the procedure. According to the American Academy of Orthopedic Surgeons, about six million Americans go to the doctor each year for shoulder pain, dislocation, or other shoulder problems and up to 500,000 arthroscopic shoulder surgeries are performed in the United States each year.
This multicenter, randomized, double-blind, dose-escalating, placebo-controlled study is evaluating the safety, tolerability, efficacy, and pharmacokinetics of a single dose of Adlea administered via injection following surgical closure of the wound. The trial is designed to enroll 74 patients.
Anesiva announced approval of its investigational new drug application for Adlea in South Korea in June 2008.
How Adlea May Address the Need for Long-Duration, Well-Tolerated Pain Relief
Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of action results in site-specific analgesia, which has the potential to reduce the use of and minimize the side effects associated with systemically administered analgesic drugs, such as opioids and NSAIDs.
Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts primarily on C-fiber neurons, which transmit long-term pain, by binding to and desensitizing the TRPV1 pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of 1 to 2 hours, and is undetectable in the blood after 24 hours.
Adlea's short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain, as well as pain due to moderate to severe osteoarthritis. In clinical trials to date, adverse events have been similar in patients receiving Adlea or 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 pharmaceutical products for pain management. The company's first commercial product, Zingo(TM), is available in the U.S. for the reduction of pain associated with peripheral venous access procedures in children ages three to 18.
The next product in Anesiva's pipeline, Adlea(TM), is currently being evaluated in two pivotal Phase 3 clinical trials to support an indication for the management of acute pain following orthopedic surgery. Adlea has been shown to reduce pain after only a single administration for weeks to months in multiple settings in mid-stage clinical trials for site-specific, acute and chronic, 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" title="http://www.anesiva.com" target="_blank"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: the timing and results of our clinical trials, and our regulatory approval strategy for Adlea. 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 annual report on Form 10-K for the year ended December 31, 2007 and most recently quarterly report on Form 10-Q.
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" title="http://www.anesiva.com" target="_blank"http://www.anesiva.com
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