BEIJING - China has banned the controversial practice of leg-lengthening, a cosmetic surgery procedure popular among young professionals who believe height will help them climb the career ladder, after a rash of botched operations has left patients disfigured.
Leg extension surgery is a procedure that looks like something out of the Middle Ages.
A doctor breaks the patient's legs and inserts steel pins into the bones, just below the knees.
For complete story, please visit The New Zealand Herald
SAN ANTONIO, July 20 /PRNewswire/ -- The Cancer Therapy & Research Center Institute for Drug Development, in collaboration with Oncolytics Biotech Inc., a biotechnology company, has enrolled the first two patients in a new Phase II clinical study for patients with various types of sarcomas that have metastasized to the lung. CTRC is one of only three sites in the United States, and the only in Texas, enrolling patients. The novel anti-cancer therapy, REOLYSIN(R), is a living virus, not a chemotherapy drug, that is toxic to cancer cells but not harmful to normal cells. This novel therapy, using a living virus, is the first of its kind available at CTRC.
According to Monica Mita, MD, principal investigator at the CTRC Institute for Drug Development, REOLYSIN(R)'s name was derived from the human reovirus, a mild virus that occurs naturally in the environment.
"This novel therapy has shown success because the reovirus replicates in and destroys the cancer cells within the patient's body," said Mita. "Cancer cells have several molecular and genetic abnormalities. In normal, healthy cells, the reovirus is unable to reproduce because of an enzyme named PKR. The enzyme is suppressed in cancer cells, and therefore the reovirus can replicate in the cancer cell and kill it."
"REOLYSIN(R) typifies the true targeted therapy approach that seeks to use fundamental differences between cancer and normal cells as the basis for effective anti-cancer approaches and we are thus very excited about the this study," said Francis Giles, MD, director of the CTRC Institute for Drug Development.
Eligible patients are those who have a bone or soft tissue sarcoma that has spread to the lung and who are deemed by their physician to be unresponsive to or untreatable by standard therapies. These include patients with osteosarcoma, Ewing sarcoma family tumors, malignant fibrous histiocytoma, synovial sarcoma, fibrosarcoma and leiomyosarcoma.
The second patient to enroll in the study was diagnosed with breast cancer in April 2005 and 11 months later received an additional diagnosis for a rare form of sarcoma. A specialist at the Dana-Farber Cancer Institute in Boston referred her to CTRC, where Mita suggested the REOLYSIN(R) study. After discussing it with her family and doctor, she decided it was the best treatment option for her.
"This new therapy gives me another option in the fight against my cancer," said the 35-year-old mother of three who travels to San Antonio for treatment with her husband and children. "Before coming to CTRC, I had already been through one chemotherapy cycle for this disease, and I got the impression that no one really knew what to do with me or how to treat my cancer. REOLYSIN(R) was a less toxic option for me."
"We are delighted, but not surprised, with the rate of accrual at the CTRC Institute for Drug Development," said Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. "As an evolving oncology company, the placement of Oncolytics' very innovative and sophisticated studies is of critical importance and we are delighted to have the CTRC Institute for Drug Development as our collaborator. This study is expected to yield information that will guide the late stage clinical development program for REOLYSIN(R)."
"We have had great success in recruiting patients into the trial, which is a testament to the promise of our approach and the efforts of our investigators," said Harold Van Wart, Ph.D., Metabolex's president and chief executive officer. "Our clinical team is now working to ensure the patients in the trial are well monitored, and we expect to share the results early next year, when all patients have completed the 16-week trial and we have examined the data."
The randomized, double-blind, placebo- and active comparator-controlled, multicenter Phase 2/3 trial is evaluating MBX-102/JNJ 39659100 at daily doses of 200, 400 and 600 mg versus Actos(R) (pioglitazone, a thiazolidinedione -- TZD -- drug) 30 mg in patients with type 2 diabetes taking concomitant insulin. The primary endpoint is change in hemoglobin A1c (HbA1c) levels -- the gold-standard measure of a patient's blood glucose control over time -- with weight gain and edema as key secondary endpoints. Fasting blood glucose, triglycerides, cholesterol, uric acid and adiponectin levels are being evaluated. The trial is being conducted at 67 clinical sites in four countries.
MBX-102/JNJ 39659100 is being studied for its potential to lower blood glucose by treating insulin resistance, an underlying cause of type 2 diabetes, and a potential contributor to cardiac disease. The drug modulates genes that are linked to insulin sensitization without appearing to affect those genes associated with weight gain and edema, unlike the currently marketed insulin sensitizers from the thiazolidinedione (TZD) class. Clinical research to date suggests the difference in gene expression may offer the efficacy advantages of TZDs with an improved safety profile.
In addition, preclinical work has shown that MBX-102/JNJ 39659100 may have potent anti-inflammatory activity. Inflammation has been linked to the development of insulin resistance and type 2 diabetes, suggesting an additional mechanism by which MBX-102/JNJ 39659100 may control the disease process in diabetes.
In June 2006, Metabolex entered into a strategic alliance with Ortho-McNeil, Inc., giving Ortho-McNeil an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100. Metabolex is conducting the Phase 2/3 trial of MBX-102/JNJ 39659100; Johnson & Johnson Pharmaceutical Research & Development, L.L.C. will be responsible for all additional testing of the compound.
About Metabolex
Metabolex is a privately held biotechnology company dedicated to the discovery and development of novel therapeutics to transform the treatment of diabetes and related metabolic disorders. Metabolex has drawn on its deep understanding of diabetes to create the largest database of genes involved in diabetes and to build a rich pipeline of product candidates and drug discovery targets. The company has three clinical-stage compounds: MBX-102/JNJ 39659100, in Phase 2/3 testing; MBX-2044, in Phase 2a; and MBX-8025, being studied in dyslipidemia, which has completed Phase 1 studies. Ortho-McNeil, Inc. has the exclusive right to develop and commercialize MBX-102/JNJ 39659100 and MBX-2044. For additional information about Metabolex and its development pipeline, visit http://www.metabolex.com/.
Source: Metabolex, Inc.
Affiris GmbH, based in Vienna, Austria, today announced the start of a phase I clinical trial for its Alzheimer's vaccine, Affitope AD01. The vaccine is being administered at the Vienna General Hospital (AKH) to up to 24 patients who have reached the disease stage "mild to moderate". The patients will be vaccinated four times over a period of three months, and the safety and suitability of the vaccine will be analysed over six months.
Dr. Walter Schmidt, CEO of Affiris GmbH, comments: "This, the most important chapter in our company history so far, is a fantastic development for both Alzheimer's sufferers and our investors. The need for such a treatment is particularly pressing given the enormous number of sufferers worldwide - over 12 million. Our investors, MIG-Fonds, are naturally also delighted that we have reached this important milestone on schedule."
Affiris has developed the Alzheimer's vaccine from patented Affitope technology, which is based on mimotopes and allows customized vaccines to be manufactured cost-effectively. Dr. Schmidt explains the special features of Affiris' approach to the Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an unintentionally formed fragment of one of the body's own proteins that occurs on the surface of brain cells and has the scientific abbreviation APP. In principle, it is extremely difficult to develop a vaccine as it is vital to ensure that the immune system only reacts after the beta-amyloid has separated into the brain fluid and not before, when it is present as a healthy component of the APP protein of brain cells. Nobody wants to provoke an immune response against the patient's brain cells. Our approach protects the brain cells and only combats the disease-causing beta-amyloid."
MCLEAN, Va., July 18 /PRNewswire/ -- In a review article published in The New England Journal of Medicine today, Dr. Michael F. Holick, Ph.D., M.D., one of the nation's leading experts on vitamin D, explores the nature of vitamin D deficiency and concludes it to be one of the most commonly unrecognized medical conditions, a condition that leaves millions at risk of developing not only osteoporosis and fractures but also numerous serious and often fatal diseases, including several common cancers, autoimmune diseases, infectious diseases and heart disease.
In his review, Dr. Holick estimates that there are over one billion people worldwide at risk for vitamin D deficiency, with 30-50% of children and adults in the United States at high risk for this potentially life threatening condition.
According to Holick, the effects of this condition can be both immediate and far-reaching for women and children. For example, pregnant women, even when taking a prenatal vitamin, are still at high risk for preeclampsia, a condition characterized by hypertension, fluid retention and protein loss in the urine. Low levels of calcium and vitamin D in utero and in childhood may prevent the maximum deposition of calcium in the skeleton. Vitamin D deficiency in early life may increase the risk of developing serious chronic diseases such as type 1 diabetes, multiple sclerosis and rheumatoid arthritis.
In adults, recent evidence has shown that vitamin D deficiency can put an individual at risk for developing a variety of deadly cancers. Holick points to prospective and retrospective studies indicating that vitamin D deficiency is associated with a 30-50% increased risk of colon, prostate and breast cancer along with higher mortality among those diagnosed with these cancers, especially darker skin individuals who have the highest incidence of vitamin D deficiency in the US. Vitamin D deficiency has also been linked to an increased risk of infectious diseases including tuberculosis and influenza as well as hypertension and cardiovascular disease.
"Vitamin D deficiency is an epidemic in this country," stated Dr. Holick. "Sensible sun exposure and the use of supplements are the best ways to address this easily preventable condition," he added.
Dr. Michael F. Holick is a Professor of Medicine, Physiology and Biophysics at Boston University. He is internationally recognized for his expertise and contributions to the fields of vitamin D, calcium, bone and the biologic effects of light in dermatology, endocrinology, and medicine. To see this article as it appears in the New England Journal of Medicine, please visit Dr. Holick's website at www.uvadvantage.org.
About the Ultraviolet Light Research and Educational Foundation -- Founded in 2004, the UV Foundation is dedicated to funding research to explore the effects of ultraviolet light on the human body. For more information about the UV Foundation, call 703.677.6885 or visit info@uvfoundation.org.
Source: Ultraviolet Light Research and Educational Foundation
AMIT Advancing Israel's Leading Scientific-Technological University
VALENCIA, Calif., July 18 /PRNewswire/ -- The Mann Foundation for Biomedical Engineering announced the opening of the most recent Alfred Mann Institute, this one at the Technion -- Israel Institute of Technology (AMIT) in Haifa, Israel. The AMIT is a university-based institute designed to enable commercialization of innovative biomedical technologies that improve human health.
The acronym AMIT stands for the Alfred Mann Institute at the Technion, which has a double meaning in Hebrew of "friend, colleague or partner." This partnership between the Mann Institute and the Technion will focus on advances in the biomedical, medical device and life sciences industries.
Alfred Mann, a world renowned entrepreneur and philanthropist, created the first AMI at the University of Southern California, which became operational in 2001 as a test-bed for the development for future AMIs. In 2004 he announced his Foundation's plans to establish a group of AMIs at a number of select universities over the coming years. Mann's vision has been to establish AMIs in an effort to make further advances in the biomedical field and bring new biomedical products to the public. AMIT is the second Institute to open its doors and the only Institute established internationally. A gift of $100M for the creation of the third AMI on the campus of Purdue University was announced earlier this year.
"We are delighted to partner with the Technion due to the university's technological innovation and tremendous contribution to Israel's economy," Al Mann stated in a conversation with Technion President, Professor Yitzhak Apeloig. "The Technion has already achieved impressive results and we believe it will continue to thrive in the areas of medicine, science, engineering and technology."
The motivation behind opening an institute within Israel came from Mann's wife, Claude Mann. Claude, who is not Jewish, has had a strong connection to the Jewish faith. Her father was active in the French Resistance during World War II and was sent to a concentration camp for hiding Jews from Nazi soldiers. Claude was born in a concentration camp and she will always hold a strong connection with the Jewish people.
During the opening ceremony of the institute, President Yitzhak Apeloig publicly applauded Claude's support of the university and honored her by dedicating a floor of the Institute in her name.
"We would like to express both our sincere gratitude and admiration to both Dr. Mann and his wife, Claude, for their generous donation to our university," stated President Apeloig. "We know that through the collaboration of our joint efforts, the Technion will continue to implement life changing research in a number of biomedical fields. We foresee that the Institute will create a platform for successful technologies and companies for years to come."
About the Mann Foundation for Biomedical Engineering
The Mann Foundation for Biomedical Engineering is a philanthropic organization that establishes university-based institutes (AMIs) to enable and support biomedical product development for the benefit of mankind. Alfred Mann's philanthropic mission is to create and expedite the delivery of life- improving biomedical products to patients.
Mann is chairman of the boards of directors for the Alfred Mann Institutes for biomedical development at USC, Purdue, and the Technion. Mann also is chairman and chief executive officer of MannKind Corp. and of Advanced Bionics Corp.; chairman of Second Sight LLC, Bioness Inc., AlleCure Corp., Quallion LLC and Inplantable Acoustics; and chairman emeritus of Pacesetter System Inc. and MiniMed. All of these highly successful companies were founded by Mann.
About the Technion
As Israel's oldest and premier institute of science and technology, the Technion -- Israel Institute of Technology has been an active and leading participant in Israel's establishment and development.
The university offers degrees in science and engineering, and related fields such as architecture, medicine, industrial management and education in an intellectually invigorating environment. Great emphasis is also placed on its humanities and social science programs, the incorporation of which take on ever-increasing importance in today's multi-faceted workplace. But Technion's goals go beyond providing a well-rounded technical education. At the institute, scientific instruction is interwoven with professional ethics, producing leaders sensitive to social and environmental issues.
As a whole, the Technion is committed to its role as one of Israel's top facilities for science and technology, a role that is necessary for the future of Israel and to all of humanity.
Source: Mann Foundation for Biomedical Engineering
CHICAGO, July 17 -- People who suffer from degenerative discs in their neck, now have a better option to relieve pain in their neck and arm, allow quick recovery and enable them to lead active and productive lives. The Food and Drug Administration (FDA) has approved the Prestige ST Cervical Disc System.
Used extensively in Europe, FDA clearance of the Prestige disc from Medtronic, follows a unanimous recommendation for approval from the FDA advisory board. The artificial disc for the cervical (neck) region is expected to impact more than 200,000 Americans who suffer from degenerative disc disease.
Currently, the most common treatment for patients with degenerative discs in the cervical spine is spinal fusion. In this procedure a surgeon removes the damaged disc then implants a bone graft and metal plate to fuse the vertebrae together. During artificial disc replacement surgery, the damaged disc is removed and replaced with an artificial disc, a stainless-steel device with a ball-in-trough design intended to allow for replication of normal motion. The disc stays in place with bone screws. The hospital stay for this procedure is approximately one-two days. Patients can begin rehabilitation and return to daily activities soon after surgery. In fact, patients receiving the Prestige ST artificial disc returned to work in 45 days, 16 days earlier than the fusion patients.
"Compared to spinal fusion, study results show that artificial cervical disc patients regain function faster, and have a higher rate of neurological success as measured by muscle tone, strength and sensation," says Dr. Dean Karahalios, CINN neurosurgeon. "Furthermore, the study demonstrated that at two year follow-up the overall success rate for the artificial disc group was 79.3% compared to the fusion group at 67.8%. These reasons are compelling enough for potential candidates to consider the option of an artificial disc."
By Tom Heneghan
WASHINGTON (Reuters) - A terminal leukemia patient must have daily blood transfusions or die. A family begs doctors to do everything possible to keep their elderly mother alive. Parents cannot accept their newborn baby will not survive.
End-of-life issues top the list of ethical dilemmas hospitals face as medical progress enables doctors to extend an endangered life to the hard-to-determine point where they may actually only be dragging out death...
Please visit Reuters.com for completed article.
The products rapidly stop even severe bleeding safely and effectively following simple package directions. Designed to fit easily into backpacks and first aid kits, QuikClot Sport(TM) and QuikClot Sport Silver(TM) come in 25gram and 50gram 'clotting sponges' that are packed into the wound. The potentially lifesaving sponges retail for as low as $9.99. The products will be available at retail stores and through catalogues this spring including at http://www.cabelas.com/. For further information, visit http://www.z-medica.com/sportinfo.
In developing the QuikClot(R) consumer products, Z-Medica's in-house product development team collaborated with Galen Stucky, a professor of chemistry and biochemistry at the University of California, Santa Barbara and with the United States Navy, which provided support for Stucky's research through the Office of Naval Research (ONR) and product testing at the Naval Medical Research Center.
"As we have transitioned our products from the military market to the first responder market, it has been an important goal of our company to next get the lifesaving capabilities of QuikClot(R) into the hands of consumers," said Huey. "Targeting our first consumer products to the outdoor adventure and sports markets was in response to countless inquiries from hunting, fishing, skiing, boating, cycling and other sporting organizations."
QuikClot(R) has saved scores of lives on the battlefields of Iraq and Afghanistan. First responders, safety and security organizations across the United States are also saving lives using various QuikClot product versions. It is the most widely used hemostatic first aid product available with more than one million units deployed worldwide.
QuikClot consumer product development accelerated when Z-Medica and its research partners worked to re-engineer the original formulation, eliminating its potential to generate heat with improper use. Dr. Galen Stucky's team also created a QuikClot formulation with silver ions that provides antimicrobial properties in addition to effective clotting. His contribution to understanding the mechanisms of action of the clotting process represents a significant scientific advance.
QuikClot Sport(TM) and QuikClot Sport Silver(TM) consist of beads of QuikClot(R) enclosed in a porous surgical fabric, similar to the latest products for the military and first responders. When introduced into a wound, this sponge takes the shape of the injury and rapidly stops even severe venous and arterial bleeding. The sponge stays in place until easily removed in the hospital. QuikClot represents the first and most effective solution to severe blood loss outside the operating room setting.
Z-Medica headquarters is located at 4 Fairfield Blvd., Wallingford, Connecticut 06492. For more information, please call (203) 294.0000 or visit http://www.z-medica.com/.
Source: Z-Medica Corporation
OXBOROUGH, Mass.--(BUSINESS WIRE)--July 17, 2007--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; Cyberkinetics) announced that the Company's BrainGate Neural Interface System was named an "R&D 100" award winner by R&D Magazine, ranking it as one of the most innovative new products of the year. The R&D 100 awards honor excellence and innovation and are presented each year to 100 new products.
The BrainGate System, a brain-computer interface technology, is designed to control movement of assistive devices by neural signaling - that is, by thought alone. The technology is currently being investigated in two clinical trials in people with severe paralysis due to spinal cord injury, stroke and ALS (Lou Gehrig's disease).
"We are honored to be picked for this prestigious industry award," stated Timothy R. Surgenor, President and Chief Executive Officer of Cyberkinetics Neurotechnology Systems, Inc. "It reflects the achievements of our work in neural signaling technology and its potential to significantly improve the quality of life for people with severe paralysis."
"We are developing the BrainGate System to one day enable paralyzed people to achieve more independence by using their own thoughts to control a wide range of external devices, including wheelchairs, as well as to someday move their own limbs," added John P. Donoghue, Ph.D., Cyberkinetics' Chief Scientific Officer and Director of the Brain Science Program at Brown University.
Battelle, the world's largest non-profit independent research and development organization, is co-winner of the award with Cyberkinetics.
"In 2006 we made a breakthrough in the development of new techniques that more accurately interpreted the brain signals we were gathering," said Chad Bouton, Senior Research Engineer at Battelle Medical Device Solutions, who worked with the BrainGate engineering team. "For the first time this allowed a person with the sensor to demonstrate control of a wheelchair directly through thought alone."
Winning candidates of the R&D 100 awards are identified by an independent panel of judges. This year's awards will be presented to winners in Chicago on October 18, 2007. The annual competition was first introduced in 1963. Previous winners have included the automated teller machine (1973), the Nicoderm anti-smoking patch (1992), and high definition television (1998).
About the BrainGate System
The BrainGate Neural Interface System is a proprietary, investigational brain-computer interface (BCI) that consists of an internal sensor to detect brain cell activity and external processors that convert these brain signals into a computer-mediated output under the person's own control. The sensor is a tiny silicon chip about the size of a baby aspirin with one hundred electrodes, each thinner than a human hair, that can detect the electrical activity of neurons. The sensor is implanted on the surface of the area of the brain responsible for movement, the motor cortex. The sensor picks up signals related to movement intentions and transmits them to computers, signal processors and monitors that enable study participants to control devices driven by their neural output - that is, by thought alone. The ultimate goal of the BrainGate System development program is to create a safe, effective and unobtrusive universal operating system that will enable those with motor impairments resulting from a variety of causes to quickly and reliably control a wide range of devices, including computers, assistive technologies and medical devices, simply by using their thoughts.
SOURCE: Adapted from Cyberkinetics press release
NATICK, Mass., July 17 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE:BSX) today announced the successful implantation of the Company's TAXUS(R) Petal(TM) Bifurcation Paclitaxel-Eluting Stent System (TAXUS Petal Stent) in a patient in New Zealand, marking the beginning of the TAXUS PETAL I First Human Use (FHU) Trial. The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease. The procedure was performed by John Ormiston, M.D., at Auckland City Hospital in Auckland, New Zealand.
A significant percentage of coronary artery disease -- as much as 30 percent -- occurs at a bifurcation, where one artery branches into two smaller arteries (one being the continuation of the main branch and the other often referred to as the side branch). Bifurcations present a common location for the buildup of plaque and are particularly difficult to treat with currently available stents. Conventional coronary stents were designed to treat tubular arteries and are considered less than optimal for the y-shaped anatomy of a bifurcation. The TAXUS Petal Stent is designed specifically to treat both the main branch and the side branch of a bifurcation.
The TAXUS Petal Stent consists of a traditional drug-eluting stent with an innovative side structure (the Petal Strut) in the middle of the stent that opens into the side branch. The TAXUS Petal is designed to provide access, coverage and support to the critical areas of the bifurcation and uses a proprietary platinum chromium alloy. Platinum chromium is designed to offer an improvement over stainless steel and cobalt chromium, enabling even thinner struts, increased flexibility and improved radiopacity. The TAXUS Petal Stent is coated with the proven, market-leading combination of the Paclitaxel drug and Translute(TM) polymer.
"The TAXUS Petal Stent enabled us to successfully treat a patient with a difficult bifurcation (coronary branch point) stenosis. Bifurcations are a major challenge in interventional cardiology, and the development of a dedicated drug-eluting bifurcation stent is an important advancement," said Dr. Ormiston, the principal investigator for the TAXUS Petal I FHU Trial. "A major strength of the TAXUS Petal Stent design is to provide consistent mechanical support and drug application not only to the main branch and but also to the side-branch ostium, where renarrowing is common with other techniques used today."
The TAXUS PETAL I FHU clinical trial is a non-randomized study with an initial assessment of acute performance and safety (death, myocardial infarction, target vessel revascularization) at 30 days and six months, as well as continued annual follow-up for five years. TAXUS PETAL I FHU will enroll a total of 45 patients in New Zealand, France and Germany. Upon successful completion of this study, Boston Scientific intends to begin a pivotal trial to gain U.S. and international approval for the commercialization of the TAXUS Petal Stent.
"We are excited about the start of the TAXUS PETAL I FHU Trial," said Hank Kucheman, Senior Vice President and Group President, Interventional Cardiology. "Boston Scientific is committed to developing innovative technologies that enable physicians to treat their most difficult patients. The TAXUS Petal Stent program reinforces our unparalleled pipeline of developing stent technologies."
The TAXUS Petal Stent is under development and not available for sale.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com/.
EDINBURGH, Scotland, July 17/PRNewswire/ --
Touch Bionics' i-LIMB Hand looks and acts like a real human hand and is the world's first widely available prosthetic device with five individually powered digits. In another industry first, Touch Bionics' ProDigits product is adapted for patients who have a partial hand, due either to congenitally missing fingers or fingers lost through an accident. Partial hand is an area of prosthetics that has been without suitable powered products in the past.
The i-LIMB Hand and ProDigits will be formally unveiled later this month at the 12th World Congress of the International Society for Prosthetics and Orthotics in Vancouver, Canada. But Touch Bionics' technology is already changing the lives of patients with its prosthetic products, working with leading U.S. clinical partners including Advanced Arm Dynamics, Benchmark Orthotics and Prosthetics, Hanger Prosthetics and Orthotics, LIVINGSKIN and Scott Sabolich Prosthetics and Research.
Sergeant U.S. Army (ret'd.) Juan Arredondo of Universal City, TX, who lost his hand in Iraq in 2004 after his patrol vehicle was struck by an improvised explosive device, is one patient who today is living a different life after being fitted with the i-LIMB Hand.
"Everyday that I have the hand, it surprises me," said Sgt. Arredondo, who was with the 2nd Infantry Division, 1/506th Destroyer Company. "Now I can pick up a Styrofoam cup without crushing it. With my other myoelectric hand, I would really have to concentrate on how much pressure I was putting on the cup. The i-LIMB hand does things naturally. I can just grab the cup like a regular person."
John German, a 40-year old medical salesman and clinical technician from Altoona, PA, who lost his hand in 1987, was recently fitted with the i-LIMB Hand. He is excited about the i-LIMB Hand's "extensive, real-world capabilities," compared to other prostheses he has used over the past 20 years.
"My previous hand was no better than a wireless mechanical hook, whereas the i-LIMB Hand is a dynamic hand," Mr. German said. "Instead of a c-shaped pincher, with the i-LIMB hand, I have a full range of grips that allow me to do everything I want to do with the hand."
Lindsay Block of Oklahoma City, OK, has had a lifetime of experience with prosthetics. Born missing the lower part of her left arm as the result of a birth defect, Ms. Block, now 26, has used almost every new generation of prosthetic technology since being fitted with her first one when only six months old. She is particularly impressed both by the life-like look of the i-LIMB and by its extensive range of motion.
"When I'm wearing the i-LIMB Hand, I'm pretty sure that someone who doesn't know me wouldn't even guess that it wasn't my own hand," she said. "It's cool how it can adjust to whatever it is grabbing on to. With this new hand, you don't have to strategize so much about what you do with it because you realize it's not limited and will adjust depending on what it's gripping on to."
The technology behind the i-LIMB Hand has come of age after many years of research and development at Touch Bionics.
"We are delighted to be the company that moves bionic hand technology from the research and development phase into the real world, and to lead a generational advance in bionics and patient care," said Touch Bionics CEO Stuart Mead. "We have always existed to change the lives of patients with severe injuries and disabilities, and it is thrilling to feel that we are now able to accomplish that goal."
The i-LIMB Hand offers a unique, highly intuitive control system that uses a traditional myoelectric signal input to open and close the hand's life-like fingers. Myoelectric controls utilize the electrical signal generated by muscles in the remaining portion of a patient's limb. This signal is picked up by electrodes that sit on the surface of the skin. Users of existing, basic myoelectric prosthetic hands are able to quickly adapt to the system and can master the device's new functionality within minutes. For new patients, the i-LIMB Hand offers a multi-function prosthetic solution that has never before been available.
"I was amazed by how quickly I could learn to do things with the i-LIMB Hand, even only an hour after being fitted with the hand," said Donald McKillop of Kilmarnock, Scotland, one of the first patients to be fitted with the i-LIMB Hand. "The most important thing is the movement of the fingers, that's what really makes the difference. It's truly incredible to see the fingers moving and gripping around objects that I haven't been able to pick up before. The hand does feel like a real replacement for my missing hand and it is now very natural for me to pick up all sorts of objects. It makes everyday activities much easier."
Touch Bionics has developed a custom cosmesis, or covering, for its products. i-LIMB Skin is a thin layer of semi-transparent material that has been computer-modeled to accurately wrap to every contour of the hand.
"Cosmesis is a hugely important area in prosthetics, both for appearance and for durability reasons. It is a vital component of our solution and brings an added dimension of personal comfort and satisfaction to our patients," said Mead. "Some patients, especially soldiers, love the more robotic look of the i-LIMB Skin, but others like their device to blend anatomically with the rest of their body, and prefer to have a life-like covering for the i-LIMB Hand and ProDigits."
For those patients who desire a more life-like appearance for the hand, Touch Bionics has partnered with some leading companies in the development of cosmesis for its products. ARTech Laboratories and LIVINGSKIN work at the forefront of high-definition cosmesis - these companies are collaborating with Touch Bionics to offer patients a life-like solution to compliment the life-like motions and performance of the hand.
WESTMINSTER, Colo., July 16 /PRNewswire-FirstCall/ -- SkyeTek, Inc., the leading provider of embedded RFID reader technology, continues to expand its footprint in Asia with the addition of three new customers and two new distributors in the region. Gaishan Technology, CADI Scientific and Taiwan Semiconductor Company Ltd are all leveraging SkyeTek's RFID reader technology to deliver advanced patron management and product authentication solutions. In addition, SkyeTek has recruited value added resellers USSEN and Hangzhou Ziytek to provide sales, systems integration and support in Taiwan and China, respectively.
"Pacific Rim countries are world leaders in the deployment of RFID as a networking technology for applications such as health services improvement and automatic product configuration," said Rob Balgley, SkyeTek Chief Executive Officer. "Given the rate of RFID innovation in the region, Asia consistently shows strong demand for intelligent, low-cost RFID readers that can be embedded inside products and connected to existing networks. As such, our growth in Asia continues to accelerate - sales have expanded by approximately 150% in the first half of 2007."
Gaishan Technology is leveraging SkyeTek software and hardware to RFID- enable audio systems that will read aloud RFID-tagged books for sight-impaired individuals. CADI Scientific uses SkyeTek modules to augment their wireless sensing and tracking solutions for enhanced patient care and monitoring. Taiwan Semiconductor Company Ltd has embedded SkyeTek's RFID readers into its thermal printers to ensure the correct placement of specialized paper inside the printer. These three are experiencing the same benefits that other OEMs using SkyeTek have experienced: revenue generation, enhanced customer service, and brand protection.
"SkyeTek's ability to provide a single, reader platform that spans frequencies and tags and incorporates software that seamlessly and securely integrates with existing applications has created new applications for RFID in Asia," said Yue Xi Savage, SkyeTek Senior Director of Sales and Business Development, Asia-Pacific Region. "The addition of new VARs enables our growing customer base in Asia to quickly implement SkyeTek's reader technology with easy access to comprehensive service and support."
To help meet the increased demand for its RFID reader technology in the region, SkyeTek has added USSEN and Hangzhou Ziytek to its global partner network which already includes Sobal in Japan and Passtech in Korea. USSEN and Hangzhou Ziytek will offer SkyeTek's full line of HF and UHF reader modules, ReaderWare software, and technical support to customers in Taiwan and China, respectively.
First study to demonstrate re-growth of anterior cruciate ligament (ACL) of the knee with a silk-based scaffold, in a large-animal model
Cabaud Award presented by American Orthopedic Society for Sports Medicine
MEDFORD, Mass. and CALGARY, Canada, July 16 /PRNewswire/ -- Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial platforms for tissue regeneration, today announced that its scientists received the Cabaud Memorial Award from the American Orthopedic Society for Sports Medicine (AOSSM), for their pre-clinical research demonstrating the potential of Serica's SeriACL(TM) Graft to regenerate or re-grow anterior cruciate ligament (ACL) tissue in the knee, in a large-animal model.
Results from the award-winning paper were highlighted in a podium presentation during the AOSSM annual meeting. In this study, 43 goats were implanted with the SeriACL Graft and followed over 3, 6 and 12 months; results demonstrated the safety of the device, with initial indications of efficacy in the animal model. The SeriACL Graft, a new biomaterial made from natural silk protein, is installed using a standard surgical procedure to repair a torn ACL and is designed to provide a strong yet temporary support structure that replaces the torn ACL and stabilizes the knee joint.
"This study provides the first evidence of sustainable ACL tissue engineering," said Gregory H. Altman, PhD, President and CEO, Serica Technologies, and senior author of the paper. "Through advances in biomedical engineering, we now have a more thorough understanding of the body's own capacity for ACL healing, if provided the correct impetus. We believe our proprietary technology can provide a long-term bioresorbable graft scaffold that anticipates the defect site's biological and mechanical requirements for ACL regeneration. We are extremely pleased with the results of this study and are aggressively moving forward with our development program, including the initiation of a study with the SeriACL Graft in humans."
Results from this study showed that all animals were weight bearing at 3, 6 and 12 months, with 95% returning to normal gait by 6 months; the majority of knees were clinically stable at all points. Range of motion assessment indicated the knees maintained a normal range flexion and extension at all points. By 12 months, the initial SeriACL graft structure was not evident, indicating the device's ability to provide sufficient direction and space for substantial ligament ingrowth while being bioresorbed.
"Current ACL repair options - either an autograft or allograft - each have well-documented, debilitating side effects," said Rebecca Horan, PhD, the study's lead author and Serica's Senior Director of Research and Development. "Our goal with the SeriACL(TM) Graft is to provide a 'scaffold,' or biomechanical support structure, implanted during a standard surgical procedure, which supports the development of functional ACL tissue, thereby avoiding the limitations and lengthy rehabilitation associated with existing options."
The SeriACL Graft or the surgical procedure did not induce early signs of acute inflammation, swelling or initial scar formation in the goat model, as indicated by rapidly declining scores for pain and knee size.
"The primary focus of our work over the past ten years has been to solve the unmet clinical need in ACL repair, offering surgeons and patients a device that would create the correct environment within the knee to regenerate ACL tissue, while supporting the mechanical structure of the joint during the healing process. Our ultimate goal is for the SeriACL Graft to serve the patient over his or her lifetime," Altman added. "Prior to our study, no one has shown successful 12 month ACL regeneration data in a large-animal model with an off-the-shelf product, due to the demanding mechanical and biological requirements of a functional ACL. We are delighted that the AOSSM has recognized this important work, which brought to bear the combined disciplines of mechanical, biomedical, chemical and textile engineering for the development of our SeriACL Graft."
This study, Clinical, Mechanical and Histopathological Evaluation of a Bioengineered Long-Term Bioresorbable Silk Fibroin Graft in a One Year Goat Study for Development of a Functional Autologous Anterior Cruciate Ligament, was funded by a grant from the National Institutes of Health (NIH) and Serica Technologies, Inc. The very first source of funding which helped to initiate the broader research program began with a $15,000 First Time Investigator Grant from the AOSSM in 1999.
Since 1986, the Cabaud Memorial Award has been presented annually, by the American Orthopedic Society of Sports Medicine, for work that "best exemplifies clinically relevant hypothesis-driven basic science research."
"This award symbolizes what can be accomplished with a strong collaboration between engineers, scientists and surgeons who share a vision to advance medical science and improve patient care," said John C. Richmond, MD, Chair, Department of Orthopedics, New England Baptist Hospital, Boston, MA, and a co-author of the paper. "We are excited by the potential of this device in ACL repair." An acknowledged expert in this area of medicine, Dr. Richmond has conducted more than 5,000 ACL and Rotator Cuff Tendon (RCT) reconstructive surgeries over the past 25 years.
Dr. Altman founded Serica in 1998, after completing his undergraduate and graduate studies at Tufts University, where he ruptured his ACL playing varsity football. His ACL repair surgery was performed by Dr. Richmond. Following knee surgery, Dr. Altman experienced the debilitating side effects of ACL reconstruction. This experience inspired his doctoral work, during which time he developed the concept and technology that became the platform for the current Serica product portfolio under development.
The ACL, one of the four major ligaments of the knee, is the second most commonly injured knee ligament, and is a very common injury among athletes. Female athletes are known to have a higher risk of injuring their ACL. Currently, 200,000 surgeries are performed each year in the U.S. to repair a torn or damaged ACL.
About the Technology
Serica is developing natural silk biomaterials designed to help stabilize soft connective tissue structures - such as ligaments and tendons - following surgical repair. The company's grafts for ACL and rotator cuff tendon repair, as well as its surgical meshes and gels, are comprised of the fiber of the B. mori silkworm. Silk has a proven track record of safety over centuries of human use and Serica's technology seeks to provide predictable and controlled bioresorption by the body, which is a major advantage in many tissue repair and reconstructive surgical procedures.
Serica's biomaterials are intended to act as "scaffolds" to provide support and relief to damaged tissues, and promote restored function. These implants are designed to allow the natural tissue to heal and resume normal function, as the implant is slowly bioresorbed by the body during the recovery period.
In pre-clinical studies, Serica's 100 percent silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, to facilitate optimal healing. Its products require no re-hydration or advance preparation for surgical implantation.
Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a growth-stage medical device company pioneering silk-based biomaterial platforms for tissue rejuvenation. Incorporated in 1998, Serica's proprietary products currently in pre-clinical and clinical development are being studied in the areas of orthopedic and sports medicine, aesthetic and reconstructive plastic surgery and other structural tissue repair needs. Serica's team of engineers and scientists are located in a state-of-the-art 22,000-square-foot office, R&D and manufacturing facility in Medford, MA. For more information about Serica Technologies, please visit http://www.sericainc.com/.
Source: Serica Technologies, Inc.
DURHAM, N.C., July 16 /PRNewswire/ -- Heart Imaging Technologies (HeartIT) announced today that medical images can be viewed on Apple's new iPhone (see examples at http://www.heartit.com/ ). Physicians can simply click on a web link sent via email by one of their colleagues, enter their password, and, for example, instantly view movies of a patient's beating heart halfway around the world. They can even put their colleagues on speakerphone and carry on a medical consultation while simultaneously browsing through the imaging results.
Viewing medical images traditionally requires dedicated workstations costing tens of thousands of dollars, which in turn are connected to proprietary picture archiving communications and storage (PACS) systems costing millions of dollars more. In order to view medical images, physicians must literally drive or walk to one of these workstations. Recent advances in World Wide Web browser technologies and the web sites that utilize their rich features, collectively referred to as Web 2.0, are challenging these expensive and cumbersome proprietary approaches.
Medical images displayed in a web browser have traditionally been of lower quality and therefore had limited diagnostic utility. This technology is the first to provide physicians with the ability to drill-down and view medical images, including movies, on a hand-held device.
"Patient privacy is obviously a critically-important issue on the internet," said Brent Reed, HeartIT's Director of Software Development. "Fortunately, medical privacy concerns can be addressed using the same encryption technologies employed by online banking and credit card transactions."
Heart Imaging Technologies' headquarters are located near North Carolina's Research Triangle Park. Formed in 2000, HeartIT provides web-based medical image management services and computing systems to regional health care systems, large hospitals and private clinics as well as drug and device companies sponsoring multi-center clinical trials. Worldwide, HeartIT's systems currently provide secure web browser access to over 50 million medical images.
Information: http://www.heartit.com/
All trademarks acknowledged.
SAN DIEGO, California, July 16-- Amira Pharmaceuticals, a small molecule pharmaceutical company focused on the discovery and development of compounds to treat inflammatory diseases, today announced initial, positive data from a Phase 1 clinical trial of AM103. The early, interim results demonstrate that a single dose of AM103 achieves highly significant inhibition of leukotriene synthesis, linked to a significant increase in the risk of myocardial infarction and stroke. AM103 binds to FLAP, inhibiting the synthesis of leukotrienes that cause inflammation. .
Turning cancer cells into mini magnets by using nanoparticles could make biopsies so sensitive and efficient that there will be no need to repeat these invasive tests.
Biopsy results can be ambiguous: sometimes they can be negative simply because there are too few malignant cells in the sample to be detected - not because all trace of disease has gone. Now researchers from the University of New Mexico and the company Senior Scientific, both in Albuquerque, have come up with a solution that harnesses the power of magnetic attraction.
BEST known as the ultra-strong material that might one day form the cables of a "space elevator" capable of raising people into Earth orbit, carbon nanotubes also have a springy side. The discovery that nanotubes keep bouncing back after being compressed repeatedly means this exotic form of carbon may be just the thing to give artificial muscles some extra strength.
Completed article at NewScientist.com
The acute implant, at the University of Pittsburgh Medical Center, focused on initial biocompatibility and mechanical function under physiologic conditions. Encouraging bench testing results led to the animal implant, performed by Peter Wearden, MD, PhD and assisted by Robert Kormos, MD (cardiac surgeons at the Children's Hospital of Pittsburgh and the University of Pittsburgh Medical Center, respectively).
The PediaFlow VAD is an implantable, magnetically levitated blood pump based on WorldHeart's proprietary rotary VAD MagLev(TM) technology. In its pediatric configuration, the device is designed to provide a flow rate from 0.3 to 1.5 L/min. Development is funded by the National Institutes of Health, and involves a consortium that includes the University of Pittsburgh, Children's Hospital of Pittsburgh and WorldHeart.
Dr. Harvey Borovetz, the Robert L. Hardesty Professor of Surgery, Chairman of Bioengineering at the University of Pittsburgh and Principal Investigator of the NIH contract remarked that, "The results of this first animal implant met our expectations and are very encouraging. It is gratifying to demonstrate in vivo that WorldHeart's Levacor(TM) MagLev technology can be applied to a miniaturized VAD. We look forward to its further development, including chronic implants, and to our goal of providing clinical benefit for newborns and infants."
Mr. Jal Jassawalla, WorldHeart's President and CEO, commented that, "WorldHeart is extremely pleased to participate in the development of this technology for infants. We are also excited about potential adaptation to a broad, adult, population with less advanced heart failure. We believe that pump miniaturization will allow implantation of the adult configuration using minimally invasive surgical techniques. This represents a complementary addition to the existing Levacor device."
About the Levacor VAD
The Levacor is a next-generation rotary VAD. It is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump with clinical experience. An advanced, continuous-flow pump, the Levacor uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The proprietary levitation technology employs a unique arrangement of magnetics expected to provide optimal system simplicity and reliability. In contrast to pumps with blood-immersed mechanical or hydrodynamic bearings, full magnetic levitation eliminates wear within the pump as well as dependence on blood properties for rotor suspension, and is expected to provide improved blood compatibility by allowing greater clearances around the rotor and more idealized flow patterns across a wider range of operation. The Levacor VAD has been designed with a high safety profile and robust range of operation to address the needs of current and future heart failure patients.
About the PediaFlow VAD
The PediaFlow VAD is being developed to provide medium-term (<>
About WorldHeart
WorldHeart is a developer of mechanical circulatory support systems with leading next-generation technologies. The Company is headquartered in Oakland, California, with additional facilities in Salt Lake City, Utah and Herkenbosch, The Netherlands. WorldHeart's registered office is Ottawa, Ontario, Canada.
Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding the Company's expectations with respect to the Company's future development plans for its next-generation Levacor VAD and PediaFlow VAD, including the timing and scope of clinical trials, the potential scope of use and clinical benefits of these devices, as well as, other statements that can be identified by the use of forward-looking language, such as "believes," "feels," "expects," "may," "will," "should," "seeks," "plans," "anticipates," or "intends" or the negative of those terms, or by discussions of strategy or intentions. Investors are cautioned that all forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements, including without limitation: delays in development, preclinical qualification and regulatory approvals, and clinical trials; Destination Therapy adoption rate for VADs; competition, the need for additional financing; and other risks detailed in the Company's filings with the United States Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2006, as amended.
Source: World Heart Corporation
SATELLITE BEACH, Fla., July 16 /PRNewswire-FirstCall/ -- Terasem Movement, Inc. announced today its Third Annual Workshop on Geoethical Nanotechnology will be held Friday, July 20, 2007 to honor the 38th anniversary of the first human lunar landing. The Workshop, accessible to the general public as a webinar at: http://terasem.acrobat.com/a987654321/, will explore downloading minds into bio-nano bodies and similar technologies thought to be essential for interstellar colonization. Geoethical nanotechnology is atom-by-atom assembly techniques that are subject to a consensual review, approval and audit process.
The Workshop proceedings are open to the public via real-time video and conference call and will be subsequently archived online for free public access. The public is invited to watch, listen, and call a toll-free conference-call dial-in line from 9:00 a.m. - 1:00 p.m. EDT. Callers from the continental US and Canada may dial 1-888-288-9321; other countries: (00+1) 1- 719-234-0201. The participant passcode number is: 942238
Each Workshop presentation is designed for a 15-20 minute delivery, followed by a 20 minute formal question and answer period, during which time questions from the worldwide audience will be invited. Presentations will also be available on the Workshop's website at http://www.terasemcentral.org/2007GeonanoProgram.html.
This year's non-affiliated speakers by order of presentation are: Professor of Cybernetics, Kevin Warwick, Ph.D., University of Reading, United Kingdom; Professor Carola Leuschner, Ph.D., Pennington Biomedical Research Center, Louisiana State University; Professor Dame Julia Polak of the Centre for Tissue Engineering & Regenerative Medicine, Imperial College, United Kingdom; and Professor Challa S.S.R. Kumar, Center for Advanced Microstructures, Louisiana State University.
For additional information, please contact: Loraine Rhodes at 321-676- 3690, ext 100, or lori@terasemcentral.org. Please visit Terasem's website at: http://www.terasemcentral.org/.
About the Terasem Movement
The Terasem Movement, Inc., is a 501(c)(3) not-for-profit charity endowed for the purpose of educating the public on the practicality and necessity of greatly extending human life, consistent with diversity and unity, via geoethical nanotechnology and personal cyberconsciousness. The Terasem Movement accomplishes its objectives by convening publicly accessible symposia, publishing explanatory analyses, conducting demonstration projects, issuing grants and encouraging public belief in a positive, technologically- based future.
For more information, please visit http://www.terasemcentral.org/.
http://www.terasemfoundation.org
Source: Terasem Movement, Inc.
CAMBRIDGE, Mass. (July 12, 2007) — Biologists have long thought that a simple on/off switch controls most genes in human cells. Flip the switch and a cell starts or stops producing a particular protein. But new evidence suggests that this model is too simple and that our genes are more ready for action than previously thought. Scientists in the lab of Whitehead Member Richard Young have discovered that many human genes hover between “on” and “off” in any given cell. According to the study, which appears online in Cell on July 12, these genes begin making RNA templates for proteins—a process termed transcription—but fail to finish. The templates never materialize, and the proteins never appear. “Surprisingly, about one-third of our genes, including all the regulators of cell identity, fall into this new class,” says Young, who is also an MIT professor of biology. “It seems awfully risky for an adult cell to leave genes primed that could change its identity.”
The human body comprises more than 200 types of cells. Each cell contains the same complete set of genes, but expresses only a unique fraction of them, churning out proteins that make it a nerve or skin or white blood cell. Scientists have known for years that a cell hides the genes it doesn’t need by coiling the dormant DNA tightly around protein spools called histones. The new study, however, suggests that DNA packaging stays loose at the beginning of many inactive genes, contrary to textbook models. Whitehead postdoctoral researchers Matthew Guenther and Stuart Levine screened the entire human genome for a chemical signature—a landmark—that corresponds with this looser DNA packaging configuration and thus with transcription initiation. They worked with embryonic stem cells, liver cells and white blood cells. “We expected to find the landmark on 30 to 40 percent of the genes because that’s how many are active in each cell,” Guenther says. “We were shocked when it showed up on more than 75 percent of the genes in both unspecialized embryonic stem cells and specialized adult cells.” Further experiments confirmed that the majority of inactive genes undergo “transcriptional tryouts.” They begin making RNA, but never complete the job. Apparently, most of an inactive gene remains tightly coiled around histones, which prevent the RNA transcriptional machinery from progressing along the DNA. “These genes are like cars revving their engines before the beginning of a race,” Guenther explains. “They’re not parked in a garage with their engines off. They’re at the starting gate, waiting for a flag that says ‘go.’” These overzealous “cars” include all the genes responsible for directing cells along particular developmental paths—master regulators that should have no reason for gearing up in healthy specialized cells. Activating such genes might cause a cell to assume new properties. This vulnerability to metamorphosis could help to explain why some cells acquire new, unhealthy states in cancer, autoimmune diseases, diabetes and other illnesses. It could also explain why researchers—including Whitehead Member Rudolf Jaenisch, who is also an author on the latest study—were recently able to convert mouse adult skin cells to embryonic stem cells by simply introducing four key genes. Given the right signals, inactive developmental regulators primed for transcription could roar to life. “This is a new model for regulation of the developmental regulators,” Young maintains. “It could bring us a step closer to reprogramming cells in a controlled fashion, which has important applications for regenerative medicine.” This research is funded by the National Institutes of Health. |  | |
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| Written by Alyssa Kneller. | |
