MEDICAL DEVICE INNOVATION - Medical Device Daily

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60 GI Dynamics’ EndoBarrier gets favorable study results By OMAR FORD Medical Device Daily Staff Writer GI Dynamics (Lexington, Massachusetts) attempts for regulatory approval for its EndoBarrier Gastrointestinal Liner received a much-needed boost with the release results of a European weightloss study targeting the device. The device, which is the flagship product of the company, was evaluated for its safety and efficacy for pre-surgical weight loss treatment, along with a positive effect on glucose homeostasis in morbidly obese patients with Type 2 diabetes mellitus. Study data were published in the Annals of Surgery. “The company is very pleased with these results,” Stu Randale, GI Dynamics, CEO told Medical Device Daily. “The results seem to coincide with other trials that we have had in South America. This was the first European clinical weight loss study conducted with the EndoBarrier, and since then the EndoBarrier has been successfully implanted in more than 250 patients. As GI Dynamics has expanded the clinical development program for EndoBarrier in patients with obesity and Type 2 diabetes, we have continued to see impressive results.” In the most recent multi-center, randomized clinical trial, 41 patients were enrolled and 37 patients were treated. Twenty-six patients received the EndoBarrier and 11 were in the diet control group. The EndoBarrier was implanted for 12 weeks. Three patients kept the device implanted for 24 weeks. Patients in both the EndoBarrier and diet control groups followed the same diet during the study period. Starting average weight for these two groups was similar with 142.5 kg (314.2 lbs) for EndoBarrier patients versus 137.5 kg (303.2 lbs) for control group patients, and body mass index (BMI) of 48.9 vs. 49.2, respectively. Mean excess weight loss (EWL) achieved after 12 weeks was 19.0 % for EndoBarrier patients versus 6.9 % for control patients (p
MEDICAL DEVICE INNOVATION 2010 Broad-scope test aims to catch cancer before it starts By AMANDA PEDERSEN Medical Device Daily Staff Writer There are a number of good cancer tests designed to catch the disease as soon as it shows up, but one company believes it has found a way to detect signs of whole-body cancers long before the disease is even present. GlycoMeds (Phoenix) says its Cancer Test is a broad-scope test that detects conditions within the body that allow cancer cell growth prior to cancer cells being active. GlycoMeds’ Cancer Test employs a process that produces consistent measurements of the chemical composition of a person’s saliva, the company says. It is an at-home test designed to alert the user to the presence of conditions within their body that are conducive to the growth of 74% of all cancers, including breast, lung, kidney, colon, liver, bone and brain cancer. The kit does not measure pH, the company noted. Unlike certain other at-home diagnostics, the results of this test are not black-and-white, Roger Brown, PhD, CEO of GlycoMeds, told Medical Device Daily. “With our test it’s a gray-scale test, we don’t tell you that you have cancer or that you don’t have cancer, we just give you the likelihood,” he said. The test is not keyed for any specific type of cancer either, Brown said, but is more sensitive to cancers that affect the whole body, such as lung cancer. Not all cancers affect the whole body, he noted. With lung cancer, for example, the patient’s entire body is affected as their pH levels drop and their system slowly goes down. It can take years before the system will degrade to the point where the cancer will be detectable clinically, Brown said. While acknowledging that there are other tests that can catch cancer as soon as it shows up, he said doctors don’t currently have a decent way to detect ahead of time the patient’s likelihood of getting cancer. According to the company, the GlycoMeds Cancer Test works because most cancer cells live in a narrow pH range within the body. As long as the body’s system pH is outside that range, most cancer cells cannot survive. The GlycoMeds test measures the changes in a person’s fluidic system once a day for three days, averages those changes, and compares them to the changes a healthy person’s fluidic system would undergo. The measurement is then equated to a condition level on a scale of 0 to 7, where 0 is healthy – no conditions conducive to the growth of whole-body cancer cells – and 7 has a prognosis of death. If the number reveals an active possibility of cancer (levels 4, 5 or 6), the person taking the test is advised to make an appointment with his or her doctor for further evaluation. But if the test shows cancer is not imminent 61 (levels 1, 2 or 3), the person taking the test can take corrective action to bring his or her system back to normal, thus inhibiting cancer cell growth. “If you’re a level 4 or a level 5 it doesn’t say ‘I have cancer’ but it says ‘I better go to the doctor’,” Brown said. “Essentially the kit is just saying ‘maybe you ought to have an extra checkup this year.” Brown said the test instructs the consumer to take the saliva test three mornings in a row and average the results together because a lot of people have never taken a saliva test and the first time they take it they may drop it on the floor or accidentally do something else that could affect its accuracy. Hopefully, he said, by taking the average of three days’ worth of results, the test will produce a reasonably accurate result. “I wanted to keep it as simple as possible, but also as accurate as possible,” Brown said. If the test is being administered by a healthcare professional, Brown said supplemental instructions included in the kit say it is fine to use the results of just one sample because “they usually know what they’re doing.” The company said it is looking for a partner to license and market the Cancer Test Kit, which has not yet been presented to the FDA for comment. Brown said the Cancer Test has been in development since 2004. He said there has been very little research done on the causes of cancer vs. system condition. In 2004, however, there was a study done in which researchers linked a low pH system to cell conduciveness to viral cancers. The lower the system pH, the more susceptible the cells are to being turned into cancer cells, Brown noted. “I think it’s important from the point of view that a lot of people would like to know whether they’re at risk more than normal for cancer or not,” Brown said. He compared the Cancer Test to a popular at-home HIV test. “From the research we’ve done, there are more people that are concerned about whether or not they have cancer than there are people who want to know if they have AIDS or HIV.” In addition to the at-home HIV test that Brown mentioned, the Cancer Test joins a whole host of diagnostics that are being sold directly to consumers now, which are designed to tell people what their risk level is of developing a particular disease. (This story originally appeared in the Feb. 6, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912 outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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