Daily Health and Medicine News

EnteroMedics to Present at the Canaccord Genuity Annual Growth Conference

EnteroMedics Inc. ETRM
+0.38% , the
developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., Chief Executive Officer, is scheduled to present at the Canaccord Genuity Annual Growth Conference in Boston, MA on Thursday, August 11, 2011 at 9:00 am ET. Dr. Knudson will provide an overview of the Company and an update on its VBLOC(R) vagal blocking therapy development program.

The presentation will be webcast live and may be accessed by visiting EnteroMedics’ website at www.enteromedics.com . A replay of the webcast will also be available immediately after the conclusion of the presentation. Investors can access the webcast under “Press Room” in the “Investors” section of EnteroMedics website.

About VBLOC(R) Therapy

EnteroMedics developed VBLOC(R) vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC(R) Therapy is delivered via the Maestro(R) System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC(R) Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

About EnteroMedics Inc.

EnteroMedics is a development stage medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity and other gastrointestinal disorders. EnteroMedics’ proprietary neuroblocking technology, VBLOC(R) vagal blocking therapy, is designed to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. These electrical impulses are delivered by a neuroregulator, EnteroMedics’ Maestro(R) System, which is powered by an integrated rechargeable battery. For more information, visit www.enteromedics.com .

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro(R) System for the treatment of obesity in the United States or in any foreign market other than the European Community; our preliminary findings from our EMPOWER(TM) pivotal trial; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC(R) vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 7, 2011. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Caution – Investigational device. Limited by Federal (United States) law to investigational use.

The implantation procedure and usage of the Maestro(R) System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.

School Obesity-Prevention Curriculum Can Reduce Medical Costs

Teaching middle-school children about nutrition and exercise and encouraging them to watch less TV can save the health care system a substantial amount of money, suggests an economic analysis from Children’s Hospital Boston and the Centers for Disease Control and Prevention.

Using data from a randomized, controlled study conducted at 10 Massachusetts middle schools, five of which adopted the obesity prevention curriculum Planet Health, the researchers created a model projecting a net savings of $14,000 for the 254 girls receiving the curriculum, by averting the costs of treating obesity and eating disorders. They project that expanding the program to even just 100 schools could save the health care system $680,000.

The study, published in the August issue of the Archives of Pediatrics & Adolescent Medicine, was led by S. Bryn Austin, ScD, an epidemiologist in Children’s Hospital Boston’s Division of Adolescent Medicine, and CDC health economist Li Yan Wang.

Planet Health, developed at the Harvard School of Public Health, is a curriculum for academic, physical education and health education teachers to guide middle-school students in choosing healthy foods, increasing physical activity and limiting TV and other screen time. It provides teacher training, lesson plans, materials and FitCheck, a self-assessment tool for students.

In an earlier study of 10 middle schools, half offering the Planet Health program and half offering regular programs (schools were matched by town, school size and ethnic composition), obesity prevalence declined in the schools with Planet Health but increased in control schools over the two years of follow-up. In addition, overweight girls in Planet Health schools were twice as likely as girls in control schools to return to a healthy weight over the two years.(Gortmaker SL et al, 1999). Unexpectedly, girls in Planet Health schools were also less than half as likely as girls in control schools to begin purging or using diet pills to control their weight (Austin SB et al, 2005); this study was later replicated in a separate group of middle schools (Austin SB et al, 2007). The effects were not statistically significant for boys.

“We were really surprised and encouraged to see how protective Planet Health was for eating disorder symptoms in girls,” says Austin, the study’s senior author. “When we found the same protective effect – cutting the risk for girls in half — in a different set of middle schools several years later, we knew we were on to something important.”

Bulimia typically develops in adolescence, and often begins with a few behaviors, such as using diet pills or purging to control weight. Full-blown bulimia is a life-threatening disorder that carries a variety of medical complications such as electrolyte imbalances, dehydration, metabolic alkalosis (an imbalance in the body’s acid/base balance), heart rhythm disturbances, tooth erosion and bowel dysfunction.

“Eating disorders cause an enormous amount of suffering,” says Austin. “They can also be chronic and expensive to treat, which is often a big financial burden on individuals, their families, and society. That’s what led us to want to do the economic study.”

In their economic analysis, Austin and Wang first estimate that 3.4 percent of girls receiving the Planet Health intervention would be prevented from developing disordered weight-control behaviors by the age of 13 1/2, based on numbers from the original randomized study (7 of 254 girls in the Planet Health schools, or 2.8 percent, developed these behaviors, versus 14 of 226 controls, or 6.2 percent). Based on current knowledge about the progression of eating disorders, they calculate that, in turn, 1 case of bulimia would be prevented by the age of 17 among the 254 girls.

Factoring in typical treatment costs — which can be tens of thousands of dollars over a decade — and known rates of remission and relapse, Austin and Wang estimate that an average of $34,000 would be saved by preventing one girl in the five Planet Health study schools from developing bulimia nervosa. Adding Wang’s previous finding of $27,042 in savings resulting from prevention and reduction of obesity in the same schools (Wang LI et al, 2003), the program would yield a net savings of $14,238 after subtracting the $46,803 cost of offering Planet Health in those schools.

“Because eating disorders can be so expensive to treat, preventing even one case in the five Planet Health schools translated into reducing medical costs by $34,000,” says Austin. “But if we scale up our calculations to include, say, 100 middle schools in Massachusetts, the medical costs reduced by preventing bulimia increase to over half a million dollars. And if we scale up nationwide, to say 1,000 schools, the potential reduction in the medical cost burden is sizable.”

Austin notes that obesity prevention programs that stigmatize obesity or create a sense of blame can actually contribute to eating disorders. “We need to be smart about choosing obesity prevention strategies that, at the same time, can prevent eating disorders,” she says. “Our study shows that when we do both, we substantially increase the benefits, both in terms of health and reducing medical costs.”

The study was funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration. Lauren Nichols of the Division of Adolescent and Young Adult Medicine at Children’s Hospital Boston was coauthor.

Lannett gets FDA approval for anti-obesity treatment

Lannett has received the US Food and Drug Administration (FDA) approval for the abbreviated new drug application (ANDA) of Phentermine Resin Extended-Release Capsules, 15mg and 30mg.

Lannett’s Phentermine Resin Extended-Release Capsules, 15mg and 30mg is the generic version of UCB’s Ionamin Capsules, 15mg and 30mg.

Phentermine Resin is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction.

Cody Laboratories, the pain management subsidiary of Lannett, is responsible for producing the active pharmaceutical ingredient (API) of the product.