Novavax, Inc. (Nasdaq NVAX) announced its initial agreement to license its proprietary, recombinant viruslikeparticle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid ROVI) of Spain. ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government under a new 60 millioneuro program sponsored and led by the Spanish Ministry of Health and other government groups to develop pandemic and seasonal flu vaccines and establish its only inborder facility. This program, which was announced by Spanish health officials, is being launched to develop safe and effective flu vaccines to serve the entire population of Spain.

Under separate agreements that are in the process of being negotiated by both companies, ROVI will receive exclusive licenses to Novavaxs portable VLP vaccine technology to commercialize flu vaccines in Spain and Portugal, and nonexclusive licenses in Europe, Latin America and Africa. Furthermore, under a stock purchase agreement executed today, ROVI has committed to make a $3 million (US) equity investment in Novavax at $2.74 per share, a 10% premium to the June 29, 2009 closing bid price on the NASDAQ Global Market. A nonprofit Foundation, jointly sponsored by ROVI and the Spanish authorities, will be formed and initially funded with a 25 million euro credit line from the Spanish government, to support Phase III clinical development and other studies necessary to achieve marketing authorization of the VLP influenza vaccines in the European Union in 2012. Additional clinical development funds will be contributed by ROVI if required. In addition, the State of Andalucia will support ROVI in building a new VLP vaccine plant in the city of Granada and bring it online in 2012 at a cost of approximately 20 million euro. The plant, with certain licensed manufacturing rights from Novavax, is expected to have enough manufacturing capacity to service Spain and other parts of Europe, Latin America, and Africa. Details of the commercial terms between ROVI and Novavax will be announced after the definitive agreements are finalized and are expected to include milestones and royalties.

Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated “We are honored to be selected by the Spanish Health Ministry and ROVI Pharmaceuticals to help develop pandemic and seasonal flu vaccine solutions for Spain, the worlds eighth largest economy with more than 43 million people. We are pleased to have found a superb partner in ROVI that has deep knowledge of the local vaccine markets as well as significant vaccine manufacturing experience. This is the first opportunity to export our technology to Europe, following the recent joint venture with Cadila Pharmaceuticals in India, and is further validation of our unique inborder vaccine supply offering. This influenza vaccine supply solution consisting of our VLP technology and portable manufacturing avoids the use of chicken eggs, creates vaccines for emerging strains faster, and promises less expensive, inborder manufacturing capacity. We continue to discuss opportunities with other pharmaceutical companies and governments to implement this compelling influenza vaccine technology around the globe.”

“Todays contemplated partnership with ROVI and the Spanish government will enable funding to support development and registration of VLPbased influenza vaccines in the European Union and possibly other countries, including the United States. Through this partnership, the goal to supply influenza vaccines for all Spanish citizens from domestic production should be achieved in year 2012,” Dr. Singhvi continued.

Juan LopezBelmonte Encina, ROVI CEO, commented “The pandemic flu vaccine business is currently a key part of the strategy of ROVI, and we are committed to the business as one of the future growth drivers for the company. We are entering a new world of high technology and complex processes, but we are confident that our knowledge in this area along with Novavaxs extensive experience will enable us to fight on the front line against the devastating effects of influenza virus infection.”

ABOUT ROVI

ROVI is a fully integrated, profitable Spanish specialty pharmaceutical company engaged in the research, development, inlicensing, manufacturing and marketing of small molecule and specialty biologic drugs. The Company has a diversified portfolio of products that it markets in Spain through its specialized sales force, calling on specialist physicians, hospitals and pharmacies. ROVIs portfolio of 23 principal marketed products is currently anchored by the internallydeveloped, second generation low molecular weight heparin, bemiparin. ROVIs research and development pipeline is focused primarily on addressing currently unmet medical needs by developing new LMWHbased products and expanding applications for its existing LMWHbased products. ROVI manufactures the active biological ingredient (bemiparin) for its principal proprietary product and product candidates and the injectable pharmaceutical products developed by its inhouse research team, and utilizes its stateoftheart filling and packaging capabilities to provide a broad array of toll manufacturing services to leading international pharmaceutical companies, primarily in the area of prefilled syringes.

ABOUT NOVAVAX

Novavax, Inc. (Nasdaq NVAX) is a clinicalstage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary viruslikeparticle (VLP) technology. The company produces these VLPbased, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. VLPs are designed to induce protective immune responses without generating infection since they are not made from a live virus and contain no genetic material in their inner core. The Company is currently conducting Phase II clinical studies of a seasonal flu vaccine and recently announced a research agreement with the National Institutes of Health to evaluate a VLPbased vaccine against the novel H1N1 influenza strain. The company also plans to initiate a seasonal flu vaccine study in elderly subjects later this year.

Forward Looking Statement

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and anticipated milestones are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forwardlooking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forwardlooking statements or historical experience include risks and uncertainties, including the Companys ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Novavaxs pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs; our ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to obtain adequate financing in the future through product licensing, copromotional arrangements, public or private equity or debt financing or otherwise; the maturity of the convertible notes on July 15, 2009; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavaxs business, financial conditions and results of operations, is contained in Novavaxs filings with the U.S.

Counseling patients with nonalcoholic fatty liver disease (NAFLD) on how to increase physical activity leads to health benefits that are independent of changes in weight. These findings are in a new study in the July issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The article is also available online at Wiley Interscience.

NAFLD is the most common form of chronic liver disease in developed countries. It is associated with the metabolic syndrome, which also includes obesity, insulin resistance and type 2 diabetes, and is characterized by elevated liver enzymes. Currently, patients with NAFLD are encouraged to alter their lifestyles, however the focus has been on weight loss through dietary changes. The effects of increasing physical activity alone have not been thoroughly investigated.

Researchers led by Jacob George of Sydney West Area Health Service in Australia, examined the health outcomes of patients who were counseled on how to increase physical activity. They prospectively enrolled 141 patients with NAFLD from the Sydney West Area Health Service. The participants were divided into a control group, a lowintensity lifestyle intervention group, and a moderateintensity lifestyle intervention group.

The patients in the intervention arms worked with exercise scientists who provided individually tailored counseling on how to increase both planned and incidental physical activity. Walking was the main type of exercise discussed and patients were encouraged to be active for at least 150 minutes per week.

After three months, participants in the intervention groups were nine times more likely to have increased their physical activity by an hour or more per week, compared to patients in the control group. Those who were active for more than 150 minutes per week, and those who increased their level of fitness, also showed improvements in liver enzymes and other metabolic indices. The effect was independent of weight loss.

Interestingly, there was no doseresponse effect for exercise increases above 60 minutes per week. However, those who increased exercise by at least 60 minutes per week had beneficial changes in liver enzymes, insulin resistance and metabolic risk factors.

While greater increases in exercise time appeared to be related to greater weight loss, there was no additional benefit to liver enzymes or glucose homeostasis. “The reason for this is unclear,” the authors write, “but we hypothesize that the threshold for change in liver enzymes may be low so that even a slight increase in physical activity is sufficient to improve liver tests.”

Patients who remained sedentary over the course of the study had no improvement in metabolic parameters, and even trended toward deterioration in these areas, even if they lost weight. “The metabolic pathway by which physical activity improves insulin sensitivity may be different to that of weight loss and this is particularly relevant for patients with NAFLD,” the authors write. “Physical activity improves insulin resistance through positive changes in fatty acid metabolism in muscle which cannot be achieved through energy restriction.”

“We have shown here that physical activity counseling can result in significant increases in physical activity and fitness and subsequent improvement in health, without the need for supervised exercise sessions,” the authors conclude.

Article “The Independent Effects of Physical Activity in Patients with NonAlcoholic Fatty Liver Disease.” St. George, Alexis; Bauman, Adrian; Johnston, Amanda; Farrell, Geoff; Chey, Tien; George, Jacob. Hepatology; July 2009.

Source
Sean Wagner

Nineteen House Democrats recently sent a letter to House Speaker Nancy Pelosi (DCalif.) stating that they will not vote for health care reform legislation “unless it explicitly excludes abortion funding from the scope of any governmentdefined or subsidized health insurance plan,” CongressDaily reports. In the letter, the lawmakers wrote that they want to ensure that the Health Benefits Advisory Committee cannot recommend that abortion services be included as part of benefits packages. They wrote, “Without an explicit exclusion, abortion could be included in a governmentsubsidized health care plan under general health care.”

The letter was signed by Reps. Dan Boren (Okla.), Bobby Bright (Ala.), Travis Childers (Miss.), Jerry Costello (Ill.), Lincoln Davis (Tenn.), Kathleen Dahlkemper (Pa.), Steve Driehaus (Ohio), Tim Holden (Pa.), Paul Kanjorski (Pa.), Marcy Kaptur (Ohio), Mike McIntyre (N.C.), Charlie Melancon (La.), John Murtha (Pa.), James Oberstar (Minn.), Solomon Ortiz (Texas), Collin Peterson (Minn.), Heath Shuler (N.C.), Bart Stupak (Mich.) and Gene Taylor (Miss.) (CongressDaily, 6/30).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

A new computer model developed at MIT can help solve a problem that has plagued drug companies trying to develop promising new treatments made of antibodies Such drugs have a relatively short shelf life because they tend to clump together, rendering them ineffective.

Antibodies are the most rapidly growing class of human drugs, with the potential to treat cancer, arthritis and other chronic inflammatory and infectious diseases. About 200 such drugs are now in clinical trials, and a few are already on the market.

Patients can administer these drugs to themselves, but this requires high doses and the drugs must therefore be stored at high concentrations. However, under these conditions the drugs tend to clump, or aggregate. Even if they are stored at lower concentrations and administered by a doctor intravenously, they often have stability issues. Addressing such issues typically takes place later in the drug development process, and the cost both in time and money is often high.

Currently there is no straightforward way to address these storage issues early in the development process.

“Drugs are usually developed with the criteria of how effective theyll be, and how well theyll bind to whatever target theyre supposed to bind,” says Bernhardt Trout, professor of chemical engineering and leader of the MIT team. “The problem is there are all of these issues down the line that were never taken into account.”

Trout and his colleagues, including Bernhard Helk of Novartis, have developed a computer model that can help designers identify which parts of an antibody are most likely to attract other molecules, allowing them to alter the antibodies to prevent such clumping. The model, which the researchers aim to incorporate in the drug discovery process, is described in a paper appearing in the online edition of the Proceedings of the National Academy of Sciences the week of June 29.

Preventing aggregation

Most of the aggregation seen in antibodies is due to interactions between exposed hydrophobic (waterfearing) regions of the proteins.

Trouts new model, known as SAP (spatial aggregation propensity), offers a dynamic, threedimensional simulation of antibody molecules. Unlike static representations such as those provided by Xray crystallography, the new model can reveal hydrophobic regions and also indicates how much those regions are exposed when the molecule is in solution. The other important aspect of the model is that it selects out regions responsible for aggregation, as opposed to just single sites.

Once the hydrophobic regions are known, researchers can mutate the amino acids in those regions to decrease hydrophobicity and make the molecule more stable. Using the model, the team produced mutated antibodies with greatly enhanced stability (up to 50 percent more than the original antibodies), and the mutations had no adverse affect on their function.

Lead authors of the PNAS paper are Naresh Chennamsetty and Vladimir Voynov, postdoctoral associates in MITs Department of Chemical Engineering. Other authors are chemical engineering postdoctoral associate Veysel Kayser and Bernhard Helk of Novartis.

The research was funded by Novartis Pharma AG and computer time was provided in part by the National Center for Supercomputing Applications.

Source
Elizabeth Thomson

A bill (S. 221) approved by the North Carolina Legislature that would require a public school sex education curriculum covering abstinence, contraception and sexually transmitted infections “will be the most comprehensive and sciencebased approach the state has used” for sex education, a Charlotte Observer editorial states, adding that Gov. Bev Perdue (D) “should sign it.” The bill would require all public school districts in the state to teach a curriculum that focuses on abstinence but also includes information on preventing pregnancy and STIs. Parents would be able to have their children removed from the comprehensive portions of instruction. According to the editorial, the measure “still gives parents a choice in deciding what kind of sex education their children will receive.” The editorial adds, “It also finally provides a curriculum that gives N.C. students vital access to ageappropriate, sciencebased information critical to their health, safety and wellbeing,” which is “the kind of information that can help them make smart choices in serious situations.”

Parents are “often the best people for kids to turn to for advice and information” on sex, but “not all children have parents who can provide it, or are even willing to,” and “not all children [who] go to their parents adhere to their advice,” the editorial states. It continues, “The schools provide another avenue to get this critical advice and information and state lawmakers are right to make it available.” According to the Observer, North Carolina has the ninthhighest teenage pregnancy rate in the U.S., and about “20,000 teenagers will get pregnant in North Carolina this year.” A “comprehensive, sciencebased education program can help reduce the number of unintended teen pregnancies” and help reduce the spread of STIs, the editorial says. It concludes, “By reaching agreement on this matter, state lawmakers have given the children of this state vital tools to safeguard their health and welfare. … Perdue should sign this bill and make it law” (Charlotte Observer, 6/26).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

On June 26, 2009 several articles published online in Diabetologia by the European Association for the Study of Diabetes investigated the possible relationship between use of insulin glargine (Lantus, sanofiaventis) and the development of certain malignancies. The authors themselves, and the accompanying editorial, cautioned against overinterpretation of their limited data and analyses, which precluded them from drawing any firm conclusions. For example, there were contradictory findings among the studies, patient populations were not always comparable, and the duration of observation was short. Nonetheless, since the relationship of type 2 diabetes to cancer is of critical importance, further study is warranted.

The American Association of Clinical Endocrinologists (AACE) does not recommend that the use of any insulin be changed. AACE supports further research into the effectiveness and safety of all diabetes therapies and will continue to update recommendations as further data becomes available. Individual patient concerns should be discussed with their physicians.

About AACE

AACE is a professional medical organization with more than 6,200 members in the United States and 92 other countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE initiatives inform the public about endocrine disorders. AACE also conducts continuing education programs for clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine disease, such as diabetes, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension and obesity.

Source American Association of Clinical Endocrinologists

Morbidly obese seniors, age 65 and over, who had laparoscopic gastric bypass surgery lost nearly 76 percent of their excess weight after two years and had low complication rates and short hospital stays comparable to younger surgical patients, according to a new study presented today at the 26th Annual Meeting of the American Society for Metabolic & Bariatric Surgery (ASMBS).

“Bariatric surgery in the older population is underutilized because of a misperception that old age alone puts patients at higher risk for complications and mortality,” said Joseph Kuhn, MD, coauthor and director of General Surgical Research at Baylor University Medical Center in Dallas, TX. “We found seniors can benefit just as much as younger people from bariatric surgery without taking on additional risk.”

In one of the largest series of laparoscopic gastric bypass surgeries performed on elderly patients, researchers from Baylor University Medical Center analyzed a prospective database of 100 patients over age 65 and compared safety and outcomes to a younger population. All patients had laparoscopic gastric bypass surgery between January 2005 and July 2008. Prior to surgery, older patients demonstrated higher operative risk profiles compared to their younger counterparts in relation to sleep apnea (45% vs. 34%), Type 2 diabetes (65% vs. 33%) and hypertension (81% vs. 57%). Older patients ranged in age from 65 to 77 with an average BMI of 45, and younger patients ranged in age from 18 to 64 with an average BMI of 47.

Postoperative excess body weight loss (EWL) and complication rates were comparable in both groups. At 12 and 24 months, both lost nearly the same amount of weight patients over age 65 showed 75.9 percent EWL after one year and 75.5 percent after two years; patients under 65 showed 77.8 percent EWL after one year and 79.2 percent after two years. Neither group reported any deaths in the two year followup period, and postoperative complications were low bleeding (>65 1% v. < 65 1.3%), pulmonary infections (>65 3% v. 65 2% vs. 65 1% v.

A UK consumer watchdog that is campaiging for clearer food labelling analysed a selection of prepacked salads from high street supermarkets and found that while many provided the recommended “5 a day”, they varied widely in the amount of calories, fat and salt they contained, and one in particular had more calories and fat than a “Big Mac”.

Producttesting and consumer rights group Which? analysed 20 prepacked salalds they bought from Asda, Boots, Marks & Spencer, Morrisons, Sainsburys, Tesco and Waitrose and discovered that Smedleys Atlantic Prawn Marie Rose Salad, for sale at £1.49 for a 300g pack at Morrisons, “contained 855 calories and 66.3g fat, which is more than a McDonalds Big Mac and medium fries and 70 per cent of the fat a man should eat in a day”, they said in a press statement released yesterday.

Editor of Which? Martyn Hocking, said

“If you thought your highstreet salad was healthy, you could be in for a surprise.”

“Which? has found that there were large differences between the amount of fat, saturated fat, salt and calories in prepackaged salads.”

The point of the exercise was not just to highlight the “unhealthy” options, but to show how the labelling is confusing and people may not realize what they are buying just calling a product a salad doesnt really tell you much about its nutritional value.

For instance, the label on Sainsburys Tomato & Basil Chicken salad, selling at £2.95 for a 350g pack, said it had no mayo but the ingredients list showed it contained egg yolk, oil and white wine vinegar, which is more or less what goes into making mayonnaise.

An even more confusing label was on a 350g pack of Tesco Tuna Layered Salad. The way the ingredients are listed it looks at first like the whole pack contains just 275 calories and 20.5g fat, but a closer look reveals this is for just half the pack, the whole pack actually contains 550 calories and 41g fat, said the Which? report.

And Asdas Chicken Caesar Pasta Salad, costing £2 for a 297g pack, contained nearly as much fat as six Cadburys Creme eggs, they said. This salad had 41.3g of fat, and nearly a quarter of the salad comprised highcalorie dressing with mayonnaise (13 per cent) and Caesar dressing (10 per cent) in roughly equal parts.

The main reason that so many of the salads were high in calories and fat was the surprisingly high amount of mayonnaise and creamy sauces they contained.

Take for instance the Marks and Spencer Pasta with Tomato & Basil Chicken salad, selling at £3.20 for a 380g pack. This contained 760 calories and 46g fat, and mayonnaise was the second highest ingredient.

Some salads however, did get the thumbs up. Sainsburys Thai Chicken Noodle, selling at £2.95 for a 260g pack, has the dressing in a separate container so you can choose how much to add, and it is also low in fat, salt and saturated fat.

And another healthy option was Sainsburys Rainbow Salad, selling at £2.20 for a 215g pack. This met the “5 a day” suggestion by providing lots of vegetables, and also contained soya beans and lentils, rich sources of protein that are also low in fat. The dressing is separate on this salad too.

The watchdog wants UK food retailers to use one labelling convention that is easy for consumers to see at a glance the amount of calories, fat, sugar and salt in the food they are buying.

They cite research by the Food Standards Agency (FSA) that found what consumers would find most helpful would be a straightforward scheme that uses a “traffic light” colour scheme, with suggested daily amounts, indicating grams of nutritients in each portion and using words like “high”, “medium” and “low”.

Which? had these suggestions for consumers looking to make healthier choices when buying saladsPick salads with lots of different colours because this is a quick way to make sure you get one or two of your “5 a day”.
Choose salads that have dressings and sauces in separate containers, so you can add as much or as little as you want.
Salads with a lot of cheese tend to be higher in fat.
Vegetarians looking for a lower fat option to cheese would be advised to choose salads with pulses like lentils and beans.Hocking warned

“Check the label or you could end up with egg on your face.”

He said that this latest research highlights what Which? have been saying for some time

“Clear, consistent labelling scheme is important to help people spot how much fat, sugar and salt is in the food theyre buying.”

Source Which? magazine.

Written by Catharine Paddock, PhD

Joel B. Nelson, M.D., chairman of the University of Pittsburgh Medical Centers (UPMC) Department of Urology, performed his 2,000th radical prostatectomy at UPMC Shadyside, a milestone achieved by only a handful of surgeons worldwide. Radical prostatectomy, or removal of the entire prostate gland, is the most common treatment for patients with localized prostate cancer. Studies show that recovery from prostate cancer is significantly associated with a surgeons lifetime experience performing this operation.

“Research supports common sense Patients undergoing surgery by more experienced surgeons will have a better chance of being cured of their cancer,” said Dr. Nelson. “With a practice entirely focused on men with localized prostate cancer has come a wealth of experience, leading to continuous refinement in surgical technique and improved outcomes. For most patients, a oneday hospital stay is routine.”

Surgeons in the Department of Urology also offer roboticassisted laparoscopic radical prostatectomy. Initiated in 2004, UPMCs robotic prostatectomy program was the first in the region, and surgeons in the department recently performed their 500th robotic procedure.

Dr. Nelson joined UPMC in 1999 to lead the newly formed Department of Urology. He is one of the countrys leading surgeons performing nervesparing radical prostatectomy, an operation in which a cancerous prostate gland is removed but the nerves controlling erections are not. More than 90 percent of his operations are nervesparing, which is a significantly higher percentage than the national average.

After earning his medical degree from Northwestern University, Dr. Nelson completed surgical and urological residencies at the McGraw Medical Center of Northwestern University and a fellowship at the Johns Hopkins Brady Urological Institute. He also served as assistant professor of urology and oncology at the Johns Hopkins University School of Medicine and director of urologic oncology at the Johns Hopkins Bayview Medical Center.

Source

Novasys Medical, Inc., a developer of innovative therapies in womens health, announced that as of July 1, 2009, First Coast Service Options, Inc. (”First Coast”), a large regional Medicare carrier serving over 3 million beneficiaries in Florida, Puerto Rico and the U.S. Virgin Islands, has removed the nonsurgical Renessa(R) treatment for women with stress urinary incontinence (SUI) from its noncovered services list and will be looking at claims for the Renessa procedure on an individual case by case basis.

On its Web site, First Coast states, “in order to provide an option for those physicians who are appropriately trained in treating women with stress urinary incontinence (SUI) and who are appropriately trained in performing the Renessa procedure, we will be removing Renessa from our noncovered LCD and we will be looking at claims for the Renessa procedure on an individual case by case basis.” First Coast goes on to state that it “expects that providers submitting claims for Renessa are providing the services within the FDA approved guidelines and in accordance with the indications supported by peerreviewed literature which limits its use to moderate to severe stress urinary incontinence (SUI) in females.”

“We are very pleased with First Coasts decision,” said Debra Reisenthel, Novasys Medical President and Chief Executive Officer, “as it enables access to this safe and effective treatment option for Medicare beneficiaries in Florida with moderate to severe SUI.” First Coast joins Noridian Medicare, a large regional carrier administering benefits in nine states, in providing reimbursement for the Renessa procedure. Other private insurers, including AvMed and HealthFirst in Florida and Aetna US Healthcare nationwide, also cover this safe and effective nonsurgical treatment for women who suffer from the debilitating effects of SUI.

Female Stress Urinary Incontinence

SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of a significant number of women. With currently available surgical and nonsurgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness.

The FDAcleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing the patients own collagen in the tissue, thereby reducing or eliminating leaks. The Renessa treatment can be performed in the convenience of a physicians office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal postprocedure limitations. The Renessa treatment offers an option for women who have tried conservative therapies such as Kegel exercises or biofeedback without success, but who cannot have or do not desire an invasive surgical procedure. To date, over 350 urologists, urogynecologists and gynecologists in 40 states have been trained and have performed the Renessa procedure in over 2500 patients.

About Novasys Medical

Novasys Medical, Inc. is a privately held, venturebacked company which develops innovative therapies in womens health. The companys initial focus is the development and commercialization of the Renessa System, a proprietary, nonsurgical approach to the treatment of female stress urinary incontinence (SUI).