Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board ADLS), announced positive topline results from a pivotal, nonhuman primate study involving its novel, onceaday, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague. The study tested Restanzas protective efficacy at various doses up to 64 mg/kg, where nine out of ten animals in the study that received a 14day course of Restanza initiated within 24 hours after exposure to a lethal dose of plague survived while only one out of ten of the animals that received placebo survived.

Known as the “black death,” a plague epidemic decimated Europe in the Middle Ages, killed more than 10 million people in India a century ago and today mainly affects people who come into contact with infected rodents. In weaponized form, plague could be engineered to resist antibiotic intervention and to be widely spread through human transmission. Yersinia pestis, the causative agent of plague, is classified by the Centers for Disease Control as a Category A Bioterrorism Agent and is prioritized by the Department of Defense and Department of Health and Human Services as one of the most serious biological weapons, along with anthrax and tularemia.

The Johns Hopkins Working Group on Civilian Biodefense notes that because of “the availability of Y. pestis around the world, capacity for its mass production and aerosol dissemination, difficulty in preventing such activities, high fatality rate of pneumonic plague, and potential for secondary spread of cases during an epidemic, the potential use of plague as a biological weapon is of great concern.”(1) Unlike anthrax, there is no FDAapproved vaccine available to protect against plague, and the only antibiotic treatments currently available for improving survival in the event of a plague outbreak are older agents, such as tetracycline and doxycycline.

“We believe that the impressive survival data in plague, combined with previously reported survival data in anthrax and tularemia, confirm the profile of Restanza as a potent, broad spectrum medical countermeasure for biodefense and underscore Restanzas impressive efficacy and safety against lethal pathogens which could represent significant threats to public health and safety,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “Through our work with the U.S. government, we continue to advance Restanza toward potential registration as a new biodefense agent. Achieving regulatory approval for Restanza could lay the groundwork for securing important government stockpiling contracts that could bring significant value to our company. We plan to meet with the FDA in the coming months to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment in the first part of 2010 seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague.”

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as anthrax, Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a twoyear, $3.8 million contract with the U.S. Department of Defense. The FDA has designated Restanza as an orphan drug for the postexposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.

FDAs “Animal Efficacy Rule” and the Use of NonHuman Primates

The FDAs “Animal Efficacy Rule” allows for approval of new drug products based on animal datawhen adequate and wellcontrolled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the “Animal Efficacy Rule” is subject to certain postapproval commitments, including the submission of a plan for conducting postmarketing studies, postmarketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the products approval was based on efficacy studies conducted in animals alone.

The nonhuman primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to FDAs “Animal Efficacy Rule” (21 C.F.R. Section 314.600650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.

Any statements contained in this presentation that relate to future plans, events or performance are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forwardlooking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forwardlooking statements as a result of new information, future events or otherwise.

(1) Journal of the American Medical Association (JAMA) Vol. 283 No. 17, May 3, 2000.

Source Advanced Life Sciences Holdings, Inc

The G20 said the World Bank trust fund for agricultural investment in poor countries that they called for on Friday “should be designed so that money will be disbursed quickly and countries can decide for themselves where they want it spent,” Reuters reports. Leaders, who wrapped up their meeting in Pittsburgh, Pennsylvania last week, said, “We call on the World Bank to work with interested donors and organizations to develop a multilateral trust fund to scale up agricultural assistance to lowincome countries.”

According to Reuters, “[a]gricultural investment in poor countries has shrunk over the last decade as development agencies focused more on health issues, including malaria and HIV/AIDS.” The G20 set forth no timeline for the funds creation, the news service reports (Wroughton, 9/25).

The Pittsburgh PostGazette examines advocates reaction to commitments made at the summit, which include, “the need to help poor countries weather the tumultuous financial climate; reform the membership of the International Monetary Fund and the World Bank to include more of the poorest countries; carry forward the framework of the G8 agreement on food security in Italy; and to deliver on the $100 billion the G8 promised to loan developing countries.”

Save the Childrens Michael Klosson said, “[W]e urge the G20 to go beyond what they said in Pittsburgh. To acknowledge that development aid is the very foundation for an economic recovery.” Nine million children under age 5 will die this year from mostly treatable or preventable causes, according to Klosson (9/26).

The full Leaders Statement from the summit is available online.

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Diabetes increases by 26 percent the likelihood that women will develop atrial fibrillation (AF), a potentially dangerous irregular heart rhythm that can lead to stroke, heart failure, and chronic fatigue. These are the findings of a new Kaiser Permanente study, published in the October issue of Diabetes Care, a journal of the American Diabetes Association.

While other studies have found that patients with diabetes are more likely to have AF, this is the first large studyinvolving nearly 35,000 Kaiser Permanente patients over the course of seven yearsto isolate the effect of diabetes and determine that it is an independent risk factor for women.

“The most important finding from our study is that women with diabetes have an increased risk of developing this abnormal heart rhythm,” said the studys lead author, Greg Nichols, PhD, investigator at the Kaiser Permanente Center for Health Research in Portland, Ore. “Men with diabetes are also at higher risk, but the association between the two conditions is not as strong. For men, obesity and high blood pressure are bigger risk factors from diabetes.”

“AF is the most common arrhythmia in the world, and diabetes is one of the most common and costly health conditions. Our study points out that there is a connection between these two growing epidemicsone we should pay closer attention to, especially among women,” says Sumeet Chugh, MD, coauthor and associate director of the CedarsSinai Heart Institute in Los Angeles. “The gender differences need to be looked at more closely because they could have significant implications for how we treat diabetes in men and women.”

Atrial fibrillation occurs when the two upper chambers of the heart beat irregularly and too fast, causing blood to pool and clot. If the clot travels out of the heart and becomes lodged in an artery or in the brain, it can cause a stroke. About 2.2 million Americans are diagnosed with AF; however, many more people have the condition but dont know it. Diabetes affects more than 23 million Americansand, according to the study, nearly 4 percent, or 1 million, have atrial fibrillation.

The study involved 17,372 patients in Kaiser Permanentes diabetes registry in Oregon and Washington and an equal number of nondiabetic patients, matched for age and sex. Researchers used Kaiser Permanente HealthConnect®, the worlds largest civilian electronic health records system, to identify the nondiabetic patients. The two groups were followed for an average of 7.2 years until Dec., 31, 2008 or until they died or left the health plan. At the start of the study, 3.6 percent of the patients with diabetes had AF, vs. only 2.5 percent of the nondiabetic patientsa difference of 44 percent. During the study period, diabetics were more likely than nondiabetics to develop AF. But after controlling for other factors like obesity, high blood pressure and age, the increased risk was only significant among women. Women with diabetes were 26 percent more likely than their nondiabetic counterparts to develop AF.

Authors include Gregory A. Nichols, PhD, Kaiser Permanente Center for Health Research; Kyndaron Reinier, PhD, and Sumeet S. Chugh, MD, CedarsSinai Heart Institute, Los Angeles.

About the Kaiser Permanente Center for Health Research

Kaiser Permanentes Center for Health Research, founded in 1964, is a nonprofit research institution dedicated to advancing knowledge to improve health. It has research sites in Portland, Ore., Honolulu, Hawaii and Atlanta.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of Americas leading health care providers and notforprofit health plans. Founded in 1945, our mission is to provide highquality, affordable health care services to improve the health of our members and the communities we serve. We currently serve 8.6 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industryleading technology advances and tools for health promotion, disease prevention, stateofthe art care delivery and worldclass chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health.

Source Kaiser Permanente

What

In recognition of American Diabetes Month® in November, the American Diabetes Association will be launching a movement to encourage Americans to confront, fight and Stop Diabetes (SM).

Anyone can join the movement by choosing to share their experiences with diabetes, helping to raise awareness about diabetes, becoming active in their community, learning about diabetes, giving of their time and passion, or donating funds to support diabetes research, information, or advocacy efforts.

Who

The American Diabetes Association is leading the fight against the deadly consequences of diabetes and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes.

When

November 2, 2009

Why

With nearly 24 million children and adults afflicted with the disease in the U.S. and an additional 57 million at risk for type 2 diabetes, diabetes has reached epidemic proportions. If current trends continue, one out of three children will face a future with diabetes.

How

To let your viewers/listeners/readers know about American Diabetes Month and the Stop Diabetes movement. Interviews with an American Diabetes Association spokesperson are available upon request.

This conference and networking event will present a fresh and original perspective on communicating the value and costeffectiveness of highvalue oncology drugs with payers, HTA assessors and other key stakeholders.

Unlike other general pricing & reimbursement meetings which broadly discuss many therapeutic areas, this event will be focused specifically on the oncology marketplace. This conference will look at the latest innovative market access techniques such as valuebased pricing schemes, risk sharing, as well as satisfying HTA requirements to build the right dossier.

Why attend?Benchmark, network and cooperate with pharma & nonpharma decision makers.Get up to date on innovative reimbursement schemes and their implementation.Learn what data makes the difference for HTA agencies and payers and how to present it.Understand the best ways to communicate value and achieve maximum patient and market access.Hear multistakeholder perspectives from pharmaceutical industry, academia, public insurers, HTA, policy makers, patient groups.Discover how payers are viewing risksharing and valuebased pricing agreements and what their initiatives in the field are.Understand what patients want and what they view as quality treatment.Who will benefit?

Pharmaceutical companies
VicePresidents, Directors, Managers involved in oncology Pricing & Reimbursement, Health Economics & Outcomes, Government & Stakeholder Relations, Regulatory Affairs, Medical Affairs, Marketing, Therapy Area Heads, Market Access, Country Managers

Solution providers & consultants
CEOs, Business Development, Senior Consultants, Regional Heads

Independent Academics, Health Economists, Senior Doctors, & Patient Representatives.

Date and Location

The conference will be held on the 14th and 15th December 2009 in Prague, Czech Republic.

Agenda request

To request the full agenda please follow this link.

For Booking Information contact

Erika Vavrovicova
Tel +421 232 660 382
Fax +421 232 660 397
erika@nextlevelpharma.com
nextlevelpharma.com

Two papers published on bmj.com today report that there is unsatisfactory evidence to support populationwide screening for prostate cancer using the prostate specific antigen (PSA) test.

The PSA test cannot differentiate lethal from harmless prostate cancer, according to the authors. This could lead to over diagnosis and overtreatment of healthy men.

Prostate specific antigen (PSA) is a protein formed in the cells of the prostate gland. It is present in small quantities in the blood of healthy men. It is frequently elevated in men with prostate cancer and in men with benign prostatic enlargement.

Although it remains controversial, PSA screening is commonly used in many countries. The latest study suggests that prostate cancer deaths were lower among screened men but at a cost of significant over diagnosis and treatment.

A Swedish team of researchers set out in the first study to evaluate how well prostate specific antigen predicted a potential prostate cancer diagnosis.

They used PSA test results from 540 men diagnosed with prostate cancer measured several years before diagnosis and from 1,034 healthy controls. Results indicated that the PSA test did not reach the probability ratios. It is a measure used to predict disease required for a screening test. Only very low concentrations of PSA (less than 1ng/ml) virtually ruled out a diagnosis of prostate cancer during monitoring.

The researchers inform that there is a need for other biomarkers for early detection of prostate cancer and before population based screening for prostate cancer should be introduced.

US researchers looked at the benefits and risks of PSA screening in a second analysis paper. They concluded that data on costs and benefits remain insufficient to support population based screening. In addition, they recommend further accurate measuring of the financial and psychological costs of false positive results, over diagnosis and overtreatment of prostate cancer.

In conclusion, they consider that men should be entirely informed of the benefits, harms and uncertainties associated with the PSA test before they are screened.

This observation is supported in a complementary editorial by researchers at Monash University in Australia.

Dr Dragan Ilic and Professor Sally Green write “Clinicians and patients are faced with many uncertainties when considering whether or not to undergo prostate screening.”

They remark “Further research is required to develop and evaluate a valid screening test for prostate cancer.” Until such a test exists, the choice to undertake screening should follow a shared decision making approach.

“Prostate specific antigen for early detection of prostate cancer longitudinal study”
Benny Holmstro¨m, urologist, Mattias Johansson, postdoctoral fellow, Anders Bergh, professor of pathology, UlfHa°kan Stenman, professor of clinical chemistry, Go¨ran Hallmans, professor of nutritional research, Pa¨r Stattin, professor of urology
BMJ 2009;339b3537
doi10.1136/bmj.b3537

“Screening for prostate cancer remains controversial”
Jennifer R Stark postdoctoral fellow of epidemiology, Lorelei Mucci assistant professor of epidemiology, Kenneth J Rothman professor of epidemiology and medicine, HansOlov Adami professor of epidemiology
BMJ 2009; 339b3601

“Prostate specific antigen for detecting early prostate cancer”
Dragan Ilic senior lecturer, Sally Green professorial fellow
BMJ 2009; 339b3572
bmj.com

Protalix Biotherapeutics, Inc. (NYSEAmex PLX), reported preclinical data on prantiTNF, a biosimilar version of etanercept (Enbrel™). Produced using the Companys proprietary ProCellEx™ technology, prantiTNF is a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. PrantiTNF has an identical amino acid sequence to Enbrel™.

In vitro and preclinical animal studies have demonstrated that prantiTNF exhibits similar activity to Enbrel™. Specifically, prantiTNF binds TNF alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNFinduced apoptosis in a dosedependent manner. In a proofofconcept in vivo study using an established arthritis animal model, prantiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model including joint inflammation, swelling and tissue degradation. Data from the collagen induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

“We are very encouraged by the preclinical data generated from our prantiTNF thus far,” said Dr. Yoseph Shaaltiel, Executive Vice President, R&D of Protalix. “These data further validate our ProCellEx™ technology and its ability to produce a wide range of complex therapeutic proteins in plant cells. Given our highly efficient and cost effective manufacturing process, we feel the Company is well positioned to be an active participant in the biosimilar market.”

Source

A study published in Neurology by researchers in the US has found that declining financial skills could be an early indicator of Alzheimers disease in people with mild cognitive impairment (MCI).

The year long study worked with 87 people with MCI, 25 of whom developed Alzheimertype dementia during the study period and 62 who did not; and with 76 cognitively healthy people as controls. The group was tested at the beginning of the year and at the end with a tool called the Financial Capacity Instrument (FCI). This measured skills including understanding of financial concepts, cash transactions, bank statement management and bill payment.

This could be a useful indicator for doctors supporting people with memory problems.

Everyone struggles now and then to divide a restaurant bill or tot up your chequebook. However, this study suggests that if you already experience significant memory problems and start to notice a decline in your financial skills it could be a sign of developing dementia.

More research is needed into memory decline to begin to find useful, early indicators of the development of dementia. Dementia research is desperately underfunded. One million people will develop dementia in the next 10 years. We must act now.

Dr. Susanne Sorensen
Head of Research
Alzheimers Society

Reference
Declining financial capacity in mild cognitive impairment by K.L. Triebel, PsyD, R.Martin, PhD, H.R. Griffith, PhD et al

Public speaking, anyone? Or maybe a big job interview? Dry your palms and take a deep, calming breath; there may be a silver lining. Researchers at the Stanford University School of Medicine have shown that, at least in laboratory mice, bouts of relatively shortterm stress can boost the immune system and protect against one type of cancer. Furthermore, the beneficial effects of this occasional angst seem to last for weeks after the stressful situation has ended. The finding is surprising because chronic stress has the opposite effect taxing the immune system and increasing susceptibility to disease.

“This is the first evidence that this type of shortlived stress may enhance antitumor activity,” said Firdaus Dhabhar, PhD, associate professor of psychiatry and behavioral sciences and a member of Stanfords Cancer Center, and Institute for Immunity, Transplantation and Infection. “This is a promising new way of thinking that calls for more research. We hope that it will eventually lead to applications that help us to care for those who are ill, by maximally harnessing the bodys natural defenses while also using other medical treatments.”

The study will be published in a future print issue of the journal Brain, Behavior, and Immunity, and a review copy of the article is now available on the journals Web site.

The researchers studied a particular type of skin cancer called squamous cell carcinoma that is known to be vulnerable to attack by the immune system.

Understanding how the intricate twostep between stress and the immune system plays out in the dance hall of diseases like cancer is important for future therapies. Certain types of stress, such as the socalled fightorflight response to an immediate but temporary threat, has been shown to increase the recruitment of immune cells to the surface of the skin and the surrounding lymph nodes presumably in preparation for imminent injury.

“Acute stress galvanizes an organisms protective systems,” said Dhabhar, whose laboratory focuses on understanding the physiological effects of both acute and chronic stress. “But although its one of natures fundamental survival systems, thus far its been rather underappreciated.”

The researchers investigated the effect of shortterm, or acute, stress on 30 laboratory mice exposed for 10 weeks to thriceweekly doses of cancercausing ultraviolet light. The light was nonblistering and nonburning and the mice experienced only a slight reddening of the skin after each exposure. But because the light was composed mainly of the most dangerous wavelength called UVB starting at week 11, many of the mice went on to develop precancerous and cancerous growths similar to those seen in humans.

To stress the mice, the researchers placed them in wellventilated plastic tubes for 2.5 hours prior to UV exposure from weeks four to six, for a total of nine bouts of stress. The mice were not squeezed or compressed, but their ability to move was restricted. Previous research showed that mice confined in such a way mount a behavioral and hormonal stress response.

Dhabhar and his colleagues compared the prevalence and tumor burden of the skin cancers in the stressed mice with that of a nonstressed, UVexposed control group of 30 mice. They found that fewer of the mice that had been acutely stressed developed skin cancer during weeks 11 through 21, and that those that did exhibited a lower total amount of tumors (a measurement called tumor burden) than the nonstressed mice.

The stressed mice werent protected indefinitely. Approximately 90 percent of the mice in both groups developed cancer after week 22, though the stressed group continued to have fewer tumors until week 26.

“Its possible that the pretumor cells were eliminated more efficiently in the group that was stressed. There may also have been a longerterm enhancement of immunity as we have seen in our noncancerrelated studies,” said Dhabhar, explaining why tumor development appeared to lag in the stressed mice. “However, acute stress did not lower tumor burden beyond week 26. We are in the process of determining why.”

Other stressinduced changes lingered for weeks, however. The researchers found that, during the same time period, the skin of the stressed mice had higher levels of immuneactivating genes than did the control group almost as if the mice were preparing for battle.

“Evolutionarily, it makes sense,” said Dhabhar. “In nature, stress and immune activity are typically coupled. Its like a lion chasing and wounding a gazelle. Nature taps into this stress response to give a boost to the immune system in the face of danger.” He compared the effect to how drugmakers often increase the potency of vaccines by including generic immuneactivating molecules called adjuvants.

As intriguing as the results are, Dhabhar doesnt really imagine that well be confining human patients in straightjackets or tossing them in front of an intimidating audience as a therapeutic technique any time soon (thank goodness!). But he is convinced that acute stress may be better for us than most of us think, and that biobehavioral interventions are worth investigating. As long as you can return to a normal, psychophysiological resting state within a few hours of a stressful event, youll probably be fine.

“The key is not to let the stress response linger,” he said. To understand why, Dhabhar and his colleagues are now probing more deeply into the biological basis of these protective effects of the acute stress response.

“What we want to do now is to finetune the stress dynamics so that we can get maximal benefits,” he said. “We are working to determine what molecules and cells are involved, and when. It may be possible one day to harness these protective effects by behaviorally or pharmacologically activating the pathways involved.”

Dhabhars Stanford colleagues on the work include senior research scientist Tyson Holmes, PhD, and Donna Bouley, PhD. They also collaborated with colleagues at Ohio State University.

The research was supported by the National Cancer Institute at the National Institutes of Health.

Source
Ruthann Richter

Elite cardiovascular surgeons from around the world will travel to suburban Atlanta this week for the twoday Ross Summit to review and discuss current peerreviewed data relating to the survival advantage of the Ross Procedure and to practice the technical nuances required to perform this heart surgery successfully.

The Ross Procedure is a type of specialized aortic valve surgery in which the patients diseased aortic valve is replaced with his or her own pulmonary valve. The pulmonary valve can then be replaced with a cryopreserved human pulmonary valve.

Nine peerreviewed articles regarding the Ross Procedure representing individual series from eight different countries, comprising a total of 2,234 patients have appeared in major medical journals over the past four years and report that The Ross Procedure is associated with excellent longterm survival;

Late survival with the Ross Procedure is comparable to that of the agematched general population; and

There is an excellent propensityadjusted survival with the Ross Procedure in a pediatric patient population study compared to the excess mortality demonstrated with using a mechanical valve (as reported by one of the nine reports). Led by Professor Sir Magdi Yacoub, FRS, FRCS, of Imperial Colleges Heart Science Center in London in tandem with William F. Northrup III, MD, vice president of physician relations and education at CryoLife, the Ross Summit will have a faculty of more than 30 worldrenowned cardiovascular surgeons and cardiologists, who will present clinical data on heart reconstruction surgery at their respective clinics. The summit includes two sessions of handson instruction in the various techniques of cardiac reconstruction.

The Ross Procedure is performed on up to 1,500 individuals globally each year a number that is expected to increase as survival data become more widely known.

“In children, young adults and in active older adults, the Ross Procedure offers several advantages over other traditional aortic valve replacement options,” said Dr. Northrup. “The most important advantage is growing evidence of improved longterm survival over other valve replacement options. The procedure is also attractive because patients do not have to take longterm, bloodthinning medications after surgery as they would with mechanical valves. This is particularly appealing to women of childbearing age, athletes and active adults.”

These clear advantages along with the growing catalog of survivability data spotlighted at the summit are bringing new attention to the procedure from surgeons and potential patients.

“The Ross Procedure requires very specific surgical expertise to achieve predictable, longlasting results, and The Ross Summit was created to foster data exchange to provide a wellrounded point of view in addition to offering critical procedural training,” noted Steven G. Anderson, chairman, president and CEO of CryoLife.

A full faculty list and summit agenda can be found at TheRossSummit.org. A live webcast of the Ross Summit can be viewed at TheRossCommunity.org.

A decellularized human pulmonary heart valve, CryoValve(R) SG, processed using CryoLifes SynerGraft(R) technology, was cleared by the FDA in February 2008 for use in cardiac reconstruction procedures, which includes the Ross Procedure.

Source
Dana Hartline