Respironics Receives 510(k) Clearance From FDA For BiPAP(R) AutoSV(TM) Device Designed For Complicated Sleep-Disordered Breathing Patients
Respironics, Inc.
(Nasdaq: RESP) today announced that the U.S. Food and Drug Administration
(FDA) granted 510(k) clearance of the BiPAP autoSV device, which is
intended to provide noninvasive ventilatory support to treat adult patients
with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency caused by
central and/or mixed apneas and periodic breathing.
“We are excited about broadening our product portfolio in the sleep and
respiratory markets with the BiPAP autoSV device, which expands our ability
to provide life-changing therapy to a wider population of patients,” said
John L. Miclot, president and CEO of Respironics.
The BiPAP autoSV device was previously launched in Europe and Canada
and to date the market acceptance of this product has been very positive.
This product is designed for managing complicated sleep-disordered
breathing patients and combines a number of Respironics’ core technologies
to recognize and respond to patients’ changing pressure needs.
The BiPAP autoSV device delivers optimal therapy for these complicated
sleep-disordered breathing patients utilizing a multi-level algorithm. On a
breath-by-breath basis, the revolutionary algorithm utilizes Respironics’
core technologies to adjust pressure support upon detecting a sleep event,
such as an apnea, hypopnea or periodic breathing, to stabilize the
patient’s breathing pattern. This algorithm also calculates the patient’s
spontaneous breathing rate and will automatically trigger a breath for the
patient should a sleep event occur. This device also combines Respironics’
proven BiPAP technology, Encore(R) Pro Data Management Software, Digital
Auto-Trak(TM) Sensitivity, integrated alarms and optional integrated heated
humidification. Respironics plans to begin domestic distribution of this
product later in the current fiscal year.
The Company stated that it will not be changing its financial guidance
or outlook based on this announcement.
Respironics is a leading developer, manufacturer and distributor of
innovative products and programs that serve the global sleep and
respiratory markets. Focusing on emerging market needs, the Company is
committed to providing valued solutions to help improve outcomes for
patients, clinicians and health care providers. Respironics markets its
products in 131 countries and employs over 4,900 associates worldwide.
Further information can be found on the Company’s Web site:
respironics.
This document contains forward-looking statements, including statements
relating to, among other things, developments in the healthcare industry;
the success of the Company’s marketing, sales, and promotion programs;
future sales, acceptance, and quality of the Company’s products and
programs; the timing and success of new product introductions; new product
development; anticipated cost savings; FDA and other regulatory
requirements, enforcement actions, product recalls or related field
actions; future results from acquisitions and strategic investments; growth
rates in foreign markets; regulations and other factors affecting
operations and sales outside the United States; foreign currency
fluctuations; the effects of a major earthquake, cyber-attack or other
catastrophic event that results in the destruction or disruption of any
critical business or information technology systems; customer consolidation
and concentration; increasing price competition and other competitive
factors in the manufacture, distribution, and sale of products; interest
rate fluctuations; expiration of intellectual property rights; intellectual
property and related litigation; other litigation; future levels of
earnings and revenues; the number of equity awards granted to employees and
changes in the Company’s stock price; and third party reimbursement; all of
which are subject to change. Actual results may differ materially from
those described in any forward-looking statements. Additional information
on potential factors that could affect the Company’s financial results are
included in the reports filed with the SEC, including the reports on Form
10-K, 10-Q and 8-K.
Respironics, Inc.
respironics
Seasonal Flu Campaign In England Continues To Achieve One Of The Highest Uptakes Rates In The 65+ Age Group In Europe
Figures from the flu vaccination programme 2006/07, showed seventy
four per cent of those aged 65 and over received a flu jab by the end
of January 2007, and 42 per cent of those under 65 in at risk groups
were vaccinated.
In 2006/07, 6.2 million people in the 65 and over group were
vaccinationed against flu. This figure is comparable to last year’s
campaign. (2005/06.)
The achievements of the flu campaign are all the more impressive
considering that vaccine deliveries were delayed by several weeks due
to manufacturing problems.
A new flu vaccination programme was announced in January for people
who work in close contact with poultry; nearly all PCTs have plans
to implement the programme, targeted for completion by March 31.
The Department of Health is also publishing today the review of the
seasonal flu programme commissioned by the Health Secretary after the
2005/06 campaign. The review identifies a number of ways for the
Department of Health and the NHS to build on the programme’s
successes. The main recommendations are:
Sustain progress achieved so far:
– Improve uptake among occupational health groups (health workers)
– Enhance the role of influenza co-ordinators and improve national,
regional and local co-ordination and contingency planning.
– Explore the full range of delivery mechanisms available to the NHS
through different contract types
– Review future options for the purchase, supply and delivery of
vaccine
Many recommendations have already been implemented, for example,
improving communication with vaccine manufacturers and GPs.
Secretary of State Patricia Hewitt welcomed the report and commended
the reviewers for such a thorough piece of work and said that the
Department will be considering the detailed recommendations.
The review found greater public awareness of avian and pandemic flu
in 2005 meant that some GP practices could not immediately meet
public demand for flu vaccine and this may have led to reports of
shortages.
Dr David Salisbury, Director of Immunisation at the Department of
Health said;
“It is important to acknowledge the excellent achievement made by the
GPs, nurses, health service providers and primary care organisations
in delivering the seasonal flu programme in 2006/07. More than six
million people aged 65 and over were immunised against flu, which can
be a serious illness for older people.
“The seasonal flu review recognises that England runs an effective
seasonal flu vaccination programme that achieves one of the highest
uptakes in Europe. We accept in principle the recommendations to
strengthen the programme, while recognising that some details may
need to be considered more fully . We look forward to consulting
widely about this.”
– Copies of the review are available from the Department of Health here.
– Regarding flu vaccine uptake figures, we have extrapolated the
figures up to assume a 100 per cent return from GP practices. We have
worked out how many people would have been vaccinated if we had
received a 100 per cent return for each of the years. This makes the
assumption that there are no differences in the size of the GP
practices returning data.
– Flu uptake figures are published by the HPA.
5. For risk groups announced in last year’s CMO annual letter to the
NHS for the 2006/07 seasonal flu campaign see, click here (PDF).
– Influenza is an acute viral infection and in most years occurs
predominantly during a six to eight week period during the winter.
– For most people, this seasonal influenza is an unpleasant but self
limiting and not life endangering illness. In some people it may be
more severe, or complicated by secondary bacterial infections. The
very young, the elderly and people with underlying diseases such as
heart or chest disease are particularly at risk of serious illness
from influenza.
– Poultry workers are being vaccinated as a precautionary measure
against a pandemic flu virus emerging in England.
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New Adherence Factor, Pili, Produced By Tuberculosis Identified By UA Researchers
Researchers at The University of Arizona College of Medicine’s Department of Immunobiology have discovered that the agent that causes tuberculosis (TB), Mycobacterium tuberculosis, produces a new type of virulence factor called Mycobacterium Tuberculosis Pili (MTP). Their findings suggest that MTP could be a promising, new TB-vaccine candidate.
The study, “Mycobacterium tuberculosis produces pili during human infection,” published in the Proceedings of the National Academy of Sciences, Volume 104, could spur further scientific investigations on TB, which is the No. 1 cause of bacterial infectious disease in the world today. Worldwide, 3 million people die each year from tuberculosis and an estimated 1.2 billion are infected with the bacteria.
Virulence factors, such as MTP, are essential for causing disease in the host. Pili, also called fimbriae, are hair-like adhesive structures that facilitate the initial attachment and subsequent colonization of bacteria on human cells during bacterial infections.
Many other bacteria that cause human disease produce similar adhesive factors known as pili or fimbriae that play a critical role in allowing infections to develop in the patient. This is the first report of pili being produced by M. tuberculosis.
“Tuberculosis remains the most devastating bacterial cause of human mortality today. Despite improved diagnosis, surveillance, and treatment regimens, the incidence of TB increases annually. The ability to combat this deadly pathogen hinges on the dissection and understanding of the mechanisms of pathogenesis for M. tuberculosis,” writes Christopher Alteri, PhD, a former UA graduate student who is principal author on this study.
This important work was part of his dissertation research at the UA under the direction of Richard L. Friedman, PhD, professor of immunobiology. Dr. Alteri now is a postdoctoral fellow at the University of Michigan Medical School. Jorge A. GirГіn, PhD, UA assistant professor of immunobiology, and Juan XicohtГ©ncatal, PhD, his postdoctoral fellow, collaborated on this study.
If M. tuberculosis pili are important for the bacillus to establish infections in humans, as with other microbes, then MTP could be considered an attractive new TB vaccine candidate, according to the study. Presently, there is a great need to develop more effective immunization strategies against this devastating disease.
Focusing on the pili adhesive factor produced by M. tuberculosis, which may enable the bacillus to colonize and grow within the human host, the UA experiments demonstrated that when the gene for pili is inactivated, the bacteria do not bind as well to host surface cell proteins, said Dr. Friedman. Serum from TB patients was found to have antibodies to MTP, which indicates that the pili are produced by the bacteria during human infection.
While most tuberculosis infections and deaths occur in Africa, Asia and India, the United States has experienced recent outbreaks. “AIDS patients, who do not have intact immune systems, are highly susceptible to TB infection. This is a major reason for the worldwide increase in the incidence of TB. This increase also is associated with poverty, the growing numbers of homeless, alcohol- and drug-abusing populations, as well as with the emergence of multi-drug resistant strains of M. tuberculosis. Such strains constitute a very serious public health problem because they cannot be treated with any of the most commonly used anti-tuberculosis antibiotics, resulting in high mortality and rates of transmission,” said Dr. Friedman.
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In addition to Drs. Alteri, Friedman, GirГіn and XicohtГ©ncatl, researchers who participated in this study are Sonja Hess, National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH), and Guillermo Caballero-OlГn, Instituto Mexicano del Seguro Social, Mexico.
Contact: Katie Maass
University of Arizona Health Sciences Center
Important Step On Path To Reducing Transplant Rejection Rates
A new study involving a type of stem cells from the lungs of transplant patients demonstrates for the first time that these progenitor cells reside in adult organs and are not derived from bone marrow, which leads to the possibility that the cells may be able to help with the rejection of donated organs and with various kinds of lung disease.
The study by University of Michigan Health System researchers is significant because of the large number of lung transplant patients who experience chronic rejection of donated lungs, with rejection rates of about 60 percent during the first five years after transplantation.
The researchers studied mesenchymal stem cells (MSCs), a type of progenitor cell that most commonly originates in the bone marrow. In this study, lead author Vibha N. Lama, M.D., M.S., and her research team found that the MSCs in lung transplant patients are not derived from bone marrow, but rather that they reside – sometimes for many years – in the lungs. The researchers also found that these cells have the capacity to differentiate into multiple connective tissue cell types.
One of the most telling findings was that, in cases where the transplant donor and recipient were not of the same sex, nearly all the MSCs (about 97 percent) originated in the donor, indicating that they were present in the tissue since the time of transplantation. “We were able to isolate the cells derived from the donor as far as 11,5 years after transplantation,” says Lama, assistant professor in the Division of Pulmonary and Critical Care Medicine at the U-M Medical School. “We discovered the existence of a population of MSCs that reside and self-renew in the tissues of the adult lung – something that might hold true for other organ systems as well.
“Potentially the most important outcome of our finding is that it could lead to an understanding about therapeutic options using MSCs that reside in adult organs,” Lama continues. “These lung-derived cells are different from MSCs derived from bone marrow in the expression of various genes, which makes us believe that they are specific to the organ they are isolated from.”
The study appears online in advance of publication in the April print issue of the Journal of Clinical Investigation.
MSCs are widely seen as a potential source of therapies for numerous diseases and conditions, such as heart disease, cystic fibrosis, graft-versus-host disease, muscular dystrophy, and as a possible source for improved recovery of cancer patients undergoing chemotherapy.
Lama’s laboratory currently is working on another study involving the lung-derived MSCs that shows potential importance of these cells in lung transplantation. That study is not yet complete, but so far it indicates a very strong ability of these MSCs to suppress the immune cells that are involved in organ rejection. In addition to helping prevent organ rejection, other possible uses for the lung-derived MSCs could be therapies related to heart attack and pulmonary fibrosis, Lama says.
MSCs are termed progenitor cells; that is, they can differentiate into only limited number of cell types such as bone, cartilage and fat cells. However, previous laboratory studies have demonstrated the beneficial effect of these cells in various diseases, such as models of heart attacks and pulmonary fibrosis.
The current study of MSCs included 172 bronchoalveolar lavage fluid samples collected and analyzed from 76 lung transplant recipients at the U-M Health System. The ability to isolate these cells with relative ease from lavage fluid is a very significant finding as it provides a potential source to isolate MSCs, says Victor J. Thannickal, M.D., associate professor of Internal Medicine in the Division of Pulmonary and Critical Care Medicine and senior author on this study. “The specific roles of these cells in chronic lung diseases are yet to be fully defined, but will be an active area of research in years to come.”
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In addition to Lama and Thannickal, authors of the study were Linda Badri, Hui Liao, Galen B. Toews, Marc Peters-Golden, David J. Pinsky and Fernando J. Martinez of the Division of Pulmonary and Critical Care Medicine, some with appointments in the Cardiovascular Center; Lisa Smith and Andrew J. Flint of the Department of Pathology; Adin-Cristian Andrei and Susan Murray of the Department of Biostatistics, School of Public Health; and Zhuo Wang and Paul H. Krebsbach of the School of Dentistry.
The research was supported by a grant from the National Institutes of Health and funding from the Scleroderma Research Foundation.
Reference: “Evidence for tissue-resident mesenchymal stem cells in human adult lung from studies of transplanted allografts,” The Journal of Clinical Investigation; online March 8, 2007; April 2007 print issue.
Contact: Katie Gazella
University of Michigan Health System
Mesenchymal Stem Cells Are Long-Term Tissue Residents
The process of repairing a damaged tissue requires the generation of a new set of the cells that form that tissue. Most tissues contain connective tissue cells and these can be derived from mesenchymal stem cells (MSCs). However, it has not been clearly determined whether MSCs are recruited to a damaged tissue from the bone marrow or whether each tissue has its own population of resident MSCs.
In a study that appears online in advance of publication in the April print issue of the Journal of Clinical Investigation, Vibha Lama and colleagues from the University of Michigan, Ann Arbor, show that in transplanted human lungs there is a tissue-resident population of MSCs. Cells that expressed the cell surface molecules known to characterize MSCs and that were able to generate various connective tissue cells were isolated from transplanted human lungs. In cases where the transplant donor and recipient were not of the same sex it was determined that the MSCs were nearly all (97.2% В± 2.1%) of donor origin, indicating that they had persisted in the tissue since the time of transplantation. This study indicates that the lung contains a population of long-lived tissue-resident MSCs, raising the possibility that other organs also have a tissue-resident MSC population.
TITLE: Evidence for tissue-resident mesenchymal stem cells in human adult lung from studies of transplanted allografts
AUTHOR CONTACT:
Vibha N. Lama
University of Michigan Health System, Ann Arbor, Michigan, USA.
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JCI table of contents — March 8, 2006
Contact: Karen Honey
Journal of Clinical Investigation
Self-Regulation Key To Academic Success For At-Risk Children
A study that will be published in a forthcoming Early Childhood Research Quarterly adds to the mounting evidence that self-regulation – or children’s ability to control their behavior and impulses – is directly related to academic performance.
A key finding in that study shows that at-risk children who can self-regulate have higher reading, math and vocabulary achievement.
The study was conducted by then-Oregon State University graduate student Michaella Sektnan, who did the research as her master’s thesis working with Megan McClelland, an associate professor at OSU and a nationally recognized leader in the areas of self-regulation and early childhood development. Sektnan is now a faculty research assistant for OSU Extension Family and Community Health.
In her paper to be published in a fall edition of Early Childhood Research Quarterly, Sektnan used data on 1,298 children from birth through the first grade from the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development. “Family risk” in the data was defined by ethnic minority status, low maternal education, low family income and chronic depressive symptoms in the mother.
“We know that these risk factors can lead to a gap in academic achievement,” Sektnan said. “The relationship to risks such as poverty, ethnic status, and maternal education has been well-documented. What we wanted to know was, controlling for these factors, does self-regulation make a difference?”
It turns out the answer to that question is yes. Controlling for these risk factors, Sektnan found that children whose parents and teachers reported that they had strong self-regulation in preschool and kindergarten did significantly better on math, reading and vocabulary at the end of first grade.
“For all outcomes, higher self-regulation was related to higher reading, math and vocabulary, regardless of which risk factor was present,” Sektnan said. “This builds on the increasing body of knowledge about the need to develop self-regulation skills in young children.”
To give an example, McClelland points to the test scores of the children in this national survey. At-risk children with stronger self-regulation in kindergarten scored 15 points higher on a standardized math test in first grade, 11 points higher on an early reading test, and nearly seven points higher on a vocabulary test than at-risk children with weaker self-regulation.
“These were pretty impressive increases in children’s achievement,” McClelland said. “I’m a proponent of building self-regulation in children but even for me, these results were surprising. The discrepancy between these children, tested at a very young age, and their academic scores compared to their peers who were not as able to regulate their behavior was larger than we anticipated.”
McClelland, who has developed simple games such as the Head-to-Toes task to measure self-regulation and predict academic achievement, said it is obvious that in the case of at-risk children, merely focusing on self-regulation skills won’t be enough.
“Obviously, these issues – poverty, educational status, maternal depression – are extremely serious and must be addressed,” she said. “But we now know that we can also help children be successful by teaching them how to self-regulate.”
McClelland added that the data is clearer now than ever: a child that can listen, pay attention, follow instructions, and persist on a task, even if faced with what seems to be giant hurdles at a very young age, will achieve greater success in school.
“Self-regulation is not just about compliance or being obedient,” McClelland said. “It’s about a very basic, but very necessary skill: being able to listen and pay attention, think, and then act. The message to parents may be to put down the flash cards and see if another approach, like playing a simple game of ‘Simon Says’ works better.”
Alan Acock of OSU and Frederick Morrison of the University of Michigan assisted on this study, which included funding support from the National Institute of Child and Human Development and the National Science Foundation.
Source:
Oregon State University
SPDEF Makes The Lungs More “Asthma-Like”
Chronic lung diseases such as asthma and cystic fibrosis are characterized by an increase in the number of cells known as goblet cells and an increase in the production of lung mucous. Although the molecular details of how these changes are regulated are not well defined, a new study by researchers from Cincinnati Children’s Hospital indicates that a protein known as SPDEF has an important role in controlling these processes.
In the study, which appears online in advance of publication in the April print issue of the Journal of Clinical Investigation, Jeffrey Whitsett and colleagues show that in vivo expression of SPDEF in mouse lung epithelial cells is increased by IL-13 (a soluble factor associated with asthma) and exposure to dust mite allergens. This increased SPDEF expression was associated with an increase in the number of goblet cells. In vitro, SPDEF was shown to interact with a protein known as TFF-1 and to increase the expression of genes encoding proteins that caused the epithelial cells to become goblet cells and to produce mucous proteins. This study therefore indicates that SPDEF has a crucial role in endowing the lung with the characteristics of chronic lung disease.
TITLE: SPDEF regulates goblet cell hyperplasia in the airway epithelium
AUTHOR CONTACT:
Jeffrey A. Whitsett
Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA.
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JCI table of contents — March 8, 2006
Contact: Karen Honey
Journal of Clinical Investigation
Young Boy Is 24th Egyptian To Become Infected With Bird Flu Virus
Mohammed Mahmoud Ibrahim, aged 4, is the 24th human to become infected with the H5N1 bird flu virus strain in Egypt since the disease appeared in the country in 2006, according to the country’s Ministry of Health today. On the 8th March, Mohammed, from Daqahliya, was admitted to the Manshiyat Al Bakri Children’s Hospital, Cairo, with bird flu like symptoms.
According to Health Ministry Officials, the boy was infected by poultry raised by his family.
Of the 24 humans who have become infected so far in Egypt, 13 have died. Egypt lies in the flight path of several types of migratory birds.
Experts fear that the H5N1 bird flu virus strain, the most virulent one, will eventually mutate and become easily human transmissible. This has not happened yet. It is still difficult for a person to catch bird flu from a bird – it is even harder for a human to infect another human.
If the bird flu virus infects a person who is ill with a normal human flu virus, it could have the ideal opportunity to mutate. The bird flu virus could exchange genetic information with the human flu virus and acquire its ability to transmit easily from human-to-human.
Global Health Institute Joins With India To Control Deadly HIV/TB Co-Infection
Researchers at Emory University’s Global Health Institute and the Emory Vaccine Center are collaborating with one of India’s premier research centers in a push to enhance the immune systems of people infected with both HIV and tuberculosis.
Located in New Delhi, the institute, known as the International Center for Genetic Engineering and Biotechnology (ICGEB), will provide state-of-the-art lab space for newly recruited Emory scientists and their ICGEB collaborators to form the Center for Global Vaccines.
“Our initial studies will focus on the basic aspects of the HIV/TB co-infection. There is an interesting interplay between HIV and TB,” says Rafi Ahmed, PhD, director of the Emory Vaccine Center and a Georgia Research Alliance Eminent Scholar. “In fact, the World Health Organization has just classified HIV/TB as a unique disease.”
It is estimated that one-third of the world’s 40 million people with HIV/AIDS are also infected with TB and that 90 percent of those with HIV die within months of contracting TB if they are not properly treated. However, finding effective treatments is growing more difficult as various strains of TB are becoming more widespread and more virulent, especially in sub-Saharan Africa and India.
“In terms of sheer numbers, India now has the largest number of HIV-infected people in the world, and 5.7 million of them have the HIV/TB co-infection,” says Dr. Ahmed. “The majority of people infected with HIV also have TB, which is endemic in India. Most people get primary TB as children, and the majority of them will live a healthy life and die of old age, not of TB. But when they get infected with HIV and they already have TB their immune system becomes compromised, and the TB reactivates,” he says.
Although a vaccine exists to prevent TB, it can be used in only limited circumstances. Thus, Emory and ICGEB will be focusing on developing a therapeutic vaccine that can be used more widely; that is, one that can be given to those people already infected with HIV/TB. “We want to tackle very big problems, and this is a very big problem,” says Ahmed. “This is very big science.”
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The mission of the Center for Global Vaccines is to improve the control of infectious diseases with a focus on those diseases that disproportionately affect vulnerable populations in developing countries. Likewise, ICGEB’s diverse areas of research include the life sciences, with the aim of benefiting developing countries by focusing on advanced research and training in molecular biology and biotechnology.
Contact: Holly Korschun
Emory University
Health Experts Need To Ensure That XDR-TB Does Not Spread Among People With Compromised Immune Systems, Inc. HIV-Positive People, WHO Official Says
Health experts need to contain the spread of extensively drug-resistant tuberculosis, TB that is resistant to the two most potent first-line treatments and some of the available second-line drugs, so that it does not spread among people with compromised immune systems, Mario Raviglione, head of the World Health Organization’s Stop TB Department, said recently, Reuters reports. According to Raviglione, XDR-TB could trigger a wave of deaths among people living with HIV/AIDS, who are more vulnerable to the disease, given the difficulty in treating the strain. “Either we intervene rapidly to stop the spread of this strain or you could foresee in the future that this strain would replace the other one,” Raviglione said, adding, “That would make it practically uncontrollable.” He said enhanced diagnostic tools and better health care practices, such as isolation rooms for people with XDR-TB, are crucial to curbing the spread of the disease. He also said that because it might be five years before new drugs to successfully treat XDR-TB are available, countries need to improve their laboratory capacities to rapidly detect drug-resistant TB strains. “In South Africa they are capable, that is why they discovered it,” Raviglione said, adding, “But we don’t know what’s happening in Mozambique and Lesotho, in Swaziland, in Zimbabwe.” He added that the strain could be widespread in Southern Africa (MacInnis, Reuters, 3/6).
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