Cepheid Receives FDA Clearance for Xpert(R) HemosIL(R) FII & FV Test

September 24th, 2009 | Uncategorized | No Comments »

SUNNYVALE, Calif. and BEDFORD, Mass., Sept. 24 /PRNewswire-FirstCall/ — Cepheid (Nasdaq: CPHD) and Instrumentation Laboratory (IL) today announced that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) FII & FV test. The test detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). Xpert HemosIL FII & FV delivers results in just over thirty minutes using a single GeneXpert(R) cartridge. Developed and manufactured by Cepheid, the test will be available worldwide through a partnership with IL, the exclusive worldwide distributor for the Xpert HemosIL FII & FV test.

“The Xpert HemosIL FII & FV test is the first product developed in conjunction with our partnering model to be marketed in the U.S.,” said John Bishop, Cepheid’s Chief Executive Officer. “Programs such as this have been strategically developed to help provide incremental leverage in the development of a broad test menu for our GeneXpert System. IL is a leader in the hemostasis market and the Xpert HemosIL FII & FV test will enable laboratories to perform the test immediately — and integrate the results with those from other tests — providing physicians a more comprehensive thrombophilia profile of their patients.”

Testing for genetic and acquired defects, which may lead to thrombosis, is performed with the aid of both classic coagulation assays and molecular tests. In the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Cepheid’s GeneXpert System enables rapid FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory.

“The availability of an FDA cleared test for FII & FV polymorphisms that is rapid, accurate, easy to use and performed on-demand is important for several reasons,” said Alan H.B. Wu, PhD, Chief of the Clinical Chemistry, Toxicology and Pharmacogenomics Laboratories at San Francisco General Hospital & Trauma Center and the University of California, San Francisco. “First, labs will likely save money because such testing is performed in national reference or academic molecular diagnostic labs, often at significant cost and with the inherent delays of send-out testing. Second, with a turnaround time of about 30 minutes for the genetic test, results can be made available in real-time, to facilitate discussions between physician and patient.”

“The response to the Xpert HemosIL FII & FV test from our customers in Europe has been extremely positive. We are very pleased that laboratorians in the U.S. will now have the ability to perform, in combination with our ACL TOP(R) Family of systems, a complete thrombophilia work-up, rapidly, efficiently and accurately,” said Josep Manent, Chief Executive Officer at IL. “This is another example of IL’s dedication to providing innovation in hemostasis to our customers around the world.”

Xpert HemosIL FII & FV is Cepheid’s eighth test to receive FDA clearance. IL has been exclusively distributing the test in Europe as a CE IVD mark product since March 2008. With FDA clearance, IL will now exclusively distribute the product worldwide.

About Instrumentation Laboratory

Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company’s product lines include critical care systems, hemostasis systems and information management systems. IL’s GEM(R) product offerings, part of the critical care line, include the GEM Premier(TM) 4000 analyzer with Intelligent Quality Management (iQM(R)), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL’s hemostasis portfolio includes the ACL TOP(R) Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the new ACL AcuStar Hemostasis Testing System, the ACL ELITE(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line of reagents. IL is based in Bedford, Massachusetts.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.

This press release contains forward-looking statements that are not purely historical regarding Cepheid’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to product performance and Cepheid’s partnering program. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; regulatory developments and practices regarding testing; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; product development risks and uncertainties inherent in the product development success; market acceptance of any new products; the impact of competitive products; pricing; the reliance on third parties to sell products. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2009 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.

The Instrumentation Laboratory logo, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar, iQM GEM, Premier and GEM OPL are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. 

    Media Inquiries at Cepheid:
    Jared Tipton
    Cepheid Corporate Communications
    408-400-8377
    jared.tipton@cepheid.com

    Investor Inquiries at Cepheid:
    Jacquie Ross
    Cepheid Investor Relations
    408-400-8329
    jacquie.ross@cepheid.com

    At Instrumentation Laboratory:
    Sally McCraven
    781-861-4577
    smccraven@ilww.com

New Procedure Raises Brows Without Surgery Or Injectibles

September 23rd, 2009 | Uncategorized | No Comments »

LIVINGSTON, N.J., Sept. 23 /PRNewswire/ — The Ulthera System is the first technology to combine ultrasonic visualization beneath the skin surface with non-invasive delivery of ultrasound energy at depths that enable significant lifting and tightening of the skin. Reflections, Center for Skin and Body, in Livingston and Bridgewater, N.J. will be an early adopter of this revolutionary new technology.

“We are very excited about the Ulthera device. It represents a unique approach to skin rejuvenation and is poised to revolutionize the aesthetics industry,” said Dr. Mitchell Chasin, Medical Director and founder of Reflections. “This is not a laser or light-based procedure. Instead, Ulthera uses ultrasonic sound waves to zero in on its target beneath the skin’s surface. The sound waves stimulate collagen growth, leading to lifting and tightening of the skin and creating a brow lift that we have been unable to obtain without surgery.”

The newly FDA cleared Ulthera device delivers ultrasound energy to provide a refreshed look around the eyes and tighter skin on the face in one easy non-invasive treatment and without the need for downtime. The device goes deep, bypassing the upper skin layers, which leads to only mild redness for about thirty minutes after treatment. The sound waves trigger a natural healing process, which results in new collagen synthesis and progressive firming, tightening and lifting of the skin. The results from Ulthera treatment appear gradually and the skin continues to improve for up to six months. This is an exciting development in facial rejuvenation, one that some cosmetic physicians have spent years waiting for.

Dr. Mitchell Chasin is available for interviews and can explain how the Ulthera System works, how it will transform the cosmetics industry and who will benefit most from this new technology.

About Reflections, Center for Skin and Body:

Reflections, Center for Skin and Body is located in Livingston and Bridgewater, N.J. and was New Jersey’s first dedicated Laser and Aesthetic Medical Practice. The center offers a highly personalized multi-skincare approach and hosts an array of hi-tech lasers and other technologies.

MedShape Solutions, Inc. Announces First FDA-cleared Shape Memory PEEK Device; Closing of $10M Equity Offering

September 23rd, 2009 | Uncategorized | No Comments »

ATLANTA, Sept. 23 /PRNewswire/ — MedShape Solutions, Inc. announced today the first FDA cleared shape memory PEEK (polyaryletheretherketone) device for orthopedics using proprietary shape memory PEEK Altera(TM) material. The Morphix(TM) Suture Anchor was recently granted FDA clearance and will be released to select U.S. markets in the coming months. Over $2.5B of PEEK-based implants are sold every year in the field of orthopedics. These devices range from spinal cages to suture anchors and across all sectors of orthopedics. As a material, PEEK provides excellent benefits such as strength, radiolucency and reliability.

“PEEK Altera(TM) is a proprietary shape memory material that will allow us to develop devices that will be ‘dynamic’ in nature versus the current PEEK technology which is ‘static’,” stated Chris Fair, MedShape Solutions’ COO. The Morphix(TM) Suture Anchor system design takes advantage of the shape memory material and provides the clinician with superior fixation strength both in pull out as well as improved performance under cyclic loading. “Shape memory allows us to design and develop implants that can enter a cavity or bony tunnel in one diameter and deploy them to a much larger size. This shape change can drastically improve the strength profile of the device as well as improve the delivery environment. As an example, our 3.5mm Morphix(TM) device has a greater strength profile than most 5.5mm devices currently in the market,” stated Ken Gall, PhD, founder and CTO of MedShape Solutions.

“What is unique about the Morphix(TM) device is the simplicity of its design coupled with outstanding performance when compared to competitive devices,” stated orthopedic surgeon Bill Bryan, MD, Houston, TX. “I love the fact that the dynamic nature of the implant allows it to adjust to the surrounding changes in the bone that occur after cyclic loading. The Morphix(TM) is the only implant I am aware of that can do this.”

MedShape Solutions also announced that it has recently closed approximately $10M of equity funding from various qualified private investors. “This recent round of financing will allow MedShape to bring forward several unique shape memory orthopedic devices that will improve patient outcomes and improve surgical procedures,” stated Kurt Jacobus, PhD, President & CEO. “We continue to make progress in building a company of significant value centered around our shape memory technology platform.”

Contact: Chris Fair, Chief Operating Officer, 404-249-9155, chris.fair@medshapesolutions.com

About MedShape Solutions, Inc.:

MedShape Solutions, Inc. is a privately held medical device company based in Atlanta, GA. MedShape Solutions is committed to creating and delivering unique shape memory based technologies in the field of orthopedics and to Shaping the Future of Orthopedics(TM). More information can be found at www.medshapesolutions.com

Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First ‘Modified Risk’ Tobacco Product; Nominates Curtis Wright, MD, MPH for FDA Advisory Committee

September 22nd, 2009 | Uncategorized | No Comments »

PETERSBURG, Va., Sept. 22 /PRNewswire-FirstCall/ — Star Scientific, Inc. (Nasdaq: STSI) makers of low-nitrosamine smokeless tobacco products, announced today that the company will utilize a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December, 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured(R) curing process: the International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star’s products. The company believes that this novel process, as reflected in its patent application, will enable the company to achieve the lowest toxin levels anywhere in the world. Star plans to submit the products to the FDA for approval to market as “modified risk” tobacco products, under Section 911 of the new Family Smoking Prevention and Tobacco Control Act, once formulation and testing of the new product is completed in early 2010.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO )

Curtis Wright, MD, MPH, Chief Medical Officer for Rock Creek Pharmaceuticals, Star Scientific’s pharmaceutical division, commented, “I am excited to see how low the nitrosamine content of this new material will be once it is processed and formulated.” Laboratory testing of some of the tobacco leaf samples after curing has revealed levels for NNN and NNK, the most lethal forms of TSNAs, below ten parts per billion. These values are comparable to NNN and NNK levels found in several nicotine replacement therapy products (NRT) as reported by a University of Minnesota research team in December, 2007.

Late last week Star Scientific submitted comments to the FDA in response to the agency’s request for input on the regulatory framework established by the Family Smoking Prevention and Tobacco Control Act, which was signed into law by President Obama in June, 2009. The company’s comments, which can be viewed at http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a2524f, focus on the need for tobacco product labeling that lists the levels of the most lethal carcinogens in the products in a way that is clear to adult tobacco users. Paul L. Perito, Star’s chairman and president commented that “Adult tobacco users need to have access to information about the spectrum of harm associated with tobacco use in order to be able make informed choices about the products they purchase.” Mr. Perito added that he hopes clear and accurate labeling will be one of the cornerstones of tobacco regulation policy.

The company also formally nominated Dr. Wright for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation. In a letter submitted to the agency on September 21, the company pointed out that “Dr. Wright has an enormous breadth of experience in the area of addictive substances, and eight years of his career were spent at the Food & Drug Administration. . .Dr. Wright can contribute not only as a scientist, but also as an executive with significant industry experience. “

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Star Scientific, Inc. and its consolidated subsidiaries (collectively, the “Company”) has tried, whenever possible, to identify these forward-looking statements using words such as “anticipates”, “believes”, “estimates”, “expects”, “plans”, “intends” and similar expressions. These statements reflect the Company’s current beliefs and are based upon information currently available to it. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance or achievements to differ materially from those expressed in, or implied by, such statements. These risks, uncertainties and contingencies include, without limitation, the challenges inherent in new product development initiatives, the uncertainties inherent in the progress of scientific research, the Company’s ability to raise additional capital in the future necessary to maintain its business, potential disputes concerning the Company’s intellectual property, risks associated with litigation regarding such intellectual property, potential delays in obtaining any necessary government approvals of the Company’s low-TSNA tobacco products, market acceptance of the Company’s new smokeless tobacco products, competition from companies with greater resources than the Company, the Company’s decision not to join the Master Settlement Agreement (“MSA”), the effect of state statutes adopted under the MSA, and the Company’s dependence on key employees and on its strategic relationships with Brown & Williamson Tobacco Corporation in light of its combination with RJ Reynolds Tobacco Company, Inc. The impact of potential litigation, if initiated against or by individual states that have adopted the MSA, could be materially adverse to the Company.

Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that the expectations will be attained or that any deviation will not be material. See additional discussion under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, as filed with the SEC on March 16, 2009, and other factors detailed from time to time in the Company’s other filings with the SEC, available at www.sec.gov. All information in this release is current as of this date, and the Company undertakes no obligation to update or advise upon any such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

About Star Scientific

Star Scientific is a technology-oriented tobacco company with a toxin reduction mission. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins (principally tobacco specific nitrosamines, or TSNAs), through the utilization of the innovative StarCured(R) tobacco curing technology, and in sublicensing that technology to others. Star Scientific has a Corporate and Sales Office in Petersburg, VA, an Executive, Scientific & Regulatory Affairs office in Bethesda, MD, and manufacturing facilities in Chase City, VA.

About Rock Creek Pharmaceuticals

Rock Creek Pharmaceuticals develops pharmaceutical products for treatment of addiction and other neurological disorders. The company supports third-party academic, educational and therapeutic advances in both these areas of research. Rock Creek has scientific and research offices in Gloucester, MA.

See Star’s website at: http://www.starscientific.com

    Contact:
    Sara Troy Machir
    Vice President, Communications & Investor Relations
    smachir@starscientific.com
    (301) 654-8300

FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing

September 22nd, 2009 | Uncategorized | No Comments »

MUNDELEIN, Ill., Sept. 22 /PRNewswire/ — Sysmex, a global leader in medical diagnostic testing equipment and information systems technology, today announced that its Sysmex XE-2100D Automated Hematology Analyzer has been cleared by the United States Food and Drug Administration (FDA) for blood processing center Quality Control release testing of post-processed red blood cell and platelet components collected using a variety of anticoagulants. Historically, the Sysmex XE-2100D had been cleared for in vitro diagnostic use in clinical laboratories and donor centers as a multi-parameter hematology analyzer for whole blood samples using EDTA anticoagulant. Sysmex is the only original equipment manufacturer to receive FDA cleared anticoagulant Intended Use claims for the Blood Center/Blood Bank market that addresses Quality Control needs, said John Kershaw, CEO, Sysmex America, Inc.

“The nation’s blood centers play a critical role in servicing the blood transfusion needs of hospitals across the country. As a best-in-class hematology instrument provider, Sysmex continued development based on blood center customer input. We invested the time and money necessary to conduct the extensive studies required by the FDA to achieve this clearance milestone. The ability to use the XE-2100D with these anticoagulants enables blood centers to meet the FDA’s rigorous manufacturing classification demands. It streamlines the validation and documentation process necessary to meet those requirements, providing the potential for improving efficiency and labor utilization,” said Kershaw.

Since blood centers are classified as manufacturing organizations, they are highly regulated by the FDA. All instruments and products are to be used according to the manufacturer’s intended use and instructions. Any deviation from any of the manufacturers’ intended use statements requires extensive validation and documentation by the blood centers. The Intended Use clearance for the Sysmex XE-2100D greatly reduces the validation effort needed prior to placing the XE-2100D into production. This means a significant saving in time, materials and labor, explained Kershaw. No other currently available hematology analyzer has been cleared for such use.

About Sysmex XE-2100D Blood Center Anticoagulant Clearance

The Sysmex(R) XE-2100D Automated Hematology Analyzer is intended for in vitro diagnostic use in clinical laboratories and donor centers on EDTA anticoagulated whole blood.

Also, in blood processing centers the XE-2100D can now be used as a multi-parameter hematology analyzer and for QC release testing of the following post-processed components:


  • Red blood cell components for RBC, HGB and HCT parameters using CPD, CP2D, ACD-A, CPDA-1 as anticoagulants.

  • Platelet components for PLT and MPV parameters using CPD and ACD-A as anticoagulants.

About the Sysmex XE-2100D Automated Hematology Analyzer

The Sysmex XE-2100D Automated Hematology Analyzer utilizes Sysmex’s advanced, hydro-dynamically focused, impedance technology and state-of-the-art cell-counting methods to rapidly and accurately measure parameters such as hemoglobin, hematocrit (direct) and platelet count. The analyzer has extended linearity capabilities required for concentrated cell preparations that make up component therapy, eliminating the need for dilution. Sysmex automated hematology analyzers also rank the industry’s best in performance and reliability according to IMV Service Trak(TM) independent industry surveys.

About Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems. Serving customers for over 40 years, Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide. For more information about Sysmex, please visit www.sysmex.com/usa.

GeoVax Labs Requests pre-IND Meeting With FDA

September 21st, 2009 | Uncategorized | No Comments »

ATLANTA, Sept. 21 /PRNewswire-FirstCall/ — GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the “Company”), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that it has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss a proposed IND for GeoVax’s therapeutic vaccine as a treatment for individuals infected with HIV/AIDS.

HIV affects the entire globe and comes in a variety of subtypes. Clade B is the predominant subtype in North America, where there are roughly 60,000 new infections each year. Globally, there are about 2.5 million AIDS infections per year, most primarily involving subtypes AG, B, and C. In 2007, UNAIDS reported 1.3 million people living with AIDS in North America and 33.2 million people living with AIDS worldwide.

“This pre-IND meeting with the FDA is a significant step toward meeting the needs of those individuals currently infected with HIV/AIDS. The FDA has 60 days from our submission to review our proposal and respond with questions or comments,” stated Robert McNally, Ph.D., president and chief executive officer. “The need for a HIV/AIDS vaccine is clear, based on the continued increase of new infections in the United States, despite years of education and preventative measures. Current costs for oral medications and the numerous side effects of these drugs give further urgency to the need for a therapeutic vaccine,” noted Dr. McNally.

A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The Phase 1 therapeutic protocol stresses safety parameters to minimize any risk to the volunteers. The protocol, conceived with collaboration from ARCA (AIDS Research Consortium of Atlanta), has specific objectives to optimize safety while evaluating the ability for the vaccine to elicit protective immune responses in vaccinated participants. The proposed trial is based on the achievement of excellent post vaccine viral control in animal trials conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University. The proposed human trial follows the precedents set in the preclinical animal trials and is a critical step towards developing a therapeutic vaccine for HIV-1 infected humans.

Submission of a request to the FDA for a pre-IND meeting is the first step in a process that is expected to take a number of months to complete. Commencement of the trial is targeted for the first quarter of 2010.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax’s AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person become infected. GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for people already infected with the HIV-1 virus).

GeoVax’s core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, through a collaboration of colleagues at Emory University’s Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.

GeoVax’s AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $17 million IPCAVD grant awarded in late 2007.

Safe Harbor Statement

All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitation, risks detailed in the Company’s Securities and Exchange Commission filings and reports.

Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial

September 21st, 2009 | Uncategorized | No Comments »

ROCKVILLE, Md., Sept. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )

Neuralstem is the first company to commence a stem cell trial to treat ALS. The trial will study the safety of Neuralstem’s cells and the surgical procedures and devices required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans. ALS affects roughly 30,000 people in the U.S., with about 7,000 new diagnoses per year.

Neuralstem CEO and President, Richard Garr, stated, “The beginning of our clinical trial program is a major step towards achieving Neuralstem’s goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process. This trial will be in the extremely capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery, and Dr. Jonathan Glass, Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, world-renowned for their study and treatment of ALS patients. We believe that there is no better team to conduct this study for us,” said Garr. Their participation is subject to formal IRB approval by their institutions.

“We are very excited about this clinical trial,” said Dr. Eva L. Feldman, who will direct the Neuralstem clinical trial program for ALS. “This is a major advancement in what still could be a long road to a new and improved treatment for ALS. ALS is a terrible disease that ultimately kills by paralysis,” said Feldman, who also directs the A. Alfred Taubman Medical Research Institute. “In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS,” Dr. Feldman concluded.

About the Trial

The ALS patients will be treated through spinal injections of its patented human neural stem cells.

This first trial, which will primarily evaluate safety of the cells and the surgery procedure, will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord. The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.

Neuralstem expects to conduct the trial at Emory University with Dr. Jonathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI) and with Dr. Nicholas Boulis, M. D. performing the neurosurgery. The overall PI for the ALS trial program is Dr. Eva Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery.

About Neuralstem, Inc.

Neuralstem’s patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington’s disease and Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig’s disease. Neuralstem plans to initiate a Phase I clinical trial to treat ALS with its stem cells. ALS is a progressive fatal neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control muscle movement. Pre-clinical work has shown Neuralstem’s cells to extend the life of rats with ALS (as reported the journal TRANSPLANTATION, October 16, 2006, in collaboration with Johns Hopkins University researchers), and also reversed paralysis in rats with Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE, June 29, 2007, in collaboration with researchers at University of California San Diego).

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the annual report on Form 10-K for the year ended December 31, 2008 and the quarterly report on form 10-Q for the period ended June 30, 2009.

Simbionix USA Corporation’s Innovative Development Division Releases Two New Breakthrough Technologies

September 21st, 2009 | Uncategorized | No Comments »

CLEVELAND, Ohio, September 21 /PRNewswire/ — Simbionix USA Corporation,

the world’s leading developer of medical simulation systems, just released

two new products: a new Laparoscopic Essential Tasks Module for its LAP

Mentor(TM) and a breakthrough technology for patient-specific simulation

based on actual patient data – the PROcedure Rehearsal Studio(TM).

The new Laparoscopic Essential Tasks Module is an addition to the LAP

Mentor’s ever-expanding library of modules. This new module takes hands-on

skill training another step forward, enabling the trainee to practice three

essential tasks, similar to the Fundamentals of Laparoscopic Surgery Program

(FLS) developed by SAGES.

“The module is a breakthrough technology that provides an efficient and

exciting virtual reality environment,” explains Simbionix President Ran

Bronstein.

During the same week, Simbionix released a new, enhanced version of the

PROcedure Rehearsal Studio(TM), marking another important advance in its

innovative simulation technology.

This unique product, previously introduced by Simbionix last year, is the

world’s first medical simulator to enable clinicians to create practice

scenarios based on their patient’s unique anatomy as reconstructed from CT

data.

Inbal Mazor, Simbionix Vice President of Corporate Marketing, adds:”This

week’s release of the PROcedure Rehearsal Studio with the PACS-enabled

capability allows for a wide range of scans and enables the sharing of

training cases for educational use. With this new version, the system is now

more efficient, easier to use and extremely reliable. We are extremely proud

of this new product, which will undoubtedly benefit both patient and

clinicians.”

Simbionix will present these new releases at upcoming US medical

tradeshows this fall: The PROcedure Rehearsal Studio on September 23rd at TCT

2009 in San Francisco and the new Laparoscopic Essential Tasks on Oct 12th at

the ACS 2009 annual meeting.

About Simbionix USA Corporation

Simbionix is the leader in the development and delivery of innovative and

effective virtual reality simulation products and solutions for clinical

education and training of medical professionals. The products are designed to

accelerate best-practice medical training, advance clinical performance, and

improve patient safety.

The Simbionix product line includes the ANGIO Mentor(TM) line for

endovascular procedures, LAP Mentor(TM) line for laparoscopic surgical

procedures, GI Mentor(TM) for upper and lower gastrointestinal procedures and

the URO Mentor(TM) for urological procedures. In addition, Simbionix

distributes the HystSim(TM) for hysteroscopic procedures. Each simulation

platform is a leading simulator in the relevant clinical area.

Simbionix simulation products have been validated in several scientific

studies and the company cooperates closely with both industry and leading

medical institutions to develop the most advanced simulators for the training

and assessment of medical professionals.

   http://www.simbionix.com

    Contact:

    Galia Zilbershtein-Salant
    Exhibition Manager
    Simbionix
    Tel : +1-216-229-2040
    galia@simbionix.com

Bayer Introduces CONTOUR USB – The First Blood Glucose Meter With Unique Plug & Play Diabetes Management Software

September 21st, 2009 | Uncategorized | No Comments »

TARRYTOWN, N.Y., Sept. 21 /PRNewswire/ — Bayer Diabetes Care today announced U.S. Food & Drug Administration clearance to market the CONTOUR(R) USB blood glucose meter. Bayer’s CONTOUR USB meter is the first and only blood glucose monitor that plugs directly into a computer providing users with instant access to information that can help optimize diabetes management. The CONTOUR USB meter is integrated with Glucofacts(TM) DELUXE software for easy retrieval of data as well as longer-term tracking and analysis of blood glucose test results.

Bayer’s CONTOUR USB meter is a cutting edge, premium meter that connects directly to a PC or MAC and the meter can store up to 2,000 test results. The built-in USB technology allows patients to simply plug in to gain knowledge about trends and patterns in their blood glucose levels.

Ongoing data tracking and accurate information sharing are key to good diabetes management. The CONTOUR USB meter facilitates data organization and management – transforming results into meaningful insights that healthcare professionals and their patients can readily discuss.

“This is an ideal blood glucose monitor for patients who are highly engaged in managing their diabetes, particularly those on insulin who must test frequently,” said David Simmons, MD, chief medical officer for Bayer Diabetes Care. “With the CONTOUR USB meter, patients are able to review their results with their healthcare professional during an office visit, over the phone, or via email, giving them the opportunity to make treatment adjustments, such as taking action to reduce their A1C levels, if necessary.”

Measurement of A1C provides an average assessment of blood sugar levels over the past three months – and is an indicator of how well diabetes is being controlled over the longer term. Studies have shown that routine tracking of blood glucose can help patients better manage their blood sugar and may result in a lower A1C level, which is important for consistent diabetes management. In fact, even a one-percent reduction in A1C reduces the risk of serious complications by 40 percent(1).

Bayer’s CONTOUR USB meter features:


  • A bright color display screen visible in any light that shows average, high and low readings with

  • Customizable features such as intuitive pre- and post-meal marking

  • 500MB extra memory for storage of personal diabetes information

  • Rechargeable battery that can charge from any USB port or via the CONTOUR USB wall charger provided

  • Glucofacts(TM) DELUXE diabetes management software (use of Bayer’s diabetes management software has been shown to significantly lower A1C(2) and a sustained A1C reduction could lead to potential cost savings.)

The CONTOUR USB meter is based on Bayer’s trusted CONTOUR system, providing the same easy accuracy, No Coding(TM) technology, no interference with maltose, galactose, and oxygen and automatic correction for hematocrit and common interfering substances (e.g. acetaminophen, ascorbic acid), as well as a 5-second test time and small (0.6 microlitre) sample size – all helping to simplify life with diabetes. The CONTOUR USB meter uses CONTOUR blood glucose test strips currently available for other CONTOUR meters.

Nick Jonas of The Jonas Brothers, who has diabetes and is a diabetes ambassador for Bayer, said, “I already use Bayer’s CONTOUR meter to monitor my blood glucose and my doctor always talks about how important it is to track my results. I am excited to try out the new CONTOUR USB meter, because I can plug it in to a computer from wherever I am to get the information I need to manage my diabetes.”

Bayer’s CONTOUR USB meter will soon be available for sale in the U.S. For more information, visit www.BayerContourUSB.com or www.simplewins.com.

About Diabetes

Diabetes is a disease in which the body does not produce or properly use insulin. Approximately 23.6 million children and adults in the United States have diabetes, which puts them at risk for developing serious health complications over time, such as heart disease, kidney disease, blindness, and stroke.(3) Type 1 diabetes, also called juvenile diabetes, is usually diagnosed in children and young adults. In persons with type 1 diabetes, the body makes little or no insulin, which may result in many complications if glucose levels are not controlled.(4) Type 2 diabetes is usually diagnosed in adults, although increasingly, children are being diagnosed with this disease. Type 2 is associated with obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity.(5)

Bayer Diabetes Care

Bayer Diabetes Care is a worldwide leader in diabetes, supporting customers in 100 countries, and, for more than 40 years, has led the way in diabetes care product innovation. Bayer introduced the first portable blood glucose meter and test strips, innovated the measurement of A1C (glycated hemoglobin) with A1CNow+(R) and A1CNow(R) SELFCHECK and was the first to offer a suite of blood glucose monitors (CONTOUR(R) and BREEZE(R)2). Certain features of Bayer’s blood glucose monitors such as No Coding technology and no interference from maltose and galactose make diabetes management easier. Today, Bayer Diabetes Care offers an unparalleled choice in diabetes management systems and comprehensive support including education, tools and resources designed to simplify life with diabetes.

Bayer Diabetes Care is a business of the Bayer HealthCare LLC, Medical Care Division and has its global headquarters located in Tarrytown, New York. For more information visit, www.bayerdiabetes.com or in the U.S. www.simplewins.com.

Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Collateral available:


  • Spokesperson: Davida Kruger, Certified Diabetes Nurse Practitioner; Dr. David Simmons, Bayer

  • Photos: Bayer’s CONTOUR USB blood glucose meter

  • Backgrounders: Bayer Diabetes Care 40 Year History, Bayer Innovations in Diabetes Management Timeline, FAQ

(1) Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2003. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. Last accessed May 11, 2009

(2) Janssen M. Portalalin M, Wallace J, et al.: Ascensia WinGLUCOFACTS(TM) Professional Software Improves

Diabetes Health Outcomes. J Diabetes Sci Technol 2007: 1:47-53.

(3)http://www.diabetes.org/diabetes-statistics/prevalence.jsp Last accessed May 11, 2009

(4)http://www.cdc.gov/diabetes/pubs/pdf/search.pdf. Last accessed May 4, 2009

(5)http://www.cdc.gov/diabetes/pubs/general.htm Last accessed May 4, 2009

FDA Approves Donor Screening Test for Antibodies to HIV

September 18th, 2009 | Uncategorized | No Comments »

SILVER SPRING, Md., Sept. 18 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today announced approval of the Abbott Prism HIV O Plus assay, as a screening tool designed to detect the presence of certain antibodies to HIV. The assay is one of five assays that run on the fully automated Abbott Prism System.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

There are two types of HIV. HIV type 1 consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa.

HIV type 2 is found mostly in West Africa. Both types have been detected in the United States and Europe.

The Abbott Prism HIV O Plus assay detects antibodies to HIV type 1, groups M and O, and HIV type 2. It is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.

The Abbott Prism HIV O Plus assay is licensed to screen donated blood and blood specimens from other living donors for these specific types of HIV and subgroups of HIV type 1. The assay is also licensed to screen specimens from organ donors when specimens are obtained while the donor’s heart is still beating and from cadavers. Positive results from the screening test require confirmation from supplemental tests.

The Abbott Prism HIV O Plus assay and the Abbot Prism system are manufactured by Abbott Laboratories, Abbott Park, Ill.

Consumer Inquiries: 1-888-INFO-FDA

« Older Entries