Gov't to pay 40%, firms 60% of benefits for hepatitis victims

TOKYO —

The government will shoulder about 40% and two drug companies 60% of relief money they agreed to pay patients infected with hepatitis C through tainted blood products in line with out-of-court settlements in 2008, the health ministry said Friday. The government will put up one-third and the companies—Osaka-based Mitsubishi Tanabe Pharma Corp and Tokyo-based Nihon Pharmaceutical Co—two-thirds of the benefits for the patients given hepatitis C virus-tainted fibrinogen between April 22, 1987 and June 23, 1988, said the Ministry of Health, Labor and Welfare.

Welsh scientist pioneers lifesaving synthetic blood

A REVOLUTIONARY scientific breakthrough, which would create an unlimited supply of synthetic human blood, moved a step closer last night. A group of researchers, led by Welsh scientist Professor Marc Turner, plan to use stem cells to become the first team in the world to create a supply of disease-free blood that cannot be rejected during transfusions. Last night it was announced the group had been awarded a £3m funding boost, allowing the pioneering research to be taken to the next level. The researchers will use stem cells from embryos left over from IVF, then screen them to find those genetically programmed to create the rare O negative blood group. O negative is regarded as the universal donor group which can be transfused into anyone without fear of rejection. The scientists will be able to create an unlimited supply because of the ability of stem cells to reproduce indefinitely in the laboratory. Prof Turner, originally from Cardiff, told the Western Mail that even though his team’s plans were at an early stage, last night they received an “encouraging” £3m funding boost from the Wellcome Trust, the world’s biggest medical research charity. “We have known about this deal for some time but it was made official today,” he said yesterday. “I cannot overstate how early a stage we are at, but this deal, which is worth millions, will help us take our research to the next level.” The academics’ work will culminate in about three years, when they will make the first transfusions of synthetic blood into human volunteers. If successful, their supply could help endless victims of road accidents and military casualties in the field, and be useful in situations where clean blood is not freely available. It will avoid the transmission of life-threatening diseases such as HIV, hepatitis and variant CJD – the human form of mad cow disease – during transfusions. Prof Turner of the University of Edinburgh, who is scientific director of the Scottish National Blood Transfusion Service, added: “From a personal point of view I think it is hugely encouraging and exciting that we have been able to use our knowledge of stem cells and haematology to get to this stage. “Our research is based on something we have been looking to do for about three or four years, looking at an ability to generate red blood cells from so-called adult stem cells, and I really think we have got to the point where we can do this in a research laboratory. “The next step will be transferring this into a clinical environment in an appropriate quality for human trials, which hopefully we will do in about three years. “We are looking forward to being able to get started on the real work when the grant kicks in this July.” Scientists, mainly in Sweden, France and Australia, have been working on similar plans to create synthetic blood, also using stem cells. And last year, the US company Advanced Cell Technology announced it had been able to create blood cells using embryonic stem cells. Their plans were held up because of former President George Bush’s opposition to embryonic cell work. Barack Obama has since reversed the policy. The multi-collaborative British project could eventually help plug the gap between the numbers donating blood regularly and the supply needed by hospitals. The National Blood Service for Wales said: “This is a very encouraging piece of research which has the possibility to show great promise for the future.” The Welsh Blood Service provides supplies of blood and its products to 16 hospitals in South, Mid and West Wales. It needs to collect more than 100,000 whole blood donations and 10,000 platelets every year, but only 6% of the nation currently gives blood

Vascular Solutions Announces First Quarter Results; Net Revenue Increases 12% to $15.8 Million; Net Income Increases 300% to $0.06 Per Share

MINNEAPOLIS, April 16, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today reported financial results for the first quarter ended March 31, 2009........  While our net revenue increased by 12% over the first quarter of 2008, it was approximately $700,000 below our expectations. The primary reason for the revenue shortfall was the decision by our partner King Pharmaceuticals to suspend the clinical development of our Thrombi-Paste(tm) product, solely due to economic reasons...............

Net revenue from hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable, Thrombi-Gel(r), Thrombi-Pad(r) and D-Stat Radial products) was $5.8 million during the first quarter, essentially even compared to the first quarter of 2008. "The hemostatic patch market continues to be very competitive, but with the imminent exit of a major competitor and the launch of our new D-Stat Dry Wrap version in the first quarter, we believe that we will continue to hold and increase our market-leading position in this market," commented Mr. Root. Vascular Solutions will host a live webcast starting at 3:30 p.m., Central Time today to discuss the information contained in this press release. The live web cast may be accessed on the investor relations portion of the company's web site at www.vascularsolutions.com. An audio replay of the call will be available until Thursday, April 23, 2009 by dialing 1-888-203-1112 and entering conference ID# 8256754. A recording of the call will also be archived on the Company's web site, www.vascularsolutions.com until Thursday, April 23, 2009. During the conference call the Company may answer one or more questions concerning business and financial developments and trends, the Company's view on earnings forecasts and new product development and financial matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.

New Tool Calculates Risk Of Bleeding In Heart Attack Patients

Led by Sumeet Subherwal, M.D., formerly a Barnes-Jewish Hospital medical resident at Washington University Medical Center and now a cardiology fellow at Duke University, and in collaboration with several investigators including Karen Alexander, M.D., a cardiologist at the Duke Clinical Research Institute, the researchers analyzed the medical histories of more than 89,000 patients hospitalized in the United States for non-ST-elevation heart attack. This type of heart attack is the most common and usually results from a partial rather than complete blockage of the heart's arteries.
The patient histories were part of the CRUSADE Quality Improvement Initiative, a national multicenter program that aims to improve outcomes for heart attack patients. The risk assessment tool is called the CRUSADE bleeding score.
"A lot of treatment decisions have to be made very promptly after the patient arrives," says Bach, also associate professor of medicine in the Cardiovascular Division at Washington University School of Medicine. "So we designed a bleeding-risk stratification tool that would require only those variables that can be obtained up front. It's a practical tool that can be used in any hospital setting."
The CRUSADE analysis identified eight factors that could predict the odds that a heart attack patient might suffer a bleeding event. The factors are gender, heart rate, blood pressure, hematocrit (the concentration of red cells in the blood), creatinine clearance (a measure of kidney function), diabetes, peripheral vascular disease or stroke, and congestive heart failure.
The bleeding score calculation assigns points to each factor so that the total score coincides with risk of bleeding evidenced in the CRUSADE cases. The range of possible scores is divided into five categories from very low to very high risk of bleeding.
The bleeding risk score is intended to help guide critical early treatment decisions for clinicians caring for heart attack patients, but the impact of its use on outcomes will need to be tested in clinical trials, says Bach. Potentially, the score will be used in conjunction with other practice guidelines to optimize heart attack treatment and minimize risk.

Full article HERE

Surgical Gel Used to Stop Bleeding Could Confuse Mammograms

The Loyola University Health System radiologist saw a suspicious pattern of white specks, much like grains of salt. The specks were calcium deposits similar to microcalcifications that sometimes are a sign of early breast cancer. But it was too early for the patient's breast cancer to have returned because it had been only a month since her lumpectomy. It turns out the microcalcifications were not from cancer. Rather, they were due to a gel that is sometimes used during surgery to stop bleeding. In a recent article in the American Journal of Roentgenology, Ward and colleagues reported seven cases in which the sealant mimicked malignant microcalcifications in mammograms. The sealant, FloSeal, "is not recommenderd for use on breast tissue," Ward and colleagues wrote. Ward is Medical Director of Women's Health Imaging and an assistant professor in the Department of Radiology at Loyola University Chicago Stritch School of Medicine.

Full article available HERE.

CryoLife Announces Release Date and Teleconference Call Details for 2009 First Quarter Financial Results

CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and tissue processing company, announced today that 2009 first quarter financial results will be released on Thursday, April 30, 2009. On that day, the Company will hold a teleconference call and live webcast at 10:00 a.m. Eastern Time to discuss the results, followed by a question and answer session hosted by Steven G. Anderson, president and chief executive officer of CryoLife, Inc.

To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 10:00 a.m. A replay of the teleconference will be available April 30 through May 7 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The account number for the replay is 244 and the conference number is 319410.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife web site at www.cryolife.com and selecting the heading Webcasts & Presentations.

Baxter International Inc. continuing partnership with the World Federation of Hemophilia

DEERFIELD, Ill.--(EON: Enhanced Online News)--In recognition of the 20^th anniversary of World Hemophilia Day, Baxter International Inc., in its continuing partnership with the World Federation of Hemophilia, today announced the availability of the “Together, We Care” video podcast (available at www.wfh.org/whd) to help raise awareness of the vital role of comprehensive care in hemophilia management and to call attention to disparities in care around the world. While research shows that comprehensive care reduces risk of death among hemophilia patients by 40 percent, tragically, only about 25 percent of all people living with hemophilia receive adequate treatment.^1,2

“Baxter is proud to contribute resources such as the ‘Together, We Care’ video podcast to encourage a global dialogue around these issues with the goal of improving the standard of care for all people living with hemophilia.”

“Hemophilia is serious, and can be life-threatening, but with a comprehensive care management approach, including treatment and care from a team of healthcare professionals, people with hemophilia can live longer, healthier lives,” said Mark Skinner, president, World Federation of Hemophilia. “We are grateful to Baxter for its support of the ‘Together, We Care’ video podcast, an important educational tool to help ensure that all patients with a bleeding disorder, regardless of where they live in the world, have access to proper management, care and treatment.”

The video podcast provides a forum for the World Federation of Hemophilia’s National Member Organizations, Baxter employees and community members worldwide to help advocate for local care of people living with hemophilia. It spotlights the importance of comprehensive care teams in improving these individuals’ lives through the perspectives of the patient, physician, nurse coordinator and advocacy group representative. The video podcast also builds on Baxter’s long-standing commitment to initiatives aimed at improving access for bleeding disorder patients.

CPC OF AMERICA INC

Below are edited highlights of CPC's 10-Q/A. 

To date, our activities have included the market analysis and development of our MedClose device and counterpulsation units and the raising of development and working capital. We have developed and prepared for market our counterpulsation units, including a stand-alone unit known as the CPCA 2000. In March 2003, we received FDA clearance to market the CPCA 2000 counterpulsation unit as a Class III medical device. We are also engaged in the business of developing a patented internal puncture closure device and technique known as "MedClose". We have not commenced revenue producing operations...........As previously disclosed in our reports filed with the SEC, in April 2007 we received a warning letter from the FDA which expressed, among other things, that:

· The FDA believed the MedClose device was a significant risk device and not eligible for investigation in the U.S. without an IDE approved by the FDA;

· We had violated IDE regulations governing the proper conduct of clinical studies, including our failure to provide the U.S. reviewing institutional review board's and clinical review site with information they needed to conduct the clinical investigation properly;

· We failed to provide accurate information about the investigations to the FDA and failed to provide to the FDA staff access to the sites pertaining to the MedClose; and

· We provide to the FDA certain information and records concerning our clinical studies.

We disagreed with the claims made by the FDA and filed an appropriate response with the agency. Meanwhile, we suspended human clinical investigations of the MedClose device in the U.S. pending further discussions with the FDA. During the remainder of 2007 and the first part of 2008, we engaged in an ongoing dialogue with the FDA for purposes of addressing its concerns and explaining our positions taken. On May 23, 2008, the FDA advised us by letter that our responses were satisfactory and that no further response to the FDA's warning letter was required. Based on the FDA's letter dated May 23, 2008 and subsequent written correspondence and discussions with the FDA staff, we believe the matter to be closed with no prospect of fine or penalty by the FDA. We also believe that we have addressed substantially all of the FDA's concerns over our human clinical trials and we expect to resume human clinical trials in the United States subject to the FDA's review and approval of our investigative device exemption (IDE) application. We submitted an IDE application to the FDA on November 30, 2007, which, if approved, will facilitate a continuance of the US clinical trials that were suspended by us in November 2006. In December 2007, the FDA responded to our IDE application with a disapproval letter. We have since filed three IDE supplements to address deficiencies cited by the FDA, the third of these was submitted on September 5, 2008. On October 8, 2008, the FDA responded to our third supplemental filing with two cited deficiencies. We are presently preparing a fourth supplemental filing for purposes of addressing the FDA's remaining comments. We estimate that the costs of conducting and completing clinical studies of the MedClose device to be between $178,000 to $430,000. We believe that we have sufficient working capital on hand to complete clinical studies. We intend to analyze our options for moving forward with the commercial exploitation of the MedClose, including licensing or sale of the product and our manufacture, marketing and sale of the product directly. If we pursue the manufacture or marketing of the MedClose product, we will, in all likelihood require significant additional capital. In that event we will endeavor to acquire the necessary working capital from the sale of our securities. However, there can be no assurance we will be able to obtain the required additional working capital on commercially reasonable terms or at all...........However, there are no agreements or understandings with any third parties at this time for our receipt of additional working capital and there can be no guarantee that such funds will be available on commercially reasonable terms, if at all. If we are unable to access additional capital on a timely basis, we will be unable to expand or continue our development of the MedClose device and our operating results will be adversely affected..... Full story HERE

Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology

CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and tissue processing company, today announced it has been awarded approximately $1.7 million under the Department of Defense (DoD) Appropriations Bill to continue further development of CryoLife's protein hydrogel technology. Preclinical studies of CryoLife's BioFoam(R) Surgical Matrix, a protein hydrogel product under development for organ sealing, are nearing completion. This grant will help fund upcoming clinical studies of BioFoam in the United States. In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the Company's BioFoam IDE submission for liver parenchyma sealing. Before beginning the feasibility study, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the same from the U.S. Department of Defense. The Company is in the final review process with the Department of Defense. The Company also filed a CE Mark submission with its Notified Body in December 2008 for BioFoam's use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The Company also continues to conduct preclinical research with BioFoam for use in wound sealing in trauma surgery. "Over the past four fiscal years the DoD has allocated a total of approximately $5.4 million to CryoLife for the development of protein hydrogel products," said Steven G. Anderson, CryoLife president and chief executive officer. "We are excited about advancing this product through the clinical process.BioFoam, a protein hydrogel biomaterial under development by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and minimize pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future operations in liver resections. BioFoam is based on the same technology as BioGlue(R), a CryoLife product approved by the U. S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.

JnJ release Q1 results - edited

We completed our acquisition of Mentor Corporation at the end of January and we are moving full speed ahead on integration of Mentor and Omrix Biopharmaceuticals within our Ethicon Surgical business. We are making progress with the integration of health media and human performance institute as we advance our new wellness and prevention platform. This business is now being reported as part of the Consumer segments financial results. These and our other acquisitions like Dabao Cosmetics and SurgRX are adding important sales and growth opportunities to our business but I would remind you that this quarter and the years results will also reflect the divestiture of our professional wound care business which was sold in the fourth quarter of 2008. Ethicon worldwide sales grew operationally by 9.1% with the US up 18.8% and sales outside the US up 3.7% operationally. The acquisitions of Mentor and Omrix offset by the divestiture of the professional wound care business added approximately two points to the worldwide growth. Sales in the US on a pro-forma basis for our newly acquired aesthetics products from Mentor although lower then 2008 performed better then the estimated market. Strong double digit growth was achieved in meshes and bio-surgical.