J 'n J Q3 - Edited

Ethicon worldwide sales grew operationally by 9.4% with US up 18% and sales outside the US up 3.8% operationally. The acquisitions of Mentor and Omrix partially offset by the divestiture of the professional wound care business added approximately 3.5 points to the worldwide operational growth. Sales for our newly acquired aesthetics products for Mentor were in line with 2008. On a worldwide basis double digit operational growth was achieved in biosurgicals and meshes.
Johnson & Johnson leads the industry in developing and next generation of advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings. A truly unique example of convergence three Johnson & Johnson companies; Ethicon, [Senacore], and the recently acquired Omrix Biopharmaceuticals have been working together to develop one such hemostat that we call the Fibrin pad.
With our heman plasma based biologics embedded directly into proprietary matrix the fibrin pad has the potential to uniquely and effectively dress bleeding challenges that are currently unmet by traditional hemostats. It’s designed to combine the functions of mechanical sealing and biological hemostatis. Upon contact with blood the biodegradable device causes a clot to form rapidly and stop bleeding without any other action. A BLA for the fibron pad is targeted for submission by the end of 2009.

Patch Uses Stem Cells To Plug Holes in The Heart

They say only time heals a broken heart, but Duke University researchers think they can do better. Using embryonic stem cells from mice and their own novel molding technique, a team of researchers at Duke has developed a three-dimensional heart cell “patch” that conducts electrical impulses and contracts, two all important characteristics of heart tissue.

Cardiomyocytes, the heart muscle cells that keep the blood pumping, are difficult to grow effectively because left to their own devices, they will simply develop into a disorganized clump of cells. To get around this, the team coaxed embryonic stem cells to develop into cardiomyocytes by placing them in an environment much like the one in which they develop naturally. By encapsulating the cells in a gel made of fibrin, a blood-clotting protein, the researchers provided the mechanical support for the cells to form an organized, three-dimensional structure.
But the key ingredient for the researchers were helper cells called cardiac fibroblasts. These cells make up as much as 60 percent of the cells present in the heart, and when introduced to the mold they caused the cardiomyocytes to pull together as if they were growing in a developing human heart. The alignment of the cells in the correct direction allows them to contract and carry electrical signals as though they are native tissue, allowing them to function fairly seamlessly alongside existing heart tissue.
After being cast in the fibrin mold, the patches can be placed on the heart where the tissue is thin or compromised and injected with cells that would then generate new heart tissue. But obstacles remain; aside from the many regulatory hurdles a procedure like the heart patch must leap, engineering a blood vessel supply to sustain the patch also presents substantial challenges. The use of embryonic stem cells also invites controversy, so the Duke team also plans to test their patch using non-embryonic stem cells. Ethical and regulatory issues aside, the proof of concept is an important breakthrough for cardiac researchers who have a limited arsenal with which to battle heart disease, the leading cause of death in many developed countries. An effective non-embyronic stem cell heart patch would not only circumvent the problem of immune system reactions, but sidestep sensitive ethical land mines, clearing the way to put broken hearts on the mend.

HyperBranch Medical Technology, Inc. Receives CE Mark for its NuSeal 30 Hernia Mesh Fixation Sealant Product

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to adhere the mesh. NuSeal 30 provides for secure mesh placement, minimizes pain caused by other fixation devices and gradually degrades as the body heals. The CE Mark for NuSeal 30 provides regulatory approval for the company to begin the registration process in countries outside the U.S. The unique, single use device is terminally sterilized and sets on contact after a spray application. The synthetic, biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure. The intended users of NuSeal 30 are General Surgeons in a surgical environment. John Conn, President and CEO, said, "NuSeal 30 is a follow on product to the platform technology developed at Hyperbranch. NuSeal 30 is a major improvement to mesh fixation eliminating the need for staples and tacks while providing secure fixation, reducing pain and creating an anti-microbial environment. The Company will continue to introduce this technology in other indications." The Durham, N.C. medical device company recently announced the CE Mark approval of its NuSeal 100 for dural closure and the licensing of OcuSeal ophthalmic bandage to BD Medical. The company is currently conducting US clinical evaluations for the dural closure product and is in various stages of development for other indications of the platform technology. About HyperBranch Medical Technology, Inc. HyperBranch Medical Technology, a privately-held company based in Durham, N.C., is developing innovative medical devices for the ophthalmology, general, and specialty surgery markets. The company is focused on the development of unique products based on its novel hydrogel technology. Development work on HyperBranch`s surgical sealant platform has led to the recognition of several novel hydrogel properties that suggest significant utility in a variety of additional clinical applications. For more information visit www.hyperbranch.com.

Curasan Ag To Invest Approximately 1 Million Euros In Future Growth

Oct 12, 2009 – Kleinostheim, Germany – curasan AG, which is listed on the General Standard of the German Stock Exchange (ISIN: DE 000 549 453 8), is to invest in its future growth by implementing a technological investment programme amounting to approximately 1 million euros, despite the current crisis in the financial markets.
The aim of the investment package is to significantly strengthen and expand the company’s research, development and production capacities and to integrate modern technologies. Part of this strategy will involve relocating the Frankfurt production and development centre to larger premises in the immediate vicinity of the current location. The relocation will take place step by step and is scheduled to be completed by mid-2010.
“We have a wide range of products that will be ready for market launch in the near future and this investment is therefore necessary in order to be able to provide sufficient supplies to future sales partners”, explains Hans Dieter Rössler, Chairman of the Management Board.
Two of the new products will be ready for the market later this year: towards the end of 2009, curasan AG will enter into negotiations regarding the award of a sales licence for a product that helps to retrieve autologous (patient’s own) growth factors (ATR®). A further product, Osbone®, will be ready for licensing this year. This is a synthetically manufactured, non-resorbant bone replacement material.
The development of a paste version of Cerasorb® could also be pushed forwards during 2009. For physicians, this pharmaceutical form is easier to handle than granulates when used in places that are difficult to access (“bone out of a syringe”). The production of pilot batches, as well as the creation of all the documentation required for approval, is planned for 2010.
The focus of curasan AG medical products currently on the market is the area of biomaterials. This includes products for bone replacement (Cerasorb®), osteoarthritis (Curavisc®) and haemostasis (stypro®). In the pharmaceutical sector, curasan AG supplies a medication for the treatment of superficial bladder carcinomas (Mitem®), which is marketed and sold by Schwarz Pharma AG / UCB-Group.
“We are forecasting continued growth in the future”, states Hans Dieter Rössler, Chairman of the curasan AG Management Board.

Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve

MINNEAPOLIS and GALWAY, Ireland, Oct. 12, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) and Zerusa Limited today announced that they have received 510(k) clearance with the FDA for the sale of the Guardian(r) II Next Generation hemostasis valve in the United States. Under the terms of an agreement between the two companies from July 2007, Vascular Solutions is the exclusive distributor of the Guardian device in the United States. Zerusa recently began the rollout of its CE marked Guardian II launch through its distribution network in Europe, the Middle East and other markets. Howard Root, Chief Executive Officer of Vascular Solutions, commented: "We're delighted to be able to offer this next generation of the Guardian hemostasis valve to our customers through our 85+ employee direct U.S. sales force. The device enhancements contained in this new device are well suited to our U.S. customers, and we're looking forward to making an expanded impact with this product in the marketplace." Liam Mulloy, Chief Executive Officer of Zerusa Limited, commented: "We appreciate all the market feedback both from Vascular Solutions and our other partners to date. This has directly led to device enhancements on our Guardian II hemostasis valve - while maintaining the key benefits appreciated by our customers worldwide such as blood loss minimization, management of multiple devices and ease of use. We look forward to building on our relationship with Vascular Solutions to further develop the U.S. market opportunity."

Guardian II - Unique Seal Technology (Click image to enlarge).

Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
Allows separation of guidewires and other devices during complex procedures.
Click-open and Click-close Design
Allows single handed operation
Unique proximal cap is easily depressed for both opening and closing the lumen.
Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.

Ergonomic Design

Practical design allows the Guardian to fit comfortably in a physician’s hand.
Subtle finger tabs have been added for improved handling characteristics.
Actual device length 92mm.
8 French Lumen
Allows multiple or large therapeutic devices to be inserted during procedures.
Secure Device Lock
Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.

FDA - Dangers of Intravascular Thrombin

Specialty Medical Products Company Enters $10 Billion Orthopedic Biomaterials Market with Patented Technologies

FORT WORTH, Texas, Oct. 1 /PRNewswire-FirstCall/ -- Wound Management Technologies, Inc., (OTC Bulletin Board: WNDM) a rapidly growing provider of specialty medical products, announced today it has closed on its acquisition of Resorbable Orthopedics LLC, a private company with patented technologies including a resorbable bone wax and a delivery system for orthopedic bone void fillers, among others.Under the terms of the agreement, Resorbable Orthopedics has become a wholly owned subsidiary of Wound Management Technologies in a stock transaction.
Scott Haire, CEO of Wound Management Technologies, said, "This highly significant acquisition adds complementary orthopedic biomaterials products to our existing CellerateRx wound care products. Wound Management Technologies, through two subsidiaries, is participating in one of the fastest growing medical markets worldwide. The total global biomaterial market is currently $28 billion and is expected to exceed $58 billion in the next five years. The orthopedic biomaterials market is approximately $10 billion alone, driven by improved patient benefits, a shorter FDA approval cycle and an aging population ever more aware of biomaterial benefits."
"Wound Management Technologies is executing our strategy for rapid growth. The building blocks are coming together and the acquisition of Resorbable Orthopedics is another accomplishment for Wound Management Technologies. We are executing on our strategy to broaden our platform technologies that target a growing patient population. Diabetes and orthopedic disorders are expanding internationally and we are responding by establishing global distribution channels," said Haire.
Barry Constantine, founder of Resorbable Orthopedics LLC, said, "The patents offer innovative, safe and effective resorbable orthopedic products. The bone wax and delivery system address issues such as 'bone wax granuloma' and the delivery of materials that manage bone wound healing in a cost effective manner. At a time when there is a great need for safer and more affordable health care products, these are well timed solutions."

$16.8 million grant awarded to develop platelet recovery treatments

SEATTLE – The National Heart, Lung and Blood Institute of the National Institutes of Health has awarded a $16.8 million, seven-year grant to launch a bicoastal research partnership between

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium and Children's Hospital of Philadelphia.
The collaboration, led by scientists at the Hutchinson Center, will develop molecular- and cell-based therapies for a range of blood diseases, with an initial focus on a life-threatening complication of stem-cell transplantation called thrombocytopenia. The condition, which is sometimes associated with abnormal bleeding, is caused by a delayed recovery of blood-clotting cells called platelets.
The problem is that some stem cell transplant patients, particularly those receiving stem cells from cord blood, often do not produce enough platelets in a timely fashion which puts them at risk for life-threatening bleeding. Platelet production can be delayed by several months in persons who receive a stem cell transplant to treat certain cancers. Transfusions can help, but the number of platelet donors is limited, transfusions carry a risk of blood-borne diseases, and patients who receive multiple transfusions can develop antibodies that destroy the platelets.
According to principal investigator Beverly Torok-Storb, Ph.D., a member of the Hutchinson Center's Clinical Research Division, the goal is to control the process of blood cell production so that all types of blood cells - red cells to carry oxygen, white cells to fight infection and platelets to prevent bleeding - recover together within a few days.
The partner institutions will focus on two complementary strategies to address delayed platelet production. Scientists at the Hutchinson Center and the UW will develop reagents that can be administered to patients to stimulate the differentiation and proliferation of precursor cells into platelets. The Philadelphia group will work to generate "ex vivo," or outside the body, platelets and their precursors from embryonic stem cells for use as cell therapy. The principal investigator in Philadelphia is Mortimer Poncz, M.D., chief of the Division of Hematology at Children's Hospital of Philadelphia.
The Hutchinson Center/UW group will receive a total of $8.2 million during the seven-year grant; the Philadelphia research group will receive $8.6 million.
"This coast-to-coast collaborative effort will take advantage of complementary skills and interests in these two institutions to develop new therapies for all patients needing platelet transfusions," Poncz said.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit HERE.

Old red blood cells may double mortality in trauma patients

Severe trauma patients requiring a major transfusion are twice as likely to die if they receive red blood cells stored for a month or longer, according to research published in BioMed Central's open access journal Critical Care. The increased rate of death was measured up to six months post transfusion which is consistent with previous reports in cardiac surgery patients.
Philip Spinella and Christopher Carroll, both paediatric intensivists from Connecticut Children's Medical Centre, Hartford, Connecticut, USA and their team studied 202 severe trauma patients treated at Hartford Hospital following a critical injury with five or more units of red blood cells. They found that even one unit of red blood cells stored more than 28 days doubled the incidence of deep vein thrombosis and increased death secondary to multiple organ failure. Though medical experts had long suspected that older red blood cells caused complications, this is one of the first studies to strongly support this dramatic link. This study differs from previous studies since the amount of RBC units transfused to the fresh and old RBC study groups were equal. As a result, this eliminated the major criticism of previous studies that it is the amount of RBCs transfused not the storage age that was affecting outcomes.
Over 29 million units of blood were transfused in the United States in 2004, and this is a routine and reliable part of trauma care treatment around the world. However, red blood cell transfusion continues to be associated with adverse complications. This study provides evidence that allows doctors to reduce these risks by giving fresher red blood cells to severe trauma patients who need these major transfusions for life-saving procedures.
According to Spinella, 'The preferential use of younger RBCs to critically ill patients has the potential to increase waste due to outdating. Since blood is often a scarce resource this is important and methods need to be developed to minimise waste while providing the most efficacious and safe blood product for a given patient.
The authors speculate, 'These important findings should encourage research into the effects of old blood and coagulation in critically ill patients. With the widespread of use of red blood cell transfusion for critically injured patients, this study has the potential to cut deaths in hospitals around the world.'

Vascular Solutions - UBS Global Life Sciences Conference