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.