The study outcomes will evaluate if injections of rhGDF-5 into the lower spine can relieve pain and slow or even reverse early stage degenerative disc disease. Researchers at 10 centers in the U.S. are part of this placebo-controlled, double-blind, randomized Phase I-II study that will follow patients for up to three years. This product is investigational only within the United States. The rhGDF-5 protein is being used under license from Biopharm GmbH.

“In animal studies, the injection of rhGDF-5 influenced the growth and differentiation of numerous tissues including the intervertebral disc but these studies are limited in their ability to assess discogenic pain,” said Richard Guyer, MD, a clinical investigator and spine surgeon at Texas Back Institute. “For the first time, in a carefully controlled study, we will see how this recombinant version of human growth and differentiation factor-5 works with actual patients.”

The study consists of patients who have had persistent discogenic back pain for at least three months at one symptomatic lumbar level from L3/L4 to L5/S1 and who have not responded to conservative medical treatment such as physical therapy. Clinical outcomes will be measured using standard validated tools and lumbar disc changes will be measured using magnetic resonance imaging (MRI) data.

“Numerous physicians are trained and now doing the mild procedure, and there is a growing interest in training from the physician community. To support this effort, we’ve opened a new state-of-the-art training facility,” said James M. Corbett, president and chief executive officer of Vertos. “This better enables Vertos to train large groups of doctors efficiently and effectively.” The San Jose operations have been converted to the Vertos Technology Center where research and development and manufacturing will remain.

About Vertos Medical, Inc.

Vertos Medical was founded in 2005 to develop a percutaneous method for lumbar spine decompression to treat patients with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal. Its first proprietary platform technology, called mild® (Minimally Invasive Lumbar Decompression), is the least invasive surgical procedure for treating LSS, with no implants left behind. *

mild is market cleared by the U.S. Food and Drug Administration for decompression of the lumbar spine.

More than 1.5 million Americans suffer from chronic pain and immobility caused by lumbar spinal stenosis. Approximately 700,000 of them are in some form of treatment for LSS every year (Source: CMS database). Treating LSS patients earlier and least invasively, which mild provides for, reduces overall health care costs. For more information, visit www.vertosmed.com.

There was a general consensus going into the meeting that the trial results made the likelihood of OP-1’s approval very low. Stryker has been struggling with the product’s approval since submitting the PMA application to the FDA back in 2006, at which point the clinical data was not supportive of product approval and the FDA required additional studies.

The FDA panel cited numerous issues with the data presented, including:

* The study results presented by Stryker were based on post-hoc analysis, a “flag” the group could not get past. In addition, the panelists cited biases within the study design as well as the introduction of type I errors (false positives).
* The clinicians argued that the presence of bone is not equivalent to bridging bone and the stabilization seen could have resulted from fibrous tissue formation.
* The patients selected for the study were a “stiff” patient population to start.
* There are unanswered questions related to immunologic effects of the protein.

The ROI-A™ ALIF is a stand-alone implant system with zero profile, self-locking plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved plates inserted along the sagittal plane thus requiring no additional exposure to the vertebral bodies.

The ROI-A™ ALIF device is made of PEEK-Optima® for biocompatibility and radiolucency along with Tantalum markers for verification of implant positioning. The system is comprised of multiple footprint sizes, lordotic angles and heights for optimized fit per anatomical requirements. An innovative inserter holds the implant, protecting vascular structures and guiding the plates during insertion.

Christophe Lavigne, CEO of LDR, comments, “Since launching the system in the United States in 2008, close to 500 of the ROI-A devices have been implanted with extremely positive feedback from the surgeons. We are very optimistic about the future of this device for ALIF procedures.”

LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.

Mesoblast’s Executive Director, Professor Silviu Itescu, said he welcomed the ongoing strong support from the Company’s institutional and major shareholders.
“We are very pleased with the continued confidence displayed by our shareholders in the value of Mesoblast’s adult stem cell platform technology, and in the ability of the Company’s management to achieve timely technical milestones and deliver commercial outcomes”.

About Mesoblast Limited

Mesoblast Limited (ASX:MSB)(USOTC:MBLTY) is an Australian biotechnology company committed to the development of novel treatments for orthopaedic conditions, including the rapid commercialisation of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Our focus is to progress through clinical trials and international regulatory processes necessary to commercialise the technology in as short a timeframe as possible.

Mesoblast has the worldwide exclusive rights for a series of patents and technologies that have been developed over more than 10 years and which relate to the identification, extraction and culture of adult Mesenchymal Precursor Cells (MPCs). The Company has also acquired a substantial interest in Angioblast Systems Inc, an American company developing the platform MPC technology for the treatment of cardiovascular diseases, including repair and regeneration of blood vessels and heart muscle. Mesoblast and Angioblast are jointly funding and progressing the core technology.

MicroFuse’s strength is derived from its unique three-dimensional structure which translates into better intra-operating handling characteristics. Due to its bonded sphere structure, MicroFuse is less likely to break apart while mixing with bone graft and during impaction at the bone defect site. MicroFuse’s structure is also designed to maximize the amount of pores in the optimal range for bone formation.

“MicroFuse technology represents a unique entry into the synthetic bone substitute market. With an optimal combination of strength and porosity, MicroFuse is specifically engineered to resorb and be fully replaced by bone,” said Mark Borden, Ph.D., Director of Biomaterials, Globus Medical, Inc. “From the choice of resorbable polymers to the size of the individual microspheres, developmental efforts were focused on providing the best possible environment for bone growth.”

About Globus Medical, Inc.

Globus Medical, Inc., is the largest privately held spinal implant manufacturer in the world and is based in Audubon, Pa. The company was founded in 2003 by an experienced team of spine professionals with a shared vision to create products that enable spine surgeons to promote healing in patients with spinal disorders.

SOURCE Globus Medical, Inc.

Just a few minutes a day does the trick. And when you’re done, simply store the compact machine in a corner or in a closet. Order you back stretcher today and start feeling like a new person!

What customer’s have to say:

“This is just what I wanted and needed. It feels great. All the tension and compression is released from my spine when I use this back stretcher. I don’t know if it does much for my stomach, you can’t do crunches, but I bought it for my back. I use it all the time and my kids and friends love it too. After a long day working or even shopping, I stretch out and feel relaxed and relieved. The pain in my lower back has subsided tremendously!!!”

“I purchased this about 3 weeks ago… my Husband and I LOVE it! It’s compact, easy to assemble, and actually WORKS! We can’t stay away from it. My husband has suffered two back injuries and this is the FIRST product that actually seems to help him. I am going to have major abdominal surgery in November, and wanted to strengthen my Abs and Back before hand. It’s working wonders! We’ve already started the “Ok, it’s my turn” thing. This piece of equipment will never become a clothes rack… Hurray!”

This machine is also a great way to add extra crunch to exercises like sit-ups. The F5000 is specially engineered to provide a comfortable and secure inversion experience. The equipment features heat-treated, high quality carbon steel and triple-plated chrome.

The Teeter Hang Ups F5000 rotates on a pivot system. With simple arm movements (rotation is accomplished by shifting the weight of the arms), the table easily rotates to any comfortable angle. The smooth rotation allows for oscillation and intermittent traction. Adjustable roller hinges allow you to pre-select three levels to control the aggressiveness of rotation, and the tether strap allows you to pre-select the maximum angle of inversion. Comfortable ankle clamps hold you securely while inverting. Additional support can be gained by use of the optional Teeter Hang Ups Gravity Boots.

It’s able to lock at full 90 degrees inversion (this is only possible when using the more aggressive roller hinge setting). While at 90 degrees, you can perform inverted sit-ups and squats. The table is self-controlled and can be unlocked with simple arm movements.

Feature Detail:

* Removable, washable nylon mat with triple-stitched seams removes easily for cleaning
* Teflon embedded epoxy-coated roller hinges for guaranteed smooth rotation with no squeaks for the life of the table; patented cam locks ensure proper assembly
* Durable, injection-coated rubber hand grips feature an embossed guide to the angles of inversion
* Adjustable tether strap allows you to preset the tether strap for worry-free inversion to any angle
* Heat treated high quality carbon steel used in key structural components for increased strength and durability
* Curved foam ankle clamps offer a unique design that allows for greater comfort and security while inverted
* Self-locking hinges secure the table bed to the A-frame for improved security and portability
* De-rattler knob reduces shaft movement to allow for quiet, shift-free rotation–the only design on the market to structurally engage the main shaft
* Triple-plated chrome main shaft with steel wall thickness at least 20 percent greater than any main shaft on the market. Features embossed height markers in both inches and centimeters for easy adjustment
* Height capacity: 4′8″ to 6′6″
* Weight capacity: 300 pounds
* Assembled dimensions: 45 x 28 x 58 inches
* Folded dimensions: 66 x 28 x 14 inches

The F5000 Inversion Table folds compactly for storage in a closet or in a corner. The nylon mat can be removed for washing. Every table comes with an instructional DVD and laminated owner’s manual.

Manufacturer’s Warranty
Five-year warranty covers all components

Rigid muscles, overstretching, poor spinal alignment… just a few of the culprits that can wreak havoc on your back. Fight back with the Lumbar Extender. Simply place this curved, multi-level back stretching device on the floor, recline onto its arched surface, and center your spine in the cradle. Just a few minutes a day in the Lumbar Extender can help shift muscles. You may not only better your posture and flexibility, but also reduce back pain and strain. 3 levels of adjustment; increase arch level as flexibility and posture improve; Compact and portable for travel; Minimal assembly required;

Here’s what one customer had to say:
“This is a simple, compact device that travels easily (collapse it and toss it in your suitcase). It is almost pain free after several uses. It does what it’s advertised to do and is cheaper than visits to the doctor and muscle relaxers (which don’t do a lot for you anyway). It is slightly uncomfortable, initially, only because of the stretch. RELAX the muscles and it works great! Relaxing the muscles is the hard part. Make sure to follow the post usage directions or you’ll undo all of your gain. Roll off of the stretcher and lay on your stomach for a few moments. Then slowly and carefully, raise yourself up to your hands and knees and remain there for a bit. Finally, use a table or a chair to help yourself get up. Do not simply attempt to stand or you’ll send everything back to the pain position.”

According to the company, the CCD Camera can produce more than 4,000 gray scales and features a metal correction program that limits overexposure caused by metal implants.

Ziehm Imaging responded to the requirements of small ORs by designing a system that occupies minimal space while providing optimal image processing and display.
“The Ziehm Solo addresses especially the needs of the Orthopedic, Trauma and Spine Surgeon,” explains Martin Herzmann, Global Marketing Director at Ziehm Imaging. “We aimed to develop a compact, flexible design with reduced space requirements. We’ve carried our experience and know-how in developing high-end systems over to our latest, more cost effective multi-purpose system. Our refined image processing is now available in our entire product folio. Ziehm Solo is especially interesting for smaller clinics and efficiency-driven facilities. It is a good choice because it requires minimal space, is exceptionally flexible and delivers an attractive price/performance ratio.”

About Ziehm Imaging

Ziehm imaging specializes in the development, manufacturing and worldwide marketing of mobile X-ray-based imaging solutions. The company has been market leader in Germany for more than seven years as well as in many other European countries for two years. Today, Ziehm Imaging is a global systems provider, employing over 250 people worldwide. Extensive in-house development know-how is reflected in the Ziehm Imaging C-arms’ high medical imaging performance, intelligent generator technology, significant dose savings and seamless digital network integration. Building on competence and creativity, as well as continuous dialog and close cooperation with renowned universities, research centres and hospitals, Ziehm Imaging has developed groundbreaking technologies that have made the company a global trendsetter in intelligent interventional imaging. Ziehm Imaging products are known for their outstanding versatility and their easy handling for a wide variety of medical applications. In addition, they offer seamless integration into existing IT environments for digital image data acquisition, image evaluation and image management.

Ziehm Imaging Corporate Communications
Martin Herzmann
martin.herzmann@ziehm-eu.com
Tel: +49-911-2172-0
Fax: +49-911-2172-390

Fleishman-Hillard Germany GmbH
Anja Feuerstacke / Cornelia Hild
Tel: +49-89-230-31-60
Fax: +49-89-230-31-631
Anja.Feuerstacke@fleishmaneurope.com
Cornelia.Hild@fleismaneurope.com