Orthopedic and Spine News (www.orthospinenews.com)

R.I.P. Blogger version of OSN, Long Live New OSN!

2009-12-31T21:01:00.003-07:00

That's it! We're done using Blogger for our site. We've outgrown it and have moved to a totally new platform with better features for you, the end user.

So go ahead and go to the new site:

OrthoSpineNews.com

So please change your bookmarks, change your feeds, change everything that pointed to this version of the site. Thank you so much for your readership and have a happy new year!

OrthoSpineNews to Launch Fully Re-Designed Site on January 1st, 2010

2009-12-29T10:12:00.003-07:00

We at OrthoSpineNews.com have had a lot of fun providing news to the industry in a format that has not previously been done throughout 2009. Because of the overwhelming response and website traffic, we have completely redesigned our site and will be launching the new look on Friday, January 1st.

A little housekeeping

Website address-

Because we have created a full service website now, and not simply a blog, we will no longer be updating http://www.orthospinenews.blogspot.com.

We will launch our site on our new domain http://www.orthospinenews.com.

RSS Feeds-

If you currently subscribe to our RSS feeds, those will need to be redone also. We will make another post on Friday with all links to the ATOM RSS feeds as well as the new site.

All of the content will be transferred and as always, it will be free to the viewing public. We just wanted to let everyone know in advance that the site will be making a dramatic change and we are very excited about additional features we will be adding in the near future. If you have any questions, please contact Josh at orthospinenews@gmail.com or js@tdg-llc.com.

Happy New Year!!!

Balloon Kyphoplasty in the Treatment of Osteoporotic Vertebral Compression Fracture Nonunion

2009-12-29T10:09:00.000-07:00

Abstract

Patients with nonunion of osteoporotic vertebral compression fractures that are refractory to conservative treatments have persistent back pain, progressive vertebral body collapse and kyphosis, and mobility of the fracture. Although many previous reports have reported vertebral compression fractures treated by balloon kyphoplasty, few data is available on using this method to treat nonunion of vertebral compression fractures. This study evaluated the therapeutic potential of balloon kyphoplasty in the treatment of nonunion of osteoporotic vertebral compression fractures. Twenty-one patients with nonunion of osteoporotic vertebral compression fractures were treated with balloon kyphoplasty. The criteria for diagnosis of nonunion osteoporotic vertebral compression fractures included the following: (1) history of pain for at least 6 months at the fracture site; (2) low T1- and high T2-signal on magnetic resonance images; (3) widening of fracture line on routine radiographs; and (4) movement of the endplate and changes of anterior vertebral heights on hyperextension radiographs. All patients were followed for 9 to 33 months postoperatively (mean 25 months). Statistically significant improvements in the mean postoperative anterior and middle vertebral body heights were observed compared with preoperative values. There was also statistically significant improvement in the mean values for Cobb’s angle, pain (visual analog scale), and the Oswestry Disability Index at the postoperative assessment compared with the preoperative assessment. No statistically significant differences were noted between the postoperative and final follow-up assessment in any of the evaluated efficacy measures. The study suggests that balloon kyphoplasty is an effective technique to treat nonunion of osteoporotic vertebral compression fractures.

Nucleus Replacement- A New Option For Treating Degenerative Disc Disease

2009-12-29T10:08:00.000-07:00

(PressZoom) - The nucleus replacement market is forecast to be driven by a growing awareness of non–fusion technologies in spinal surgery. This early stage market with most products under the pipeline expected to release in the next couple of years, is touted to position itself as the gold standard for the treatment of early stage disc degeneration.

It is estimated that 85% of the population over the age of 60 show evidence of spinal disc degeneration. Nucleus replacement will be the leading motion preserving treatment option in the US and Europe that holds a large pool of this aging population. Nucleus replacement technique is less invasive, less traumatic and most importantly, offers motion preservation. These factors will aid in positioning nucleus replacement as a dominant driver in the spinal surgery market.

This analysis was taken from a research paper published by GlobalData.

Access the latest Orthopedic Devices analysis for free at researchviews.com

DePuy Voluntarily Recall LCS Duofix

2009-12-28T09:31:00.000-07:00

Medical device company DePuy (a Johnson & Johnson company) in July voluntarily recalled a prosthesis known as the LCS Duofix Femoral Component because one material used affected the tissue in the joint.

The knees were recalled after the problem was detected. Fewer than 1000 South Australians are believed to have had them put in, and up to 10 had to have them taken out again.

The company refused to release specific figures because of "commercial sensitivity". A field safety notice issued by DePuy says the Australian revision rate this year was 1.45 per cent, although globally it was 0.57 per cent.

"A subset of these revision patients presented within three years of implantation with symptoms of pain and swelling," it says. "Third body wear and/or tissue staining were found upon investigation."

DePuy admits it does not understand all factors contributing to the revisions and says it will set up an independent medical review team.

Johnson & Johnson Medical communications director Michelle Lawlor said less than 1 per cent of implants in South Australia since 2005 had been revised.

MiMedx Group Announces Launch of its Paradis Vaso Shield(TM) Device

2009-12-23T10:10:00.001-07:00

ATLANTA, Dec. 23 /PRNewswire-FirstCall/ -- MiMedx Group, Inc. (OTC Bulletin Board: MDXG.OB) announced today that it has officially launched its first product, Paradis Vaso Shield™. In April 2009, The Food and Drug Administration cleared the Vaso Shield for use as a cover for vessels following anterior vertebral surgeries. The Vaso Shield is a permanent and transparent hydrogel product protected by multiple patents and patent applications, as well as a proprietary manufacturing process.

Upon completion of an anterior spinal implant procedure, the physician places the Vaso Shield between the spinal implant site and the vessels and then sutures it to the perivertebral, non-vascular soft tissue to secure the implant. The device is designed to protect the vessels in subsequent anterior revision surgeries.

The Company also announced the hiring of a Vice President of Sales and Marketing, Mr. Michael W. Carlton. Mr. Carlton brings an extensive background in the management of orthopedic and vascular implant sales and marketing. Mr. Carlton commented, "I am very impressed with MiMedx Group's two new biomaterials, namely its hydrogel and collagen fiber. These products have the potential to improve patient outcomes and significantly reduce costs. I look forward to joining this very experienced management team and assisting with the growth of MiMedx Group."

Parker H. "Pete" Petit, MiMedx Chairman and CEO, also commented, "This is an exciting day for MiMedx Group because it represents the commercialization of our first in a series of new products from our hydrogel material. With the hiring of Mike Carlton, we have added another experienced executive to our team. His expertise and leadership will be instrumental in developing our distribution network for our hydrogel spine products and for our future sports medicine collagen fiber products. We look forward to reporting the progress of our market acceptance and the growth of our revenues from Vaso Shield beginning in our first calendar quarter of 2010."

Medtronic announces launch of Sovereign spinal system

2009-12-23T08:56:00.000-07:00

Dec 23, 2009 (Datamonitor via COMTEX) -- MDT | Quote | Chart | News | PowerRating -- Medtronic, a medical technology company, has announced the US launch of the Sovereign spinal system.

The Sovereign spinal system is an intervertebral body fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine.

When a lumbar disc is diseased, it can lose height, compressing nerve roots and the spinalcord, causing pain in the legs and lower back. The Sovereign spinal system is designed to stabilize the spine and promote bony fusion, which involves the joining of two bones together, such as adjacent vertebrae, said Medtronic.

The Sovereign spinal system incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone, the Sovereign device is radiolucent on x-rays, which allows the surgeon

I-Team: Man Died Under Medical Mafia Member's Care

2009-12-22T08:07:00.000-07:00

LAS VEGAS -- The death of a 38-year-old Las Vegas man following spinal surgery has caused a buzz in local medical circles. That's because the surgeon who performed the operation recently plead guilty to federal charges.

The doctor, Mark Kabins, is considered a central player in the FBI's ongoing Medical Mafia investigation.

There's no indication the doctor or the hospital did anything wrong or screwed up in any way. But anytime a patient dies days after surgery, and the surgeon who performed the operation is at the heart of an ongoing FBI investigation, something like this is bound to get noticed.

David Fletcher was a U.S. Marine who served with a tank division in Desert Storm. He was happily married with two children. He knew there were risks associated with back surgery, but gave his consent when he entered Valley Hospital on December 5, 2009.

Dr. Kabins was listed as the admitting physician, the attending physician and the person who performed the operation on Fletcher's aching spine. But something went terribly wrong following the operation, and on December 10, 2009, Fletcher was dead.

Valley Hospital notified the Clark County Coroner's Office of Fletcher's death, though Kabins was not mentioned as the surgeon of record. The Coroner's Office says they have been told Dr. Annie Cheanvechai, a vascular surgeon who was part of Fletcher's surgical team and did prep work for Kabins to operate on the spine, will sign the death certificate. The doctor says she was not the surgeon of record, but declined further comment.

Valley Hospital initially declined to say anything because of patient confidentiality, and then denied Dr. Chevenchai had anything to do with the patient, then told us she did. A spokesperson also said cause of death was not related to the surgery. The coroner says Fletcher died of cardiac arrest and thrombosis, which is akin to blood clotting.

Some of Kabins' colleagues say, off the record, they are astonished by the ambitious schedule of surgeries he has maintained, even though just a few weeks ago he plead guilty to participating in the self-titled Medical Mafia conspiracy.

The FBI has been investigating a network of local doctors and lawyers for the past five years. Prosecutors allege the conspiracy raked in tens of millions of dollars, money that otherwise would have gone to the injured patients.

In late November, Kabins admitted in his plea agreement that he participated in a conspiracy with co-defendants Howard Awand and attorney Noel Gage regarding patient Melodie Simon, who became a paraplegic after a botched surgery. Kabins agreed to focus the blame on another doctor and was assured he would not face a malpractice suit.

The FBI has also investigated the use of medical liens on patient accounts, a practice allegedly encouraged by Awand's company, which had a contractual relationship with Valley Hospital regarding medical liens.

Kabins will be sentenced in January. He has agreed to serve six months of house arrest, pay $3.5 million to Simon, and serve five years probation. The question is whether he will still be able to practice medicine and care for the 17 patients he has operated on since pleading guilty in late November.

It will be up to Nevada's Medical Board to decide if Dr. Kabins will be allowed to continue his practice after he becomes a convicted felon.

Valley Hospital says although Fletcher died because of complications following surgery, it doesn't mean there was anything wrong about the operation. Sometimes, the body simply reacts. We were also told that just because a doctor other than Kabins signed death certificate, it doesn't mean there is any attempt to hide his involvement with the patient.

As federal authorities await the Kabins' sentencing and the trial of the other alleged conspirators, they are understandably interested in anything that involves someone who will likely be a key witness in a pretty big case.

Robotic ankle only steps away from daily use

2009-12-21T14:07:00.000-07:00

Two years ago, George Wolf was injured in a hang-gliding accident. His left leg was amputated below the knee.

He now has an artificial limb, but he longs to walk with fluid movement.

When he heard that fellow Arizona StateUniversity professor Thomas Sugar was looking for candidates to test a new spring-loaded robotic ankle that his team was developing, Wolf couldn't wait to volunteer.

"I dream about running and walking normally," said Wolf, a 54-year-old chemistry professor. "I walk pretty well with my prosthetic, but what I noticed when I got on (the device) was how smooth the gait was, just a flow, with no hint of a limp or any asymmetry."

Sugar and his ASU team have been working with the Military Amputee Research Program at Walter Reed Army Medical Center to develop a technology called Spring Ankle with Regenerative Kinetics, nicknamed SPARKy after the ASU Sun Devil mascot.

They believe they are close to perfecting it.

Sugar says the device is one of a kind because it uses lightweight energy-storing springs to provide a flex that traditional devices just can't give.

"About 1,000 servicemen and women have had below-the-knee-amputations in the wars in Afghanistan and Iraq, and every year about 100,000 diabetics have the same amputation," said Sugar, an engineering professor based at ASU's Polytechnic campus in Mesa. "We believe this device could mean a different life for many of those people."

The shortcomings of current prosthetics are numerous because the mechanics are "largely passive," Sugar said.

Amputees use 20 to 30 percent more energy than able-bodied people just to walk. Their gait is uneven because they must swing their hips to propel their prosthetics. When they're climbing stairs or even walking backward, the challenges increase.

But SPARKy's technology is radically different because it relies on a "robotic tendon" that stretches with each step, generating energy stored in a small motor in the ankle.

The motor in turn moves uniquely tuned springs as the upper leg moves over the ankle. The springs in turn propel the artificial leg forward with each step.

The result: a fluid gait that looks and feels no different from a real leg.

SPARKy is the culmination of Sugar's research that began in the 1990s during his doctoral research in rehabilitative robotics at the University of Pennsylvania.

He said once he could show that he could store energy in the springs and use it to propel the artificial leg, he attracted the attention of the Department of Defense about three years ago.

Eager to see Sugar's idea lead to a better prosthetic for maimed soldiers, the department gave him and his team a $680,000 grant to build the technology.

His team includes Jeff Ward and Matt Holgate, who recently received their doctorates in engineering, and engineer Thierry Flaven.

Now, Sugar believes SPARKy has great promise as a marketable product.

CSC completes a Series B financing round

2009-12-21T09:08:00.003-07:00

California Stem Cell, Inc. (CSC), a leading stem cell company, announced that it has completed a Series B financing round with private investors. The financing will enable the company to support the advancement of its therapeutic products to human clinical trials, as well as the generation and distribution of its tools to aid in stem cell research and drug discovery.

CSC is a privately held company developing proprietary therapeutic products to treat several neurodegenerative diseases, as well as innovative stem cell-based human cell products to facilitate research and conventional drug discovery. Its lead therapeutic candidate, MOTORGRAFT™, is a stem cell-derived motor neuron replacement for the treatment of Spinal Muscular Atrophy (SMA), a genetic disorder that causes the deterioration of the muscles that control crawling, walking, swallowing and breathing and for which there is no current treatment.

CSC has completed pre-clinical GLP safety and efficacy studies to support filing of an Investigational New Drug Application (IND) for the treatment of SMA. MOTORGRAFT^TM was recently granted orphan drug designation and the company held a Pre-IND meeting with the FDA last October. CSC anticipates a Phase I safety study to begin in 2010.

“The ability to raise money in this difficult economic environment is a testament to the significant progress we’ve made the last year in advancing our clinical development programs and developing innovative new research tools. Backed by excellent science and a strong management team, CSC has the momentum, vision, technology and now capital to advance its cell-based therapies and bring its innovative products to the market,” stated Chris Airriess, CSC’s Chief Operating Officer.

William Christy Takes Helm as SpineMatrix CEO

2009-12-21T09:08:00.001-07:00

Medical Device Entrepreneur to Guide Company's Growth and Ongoing Innovation

AKRON, Ohio, Dec. 21 /PRNewswire/ -- William "Bill" Christy, a veteran of five successful medical device start-up companies, has been named chief executive officer of SpineMatrix, an Akron, Ohio-based medical technology company specializing in advanced spinal diagnostics. He joins the company after serving as president and CEO of AOI Medical, a developer of medical devices for the treatment of osteoporotic spine disorders.

Christy brings 23 years of medical device industry research and development, sales, marketing, and global reach to SpineMatrix. Throughout his career, he has served as founder and CEO of Ortheon Medical LLC, a company that focused on orthopedic tendon repair; founder and CEO of ESD Medical LLC, a developer of tubal ligation products, which was transacted to U.S. Surgical Corp.; and founder and CEO of Synergistic Medical Technologies Inc, a laparoscopic product company that was transacted to Ethicon Endo-Surgery. Christy has been instrumental in launching 20 new medical devices to the marketplace. He also holds more than 20 issued and published patents.

"Bill's extensive professional experience in the medical industry and as an entrepreneur is the perfect fit for our expansion objectives," said Jeff Krauss, chairman of SpineMatrix's board of directors. "He knows exactly the right steps in guiding the company through its expanded launch in the marketplace and will shepherd us through this crucial growth phase."

SpineMatrix's innovative technology and market opportunity are what attracted Christy to the company. "Spine care desperately needs more accurate diagnostic tools, and the healthcare industry is in search of ways to remove cost from the system and improve the quality of care. I believe SpineMatrix can have a major impact on both fronts and am excited by the opportunity," the new CEO said.

Christy received his bachelor's degree from the University of Central Florida and earned his MBA from Rollins College Crummer Graduate School of Business.

California Stem Cell Raises Series B

2009-12-21T09:05:00.000-07:00

Irvine-based California Stem Cell, a manufacturer of human stem cells, said today that it has raised a Series B round of funding. Amount of funding, and the investors, was not disclosed by the company. The firm said the new funding will go to support the advancement of its products toward human clinical trials, plus towards generation and distribution of its tools. California Stem Cell is developing stem cell products for both research, as well as a product for treating Spinal Muscular Atrophy (SMA).

Tax Break Allows Smith & Nephew Expansion

2009-12-18T15:39:00.002-07:00

Tax break in hand, Smith & Nephew can move forward with a $42 million investment to convert an office complex formerly occupied by a casino company into a centralized hub for research, marketing and medical education.

More surgeons will be flying into Memphis to learn about the company’s medical innovations because of the new center, said Joseph M. DeVivo, the president of Smith & Nephew’s global orthopedics division, which is based in Memphis. The money the doctors will spend is lagniappe on top of more than $13 million in annual payroll generated by the expansion. The expansion will create 160 high-salary jobs.

The Memphis and Shelby County Industrial Development Board approved on Wednesday a $6.2 million payment-in-lieu-of-taxes (PILOT) agreement with Smith & Nephew, along with tax breaks for two other large local employers, The ServiceMaster Co. and Nike.

‘Added commitment’

Smith & Nephew plans to close on Jan. 15 the purchase of 7216 Goodlett Farms Road, a property outside the Memphis city limits where Las Vegas-based Harrah’s Entertainment once had its division headquarters for the central United States.

The site will host the research, marketing and development functions of Smith & Nephew’s orthopedics division. The average annual wage for the workers at the new site will be $93,427, excluding benefits.

The company will spend $32 million for the property and invest another $10 million for furniture and equipment. The 40-acre site has 285,000 square feet of office space.

Smith & Nephew already employs 2,005 people at its Brooks Road campus and other locations in the Memphis area. The new campus at Goodlett Farms will make room for more investment at Brooks Road and the company’s Holmes Road locations, where future expansions are possible, Smith & Nephew said in its application for the tax break.

“This is not a move out of Brooks Road,” DeVivo said. “This is added commitment and investment.”

The company will continue pushing for improvements around the Memphis International Airport.

“We will continue our commitment to aerotropolis,” DeVivo said. “As a committee member on that (initiative), we will continue to be very active. We look forward to getting more action, to be quite honest with you. We definitely need to see an improved area for everybody. We will maintain our activism toward that.”

The first wave of the 160 employees who will work at the new property could be in place by next summer, he said. A second phase of the project will be the conversion of a warehouse into a teaching center, which is expected to take up to 18 months to complete. The center will include an auditorium and skills center.

Smith & Nephew has in many cases had to host large gatherings of surgeons at locations outside of Memphis because the company did not have the space it needed here, DeVivo said. The center also will be used for gatherings of the company’s far-flung sales staff.

“We hope to centralize that at Goodlett Farms and really make it a place where we are not only developing technology, but we are also bringing leading surgeons in for education and conferences and training on that technology,” DeVivo said.

Novation Awards Single Source Agreement to OrthoScan, Inc. for Mini C-Arms

2009-12-18T14:01:00.000-07:00

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--OrthoScan, Inc., a privately held medical device company based in Scottsdale, Arizona today announced that Novation, the healthcare industry's leading contracting services company, has named OrthoScan its sole supplier of Mini C-Arms.

The agreement is effective December 15^th for three years with two one year extension options. Under the terms of the deal, OrthoScan will be the exclusive provider of Mini C-Arms to the VHA, UHC and Provista members of Novation.

"The Novation contract confirms OrthoScan’s industry-leading technology," said Rob Morocco President & CEO of OrthoScan. “As a result of this agreement, we're able to provide Novation customers with the HD Mini C-Arm, which offers a small and lightweight design, intuitive operation, and adjustment free imaging.”The agreement is effective December 15^th for three years with two one year extension options. Under the terms of the deal, OrthoScan will be the exclusive provider of Mini C-Arms to the VHA, UHC and Provista members of Novation.

CMS final rule announces a 21.2% Medicare physician payment cut for 2010

2009-12-18T10:13:00.000-07:00

By Gina Brockenbrough
ORTHOPEDICS TODAY 2009; 29:18

A final ruling by the Centers for Medicare & Medicaid Services calls for a 21.2% Medicare physician payment cut and includes refinements that will increase payment rates for primary care services.

Although original estimates projected that Medicare physicians would face a 21.5% drop in reimbursement, the new negative payment update reflects more recent data.

“The Administration tried to avert the pending fee schedule cut in the FY 2010 budget proposal that it submitted to Congress, and remains committed to repealing the SGR,” Jonathan Blum, director of the Centers for Medicare & Medicaid Services (CMS) Center for Medicare Management, stated in a press release.

“In the meantime, CMS is finalizing its proposal to remove physician-administered drugs from the definition of ‘physicians’ services’ for purposes of computing the physician fee schedule update. While this decision will not affect payments for services during CY 2010, CMS projects it will have a positive effect on future payment updates.”

Potential ramifications

Jack M. Bert

Orthopedics Today’s Business of Orthopedics Section Editor Jack M. Bert, MD, said that thesustainable growth rate (SGR) formula is flawed and that future cuts may have physicians looking for a Medicare-exit strategy.

“It serves political aims and goals, but does not serve the medical community well,” he toldOrthopedics Today.

“Wondering if a 21.2% payment cut is going to occur distracts doctors, group administrators, and even patients from the larger questions at hand. A cut so drastic and dramatic would create rapid changes in behavior and set into motion future strategic plans which Congress and CMS may not have predicted,” he said

He added, “Eighty percent of the physicians in my 37-man group have decided to electively cease seeing Medicare patients if the 21% reduction goes into effect.”

Bert also projected that practices with large Medicare populations would likely enact overhead reductions within 6 months of the cut.

“It is sadly ironic that the patients who are most vulnerable, require the most attentive care and often require the most complex surgical cases are being devalued by Congress,” he said.

New initiative from orthopedic group guides physicians, hospitals in bone health education and treatment

2009-12-18T10:12:00.000-07:00

1^st on the web (December 18, 2009)

The American Orthopaedic Association has developed a multidisciplinary, Web-based, quality improvement initiative to guide hospitals and practitioners in addressing bone health and fragility fractures.

The Own the Bone initiative offers a registry, testing, counseling, treatment, education and communication components. According to its organizers, the program is steadily gaining momentum. However, patients at risk of fragility fractures can only benefit from the initiative once a local site such as, a physician, hospital or health care system, enrolls in the Own the Bone program.

“We want to close this treatment gap that one in five Americans get appropriate evaluation and treatment for their bone health,” Douglas R. Dirschl, MD, chairman of the University of North Carolina’s department of orthopedics, said during an Own the Bone Webinar. “That is simply not acceptable. We want to begin to close that gap with a national program,” he said.

Analyst: Medical device sector should outperform in 2010

2009-12-18T10:11:00.001-07:00

A more positive environment will lure generalist investors back into the fold, helping the medical device sector bounce back in 2010, according to Leerink Swann analyst Rick Wise.

Après le deluge, le bounce. Or at least a solid rebound for the medical device sector, according to analysts at New York investment firm Leerink Swann, who predict a rising tide that should lift most ships in the coming year.

In the firm's 120-page 2010 outlook, Leerink analysts say they expect most healthcare sectors to outperform 2009, as earnings start to come back and the looming specter of dramatic healthcare reform lifts in favor of more modest changes. In addition, the analysts say positive activity on Wall Street will also start luring the individual investor back into the fold.

According to Leerink Swann analyst Rick Wise, the medical devices market will have strong top- and bottom-line growth in the coming year, fueled by stabilizing hospital budgets that saw massive cutbacks in 2009. Wise expects a gradual return to "normalcy" as hospitals begin re-stocking inventories and the capital equipment market freeze begins to thaw.

Wise is also bullish on the atrial fibrillation, spine and structural heart device markets. Companies in the capital equipment space should look for some rebound as well, he writes, and improving economic conditions could lead to more elective procedures being performed in 2010 — particularly welcome news for orthopedic procedures like hip and knee replacement surgeries, not to mention cosmetic procedures.

Mergers and acquisitions will continue to be attractive to large, cash-rich companies looking to expand their product pipelines. Wise expects average top-line growth of around 7 percent for large med-tech companies, with bottom-line increases of around 11 percent.

Stocks poised for gains in 2010 include Boston Scientific (NYSE:BSX), Baxter (NYSE:BAX), Stryker Corp. (NYSE:SYK), Covidien (NYSE:COV) and Insulet Corp. (NSDQ:PODD). Leerink rated all of them as "Outperform," defined as a stock that outperforms its benchmark by more than 10 percent in the next 12 months.

Symmetry Medical Announces Restructuring

2009-12-18T10:10:00.001-07:00

WARSAW, Ind., Dec. 18 /PRNewswire-FirstCall/ -- Symmetry Medical Inc. (NYSE: SMA), a leading independent provider of products to the global orthopaedic device industry and other medical markets, announced today a restructuring that includes a facility consolidation and other staff reductions designed to increase operational efficiency and drive annualized cost savings. The restructuring is designed to position the Company for continued market leadership during the anticipated orthopedic industry recovery.

As part of the restructuring, the Company will consolidate its Auburn, ME operations into other existing Symmetry Medical facilities by the middle of 2010. The consolidation will include the transfer of current production capacity, including equipment and machinery. The Company is taking steps to minimize any disruptions, and expects to continue to provide a seamless high level of quality and service to its customers during the consolidation.

The restructuring, once complete, is expected to generate an ongoing annualized cost savings of approximately $3.4 million, on a pre-tax basis. The total one-time cost of these actions is anticipated to be in the range of $2.4 to $2.8 million.

As a result of these actions, the Company will incur a fourth quarter 2009 restructuring charge of between $1.8 million and $2.2 million, on a pre-tax basis, consisting of primarily of severance costs and impairment of property, plant and equipment.

The Company also anticipates approximately $0.4 million of related expense in 2010 resulting from relocation and equipment moving expenses.

In addition to the restructuring charges noted above, the Company is currently evaluating long-lived intangible assets including goodwill related to the Auburn, ME operations, which were acquired in May 2006, for potential impairment. The Company will communicate any required non-cash charges related to these assets when the analysis is completed.

Excluding the above one-time charges, the Company is reconfirming its latest 2009 full year guidance of earnings per diluted share in the range of $0.63 to $0.68.

Brian Moore, President and Chief Executive Officer of Symmetry Medical, stated, "These decisions are difficult under any circumstances, and we recognize the personal impact they have on those dedicated employees who have made contributions to the success of our business. We are committed to treating them fairly and with respect throughout this process."

Mr. Moore continued, "These initiatives reflect our continuing efforts to streamline our cost structure and improve operational efficiencies throughout our Total Solutions® global network. We believe these strategic decisions are being made at an opportune time to further strengthen profitability and help us prepare for the anticipated resurgence of growth in the orthopedic industry. We remain well positioned to respond to increased global customer demand and believe this consolidation will further strengthen our competitive position in the industry."

Spinal surgery goes 3D

2009-12-18T10:08:00.000-07:00

RALEIGH, N.C. — Ten percent of people withback pain undergo surgery, and a new three-dimensional imaging system is helping surgeons more accurately fix patients' problems.

WATCH VIDEO
3-D imagery makes spinal surgery easier

Dr. Robert Allen, a neurosurgeon at WakeMed in Raleigh, recently performed surgery on a patient to relieve to lower back pain. The problem was caused by a combination of arthritis, disc herniation and bones pressing on nerves.

"In addition to getting the pressure off the nerves ... we fused that segment (of the spine)," Allen said.

Spinal fusions can be done at any level of the spine, such as the cervical area of the neck, but are most commonly done in the lumbar area.

The problem surgeons face is that everyone's spines aren't the same. Some spinal deformities cannot be seen with the traditional two-dimensional imaging systems.

"Sometimes, getting them in exactly the right spot can be challenging," Allen said.

Allen, though, has a new set of tools to help him, including the O-arm Multidimensional Imaging System.

"That will give you imaging very similar to what you would get in a CT scan, but you have it right there in the (operating room)," he said.

It provides a traditional flat image, and a computer combines pictures to create a nearly 3D view.

"We use these images to help us target a perfect trajectory," Allen said.

When the surgery is done, the O-arm is used again to look for possible errors in screw placement. If there is a problem, surgeons can correct it then, rather than in another surgery later.

For more complex spinal fusion surgeries, the O-arm system exposes the patient to less radiation than does the traditional flouroscopic imaging used in most procedures.

Medtronic Introduces the SOVEREIGN™ Spinal System for Lumbar Surgery

2009-12-18T10:07:00.000-07:00

MEMPHIS, Tenn. - (Business Wire) Medtronic, Inc. (NYSE: MDT) today announced the U.S. launch of the SOVEREIGN^™ Spinal System.

The SOVEREIGN Spinal System is an intervertebral body (interbody) fusion device used to treat patients who suffer from a degenerative condition that affects the lumbar spine. When a lumbar disc is diseased, it can lose height, compressing nerve roots and the spinal cord, causing pain in the legs and lower back. The SOVEREIGN Spinal System is designed to stabilize the spine and promote bony fusion, which involves the joining of two bones together, such as adjacent vertebrae. There are more than 200,000 lumbar fusion procedures performed each year to relieve leg and lower-back pain.

To restore a patient’s disc height, surgeons have traditionally used bone grafts, stabilized and held in place by metal plates anchored to the spine with bone screws. The SOVEREIGN Spinal System incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the SOVEREIGN device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.

The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The implant may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been cleared by the U.S. Food and Drug Administration for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.

The SOVEREIGN^™ Spinal System incorporates technology developed by Gary K. Michelson, MD.

Interleukin Genetics Launches Bone Health Genetic Test

2009-12-17T16:19:00.001-07:00

WALTHAM, MA – December 17, 2009 – Interleukin Genetics, Inc. (NYSE Amex: ILI) announced today availability of the Bone Health Genetic Test designed to detect genetic patterns associated with the development of osteoporosis-related outcomes. The test determines an individual’s risk for developing vertebral or spinal fractures and low bone mineral density. Knowing one’s genetic risk could allow an individual to take action towards building optimal bone health by following personalized guidance outlined in their genetic report, that may include recommendations for certain exercises, changing intake of Calcium and Vitamin D, as well as other lifestyle choices. The Bone Health Genetic Test is available through the Inherent Health brand of genetic tests at www.inherenthealth.com.

The Bone Health Genetic Test was developed following the completion of a 2,500-person clinical study conducted by Interleukin Genetics in collaboration with a university partner. In October at the American Society of Human Genetics 59th Annual Meeting, data from the study was presented by Interleukin Genetics that showed variations in the Interleukin 1 beta (IL1-B), Vitamin D receptor (VDR), and Estrogen receptor 1 (ESR1) genes were strongly associated with risk of spine fracture or low bone mineral density. Association between these variations and vertebral fracture or bone mineral density was determined by logistic regression analysis with adjustment for age, BMI, estrogen use and other covariates.

The Bone Health Genetic Test analyzes gene variations that were identified from the study as showing statistically significantly increased risk for spinal fracture and low bone mineral density and provides risk information beyond that provided by traditional risk factors, such as age and Body Mass Index (BMI), in the assessment of an individual’s overall risk for bone health.

“Through knowledge of one’s genetic risk for fractures and low bone density, individuals will be able to take appropriate steps to maintain strong bone health prior to any measurable signs. Through proper diet and exercise the opportunity to prevent low bone mineral density and reduce the risk of spinal fracture is significantly improved,” said Lewis H. Bender, CEO, Interleukin Genetics. “Not everyone has genetic predisposition for osteoporosis, which can progress painlessly until serious fracture occurs, but for those that do our new Bone Health Genetic Test can be a powerful preventative tool.”

AlloSource Recognized for Exemplifying Ethics Amongst Colorado Non-Profits

2009-12-17T16:18:00.000-07:00

AlloSource a Samaritan Institute finalist in the 2010 Colorado Ethics in Business Alliance Awards

CENTENNIAL, Colo., Dec. 17 /PRNewswire/ -- AlloSource, one of the nation's largest non-profit providers of skin, bone and soft tissue allografts for use in surgical procedures and the world's largest processor of live cellular bone growth substitutes, today announced that is has been selected as a finalist in the 2010 Colorado Ethics in Business Alliance (CEBA) Awards, in the Samaritan Institute category honoring non-profits. This is the second year in a row that AlloSource has been selected as a finalist by the annual awards program, now in its 18th year.

CEBA's Samaritan Institute Award recognizes non-profits that demonstrate a high level of effectiveness in carrying out their stated missions. Additionally, the award seeks organizations that adhere firmly to ethical standards of conduct, treatment of staff and treatment of clients, are highly successful at raising funds and run effective business operations that include cooperation and coordination with other entities and individuals.

Since 1994, AlloSource has been run on a promise: to honor and respect the gift of tissue donation by responsibly developing, processing and distributing life-saving and life-enhancing allografts for its communities. The Company delivers on this promise with safe, effective and innovative allografts.

"It is with great pride that we are again named a CEBA finalist, because living our mission is at the core of what we do," said Thomas Cycyota, AlloSource President and CEO. "We strive to be a trusted, valued, knowledgeable partner to the medical community as well as to patients and donor families, and our associates are instrumental in making that happen every day."

In 2008, AlloSource saved and enhanced the lives of more people in more communities than ever before. The Company processed more than 4,150 tissue donors whose gifts helped thousands of people to improve their mobility and functionality. This allowed AlloSource to provide 144,899 allografts, 10% more than the previous year, to patients in its local communities, including in Colorado. Additionally, AlloSource processed more than 3,200 skin donors whose generous gifts helped save the lives of burn victims around the country.

$58M venture fund targeted at life science startups

2009-12-17T16:17:00.002-07:00

A new $58 million venture capital fund has been established by BioCrossroads, organizers said today, meaning a huge pool of money to help start-up companies both statewide and nationally.

Called INext Fund, the public-private effort will be a needed source of equity for new life sciences-related busin

INext is a follow-up to the $73 million Indiana Future Fund, launched six years ago that helped 14 Indianacompanies, including BioStorage Technologies in 2006.

The announcement was made on the corporate campus of Eli Lilly and Co. Lilly Ventures is part of the team of collaborators.

Credit Suisse Customized Fund Investment Group will be the fund manager.

"We've made incredible progress building a market where VC firms, both local and out of state, are investingin our promising life sciences companies," said David Johnson, president and CEO of BioCrossroads.

The INnext Fund includes investments from Lilly; the Indiana State Teachers Retirement Fund; Indiana University; Purdue University; Notre Dame (a first-time participant); and the Fairbanks Foundation.

Alphatec Spine Agrees to Acquire Scient'x Groupe SAS

2009-12-17T16:17:00.001-07:00

CARLSBAD, Calif., Dec. 17, 2009 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France.

The transaction is structured as an all stock transaction such that 100% of outstanding Scient'x stock will be exchanged pursuant to a fixed ratio for 24 million shares of the Company's common stock. On a pro forma basis, current Alphatec shareholders will own approximately 69% of the combined company and approximately 31% will be held by current Scient'x shareholders. The transaction is currently expected to close by the end of the first quarter of 2010 and is subject to the approval of the Company's shareholders. Subject to the closing of the transaction, the Company expects 2010 pro forma full-year revenues to be in a range of $220 million to $225 million, and pro forma full-year 2010 adjusted EBITDA to be in a range of $32 million to $35 million. The transaction is expected to be neutral to slightly positive to 2010 EPS and accretive to 2011 EPS, excluding amortization of intangible assets, transaction expenses and related restructuring charges. The Company has absorbed transaction-related costs that had a negative impact to EPS in the third quarter and are expected to negatively impact previously issued EPS guidance for the fourth quarter of 2009. The Company also expects to absorb additional transaction-related expenses in the first quarter of 2010.

The combined company will create the third-largest independent spinal company with a global span of product distribution. Scient'x is the largest privately held independent spine company outside of the United States with product distribution in over 50 countries.

The transaction was unanimously approved by a Special Committee of independent members of the Company's Board of Directors. Following such approval by the Special Committee, the Company's Board of Directors unanimously approved the acquisition agreement. Thomas Weisel Partners LLC acted as exclusive financial advisor to the Special Committee and provided a fairness opinion to the Board of Directors that the transaction was fair to the Company from a financial point of view as of the date of this press release. DLA Piper LLP (US) acted as independent counsel to the Special Committee.

Osteotech Submits 510(k) Application to FDA for Clearance of its Duratech(TM) BioRegeneration Matrix

2009-12-17T16:16:00.000-07:00

EATONTOWN, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that it has submitted a 510(k) application to the United States Food and Drug Administration (FDA) to obtain marketing clearance for the use of its Duratech™ BioRegeneration Matrix to repair or replace the dura mater (the outermost membrane surrounding the brain) in various cranial surgical procedures. This filing is based, in part, on data collected during the Company's human clinical study, which demonstrated the safety and performance of Duratech compared to currently marketed predicate dura substitute devices. Based on available data, Osteotech estimates that the annual market for dura repair substitutes is approximately $100 million.

"Our 510(k) application for Duratech is another key milestone in our new product development initiatives and is the first step in the commercial development of our HCT™ (human collagen technology) platform," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "We believe HCT will eventually support a family of first-in-class, procedure-specific biologic products with a total addressable market opportunity in excess of $1 billion. We believe the data in our filing demonstrates Duratech's safety and performance in the challenging neurosurgical environment and that this data will pave the way in developing the HCT platform for a variety of surgical applications. Duratech was developed in response to the physician community's need for a single biomaterial that has exceptional handling, is flexible yet strong and can be cut, shaped and sutured to fit surgical needs. Once cleared by the FDA, we believe Duratech's unique characteristics will give us a competitive advantage in the marketplace."

Duratech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. The Duratech 510(k) filing included data on 60 patients who underwent a variety of cranial surgical procedures utilizing Duratech where dura mater repair or replacement was required. The patients were evaluated at 30 and 90 day time points post-operatively to assess the safety and performance of Duratech.