U.S. Army Aiming for ‘Disruptive Technologies’
By Robin Young (posted December 15, 2008)
Who knew there was a U.S. Army Science Conference?  In the shadow of Disneyworld no less. But, sure enough, it does exist and this past week a number of cool, futuristic, and potentially “disruptive” medical technologies were on display at the U.S. Army Science Conference in Orlando, Florida.

Balloon, Schmalloon – Wand Please!
By Robin Young (posted December 15, 2008)
Sign of the times—two key spine studies were delivered last month at the interventional radiologist’s meeting—not NASS, ANS or SAS.

Spine Market Share Changes This Year
By Matt Menze (posted December 9, 2008)
Sales reports for the first nine months of this year confirm that, with only two key exceptions, major spine companies are losing share to smaller players. Can they reverse these trends? Or, will the big guys resort to acquisition and consolidation strategies?

Off-Label Use of InFuse® Bone Graft
By Robin Young (posted December 2, 2008)
InFuse® is used off-label—perfectly legally. Why? It works really well and the FDA screwed up the label. Now that the DOJ is subpoenaing Medtronic over off-label use of Infuse, have two federal agencies screwed up?

Orthopedics in China. Wow!
By Robin Young (posted November 17, 2008)
The Chinese Orthopedic Association (COA) is setting its sights on becoming the AAOS of Asia, if not the globe.   Thirty thousand members, 7,200 papers and surging patient demand.  Who are the leaders? Who are the laggards? Check it out.

Half a Million Kyphoplasties Served
By Robin Young (posted November 12, 2008)
On the occasion of World Osteoporosis Day, Medtronic announced that more than 500,000 vertebral compression fractures (VCF) have been treated with Kyphon Balloon Kyphoplasty since the minimally invasive procedure was commercialized in 2000.

The Cervical Fusion Market and Complication Rates
By Matt Menze (posted November 10, 2008)
“If you want something done, give it to the busy man.” Spine surgeons are busy, performing 230,000 cervical fusions annually. That is a lot of pains in the neck!  Our PearlDiver analysts dive into all things “cervical fusion” this week including complication rates.  It’s a busy schedule.

Alphatec’s Answer to Kyphoplasty, OsseoFix™, Gets CE Mark
By Robin Young (posted November 7, 2008)
If OsseoFix™ is the “answer”, then what’s the question?  The question is: Can anyone improve on Kyphoplasty?  Kyphoplasty is expected to be used in more than 120,000 vertebral compression fracture (VCF) procedures this year.  It will consistently, reliably relieve patient pain.  So, again, how can a new product improve on that?

Double the Results: The Twin Spine Study
By Elizabeth Hofheinz (posted November 3, 2008)
For years the predominant model of disc degeneration was wear and tear from environmental influences. Now, findings from The Twin Spine Study are shedding light on the role of genetics. Learn details from the study’s lead researcher, Michele Crites Battié, Ph.D. of the University of Alberta’s Faculty of Rehabilitation Medicine.

Centinel Spine Commences U.S. Evaluation of STALIF C™ Stand Alone Cervical IBF Device
By Elizabeth Hofheinz (posted November 3, 2008)
Centinel Spine, formerly know as Raymedica and now run by industry veteran Craig Corrance, has initiated a U.S. Alpha Site evaluation of the STALIF C™ NO PROFILE™ Stand Alone Cervical IBF device for single-level use in the treatment of cervical degenerative disc disease.

Cartilage Generation, A Pig’s Disc and ISTO's NuQu™
By Walter Eisner (posted November 3, 2008)
ISTO Technologies had good news to report at the NASS meeting this year on pre-clinical studies on its NuQu™ injectable cell-based therapy for spinal disc repair. Scientists at the University of California San Francisco (UCSF) Department of Orthopedics removed the disc nucleus from an adult pig and replaced it with juvenile chondrocytes in a protein gel carrier.

Medtronic Launches PEEK Version of X-Stop®
By Walter Eisner (posted October 30, 2008)
As promised by Medtronic senior management during their last quarterly call with analysts, the company’s Spinal and Biologic’s division used the recent NASS meeting in Toronto to launch a PEEK version of its X-Stop® system. Management had acknowledged some softening of the system’s sales.

Pioneer Surgical/Yuan Bring New Technology to China
By Walter Eisner (posted October 23, 2008)
Pioneer Surgical continues to make an impression in China. On October 16, the company announced that Hansen Yuan, M.D., performed the first successful human implantations of the company's new biologic interbody spacer at hospitals in China.

Amedica Receives FDA Cervical Plate Clearance
By Walter Eisner (posted October 23, 2008)
Amedica Corporation's SEEplate™ Cervical plate system has received 510(k) clearance from the FDA.

The Elderly Spine Patient: 54 Million Reasons This Market Will Boom
By Matt Menze (posted October 21, 2008)
“Surf’s up! An industry-wide wave is rising. Catch it and don’t get left on the beach. Below is our forecast of procedure volumes through 2009 for elderly spine patients. Read on.

Alphatec Increases Sales Forecast
By Robin Young (posted October 16, 2008)
First, CEO Dirk Kuyper announced that sales growth last quarter tracked at around 27% year-over-year—better than his analysts expected—then he raised the ante further by saying that sales for the full year will likely reach $100 million.

Facet Solutions Completes Facet Joint and Disc Replacement Study
By Elizabeth Hofheinz (posted October 15, 2008)
Facet Solutions, Inc. has announced the successful completion of a scientific evaluation for a total joint reconstruction in the lumbar spine.

Archus Performs First Facet Replacement With Artificial Disc
By Elizabeth Hofheinz (posted October 13, 2008)
Archus Orthopedics, Inc. has announced the first human use of its facet replacement technology to complement an artificial disc.

Novel, Novel® Cervical Implant From Alphatec
By Robin Young (posted October 10, 2008)
Check out this novel implant for the aging neck—the just cleared Novel® Cervical Interbody implant. It’s the latest product from Alphatec Spine's growing pipeline of products to address disorders affecting the cervical spine.

Pioneer Raises $15 Million for NuBac IDE Study
Pioneer Surgical is getting a helping hand from the State of Michigan. The Upper Peninsula device company has raised $15 million in new investments to pay for an FDA pivotal study for its NuBac nucleus replacement device.

FDA Holiday Present for ReGen Biologics
Merry Christmas, Happy Hanukah and Happy New Year ReGen Biologics shareholders. We’ll also throw in a Happy Kwanzaa and Solstice for good measure. ReGen needs all the friends it can get.

Synovial Celebration: MabThera Inhibits Joint Destruction in RA
Hope flowing from the lab…MabThera. Roche is announcing today that MabThera (rituximab) has been shown to significantly inhibit structural damage to joints in patients with early rheumatoid arthritis (RA) who have not been treated with methotrexate (MTX), the current standard of care for RA treatment.

Canadians Receive $1.3 Million for Engineering
Taking a bite out of arthritis, osteoporosis, etc…Dr. Douglas Hamilton, a dental researcher with the University of Western Ontario, has received substantial funding from The Canadian Foundation for Innovation (CFI) to engineer stronger bone and cartilage tissue to treat patients with traumatic injuries or bone disease.

Congressional Healthcare Reform: Irresistible Forces and Immovable Objects
Those who believe that Congress will move quickly and dramatically during the first days of the Obama Administration on comprehensive national healthcare reform got a cold shower on December 19.

Study: Pycnogenol® Reduces Marker in OA
Another reason to make a pilgrimage to France…Horphag Research Ltd. is announcing that the third osteoarthritis (OA) study this year is showing that Pycnogenol® lowers the inflammatory marker C-reactive protein (CRP).

Daschle Will Lead Health Care Reform for Obama
Former Senate Majority Leader Tom Daschle of South Dakota will be the country's new health care czar. He’ll be health care czar who has written that “doctors and patients might resent any encroachment on their ability to choose certain treatments, even if they are expensive or ineffective compared to the alternatives.”

Medtronic’s Excellent China Spine Adventure
Medtronic's toe in China just got a little wetter. The company announced on December 18th that it had completed its equity investment in China's Weigao Group Medical Polymer Company Limited.

Baring the Medical Soul: Disclosure Summit
The first annual summit on disclosure, transparency and aggregate spend for drug, device and biotech companies will be held March 5 and 6, 2009 at the Renaissance Washington D.C. Hotel…and now they are announcing the keynote faculty, agenda and Disclosure Training Program.

Centinel Spine Continues Transformation
Centinel Spine, the descendant of Raymedica, continues to morph into its new form. On December 16, Centinel Spine announced that the company was on track to see increased revenue by early 2009 due to having secured exclusive distribution rights to market STALIF TT™ (Stand Alone Lumbar Interbody Fusion) products for the entire globe.

Orthofix Defends Itself and Dumps Debt
As Orthofix fights off a hedge fund threatening to board its corporate ship, the company announced that it was going to dump some ballast by paying off some debt early.

New AAOS Guideline for Knee OA
Before you cut…AAOS is announcing the release of an evidence-based clinical practice guideline on “Treatment of Osteoarthritis of the Knee,” a protocol that was explicitly developed to include only treatments which are less invasive than knee replacement surgery.

Nose to Bones: Tentative FDA Nod for Osteoporosis Spray
MDRNA, Inc., a company focused on products based on RNA interference (RNAi), has announced that the FDA has granted tentative approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis.

Cool Discovery: New Genetic Info on Low BMD
Icelandic researchers from deCODE genetics, along with colleagues from Australia and Denmark are reporting the discovery of common single-letter variations (SNPs) in the human genome linked to low bone mineral density (BMD).

MA Plans Bring $1.3 Billion Extra Profits to Insurers
Congress stuck another fork into the Medicare Advantage (MA) program on December 11. House Ways and Means Health Subcommittee Chair, Congressman Pete Stark of California, had requested an analysis from the Government Accountability Office (GAO) about the MA plans' profits for 2006.

Gang of Four Named To Challenge Orthofix Directors
We recently reported that hedge fund Ramius LLC was threatening to call a special meeting of Orthofix shareholders. At the meeting, if called, they would vote to throw four of ten current Orthofix board members overboard and replace them with Ramius' own slate of candidates.

Direct Hit: BioMimetic Achieves Enrollment Target
BioMimetic Therapeutics, Inc. has announced that the company has completed the enrollment of 396 patients in its North American pivotal clinical study for its lead orthopedic product candidate Augment™ Bone Graft. The study is designed to assess the safety and efficacy of Augment for the treatment of hindfoot and ankle fusions as compared to autograft.

U.S. Army Aiming for ‘Disruptive Technologies’
Who knew there was a U.S. Army Science Conference?  In the shadow of Disneyworld no less. But, sure enough, it does exist and this past week a number of cool, futuristic, and potentially “disruptive” medical technologies were on display at the U.S. Army Science Conference in Orlando, Florida.

People in the News

Dr. Andrew Lynn Garners Entrepreneurial Award

Dr. Richard D. Scott Joins ConforMIS Board

Pete Wehrly Lands at Medingo

Upcoming Conferences

5th Annual Emerging Technologies Spine Education Summit
February 4 - 7, 2009 – Steamboat Springs, Colorado

4th Annual Stem Cell Summit
February 17, 2009 – New York

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