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Procedure of the Month

This month's Procedure of the Month patient presented with chronic low back pain (3/10), with acute onset of right lower extremity pain (5/10). A physical exam showed weakness (4/5) of Rt. Extensor Halitus Longus, otherwise normal. X-ray images show Degenerative Disc Disease at L4/5. Provided below are two images of the patient’s lumbar spine.

Pre-op images - AP and Lateral View


Which choice do you think best describes the patient's treatment options (click on the x-rays above to take the multiple choice/guess test)?

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Procedure of the Month
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Company News

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Pioneer Raises $15 Million for NuBac IDE Study
By Walter Eisner (posted January 5, 2009)
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
By Walter Eisner (posted January 5, 2009)
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.

Medtronic’s Excellent China Spine Adventure
By Walter Eisner (posted December 19, 2008)
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.

Centinel Spine Continues Transformation
By Walter Eisner (posted December 18, 2008)
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
By Walter Eisner (posted December 18, 2008)
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.

Gang of Four Named To Challenge Orthofix Directors
By Walter Eisner (posted December 15, 2008)
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.

Veteran-Friendly Carbondale Prosthetic’s Firm Wins Award
By Robin Young (posted December 15, 2008)
U.S. military veterans from throughout southern Illinois have been making their way down Highway 51 to get to the winner of The Freedom Award for excellence in treating U.S. military veterans.

Direct Hit: BioMimetic Achieves Enrollment Target
By Elizabeth Hofheinz (posted December 15, 2008)
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.

Dodging Bullets at ArthroCare
By Robin Young (posted December 15, 2008)
NASDAQ was going to take this $350 million (revenue), $420 million market value and $40 million annual earnings company off of its listing of stocks.  Being “delisted” means that investors will have a harder time buying and selling the common stock of ArthroCare.

The Cheapest Orthopedic Company Ever
By Robin Young (posted December 9, 2008)
The market for equities has become a flea market, a thrift shop, a place where cheapskate buyers pick through piles of discarded, broken and ignored pieces of companies. Like Osteotech—the cheapest orthopedic company ever.

“Pirates” of the Caribbean Attack Orthofix
By Walter Eisner (posted December 9, 2008)
Caribbean-based Orthofix International is under threat of being boarded by hedge fund pirates who want it to toss Blackstone Medical overboard. Read about this swashbuckling drama here.

OtisMed Gets ISO 13485 Certification
By Elizabeth Hofheinz (posted December 8, 2008)
OtisMed Corp. has announced that it has cleared the ISO 13485:2003 certification hurdle for its quality management system by one of the world’s largest notified bodies, BSI Management Systems.

Stryker Offers Tritanium™ System to Patients and Dividend to Shareholders
By Walter Eisner (posted December 5, 2008)
Stryker is now making its Tritanium Primary Acetabular System widely available. On December 3, the company said that its system, was previously only available on a limited basis for revision cases due to its cost.

ReGen Biologics’ Reverse Stock Split
By Walter Eisner (posted December 5, 2008)
A couple of weeks after receiving a favorable recommendation from the FDA's Ortho panel for its collagen scaffold technology, ReGen Biologics announced on December 1 that it had executed a 1-for-20 reverse split of its common stock.

Biospace med’s EOS Tops Computed Radiography
By Elizabeth Hofheinz (posted December 3, 2008)
Biospace med is announcing positive results from a clinical study of its FDA-cleared ‘EOS’ 3D X-ray orthopedic imaging system. Conducted by a Montreal-based hospital, the study showed that the EOS ultra-low-dose orthopedic imaging system makes possible “better image quality” than CR (computed radiography) imaging while using nearly 10 times less radiation.

OrthoPediatrics Recognized by Fibrous Dysplasia Foundation
By Elizabeth Hofheinz (posted November 23, 2008)
The Fibrous Dysplasia Foundation (FDF) has presented the 2008 Constellation Award to OrthoPediatrics, Corp. (OP) of Warsaw, Indiana. for their efforts to understand and meet the needs of children with orthopedic problems.

Spine Tingling: New Contracts for Big Players
By Elizabeth Hofheinz (posted November 20, 2008)
Novation, a healthcare contracting services company of VHA Inc., University HealthSystem Consortium (UHC) and Provista, LLC, is announcing that it has awarded new spine contracts to some major players, namely, Biomet, DePuy, Medtronic, Stryker, and Synthes.

Deloitte: BioMimetic on Technology Fast 500
By Elizabeth Hofheinz (posted November 16, 2008)
Burnin’ up the balance sheets…BioMimetic Therapeutics, Inc., a company focused on developing and commercializing bio-active recombinant protein-device combination products, is announcing that it ranked number 181 on Deloitte’s 2008 Technology Fast 500, a ranking of the 500 fastest growing technology, media, telecommunications, and life sciences companies in North America.

CE Mark for Amedica's Ceramic Implant
By Walter Eisner (posted November 14, 2008)
Amedica's Valeo™ family of ceramic spinal intervertebral spacers, utilizing silicon nitride ceramic technology, has received a CE (Conformité Européene) Mark.

Blackstone Loss, Ortho Growth Highlight Orthofix Quarter
By Walter Eisner (posted November 12, 2008)
Orthofix reported a massive loss of $237 million for the third quarter due to a "hefty impairment charge" for its Blackstone unit. In a November 6 press release, excluding the inventory and reserve charge for Blackstone, the company said it earned $5.8 million for the quarter.

   

News Shorts
Complete Issue - PDF Past Issues

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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