BioSET Starts Bone Graft Trials
By Elizabeth Hofheinz (posted December 11, 2008)
BioSurface Engineering Technologies, Inc.[BioSET], a privately held company developing synthetic peptide growth factor mimetics for advanced tissue repair, is reporting that two pilot clinical trials, one in the U.S. and one in Canada, have been initiated with the company’s AMPLEX osteo-promotive bone graft system.

Potent Patent: BioMimetic Celebrates Rights to PDGF
By Elizabeth Hofheinz (posted November 28, 2008)
BioMimetic Therapeutics, Inc. is announcing that the U.S. Patent Office has allowed the company’s U.S. patent application No. 11/159,533 titled “Platelet-Derived Growth Factor Compositions and Methods of Use Thereof.”

Evo3™ -- High Tech Bone Fill From Integra
By Robin Young (posted November 12, 2008)
Evo3™ is, get ready, a poloxamer Reverse Phase Medium, thermo-reversible carrier for bone void fill. What does that mean? It means that this bone void fill thickens at body temperature but becomes more flowable at the lower room temperature.

A Marriage of Cells…Orthomimetics Gets Grant for Tissue Regeneration
By Elizabeth Hofheinz (posted October 29, 2008)
The U.K. government has yet again stepped forward to further the development of Orthomimetics (OM), the Cambridge-based medical device company.

Goin’ to Carolina: S&N to Locate Biologics in Durham
By Elizabeth Hofheinz (posted October 24, 2008)
A recent article in the Triangle Business Journal discusses Smith & Nephew’s decision to locate its base of operations in Durham, North Carolina, for a new line of biologic therapies and spine products.

Pioneer’s Bone Graft Substitute Released at NASS
By Walter Eisner (posted October 23, 2008)
Pioneer Surgical released its FortrOss™ bone graft substitute at the recent NASS meeting in Toronto.

The Tissue Issue: Safety When Using Bone and Allograft
By Elizabeth Hofheinz (posted October 20, 2008)
A new review article published in the October 2008 issue of the Journal of the American Academy of Orthopaedic Surgeons says that while improvements in allograft safety have been made, there is still work to be done.

Orthobiologic ProFUSE Scaffold Launched at Alphatec
By Walter Eisner (posted October 13, 2008)
Staking its flag in the ground of an expected $2.1 billion U.S. orthopedic biomaterial market, Alphatec has launched it ProFUSE demineralized bone scaffold. The scaffold is a porous, malleable allograft that can be used with Alphatec Spine's Novel® Spacers and AlphaGRAFT™ structural allografts.

Collagen + Ceramic in a Bone Graft?
By Robin Young (posted October 10, 2008)
That’s new. Novation apparently agrees and has signed a deal with supplier Integra LifeSciences Holdings Corp. to supply the osteoconductive scaffold, named Mozaik®, to its massive network of hospitals in the VHA, UHC, and Provista systems (total of 14,500 members) for a period of three years.

Stem Cells in Orthopedics
By Robin Young (posted September 29, 2008)
By this time next year 50,000 orthopedic patients will likely have received allograft or autologous concentrated stem cells to augment spine fusion or fracture healing. What are these cells? What is their mechanism of action? How safe are they? Here’s our take.

As You Were: No Changes for BioMimetic’s Trial
By Elizabeth Hofheinz (posted September 26, 2008)
BioMimetic Therapeutics has announced that the independent Data Monitoring Committee (DMC) overseeing its U.S. pivotal trial evaluating Augment™ Bone Graft for foot and ankle fusions has recommended that the company’s trial proceed unchanged.

The Craft of Bone Graft: Orthovita’s New VITOSS
By Elizabeth Hofheinz (posted September 24, 2008)
Comfortable in the fingers and speedy on the healing…Orthovita has announced VITOSS® Bioactive Foam Pack as the newest addition to its bone graft substitute product line.

Stem Cell for Treating Spinal Cord Injuries
By Robin Young (posted September 22, 2008)
Two teams of researchers—Chris Proschel, Ph.D., Margot Mayer-Proschel, Ph.D., and Mark Noble, Ph.D from the University of Rochester Medical Center in Rochester, New York, and Stephen Davies, Ph.D. and Jeannette Davies, Ph.D of the University of Colorado Denver School of Medicine—have published key studies on the use of stem cells for spinal cord injury treatment.

Glue vs. Nature
By Robin Young (posted September 22, 2008)
Which is stronger, the natural strength of periosteum attached to bone or the strength of CryoLife’s BioGlue® to hold periosteum to bone? Test results—as published in Arch Facial Plast Surg. 2008;10(5):316-320—say that the two are equal.

Stem Cell Pioneer, Aastrom Biosciences, Strong Clinical Data and $22 Million in the Bank
By Robin Young (posted September 4, 2008)
Aastrom Biosciences reported negligible sales but strong clinical data and, perhaps most importantly, cash in the bank, for the first half of 2008.

The Future Is Happening Now in Bone Biomaterials
By Robin Young (posted August 7, 2008)
For smaller bone defects composite graft therapies utilize cellular bone marrow aspirates, concentrating the colony forming units. These cellular components are then combined with BMP cocktails, and conductive substrates which offer the surgeon a powerful bone graft tool.

Heard the One About the 200-Year-Old Man?
By Robin Young (posted August 4, 2008)
Dr. Aubrey de Grey is the director of the Methuselah foundation—an organization dedicated to extending the life span of humans. In other words, he’s a philosopher. Recently he spun an interesting tale at a conference hosted by UCLA about the promise of existing technologies to delay the inevitable—no, not taxes, the other thing—death.

Engineering an Unfair Advantage
By Robin Young (posted July 24, 2008)
After $1.2 billion in equity capital, what did the tissue engineering pioneers accomplish between 1990 and 2000? For one thing, LifeCell, Integra and Osiris. For another, a generation of wiser, tougher managers who are targeting the big orthopedic markets. Now all they ask for is an unfair advantage. Are the big guys ready?

Going to the Head of the Class: Biocomposites Releases geneX® Putty
By Elizabeth Hofheinz (posted July 23, 2008)
Biocomposites, a company headquartered in the U.K., has announced that its bone graft substitute, geneX® putty, has received FDA 510(k) clearance. geneX is a resorbable bone graft material manufactured through a proprietary process that confers the product with a reproducible negative surface charge.

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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