Cleveland Clinic and Rutgers University Create Institute for Wounded Soldiers
By Elizabeth Hofheinz (posted April 22, 2008)
According to WKYC-TV in Cleveland, Ohio, (“Cleveland Clinic to lead institute for war wounded,” Monica Robins, April 17, 2008) The Cleveland Clinic and Rutgers University have developed a new facility, the Armed Forces Institute of Regenerative Medicine (AFIRM), which will develop innovative medical therapies for the treatment of wounded soldiers.

Tornier Lands a Deal for LifeCell’s Strattice™ ne: Conexa™
By Robin Young (posted April 7, 2008)
Tornier (pronounced ‘Torneay’) is the French extremity company that has been reborn as a Minnesota-based extremity growth company. It announced last week that it had signed a key agreement with biologic powerhouse LifeCell for that firm’s new porcine-based soft tissue matrix, Conexa™.

FDA OKs Osteotech’s Plexur M™
By Robin Young (posted March 26, 2008)
Earlier this month (March) the FDA cleared Osteotech’s 510(k) submission for its Plexur M™ biocomposite bone void fill. Plexur M is a bone void fill unlike, really, any other.

Integra Introduces Three New Lines of Bone Void Fill
By Robin Young (posted March 26, 2008)
Integra LifeSciences introduced three new lines of bone void fill. The new products are Integra OS™ Osteoconductive Scaffold and two versions of the Trel-X™ and Trel-XC™ Demineralized Bone Matrix.

Harvest Technologies Starts Enrollment for Critical Limb Ischemia (CLI) Clinical Trial
By Robin Young (posted March 24, 2008)
Harvest Technologies has begun enrolling patients in Chennai, India, for a 60-patient clinical trial using the company’s BMAC™ System to treat patients with non-reconstructible Critical Limb Ischemia.

Osteotech Adds Bone Marrow Concentrate System to Product Line
By Robin Young (posted March 24, 2008)
Osteotech has agreed to become the exclusive U.S. distributor for Harvest Technologies’ Bone Marrow Aspirate Concentrate (BMAC™) System. The system is essentially a concentrator and, if successful, it will add a high concentration of progenitor cells, growth factors, and platelets.

Biomet to Market BHS-Mini™ Stimulator
By Elizabeth Hofheinz (posted March 21, 2008)
They could call it the vibratabone…or the ossostim. But alas, they have come up with a better name…it’s the BHS-Mini™ stimulator. Biomet, Inc. announced that the Biomet Osteobiologics business unit of its EBI, LLC subsidiary has received approval from the FDA to market its latest design in bone healing systems, the Biomet™ BHS-Mini™ stimulator.

Exactech Signs License Agreement for Cartilage Repair Technology, Patent Rights
By Elizabeth Hofheinz (posted March 13, 2008)
Exactech, Inc. has announced that its Taiwanese subsidiary, Exactech Taiwan, has entered into an exclusive license agreement with the Industrial Technology Research Institute (ITRI) and the National Taiwan University Hospital (NTUH) for the rights to technology and patents related to the repair of cartilage lesions.

Key PEEK-on-PEEK Wear Study Results Released
By Robin Young (posted March 6, 2008)
Researchers from Rush University in Chicago released the results of accelerated wear testing of articulating materials made from PEEK (Poly-ether-ether-ketone) polymer. PEEK is an increasingly popular implant in spine surgery.

Unigene Reports Publication of Initial Results of Site-Directed Bone Growth Studies
By Elizabeth Hofheinz (posted February 15, 2008)
Biopharmaceutical company Unigene Laboratories, Inc. is announcing the publication of results of animal studies confirming the ability of its novel technology to rapidly form and maintain natural bone growth at targeted locations.

Tornier and BioSET Collaborate to Repair Tendons and Ligaments
By Walter Eisner (posted February 10, 2008)
Edina, Minnesota-based Tornier has entered into an exclusive worldwide technology collaboration with BioSurface Engineering Technologies (BioSET, based in College Park, Maryland).

Biggest Order Ever for a Stem Cell Product
By Robin Young (posted January 15, 2008)
To load $224.7 million of stem cell products, more than one semi-tractor trailer will have to back up to the loading dock on Aliceanna Street in Baltimore, Maryland. Last week the Department of Defense issued a landmark purchase order for stem cell products. The business of stem cells is gaining momentum. The implications are huge. Read on.

Scientific American Bestows Award on UVA Stem Cell Researcher
By Robin Young (posted January 14, 2008)
Dr. Cato Laurencin, whose work with stem cells in musculoskeletal tissue regeneration was the subject of a 2007 paper describing the creation of an anterior cruciate ligament using adult stem cells that was published in the proceedings of the National Academy of Sciences, was selected last week by Scientific American as one of 50 people or teams shaping new and old technologies.

Stem Cells Beat HA for Knee Pain Relief—Updated Chondrogen™ Results
By Robin Young (posted January 8, 2008)
New one-year data shows that a single, direct injection of Mesenchemal Stem Cells (MSC) beats multiple injections of hyaluronic acid (HA). Beyond pain relieve, the study also delivered evidence that stem cells reduce subchrondral sclerosis and osteophyte formation in OA patients. The evidence FOR stem cells keeps piling up.

Stryker Acquires BMP-7 Technologies From Curis
By Walter Eisner (posted January 4, 2008)
Stryker has acquired Curis, Inc.'s bone morphogenetic BMP-7 technologies for $1 million. In addition to the initial payment, Stryker has agreed to make cash payments to Curis upon the successful achievement of specified clinical development and drug approval objectives.

Preview of LifeCell’s New Soft Tissue Implant
By Robin Young (posted January 3, 2008)
LifeCell Corporation, which has built a billion-dollar business on a single soft tissue product, AlloDerm®, is poised to launch what may well be the successor product to AlloDerm—Strattice™. Just before 2007 ended, analysts at Bank of America wrote a research note calling attention to a new soft tissue product set to be launched by LifeCell in 2008.

Milestones on the Road to Stem Cell Therapies
By Robin Young (posted January 3, 2008)
One of the more persistent questions we hear regarding the use of adult stem cells in therapeutic applications concerns the number of stem cells available for therapeutic application.

AxoGen™ Receives $12.1 Million in Venture Capital Funding
By Robin Young (posted December 13, 2007)
One of our favorite young/old biologic companies has just received a well-deserved influx of new capital. AxoGen, founded by allograft industry maven and serial innovator Jamie Grooms, announced last week that it had received $12.1 million in new equity funding from a strong group of investors including Accuitive Medical Ventures, Cardinal Partners, DeNovo Ventures, and Springboard Capital II.

Scient'x Doubles 510(k) Clearance With DUO™ Dynamic Stabilization System
First there was one level...now there are two. Scient'x announced on May 6 that it had received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System.

Alphatec Ponies Up $11 Million Settlement for ‘678 Patent
"Alphatec can now achieve some certainty." That's what Alphatec's President and CEO, Dirk Kuyper, told us at the SAS annual meeting in Miami Beach. He was referring to his company's announcement that its 2006 lawsuit with Biedermann and DePuy over the ‘678 pedicle screw patent is settled.

Abbott Spine’s Universal Clamp™ Now Available Stateside
The Universal Clamp™ spinal fixation system, developed by Abbott Spine, may now be enjoyed by Americans. The implant, which has been available in Europe for over a year, can be used to correct a wide variety of complex spinal pathologies including sagittal and coronal malalignment, as well as degenerative conditions of the thoracolumbar spine.

Facet Solutions, Inc. Completes Combination Facet Joint and Disc Replacement Study
It’s the motion in Miami…Facet Solutions, Inc. is announcing the successful completion of a scientific evaluation for a total joint reconstruction in the lumbar spine. The study evaluated the combination of Facet Solutions’ Anatomic Facet Replacement System (AFRS™) with a semi-constrained disc replacement device in a finite element model.

Biologic Bummer for Stryker in Beantown
Stryker's stock stopped trading for 16 minutes before resuming on Friday, May 2. The reason was because Stryker was about to announce that its Biotech division, in the Boston suburb of Hopkinton, had received a warning letter from the U.S. Food and Drug Administration (FDA) related to quality systems and compliance issues.

MAKO’s Robot Zaps 1st Quarter Expectations
MAKO Surgical Corp. reported 2008 first quarter revenues of $500,000. Analysts had expected revenues of only $300,000. The company markets its Tactile Guidance System™ (TGS™), an advanced robotic-arm solution, and its implants for minimally invasive orthopedic knee procedures, known as MAKOplasty®.

Shake Up at Medtronic Sofamor Danek
We were frankly surprised as were many people both inside and outside the company to hear of Pete Wehrly’s sudden departure from Medtronic Sofamor Danek day before yesterday. Mr. Wehrly, 49, was the President of Medtronic Sofamor Danek and the abruptness of his departure followed by Medtronic’s extreme caution in commenting adds additional mystery to the circumstances of Pete’s leaving.

DePuy Puts 3 Million Sq. Ft. to Work in China
DePuy products have gone into production in Suzhou, China. Tradingmarkets.com reported on April 25 that Johnson & Johnson Medical (DePuy-Suzhou) Ltd. has started operations at its first Chinese facility to produce medical equipment in the Suzhou Industrial Park in eastern China.

Smith & Nephew Endoscopy Launches FOOTPRINT PK Suture
Just try to follow in their footsteps! Smith & Nephew's Endoscopy Division has announced the launch of the FOOTPRINT PK Suture Anchor, a system used to attach rotator cuff tissue to bone in the shoulder.

Put on Your Futuristic Headgear: Immersion Medical and GMV Sign Agreement for Reality Arthroscopy Simulation System
So much for skiddishness about minimally invasive surgery…Immersion Corporation, a touch feedback technology firm, and GMV, an engineering firm, have announced that Immersion Medical, a wholly owned subsidiary of Immersion, and GMV have signed an agreement whereby Immersion Medical will market and sell GMV's insightArthroVR® virtual reality arthroscopy surgical simulator in most countries around the world.

Zimmer Revenues On Target for First Quarter. Disappoints Investors
Zimmer reported first quarter 2008 revenues (constant currency) on April 24. Total Revenues: up 6.2% to $1.06 billion. The company also announced a $1.25 billion stock repurchasing program and reaffirmed earlier guidance for the year of 6%–7% revenue growth (in constant currency).

Physician Disciplinary Actions Decline 22% Since 2004
With the current hyper-vigilant focus on surgeon and industry relationships, it begs the question: Are disciplinary actions against physicians increasing or decreasing?

Frost & Sullivan Shines Light on Raymedica
Feelin’ hot, hot, hot! Frost & Sullivan has named Raymedica, LLC, as winner of the 2008 Frost & Sullivan Hot Investment Opportunity Award.

NuVasive Revenues Break Expectations, Lukianov Waives HIPAA
The NuVasive Chairman and CEO waived all his HIPAA rights during a first quarter 2008 conference call with analysts on April 22 when asked about his own back surgery. He said he's doing very well after his two-level XLIF® procedure, thank you very much.

Good News for Lower Extremities: Archus Completes First Human Implant of TFAS-C™ System
They’ve come to a conclusion: Some patients can be done with fusion. The reconstructive implant aficionados at Archus Orthopedics, Inc. have announced the successful completion of the first human implant of their TFAS-C™ system, the newest addition to the company's product line for treating spinal stenosis.

DePuy Launches Spine System for Small-Stature Patients
DePuy Spine has launched a titanium and stainless steel hook, rod and screw system designed to treat complex spinal deformities in small-stature patients.

BoundaryMedical Inc. Launches Orthopedic Outcome Measurement Software
BoundaryMedical, Inc. may be able to streamline things. It has just introduced the new Outcome Enterprise™ Study Manager platform for measuring outcomes relating to orthopedic treatments.

People in the News

Jack Maertens Joins Theken Family of Companies as VP of Marketing

Mike McCarthy Joins Board at Facet Solutions

Patrick O’Donnell Joins Medical Capital Advisors

St. Francis Founder Joins Active Implants’ Board

Upcoming Conferences

SpineWeek
May 26 - 31, 2008 – Geneva, Switzerland

CMSA's 18th Annual Conference & Expo
June 17 - 20, 2008 – Orlando, Florida

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