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Orthopedic and Dental Industry News Complete Archive »

BioMimetic Therapeutics

Wright Medical to Acquire BioMimetic Therapeutics BY ANDREW VAHRADIAN, NOVEMBER 19, 2012

Wright Medical announced that it reached an agreement with BioMimetic Therapeutics to combine the businesses, in which it will potentially pay up to $380 million, or $12.97 per share, for BioMimetic in cash and stock, implying a premium range of... more

Musculoskeletal News Roundup 12-Jul-12 BY EDITOR, JULY 12, 2012

MAKO pre-announces ... Blue Belt's first surgery... CartiHeal raised $10M... Cleveland Clinic receives OREF grant... Stryker voluntary recall... more more

BMTI's Positive Canadian Augment Data BY LAUREN UZDIENSKI, JUNE 25, 2012

At the American Orthopaedic Foot and Ankle Society annual meeting last week, BioMimetic Therapeutics noted positive results from an Augment Injectable Bone Graft registration study, conducted in Canada on foot and ankle fusion cases. The study, which will support a Canadian Device License application, met its primary endpoint of non-inferiority of AIBG to autograft as assessed by CT scan at six months. more

Musculoskeletal News Roundup 10-May-12 BY LAUREN UZDIENSKI, MAY 10, 2012

ATEC, ANIK, BMTI, MAKO, TRNX, TSON report 1Q ... OrthoSensor raises $15M ... Internal Fixation Systems announces distribution agreement with Intelligent Orthopaedics ... Seikagaku announces marketing agreement with Kaken for lumbar disc herniation treatment ... Bioventus officially launched more

Musculoskeletal News Roundup 15-Mar-12 BY LAUREN UZDIENSKI, MARCH 15, 2012

BMTI reports 4Q11 ... Interventional Spine to present PerX360 System at ISASS ... DFINE announces first implantation of STAR System ... Simpirica Spine receives FDA approval for pivotal study ... Mazor Robotics signs distribution agreement for China more

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Product launches from AAOS ... Nobel Biocare announces 4Q ... Hospitals settle Medicare fraud claims over kyphoplasty billing ... Updates on the American Joint Replacement Registry ... Stryker announces inventory management system rollout more

Musculoskeletal News Roundup 5-Jan-12 BY LAUREN UZDIENSKI, JANUARY 5, 2012

IART pre-announces . . . China Kanghui subsidiary receives FDA clearance for hip and knee systems . . . first procedure performed with Ellipse Technologies device . . . Pioneer Surgical announces first clinical use of nanOss Bioactive 3D . . . Wright Medical launches ORTHOLOC 3Di Ankle Fracture System and the QUICKDRAW Knotless Soft Tissue Fixation System . . . Globus appoints SVP and CFO . . . Vexim appoints CEO more

FDA Requests More Info from BMTI BY LAUREN UZDIENSKI, JANUARY 4, 2012

Seven months after an FDA panel issued a tentative positive recommendation for approval for BioMimetic Therapeutics' Augment, the FDA has followed up with a request for more information on the bone graft substitute. more

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

KNSY, JNJ, Medicrea, SYK, SYST announce 3Q . . . BMTI receives Australian approval for Augment . . . FDA clears Medtronic's Aquamantys3 System . . . K2M launches RAVINE Lateral Access System . . . Medicrea highlights six products at Eurospine . . . Globus to fund MIS spine outcomes registry . . . Zimmer to distribute Benvenue's Kiva . . . Lanx creates Surgeon Advisory Board more

BMTI Hits New 52-Week Low BY LAUREN UZDIENSKI, JUNE 9, 2011

BioMimetic Therapeutics announced on Tuesday that they've completed enrollment in their Augment Rotator Cuff Graft pilot study, and they've also been granted some additional patent protection for Augment through 2029. Despite this news, the stock sank to a new 52-week low. more

Musculoskeletal News Roundup 9-Jun-11 BY LAUREN UZDIENSKI, JUNE 9, 2011

Brainlab to acquire Voyant Health . . . FDA clears ARTC's Spartan 6.5 Needled Anchor . . . Mazor Robotics launches next-gen Renaissance system . . . DFINE comments on VCF study results . . . Senators request investigation of PODs . . . Arteriocyte announces army stem-cell research project more

FDA Panel Narrowly Votes in Favor of BMTI's Augment BY LAUREN UZDIENSKI, MAY 12, 2011

It's been a roller coaster week for BioMimetic Therapeutics, with the stock dipping to a new 52-week low on Tuesday in response to an FDA summary of their Augment pivotal study. However, the week should end on a more positive note for the company, who received a cautious recommendation from a CDRH panel in favor of approval of Augment. more

Musculoskeletal News Roundup 12-May-11 BY LAUREN UZDIENSKI, MAY 12, 2011

DJO, Tornier, TSON announce earnings . . . OsteoGeneX receives grant funds . . . BMTI introduces new Augment kit size in Canada . . . Wright Medical commences full commercial launch of the INBONE II Total Ankle . . . Orthovita notes positive vertebroplasty coverage decision . . . RTI Biologics splits Chairman, CEO roles more

Ahead of Thursday's Panel, FDA Voices Augment Concerns BY LAUREN UZDIENSKI, MAY 10, 2011

BioMimetic Therapeutics is facing some turbulence heading into its FDA panel meeting this week. The stock dove over 30% this morning on concerns about the Augment IDE study, detailed in the FDA's executive summary of the Augment PMA. more

Musculoskeletal News Roundup 9-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 9, 2010

Amedica raises $30M . . . BioMimetic affirms Augment PMA timeline . . . Aesculap, K2M announce 510(k) clearances . . . BMTI and Eden Spine announce U.S. and EU patents . . . Tornier announces early clinical results more

BioMimetic Therapeutics Receives Orphan Drug Designation for PDGF Treatment of Osteochondritis Dissecans BY LAUREN UZDIENSKI, AUGUST 12, 2010

BioMimetic Therapeutics announced this morning that it has received orphan drug designation from the FDA for their PDGF technology in the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle. Similar to an HDE designation for devices, orphan drugs address conditions affecting less than 200,000 people in the United States. more

Musculoskeletal News Roundup 5-Aug-10 BY LAUREN UZDIENSKI, AUGUST 5, 2010

ATEC, ARTC, BMTI, DJO, EXAC, MAKO, VITA, RTIX, SNN, SMA, TSON, WMGI report 2Q:10 . . . Bacterin closes private placement . . . Wright Medical launches the EVOLUTION Medial-Pivot Knee . . . VertiFlex enrolls 150th patient in their IDE study more

BioMimetic Hiring a Sales Force for Augment BY LAUREN UZDIENSKI, JUNE 2, 2010

BMTI.pngBioMimetic plans to launch Augment in the U.S. with a mix of 100 independent and direct sales reps, whom they say will cover about 75% of all U.S. foot and ankle procedures. The company intends to increase their sales force to 150 to 200 reps within two to three years of Augment's launch. Internationally, the company will set up independent distributors or partners in Europe and Australia and has a partnership in place in Canada. more

Musculoskeletal News Roundup 13-May-2010 BY LAUREN UZDIENSKI, MAY 13, 2010

aap Implantate, ATEC, ANIK, BMTI, OSTE report Q1 earnings . . . SBi announces Olympus investment . . . Aesculap launches pedicle screw system . . . data on B Braun's Targon screw . . . BioSyntech files for bankruptcy more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

OR_small.jpg The latest news from AAOS! VITA and MAKO report 4Q09 . . . ETEX receives 510(k) . . . DePuy, Integra, Medtronic, Smith & Nephew and more announce product launches . . . SEC Drops Wright Medical Investigation . . . BioMimetic Therapeutics shares study results . . . Long-term use of bisphosphonates may increase fracture risk . . . NeoStem wins research grant more

Musculoskeletal News Roundup 18-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 18, 2010

Earnings DJO reported 4Q:09 revenues of $257.2 million, up 5% over 4Q:08, with domestic rehab sales up 3% and domestic surgical implant sales up 8%. The company attributed the latter largely to "strong sales of our Reverse Shoulder Prosthesis." Net... more

Musculoskeletal News Roundup 4-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 4, 2010

Earnings CONMED reported 4Q:09 sales of $190.6 million, up 3% over the year-ago period and beating estimates by $6.0 million. Arthroscopy sales rose 3% to $75.7 million. All growth rates exclude the effects of currency. 4Q:09 EPS of $0.37 beat... more

Musculoskeletal News Roundup 7-Jan-10 BY LAUREN UZDIENSKI, JANUARY 7, 2010

Earnings Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally,... more

Musculoskeletal News Roundup 17-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 17, 2009

M&A Alphatec Holdings, Inc. announced 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... more

Musculoskeletal News Roundup 5-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 5, 2009

Earnings aap Implantate reported nine-month revenue of EUR 25.6 million ($37.4 million), which represents a 6% increase over the year-ago period. The company said third-quarter highlights included the signing of several IP agreements that emphasize orthopedics, trauma ad spine. Artimplant... more

BMTI Study Shows Non-Inferiority for Augment Bone Graft BY LAUREN UZDIENSKI, OCTOBER 14, 2009

Yesterday BioMimetic Therapeutics released positive results from its North American pivotal study of Augment bone graft, the company's fully-synthetic, PDGF-derived PMA candidate. On a modified intent-to-treat basis, Augment achieved its primary endpoint of non-inferiority to autograft in attaining foot and... more

Musculoskeletal News Roundup 13-Aug-09 BY LAUREN UZDIENSKI, AUGUST 13, 2009

Earnings BioMimetic Therapeutics reported 2Q:09 royalty and sublicense revenue of $0.4 million, missing estimates by $0.1 million. The company reported a net loss of $6.3 million, or $0.32 per share, beating estimates by $0.17. Among the highlights for the quarter... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI, JUNE 25, 2009

Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more

Musculoskeletal News Roundup 7-May-09 BY LAUREN UZDIENSKI, MAY 7, 2009

Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI, APRIL 9, 2009

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

Musculoskeletal News Roundup 12-Mar-09 BY LAUREN UZDIENSKI, MARCH 12, 2009

Earnings BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share.... more

Musculoskeletal News Roundup 8-Jan-09 BY LAUREN UZDIENSKI, JANUARY 8, 2009

Earnings CONMED Corp. lowered 4Q:08 revenue projections to $176-$178 million, 9% lower than forecast and approximately 7% lower than 4Q:07. Reduced revenues were attributed to unfavorable foreign currency exchange fluctuations and lower than anticipated sales of capital equipment to hospitals.... more

Musculoskeletal News Roundup 26-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 26, 2008

M&A Trading was suspended for Portland Orthopaedics on news that the company may be selling its assets. Intellectual Property BioMimetic Therapeutics has received patent No. 11/159,533 covering its PDGF technology, including Augment Bone Graft and Augment Injectable Bone Graft. The... more

Musculoskeletal News Roundup 13-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 13, 2008

Earnings aap Implantate AG reported sales for the first nine months of 2008 of EUR 24.2 million ($35.0 million), up 30% from the same period last year. The company attributed the sales growth to the Traumatology & Orthopaedics division, where... more

BioMimetics' Experience A Microcosm of Current Credit Crisis within Ortho BY DAVID KRESSEL, OCTOBER 27, 2008

This evening, BioMimetic Therapeutics (BMTI) issued a press release stating it has reached a settlement with Deutsche Bank regarding BMTI's holdings of auction-rate securities (ARS). BMTI told investors on its 2Q08 conference call that it had approximately $60 million of... more

Musculoskeletal News Roundup 25-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 25, 2008

Funding Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the... more

Musculoskeletal News Roundup 14-Aug-08 BY LAUREN UZDIENSKI, AUGUST 14, 2008

Earnings BioMimetic Therapeutics reported a 2Q:08 net loss of $9.2 million, or $0.50 per diluted share, widening from a net loss of $6.4 million, or $0.35 per diluted share, in 2Q:07. Clinical highlights for the quarter include the announcement of... more

Musculoskeletal News Roundup 26-Jun-08 BY LAUREN UZDIENSKI, JUNE 27, 2008

Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more

Musculoskeletal News Roundup 8-May-08 BY LAUREN UZDIENSKI, MAY 8, 2008

Earnings Artimplant announced 1Q:08 revenues of SEK 2.1 million ($0.35 million), down from SEK 3.9 million ($0.66 million) in 1Q:07. Net loss for the quarter was SEK 6.2 million ($1.04 million), or SEK 10 ($1.68) per share, a deterioration from... more

Musculoskeletal News Roundup 24-Apr-08 BY LAUREN UZDIENSKI, APRIL 24, 2008

Earnings Alphatec Holdings reported consolidated revenues for 1Q:08 of $23.2 million, an increase of 19% from the year-ago period. U.S. revenues for the first quarter of 2008 were $18.6 million, an increase of 12% from the year-ago period. Asia revenues... more

BioMimetic's GEM OS1 Study Can Proceed as Planned BY LAUREN UZDIENSKI, APRIL 22, 2008

In an "unusual and positive" move, the FDA has sent BioMimetic Therapeutics a letter confirming that the company's GEM OS1 IDE study can proceed as planned. This news comes three weeks after an FDA communication to J&J regarding an increase... more

BioMimetic Dives on FDA Communication to J&J BY DAVID KRESSEL, APRIL 2, 2008

BioMimetic Therapeutics' shares dove sharply last week (and recovered somewhat less sharply) because the FDA raised the possibility that the active ingredient of all of the company's products, PDGF (Platelet-Derived Growth Factor), caused cancer. From Thursday's intraday high price per... more

Musculoskeletal News Roundup 13-Mar-2008 BY LAUREN UZDIENSKI, MARCH 13, 2008

Earnings BioMimetic Therapeutics reported 4Q:07 revenues of $4.5 million, up from $1.9 million in 4Q:06 but missing analysts' estimates by $1.1 million. Revenues included $3.6 million of product sales of GEM 21S to Luitpold, $0.7 million of royalty income and... more

Musculoskeletal News Roundup 20-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 20, 2007

M&A BioMimetic announced the impending sale of its dental business and GEM 21S product to Luitpold Pharmaceuticals. Luitpold, who has been distributing the product since 2003, will pay BioMimetic $40.0 million in addition to ongoing royalty and milestone payments. The... more

BioMimetic Sells Dental Business, Reports Positive GEM OS®1 Data BY LAUREN UZDIENSKI, DECEMBER 18, 2007

There were two big announcements from BioMimetic Therapeutics this week, the first being an announcement that came yesterday on the impending sale of the dental business and the GEM 21S product to Luitpold Pharmaceuticals, which currently markets GEM 21S. BioMimetic... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 1, 2007

Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more

Musculoskeletal News Roundup 16-Aug-07 BY LAUREN UZDIENSKI, AUGUST 16, 2007

Earnings BioMimetic Therapeutics reported a 2Q:07 net loss of $6.4 million, or $(0.35) per share, beating estimates of $(0.39) per share and improving from a net loss of $3.9 million, or $(0.42) per share, in 2Q:06. 2Q:07 Revenues were $0.5... more

Musculoskeletal News Roundup 19-July-07 BY LAUREN UZDIENSKI, JULY 19, 2007

M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more

Encouraging Data for GEM OS1 BY LAUREN UZDIENSKI, JULY 19, 2007

At the AOFAS meeting last week, BioMimetic Therapeutics reported further positive interim data from its ongoing clinical trials of GEM OS1 in foot and ankle fusion indications. The U.S. arm of the study is a randomized, prospective, controlled pilot study... more

Orthopedic News Roundup 15-May-07 BY LAUREN UZDIENSKI, MAY 16, 2007

Earnings BioMimetic Therapeutics reported a 1Q:07 net loss of $5.7 million or $(0.34) per share, beating estimates of $(0.37) and comparing to a net loss of $3.8 million, or $(2.22) per share, in 1Q:06. The company reported revenues of $0.25... more

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI, MARCH 29, 2007

Earnings BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82... more

Orthopedic News Roundup 14-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 14, 2006

Regulatory CryoLife received FDA 510(k) clearance for its ProPatch™ Soft Tissue Repair Matrix, an announcement that drove its stock up 9%. Among other applications, ProPatch can be used to reinforce tissues repaired by sutures or by suture anchors during tendon... more

Orthopedics News Roundup 9-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 10, 2006

Earnings: Tissue Grafting: Regeneration Technologies, Inc. announced revenues of $18.1 million for 3Q:06, compared to $22.5 million for 3Q:05. RTI said the decrease in revenues was due to fewer tissues available for processing demand and reduced orders from primary distributors.... more

BioMimetic Therapeutics Releases Promising GEM OS1 Orthopedic Data BY ARIELLA P. GOLOMB, MD, NOVEMBER 8, 2006

GEM OS1 is BioMimetic Therapeutics' developmental product for open fracture reduction or fractures requiring surgery in orthopedic applications. The therapy consists of both particulate Beta-tricalcium phosphate (β-TCP) with recombinant human Platelet-Derived Growth Factor (rhPDGF-ββ). BioMimetic has a similar, already-marketed product,... more

Orthopedic News Roundup 19-Oct-06 BY HUYEN NGUYEN, OCTOBER 19, 2006

Earnings Dental: Lifecore Biomedical announced that 1Q:07 net sales increased 12% to $15 million. Net income for the quarter was $1.1 million, representing a year-over-year increase of 9%. The Company was in-line with analysts' estimates and reported earnings of $0.08... more

BioMimetics' Data Impresses BY DAVID KRESSEL, SEPTEMBER 19, 2006

Dr. William Giannobile, a professor of dentistry at the University of Michigan, presented new data on BioMimetics' only approved product, GEM21S, at the American Academy of Periodontology meeting in San Diego yesterday. GEM21S is short for "Growth-factor Enhanced Matrix," a... more


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