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
M&A BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed. Funding Formae received an investment of $0.5 million from BioAdvance, the Biotechnology... more
M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more
Earnings Inion reported 2Q:08 sales of EUR 1.8 million ($2.8 million), up 34% over 2Q:07. 1H:08 sales were EUR 2.59 ($4.1 million), a 12% increase over 1H:07. Operating loss for 1H:08 was EUR 4.85 million ($7.6 million), a 20% decrease... more
A cartilage company raising venture money is a not-so-common development in the world of sports medicine. In this instance, Waltham, MA based Histogenics just announced it has raised $9 million from venture investors. Of interest, Stryker was included in the... more
Researchers at Boston's Joslin Diabetes Center have identified what could be a surprising new way to treat obesity - BMP-7, the bone growth protein familiar to the orthopedic sector as the active protein in Stryker's OP-1, may also support weight... more
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
Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more
Mesoblast announced positive results from an Australian study evaluating the use of its proprietary stem cell therapy in the treatment of non-healing long bone fractures. 10 patients with 11 fractures were enrolled in the study and received the stem cell... more
Earnings Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net... more
Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more
Earnings Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to... more
On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative Devices Panel, Oxiplex/SP was voted "Not Approvable" by a 5-2 vote, based largely on the sponsoring company's inability to definitively demonstrate product effectiveness. The two dissenters would have voted it "Approvable... more
Researchers at the Mississippi Sports Medicine and Orthopaedic Center have found a failure rate nearing 24% for ACL reconstruction in young, athletic patients, according to a new study. Of 61 patients aged 15-39 who underwent ACL reconstruction, 14 were deemed... more
A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... more
Last week the FDA released a public health notification regarding the off-label use of of rhBMP (InFuse, OP-1) in the cervical spine. The agency says that over the past four years there have been at least 38 reports of complications... more
Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more
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
China was a hot topic at the In3 Medical Device Summit, but one event focused on the device industry more broadly: where devices have been and where they're heading. The presentation, led by David Cassak of Windhover Information, described the... more
Funding Exactech received a $40.0 million syndicated line of credit which will be used to fund future acquisitions and refinance debt, among other expenses. SunTrust Bank served as lead agent with participation by Compass Bank. M&A clickNsettle announced plans... more
Having already received market approval in 49 countries, FzioMed now has its sights set on U.S. clearance for its Oxiplex/SP Gel, an adhesion barrier used in lumbar spinal surgery. The FDA announced last week that the Oxiplex technology will be... more
M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more
Earnings Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the... more
M&A Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares... more
Earnings Medtronic reported FQ4:08 revenue of $3.86 billion, representing an 18% increase over the year-ago period and beating estimates by $0.14 billion. Currency translation had a positive impact of $160.0 million. Adjusted net earnings for the quarter were $884.0 million,... more
Earnings aap Implantate AG announced 1Q:08 revenues of EUR 8.0 million ($12.64 million), up 36% over the year-ago period. The company attributed the growth to a 146% increase in sales in its Trauma & Orthopaedics division, which contributed EUR 3.7... more
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
Earnings Anika Therapeutics reported 1Q:08 total revenues of $8.55 million, an increase of 46% over the year-ago period, which the company attributed to strong domestic and international sales of ORTHOVISC. Revenues beat analysts' expectations by $0.2 million. Net income for... more
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
M&A Kinetic Concepts, Inc. announced plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading price. KCI... more
Kinetic Concepts, Inc. announced this morning its plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading... more
Earnings aap Implantate reported 2007 revenue of EUR 28.0 million ($41.24 million), an increase of 52% over 2006. Net profit for the year was EUR 1.5 million ($2.21 million), down from EUR 1.6 million ($2.36 million) in 2006, which the... more
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
Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more
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
Earnings Anika Therapeutics reported 4Q:07 product revenue of $7.9 million, in line with estimates and up from $5.08 million for the same period last year. The revenue growth was attributed to domestic and international sales of the ORTHOVISC product line,... more
This week we attended Robin Young's packed-to-the-gills Stem Cell Summit in New York along with many of the industry's leading scientists and executives. The takeaway was loud and clear: the path to commercialization of this technology is happening faster than... more
Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more
Earnings Hanger Orthopedic Group reported 4Q:07 net sales of $170.8 million, beating estimates by $7.5 million and representing an 11% over the year-ago period. Revenue growth was attributed to an increase in same-center sales from Hanger's patient care business, an... more
Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more
Earnings Biomet reported earnings for 2FQ:08 last week, with net sales up 11% to $578.1 million over the comparable quarter. Worldwide, knee sales were up 17%, and hip was up 12%. Extremity sales increased 11% and bone cements and accessories... more
Lifecore announced yesterday that it has entered into definitive documentation to be acquired by affiliates of the private equity firm Warburg Pincus for $239m, implying an enterprise value of $200m. Lifecore has two business units. One sells dental implants and... more
M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more
M&A Curis, Inc. entered into an agreement to sell and assign its remaining BMP-7 technologies to Stryker Corporation. Curis will receive an initial payment of $1.0 million as well as additional cash payments based on specified clinical, regulatory and sales... more
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
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
Earnings Tutogen reported FY07 revenues of $53.8 million, an increase of 42% over FY06. The Company reported net income of $6.8 million, or $0.36 per fully diluted share in fiscal year 2007 compared to a net loss of $0.6 million,... more
Osiris announced results from an ongoing Chrondogen study this week, with enrolled patients showing less pain and fewer degenerative bone changes when compared to patients receiving HA. Among the highlights: OA patients receiving Chondrogen experienced a statistically significant reduction in... more
Regulatory Amedica received FDA clearance for their Valeo™ Pedicle Screw system, a low profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5. Corin announced FDA clearance for additional sizes of its Cormet hip... more
Earnings Medtronic reported FQ2:08 revenue of $3.12 billion, beating estimates by $0.02 million and representing a 2% increase over the year-ago period. Net earnings for FQ2:08 were $666.0 million, or $0.58 per diluted share, beating estimates by $0.02 but down... more
Earnings Artimplant announced 3Q:07 revenue of SEK 2.6 million, up from SEK 0.9 million in the year-ago period. 3Q:07 net loss was SEK 3.6 million, down from SEK 10.4 in 3Q:06. Earnings per share, including a non-recurring item, amounted to... more
This morning Regeneration Technologies (RTI) and Tutogen announced their intent to merge. These are two of the larger players in the tissue processing business though their businesses have surprisingly little overlap. RTI has been more focused on allograft hard tissue... more
We attended the American Academy of Periodontology meeting this past week in Washington DC. Although there weren't any revolutionary introductions, we noticed a few trends from the exhibit hall. *Straumann featured its first bone level implant and the etkon system.... more
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
Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more
M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... more
ReGen Biologics today announced it received a "Not Substantially Equivalent" (NSE) letter from the FDA in response to the 510(k) premarket notification the company submitted for its meniscal repair implant. In a press release and conference call, a clearly frustrated... more
Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more
Earnings Globus Medical announced 2Q:07 revenues of $30.2 million, an increase of 52% over the comparable quarter. The company attributes the revenue growth to the expansion of its sales and distribution footprint, product introductions in its fusion, MIS and biomaterials... more
Our own John Chopack Jr. is featured in the July/August issue of Orthopedic Design & Technology. We've republished the article for you here. Car manufacturers pitch their latest vehicles’ ability to go from zero to 60 mph in just five... more
IsoTis announced this morning that the Accell family of products has been granted 510(k) approval by the FDA as a Class II device. The clearance follows nearly a year of back-and-forth between IsoTis and the FDA over the nature of... more
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
Earnings Biologics: Orthovita reported 2Q:07 revenues of $14.85 million, beating estimates of $14.13 million and reflecting a 33% increase over 2Q:06. Sales growth was attributed to increased U.S. sales of VITOSS® FOAM and VITAGEL® products. Net loss decreased to $3.17... more
Earnings Large Joint: Exactech announced 2Q:07 revenue of $31.6 million, beating estimates of $29.9 million and up 19% from the comparable quarter. CEO Bill Petty attributed the growth to "acceptance of our new products and continuing success of our products... more
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
M&A Biomet Inc. shareholders accepted an $11.4 billion buyout offer from a private equity consortium attempting to acquire the medical device maker. The consortium, LVB Acquisition LLC, announced Thursday that nearly 83 percent of Biomet's shares were tendered. The company... more
The week prior to the 4th, we attended the Spine Technology Education Group meeting in Los Cabos, Mexico, which addressed numerous topics on innovative techniques in spine surgery. Kudos to Drs. Phillips, Albert and Vaccaro for organizing a meeting that... more
Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more
Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more
The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was... more
Just as one DOJ investigation seemed to be coming to a close, Biomet reported late last week that the company is facing new subpoenas from federal prosecutors. The government is requesting documents from as far back as 1999 relating to... more
Earnings Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was... more
Yestderday, Utah-based Amedica Corp. filed an initial public offering Securities and Exchange Commission to sell up to $74.75 million in common stock. The company's technology platform is in silicon nitride ceramics as applied to various types of orthopedic implants including... more
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
Earnings Biologics Integra LifeSciences announced 1Q:07 revenues of $123.0 million, beating estimates of $119.25 million and reflecting a 60% increase over 1Q:06. Net income for the quarter was $9.07 million, or $0.33 per share, meeting analysts' estimates. President and CEO... more
Stryker's 1Q:07 earnings call last week highlighted strong profits, but Chief Executive Stephen MacMillan noted a potential snag in its pipeline - OP-1 putty, the company's bone morphogenic protein for spinal fusion indications, may not reach the market until late... more
Last week, we attended the Society for Biomaterials' annual conference. The event showcases the latest academic research and its broad applications across medical specialties. Roughly a third of the poster presentations focused on orthopedics, and most of the rest related... more
Earnings Stryker announced 1Q:07 earnings on Wednesday. Net income increased to $243.5 million, or $0.59 per share, beating analysts' estimates of $0.58 per share. In the comparable quarter, net income was $147.5 million, or $0.36 per share. Revenues increased 13%... more
New research out of the University of Pittsburgh Medical Center show that female stem cells have an edge over male stem cells in regenerating muscle. Johnny Huard et al suggest in the Journal of Cell Biology that this research is... more
Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more
Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more
Earnings Orthovita reported 4Q:06 revenues of $13.81 million, beating analysts' estimates of $13.76 million and reflecting 38% growth compared to $9.97 million in 4Q:05. Orthovita attributed the growth to increased U.S. sales of VITOSS® FOAM and VITAGEL®. OrthoLogic announced 2006... more
Earnings Orthofix International N.V. announced 4Q:06 revenue of $116.1 million, an increase of 45% over 4Q:05 and just missing estimates of $116.6 million. $28.1 million of 4Q:06's revenue can be attributed to the September 2006 acquisition of Blackstone Medical, Inc.... more
Earnings Biologics LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix.... more
Earnings Medtronic reported 3Q:07 (ended 1/26/07) Spinal and Navigation revenue of US $629.0 million, and the Spinal segment increased 12% over 3Q:06. Growth was attributed to the Biologics product line and the CD HORIZON® LEGACY™ family of products, which includes... more
Yesterday, TiGenix, a Belgium-based biomedical company, announced the results of their phase III multi-center randomized trial of ChondroCelect as first-line treatment for symptomatic knee cartilage defects. ChondroCelect is designed to be used in combination with autologous chondrocyte implantation (ACI) surgery... more
Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more
Earnings Lifecore Biomedical reported earnings for the second quarter ending December 31, 2006. Net income fell to $1.37 million, or $.10 per diluted share during the quarter from $1.39 or $.10 per diluted share, in the quarter ending December 31,... more
MIT's Technology Review reported recently on a new development out of Carnegie Mellon and the University of Pittsburgh: a custom ink-jet printer that can print tissue using stem cells from mice and growth factor. This is how the Carnegie Mellon/University... more
Following up on an earlier blog about orthopedics' demand for a blood substitute, new research developments don't bode well for two synthetic products. Elective orthopedic surgery has one of the highest rates of patient blood loss; an effective blood substitute... more
Allograft companies, Regeneration Technologies (RTI) and Cryolife announced a non-cash exchange and service agreement this morning concerning their orthopedic and cardiovascular processing. With respect to orthopedics, starting January 1, CryoLife will work to transition existing tissue recovery and donation arrangements... more
In October we reported that Genzyme, maker of the viscosupplement Synvisc, announced a CMS decision grouping all industry viscosupplementation products into the same reimbursement code in January 2007. The coding change meant that reimbursement for viscosupplementation treatments will be based... more
OrthoMimetics announced it has completed a Gbp5 million Series A raise. Participants include Oxford Capital Partners, Schroders Investment Management, and Sloane Robinson Private Equity, as well as clients of Eden Financial, the placement agent. Joining the board will be Heidi... more
For 2Q:07, Medtronic reported overall revenue of $3.08 billion, which represented year over year growth of 11% (10% on a constant currency basis), beating analyst estimates of $2.97 billion. During the quarter spinal instrumentation generated revenues of $421 million, an... more
This morning Orthovita announced that it hopes to do a 7.7 million share offering at $3.25 a share in order to raise approximately $23 million net of fees. At least $9 million of the proceeds is expected to be used... more
Medtronic, Inc. announced yesterday that the FDA Dental Products Advisory Panel had unanimously voted to recommend approval of INFUSE Bone Graft for certain oral and maxillofacial procedures. If the FDA agrees with that panel's recommendation, the US indications for INFUSE... more
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
Earnings Biologics: Orthovita reported 3Q:06 product sales came in at $11 million, up 32% compared to 3Q:05. Net loss for the quarter was $3.7 million, or a loss of $0.07 per share. The Company beat analysts' EPS estimates by $0.02,... more
In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more
Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more
Nanotechonology is clearly making strides in the orthopedic marketplace. The question is, will the FDA will be able to keep up? Report Claims FDA Not "Nano Ready" Yesterday, Michael Tayor, an attorney and former Deputy Commissioner for Policy at the... more
Earnings Update: Tutogen Medical, Inc. provided an update on its 4Q:06 projected revenues which are estimated at ~$10.8 million, representing a 36% increase over the comparable quarter of 2005. Revenues for the fiscal year will be ~$38 million, an increase... more
Earnings: Biomet reported its 1Q:07 earnings totaled $0.44 per share (excluding the adoption of the share-based payment) which was $0.01 more than what analysts were expecting. Revenues increased by 5% to $508 million (foreign currency had a $3 million favorable... more
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
Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more
As the Wall Street Journal (subscription required) reported this week, the American Red Cross will be fined $4.2 million for failing to honor federal blood-collection regulations. More than 12,000 units of blood were recalled during 2002 and 2005, and these... more
Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more
Appointment: SpineVision® SA has hired Julian Mackenzie as its new Chairman and CEO. Previously, Mr. Mackenzie was with Wright Medical serving as Director General and CFO. Business Update: Donor Referral Services of North Carolina is at the center of a... more
Orthologic reported yesterday that an interim analysis of its Chrysalin Phase IIb dose response distal radius fracture healing clinical trial did not meet its primary efficacy endpoint of having a benefit over a placebo in time to removal of immobilization.... more
Earnings: Biologics: Tutogen reported 3Q:06 sales of $10 million and a net loss of $1.1 million, or $0.07 per fully diluted share compared to the same quarter last year. The Company would have experienced breakeven results without ~$1.1 million in... more
Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more
On Monday, ReGen Biologics announced that it had received a letter from the FDA rejecting to approve the ReGen® collagen scaffold technology to be classified as a Class II medical device. In its exact words, the collagen scaffold technology, "is... more
Osiris Therapeutics Inc. raised $38.5 million when it went public last Friday. The Company offered 3,500,000 shares of its common stock at a price of $11.00 per share and up to an additional 525,000 shares have been made available to... more
Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more
On Tuesday, Exactech reported 2Q:06 revenues of $26.6 million, which represents an increase of 11% over 2Q:05. The Company reported $0.18 diluted earnings per share (EPS) and beat analysts' earnings estimates by $0.01. Net income for the quarter was a... more
LifeCell Corporation, a maker of regenerative human tissue products, yesterday reported record 2Q:06 financial results. Product revenues were $35.7 million for the quarter, up 60% from the $22.3 million reported in 2Q:05. Growth in product revenues can be attributed to... more
Earnings Results: Biologics: Anika Therapeutics announced 2Q:06 net sales increased 11% to $7.1 million. Product revenues grew 74% while licensing, milestone and contract revenue was down 77%. The large product sales growth was partially driven by higher demand for OrthoVisc®;... more
Appointment: Biomet, Inc. appointed Charles E. Niemier as President of EBI's operations following the resignation of its former president, Bart J. Doedens, M.D. Mr. Niemier has been a member of the senior management team and Board of Directors for more... more
Smith & Nephew plc (SNN) announced today that it has acquired Osteobiologics (OBI) for a net consideration of $72.3m in cash, representing ~20x OBI's 2005 revenues of $3.3m. The acquisition is expected to reduce SNN's earnings by $7m in the... more
Tutogen Medical ("TTG") reported 2Q:06 (ending March 31, 2006) revenue increased 21% during the 2Q:06 to $9.1 million and net income for the quarter totaled $22,000 compared to a net loss of $1.1 million last year. During the quarter, TTG's... more
Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more
Viscosupplementation to treat osteoarthritis has traditionally been performed with a course of three or five injections. Today Smith & Nephew Inc. and Q-MED AB announced an alliance which paves the way for the US marketing of DUROLANE, the first and... more
Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application... more
Orthovita announced that it has obtained pre-market approval (PMA) from the FDA to market its VITAGEL(TM) surgical hemostat manufactured on-site at its Malvern, Pennsylvania facility. Orthovita has been distributing VITAGEL since the first quarter of 2005 through a distribution agreement... more
A Single Codon Mutation Causes A Debilitating Disease Fibrodysplasia Ossificans Progressiva (FOP) is a rare autosomal dominant genetic disorder that causes muscles and other connective tissue to turn into bone and is estimated to affect one in two million patients... more
Business Update: NuVasive announced that 90% of its sales force is now exclusively distributing its spine surgery products. This exclusive 175 person sales force includes both direct and independent sales representatives. Development & Distribution Agreement: Ars Arthro Biotechnologie GmbH, a... more
Appointment: A medical imaging company ONI Medical appointed Victor Ruiz to Vice President, of the Corporate Strategy and Marketing division. Mr. Ruiz's past experience include world-famous imaging companies: GE Medical Systems and Cardinal Health Inc. Clinical Update: LDR Spine announced... more
To update from previous blog, twenty of twenty-four orthopedic companies reported revenues and earnings for the period of January 1, 2006 to April 1, 2006. Excluding Inion, Osteotech, RTI (Regeneration Technologies) and Tutogen, which have not reported yet, total orthopedic... more
The first group of orthopedic companies reported their 1Q:06 this week and took in $5.3 billion so far. The total aggregated revenues for the quarter were up by 7% from $4.9 billion in 1Q:05. The industry netted $637.8 million, a... more
In the swarm of public earnings reports for the first quarter, we thought LifeCell's results were particularly newsworthy. Thanks to the Company's AlloDerm Regenerative Tissue Matrix which grew at an astounding 69% year-over-year ($25.3 million in 1Q:06 compared to $14.9... more
Dane Miller of Biomet called it quits a week after releasing its 3Q:06 earnings report. Last week, the Company reported earnings per share (EPS) of $0.43 which was in line with Street's estimate but did not meet analysts' expectation for... more
On the heels of BioMimetics' approval for GEM 21S for dental use, they initiated one clinical study on GEM OS1 for distal radius fractures and two on GEM OS1 in foot and ankle fusion. GEM OS1 is a combination of... more
In addition to the Top Sessions we chose, we have added AAOS presentations by our Scientific Advisory Board members. Please click on the link at the bottom to view the entire list. Wednesday, March 22 10:30 AM - 12:30 PM127Changing... more
Orthologic announced this morning that its 503-person clinical trial of its synthetic peptide Chrysalin to treat wrist fractures failed to meet its primary goal of accelerating recovery. In an instant, its market capitalization was cut in half and the company... more
Developments in ceramics has always been of great interest to participants in our industry. We thought we would alert you to this article in Wired Magazine that summarized some recent findings in ceramic technology. In essence, scientists are finding that... more
We are preparing for AAOS in Chicago, IL and invite you to check back to our website for information on analyst meetings and our top picks of scientific events happening at AAOS. Earnings: Two hip & knee orthopedic companies (Exactech,... more
Tutogen Medical, a leading player in the allograft market, has named Robert Johnston to the post of CFO. Johnston joins Tutogen from Power Medical Interventions, where he was also CFO. He has been at a number of healthcare products companies... more
In an article published in February's Arthritis and Rheumatism, researchers at the University of Pittsburgh reported on their success in using stem cells to repair cartilage. Using a rat model, researchers extracted stem cells from adult muscle tissue, retrovirally transduced... more
It has now surfaced that Sen. Charles Schumer has sent a letter to the acting head of the Food and Drug Administration, Dr. Andrew von Eschenbach calling for more oversight of the tissue transplant industry noting that he was "deeply... more
Last Wednesday, Osteotech announced that their beleaguered Chief Executive Richard Bauer will retire at the end of December - sooner than expected. While he will remain on the Osteotech board, Sam Owusu-Akyaw, the Company's current president and chief operating officer,... more
Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more
We wrap up this quarter with aggregated earnings and sales in the public orthopedic sector of $560 million and $5 billion, respectively, as a few more companies reported this week. For 3Q:05, orthopedic sales were up by 13% ($5.0 billion... more
It has been a busy week for many CEOs and CFOs in the orthopedic device sector. In the past two weeks orthopedic companies reported 3Q:05 sales of $4.7 billion which was a 12% increase over the 3Q:04. Net earnings for... more
Last night Osteotech, Inc. (Nasdaq: OSTE) communicated that Musculoskeletal Transplant Foundation ("MTF") has withdrawn its $6.25 a share bid. Today many shareholders voted with their feet and the stock has dropped by $1 a share to $3.88 (or over 20%).... more
Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX), the highly reputable allograft industry leader, said this morning that it issued a voluntary recall of allograft implants that have been processed from donor tissue received from Biomedical Tissue Services. RTIX attributed this to... more
The allograft industry was scrutinized recently due to the highly publicized case of Biomedical Tissue Services (BTS). The company is being investigated by the Brooklyn district attorney's office for operating a scam to profit from body parts. The first company... more
In the wake of an FDA, NYPD and Brooklyn district attorney's investigation into Biomedical Tissue Services, Lifecell has recalled and halted sales of all tissue from BTS. BTS's CEO is under investigation for illegally harvesting tissue from cadavers at a... more
One of the leaders in this emerging meniscus repair market is ReGen Biologics. We recently had a chance to do a catch up with Gary Bisbee, CEO of ReGen Biologics who we interviewed last year. Disclosure: Individual members of HealthpointCapital,... more
On Friday ReGen Biologics, Inc. reported that it received a warning letter dated September 16, 2005 from the FDA. The warning letter was a follow-up to the FDA Form 483 notice of inspectional observations received by ReGen and, along with... more
Invibio scored a coup in Japan recently. Today the Company announced that the Japanese Ministry of Health has approved for use the first implantable medical device using the Company's PEEK-OPTIMA polymer. The device is an arthroscopic tissue repair system used... more
The FDA Orthopedic and Rehabilitation Devices Panel held a meeting September 8th and 9th to rule on two important issues: Smith & Nephew's hip resurfacing device and the design of clinical studies for spinal devices. You can find background information... more
This week, we decided to post the Orthopedic News Roundup for Thursday, instead of Friday due to the upcoming holiday. Clearly the biggest headline this week is the announcement of a take-over bid by Musculoskeletal Transplant Foundation ("MTF") for Osteotech... more
As many of you now know, the venerable (and world's largest) non-profit tissue bank Musculoskeletal Transplant Foundation (MTF) announced on Monday that is had proposed to acquire all of the outstanding common stock of Osteotech, Inc. (Nasdaq: OSTE) for $6.25... more
Allograft and tissue processing stalwart Regeneration Technologies, Inc. (Nasdaq: RTIX - News), announced Thursday that it entered into definitive agreements to undertake a private placement of its common stock with a group of accredited investors (institutional firms or wealthy individuals).... more
This week we completed the orthopedic reporting calendar as a few more companies reported earnings, starting with Synthes, the number #1 trauma company worldwide. Synthes reported 20% growth in both top and bottom line for 1H:05. Consolidated sales reported at... more
This week we finish off the first half of 2005 reporting season with 17 orthopedic companies* released their financial numbers. In 2Q:05, in an aggregated total, orthopedic revenues increased 16% ($3.8 billion vs. $3.2 billion) and a 25% increased in... more
DBM developer Osteotech Inc. which is famous for producing Grafton, announced on Friday that Chief Financial Officer, Michael J. Jeffries, was retiring. This morning, the Company announced that Mark H. Burroughs, VP of Finance, would succeed him. Burroughs has been... more
This is an excerpt from our Orthopedic Biomaterials 2005 report, which is a comprehensive listing of all the products and manufacturers in this exciting space. The report has six more sections like this one (for the other orthopedic applications of... more
Fziomed, Inc. recently announced that its Oxiplex Gel demonstrated efficacy in acting as a delivery platform for a novel peptide bone growth factor being developed by the Company. The study was presented at the 12th International Meeting on Advanced Spine... more
On Friday of last week, Tredegar Corporation announced that it sold the assets of Therics, Inc. to a new company controlled and managed by Randall R. Theken (not the actual Theken Spine company itself). The new stand-alone company will simply... more
At a recent shareholders' meeting IsoTis OrthoBiologics announced that it appointed James (Jim) Hart to its Board of Directors. Jim is familiar to many of you as the former CEO of Opus Medical which was sold to ArthroCare for over... more
One of our readers recently posted asking for everyone's opinion on allograft and xenograft. We thought we would give you our take first and then let the readers respond. First, we should define both for all the readers: allografts are... more
Today we are publishing our recent interview with Mike Callahan Managing Director of Invibio, ltd. Many of you know Invibio as a principal supplier of PEEK polymer to the industry an increasingly important material used in orthopedic applications. Q: How... more
NuVasive (nasdaqNM: NUVA) announced on Monday that they are acquiring RSB Spine's dynamic cervical plate technology and a right of first refusal for additional products developed by RSB for about $14.5 million in cash and stock. In addition, RSB will... more
Talk to anyone in orthopedics and all admit that a transition from replacing worn out joints and soft tissue to regenerating these parts is anticipated. But the $20 billion (size of the orthopedic market) questions are when and, more importantly,... more
The allograft industry is a curious phenomenon. Companies in this segment of the orthopedic industry are stand alone processors of human cadaveric musculoskeletal tissue for surgical implantation. Companies are stand alone because it seems that the metal benders in Warsaw,...
