Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more
Baxter announced plans to acquire ApaTech for up to $330 million, with $240 million in cash up front (a 4x revenue multiple) and additional milestone payments of up to $90 million. more
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
Earnings Nobel Biocare reported 4Q:09 revenues of EUR 156.0 million ($213.6 million), flat over the year-ago period and missing estimates by EUR 5.0 million ($6.9 million.) EPS of EUR 0.21 ($0.29) missed estimates by EUR 0.05 ($0.07). The company called... more
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
Earnings aap Implantate reported preliminary sales of EUR 7.4 million ($10.6 million) in 4Q:09, down 4% from the year-ago period. Full year sales were up 3% to EUR 33.0 million ($47.3 million). Company highlights for the year include "optimizing its... more
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
On December 31, Anika Therapeutics announced the acquisition of Fidia Advanced Biopolymers for $17.1 million in cash and 1.9 million shares of stock, which values the deal at roughly $34.0 million. Fidia is a tissue engineering company based in Abano... more
CNN published a list of the top 10 health innovations of 2009, and two orthopedic products made the list: a bone graft substitute made from wood and the economical Jaipur Knee. Researchers in Italy have discovered a way to convert... more
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
M&A The Yorkshire Post reported that DePuy Orthopaedics acquired Finsbury Orthopaedics. Finsbury has a range of hip, knee and small joint replacement products, including a hip resurfacing device. No details of the transaction were disclosed. Funding BioMedFlex raised $0.25 million... more
M&A Stryker entered into a definitive agreement to acquire Ascent Healthcare Solutions, a medical device reprocessing company, for $525.0 million in cash. Ascent describes its operations as including the "cleaning, testing/verifying, packaging and sterilizing" or devices, as well as "remanufacturing,"... more
Earnings ArthroCare restated its earnings from 2004 through 2Q:09. The company reported total revenue for 2008 of $314.2 million, up 12% over 2007. Relative to prior-year periods, 1Q:09 revenues increased 2% to $78.8 million; 2Q:09 revenues decreased 6% to $80.8... more
Earnings Alphatec Holdings, Inc. announced record consolidated revenue of $32.7 million in 3Q:09, which represents 27% growth over 3Q:08. U.S. revenue increased 21% over the prior-year third quarter and 28% over the first nine months of 2008. International revenue was... more
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
Earnings Anika Therapeutics reported 3Q:09 revenues of $10.1 million, representing an 18% increase over the year-ago period and missing estimates by $0.3 million. Joint Health sales, including the Orthovisc and Monovisc products, were up 31% to $6.1 million. Anika noted... more
Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more
Biomet has acquired the assets of Cartilix for an undisclosed sum. The target company is developing ChonDux, a new technology that uses a biological adhesive and hydrogel to fill lesions in the articular cartilage. Previous investors in the company include... more
Earnings Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude... more
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
Earnings TranS1 pre-announced 3Q:09 revenues, saying sales for the quarter would be in the range of $6.8 to $6.9 million. This represents a 15% increase over year-ago sales, though it is below 3Q:09 guidance of $7.4 to $7.9 million. Analysts... more
TiGenix announced that ChondroCelect, its ACI treatment for cartilage regeneration, has been cleared by the European Commission for sale on the EU market. This is the first product to be approved in the EU as an advanced therapy medicinal product,... more
Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more
Yesterday the FDA issued a preliminary report on the process by which ReGen Biologics obtained 510(k) market clearance for its Menaflex device, concerns that were first publicized by the Wall Street Journal earlier this year. The Journal initially reported that... more
Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more
A strain of bacteria capable of producing hydroxyapatite (HA) could result in more effective coatings for medical devices, according to early research out of Birmingham, England. When applied to common materials for joint replacement devices, serratia bacteria were shown to... more
M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more
M&A Kapstone Medical acquired exclusive rights to Spherofix's screw-locking technology, which the company plans to incorporate into a line of spinal implants. Terms of the deal were not disclosed. Regulatory Covidien received FDA approval to market its DuraSeal spine sealant,... more
Regulatory Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage. MEDICREA received 510(k) clearance... more
Earnings Corin reported 1H:09 sales of GBP 20.1 million ($33.0 million), down 25% over 1H:08 after adjusting for currency and beating estimates by GBP 2.1 million ($3.5 million). Outside the U.S., revenues increased by 10%, which the company attributed to... more
Scientists at the University of Utah have uncovered a way to produce a synthetic adhesive based on a natural glue created by the sandcastle worm. This ocean worm builds its home by sticking pieces of sand and shells together, and... more
Earnings aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand... more
An FDA panel determined in a 6-1 vote that Q-Med's single-injection Durolane, a hyaluronic acid, should not receive market approval. The panel raised efficacy concerns based on study data showing limited benefit for the product compared to placebo. The panel... more
Researchers in Japan have successfully used stem cells to grow a tooth in a mouse model in what the Wall Street Journal calls "the first time scientists have developed a fully functioning three-dimensional organ replacement." The replacement tooth's structure, hardness... more
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
Earnings Alphatec Spine, Inc. announced financial results for FQ2:09. Consolidated revenues for the second quarter 2009 were $32.3 million, an increase of 35% from 2Q:08 and an increase of 5% over first quarter 2009. Adjusted EBITDA reached $2.8 million in... more
Osiris Therapeutics has been at the forefront of developing stem-cell-based products in orthopedics, most notably with their commercialization of Osteocel. That product line was sold to NuVasive last year, leaving Orthofix (who had previously distributed Osteocel under the name Trinity)... more
Earnings Exactech reported 2Q:09 revenues of $43.3 million, representing a 1% decrease from the year-ago period and beating estimates by $0.3 million. The company reported net income of $2.6 million, or $0.20 per share, representing a 14% decrease from 2Q:08... more
A new study published in the journal Stem Cells found that circulating blood may hold the potential to generate bone. Scientists evaluated blood samples from patients with fibrodysplasia ossificans progressiva (FOP, a rare genetic disorder where bone forms outside the... more
Earnings Anika Therapeutics reported 2Q:09 revenue of $9.5 million, representing a 5% increase over 2Q:08 and missing estimates by $0.4 million. The company attributed revenue growth to both the ORTHOVISC and MONOVISC product lines, which contributed $5.6 million to total... more
Synovis Life Technologies, Inc. announced plans this week to acquire Pegasus Biologics, Inc. for $12.1 million in cash (a 1.3x revenue multiple.) Pegasus manufactures a collagen-based soft tissue scaffold as well as a wound healing device. According to the Synovis... more
Earnings Exactech announced that 2Q:09 revenues would be approximately $43.0 million, below earlier guidance and analyst expectations of approximately $45.0 million. The range for full-year 2009 revenue guidance has also been lowered to $167-$173 million. The company attributed 2Q's sales... more
Earnings Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by... more
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
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
Funding Alphatec Spine, Inc. has successfully completed a private placement of $10.0 million of shares of its common stock to one of its existing shareholders, HealthpointCapital Partners II, L.P. Alphatec plans to use the net proceeds of the private placement... more
Orthovita has received 510(k) clearance to market Cortoss Bone Augmentation Material for the treatment of vertebral compression fractures, and it's the first cement other than PMMA to be cleared for this use. The product was under review by the FDA... more
Regulatory Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed... more
Last week an FDA panel voted 4-0 in favor of broadening the approved applications for Covidien's Duraseal sealant to include spinal surgery. Duraseal is a resorbable polymer gel designed, along with sutures, to close small gaps in the dura mater... more
Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more
The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS. The study in question evaluated the use of InFuse for... more
Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more
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
Earnings aap Implantate reported 2008 revenues of EUR 31.9 million ($45.0 million), a 14% increase over 2007 sales. Sales in the Trauma & Orthopedics division grew by 35%. Biomaterials sales increased by 4%, with the company attributing slower growth to... more
Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more
Teriparatide, a recombinant form of parathyroid hormone marketed by Eli Lilly as Forteo, has been shown to stimulate stem cell production and accelerate the healing of fractured bones, according to study data presented at the Orthopaedic Research Society meeting in... more
In recent interviews, Medtronic CEO Bill Hawkins discussed some of the challenges associated with the company's $4.2 billion acquisition of Kyphon in 2007 as well as plans for future acquisitions. Kyphon brought innovative products and an entree into new markets,... more
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
The WSJ published additional details of its investigation into ReGen Biologics' FDA clearance for its Menaflex meniscal implant. New information out this morning includes details of campaign donations from ReGen executives to the New Jersey politicians who stood behind ReGen... more
Patients suffering crippling pain from metastatic cancer or even "benign" conditions like rheumatoid arthritis may find relief in a minimally-invasive treatment called osteoplasty. Similar to vertebroplasty, osteoplasty is the injection of bone cement into cancerous lesions in the skeleton, and... more
Orthofix announced some preliminary results from their Special General Meeting of Shareholders spurred by Ramius LLC's criticism of the company. Ramius, which owns 5.1% of Orthofix, was seeking to remove four members of the Board of Directors and replace them... more
Earnings Corin reported 2008 revenues of GBP 39.8 million ($57.6 million), an 8% increase over 2007 sales. The company also reported a pretax loss of GBP 3.9 million ($5.6 million), which reflected a GBP 5.2 million ($7.2 million) inventory write-down... more
Yesterday an FDA advisory panel voted 6-1 that Stryker's PMA for its OP-1 Putty for uninstrumented posterolateral fusion for the treatment of lumbar spondylolisthesis was "not approvable." Stryker was seeking this approval based on 24 months of clinical outcome data... more
Regulatory Bonesupport received the CE mark for Cerament Bone Void Filler, a ceramic bone substitute primarily used for the treatment of osteoporotic fractures. IlluminOss Medical received the CE mark for its Photodynamic Bone Stabilization System. According to the company, the... more
Earnings TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As the... more
As Stryker's long-awaited FDA panel session for OP-1 approaches, the company announced that it's facing a federal grand jury investigation into marketing practices surrounding the device. Specifically, allegations include the illegal promotion of OP-1 products and Calstrux, misbranding of devices... more
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
At AAOS last month, Allan Mishra, M.D. and Pietro S. Randelli, M.D. co-chaired the inaugural meeting of the Biologic Orthopaedic Society, a new organization designed to further the study and market adoption of biologics worldwide. Prior to BOS's formation, “No... more
Earnings Alphatec Spine reported consolidated revenues for 4Q:08 of $28.4 million, an increase of 33% from the $21.3 million reported for 4Q:07. U.S. revenues for 4Q:08 were $22.0 million, an increase of 29% from the $17.1 million reported for 4Q:07.... more
Earnings Artimplant reported 4Q:08 revenues of SEK 4.6 million ($0.6 million), down from SEK 5.0 million ($0.8 million) in 4Q:07. During the quarter, the company reported sales of 900 Artelon Spacers (down from 1,100 in 4Q:07) and 300 units of... more
Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more
Robin Young's Fourth Annual Stem Cell Summit was about as far removed as you could get from the grim economic headlines. Companies at the summit were presenting in the halo of a market forecast suggesting that this current $65 million... more
The New York Times ran an article on Monday describing platelet-rich plasma therapy (or PRP), a relatively inexpensive and promising autologous treatment for sports injuries. The treatment, which has attracted a host of professional athletes (the article names two Pittsburgh... more
Earnings Nobel Biocare reported 4Q:08 revenue of EUR 162.6 ($229.2 million), down 13% from 4Q:07. 4Q net profit of EUR 24.9 million ($32.3 million) was down 45% from the year-ago period and missed estimates of EUR 29.0 million ($40.9) million.... more
Earnings CONMED Corp. reported 4Q:08 revenues of $179.2 million, down 5% versus 4Q:07 and beating estimates by $2.26 million. Non-GAAP diluted earnings per share were $0.34, down 23% from 4Q:07 and beating estimates by $0.05. The company reported 4Q:08 arthroscopy... more
Earnings Kensey Nash reported FQ2:09 revenues of $20.8 million, up 6% over the year-ago period and beating estimates by $0.4 million. Net income for the quarter was $5.2 million, or $0.44 per diluted share, beating estimates by $0.04 and representing... more
Geron announced this week that it received an FDA green light to initiate a human clinical study for their embryonic stem cell treatment for spinal cord injuries. The cell formulation, known as GRNOPC1, will be injected in up to 10... more
Mesoblast announced this week that the company received Australian institutional ethics committee approval to begin a clinical study evaluating the use of its adult stem cell product, RepliCart, for the prevention of OA in patients who have had ACL repair.... more
Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... more
Earnings Alphatec Spine announced that, based on preliminary financial data, the company will report record consolidated quarterly revenues for 4Q:08 of approximately $28.4 million, an increase of approximately 33% over revenues from the prior year fourth quarter. For the year... more
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
This morning Regen Biologics announced that it received its long awaited FDA 510(k) clearance to market its collagen meniscus implant for the knee. This marks the end of a long and tortured back and forth between the company and the... more
Funding In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time... more
Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million to... more
When George W. Bush took office in 2001, one of his first executive orders was to restrict federal funding of stem cell research based on his belief that destroying embryos to obtain the cells was equivalent to destroying human life.... more
Earnings Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong... more
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
Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more
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
Earnings Alphatec Spine, Inc. announced that consolidated revenues for 3Q:08 were $25.8 million, an increase of 27.1% from the $20.3 million reported for the 3Q:07. U.S. revenues for 3Q:08 were $21.5 million, an increase of 27.7% from the $16.8 million... more
A study published this month in JBJS identifies progenitor cells in traumatized human tissue - which could lead to new options in tissue engineering. The authors point out that while there are multiple sources of progenitor cells (such as bone... more
Earnings Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%;... more
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
Earnings CONMED reported 3Q:08 revenues of $179.4 million, up 9% over the year-ago period and beating estimates by $2.95 million. Arthroscopy was up 18% (17% constant currency), contributing $69.5 million to total sales. On a non-GAAP basis, diluted earnings per... more
At NASS this week, ISTO Technologies announced promising data from an animal study evaluating their NuQu cell therapy for the treatment of degenerative disc disease. NuQu is a non-invasive cell therapy derived from juvenile chondrocytes and delivered with a protein... more
Earnings Biomet reported FQ1:09 revenues of $607.0 million, up 13% (9% constant currency) over the year-ago period. Excluding special charges, adjusted operating income was $171.6 million for FQ1:09, up 12% over FQ1:08. Among segments, reconstructive reported $449.3 million in sales,... more
M&A Life Spine, Inc. has acquired the "majority" of the intellectual property of Spinal Generations, LLC. Neither details on the acquired technology nor terms of the transaction were disclosed. Funding Harvard received a $125 million donation from Synthes Chairman Hansjorg... more
M&A Arthro Kinetics announced that they are pursuing a potential asset sale. The company said this week that their current $5.0 million cash balance was not sufficient to sustain operations. Tecomet has been acquired from Cardinal Health by Charlesbank Capital... more
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,... more
LIFC reported strong product revenue growth in 1Q:05 as sales increased by 48%.' Product sales totaled $19.7 million compared to $13.3 million in 1Q:04. Sales were driven by higher demand for the AlloDerm® Regenerative Tissue Matrix used in complex hernia... more
Wright reported 1Q:05 revenues of $82.6 million which was a 10% increase over the 1Q:04. Excluding the effect of currency, WMGI revenues increased 9%. The 10% growth in revenues was almost 3% slower than the revenue growth reported during the... more
Last Thursday the US Census Bureau released new state-by-state projections on the aging of the U.S. population which showed not only how it expects the nation to age, but how the population is expected to shift geographically over the next... more
Background on Gain Sharing. The Hospital Corporation of America ("HCA") has recently asked the Office of Inspector General ("OIG") of the Department of Health & Human Services ("HHS") to allow for "gain-sharing" arrangements. These gain-sharing arrangements would allow hospitals to... more
Claude LeDuc, CEO Biosyntech Last week we interviewed Claude LeDuc, President and Chief Executive Officer of BioSyntech, a Canadian developer of thermosensitive gels that address articular cartilage repair and other clinical needs. JM: Introduce our readers to BST-Gel™ and... more
OSTE reported 4Q:04 revenues of $20.4 million which was a 15% lower than 4Q:03 revenues of $24.0 million. Earnings totaled ($0.27) per diluted share which included a pre-tax gain of $1.1 million related to the sale of inventory and intellectual... more
The healthcare industry has long been the subject of regulation by complex laws that do not exist in other industries and which, under certain circumstances, may seem almost excessive and counter-intuitive. The enforcement of these laws has been significant and... more
ReGen Biologics, Inc. (OTC:RGBI), a New Jersey-based tissue regeneration company, reported full year 2004 selected financial results on Friday of last week. In 2004, ReGen reported total sales of $504,000, a 72% increase over the $293,000 reported in 2003. Net... more
At the end of last week, we attended the University of South Florida's "Preservation of Motion in the Lumbar Spine" course to check in on how leading surgeons are coming along with motion preserving spinal procedures and related surgical implant... more
I was struck by economist Paul Krugman's article "America's Senior Moment" in the most recent New York Review of Books. In the article Krugman assails the Bush Administration's push for social security "privatization" with the fervor of a campus radical,... more
LifeCell Corp. (NASDAQ:LIFC) reported a strong 49% increase in product revenues in 4Q:04 which was in line with consensus estimate of $0.04 per diluted share on a non-GAAP reporting standard. Product revenues in the 4Q:04 were $16 million compared to... more
We have aggregated the 4Q:04 and 3Q:04 reported revenues (includes the effects of foreign currency) for 16 public orthopedic companies. Although we would have liked to use revenue growth rates which excluded foreign currency, a majority of the companies report... more
EXAC reported revenues of $21.3 million during the 4Q:04 which was a 14% increase over the 4Q:03 but was $300 thousand below analyst's expectations. Earnings-per-share on a diluted basis totaled $0.17 which was also slightly below analyst expectations of $0.16.... more
A biomaterial company, Orthovita, Inc. (Nasdaq: VITA), reported 4Q:04 and FY2004 financial results with product revenues increased to 62% and 59%, respectively. Despite its consistent 60% top-line growth in Q3 & Q4, VITA failed to meet the street estimate of... more
This year we attended Smith & Nephew's, Biomet's, Stryker's, and Encore Medical's analyst meetings. All were very professional and well attended. Here are our notes from each: Smith & Nephew Overview: Although Smith & Nephew posted the best large joint... more
Overwhelmed with all the education opportunities? Join the club. Good news for you, though - the HealthpointCapital research team has whittled down the program to 26 of the most controversial and best-hosted side sessions. Minimally Invasive Breaks Out Every year... more
It's here again, the annual AAOS conference. Thousands are ready to descend on Washington, D.C. the week of February 21st to learn of new surgical techniques, new products and to develop business and relationships. While it is hard to predict... more
On Tuesday of last week, Genzyme Corporation (Nasdaq: GENZ) announced another foray into the world of cartilage repair with the acquisition of Germany's Verigen AG. Founded only in 1999, Verigen has been selling a proprietary cell therapy system for cartilage... more
Last week, Canadian's Millenium Biologix Corp. (TSX: MBC), a biomedical company that develops and supplies minimally invasive devices and skeletal tissue regeneration products, reported its 3Q:05 and its twelve months results for December 31, 2004. Millenium Biologix Corporation is the... more
Wright reported both 4Q:04 and year-end 2004 financials on Thursday evening. 4Q:04 revenues totaled $77.7 million a 13% increase over 4Q:03 revenues and at the upper end of management's previous guidance of revenues of $76-$78 million. Revenues for the year... more
On Thursday of last week, OrthoLogic Corp. (Nasdaq: OLGC) announced its Q4:04 results. The Company, which has effectively been a drug development company since the sale of its bone growth stim business, reported a net loss of $4.9 million or... more
Direct-to-consumer advertising has become the most powerful means of marketing pharmaceuticals over the last decade. For years we have seen these strange advertisements which typically only mention the name of a drug and the manufacturer, but withhold any information regarding... more
LIFC reported that it anticipated 4Q:04 product revenues to total $16.0 million which is a 49% increase over the 4Q:03. The company is anticipating 2004 product revenues to total $59 million compared to the $39 million reported during 2003 (52%... more
OSTE announced on Thursday that it was taking a $5.8 million pre-tax charge to write down assets during the 4Q:04. The Company now expects a loss of $0.28 to $0.31 for the fiscal year 2004 compared to the previous forecast... more
Wright Medical reported a blistering 28% rate of growth for its biologics products as well as a solid 23% rate of revenue growth for its hip products. Clearly, this is a company that is gaining market share from biomaterials. Hip... more
On July 13/2004 a small group of researchers and businessmen presented to an FDA panel the results of 15 years of research and clinical study the net effect of which was a unanimous panel approval for a new, recombinant platelet-derived... more
Data from the largest clinical trial ever conducted on the human meniscus is starting to make its way into the FDA. The first module was submitted in early July. The next modules are being submitted over the course of 2004.... more
Headlining this year's one-day Biomaterials Summit will be Wright Medical, Regeneration Technologies, LifeCell, Orthovita, MacroPore and Stellar International. All are leaders in the field and working on significant new technologies. Wright Medical, whose sales for the first half of 2004... more
Calcium has been good to Orthovita; particularly the nano-particle version known as beta tri calcium phosphate, sold by Orthovita under the brand name VITOSS'. VITOSS' is offered in either blocks or morsels. Compared to HA-CC blends (Hydroxyapatite and Calcium Carbonate),... more
Osteotech's stock price is now down to $3.87. With 17 million shares outstanding, the company's market value is $67 million. The last time Osteotech was valued so low was in September of 2001. In 2001, Osteotech lost $4.4 million on... more
For the June quarter, LIFC reported that sales hit $15.1 million, a stellar 58% increase over prior year levels. Sales for the superstar product, Alloderm', accounted for 68% of the overall sales and rose 89% over prior year levels. The... more
We couldn't help but come to the following conclusion after reading RTI's Stryker notice last week: Stryker has accomplished the interesting task of contracting with the industry's #2 bone void fill supplier for soft tissue, and the industry's soft tissue... more
Cash and hemostats stop two kinds of bleeding. Last week, Orthovita (VITA) added both in an important and impressive deal with AngioTech. This deal will bring a new product to its growing arsenal of biomaterials, as well as a whopping... more
The best source of replacement body parts is the patient. Whether it is skin, tendons, bone, blood or whatever, harvesting from one spot to implant in another spot of the same patient is the gold standard, for more reasons than... more
On Thursday, ReGen Biologics named William R. Timken, a founding partner of Hambrecht & Quist, to its Board of Directors. This is not necessarily a new relationship since Timken has been an investor and advisor to the Company for over... more
Biomaterials are a disruptive technology platform. Consider the effect of titanium implants on stainless steel. Better yet, consider the effect of ceramics today on titanium. Ceramics represent an incremental $2,000 - $4,000 in revenue per implant over titanium and an... more
It's been an extraordinary year for companies that employ or supply biomaterials. Sales are now running at a rate of $6 million per day and will, we believe, accelerate in 2005 with a new generation of growth factors, cartilage repair... more
Over 2,000 scientists and entrepreneurs from 43 countries converged on Sydney, Australia last week to advance the extraordinary science and practice of biomaterials. Over 2,000 papers and posters were submitted representing some of the finest biomaterials science in the world.... more
If CryoLife is to survive, it must achieve three fundamental goals: resolve its lawsuits, avoid trouble with any U.S. government agency and re-establish a reputation as a reliable supplier of biologic products to surgeons. Last week's quarterly update report from... more
VITOSS sales rocketed in the quarter, beating our expectations and demonstrating that Orthovita is becoming one of the premier calcium based suppliers in orthopedics. VITOSS (a resorbable beta tri-calcium material) sales reached an estimated $4.5 million (the actual number included... more
By Wednesday the most popular document circulating the floor of AANS was a crossword puzzle followed by USA Today's sports section. Compared to AAOS (which was like Times Square), AANS was a monastic retreat; for the exhibitors. For surgeons it... more
Watch what is happening in hernia repair and then start thinking cartilage, tendon and ligament. LifeCell, which could call itself a 'biomaterial' company, but won't - posted the #1 rate of revenue growth of all 'biomaterials' companies with an impressive... more
Taking a quote from Butch Cassidy and the Sundance Kid, 'Who are those guys?' Tom Trotter's OrthoLogic could eventually possess more 'growth factor' indications than Medtronic, operate at significantly lower costs than Medtronic and have obtained a drug approval for... more
Regeneration Technologies (RTI) is like the proverbial duck on the water, calm on the surface, but paddling like crazy beneath. For the first quarter ended March 31/2004, Regeneration reported a 19% increase in sales to $23.4 million, which was about... more
In two separate studies, stem cells derived from the patient's own fat tissue, otherwise known as adipose derived stem cells, were shown to adapt and grow into either bone tissue or heart muscle tissue, without requiring any external growth factors... more
Macropore, the San Diego based biomaterials company whose stock trades on the Frankfurt exchange (go figure), posted exceptional revenue growth for the December quarter. (They're a little behind on their announcements. March quarter numbers due in June?) Sales for the... more
Stryker Corp. (SYK:NYSE), in similar fashion to last year, brought and introduced a majority of its operational leaders of its various operating divisions. However, a significant portion of the analyst meeting, especially Q&A, centered around Stephen MacMillan, President & COO,... more
After two disappointing quarters, Regeneration Technology's (NASDAQ NM:RTIX) message at AAOS was that the distribution system had to change in order to become more effective and that the company's new product pipeline had to grow. Roger Rose, RTI's VP of... more
The Acid Test for early stage Medical Device companies is profitability, before obtaining FDA approval for the core product. It's an almost impossible feat, yet a couple companies have accomplished this over the years; Vascular Solutions almost seven years ago.;... more
Allograft tissue processing revenues may be down ($30.8 million in 2003 vs. $55.4 million in 2002) but with BioGlue revenues up 33% to reach $27.8 million and an infusion of $20 million in cash, CryoLife's management had a definite spring... more
Integra Life Sciences (IART), which reported a 58% jump in revenues to $185 million for the year ended December 31st, 2003, was downgraded by W.R. Hambrecht this past week. We have known IART CEO Stu Essig for quite a while... more
Interpore Cross sold $44.6 million of spinal implants (not counting bone void fill) in 2003, a 21% increase over its level in 2002. Industry-wide, we estimate spinal implant sales rose 29% to $2.8 billion in 2003. Interpore's market share, we... more
For the just completed quarter and year, Wright Medical (NASDAQ:WMGI) reported, we believe, the best quarter and year in orthopedics. First, Wright's seven year investment in the Investigational Device Exemption (IDE) ceramic-on-ceramic clinical hip trial delivered huge dividends in 2003.... more
Last week Regeneration Technologies (RTI), the third largest supplier of allograft products, reported that sales of allograft products to Medtronic Sofamor Danek (MSD) dropped 61% in the 4th quarter to $5.1 million. MSD is Regeneration's largest customer accounting for 60%... more
Last week CryoLife announced that it had sold 3.4 million shares in a private placement, raising $20 million (before expenses). With cash levels sitting at approximately $11 million as of the end of 2003 and with quarterly losses running about... more
It's official. Tom Trotter, CEO of OrthoLogic (OLGC), has completed his transition of OLGC from a medical device company to a pure play orthobiologics organization. The feat took Trotter approximately three years beginning in 2001. During that time he divested... more
Raises Fiscal 2004 Guidance. Ortho and sports medicine key growth driver. Biomaterials company Kensey Nash (KNSY) held a conference call to discuss its stellar Second Quarter earnings results last week. KNSY revenues were up 30% from $10.5 million to $13.7... more
LifeCell continues to post very impressive top line growth. Sales in the fourth quarter broke out of its sub-$10 million plateau and reached a solid $11.1 million. For the past six quarters LifeCell has been posting between $8-10 million in... more
To quote from Dow Jones' press release, "Despite recording a $4.6 million profit in the first nine months of this year, Osteotech's metal spinal implant products have suffered big losses because an insufficient unit volume has failed to cover overhead... more
4th Quarter revenues came in roughly $3 million under the third quarter's reported $15.1 million and certainly below our own expectations for the quarter. Revenues for the December quarter were approximately $12.8 million, up slightly from the prior year's $12.2... more
Any volunteers for the audit committee? With roughly three quarters of cash left (assuming the current cash burn rate doesn't subside) and sizeable bank and litigation payments looming, management has decided to put a couple of savvy CFOs on its... more
...more metal cages. Our friends in high places at Medtronic tell us that Sofamor Danek is considered to be Medtronic's best acquisition-ever. A worthy competitor calls the boys in Memphis “the machine.” Indeed. No doubt Mike DeMane's “threat” to replace... more
Guidance to 2005? This is a famously conservative management, so to guide out to 2005 is cause to sit up and take notice. What's going on at Wright medical? Strong biologics and ceramic on ceramic hip components certainly. But, we... more
Last Thursday, dj Orthopedics, Inc. (DJO) held a conference call to help investors wade through the new numbers from its acquisition of OrthoLogic's bone growth stimulation division. The deal is now signed, sealed and delivered. Bone growth stimulation products are... more
At the 78th annual reunion of the Société Française de Chirurgie Orthopédique et Traumatologique (SO.F.C.O.T.) held last week in Paris, the focus was clearly on new materials - ceramics, plastics and biologics. And among the most successful new materials companies... more
Demineralized Bone Matrix may have picograms of BMP, but it still delivers the goods to both patients and surgeons. We were wrong... really off base... last week when we took the bait offered in a NASS presentation and declared that... more
All that was missing was mud and rain. We even had the crowds and chemical enhancements (basically caffeine). Certainly from the organizers perspective, crowded halls and rooms (standing room only usually) were mighty gratifying. From the attendees standpoint... we needed... more
Orthovita announced this week that it had been granted a patent covering 14 claims related to its ALIQUOT™ Micro Delivery System. ALIQUOT™ is a minimally invasive system to deliver the company's innovative and very interesting new product CORTOSS – which... more
Two major allograft suppliers, Regeneration Technologies and Osteotech, pre-announced 3rd quarter results last week and, as a result, endured fairly severe sell-offs. While the reasons given by each firm were different, the fact that it was these two suppliers caused... more
GenSci Orthobiologics is in the final stages of emerging from Chapter 11 bankruptcy. ISOTIS, the Netherlands based tissue engineering company, is merging with GenSci and setting the stage for a dramatic and interesting rebirth of this company that many, including... more
In this era of recombinant bone morphogenic proteins that cost $5,000 per patient per level, it's refreshing to note that there are more ways to jump start bone healing. Last week, Orthofix announced it had submitted data to the FDA... more
Here's a trick question for all you orthopods reading this newsletter. Name the bone void fill for spinal applications with 9 years of documented clinical success, an FDA controlled randomized clinical trial and over 75,000 cases at 1,500 hospitals. Grafton?... more
For the June quarter, Orthovita reported a 37% YOY jump in sales to $3.7 million. Gross margins were a stellar 83%. But losses for the quarter came in at $2.3 million (down from the prior year's $3.0 million loss for... more
CryoLife reported a loss of $22.3 million on sales of $15.7 million for the quarter ended June 30. Orthopedic sales, which amounted to $280,000, were less than we'd expected and appear to have been delayed from management's earlier forecasts. But... more
Rejected one year ago... Medtronic came back with new data and CMS, while rejecting InFuse again using one analytical approach found another way to show that InFUSE does indeed meet the threshold requirement for receiving a new technology add-on payment.... more
Zimmer: There is no doubt in our mind that Zimmer is grabbing market share – quickly. It is clear that MIS at Zimmer is bigger than instruments and implants; it is really about (aside from improving patient outcomes) reimbursement. CEO... more
It's been 19 months since a surgeon in central Minnesota unknowingly implanted a c.sordelli contaminated allograft tissue into a healthy 23 year old male. It's been 15 months since the Centers for Disease Control published its first findings from the... more
Osteotech is in the midst of a significant turn-around year with sales expected to reach or exceed $96 million and for cash flow (defined as EBITDA) to clear $23 million. This stands in contrast to last year's $83 million in... more
Complete Archive
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 