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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 26-Feb-15

Earnings
Anika Therapeutics reported financial results for 4Q:14. Product revenue was $17.9 million in 4Q:14, representing an decrease of 11% compared to $20.2 million in 4Q:13. Product gross margin for 4Q:14 increased slightly to 69.2%, from 69.1% in 4Q:13. The company's segments grew by: Orthobiologics (14%), Dermal (47%), Surgical (15%), Ophthalmic 20% and Veterinary 2% in 4Q:14 respectively. United States, European and ROW revenues increased by 19%, (58%) and 8% respectively in 4Q:14 compared to 4Q:13. All growth rates are on a reported basis.

DJO Global reported financial results for 4Q:14. Revenue was $327.1 million in 4Q:14, increasing 4% compared to $313.6 million in 4Q:13. Adjusted EBITDA was $82.0 million in 4Q:14, increasing 11% on a reported basis from $74.2 million in 4Q:13. Adjusted EBITDA margin increased to 25.1% in 4Q:14 from 23.7% in 4Q:13. Gross margin for 4Q:14 increased to 60.4%, from 59.6% in 4Q:13. The company's segments grew by: Bracing & Vascular +6%, Recovery Sciences 5% and Surgical Implant +11% in 4Q:14 respectively. International revenues grew by 10% in 4Q:14 compared to 4Q:13 and represented 25% of total revenue in 4Q:14. All growth rates are on a constant currency.

Globus Medical reported financial results for 4Q:14. Total revenue was $128.8 million in 4Q:14, beating consensus estimates by 1% and representing an increase of 12% compared to $115.2 million in 4Q:13. Adjusted EBITDA was $47.2 million in 4Q:14, increasing 10% from $42.9 million in 4Q:13. Adjusted EBITDA margin decreased slightly to 36.7% in 4Q:14 from 37.3% in 4Q:13. Gross margin for 4Q:14 decreased to 75.7%, from 76.8% in 4Q:13. All growth rates are on a reported basis.

Integra LifeSciences reported 4Q:14 financial results. Total revenue was $252.2 million in 4Q:14, beating consensus estimates by 3% and representing a increase of 14% compared to $220.8 million in 4Q:13. Adjusted EBITDA was $58.2 million in 4Q:14, increasing 19% on a reported basis from $42.7 million in 4Q:13. Adjusted EBITDA margin increased to 23.1% in 4Q:14 from 19.3% in 4Q:13. Gross margin for 4Q:14 decreased to 61.3%, from 62.0% in 4Q:13. The company's U.S.-based Neurosurgery, Instruments, Extremities and Spine & Other segments grew by 45%, (1%), 17% and (8%) respectively in 4Q:14. The company's International segment increased 18% in 4Q:14. All growth rates are on a constant currency basis unless stated otherwise.

NuVasive reported financial results for 4Q:14. Revenue was $204.3 million in 4Q:14, beating consensus estimates by 1% and representing an increase of 12% compared to $190.8 million in 4Q:13. Gross margin for 4Q:14 increased to 77.2%, from 74.1% in 4Q:13. All growth rates are on a reported basis.

Tornier reported financial results for 4Q:14. Revenue was $92.4 million in 4Q:14, slightly below consensus estimates and representing an increase of 14% compared to $83.4 million in 4Q:13. The company's segments grew by: Total Extremities +16% and Large Joints & Other +8% in 4Q:14 respectively. All growth rates are on a constant currency basis.

Wright Medical reported financial results for 4Q:14. Revenue was $83.3 million in 4Q:14, in-line with consensus estimates and representing an increase of 23% compared to $67.8 million in 4Q:13. Gross margin for 4Q:14 increased to 77.1%, from 74.3% in 4Q:14. The company's segments grew by: Foot & Ankle +39%, Upper Extremity (14%), Biologics +10% and Other Extremities (10%) in 4Q:14 respectively. All growth rates on a constant currency basis.

M&A
Globus Medical entered into an agreement to acquire a third party manufacturer of high precision medical devices, Branch Medical Group, Inc (BMG) for $52.9 million in cash, on a cash-free, debt-free basis. This represents 2.3x BMG's 2014 sales of $23.3 million, and 5.8x adjusted EBITDA of $9.1 million.

Funding
Shandong Weigao Group Medical Polymer Company announced plans to spin off the Weigao Ortho subsidiary business and list on the Main Board of the Hong Kong Stock Exchange in an Initial Public Offering (IPO). The company filed a preliminary prospectus on February 23 to offer no less than 26.5% of the enlarged share capital of the company.

Regulatory
McGinley Orthopaedic Innovations received FDA clearance to market the IntelliSense Drill. The drill features auto-stop bone edge detection, integrated depth measurement and direct surgical lighting. This is the company's first FDA cleared product.

Providence Medical Technology, a privately held, spinal focused medical device company, was granted CE Mark approval to market their DTRAX line of cervical spine products in Europe.


Appointments
OrthAlign, Inc's Board of Directors appointed Gary D. Henley as Executive Chairman. Mr. Henley was President, Chief Executive Officer and Board Member of United Orthopedic Group from 2011 to 2014. Prior to that he served as President and Chief Executive Officer of Wright Medical Group from 2006 to 2011, and as President of the Americas Division of Orthofix International from 1997 to 2006.

ChoiceSpine announced two executive hires. Tom McLeer has been hired as Senior Vice-President. In his roll, Mr. McLeer will act as advisor to the founders and assist with strategic planning and business development. Most recently, Mr. McLeer served as Senior Vice President of U.S. Commercial Operations for Alphatec Spine. Steve Ainsworth, PhD has been hired as Vice President R&D. Previously, Dr. Ainsworth was Vice President of TranS1.


Weigao to Spin Off Ortho Subsidiary in IPO

Shandong Weigao Group Medical Polymer Company announced plans to spin off the Weigao Ortho subsidiary business and list on the Main Board of the Hong Kong Stock Exchange in an Initial Public Offering (IPO). The company filed a preliminary prospectus on February 23 to offer no less than 26.5% of the enlarged share capital of the company.

Spin-offs occur when a publicly traded diversified business seeks to unlock shareholder value by divesting a division to its shareholders that may offer a higher multiple when traded separately.

Weigao Ortho, well known in the industry for previously partnering with Medtronic, describes themselves as the largest domestic orthopedic implant producer in China and the fifth largest, in terms of recent revenues, of all orthopedic implant producers in China. With orthopedic multiples on the increase, this may make sense for Weigao.

Weigao Group's Chairman, President and Chief Marketing Officer, told AAStocks.com that he believes this spin off reflects the growth potential within the industry. The Company's goal is to raise approximately US$300 million. Global Capital reported that "the IPO will mainly involve primary shares, according to a banker on the deal," and that CICC, Morgan Stanley and UBS are the joint sponsors.


Globus Medical to Acquire Branch Medical Group

Globus Medical entered into an agreement to acquire a third party manufacturer of high precision medical devices, Branch Medical Group, Inc (BMG) for $52.9 million in cash, on a cash-free, debt-free basis. This represents 2.3x BMG's 2014 sales of $23.3 million, and 5.8x adjusted EBITDA of $9.1 million.

Branch Medical Group has become Globus' top parts supplier, and Globus plans to invest an additional $15 to $17 million over the next three years to increase BMG' capacity and double the number of parts sourced from the BMG manufacturing facility. With the cost benefit from vertically integrating manufactured parts, and after expanding manufacturing capability, Globus expects the acquisition to be neutral to 2015 earnings. The companies expect the acquisition to occur in March 2015.


Musculoskeletal News Roundup 19-Feb-15

Earnings
Exactech reported financial results for 4Q:14. Total revenue was $63.3 million in 4Q:14, slightly below consensus estimates and representing an increase of 3% compared to $61.6 million in 4Q:13. Gross margin for 4Q:14 increased to 69.8%, from 68.8% in 4Q:13. The company's segments grew by: Knee (7%), Hip +12%, and Biologic & Spine (8%) in 4Q:14 respectively. All growth rates are on a reported basis.

LDR Holdings reported financial results for 4Q:14. Total revenue was $39.5 million in 4Q:14, beating consensus estimates by 9% and representing an increase of 24% compared to $32.0 million in 4Q:13. Adjusted EBITDA was $(0.7) million in 4Q:14, decreasing from $1.0 million in 4Q:13. Gross margin for 4Q:14 decreased to 82.7%, from 83.2% in 4Q:13. Domestic U.S. revenue increased 29% to $32.0 million in 4Q:14 from $25 million in 2Q:13. International revenue increased 6% during 4Q:14 to $7.5 million, representing 19% of total revenue. All growth rates are on a reported basis.

Mazor Robotics reported financial results for 4Q:14. Total revenue was $5.7 million in 4Q:14, decreasing slightly compared to $5.7 million in 4Q:13. Revenue generated in the U.S. decreased from $4.2 million in 4Q:13 to $3.1 million in 4Q:14. International non-U.S. revenue increased from $1.5 million in 4Q:13 to $2.3 million in 4Q:14, reflecting four system sales in 4Q:14 compared to three system sales in 3Q:13. Revenue from system kit sales, services & other was $2.5 million in 4Q:14, representing a 32% increase compared to $1.9 million in 4Q:13, due to increased utilization of the Renaissance system. Gross margin for 4Q:14 declined slightly to 78.4%, from 78.5% in 4Q:13. All growth rates are on a reported basis.

Medtronic reported financial results for its fiscal 3Q:15. Revenue was $4.3 billion in 3Q:15, beating consensus estimates by 2% and increasing 8% from $4.2 billion in 3Q:14. Gross margin for 3Q:15 decreased to 73.9%, from 74.8% in 3Q:14. The company's Core Spine and Interventional Spine segments declined by 1% and 0% in 3Q:15 respectively, while BMP (Biologics), increased by 9%. The company's overall Spine segment increased by 2%. International revenue was $1.9 billion in 3Q:15, increasing 7% from $1.9 billion in 3Q:14. International revenue accounted for 43.1% of Medtronic's total revenue in 3Q:15, decreasing from 43.8% in 3Q:14. All growth rates are on a constant currency basis.

M&A
Ferring Pharmaceuticals entered into an agreement to acquire the assets of BioSurface Engineering Technologies Inc. (BioSET), a developer of biomimetic growth factor peptide medical devices intended to regenerate bone and improve soft tissue repair.

Funding
Invuity raised $20 million in an equity financing round led by Wellington Management Company. The Company plans to use the proceeds to accelerate growth and commercialize product initiatives.

Precision Spine announced that they had finalized an agreement to refinance its existing debt and pursue strategic acquisitions. Commenting on the Company's growth, Jim Pastena, CEO and Chairman of the Board stated that "full year sales increased 26% in 2014 over 2013, and 4th quarter 2014 sales alone grew 45% over the same period in 2013."

Regulatory
Dallen Medical received U.S. FDA clearance to market the Tensyn Plug, a knotless fixation implant with a lower profile, than its Tensyn Band. The Tensyn products are used for stabilized fixation of soft tissue in the extremities while allowing physiologically natural movement of those joints.

Medtronic received U.S. FDA clearance to expand the indications of the VERTEX Reconstruction System. The new clearance allows for lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine.

Simplify Medical received a CE mark to market its Simplify Disc in Europe. The product is a cervical disc replacement composed of MRI friendly materials by utilizing PEEK endplates on a ceramic core.

Sonoma Orthopedic Products received U.S. FDA clearance for the intramedullary FibuLock Nail. The product is designed to treat fractures of the lower end of the fibula with a less invasive approach compared to the traditional treatment with plates. It uses internal bone anchors which allow alignment and support of the fracture. The company plans to launch in 2Q:15 in limited geographies.

Product Introduction & Update
Blue Belt Technologies announced the 1,000th partial knee replacement procedure performed using their Navio® Surgical System. The case was performed by Dr. Michael Higgins, Orthopedic Surgeon at Sentera CarePlex Hospital in Hampton, VA. The Navio system utilizes computer navigation and handheld robotic-assisted technology to provide accurate and precise bone preparation for unicondylar and patellofemoral knee replacement procedures.

Clinical
Cerapedics announced the results of a study, published in the International Journal of Spine Surgery, that compared bone growth inside hollow disc cages for 40 patients receiving posterior lumbar interbody fusion (PLIF) surgery. The control group received autograph, while the study group received Cerapedics i-Factor biologic bone graft. The study team followed the patients for 24 months. At 6 months, the researchers found that intra-cage bridging bone occurred earlier with the biologic bone graft (97%) than with autograft (59%). The study concluded that the biologic bone graft had greater efficacy at 6 and 12 months. Additionally, pain improvements and functional improvements exceeded success criteria at all time points.


Ferring Pharmaceuticals Acquires BioSurface Engineering Technologies

Ferring Pharmaceuticals entered into an agreement to acquire the assets of BioSurface Engineering Technologies Inc. (BioSET), a developer of biomimetic growth factor peptide medical devices intended to regenerate bone and improve soft tissue repair.

Under the terms of the transaction, Ferring will acquire AMPLEX and PREFIX, two phase III-ready orthobiologic product candidates in development for foot/ankle and lumbar spine respectively. Both products are based on a unique biomimetic peptide and aim to enhance the body’s own natural mechanisms of bone repair. In addition to AMPLEX and PREFIX, Ferring has also acquired a supplemental library of biomimetic peptides intended for applications in bone and tissue repair.

In 2005, Ferring launched EUFLEXXA, a sodium hyaluronate injection indicated for the treatment of knee pain brought on by osteoarthritis (OA). Since then, the company has outlined the orthopedics sector as one of its five key therapeutic segments for its growth strategy. This transaction expands and diversifies Ferring’s product portfolio by giving the company a platform to develop orthobiologic products for joint fusion and other orthopedic surgical procedures.

BioSET was formed in 2001 as a spin out of U.S. Surgical’s acquisition of InnerDyne, Inc.


Blue Belt Technologies Announces 1,000 Navio Assisted Partial Knee Replacements

Blue Belt Technologies, a medical device company specializing in solutions for orthopedic surgery, announced the 1,000th partial knee replacement procedure performed using their Navio® Surgical System. The case was performed by Dr. Michael Higgins, Orthopedic Surgeon at Sentera CarePlex Hospital in Hampton, VA. The Navio system utilizes computer navigation and handheld robotic-assisted technology to provide accurate and precise bone preparation for unicondylar and patellofemoral knee replacement procedures.

“The precision, ease of use and predictability of outcomes that Navio’s robotic-assistance offers have made partial knee replacements a true pleasure to perform,” said Dr. Higgins.

After receiving CE Mark for the Navio system in February 2012 and FDA clearance in December 2012, Blue Belt began full commercialization in March 2013. The technology has experienced widening adoption and use since then. In 2014, Blue Belt Technologies achieved several commercial milestones including selling 33 Navio systems, partnering with two major implant companies, and receiving FDA clearance for a patellofemoral joint replacement application.

“Navio has had tremendous success in the last two years,” said Eric Timko, President and CEO of Blue Belt Technologies. “Last August Blue Belt announced our 500th case; 6 months later we’ve seen our incredible growth continue. Our company remains committed to bringing truly innovative technology to our customers and fostering the growth that happens when we do.”

The Navio system provides robotic assistance for partial knee replacement procedures through proprietary CT-free navigation software and a unique handheld, computer-controlled, bone shaping tool. Navio brings a high degree of implant placement accuracy, soft tissue balancing benefits, and supports 6 different knee systems to provide access to robotic-assistance for a wide surgical audience.



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