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Musculoskeletal News Roundup 31-Oct-14

EARNINGS
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today financial results for the third quarter ended September 30, 2014. Consolidated net revenues for the third quarter of 2014 were $51.0 million, up approximately 2%, as reported and over 2% on a constant-currency basis, compared to $50.2 million reported for the third quarter of 2013. U.S. net revenues for the third quarter of 2014 were $34.8 million, up approximately 3%, compared to $33.7 million reported for the third quarter of 2013. International net revenues for the third quarter of 2014 were $16.2 million, down approximately 2%, as reported and up nearly 1% on a constant-currency basis, compared to $16.5 million for the third quarter of 2013. Excluding revenues from the cessation of sales in France, international revenues grew approximately 7% over the same period in 2013. Gross margin in the third quarter increased 22.9% over prior year primarily due to a reduction in non-recurring charges to cost of goods sold during the prior period including the Company's French restructuring and discontinuation of its Puregen product, the ending of the Cross Medical settlement amortization, and continued diligence at managing costs and operational efficiencies. Adjusted EBITDA in the third quarter of 2014 was $8.2 million, or 16.1% of revenues, compared to $6.7 million, or 13.4% of revenues reported in the third quarter of 2013. Third quarter 2014 adjusted EBITDA represents net income excluding effects of interest, taxes, depreciation, amortization, stock-based compensation and IPR&D.

Anika Therapeutics reported financial results for 3Q:14. Product revenue was $22.0 million in 3Q:14, representing an increase of 29% compared to $17.0 million in 3Q:13. Product gross margin for 3Q:14 increased to 73.9%, from 68.4% in 3Q:13. The company's segments grew by: Orthobiologics +47%, Dermal 50%, Surgical 28%, Ophthalmic (74%) and Veterinary (37%) in 3Q:14 respectively. European and ROW revenues increased by 8% and 13% respectively in 3Q:14 compared to 3Q:13. All growth rates are on a reported basis.

CONMED Corporation reported financial results for 3Q:14. Total revenue was $175.0 million in 3Q:14, beating consensus estimates by 1% and representing a decrease of 3% compared to $179.3 million in 3Q:13. Adjusted EBITDA margin increased to 18.1% in 3Q:14 from 16.7% in 3Q:13. Gross margin for 2Q:14 increased to 55.1% from 53.2% in 3Q:13. The company's segments declined by: Orthopedic Surgery 3%, General Surgery 0% and Surgical Visualization 9% respectively in 3Q:14. All growth rates are on a constant currency basis.

Globus Medical reported financial results for 3Q:14. Total revenue was $117.8 million in 3Q:14, beating consensus estimates by 4% and representing an increase of 10% compared to $107.2 million in 3Q:13. Adjusted EBITDA was $42.0 million in 3Q:14, increasing 17% from $35.8 million in 3Q:13. Adjusted EBITDA margin increased to 35.6% in 3Q:14 from 33.4% in 3Q:13. Gross margin for 3Q:14 increased to 76.5%, from 76.4% in 3Q:13. Domestic and international revenues increased by 9% and 23% respectively in 3Q:14. International sales represented 10% of total revenue in 3Q:14. All growth rates are on a reported basis.

Greatbatch reported financial results for 3Q:14. Total revenue was $171.7 million in 3Q:14, in-line with consensus estimates and representing an increase of 1% compared to $167.7 million in 3Q:13. Adjusted EBITDA was $31.7 million in 3Q:14, increasing from $30.8 million in 3Q:13. Adjusted EBITDA margin increased to 18.5% in 3Q:14 from 18.4% in 3Q:13. Gross margin for 3Q:14 increased to 33.8%, from 33.3% in 3Q:13. The company's Orthopedic segment reported product line sales of $32.5 million in 3Q:14, representing an increase of 8% compared to $30.1 million in 3Q:13. All growth rates are on an organic constant currency basis.

IMPLANET reported financial results for 3Q:14. Total revenue was €1.2 million ($1.5 million), decreasing 28% compared to €1.6 million ($2.1 million) in 3Q:13. The company sold 969 units of its core spinal implant, JAZZ in 3Q:14. Total JAZZ revenues totaled €0.4 million ($0.5 million) in 3Q:14, representing an increase of 109% compared to €0.2 million ($0.3 million) 3Q:13. The company's other segments declined by: Knee & Arthroscopy 26% and Hip 100% in 3Q:14 respectively. All growth rates are on a reported basis.

K2M Group reported 3Q:14 financial results. Total revenue was $47.6 million in 3Q:14, beating consensus estimates by 8% and representing an increase of 19% compared to $39.8 million in 3Q:13. Adjusted EBITDA was ($3.1) million in 3Q:14, decreasing from $0.3 million in 3Q:13. Gross margin for 3Q:14 decreased to 68.2%, from 70.4% in 3Q:13. The company's U.S.-based segments grew by: Complex Spine +28%, Minimally Invasive 6% and Degenerative +30% in 3Q:14 respectively. The company's International segment increased 6% and represented 28% of the company's total revenue in 3Q:14. All growth rates are on a constant currency basis.

Mazor Robotics reported financial results for 3Q:14. Total revenue was $6.1 million in 3Q:14, increasing 96% compared to $3.1 million in 3Q:13. Revenue generated in the U.S. increased from $2.3 million in 3Q:13 to $5.4 million in 3Q:14, selling five of its Renaissance systems. International non-U.S. revenue decreased from $0.8 million in 3Q:13 to $0.7 million in 3Q:14. Revenue from system kit sales, services & other was $2.5 million in 3Q:14, representing a 67% increase compared to $1.5 million in 3Q:13. Gross margin for 3Q:14 increased to 80.6%, from 73.2% in 3Q:13. All growth rates are on a reported basis.

NuVasive reported financial results for 3Q:14. Total revenue was $189.9 million in 3Q:14, beating consensus estimates by 6% and representing an increase of 12% compared to $169.2 million in 3Q:13. Gross margin for 3Q:14 increased to 74.9%, from 74.4% in 3Q:13. All growth rates are on a reported basis.

Össur reported financial results for 3Q:14. Total revenue was $126.5 million in 3Q:14, missing consensus estimates by 1% and representing an increase of 6% compared to $104.7 million in 3Q:13. Adjusted EBITDA was $29.0 million in 3Q:14, increasing 30% on a reported basis from $22.3 million in 3Q:13. Adjusted EBITDA margin increased to 22.9% in 3Q:14 from 21.3% in 3Q:13. Gross margin for 3Q:14 increased to 64.0%, from 62.4% in 3Q:13. The company's segments grew by: Bracing & Supports 0%, Prosthetics +15% and Compression Therapy +2% respectively in 3Q:14. All growth rates, except where noted, are on an organic and local currency basis.

RTI Surgical reported financial results for 3Q:14. Revenue was $65.2 million in 3Q:14, beating consensus estimates by 1% and representing an increase of 19% compared to $54.7 million in 3Q:13. However, if Pioneer revenues had been included in the third quarter of both 2013 and 2014, worldwide revenues would have increased by 13%. Gross margin for 3Q:14 increased to 53.2%, from 37.1% in 3Q:13. The company's segments grew by: Spine +16%, Sport Medicine 19%, Bone Graft Substitutes +20%, Ortho Fixation +41%, Surgical Specialties +0%, Dental +1%, Other +87% in 3Q:14 respectively. Domestic and international revenues grew by 21% and 1% in 3Q:14 respectively. All growth rates are on a constant currency basis.

Smith & Nephew reported financial results for 3Q:14. Total revenue was $1,148 million in 3Q:14, beating consensus estimates by 1% and representing an increase of 3% compared to $1,028 million in 3Q:13. Gross margin for 3Q:14 decreased to 74.1%, from 74.7% in 3Q:13. The company's Knee Implant segment revenue increased 1%, comparing unfavorably to an estimated knee market growth rate of 4%. The Hip Implant segment revenue increased by 1%, comparing unfavorably to an estimated market increase of 3%. Sports Medicine / Joint Repair segment revenues grew 11% while the Trauma & Extremities segment revenues increased 8%. All growth rates are on a constant currency basis.

Symmetry Medical reported financial results for 3Q:14. Total revenue was $95.9 million in 3Q:14, missing consensus estimates by 2% and representing an increase of 0.2% compared to $99.5 million in 3Q:13. Gross margin for 3Q:14 increased to 26.8%, from 26.4% in 3Q:13. The company's segments grew by: Instruments +4%, Implants +4%, Cases (4%), Other OEM Solutions +28% and Surgical (10%) in 3Q:14 respectively. All growth rates are on a reported basis.

Tornier reported financial results for 3Q:14. Total revenue was $76.7 million in 3Q:14, in-line with consensus estimates by 9% and representing an increase of 14% compared to $66.7 million in 3Q:13. The company's segments grew by: Total Extremities +11% and Large Joints & Other +13% in 3Q:14 respectively. All growth rates are on a constant currency basis.

FUNDING
Avitus Orthopaedics received a Small Business Innovation Research (SBIR) Phase II award from the National Science Foundation (NSF) for $750,000, and raised an additional $300,000 toward its Series A financing round from Connecticut Innovations and another private investor. The company plans to utilize the capital to submit for 510k clearance and a pilot launch of its Avitus Harvester, a minimally-invasive disposable bone graft harvesting device that cuts and collects bone.

Blue Belt Technologies, Inc. and CR Group (“CRG”) announced that they have closed a senior secured term loan for up to $40 million of capital. Blue Belt Technologies is an orthopaedic surgical technology company with a focus on commercializing the next generation of robotic-assisted surgical tools. The company’s flagship product, the Navio Surgical System, received CE Mark and FDA 510(k) clearance in 2012 and has been commercial in the U.S. since February, 2013. The Navio system provides robotic-assistance for partial knee replacement procedures through proprietary CT-free navigation software and a unique hand held computer controlled bone shaping tool.

M&A
Globus Medical entered into an agreement to acquire the allograft tissue processor, Transplant Technologies of Texas, Ltd. (TTOT). Management feels the transaction is complementary to Globus' present Biologics product portfolio, and also helps the company build a broader regenerative biologics platform. Globus expects the deal to be neutral to fully diluted earnings per share (EPS) and to contribute approximately $2 and $12 million in additional sales for 4Q:14 and the FY2015 respectively.

Wright Medical Group and Tornier N.V. entered into a definitive merger agreement under which Wright and Tornier will merge in an all stock transaction with a combined equity value of approximately $3.3 billion, or 5.5x LTM revenues. After the merger closes, Wright and Tornier shareholders will own approximately 52% and 48% of the shares of the combined company on a fully diluted basis respectively. The transaction creates a pure play Extremities-Biologics company with comprehensive and complementary upper and lower extremity product portfolios. The combined company's annual revenues will be roughly split: 41% Lower Extremity, 40% Upper Extremity, 12% Sports Medicine & Biologics and 9% large joint. Once integrated, the companies anticipate revenues of the combined business growing in the mid-teens and adjusted EBITDA margins approaching 20% in three to four years. Additionally, the company projects the amount of cost synergies to be in the range of $40 to $45 million and are expected to be fully realized by the third year.

REGULAOTRY
Centric Medical, a new division of Life Spine, Inc., received 510(k) clearance for its TARSA-LINK, an osteotomy wedge fusion system intended for internal bone fixation of fractures, fusions, and osteotomies in the foot and ankle. The system features a polyetheretherketone (PEEK) wedge with integral bone screws.

Dallen Medical received 510(k) clearance from the FDA for its Tensyn Band, indicated for acromioclavicular (AC) joint and coracoacromial (CC) ligament repair in shoulder separation. Tensyn features a knotless banding for stabilized fixation of soft tissue in the shoulder, ankle and other anatomy while allowing physiologically natural movement of those joints not available with rigid screw fixation. Tensyn is also wider than other alternatives, which helps distribute fixation pressure across a larger surface area.

MicroDental Laboratories announced that MicrO2 Obstructive Sleep Apnea Device, which the FDA has granted 510(k) approval, is now also available for sale in Canada. The first CAD/CAM milled Obstructive Sleep Apnea device, the MicrO2 offers dentists a new, innovative option for treating the growing number of patients diagnosed with Obstructive Sleep Apnea (OSA).

Zyga Technology received CE Mark certification of its Glyder Facet Restoration Device, a long-term surgical treatment for low back pain caused by facet joint degeneration. The non-fusion, minimally invasive device intends to provide relief from lumbar facet pain, restore facet joint function and preserve native anatomy.

PRODUCT INTRODUCTION & UPDATE
Bacterin International launched its 3Demin Boats and 3Demin Strips demineralized bone allograft products. Both are designed to address the adult deformity and multi-level spine fusion procedures. 3Demin Boats and 3Demin Strips can be used as stand-alone bone grafts or in combination with autologous bone in a variety of spinal fusion applications.

LEGAL
Biomet will pay $6 million to resolve a whistleblower’s False Claims Act suit alleging that the company provided doctors' office staff with kickbacks to encourage the use of bone-growth stimulators, and improperly billing Medicare for certain refurbished medical devices.

CLINICAL
LDR announced the publication of a cost-effectiveness study of its two-level Mobi-C Cervical Disc in comparison to two-level Anterior Cervical Discectomy & Fusion (ACDF). The study utilized the clinical data from the two-level Mobi-C vs. ACDF randomized controlled trial in order to assign health states for the patient population. The results demonstrated that using Mobi-C for cervical total disc replacement (CTDR) procedures, is more cost-effective compared with ACDF for the treatment of two-level cervical disc disease.

OPERATIONS
Zimmer announced the future executive leadership team and organizational structure of the combined company following the eventual closing of its acquisition of Biomet. Zimmer stated that the combined company will be named "Zimmer Biomet", with the new brand to be rolled out across the combined company following the closing of the merger. David Dvorak, current President & CEO of Zimmer, will continue as President & CEO of the combined company, which will comprise 12 executives reporting directly to Mr. Dvorak, and be organized around three business units, three geographic regions and six functional areas.


Blue Belt Technologies Closes $40 Million in Debt Financing from CRG

Blue Belt Technologies, Inc. and CR Group (“CRG”) announced that they have closed a senior secured term loan for up to $40 million of capital. Blue Belt Technologies is an orthopaedic surgical technology company with a focus on commercializing the next generation of robotic-assisted surgical tools. The company’s flagship product, the Navio Surgical System, received CE Mark and FDA 510(k) clearance in 2012 and has been commercial in the U.S. since February, 2013. The Navio system provides robotic-assistance for partial knee replacement procedures through proprietary CT-free navigation software and a unique hand held computer controlled bone shaping tool.

“Blue Belt Technologies represented a unique and compelling investment opportunity for CRG. We were impressed with the company's track record that showed a history of completing important milestones on time and on budget. Over the past few months, Blue Belt has executed co-marketing agreements with major players in the space (with more expected to follow), expanded its bench strength, released a new application and has significantly progressed in the development of new applications that fulfill unmet clinical needs in orthopedics. We are pleased to provide Blue Belt with capital to invest in long term growth and continue the momentum that they have established,” said Charles Tate, Chairman of CRG.

“We could not be more pleased to partner with the team at CRG. Our ability to continue our established momentum, grow our commercial footprint and expand our technology platform across multiple specialties will be fueled by this CRG investment. Our focus remains on improving patient outcomes by delivering robotic assisted solutions for underserved clinical needs,” said Eric B. Timko, President and CEO of Blue Belt Technologies. “Further, this capital will enable us to deepen our collaborations with strategic partners across business and technology initiatives.”


Last Chance to Complete the HealthpointCapital Reader Survey

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The survey is here: 2014 HealthpointCapital Musculoskeletal Readership Survey.

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MicrO2 Sleep Apnea Device by MicroDental Laboratories and FDA cleared, is now Registered for Sale in Canada

MicroDental Laboratories announced that MicrO2 Obstructive Sleep Apnea Device, which the FDA has granted 510k approval, is now also available for sale in Canada. The first CAD/CAM milled Obstructive Sleep Apnea device, the MicrO2 offers dentists a new, innovative option for treating the growing number of patients diagnosed with Obstructive Sleep Apnea (OSA).

“Dentists are the front line for screening and managing patients with Obstructive Sleep Apnea,” noted Kim Bradshaw, CEO and President of MicroDental Laboratories. “Many of our partner dentists asked for a small, precise, and easy to use Obstructive Sleep Apnea device. The MicrO2 device has been designed, from the very beginning, with these goals in mind.”

“I believe the MicrO2 will revolutionize dental sleep medicine,” stated Dr. Bill Dickerson, DDS, FAACD, LVIM. “I can honestly say that I don’t think there is a better appliance out there. With its lingual-less design, airway constriction preventing fins, and unobtrusive size, this device is a winner.”

Featuring a patent pending design and a precision milling production process, the MicrO2 is able to utilize a PMMA material that is cured under controlled conditions. These aspects allow the MicrO2 to be small yet strong, precise, and predictable. The MicrO2 also features a unique approach to titration that is intended to make the device easier to use for the dentist and the patient. In Canada, the device is available from MicroDental Vancouver, MicroDental Ottawa, and MicroDental Hamilton.

“The MicrO2 does not require patients to manage any mechanical adjustments, such as turning screws, or changing positions with elastics. Instead the MicrO2 comes with one pair of Upper and Lower arches set to the prescription, and a second pair set in any amount of advancement increments. Advancements are easily achieved by simply removing the current Upper or Lower arch device and inserting the next advancement device in the MicrO2 series,” commented Laura Sheppard, Sr. Director of Compliance and Regulatory Affairs for MicroDental.

Obstructive Sleep Apnea is one of the fastest developing frontiers in dentistry. According to a study conducted by Université Laval researchers, 40 percent of Canadians suffer from chronic sleep disorders. More than a million Canadians have Obstructive Sleep Apnea, and over one in four Canadian adults are at high risk for having Obstructive Sleep Apnea according to The Public Health Agency of Canada. Obstructive Sleep Apnea has been linked with snoring, memory loss, headaches, depression, and an increased risk of stroke, heart problems, and motor vehicle accidents.

“MicroDental Laboratories has a legacy of partnering with dentists who are committed to enhancing the lives of their patients,” noted Len Liptak, VP of Sales and Marketing for MicroDental. “With our Health Canada registered MicrO2 device, we look forward to partnering with these dentists as they manage the growing number of patients who are diagnosed with this serious condition.”


Wright Medical and Tornier Agree to Merger

Wright Medical Group and Tornier N.V. entered into a definitive merger agreement under which Wright and Tornier will merge in an all stock transaction with a combined equity value of approximately $3.3 billion, or 5.5x LTM revenues.

Under the terms of the agreement, each outstanding share of Wright common stock will be exchanged for 1.0309 ordinary shares of Tornier. After the merger closes, Wright and Tornier shareholders will own approximately 52% and 48% of the shares of the combined company on a fully diluted basis respectively.

The company will conduct business as "Wright Medical Group N.V." and will be domiciled in the Netherlands, where Tornier has been headquartered for eight years. The company will base its Lower Extremity & Biologics business in Memphis, TN, where Wright’s current headquarters is located, while its Upper Extremity businesses will be based within Tornier’s existing facility in Bloomington, MN and its U.S. engineering center in Warsaw, IN.

Robert Palmisano, Wright's current Chief Executive Officer (CEO), will become President & CEO of the combined company, while David Mowry, Tornier's President & Chief Executive Officer, will become Executive Vice President & Chief Operating Officer. Additionally, the company's Board of Directors will comprise of five representatives from both Wright's and Tornier's existing boards, including Robert Palmisano and David Mowry.

The transaction creates a pure play Extremities-Biologics company with comprehensive and complementary upper and lower extremity product portfolios. Furthermore, the deal provides the company with a significant amount of diversity and scale across various geographies and product categories, expands the capability of selling biologic products across an expanded upper and lower extremities product portfolio, and combines two research and development teams, all with the aim of accelerating the company's route to profitability and a stronger financial profile.

The combined company's annual revenues will be greater than $600 million and be roughly split: 41% Lower Extremity, 40% Upper Extremity, 12% Sports Medicine & Biologics and 9% large joint. Once integrated, the companies anticipate revenues of the combined business growing in the mid-teens and adjusted EBITDA margins approaching 20% in three to four years. Additionally, the transaction is expected to be accretive to the combined companies’ adjusted EBITDA in the second full-year after completion of the transaction.

The company projects the amount of cost synergies to be in the range of $40 to $45 million and are expected to be fully realized by the third year after completion of the transaction. Cost synergy opportunities include: public company expenses, overlapping support function and systems costs, as well as process and vendor consolidation opportunities across the business.

The company anticipates its stock will continue to trade on the NASDAQ Global Select Market (NASDAQ GS) under ticker "WMGI". The transaction is expected to close 1H:15.


Globus Medical to Acquire Transplant Technologies of Texas

Globus Medical entered into an agreement to acquire the allograft tissue processor, Transplant Technologies of Texas, Ltd. (TTOT).

TTOT is a provider of sterile human tissue products including bone allografts, biomaterials, soft tissue products, machined spine implants, demineralized bone matrix (DBM) and sponge allografts for applications in spine, orthopedics, sports medicine, dental and wound care marketplaces. TTOT also processes and offers sports medicine tendons, birth tissue allografts and dermal allografts.

Management feels the transaction is complementary to Globus' present Biologics product portfolio, and also helps the company build a broader regenerative biologics platform.

Globus plans to maintain and develop TTOT’s operations in San Antonio, TX, and to preserve the company's existing distributor relationships.

Globus expects the deal to be neutral to fully diluted earnings per share (EPS) and to contribute approximately $2 and $12 million in additional sales for 4Q:14 and the FY2015 respectively.


Musculoskeletal News Roundup 24-Oct-14

EARNINGS
Exactech reported financial results for 3Q:14. Total revenue was $57.9 million in 3Q:14, in-line with consensus estimates and representing an increase of 4% on a constant currency basis compared to $55.7 million in 3Q:13. Gross margin for 3Q:14 decreased slightly to 70.8%, from 71.0% in 3Q:13. The company's segments grew by: Knee (2%), Hip +4%, Extremity +23% and Biologic & Spine (10%) in 3Q:14 respectively. All growth rates, unless stated, are on a reported basis.

Stryker reported financial results for 3Q:14. Total revenue was $2.4 billion in 3Q:14, beating consensus estimates by 3% and representing an increase of 11% compared to $2.2 billion in 3Q:13. Gross margin for 3Q:14 decreased to 65.6%, from 68.3% in 3Q:13. The company's segments grew by: Knees +6%, Hips 4%, Trauma & Extremities +12%, Instruments +20%, Endoscopy +19%, Medical +13%, Spine 2% and Neurotechnology +11% respectively in 3Q:14. International revenues grew by 9% in 3Q:14 compared to 3Q:13 and represented 32% of total revenue in 3Q:14. All growth rates are on a constant currency basis.

Victrex reported financial results for its fiscal year 2014. The company's Invibio revenues were £53.4 million ($86.7 million) representing an increase of 5% compared to £50.8 million ($82.0 million) in 2013. Management attributes the growth to an improvement in the global spine market. For 2015 the company plans to initiate the roll-out of its PEEK-OPTIMA HA-Enhanced product. Pending U.S. and European regulatory approval, adoption and roll-out is anticipated to commence during the first half of the company's fiscal year.

Zimmer reported financial results for 3Q:14. Total revenue was $1.11 billion in 3Q:14, beating consensus estimates by 1% and representing an increase of 3% compared to $1.07 billion in 3Q:13. Gross margin for 3Q:14 increased to 73.0%, from 69.4% in 3Q:13. The company's segments grew at: Knees +6%, Hips 3%, Extremities +2%, Dental (2%), Trauma (1%), Spine 6% and Surgical & Other 4% respectively in 3Q:14. The company's Americas, Europe and Asia-Pacific segments grew at 1%, 6% and 7% respectively in 3Q:14. All growth rates are on a constant currency basis.

FUNDING
ZipLine Medical received $5.7 million as an extension to its Series C funding from China Materialia. The new capital will help the company increase its marketing and sales efforts of its Zip surgical skin closure device.

M&A
Bone Biologics, Corp. completed a reverse merger with Bone Biologics, Inc. and AFH Acquisition X, Inc. Upon completion of the merger, the newly combined company changed its name to "Bone Biologics, Corp" and anticipates trading in the company's common stock will commence on the OTC Bulletin Board (OTCBB) following regulatory approvals. The company is developing a proprietary protein for use in bone regenerative medicine using the patented recombinant human protein known as UCB-1 (or Nell-1) for use with patients undergoing spinal fusion. Bruce Stroever, the President & CEO of Musculoskeletal Transplant Foundation (MTF), will serve as Chairman of the Bone Biologics' Board and Michael Schuler, MTF's Vice President of New Business Development, will serve as CEO. MTF is the largest shareholder of Bone Biologics.

Materialise NV entered into an agreement to acquire the U.K.-based OrthoView Holdings Limited, a leading provider of 2-D digital pre-operative planning and templating solutions for orthopedic surgeons for an enterprise value of up to £7.6 million ($12.3 million), or 2.3x LTM revenues, or approximately 8.2x LTM EBITDA. Management believes the deal better positions Materialise to provide surgeons and hospitals with more cost-effective patient-specific anatomical models and instrumentation.

REGULATORY
SafeWire received CE Mark Certification for its line of Y-Wire Anchoring Guide Wires. The Y-Wire line incorporates a patented bifurcated tip and is designed to prevent inadvertent wire advancement and reduce the amount of fluoroscopy during MIS pedicle screw placement.

PRODUCT INTRODUCTION & UPDATE
Aesculap Implant Systems launched its Plasmafit Pro Acetabular System with the Vitelene liner, which consists of a cementless titanium acetabular shell and a highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) vitamin E blended liner. The hemispherical and slightly flattened design of the Plasmafit PRO cup along with a rough titanium plasma spray on the outer surface aims to provide a high level of stability for strong primary and long-term implant fixation. The Vitelene liner is formulated with antioxidant protection that provides wear and oxidation resistance and balanced mechanical properties.

Bacterin International launched a demineralized allograft, 3Demin Cortical Fibers, intended for a number of orthopedic and reconstructive applications, particularly spinal procedures. The fibers are demineralized utilizing the company's proprietary processing technology.

Medtronic launched its Pure Titanium Coating (PTC) platform of interbody fusion devices indicated for spinal procedures. The platform consists of four products: the CAPSTONE PTC Spinal System, CLYDESDALE PTC Spinal System, ANATOMIC PEEK PTC Cervical Fusion System and CORNERSTONE-SR Ti- Coated Anatomical Cervical Cage. These devices are utilized to treat patients experiencing pain caused by compression of the spinal cord or nerve roots by helping to restore normal disc height. Additionally, the company announced the launch of its DIVERGENCE Anterior Cervical Fusion System for the treatment of single-level cervical disc disease. DIVERGENCE represents a new approach to one-level anterior cervical discectomy with fusion (ACDF) procedures, which traditionally use a four-hole plate and interbody fusion cage. DIVERGENCE's plate and interbody cage can be inserted simultaneously using a common set of instrumentation and one surgical technique.

The Orthopaedic Implant Company (OIC) launched its anatomic lower extremity and straight plates, the company's largest product launch to date. Consisting within the launch are distal fibula and tibia plates, proximal tibia plates, and straight compression and tubular plates, all addressing numerous small bone fragment indications. The plates provide lag screw fixation for comminuted patterns, non-locking screws to obtain compression across simple patterns and locking fixation in osteopenic bone and multi-fragmentary fracture patterns.

X-spine Systems launched its Axograft product portfolio, a broad line of biologics products. The line consists of Axograft DBM Putty, Axograft Cancellous Crushed Allograft, Axograft Crunch Allograft and Axograft Amniotic Membrane. Axograft complements the company’s comprehensive line of spinal fixation products and will be utilized to promote spinal fusion, bone healing and wound treatment in spinal arthrodesis procedures.

INTELLECTUAL PROPERTY
Expanding Orthopedics (EOI) received a patent from the U.S. Patent & Trademark Office (USPTO). The patent covers the company's technologies in the area of expandable interbody cages and vertebral compression fractures (VCF) solutions.

CLINICAL
Bacterin International presented preclinical results of its antimicrobial coating for orthopedic hardware. The rifampin- and minocycline-containing coating is intended to address implant-associated infections, one of the most serious complications in orthopedic surgery, by inhibiting the microbial contamination of the implant that can lead to such an infection. The study demonstrated that the coating does inhibit infection progression in a rabbit model of pin track infection and helps the orthopedic hardware in maintaining anchoring strength.

Cerapedics announced results from its first prospective clinical study evaluating the safety and efficacy of its i-FACTOR bone graft in anterior lumbar interbody fusion (ALIF). The non-blinded study was published in the peer-reviewed Journal of Neurosurgery: Spine, treated 110 patients with i-FACTOR and evaluated for fusion rates and clinical outcomes with a mean follow-up of two years. Treatment was shown to provide favorable clinical outcomes in patients who undergo ALIF surgery for degenerative spine conditions by facilitating successful fusion of two or more vertebrae, also known as arthrodesis. The study also demonstrated a statistically significant improvement between preoperative and postoperative scores when assessing patients using the Oswestry Low Back Pain Disability Questionnaire (ODI), Short Form-12, Odom's criteria score, and a visual analogue scale for pain (VAS).

COLLABORATION
Aurora Spine entered into a worldwide distribution and co-marketing agreement with Sentio, LLC to distribute the SentioMMG nerve mapping system. Sentio's system locates and maps motor nerve roots and their peripheral extensions originating from spinal levels C3-T1 and L2-S2. It utilizes smart-sensors employing proprietary technology that use non-invasive accelerometer-based sensors to measure mechanomyography (MMG) activity, the mechanical "twitch" associated with muscle contraction.

Osiris Therapeutics entered into an exclusive commercial and development partnership with Arthrex for its cartilage product, Cartiform, a viable chondral allograft intended to repair and restore damaged cartilage in the knee, foot, ankle, and other major joints. The Agreement provides Arthrex with exclusive commercial distribution rights to Cartiform. Osiris will continue to be responsible for the manufacturing, research and product improvement activities. The responsibilities related to the design and conduct of future clinical development programs will be shared between both organizations.

OPERATIONS
CMS released its Open Payments database last week. The database was mandated by the Affordable Care Act (ACA or Obamacare) and discloses the financial relationships between physicians and drug and device manufacturers.

Life Spine announced the relocation of its headquarters to Huntley, IL. The new 58,400 square-foot facility sits on 10 acres and will allow the company to add about 25 employees by the end of 2015.

Seikagaku established a U.S. office to support sales and marketing of products such as its SUPARTZ multi-injection and Gel-One single-injection joint therapies. The company anticipates a greater demand for hyaluronic acid (HA) formulations in the U.S. as the age of the general population continues to rise, increasing the occurence of knee osteoarthritis (OA).

APPOINTMENTS
Mazor Robotics appointed Christopher Prentice, the company's current Senior Vice President, America & Global Marketing, as the CEO of Mazor Robotics, Inc., the U.S.-based subsidiary of Mazor Robotics. Mr. Prentice joined Mazor in 2010 after holding leadership positions with Johnson & Johnson subsidiary Ethicon Endo-Surgery and Intuitive Surgical.


Materialise Acquires OrthoView for Up to $12.3M

Materialise NV entered into an agreement to acquire the U.K.-based OrthoView Holdings Limited, a leading provider of 2-D digital pre-operative planning and templating solutions for orthopedic surgeons for an enterprise value of up to £7.6 million ($12.3 million), or 2.3x LTM revenues, or approximately 8.2x LTM EBITDA. The transaction closed simultaneously with the signing of the agreement.

Under the terms of the transaction, Materialise acquires OrthoView for a cash payment of £8.5 million ($13.7 million), and a possible additional earn out payment of up to £0.4 million ($0.6 million). At deal completion, OrthoView had an estimated £1.2 million ($1.9 million) in cash & cash equivalents and no financial debt.

OrthoView's 2-D template platform compliments Materialise's position in 3-D pre-operative planning tools, giving the company a comprehensive range of services and solutions for 2-D as well as 3-D planning tools for practically any type of medical images, supplemented with the ability to offer corresponding 3-D printed surgical guides and models. Management believes the deal better positions Materialise to provide surgeons and hospitals with more cost-effective patient-specific anatomical models and instrumentation.


Mazor Appoints CEO of U.S. Subsidiary

Mazor Robotics appointed Christopher Prentice, the company's current Senior Vice President, America & Global Marketing, as the CEO of Mazor Robotics, Inc., the U.S.-based subsidiary of Mazor Robotics.

Mr. Prentice joined Mazor in 2010 after holding leadership positions with Johnson & Johnson subsidiary Ethicon Endo-Surgery and Intuitive Surgical.

Management feels the U.S. market represents the company's greatest growth opportunity for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain procedures.



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