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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 28-July-16 BY BLAKE MOSSY, JULY 28, 2016

EARNINGS
Globus Medical reported financial results for 2Q:16. Total revenue was $137.5 million in 2Q:16, missing consensus estimates by 3% and representing an increase of 3% compared to $133.6 million in 2Q:15. Adjusted EBITDA was $50.2 million in 2Q:16, increasing 7% from $46.7 million in 2Q:15. Adjusted EBITDA margin increased to 36.5% in 2Q:16 from 35.0% 2Q:15. Gross margin for 2Q:16 increased to 76.1%, from 75.6% in 2Q:15. On a reported basis, the company's segments grew: Innovative Fusion (3%) and Disruptive Technology +10% in 2Q:16. Domestic and international revenues increased by 3% and 8% respectively in 2Q:16. International sales represented 9% of total revenue in 2Q:16. All growth rates are on a constant currency basis, unless stated otherwise.

Johnson & Johnson reported financial results for 2Q:16. Total revenue was $18.48 billion in 2Q:15, beating consensus estimates by 3% and representing an increase of 5% compared to $17.79 billion in 2Q:15. Gross margin for 2Q:16 increased to 71.1%, from 69.9% in 2Q:15. Domestic sales increased 7%, while international sales increased 3% in 2Q:16. Total Orthopedic sales were $2.36 billion in 2Q:16 increasing 2% compared to $2.33 billion in 2Q:15 with domestic and international orthopedic sales growing 3% and 0.2% respectively. Hips increased 5% worldwide, with U.S. Hip sales up 2% and international up 10%. Knee sales worldwide increased 5%, with U.S. sales growing 3% and international sales increasing 7%. Trauma sales increased 3% worldwide, U.S. sales growing 9% and international sales decreasing 4%. Spine & Other sales decreased 1% worldwide, increasing 0.4% domestically and decreasing 3% internationally. All growth rates are on a constant currency (operational) basis.

NuVasive reported financial results for 2Q:16. Total revenue was $236.2 million in 2Q:16, beating consensus estimates by 2% and representing an increase of 16% compared to $202.9 million in 2Q:15. Adjusted EBITDA was $59.7 million and the company exhibited an adjusted EBITDA margin of 25.3% in 2Q:16. Gross margin for 2Q:16 decreased to 74.7%, from 76.1% in 2Q:15. All growth rates are on a constant currency basis.

Stryker reported financial results for 2Q:16. Total revenue was $2.84 billion in 2Q:16, beating consensus estimates by 2% and representing an organic increase of 7% compared to $2.43 billion in 2Q:16. Gross margin for 2Q:16 decreased to 64.9%, from 66.0% in 2Q:15. The company's segments grew by: Knees +8%, Hips +2%, Trauma & Extremities +6%, Other Orthopedics +1%, Instruments +7%, Endoscopy +6%, Medical +137%, Sustainability +11%, Spine +1% and Neurotechnology +14% respectively in 2Q:16. International revenues increased by 12% and represented 28% of total revenue in 2Q:16. All growth rates are on a constant currency basis.

M&A
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced that it has entered into a definitive agreement with Globus Medical (NYSE:GMED), a leading musculoskeletal implant manufacturer, whereby Globus will acquire Alphatec's international operations and distribution channel for a purchase price of $80 million. As part of the transaction, Globus has also agreed to provide Alphatec a five-year senior secured credit facility of up to $30 million. Under the terms of the agreement, Globus will acquire Alphatec's international distribution operations and agreements, including Alphatec's wholly-owned subsidiaries in Japan and Brazil and substantially all of the assets of Alphatec's remaining international business, including its sales operations in the United Kingdom and Italy.

FUNDING
Intellirod Spine raised $1.0 million in an equity financing led by new and existing investors including the Queen City Angel First Fund V and JumpStart. The new capital will be used to reach key milestones toward the commercialization of the company's sensor technologies and related lumbar fusion implants.

REGULATORY
4WEB Medical received 510(k) clearance from the FDA for its Later Spine Truss System, a lateral interbody fusion device. The 3D printed device features smart-sterile packaging which intends to improve operating room (OR) efficiencies and help the company access markets that require sterile packaging.

DeGen Medical received 510(k) clearance from the FDA for its F1 MPS Modular Pedicle Screw System for use with the company's JOUST Minimally Invasive Surgery (MIS) procedure. JOUST is a modular pedicle screw system with cobalt chrome alloy heads for percaneous procedures. The system aims to reduce muscle damage in complex lumbar spine procedures.

Medtronic received clearance from the FDA for its Prestige LP Cervical Disc, indicated for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck. Prestige has a low profile ball-and-trough design, which allows the system to move in a range of motions, including bending, rotation, and translation. This provides the patients with a wider range of motion (ROM) for their neck than fusion surgery.

Smith & Nephew (NYSE: SNN; LSE:SN), the global medical technology business, announced the first surgical case of its robotics-assisted total knee replacement procedure. The new approach, which recently received 510(k) clearance from the US Food and Drug Administration, uses the NAVIO Surgical System to implant the JOURNEY II BCS and CR total knee systems. During a total knee replacement surgery, the NAVIO system is designed to deliver consistent and accurate results through the utilization of a robotics-assisted hand piece, navigation and NAVIO specific cut guides, all of which enable better patient outcomes. The NAVIO intra-operative planning software uses 3D surface capture to predict joint laxity, enable precise implant positioning, and customize a solution for each patient. Unlike other robotics-assisted platforms, the NAVIO system does not require a pre-operative CT scan.

PRODUCT INTRODUCTION & UPDATE
Flower Orthopedics launched its MTP Fusion Plate Portfolio, which contains variable angle locking and non-locking compression screws, cannulated screws, the Flower E-Kit and all ancillary instruments for extremity procedures. The new line includes plates that provide anatomic screw fixation and incorporate up to two cannulated interfrag screws to provide a biomechanical stable system, require a smaller incision and reduce overall cost.

Kanghui Orthopedics, a division within the Restorative Therapies Group at Medronic, launched its VariLoc Locking Compression Plate System and instrument sets for the treatment of fractures in China and other select countries. The system utilizes variable angle locking technology, to help surgeons adjust screw angulations to patient anatomy, capture fracture fragments, and to position the screw trajectory after plate placement. Besides China, VariLoc will be launched in Chile, Kenya, Pakistan, Lithuania, Greece, Poland, Turkey, Thailand, and Vietnam.

MiMedx launched its next generation lyophilized (freeze-dried) version of OrthoFlo, the company's line of an amniotic allograft fluids for use in sports medicine and orthopedic applications. The use of lyophilizing eliminates the need for cryopreservation, which eliminates freezers, and allows the allograft to re-hydrate easier, enhancing safety.

Ortho Kinematics launched its VMA-Align, a diagnostic module and service that provides detailed spinal alignment measurement within the company's Vertebral Motion Analysis flagship product. The system provides surgeons with no-touch tools that gives them access to motion, instability and alignment data that helps with patient selection and planning for lumbar fusion surgery.

Zimmer Biomet introduced its Signature Solutions, a suite of clinical services and technologies comprised of interactive engagement tools, a data mining and analysis platform and consulting services. The system intends to assist hospitals and medical practices to transition to value-based healthcare models by helping them enhance patient outcomes and increase procedural and cost efficiencies.

CLINICAL
AMNIOX announced clinical results from two studies regarding the company's CLARIX FLO and CLARIX CORD 1K regenerative injection therapies, indicated for the treatment of plantar fasciitis and tarsal coalition repair. CLORIZ FLO is an injectable product comprised of umbilical cord and amniotic membrane, which are collagen, fibronectin, hyaluronic acid, growth factors and heavy chain hyaluronic acid. CLARIX CORD 1K is an umbilical cord allograft available for clinical transportation. The study results demonstrated high patient satisfaction, increased function and reduced foot pain in the weeks following treatment.

Orthofix published clinical data from a study using its Trinity Evolution product, a viable cellular bone allograft placed within and around the company's PEEK interbody spacer to promote bone growth for patients undergoing a single level vertebral fusion. The prospective, multi-center study provided patients with single-level anterior cervical discectomy and fusion (ACDF) procedures and demonstrated effectiveness in achieving a fusion.

RTI Surgical published peer-reviewed, pre-clinical study results comparing multipotent adult progenitor cells (MAPCs), similar to the company's proprietary technology used in its map3 Cellular Allogenic Bone Grafts, to mesenchymal stem cells (MSCs) in bone healing. The study revealed that MAPCs exhibited a more robust angiogenic protein release profile, enhanced revascularization and new bone formation when compared to MSCs.

OPERATIONS
Xtant Medical expanded its tissue processing facility in Belgrade, MT, which doubled the capacity of the company's processing rooms. The updated facility incorporates seven new processing rooms and aims to improve both production efficiency and utilization of resources for the company's biologic products.

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