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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 21-July-16

EARNINGS
IMPLANET reported financial results for 2Q:16. Total revenue was €2.1 million ($2.3 million) in 2Q:16, increasing 23% compared to €1.7 million ($1.9 million) in 2Q:15. The company's Spine revenue was €2.0 million ($2.2 million) in 2Q:16, increasing 38% compared to €1.5 million ($1.6 million) in 2Q:15. Total revenues from the company's core spinal implant, JAZZ, increased 100% and 35% in the U.S. and France in 2Q:16 respectively. The company's Knee & Arthroscopy revenue was €2.2 million ($2.3 million) in 2Q:16, increasing 12% compared to €1.9 million ($2.1 million) in 2Q:15. All growth rates are on a reported basis.

Life Spine reported financial results for 2Q:16 and 1H:16. Total revenues in 2Q:16 increased by 50% compared to 2Q:12. Total revenues for 1H:16 grew by 44% compared to 1H:15. All growth rates are on a reported basis.

Medicrea reported financial results for 1H:16. Total revenue was €14.8 million ($16.4 million) in 1H:16, increasing 7% from €13.8 million ($15.3 million) in 1H:15. The company sales in the United states and France grew 8% and 20% respectively. The company has seen progress slow down in countries where they are not present directly or are currently suffering fluctuations in economic conditions, notably, Brazil. Management intends to implement various strategic initiatives in these territories to strengthen the company's commercial position. All growth rates are on a reported basis.

Safe Orthopaedics reported financial results for 2Q:16. Total adjusted revenue for 2Q:16 was €0.64 million ($0.71 million), increasing 29% from €0.50 million ($0.55 million) in 2Q:15. Total revenue from the company's operations in France and the rest of the world (ROW) increased 18% and 40% respectively. The company is in the process of expanding its international distribution network by entering into additional agreements covering Australia, New Zealand and Chile and Mexico. All growth rates are on a reported basis.

M&A
Merit Medical Systems entered into an agreement to acquire DFINE, Inc., a California-based developer of minimally invasive implant systems to treat pathologies of the vertebrae, metastatic spinal tumors, and vertebral compression fractures (VCFs). The transaction price was approximately $97.5 million, which values DFINE at 2.9x 2015 revenues of $33.4 million. Under the terms of the all-cash transaction, DFINE will become a wholly-owned subsidiary of Merit. Wells Fargo, Bank of America, HSBC and U.S. Bank all provided financing to the deal.

Zimmer Biomet acquired a 59% stake in Medtech Société Anonyme, a French-based company that develops surgical robotic technologies to assist surgeons during medico-surgical interventions. The transaction values the business at an approximate enterprise value of $123.5 million, or 9.9x LTM revenues of $12.5 million. Under the terms of the transaction, Zimmer will acquire 1,406,151 common shares from Mr. Bertin Nahum, the present CEO of Medtech, Newfund and certain other selling stockholders for €50.00 ($55.15) a share. Medtech offers its ROSA Spine robotic-assistive system, indicated for minimally invasive surgery (MIS) of the brain and spine. Zimmer plans to launch an all-cash simplified tender offer to acquire the remaining outstanding shares of Medtech for the same offer price of €50.00 ($55.15) a share in the near future.

REGULATORY
Medtronic received510(k) clearance from the FDA for its CD Horizon Fenestrated Screw Set, polymethylmethacrylate (PMMA) cement-augmented pedicle screws intended for the treatment of patients diagnosed with advanced stage tumors in the thoraric and lumbar spine. The self-curing cement is injected to the fenestrations near the end of the screw, allowing for precise cement injection, allowing immediate implant stability.

NeuroPro Spinal Jaxx received 510(k) clearance from the FDA for its Spinal Jaxs, a minimally-invasive, patient-specific expandable intervertebral spacer for spinal procedures. The spacer allows surgeons to insert as much bone graft as needed after the device has been implanted and expanded. Spinal Jaxx features a locking mechanism to prevent device collapse and titanium endplates that contract the vertebral bodies.

PRODUCT INTRODUCTION & UPDATE
DePuy Synthes Trauma launched its Variable Angle Locking Hand System, an anatomically contoured and low-profile plating system for the treatment of hand fractures and deformity correction. The technology allows for patient-specific adjustment and as the screws are tightened to the plate, they lock into place, stabilizing the fracture.

Medtronic launched its Pivox Oblique Lateral Spinal System with Lateral Plate for OLIF25 and Divergence-L Anterior/Oblique Lumbar Fusion System for OLIF51, an interbody fusion system which aims to stabilize the back by fusing two or more vertebrae with bone grafts. Oblique Lateral Interbody Fusion (OLIF) technique intends to minimize cutting the muscles and by utilizing an oblique-lateral trajectory to access multiple levels of the lumbar spine. The system gives surgeons lateral access and direct visualization while preserving the psoas muscle, disc space and anterior longitudinal ligament.

Stryker Performance Solutions launched its Episode Performance Manager (EPM), a tool that translates raw claims data, provided by Medicare, into data that helps understand cost-drivers, identify opportunities for improvement and compare performance of other hospitals participating in Medicare's Comprehensive Care for Joint Replacement (CJR) model. The tool aims to reduce hospital costs by establishing incentives and accountability, increase patient satisfaction 90 days after discharge and aligning providers and hospitals around shared goals.

CLINICAL
Extremity Medical completed initial cases for its AlignX Ankle Fusion System, intended to facilitate arthrodesis of the ankle including tibiotalocalacaneal and tibiotalar joints. The system aims to provide minimal bone preparation, strong axial compression, and rigid fixation. The initial cases received positive feedback and show advancements in biomechanical and OR efficiencies.

IlluminOss Medical completed enrollment in its Photodynamic Bone Stabilization System clinical trial for the treatment of fractures using patient-specific intramedullary implants. The trial has thirteen surgical sites and 80 patients with impending or pathologic fractures in the humerus from metastatic carcinoma. The minimally invasive procedure inserts a light-curable polymer, contained by a thin walled PET balloon catheter into the intramedullary canal to conform to the shape of the patient's specific bone, providing longitudinal strength and rotational stability.

Mazor Robotics announced clinical results using its Robotic Surgical Guidance System. The retrospective study results suggest that the use of robotic guidance in minimally invasive (MIS) approach can notably reduce procedural complications and revisions surgeries in comparison to freehand guidance.


Zimmer Biomet Acquires 59% Stake in Medtech SA with Plans to Buy the Remaining Stake in the Future

Zimmer Biomet acquired a 59% stake in Medtech Société Anonyme, a French-based company that develops surgical robotic technologies to assist surgeons during medico-surgical interventions. The transaction values the business at an approximate enterprise value of $123.5 million, or 9.9x LTM revenues of $12.5 million.

Under the terms of the transaction, Zimmer will acquire 1,406,151 common shares from Mr. Bertin Nahum, the present CEO of Medtech, Newfund and certain other selling stockholders for €50.00 ($55.15) a share. Zimmer will also acquire the outstanding convertible bonds and warrants issued by Medtech to Ally Bridge Group. The price for each convertible bond and warrant are €50.03 ($55.18) and €17.17 ($18.94) respectively.

Zimmer plans to launch an all-cash simplified tender offer to acquire the remaining outstanding shares of Medtech for the same offer price of €50.00 ($55.15) a share in the near future.

Medtech offers its ROSA Spine robotic-assistive system, indicated for minimally invasive surgery (MIS) of the brain and spine. The system aids surgeons not only in the decisive stages of planning and instrument navigation, but also in positioning the implants in the patient’s vertebrae and in neurological procedures conducted in the brain.

The platform employs a robotic arm whose architecture imitates the movements of a human arm, which confers greater dexterity to the surgeon’s movements and complete freedom in the choice of trajectory. The system utilizes 3D imaging to assist with intraoperative planning and to control instrument depth during the procedure. ROSA also incorporates a dynamic guidance system that tracks and responds to patient movements in real-time and compensates for such movements without the necessity to stabilize the system by clamping it onto the spine and surrounding vertebrae.

With ROSA Spine, MedTech is aiming to expand the available MIS options in spine and implement a safer and more efficient treatment by utilizing a smaller incision and reducing radiation exposure for the patient and operating room (OR) staff. Medtech has historically focused more on ROSA's brain application, however this may change under Zimmer's leadership.

This transaction provides Zimmer with a robotics platform that might eventually have applications beyond brain and spine procedures for a relatively low price. This deal gives Zimmer a musculoskeletal robotic platform to compete against Stryker's MAKO System for hips and knees, Smith & Nephew's Navio System for knees, and Mazor and Medtronic's Mazor X robotic system for spine and Globus Medical's developing robotics system for spine surgery.

Medtech will become a wholly-owned subsidiary of Zimmer that will continue to operate out of its current headquarters in Montpellier, France. Mr. Nahum will stay with the company and lead Zimmer's robotic development activities.

To date, this is the fifth acquisition for Zimmer in 2016. The company announced its acquisition of Ortho Transmission, a Colorado-based developer of skeletal implant technology for limb amputee patients in March, the acquisition of Cayenne Medical, a company in the soft tissue repair and reconstruction segment of the sports medicine market in April, the $1.0 billion acquisition of LDR Holding, a developer of surgical implants, devices, and instrumentation for the treatment spinal disorders in June and the acquisition of Compression Therapy Concepts, a developer of medical devices and accessories for the prevention of deep vein thrombosis (DVT) in June.


Merit Medical to Acquire DFINE for $98M

Merit Medical Systems entered into an agreement to acquire DFINE, Inc., a California-based developer of minimally invasive implant systems to treat pathologies of the vertebrae, metastatic spinal tumors, and vertebral compression fractures (VCFs). The transaction price was approximately $97.5 million, which values DFINE at 2.9x 2015 revenues of $33.4 million.

Under the terms of the all-cash transaction, DFINE will become a wholly-owned subsidiary of Merit. Wells Fargo, Bank of America, HSBC and U.S. Bank all provided financing to the deal.

DFINE offers a portfolio of products directed to vertebral augmentation (kyphoplasty and vertebralplasty) systems for percutaneous delivery of bone cement and the treatment of pathological fracture, as well as targeted radiofrequency (RF) ablation of metastatic spinal tumors. The company's flagship product is its STAR device, a tumor ablation kit for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. Three-quarters of DFINE's revenues were generated in the United States, and the remaining one-fourth came from international operations.

With this transaction, Merit plans to create an interventional oncology and spine division (IOS) and merge it with its oncology segments, including embolics, microcatheters and biopsy products. The deal provides Merit with assets that will enhance its oncology business and the restructuring will enable the company to align sales and marketing efforts, improve growth opportunities and focus on offering a more therapeutic and disease state centered product line.

Merit anticipates the transaction to be neutral to its earnings per share (EPS) on a non-GAAP basis and dilutive by $0.24-$0.26 on a GAAP basis for 2016. The company further expects the deal to increase its gross margin by approximately 0.8% (80 basis points) on a non-GAAP basis and 0.6% (55 basis points) on a GAAP basis.


Musculoskeletal News Roundup 15-July-16

M&A
Wright Medical entered into an agreement to divest its hip and knee (large joint) businesses to Corin Orthopaedics for a purchase price of €29.7 million ($33 million), which values the portfolio at 0.9x 2016E revenues of $37 million and 6.0x the midpoint of 2016E EBITDA of $5-$6 million. Under the terms of the all-cash transaction, Corin acquires the entire legacy Tornier large joints business which consists primarily of hip and knee replacement systems sold throughout France and other European countries.

REGULATORY
Cartiva rreceived Premarket Approval (PMA) from the FDA for its Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis (OA) at the base of the great toe. SCI marks the first synthetic cartilage device ever to be approved by the FDA, and the first successful PMA for any product in the forefoot. The device has similar physical properties of articular cartilage and is intended for use in the treatment of patients with painful arthritis at the base of the great toe, the most common arthritic condition in the foot. SCI provides pain relief and improves both function and motion and is designed as an alternative to fusion. Furthermore, the company announced the first U.S. implantation of the device.

PRODUCT INTRODUCTION & UPDATE
Mazor Robotics unveiled its Mazor X, a surgical assurance platform for spine procedures. The guidance platform is comprised of analytical tools, multiple-source data, precision guidance, optical tracking, intra-op verification, and connectivity technologies, aiming to reduce hospital costs and increase patient satisfaction. Mazor X has three patent pending features which include pre-operative analytic software, an intra-operative guidance surgical arm tool and real-time 3D verification for visual tracking and intraoperative imaging. The company is planning to launch Mazor X in October 2016.

Spineart launched its JULIET Ti lumbar interbody systems utilizing the company's proprietary Ti-LIFE technology, a micro-porous scaffold designed to mimic trabecular bone to enable cell colonization and promote bone in-growth. The system includes a range of sizes for different anatomies and features a reduced density to optimized imaging performances.

Spine Wave launched its True Position Pivoting Spacer, a "crescent-style" interbody fusion device implanted through a transforaminal lumbar interbody fusion approach, featuring the company's Center Pivot Point Technology aiding in accurate insertion and positioning.

ulrich medical launched its neon3 Posterior Cervical System, indicated as an alternative to fusion for the immobilization and stabilization of the cervical and thoracic spine. The device features titanium alloy and cobalt chromium rods for different clinical requirements and utilizes a top loading "tulip" style screw designed for open and percutaneous applications.

INTELLECTUAL PROPERTY
Graftys received a patent from the United States Patent and Trademark Office (USPTO) for its GRFT-R02, an osteogenic putty intended for bone tissue regeneration. The biomaterial addresses acetabular reconstruction, spinal fusion and non-fusion procedures and complex cases of fracture healing with poor vascularization. In preclinical trials, the material exhibited similar efficacy to autograft.

COLLABORATION
Aurora Spine was selected to participate in the World Trade Center (WTC) San Diego's MetroConnect program, an export support program designed to help San Diego entities accelerate their growth parameters. Participants received a $10,000 grant and access to a trade and investment manager from the WTC San Diego for guidance on financing, fundraising, global expansion and export compliance.



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