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Orthopedic and Dental Industry News Complete Archive »

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Kohlberg & Company Acquires Majority Stake in Amendia

Kohlberg & Company, a middle market private equity firm, acquired a majority stake in Amendia, a Georgia-based developer of spinal surgical medical devices.

Under the terms of the transaction, Amendia has appointed Chris Fair, as Chief Operating Officer and a member of the company's Board of Directors, Dr. Larry Boyd, as Executive Vice President, Research & Development, and Dr. Scott Bruder, as a member of the company's Board of Directors and Executive Committee.

Amendia develops a range of spinal surgery products to address the deformity and degenerative segments of the market. The company's product portfolio includes cervical interbody, cervical fixation and lumbar interbody implants as well as screws, instrumentation, and minimally invasive and biologic solutions. Amendia focuses on a vertically integrated strategy for spinal disorder patients and management believes the investment professionals at Kohlberg & Co. will help the company execute on strategic initiatives for growth.

Kohlberg centers its healthcare portfolio in the healthcare services market, which makes this investment in a medical device company a bit of a deviation for the firm. However, the firm noted that Amendia has great potential for growth opportunities due to the company's product offerings, intellectual property portfolio and scalable operational infrastructure.


Stryker to Acquire Stanmore Implants for $52M

Stryker entered into an agreement to acquire Stanmore Implants Worldwide Limited in an all cash transaction for £35.6 million ($51.9 million).

Stanmore is an England-based developer of orthopedic implants and solutions for orthopedic adult and juvenile oncology, and complex primary and revision reconstruction cases for upper limb, lower limb and pelvis indications. The company’s product portfolio consists of both patient specific and off-the-shelf (OTS) implant systems targeting limb salvage.

Stryker currently offers modular replacement systems for the hip, femur, knee, and tibia affected by osteosarcoma, however this transaction bolsters Stryker's existing portfolio with differentiated technologies designed to provide specialized solutions for orthopedic oncology surgeons, expanding the company's presence in the marketplace.

At the end of April, Stryker's CEO, Kevin Lobo, remarked that he will not hesitate "to pull the trigger on new deals", and Stanmore is the company's fifth acquisition this year and the first acquisition since this statement. Stryker has executed on two billion plus deals earlier in the year, acquiring Physio-Control, a developer of emergency medical response equipment, and Sage Products, a supplier of disposable health and personal care products. The company has also executed on two tuck-in deals earlier this year including the acquisition of SafeWire, a developer of minimally invasive surgical instruments for spine procedures, and the neurology portfolio of Synergetics USA.


Musculoskeletal News Roundup 29-April-16

EARNINGS
Amplitude Surgical reported financial results for 3Q:16 of its fiscal year. Total revenue was €24.3 million ($27.5 million) in 3Q:16, representing an increase of 19% compared to €21.0 million ($22.8 million) in 3Q:15. The company's domestic sales in France were €16.9 million ($19.2 million) in 3Q:16, increasing 23% from €13.7 million ($14.9 million) in 3Q:15. International sales were €7.3 million ($8.3 million) in 3Q:16, increasing 10% from €7.3 million ($7.9 million) in 3Q:15. All growth rates are on a constant currency basis.

Aurora Spine reported 2015 financial results. Total revenue was $4.9 million in 2015, increasing of 90% compared to 2014. Total revenue was $1.5 million in 1Q:16, increasing of 15% compared to 1Q:15. The company's TiNano interbody portfolio increased 530% in 2015 compared to 2014 and represented roughly 55% of the 2015 revenues. Total revenue for the company's Hardware segment was $1.9 million in 2015, remaining flat compared to 2014. Sales outside of the U.S. represented approximately 10% of the company's revenues in 2015. All growth rates are on a reported basis.

CONMED Corporation reported financial results for 1Q:16. Total revenue was $181.2 million in 1Q:16, beating consensus estimates by 1% and representing an increase of 5% compared to $177.9 million in 1Q:15. Adjusted EBITDA margin decreased to 17.1% in 1Q:16 from 17.3% in 1Q:15. Gross margin for 1Q:16 increased to 53.9% from 51.9% in 1Q:15. The company's segments grew by: Orthopedic Surgery (1%), General Surgery +17% and Surgical Visualization (8%) respectively in 1Q:16. All growth rates are on a constant currency basis.

Exactech reported financial results for 1Q:16. Total revenue was $65.3 million in 1Q:16, beating consensus estimates by 3% and representing growth of 7% compared to $61.4 million in 1Q:15. Gross margin for 1Q:16 decreased to 68.8%, from 69.6% in 1Q:15. The company's segments grew by: Knee +6%, Hip +1%, Extremity +15%, Biologic & Spine +7% and Other +12% in 1Q:16 respectively. Domestic sales in 1Q:16 increased 7% compared to 4Q:14. All growth rates are on a constant currency basis.

IMPLANET reported financial results for 1Q:16. Total revenue was €2.0 million ($2.2 million) in 1Q:16, increasing 24% compared to €1.6 million ($1.7 million) in 1Q:15. The company's Spine revenue was €0.84 million ($0.95 million) in 1Q:16, increasing 11% compared to €0.76 million ($0.82 million) in 1Q:15. Total revenues from the company's core spinal implant, JAZZ, increased 106% and 21% in the U.S. and France in 1Q:16 respectively. The company's Knee & Arthroscopy revenue was €1.2 million ($1.3 million) in 1Q:16, increasing 36% compared to €0.8 million ($0.9 million) in 1Q:15. All growth rates are on a reported basis.

Integra LifeSciences reported 1Q:16 financial results. Total organic revenue was $216.7 million in 1Q:16, beating consensus estimates by 3% and representing 9% organic growth compared to $299.0 million in 1Q:15. Adjusted EBITDA was $52.1 million in 1Q:16, increasing 19% on a reported basis from $43.6 million in 3Q:13. Adjusted EBITDA margin increased to 22.0% in 1Q:16 from 21.5% in 1Q:15. Gross margin for 1Q:16 increased to 64.2%, from 62.9% in 1Q:15. The company's U.S.-based segments grew by: Specialty Surgical Solutions +8% and Orthopedics & Tissue Technologies +37% in 1Q:16 respectively. All growth rates are on a reported basis unless stated otherwise.

NuVasive reported financial results for 1Q:16. Total revenue was $215.1 million in 1Q:16, beating consensus estimates by 5% and representing an increase of 12% compared to $192.4 million in 1Q:15. Adjusted EBITDA was $48.3 million and the company exhibited an adjusted EBITDA margin of 22.5% in 1Q:16. Gross margin for 1Q:16 decreased to 74.8%, from 76.3% in 1Q:15. All growth rates are on a constant currency basis.

Safe Orthopaedics reported financial results for 1Q:16. Total adjusted revenue for 1Q:16 was €0.56 million ($0.63 million), increasing 2% from €0.55 million ($0.60 million) in 1Q:15. The company intends to reallocate its sales & marketing resources that were primarily devoted to the U.S. marketplace. New business operations in the Australian and New Zealand markets provided a boost to the company's growth. All growth rates are on a reported basis.

Zimmer Biomet reported financial results for 1Q:16. Total revenue was $1.90 billion in 1Q:16, beating consensus estimates by 1% and representing an increase of 1% compared to $1.1 billion in 1Q:15. Gross margin for 1Q:16 decreased to 66.6%, from 74.9% in 1Q:15. The company's segments grew at: Knees +4%, Hips +1%, Surgical, Sports Medicine, Foot and Ankle, Extremities & Trauma +0.2%, Dental (6%), Spine & CMF (1%) and Other +6% respectively in 1Q:16. Geographically, the company grew: Americas +2%, Europe (2%) and Asia-Pacific +4% respectively in 1Q:16. All growth rates are on an adjusted pro forma constant currency basis.

FUNDING
Xtant Medical was awarded two grants totaling up to $155,000 from the Montana Department of Commerce to support growth at the company’s orthobiologic processing facility. The Big Sky Economic Development Trust Fund (BSTF) provided up to $90,000 to the city of Belgrade, MT to assist the company with the purchase of incremental processing equipment and create 12 new jobs, while The Primary Workforce Training Grant (WTG), awarded the company $65,000 directly to support the training of these new positions.

M&A
Bionik Laboratories completed its all-stock acquisition of Interactive Motion Technologies, Inc. (IMT), a Boston-based developer of robotic systems that provide adaptive therapy to patients with upper and lower body mobility challenges caused by neurological disorders. Under the terms of the transaction, IMT shareholders received an aggregate of 23,650,000 shares of Bionik's common stock. This transaction expands Bionik's product offerings and adds further neurorehabilitation technologies to the company's intellectual property (IP) portfolio. Through this deal, management expects a certain amount of synergies to occur and noted that Bionik will continue to identify incremental synergistic robotic opportunities to continue to build its product portfolio.

Zimmer Biomet entered into an agreement to acquire Cayenne Medical, a company in the soft tissue repair and reconstruction segment of the sports medicine market. The financial terms of the transaction were not disclosed. This transaction expands Zimmer's arthroscopy and sports medicine portfolios and strengthens the company's capabilities in these segments. Additionally, Cayenne's product portfolio complements Zimmer's joint reconstruction offerings.

REGULATORY
Exactech received 510(k) clearance from the FDA for its Vantage Total Ankle, intended to treat patients suffering from arthritis in the ankle. The system utilizes the company’s pressfit bone cage design and is designed to support initial and long-term fixation. This is Exactech’s first offering in the foot & ankle market.

Medicrea received 510(k) clearance from the FDA for its UNiD Cervical rod, a patient-specific rod secured by the company's PASS OCT posterior cervical stabilization system. The company’s UNiD platform of personalized spinal alignment services are now indicated for the cervical, thoracic and lumbar segments of the spine.

Pinnacle Spine received patent from the Chinese Patent Office covering the company’s InFill interbody fusion device’s graft delivery methodology. InFill is designed for easier insertion and reduced subsidence through maximum contact with the apophyseal ring

SpinalCyte received a patent from the Canadian Patent Office for the company’s platform to use of human dermal fibroblasts for spinal nucleus replacement. The patent covers the company's technology that incorporates a matrix constructed of a synthetic polymer, a natural hydrogel, or a synthetic hydrogel to expose the fibroblasts to a mechanical strain using intermittent hydrostatic pressure and/or shear stress.

Spinal Elements received a patent from the United States Patent and Trademark Office (USPTO). The patent covers further developments in the company’s spinal fusion and motion preservation technologies.

PRODUCT INTRODUCTION & UPDATE
Genesys Spine announced that is Binary Anterior Cervical Plating System has been awarded the Iron A' Design Award in the category of Scientific Instruments, Medical Devices and Research Equipment Design by the grand jury panel of the A' Design Award & Competition. The technology is a combination of counter rotation functionality, and what the company calls "Zero-Step" feature: A clever ratcheted screw-head locks into place in the head of the screw with a notable click.

Integra LifeSciences announced the first U.S. implantation of its Integra Cadence Total Ankle system. Cadence allows the surgeon to maintain more bone stock and provides them with options to correctly align the ankle back to its native location.

NuVasive launched five new products including, AttraX Putty Biotextured Bone Graft, the Reline Modular System, Reline Power, MAS TLIF 2 and the Monolith Corpectomy System. AttraX is the company's next generation synthetic biologic product, indicated as an autograft extender in the posterior lateral spine. Reline is a part of NuVasive's Integrated Global Alignment (iGA) platform, which is designed to improve visualization and access to the intervertebral disc in TLIF and PLIF procedures. MAS TLIF 2 is a minimally-invasive, pedicle-based approach to provide efficient, reproducible and step-by-step technique for TLIF procedures, and Monolith is a modular, imaging-friendly PEEK implant indicated for use T1-L5 with supplemental fixation.

LEGAL
Invidio settled with the Federal Trade Commission (FTC) on allegations that the company utilizing long-term exclusive contracts to illegally maintain a high market share. Under the terms of the settlement, Invibio will be barred from demanding exclusive contracts and must allow some customers to modify their present contracts.

CLINICAL
MedShape published the first clinical results from a study evaluating its FastForward Bunion Correction System, a 3-D printed titanium alloy, bone-sparing hallux valgus (bunion) correction/deformity device. FastForward features the company’s Tether Plate, QuikCordTM suture tape and PEEK interference screws. The results demonstrated that Compared to other techniques that require osteotomies or fusions, patients that received FastForward reported faster resolution of post-operative pain and swelling.

EDUCATION
Stryker Performance Solutions launched JointCOACH, a new digital patient engagement and education platform digital patient. JointCOACH aims to help improve the overall care delivery and experience for patients undertaking joint replacement surgery and will manage a patient's entire episode of care through Comprehensive Care for Joint Replacement Model (CJR) process and voluntary payment bundles for 90 days and beyond.

APPOINTMENTS
Titan Spine appointed Ragan Cheney as the company's Vice President, General Counsel. Prior to Titan Spine, Ms. Cheney served as a Vice President, in-house senior legal consultant, with Associated Financial Group and worked as a judicial law clerk and a litigation associate in Pennsylvania.


Bionik Laboratories Completes Acquisition of Interactive Motion Technologies

Bionik Laboratories completed its all-stock acquisition of Interactive Motion Technologies, Inc. (IMT), a Boston-based developer of robotic systems that provide adaptive therapy to patients with upper and lower body mobility challenges caused by neurological disorders.

Under the terms of the transaction, IMT shareholders received an aggregate of 23,650,000 shares of Bionik's common stock. Furthermore, Jules Fried, IMT's Chief Executive Officer, has been appointed as Vice President of U.S. Operations, while IMT's Co-Founder and Chairman, Dr. Hermano Krebs, has been appointed as the Chief Science Officer of the combined company. Bionik will maintain IMT's U.S. operations in Boston.

IMT offers the InMotion Interactive Therapy, an exoskeletal robotic platform that provides rehabilitation solutions for patients with central nervous system disorders or other neurological conditions due to stroke or cerebral palsy. The technology originated out of the Massachusetts Institute of Technology (MIT), and was initially known as the MIT-Manus. The platform consists of three upper extremity clinical rehabilitation products, ARM, WRIST and HAND, that are all commercialized, and a lower-body therapy (ANKLE) and gait product, which are both still in development.

The InMotion ARM robotic system is indicated to rehabilitate stroke patients with upper body neurological limitations. InMotion WRIST is capable of overcoming most forms of hypertonicity to lift a severely impaired neurologic patient's hand against gravity, and provides the patient with a range of motion consistent with a normal functioning human wrist. Practitioners can use WRIST as a stand-alone treatment option or in addition to the InMotion ARM to offer progressive modular robotic neurorehabilitation. IMT's InMotion HAND robot provides grasp and release training with flexible positioning functionalities and is capable of continuously adapting to the patient's needs.

The InMotion ANKLE system allows paraplegics, as well as other wheelchair users, the ability to rehabilitate through walking and other motion and utilizes the same design principles as the company's upper extremity rehabilitation systems. For patients suffering from problems of walking and gait associated with neurological disorders, IMT has plans to develop a novel treatment that employs a gravity-based methodology to train gait including balance. A prototype of this gait system is currently being tested at MIT.

IMT has commercialized its three upper extremity products and currently markets the systems in more than 20 countries, including the United States. For the 2015 fiscal year, IMT's three commercialized systems generated approximately $2 million in revenues.

This transaction expands Bionik's product offerings and adds further neurorehabilitation technologies to the company's intellectual property (IP) portfolio. Through this deal, management expects a certain amount of synergies to occur and noted that Bionik will continue to identify incremental synergistic robotic opportunities to continue to build its product portfolio.



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