Musculoskeletal News Roundup 4-May-17

May 4, 2017 | Blake Mossy

EARNINGS

CONMED Corporation reported financial results for 1Q:17. Total revenue was $186.6 million in 1Q:17, beating consensus estimates by 3% and representing an increase of 4% compared to $181.2 million in 1Q:16. Adjusted EBITDA was $30.4 million in 1Q:17, decreasing 2% on a reported basis from $31.0 million in 1Q:17. Adjusted EBITDA margin decreased to 16.3% in 1Q:17 from 17.1% in 1Q:16. Gross margin for 1Q:17 decreased to 53.5% from 53.9% in 1Q:16. The company's segments grew by: Orthopedic Surgery (1%), General Surgery +10%, Single-use Products +4% and Capital Products +2% respectively in 1Q:17. All growth rates are on a constant currency basis, unless stated otherwise.

Expanding Orthopedics announced that the company recorded its largest revenue quarter to date. This quarter was supported by new surgeon users and record sales of the company’s FLXfit 3D Expanding TLIF Cage, that utilizes a large footprint design with an expansion mechanism to help restore and retain lordosis, which could lead to sagittal alignment.

K2M Group reported financial results for 1Q:17. Total revenue was $61.9 million in 1Q:17, beating consensus estimates by 3% and representing an increase of 11% compared to $56.3 million in 1Q:16. Adjusted EBITDA was $0.3 million in 1Q:17, decreasing from $1.1 million in 1Q:16. Gross margin for 1Q:17 increased to 65.3% compared to 65.2% in 1Q:16. The company's U.S.-based segments grew by: Complex Spine +8%, Minimally Invasive +14% and Degenerative +9% in 1Q:17. The company's U.S. and International segments grew 10% and 14% respectfully in 1Q:17. International revenues represented 25% of the company's total revenue in 1Q:17. All growth rates are on a constant currency basis.

Integra LifeSciences reported 1Q:17 financial results. Total organic revenue was $249.2 million in 1Q:17, beating consensus estimates by 2% and representing 6% organic growth compared to $234.2 million in 1Q:16. Adjusted EBITDA was $55.2 million in 1Q:17, increasing 6% on a reported basis from $52.1 million in 1Q:16. Adjusted EBITDA margin decreased to 21.3% in 1Q:17 from 22.0% in 1Q:16. Gross margin for 1Q:17 increased to 66.5%, from 64.2% in 1Q:16. The company's U.S.-based segments grew by: Specialty Surgical Solutions +3% and Orthopedics & Tissue Technologies +20% in 1Q:17 respectively. All growth rates are on a reported basis unless stated otherwise.

Zimmer Biomet reported financial results for 1Q:17. Total revenue was $1.98 billion in 1Q:17, beating consensus estimates by 1%and representing an increase of 5% compared to $1.90 billion in 1Q:16. Gross margin for 1Q:17 increased to 74.1%, from 66.4% in 1Q:16. The company's segments grew at: Knees (1%), Hips +2%, Surgical, Sports Medicine, Foot & Ankle, Extremities & Trauma +7%, Dental (0%), Spine & CMF +32% and Other (1%) respectively in 1Q:17. Geographically, the company grew: Americas +5%, EMEA +3% and Asia-Pacific +6% respectively in 1Q:17. All growth rates are on a constant currency basis.

M&A

Genstar Capital announced the sale of Tecomet, a global provider of high-precision manufacturing solutions for complex tight-tolerance products, to Charlesbank Capital Partners, the previous owner. Tecomet’s product portfolio includes orthopedic systems for hip, knee, trauma, extremity, spine, cranial maxillofacial (CMF) and the dental segments, complex surgical instruments, and photochemical etched products for medical device customers. The company also serves the aerospace and defense markets, operates 16 manufacturing facilities and employs more than 2,500 people.

REGULATORY

Implanet received CE Mark approval for its JAZZ Standalone implant, a rodless, freestanding posterior fixation system for the treatment of adult degenerative bone disorders. The system was launched in 2016 with the company’s JAZZ Lock implant.

Innovasis received 510(k) clearance from the FDA for its Ax Stand-Alone ALIF, an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine. The implant is designed to facilitate fusion in the lumber spine and is inserted using an anterior lumbar interbody fusion (ALIF) procedure. The system is made from PEEK-OPTIMA HA Enhanced polymer technology from Invibio.

The leader in accelerated orthodontics, OrthoAccel Technologies, Inc., today announced that its next generation of accelerated orthodontic technology, AcceleDent Optima, has been cleared by Health Canada and the company will begin fulfilling orders immediately. With this latest innovation, AcceleDent Optima is the first and only orthodontic device that directly connects patients and practices with monitoring, direct messaging and virtual rewards via the state-of-the-art AcceleDent App, which can be downloaded via iTunes and Google Play. AcceleDent Optima is the third generation accelerated orthodontic device to be commercially available from OrthoAccel within the past six years. Designed with enhanced patient convenience in mind, Optima is a smaller, more lightweight device that is waterproof and able to connect with smartphones and tablets through Bluetooth connectivity. The device’s charging case enables patients to wirelessly charge the activator, which has a five-to-seven day battery life.

PRODUCT INTRODUCTION & UPDATE

Medtronic issued a Safety Notice and revised indications related to the use of non-Medtronic instruments with the NavLock Tracker, an accessory to its StealthStation Surgical Navigation system. NavLock enables the navigation of instrumentation during spinal fusion and interbody procedures. This notice has been issued due to injuries and the death of two patients, following procedures in which non-Medtronic instruments were used with the NavLock Tracker. Therefore, the company felt it necessary to revise its indications, stating that it should only be used with Medtronic instruments.

Orthofix International launched its JuniOrtho platform, a pediatric brand focused on solutions for children and young adults with orthopedic and congenital deformities. JuniOrtho is comprised of educational resources such as literature and tools designed for parents of young patients, and hosts the websites juniortho.club, and limbhealing.com.

INTELLECTUAL PROPERTY

TheraCell received a patent from the United States Patent and Trademark Office (USPTO) covering its enhanced cancellous bone technology. The technology is a minimally manipulated tissue product that combines the osteoinductivity of demineralized cortical bone powder with the osteoconductivity exhibited by demineralized cancellous bone.

CLINICAL

Onkos Surgical completed the first procedure utilizing the company’s ELEOS Limb Salvage system. ELEOS uses Onkos’ uDesign Patient Solutions, which is an interactive experience that aims to support patient-specific planning to visualize the surgical plan to help ensure that the correct bundle of products is delivered for each procedure.

DISTRIBUTION

Johnson & Johnson entered into a 1-year contract with the U.S. Defense Department (DoD) to provide  various orthopedic products worth nearly $261 million. Under the terms of the agreement J&J will supply orthopedic products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

Vertebral Technologies entered into an agreement with Medikon for the distribution of its InterFuse product line in Turkey. InterFuse is an intra-operative assembly technology that aims to allow surgeons to implant a large footprint device through a minimally invasive approach. The shape of each device is biomechanically fitted to match the contours of the endplate and the anatomical shape and size of each patient’s disc space.