Musculoskeletal News Roundup 17-August-17

August 17, 2017 | Blake Mossy

Alphatec reported financial results for 2Q:17. Total revenue was $24.4 million in 2Q:17, decreasing 24.4% compared to $32.2 million in 2Q:16. Revenue from U.S. commercial business was $21.9 million in 2Q:17, decreasing 7% from $23.4 million in 2Q:16, with a gross margin of 71% in 2Q:17. Adjusted EBITDA was $1.2 million in 2Q:17 decreasing from $2.5 million in 2Q:16. All growth rates are on a constant currency basis.

DJO Global reported financial results for 2Q:17. Total revenue was $294.7 million in 2Q:17, increasing 1% compared to $292.9 million in 2Q:16. Adjusted EBITDA was $63.5 million in 2Q:17, compared to $63.6 million in 2Q:16. Adjusted EBITDA margin decreased to 21.6% in 2Q:17 from 21.7% in 2Q:16. The company's segments grew by: Bracing & Vascular (4.1%), Recovery Sciences +0.8% and Surgical Implant +17.4% in 2Q:17 respectively. International revenues decreased by (0.6%) in 2Q:17 compared to 2Q:16. All growth rates are on a constant currency basis.

REGULATORY

Camber Spine Technologies received 510(k) clearance from the FDA for its SPIRA Open Matric anterior lumbar fusion device. The system utilizes spiral support arches to decrease subsidence by load sharing over the entire endplate, while maximizing bone graft capacity. SPIRA is built with Surface by Design roughened surface technology, which is designed to facilitate bone growth through an optimized pore diameter, strut thickness and trabecular pattern.

Globus Medical received 510(k) clearance from the FDA for its Excelsius GPS robotic guidance and navigation system. The platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw placement applications in spine and orthopedic surgery. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

Stryker Spine received 510(k) clearance from the FDA for its Serrato Pedicle Screw system, indicated for use in the non-cervical spine as part of the company’s Xia 3 Spinal System. The system utilizes serrated cutting flutes, dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head. Xia 3 comprises screws, blockers and hooks for fixation of rods and connectors to vertebrae or the spinal column to stabilize or correct deformity.

PRODUCT INTRODUCTION & UPDATE

Spine Wave launched its Proficient Posterior Cervical Spine System, designed to make complex cervical spine surgery easier through its angulation capabilities. The system’s foundation is its proprietary universal tri-lobe screw which provides up to 120 degrees of polyaxial angulation.

INTELLECTUAL PROPERTY

Expanding Orthopedics received two patents from the United States Patent and Trademark Office (USPTO) for its expandable interbody cage technology. The technology is designed to offer an expanding mechanism and bone grafting solution in addition to versatility in the type of surgery approaches.