March 9, 2018 | Blake Mossy
Alphatec Holdings announced today that it has acquired SafeOp Surgical, Inc. SafeOp is a privately-held provider of advanced neuromonitoring technology designed to prevent the intraoperative risk of nerve injury with automated assessment that obviates the need for a technician or other neuromonitoring professional in most surgeries. The Company also announced a $50 million capital raise, the proceeds of which were used, in part, to fund the acquisition. Additionally, the Company announced several leadership updates. Pat Miles has assumed the role of Chief Executive Officer. Terry Rich has been appointed President and Chief Operating Officer. Both will retain their existing Board positions. Dr. Luiz Pimenta has been appointed Chief Medical Officer. Additional executive appointments include Richard O'Brien, M.D., former Medical Director of neuromonitoring provider Impulse Monitoring, Inc. and Robert Snow, former co-founder and SVP of Marketing at Impulse Monitoring.
Synergy Biomedical received clearance from the Therapeutic Goods Administration for its BIOSPHERE PUTTY bioactive bone graft in Australia. The system is comprised of bioactive glass spheres with a resorbable carrier. The moldable bone graft material is easy to use and compatible with a variety of bone grafting techniques.
Panther Orthopedics received 510(k) clearance from the FDA for its PUMA, an implantable flexible fixation device indicated for Syndemosis Fixation, Hallux Valgus Reconstruction, and Tarsometatarsal Fixation. The system was designed to allow anatomical joint motion with continuous compression. PUMA allows for a 2.8 mm pilot hole that preserves bone tissue and comes in one size for a simple, customized approach that can be trimmed to the specific anatomy in order to provide stable dynamic fixation of the joint.
Orthofix received premarket approval under CE Mark in the EU for its PhysiStim bone growth stimulators. The device aims to provide a non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. The system uses pulsed electromagnetic field (PEMF) signal to induce a low-level electrical field at the fracture site which stimulates bone healing.
Styker Spine received 510(k) clearance from the FDA for its Tritanium TL, a 3D-printed, highly porous posterior lumbar interbody fusion cage. The porous structure is designed to create a favorable environment for osteoblast attachment. The cage has a smooth, tapered leading edge to facilitate insertion into the intervertebral a space and a central column spanning endplate to endplate structural integrity.
PRODUCT INTRODUCTION & UPDATE
Bioventus launched its DUROLANE single-injection, hyaluronic acid (HA) product designed for joint lubrication in the treatment of pain associated with knee osteaoarthritis (OA). The company’s current portfolio includes three-injection HA GELSYN-3 and five-injection HA SUPARTZ FX. HA is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint. The system has been proven to provide greater reduction in knee pain versus Synvisc-One and longer lasting pain relief versus a steroid injection.
Corin launched its Unity Knee with EquiBalance instrumentation, indicated to facilitate ligament balancing and soft tissue preservation during total knee replacement. The system is designed to enable ligament balancing and medial collateral ligament isometry supports functional knee positioning, implant stability and performance, which may yield a reduction post-operative discomfort.
CrossRoads Extremity Systems launched its DynaFORCE Active Stabilization Vero Medical Column Implant, combing the stability of a plate with active compression of nitinol clips. The system is available is various sized and is delivered sterile packaged to the operating room.
DePuy Synthes launched its ACTIS Total Hip System, designed to be utilized with tissue-sparing approaches to help increase stability of the joint after surgery. The system is comprised of a medial collar, triple-taper geometry and twelve sizes to allow for a precise anatomical fit and supports the need for improved outcomes and better patient satisfaction.
Materialise launched its TRUMATCH Personalized Solutions Shoulder system, addressing Reverse Shoulder Arthroplasty (RSA) and Anatomic Total Shoulder Arthroplasty (TSA), aiming to offer an all-in-one, web-based planning platform as well as the ability to order patient-specific 3D printed surgical guides. The system is designed to address challenges of limited visibility, depth of the glenoid cavity in the surgical window and the lack of reliable landmarks.
Smith & Nephew launched its Q-FIX CURVED, Q-FIX MINI and SUTUREFIX CURVED all-suture anchor systems, designed to help surgeons access challenging spaces and to aid in optimal suture anchor placement during drilling and insertion. The SUTUREFIX CURVED and Q-FIX CURVED systems are designed to improve access and trajectory when drilling bone tunnels, while the Q-FIX MINI All-Suture is short in design, giving it particular application in small joint soft tissue procedures.
Paragon 28 introduced the HammerTube implant system, a single piece titanium sprayed PEEK implant intended for use in proximal interphalangeal (PIP) joint. The implant is comprised of PEEK, a non-reactive biomaterial, which closely matches the mechanical properties of the bone. HammerTube is coated both proximally and distally with a porous titanium spray to increase mechanical fixation and bone ingrowth when compared to uncoated implants.
Tyber Medical launched its TyFix, all-in-one extremity joint fixation system. TyFix is designed for the correction of Hammertoe deformities, allowing realignment for pain relief and discomfort. The system combines a bone thread with a barbed head to maximize bone purchase and compression in both the proximal and distal phalanges.
United Orthopedic Corporation launched its UTS, the United Tri-tapered Short Hip Stem, with the extension of the U-Motion II Acetabular System. The UTS is intended for the direct anterior approach, and is designed for insertion through small incisions with simple femoral preparation. The systems includes standard and high offset options, triple-taper design with titanium plasma coating for initial fixation and rotation stability, and reduced lateral shoulder to conserve bone.
Geisinger entered into a collaboration agreement with Medacta International, a global leader in orthopedic medical devices, to pilot a program to provide Geisinger Health Plan members who are receiving hip-replacement surgery an unlimited time frame for future surgical care and cost that may be needed. The companies will proportionally share all device and hospital costs, including hospital care and device replacement for future revisions, while the patient remains with the Geisinger Health Plan and is treated by Geisinger providers.
WishBone Medical entered into a license agreement with Hospital for Special Surgery (HSS) to develop a Pediatric Total Hip for the treatment of juvenile idiopathic arthritis and congenital hip dysplasia. The pediatric implants and instruments are offered in sterile-packaged, single-use disposable kits.
Ortho Regenerative Technologies received EU Notice of Allowance from the European Patent Office for its Novel Formulation of Physiological Chitosan-Inorganic Salt Solution/Blood Mixtures for Tissue Repair. The patent covers the composition of the company’s biopolymer material for the biologic repair of tissue.
Captiva Spine announced the initial clinical uses of its TransFasten Posterior SI Fusion system, which employs a form of “mortise and tenon” stabilization, providing 12 contact points across the joint without disrupting the anatomy. The company also launched its HyperLOX, a posterior cervical system for stabilization and fusion of the cervical and thoracic spine. HyperLOX utilizes a range of hyper-angulating top loading polyaxial screws, hooks, offset connectors, multiple rod-to-rod connector configurations, cross connectors, and transitional rods.
Life Spine announced the first clinical use of its SENTRY 2 Lateral Plating System. The system intends to provide the surgeon with the ability to perform a complete stabilization and fixation procedure while the patient is in the lateral decubitus position. The system’s narrow profile allows the surgeon to minimize retraction and trauma to the psoas and lumbar plexus, as well as providing a surgical solution when exposure is limited by the iliac crest or ribs.