Musculoskeletal News Roundup 30-June-17

June 30, 2017 | Blake Mossy

FUNDING

Intellirod Spine secured equity financing led by OhioHealth Innovation Development Fund and Queen City Angel First Fund V. The new capital will be used for the commercialization of the company’s sensor technologies and related lumbar fusion implants.

M&A

DePuy Synthes acquired Innovation Surgical Solutions, a Michigan based company that markets nerve localization technology for spine surgery. The system uses adhesive smart-sensors that are applied to the patients’ skin and provide the surgeon real-time feedback on nerve location. The acquisition expands DePuy Synthes product offering in the minimally invasive surgery space, and allows the company to utilize the surgeon-driven approach to reach more customers operating in an ambulatory surgery setting.

REGULATORY

K2M received 510(k) clearance from the FDA for its CAPRI Small 3D Static Corpectomy Cage System, a 3D printed corpectomy cage designed to stabilize the thoracolumbar spine in cases resulting from trauma or tumor. The system’s porous structure and rough surface architectures are designed to allow for bony integration throughout an implant, while its lordotic options help support the anterior spinal column with the goal of achieving sagittal balance.

Spineology received clearance from the FDA for its Rampart One Anterior Lumbar Interbody Fusion System, designed to minimize the exposure and vascular retraction requirements associated with anterior spinal fusion procedures. The system includes both standard and oblique interbody device footprints each with integrated fixation screws and is manufactured from Invibio PEEK-OPTIMA HA Enhanced polymer which aims to improve the osteoconductive surface for bone on-growth.

PRODUCT INTRODUCTION & UPDATE

ChoiceSpine launched its biologics portfolio, which includes two brands, STRATOFUSE and STRATOGEN. STRATOFUSE is designed to fuel fusion in spine and orthopedic surgical procedures. The system will promote demineralized bone allograft putties and sponges, synthetic bone graft substitute putties and strips, structural allograft and allograft bone extenders. STRATOGEN will focus on a full amnion offering.

Smith & Nephew launched its NAVIO platform, a handheld robotics-assisted total knee arthroplasty (TKA) application. The device is designed to aid surgeons with implant alignment, ligament balancing and bone preparation. NAVIO does not require preoperative imaging, which aims to minimize costs, steps and radiation associated with CT scans.

Paragon 28 launched its PHANTOM Lapidus Intramedullary Nail system, designed for use in correction of arthrodesis of the first TMT joint. The system utilizes crossed screw fixation both distally and proximally which has been shown to generate greater compressive force than screws placed through a plate.

Zimmer Biomet launched its X-PSI Knee System, a patient-specific surgical planning system that aims to allow implant positioning solely utilizing X-ray technology. That plan is used to manufacture patient-specific guides and bone models intended to improve implant fit and placement accuracy.

INTELLECTUAL PROPERTY

Bone Therapeutics received a patent from the European Patent Office (EPO) for its allogeneic cell therapy technology. The patent covers methods to manufacture differentiated and biologically active osteoblastic (bone-forming) cells from bone marrow stem cells, using a specific combination of growth factors, and also covers a new class of osteoblastic cells suitable for allogeneic administration to the patient. Patents for the system have been granted in Australia, Japan and Singapore.

CLINICAL

Histogenics completed patient enrollment in its NeoCart Phase III clinical trial, randomized clinical trial evaluating the safety and efficacy of a cellular therapy to treat knee cartilage defects. The system’s tissue engineered implant aims to provide effective pain relief and restore function to damaged knee cartilage.