Musculoskeletal News Roundup 8-Sept-17

September 8, 2017 | Blake Mossy

REGULATORY

Bioventus received approval from the FDA for its DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication for the treatment of pain associated with knee osteoarthritis (OA). The system is currently available in 25 countries and has been a proven knee OA pain reliever for 15 years.

Kuros Biosciences received  510(k) clearance from the FDA for its MagnetOs Putty, a synthetic bone graft putty indicated for use as an autograft extender in the posterolateral spine. The system is designed to regenerate bone in the implanted site in the body by filling in bony voids or gaps.

NuVasive received 510(k) clearance from the FDA for its MAGEC growing rod system with RELINE Small Stature pediatric deformity fixation system. MAGEC utilizes magnetic technology with adjustable growing rods to treat early-onset scoliosis in pediatric patients.

MiMedx Group received approval from the FDA to conduct its Investigational New Drug (IND) Phase 3 clinical study of its AmnioFix Injectable of Achilles Tendonitis.  The prospective, double blinded, randomized controlled trial will study the Micronized dehydrated Human Amnion Chorion Membrane (dHACM) injectable compared to saline placebo injection.

OMNIlife science received 510(k) clearance from the FDA for its OMNIBotics robotic-assisted total knee replacement technology. The platform provides the surgeon with a quantitative tool to manage the soft tissue envelope with real-time feedback. OMNIBotics utilizes the companies ART software, which is customizable to any surgical approach and allows for intra-operative adjustments, and its 3-D modeling technique eliminates the need for pre-op CT scans or x-rays.

Regentis Biomaterials received CE Mark approval for its GelrinC biodegradable implants comprised of denatured human fibrinogen, intended for the treatment of articular knee cartilage defects, both in chondral and osteaochondral. The approval covers GelrinC manufactured using denatured human fibrinogen and expands upon the existing CE mark for a version containing denatured bovine-sourced fibrinogen.

PRODUCT INTRODUCTION & UPDATE

MicroPort Orthopedics launched its Procotyl Prime acetabular cup indicated the joint replacement surgeries. The system is comprised of crosslinked polyethylene and 3D fixation surfaces and utilizes titanium alloy BIOFOAM-coated shells. The device includes instrumentation to support soft-tissue-sparing and a variety of other surgical approaches.

CLINICAL

Medtronic announced the launch of its long term clinical study program of its INFUSE Bone Graft in Posterolateral Fusion (PLT) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. INFUSE Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and eliminates the need to harvest bone from the patient's body in a secondary surgical procedure.

Orthocell announced the enrollment of its first patient in a trial comparing its Ortho-ATI, tendon regeneration therapy to corticosteroids.  The trail was undertaken in collaboration with DePuy Synthes Products, and aimed to assess the effectiveness of Ortho-ATI for the treatment of a rotator cuff tendinopathy and tear.  In previous studies, Ortho-ATI has demonstrated to be a cost effective, durable, non-surgical solution for hard-to-treat tendon injuries.

DISTRIBUTION

ApiFix entered into an agreement with Joint Solutions Alliance for the distribution rights of its scoliosis treatment in Canada. ApiFix aims to improve the quality of life of patients who undergo scoliosis surgery, save hospitalization and operating room time, and while reducing costs and recovery time associated with standard scoliosis surgery.

Mazor Robotics entered into an agreement with Medtronic for the global distribution of the Mazor X surgical assistance platform. Mazor has also agreed to make its U.S. $40 million third tranche investment in Mazor. The companies plan to co-develop spine products that capitalize on Mazor’s surgical planning and Medtronic’s navigation/implants.

NuVasive entered into an agreement to acquire Vertera Spine, a developer of porous-PEEK based spinal interbody fusion devices. Under this transaction, NuVasive is now the sole device company offering both PEEK and titanium porous interbody devices to suit surgeon preference and encourage bone ingrowth.

OrthoPediatrics entered into an agreement with Mighty Oak Medical for the distribution of its FIREFLY pedicle screw navigation guides in U.S. pediatric hospitals. The FIREFLY Pedicle Screw Navigation Guides can be used with any Spinal Deformity Correction system, including the OrthoPediatrics RESPONSE Spinal Deformity System.

APPOINTMENTS

Globus Medical appointed David M. Demski as the company’s Chief Executive Officer. Mr. Demski will report to David Paul, who has taken on the role of Executive Chairmen. Prior to CEO, Mr.Demski served as President, Emerging Technologies, which is not expected to be backfilled.