Musculoskeletal News Roundup 21-July-17

July 21, 2017 | Blake Mossy

FUNDING

OrthoSensor secured $6.5 million in a new round of mixed financing, led by 15 undisclosed investors according to an SEC filing. The new funding will be used to support the improvement of its Veransense disposable sensor used for primary and revision total knee arthroplasty. In this round, the company is offering debt, options, warrants and securities to be acquired upon the exercising of those options or warrants.

Simplify Medical secured $21 million in a Series B financing, led by Life Sciences Partners, with additional investment from Sectoral Asset Management and M.H. Carnegie. The new capital will be used to support two ongoing U.S. pivotal clinical trials of the company’s Simplify cervical artificial disc, studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease (DDD).

REGULATORY

Emerging Implant Technologies received 510(k) clearance from the FDA for its spinal interbody product portfolio to address anterior, transforaminal and posterior lumbar interbody fusion and cervical procedures. The devices are manufactures from the company’s Cellular Titanium that utilizes a porous titanium structure designed for osseointegration.

PRODUCT INTRODUCTION & UPDATE

Bioventus expanding its EXOGEN Ultrasound Bone Healing System Performance Program in Canada to include delated union and acute fractures. The system is designed to use low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process. EXOGEN’s Performance Program was formerly only applicable to nonunion fractures, excluding the skull and vertebrae.

Future Market Insights reported that the worldwide market for pedicle screw systems will see growth because of an aging population and increasing incidence of arthritis. North America has claimed the largest share of the nonmagnetic vital signs monitoring systems market because of an increased number of pedicle screws approved by the FDA.

CLINICAL

Medovex announced the first cases using its DenerveX System designed for the treatment of facet joint syndrome related to lower back pain. The minimally invasive posterior procedure removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

OrthAlign announced the first surgery using its KneeAlign System for total knee arthroplasty (TKA) in Hong Kong, in collaboration with its local distributor partner Smith & Nephew Hong Kong. The computer-assisted, handheld technology aims to offer real-time, actionable data for patient-specific alignment and positioning of components in total knee, unicondylar knee, and total hip arthroplasty surgeries.

Smith & Nephew entered into a partnership with Imperial College London to research meniscus function and the interaction of ligament in the stabilization of the knee joint. The study will investigate functional anatomy and mechanical performance of joint elements, this study will support the designed and testing of devices for the treatment of worn cartilage.

Premia Spine launched an FDA-approved pivotal study of its TOPS posterior arthroplasty device versus traditional lumbar fusion for the treatment of degenerative grade I spondylolisthesis and spinal stenosis. The randomized study will take place at 30 clinical sites and enroll 330 subjects, measuring neurologic function, device integrity, reoperation rates to establish superiority of TOPS compared to fusion.

DISTRIBUTION

ApiFix entered into an agreement with Acuna-Fombona for the distribution of its scoliosis system in Spain, the company also announced completion of the first procedure in the region. The system is a minimally invasive, non-fusion spinal implant that is inserted in a short procedure and designed to maintain spine flexibility for the correction of Adolescent Idiopathic Scoliosis (AIS). ApiFix aims to improve quality of life of patients who undergo scoliosis surgery, reduce hospitalization and OR time, and reduce costs compared to traditional scoliosis surgery.

APPOINTMENTS 

Spinal Simplicity appointed Richard Grant as an Advisor and as a member of the Board of Managers.  Mr. Grant currently serves as President, CEO and Co-Founder of Breakaway Imaging and brings over 30 years of experience in the spinal and orthopedic medial industries.