Musculoskeletal News Roundup 23-June-17

June 23, 2017 | Blake Mossy

FUNDING

Medicrea secured $14.5 million in a private placement raised from international funds and investment companies. The new capital will be utilized to support the United States development of the company’s UNiD Addictive Spine Intelligence (ASI) platform, designed with analytical and biomechanical services to collect and analyze data for the formation of patient-special implants. The funding will also be used for the commercialization of a new range of 3D-printed titanium interbody cages in the U.S. and Europe.

REGULATORY

Additive Orthopaedics received 510(k) clearance from the FDA for its Bunion Correction System, a 3D printed minimally-invasive correction system to address alignment and stabilization of bunions. The utilization of 3D printing allows for additional fixation and strengthening as the bone grows onto and through the plate.

K2M received 510(k) clearance from the FDA for its MOJAVE PL, a 3D titanium expandable posterior-lumbar interbody system to help achieve spinal balance in patients. The system provides independent control of both the anterior and posterior height separately and is able to be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

Medicrea received 510(k) clearance from the FDA for its UNiD HUB system, a data-driven digital portal that utilizes Adaptive Spine Intelligence for surgical planning. The system is designed to support workflow, identify tendencies and correlations and build predictive modeling to create patient-specific implant solutions for surgeries.

Meditech Spine received 510(k) clearance from the FDA for its Talos Lumbar PEEK interbody fusion (IBF) devices utilizing hydroxyapatite (HA) material, designed for patients suffering from degenerative disc disease (DDD). The Talos HA Peek Lumbar portfolio of interbody devices aims to allow surgeons to choose their preferred method of approach for each patient whether it be a PLIF, TLIF, TPLIF, ALIF or LLIF.

ConforMIS received 510(k) clearance from the FDA for its iTotal Hip replacement implant system that utilizes the company’s iFit image-to-implant customized knee replacement technology. The iTotal employs single-use 3D printed instruments and just-in-time delivery model to create a system that requires limited reusable instruments.

PRODUCT INTRODUCTION & UPDATE

Implanted launched its JAZZ Braid device in Europe and the U.S. after receiving regulatory clearance in both regions. The system represents improvements to the company’s JAZZ spinal fusion platform, it now utilized ultrasonically bonding to improve handling and stability.

K2M launched its SAHARA Al Expandable Stabilization System, a lordotic expandable interbody device with integrated screw fixation to assist in achieving spinal balance. The system utilizes the company’s tifix locking technology, which can allow screw readjustment up to three times without compromising the locking feature.

INTELLECTUAL PROPERTY

Camell Therapeutics received a patent from the Canadian Intellectual Property Office (CIPO) covering the methods and apparatus for manufacturing plasma based plastics. The company will launch a Phase III clinical study for its Bone Healing Accelerant, a Plasma-based Bioactive Material (PBM) product/indication, designed to accelerate the healing of both bone and soft tissues.

Creative Medical Technology announced the filing of intellectual property covering its data supporting the use of immune system cells for stimulation of perispinal angiogenesis as a treatment for patients suffering from lower back pain, as well as supporting intradiscal stem cell administration to treat degenerative disc disease (DDD). The company believes that initial correction of circulation defects in the area surrounding the spine will increase efficacy of cellular therapies for lower back pain.

Zyga received a patent from the United States Patent and Trademark Office (USPTO) covering its SImmerty Decorticator device. The system is designed to allow surgeons prepare the sacroiliac (SI) joint for fusion by creating bleeding bone and space for autologous bone graft, which is accomplished through a minimally-invasive, lateral approach that avoids disruption of supporting ligaments around the SI joint.

DISTRIBUTION

SpineGuard entered into an agreement with XinRong Medical Group for the distribution of PediGuard in China, Hong Kong and Macau. PediGuard is a disposable devices that aims to support open or minimally invasive approaches for pedicle screw insertion.

CLINICAL

Exactech announced the first clinical use of its shoulder, knee and hip replacement systems in Japan. The platform includes the company’s Optetrak Logic CR knee, Novation Crown Cup, Alteon Tapered Wedge Stem and Equinoxe Reverse Shoulder.