Musculoskeletal News Roundup 2-June-17

June 2, 2017 | Blake Mossy

FUNDING

Arthromeda secured a Series D financing following a series of successful cadaver labs led by Daniel Ward, MD at Cincinnati Children’s Hospital and Medical Center. The new capital will be used to fund the company’s ArthoSight-PS Hip Alignment System through commercial regulatory approvals and clinical validation.  

Hyalex Orthopedics secured $16 million in a Series A financing led by Canaan Partners, Osage University Partners and Johnson & Johnson Innovation. The new funding will be utilized to support the development of the company’s HYALEX synthetic polymer, which is designed to mimic hyaline cartilage for the treatment of osteoarthritis (OA).

REGULATORY

OrthoAccel Technologies, Inc. received FDA clearance for its newest accelerated treatment device, AcceleDent Optima, and will begin fulfilling orders immediately.  AcceleDent Optima is the first and only orthodontic device that directly connects patients and practices with usage monitoring, direct messaging and virtual rewards via the state-of-the-art AcceleDent App, which can be downloaded via iTunes and Google Play.

Orthocell received approval from Australia’s Therapeutic Goods Administration (TGA) that its Ortho-ACI product has been added to the Australian Register of Therapeutic Goods (ARTG).  Ortho-ACI is designed for knee and ankle cartilage repair.  

VEXIM received regulatory clearance from Brazil’s National Health Surveillance Agency (ANVISA), for its SpineJack system for the treatment of vertebral compression fractures (VCFs). The company estimates that Brazil represents a €15 million ($16.8 million) market in the VCF segment. The SpineJack is comprised of three titanium implants with at various diameters, covering most VCFs and morphologies.

Zimmer Biomet announced a recall of its SpF PLUS-Mini and SpF Xl llb Implatable Spinal Fusion Stimulators due to potential cytotoxity issues found during routine monitoring. This Class I recall affects units manufactured between October 11, 2016 and January 18, 2017, and distributed from March 28, 2017 to April 6, 2017.

PRODUCT INTRODUCTION & UPDATE

K2M launched its MESA 2 Cricket system, which expands upon the company’s MESA 2 pedicle screw system technology for the treatment of complex spinal deformity. The MESA 2 Cricket is available for both rods and MESA Rail, eliminating the need for reduction screws and allowing for simultaneous multi-axial translation and reduction. The system is designed to support a 360-degree approach to align a deformed spine.

Paragon 28 launched its PRECISION Jones Fracture Screw system, a type II anodized titanium alloy screw system for the treatment of 5th metatarsal fractures. PRECISION utilizes a short thread and blunt tip to minimize disruption to the cortical bone.  

The predictable digital workflow created by the 3Shape TRIOS intraoral scanner makes manufacturing time for ProSomnus sleep apnea and snoring devices more efficient. For dental professionals, the shorter turnaround time means getting patients into therapy faster. Once a patient is intraoral-scanned with 3Shape TRIOS, the doctor can simply select ProSomnus from the list of integrated solution providers on the TRIOS Communicate cloud. The TRIOS digital impressions are then sent to ProSomnus with just a click. ProSomnus uses the TRIOS digital impressions to CAD/CAM design and manufacture their sleep apnea and snoring devices. This creates a completely digital and authenticated workflow that simplifies the front-end steps of the device manufacturing process; ensures precision and predictability in production and delivers cases back to dentists more rapidly. For patients, the quicker turnaround time means feeling better faster. Moreover, the entire fitting procedure becomes more comfortable and impressive due to TRIOS’ accuracy, speed, image quality, and ease of use.

CLINICAL

Exactech announced the completion of the first surgery using its Truliant Knee System, a portfolio of implants and instruments designed to help surgeons address the remaining clinical challenges of a total knee replacement. The system utilizes a computer-assisted approach and ergonomic instrumentation to support the sizing and balancing during primary and revision procedures.

INTELLECTUAL PROPERTY

Aurora Spine announced that its patented Polyaxial ZIP ISP technology will be offered for out-licensing opportunities for medical and industrial applications. Polyaxial ZIP utilizes a combination of the company’s ONE-STEP locking mechanism and the polyaxial feature with no screw set.