December 1, 2017 | Blake Mossy
Xtant Medical reported financial results for 3Q:17. Total revenue was $19.8 million in 3Q:17, compared to $23.1 million in 3Q:16.The decrease in revenue is due to the company’s efforts to reduce underperforming sales channels and unprofitable distributor agreements resulting in a decrease of fixation revenue offset by an increase in biologics revenue. Gross margin for 3Q:17 decreased to 58.0%, from 70.0% in 4Q:14. EBITDA was $1.4 million in 3Q:17, increasing compared to $0.7 million in 3Q:17. All growth rates are on a reported basis.
Medicrea received clearance from the FDA for its IB3D range of 3D-printed Titanium interbody devices and launched its AdapTEK surgeon-adaptive technology. The AdapTEK technology allows the surgeon to specify the design of devices which are then produced in-house using Medicrea’s in house additive manufacturing capabilities and total control of the internal process.
SeaSpine received 510(k) clearance from the FDA for its OsteoBallast Demineralized Bone Matrix (DBM) in Resorbable Mesh. The system is designed to allow surgeons to deliver bone graft in posterior spine surgery that contours to the local anatomy while maintain shape and volume under compression.
K2M announced the completion of 300 cases using its RHINE Cervical Disc, an artificial disc replacement that utilizes a one-piece compressible polymer core design with dome-shaped, plasma-coasted endplates and a central-split keel. The system combines trialing and keel cutting into one instrument, while an adjustable stop supports customized anterior or posterior disc positioning.
Regentis Biomatericals announced the beginning of a Phase III pivotal clinical trial of its GelrinC for the treatment of focal knee cartilage defects and comparing it to the standard of care treatment, microfracture. The study will be used to support a pre-market approval application (PMA). The study’s design aims to overcome the limitation of randomized control studies in this field, and is expected to generate faster patient enrollment and reduce the time for product approval.
Rotation Medical published results from a study of its Bioinductive Implant and its ability to heal rotator cuff tears and mitigates tear progression. The study enrolled 33 patients with chronic, degenerative, intermediate to high-grade partial-thickness tears of the supraspinatus tendon, the results indicates that the system increases tendon thickness, prevents re-tears and increases patient satisfaction.