June 28, 2016
Activity
Our revenues in the US grew 44% in the first quarter of 2016 compared to the same period last year. The main growth drivers were SCARLET® AC-T, our secured cervical cage in titanium, JULIET®LL, our lateral interbody cage available in PEEK or titanium with special surface treatment and ROMEO®2, our versatile and compact posterior thoraco-lumbar fixation system for degenerative and deformity surgery. All these systems are provided to the hospital with sterile-packed barcoded implants, compliant with the FDA mandated Unique Device Identification (UDI) requirements.
New Technology
In the first quarter of 2016, we received 510(k) clearance from the FDA for PERLA®, our posterior cervico-thoracic fixation system, OTELO®LL, our next generation radiolucent carbon fiber lateral retractor and TRYPTIK®2, our cervical plate system. As with the rest of our portfolio, these new systems benefit from our compact set philosophy and sterile-packed barcoded implants. We began limited release for PERLA® and OTELO®LL in the second quarter of 2016.
Prospects
In 2016, we anticipate continued double-digit growth in the US, backed by the release of our recently approved systems, additional FDA clearances, the continued addition of new distributors in unaddressed territories and the expansion of our domestic and international education program.
About Spineart
Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.
Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment.
Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital. Spineart’s barcoding system is compliant with the FDA mandated Unique Device Identification (UDI) requirements.
For distribution opportunities, please contact us at contact@spineart.com or visit spineart.com/distributorsUSA.
