Here are five spine device companies emerging on the scene as important players in the future.
Benvenue Medical. In March, Benvenue Medical announced the full commercial launch of the Kiva VCF Treatment System after releasing a study showing the system is as effective as balloon kyphoplasty for osteolytic vertebral metastases patients in February. George Washington University Hospital was the first facility in the United States to use the system, also in February, and secured $64 million in financing for their continued penetration in the United States. With this first round of financing, Benvenue Medical will build its U.S. commercial presence, scale up manufacturing and increase administrative functions. The company has a CE mark for the Luna system and is preparing for an FDA submission for the technology as well. The VCF market is a huge opportunity for growth in the overall spine device market. In June, the company expanded senior management by adding COO Jeffrey Jones.
ChoiceSpine. Knoxville, Tenn.-based ChoiceSpine received FDA clearance for its Thunderbolt Minimally Invasive Pedicle Screw System, Lancer Pedicle Screw System and Blackbird Posterior Cervical Spinal System in 2014. The company also introduced the Typhoon Transfacet Pedicular Screw Fixation System late last year. Beyond its regulatory clearances, the company is also being recognized locally; ChoiceSpine was nominated for the 2014 Innovator Pinnacle Award presented by the Knoxville Chamber. The company was founded in 2006 with a management team that has 70 years of industry experience. The company acquired $40 million-company Orthotech with exclusive rights for the United States market, several patents and solutions for six spinal conditions.
Precision Spine. The company recently signed a development agreement with Stephen D. Cook, PhD, to design a cervical spine disc replacement device. Dr. Cook and his team will focus on designing a disc to replicate the natural spinal function. Precision Spine achieved FDA clearance for the Sure-Lok C Extended TAB Pedicle Screw System in June and for the Reform Pedicle Screw System to treat spinal deformities in August 2012. "From the surgeon's perspective, [the Reform Pedicle Screw System] was designed to have high pull-out strength and a low-profile cobalt-chrome tulip head. It's a pedicle screw system that we anticipated can be used in both adolescent and adult situations. It has a triple-lead thread design which is designed to make implanting multiple screws quicker and less tiresome for the surgeon. The lower-profile design is expected to make irritation from the hardware less likely in thinner or smaller patients," said Krishn Sharma, MD, a spine surgeon with Scoliosis & Spinal Surgery in White Plains, N.Y.
Titan Spine. This past year has been huge for Titan Spine and its proprietary Endoskeleton interbody devices designed to promote bony ongrowth, optimize intervertebral stability and increase bone graft material. The company received an FDA clearance in July to launch the Endoskeleton TL device for lateral spinal fusion in the United States. The Endoskeleton Interbody Fusion devices received regulatory approval in Australia and New Zealand in July. The technology is also making a splash at professional conferences; an Endoskeleton Interbody Fusion Device for osteoblastic differentiation study earned the Whitecloud Award for Best Basic Research at the Scoliosis Research Society's International Meeting on Advanced Spine Techniques. Titan Spine is also exploring innovative sales and marketing strategy by offering a five-year guarantee for the Endoskeleton line of spinal interbody fusion devices. The company will replace the device if the patient requires a revision surgery within the five year warranty period as outlined by the terms of the agreement.
Zyga Technologies. Founded in 2008, Zyga Technologies is focused on a minimally invasive solution for sacroiliac joint fusion — SImmetry Sacroiliac Joint Fusion System. The company enrolled its first patient in a study to evaluate the procedure in May after receiving FDA clearance in March. The study will include 15 patients and seeks to demonstrate the value of this procedure. Next year, minimally invasive SI joint fusion will have a Category I CPT code for coverage and several Medicare Administrative Contractors announced they would cover the procedure as well. In May 2012, Zyga received $25 million in venture funding to fund the SImmetry system and clinical trials for Glyder facet resurfacing product. The Glydertrial completed enrollment in 2013.