Earlier this month the first clinical use of the Avance MIS Pedicle Screw System from Baxano Surgical was performed in North Carolina.
Here are five things to know about the first implantation:
1. Sameer Mathur, MD, performed the first case in Cary, N.C., with the Avance MIS Pedicle Screw System. "The Avance system provides a step forward with a true MIS approach to spinal fixation by minimizing tissue trauma and eliminating additional rod insertion incisions," said Dr. Mathur. "The system's low-profile design, combined with Avance's intraoperative flexibility and range of operations to meet surgeon preferences makes for a durable, versatile, easy-to-use solution."
2. The Avance MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion. It is a percutaneous pedicle screw system that addresses, single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma.
3. Baxano was founded in May 2000 and merged with TranS1 to form a publicly traded spine company focused on minimally invasive technologies — Baxano Surgical. In April, the company closed $10 million private placement of convertible debentures and looks to the Avance system to further company growth.
"The first clinical use of the Avance pedicle screw system represents a major milestone in the evolution of Baxano Surgical," said Ken Reali, president and CEO of Baxano surgical. "Avance will significantly enhance our ability to service our surgeon customers' lower lumbar fusion needs where we can now offer a complete fusion solution coupled with our AxiaLIF and VEO interbody fusion implants. This is an important strategic initiative that increases our presence in the rapidly growing MIS spinal arena."
4. The Avance system will be in limited release through the end of the third quarter of 2014. There are plans for a full launch during the fourth quarter. The system received FDA clearance in April 2014.
5. In 2013, Baxano Surgical reported the preliminary full year revenue was expected to be at $18.6 million, representing a 28 percent growth over the same period in 2012. The growth was primarily due to an improved performance in the company's iO-Flex decompression instrument and VEO direct lateral system. During the first quarter of 2014, the company reported a $0.19 net loss per share, totaling $9.1 million. First quarter revenue was at $4.4 million.