Alphatec’s Arsenal™ Deformity Adolescent Scoliosis (AIS) System Launched in Limited Markets in the U.S.
CARLSBAD, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., (Nasdaq:ATEC), a global provider of spinal fusion technologies, announced today that the Company has launched its new Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS) System and has successfully completed initial patient cases. The limited release further expands the Company’s Arsenal Spinal Fixation System and targets the $650M U.S. deformity spine market.
The Arsenal AIS System gives surgeons a complete solution to address complex deformity pathologies, including unique uniplanar screws, which enable easier screw positioning and rod placement through a tulip that has 360 degrees of rotation, while restricting motion in the medial/lateral plane for derotation correction. Additionally, the AIS system includes a wide variety of low-profile implants providing a better anatomical fit and increased ability to address patient pathologies, ergonomically designed instrumentation to improve surgical efficiency and comfort during complex surgeries, and proven biomechanical strength necessary to achieve a solid fusion.
Terry Rich, Alphatec Spine’s Chief Executive Officer commented, “With the launch of our differentiated AIS Deformity System we are able to compete directly with the market leaders in complex spine and it opens up a new segment for us in pediatric procedures. This unique system extends our Arsenal platform and provides surgeons with easy-to-use, differentiated surgical tools for corrective maneuvers to better treat adolescent patients who are diagnosed with idiopathic scoliosis. These successful initial patient cases demonstrate ATEC’s ongoing commitment to developing innovative solutions that are targeted at improving overall patient outcomes and surgeon experience. The Arsenal AIS system gives us the opportunity to gain greater share in the deformity market and to benefit a vast number patients who are suffering today.”
Dr. Sheldon St. Clair, a pediatric orthopedic surgeon, and Dr. John Birknes, a pediatric neurosurgeon, co-directors of the Spine Program at the Children’s Hospital of the King’s Daughters in Virginia, have partnered to treat pediatric spine deformities and performed the first deformity correction using the Arsenal AIS system. The patient was a skeletally immature 13-year-old with a hypokyphotic 49-degree thoracic scoliosis. Drs. St. Clair and Birknes performed the surgery using the Arsenal uniplanar implants and cobalt-chromium alloy rods on a long construct across 9 levels from thoracic vertebrae T3 to T12. Post-surgery, the patient’s thoracic curve has been eliminated, appropriate kyphosis has been restored, and the patient’s rib hump is no longer present.
“The entire Arsenal Deformity AIS set is fantastic, but the shining star is the ability to spin the uniplanar bodies independent of the screw shank, which allows surgeons to achieve optimal fixation and placement of the pedicle screws,” said Dr. St. Clair. “This unique feature enables the tulips to be placed at the perfect height and orientation to accept the rod and correct the deformity. The slotted reduction towers are used both to reduce the rod into the tulips as well as to perform vertebral column manipulation to correct the spine in three planes of deformity. The reduction towers and transverse links are designed to be attached and removed with ease. The Arsenal AIS system provides strong, reliable implants, and two choices of cobalt chrome rods, enabling the surgeon to obtain excellent spinal deformity correction, which improves quality of life for the patient both now and for the future.”
About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC), is a medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.
Additional information can be found at www.alphatecspine.com.
Forward Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the Company’s ability to achieve profitable growth; the Company’s ability to achieve both domestic and international growth and future profitability. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to; the uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline within forecast timeframes, or at all, including without limitation the products discussed in this press release; the Company’s ability to compete directly with the market leaders in complex spine and open up a new segment for the Company in pediatric procedures; the Company’s ability to gain greater share in the deformity market and to benefit a vast number patients in such market; the acceptance of Alphatec Spine’s products by the surgeon community, including without limitation the products discussed in this press release; and Alphatec Spine’s ability to develop and expand its U.S. revenues. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
CONTACT: Investor/Media Contact: Christine Zedelmayer Investor Relations Alphatec Spine, Inc. (760) 494-6610 czedelmayer@alphatecspine.com
