Healthcare Industry News: Scient'x
News Release - August 23, 2012
Alphatec Spine Launches New MIS Device, the BridgePoint(TM) Spinous Process Fixation SystemCARLSBAD, Calif., Aug. 23, 2012 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that it has launched its newest Minimally Invasive Surgery (MIS) device, which is called the BridgePoint Spinous Process Fixation System.
BridgePoint is a minimally invasive system that is designed to enable spine surgeons to immobilize and stabilize spinal segments without the need for pedicle screw and rod constructs. The BridgePoint System is intended to be an adjunct to fusion of the thoracic and lumbar spine to treat disorders resulting from degenerative disc disease, spondylolisthesis, tumor and trauma.
"We are pleased to launch this important new product for surgeons," said Les Cross, Alphatec Spine's Chairman and Chief Executive Officer. "We believe BridgePoint offers unique benefits that deliver real value to surgeons and hospitals, helping patients who suffer chronic back pain regain their active lifestyles."
BridgePoint is designed to be implanted through a relatively small posterior incision of approximately 5 cm in length, which should result in less injury to muscle and tissue and less blood loss than occurs with the implantation of traditional pedicle screw and rod systems through a non-MIS approach. MIS procedures are typically shorter in length, saving valuable surgeon and hospital time and patient recovery times are typically faster and have fewer complications.
The BridgePoint System's state-of-the-art design incorporates telescoping plates that allow surgeons to compress or distract the spinous processes before immobilizing the spinal segment. The device's large contact area provides a strong anchor point to each spinous process, facilitating compression or distraction and optimal stability during the fusion process. BridgePoint can be used as an adjunct to interbody fusion or posterior fusion with decompression treatment. The large bone graft window allows surgeons to pack additional bone graft between the spinous processes.
BridgePoint's first implantation case was conducted in August 2012 at Cheyenne Regional Medical Center in Cheyenne, Wyoming by Dr. Steven Beer, a board certified neurological surgeon.
"I recently had a patient with degenerative disc disease and spinal stenosis, and BridgePoint offered a way for me to treat her less invasively," said Dr. Beer. "BridgePoint allows me to fixate the spine more efficiently than competitive systems and the device makes surgery safer and faster. At the same time, it provides an environment rich in characteristics necessary for fusion of the spine. BridgePoint will definitely be a product I offer my patients in the future."
The market for spinous process fixation devices is expected to reach $206 million by 2016, growing at a compound annual growth rate of over 24% from 2008. (Source:iData 2010)
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (ATEC). Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company's mission is to combine world-class customer service with innovative, surgeon-driven products that will help improve the aging patient's quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis, stenosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, the Company also markets its products in over 50 international markets through its affiliate, Scient'x S.A.S., via a direct sales force in France, Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In Latin America, the Company conducts its business through its subsidiary, Cibramed Produtos Medicos. In Japan, the Company markets its products through its subsidiary, Alphatec Pacific, Inc. In the rest of Asia and Australia, the Company sells its and Scient'x's products through its and Scient'x's distributors.
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, with respect to the agreement described in this press release, references to the size of the market for spinous process fixation devices, the adoption rate of the BridgePoint System by spinal surgeons. In addition, forward-looking statements include the Company's ability to develop and commercialize new products internally, and its ability to successfully pursue and commercialize complementary acquisitions of new products and technologies. 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; the uncertainty of success in acquiring new products or technologies; the successful launch of the Company's new products and the products in its development pipeline, including the product discussed in this press release; failure to achieve acceptance of Alphatec Spine's products by the surgeon community; failure to successfully implement streamlining activities to create operating cost savings; failure to successfully begin in-house manufacturing of certain products; failure to obtain or maintain FDA clearance or approval for products, including the product discussed in this press release, or unexpected or prolonged delays in the process; Alphatec Spine's ability to develop and expand its U.S. and/or global revenues; continuation of favorable third party payor reimbursement for procedures performed using Alphatec Spine's products; unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec Spine's ability to successfully control its costs or achieve profitability; uncertainty of additional funding; Alphatec Spine's ability to compete with other competing products and with emerging new technologies; product liability exposure; failure to meet all financial obligations in the Cross Medical Settlement; patent infringement claims and claims related to Alphatec Spine's intellectual property. 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.
Source: Alphatec Spine
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