Centinel Spine Announces STALIF C® Integrated Interbody™ Milestone Usage in Australia

New York, NY, September 26, 2018 –Centinel Spine, LLC announced today that Dr. Arvind Dubey, MD, FRACS, Neurosurgeon and Spine Surgeon at Hobart Brain and Spine Centre in Hobart, Tasmania, Australia, performed a milestone procedure implanting his 1,000th level of the STALIF C-Ti™ Anterior Cervical Integrated Interbody®device.  The procedure was a 2-level ACDF and took place at the Royal Hobart Hospital.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction and remains a leading provider of Integrated Interbody solutions, with over 30 years of clinical history and over 50,000 devices implanted.

After implanting his momentous 1000th STALIF® level, Dr. Arvind Dubey commented, “The STALIF C® system offers me a very simple yet clinically effective system for treating my patients with degenerative disc disease.  The STALIF® design and lag screws provide constant compressive fixation between the endplates and graft material.  The compressive fixation coupled with the titanium surface give me the best opportunity to achieve fusion and has resulted in great outcomes for my patients.”

STALIF Interbody devices are currently offered in three material options: PEEK, titanium-surfaced PEEK, and the recently launched 3D-printed, all-titanium FLX™ technology.  FLX implants feature a combination of solid and porous radiolucent titanium sections developed with the goal of reducing mechanical stiffness and improving visibility, as compared to solid titanium implants.  The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.  Furthermore, all three materials options are utilized with a single, streamlined instrument set.

“We are proud to announce Dr. Dubey reaching 1,000 STALIF levels implanted and congratulate him on this significant achievement.  This milestone further exemplifies Centinel Spine’s mission in partnering with surgeons throughout the world to become the world-wide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms,” says Centinel Spine Chairman & CEO, John Viscogliosi.

Centinel Spine will highlight the Company’s latest anterior column reconstruction technologies at the North American Spine Society (NASS) Annual Meeting−­held September 26-29, 2018 in Los Angeles, California at the Los Angeles Convention Center.  At the annual meeting, the company will demonstrate its commitment to advancing technology platforms for both fusion and motion preservation.  In Booth #2123, the company will showcase its recently acquired prodisc® Total Disc Replacement portfolio−the most extensive total disc replacement portfolio in the world−as well as its recently launched proprietary FLX 3D-printed, all-titanium devices for both cervical and lumbar fusion.  Additionally, Centinel Spine technologies will be highlighted in multiple podium presentations and hosted industry events.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc®Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the company’s website at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies, and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

Alphatec Advances Clinical Distinction With OsseoScrew® Clearance

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc.  (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew® System, making it available for clinical use for the first time in the United States.

“I am exceptionally pleased that OsseoScrew has been cleared for the U.S. market,” said Pat Miles, Chairman and Chief Executive Officer. “The system will create new market opportunities for ATEC by uniquely addressing an unmet need for an underserved patient population.  We are building an organic innovation machine and today’s announcement represents another significant step toward creating a clinically distinguished portfolio.”

The OsseoScrew System

OsseoScrew is a next-generation expandable pedicle screw system, intended to restore the integrity of the spinal column in elderly patients with advanced stage tumors involving the thoracic and lumbar spine. It is designed to be implanted into the pedicle, then expanded after implantation to achieve increased screw fixation and reduced post-operative pullout in bone with poor density.  OsseoScrew has been clinically proven to increase pullout and holding strength, improving fixation in the bone-implant interface by 29%, as compared to conventional pedicle screws.  It performs comparably to cemented fenestrated screws without the risk associated with cement leakage.

Alphatec will display OsseoScrew this week at the North American Spine Society (NASS) 2018 Annual Meeting, which is being held from September 26-29 at the Los Angeles Convention Center.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company that designs, develops, and markets technology for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Alphatec, Alphatec Spine, the Alphatec logo, SafeOp Surgical and OsseoScrew are trademarks or registered trademarks of Alphatec Holdings, Inc., its affiliates and/or subsidiary companies. All other marks are the property of their owners. Additional information can be found at www.atecspine.com.

Forward-Looking Statements

This press release contains “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. The Company 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 references to the Company’s strategy in significantly repositioning the ATEC brand and turning the Company into a growth organization.  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 the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including OsseoScrew, Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. 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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the Securities and Exchange Commission. ATEC 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.

Investor/Media Contact:
Tina Jacobsen
Investor Relations
tjacobsen@moreeffectiveir.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com

SeaSpine Announces Launch of Regatta™ Lateral System

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of the Regatta™ Lateral System, featuring NanoMetalene® technology.

Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the spine through indirect decompression and the restoration of sagittal alignment. Regatta offers a wide variety of implants to accommodate the patient’s anatomy, including 10 and 15 degree lordotic options for sagittal alignment and 18 and 23mm wide implants for complete endplate coverage. The Regatta lateral retractor and the EMG nerve detection dilators allow for customizable access with minimal tissue disruption through the psoas, while also providing the visualization necessary to effectively perform the procedure. The addition of new streamlined disc preparation and angled instruments to access challenging disc spaces combine to deliver the complete procedural solution.

“We are excited to provide this comprehensive lateral system to surgeons who perform less-invasive interbody fusion procedures that minimize the tissue disruption that typically accompanies traditional spinal fusion surgery. By optimizing each procedural element, from access to fusion, the surgeon can efficiently and effectively treat each patient’s unique spinal condition,” said Keith Valentine, President and Chief Executive Officer.

The Regatta interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene is a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide implants a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.

“The Regatta system offers a variety of sizes and angles of interbody implants to address the majority of patient anatomy requirements and my surgical correction goals. Additionally, the implant’s novel NanoMetalene titanium surface technology may allow for more rapid and reliable fusion healing, and allows me to consider a wider variety of graft materials, potentially reducing the cost of care,” stated Dr. James Bruffey, Orthopedic Spine Surgeon, Scripps Health – San Diego, CA.

SeaSpine will be conducting initial cases through a limited launch over the coming months and expects a full commercial launch of the Regatta Lateral System in the first half of 2019.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design of the Regatta Lateral System to efficiently and reproducibly treat the spine, to provide customizable access with minimal tissue disruption while providing necessary visualization, and to access challenging disc spaces; the ability of the Regatta Lateral System to deliver a complete procedural solution and efficiently and effectively treat each patient’s unique spinal condition; and the timing of initial cases and full commercial launch of the Regatta Lateral System. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including the fact that newly launched products may require substantial additional development activities, which could introduce further delay, or as a result of obtaining regulatory clearances; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5402
ir@seaspine.com

K2M to Showcase First-of-its-Kind 3D-Printed Expandable Interbody System MOJAVE™ PL 3D at NASS 2018

LEESBURG, Va., Sept. 26, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced that it will showcase its first-to-market MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology and several of its newest spinal solutions at the North American Spine Society 33rd Annual Meeting (NASS) in Los Angeles, CA, September 26-29 (Booth #2001). The Company also announced that MOJAVE PL 3D Expandable received a 2018 Spine Technology Award from Orthopedics This Week, which recognizes the best new spine technologies, engineering teams and inventors for 2018, and in the process, rewards excellence in innovation.

The MOJAVE PL 3D Expandable Interbody System is a first-of-its-kind fusion device allowing for independent control of the anterior and posterior heights in the lumbar spine—a new capability not available with any other product on the market today. Featuring infinite adjustment within its expansion range, the implant can be locked at any desired height and lordosis to help restore sagittal balance. Designed with Lamellar 3D Titanium Technology, MOJAVE PL 3D Expandable incorporates a porous structure and rough surfaces to allow for bony integration throughout the endplates.

At NASS, K2M will also showcase its YUKON OCT Spinal System, OZARK Guide and View Cervical Plate Systems and comprehensive Balance ACS® (BACS®) Platform. BACS provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

“We are excited to feature our MOJAVE PL 3D Expandable Interbody System, the world’s first 3D-printed fusion device featuring infinite adjustment tools that let surgeons more precisely match the implant to a patient’s anatomy, at this year’s NASS meeting,” said K2M Chairman, President, and CEO Eric Major. “Being recognized by Orthopedics This Week with a Spine Technology Award reflects our commitment to developing innovative solutions that ultimately help improve life for people with spinal diseases across the globe.”

The MOJAVE PL 3D Expandable Interbody System is K2M’s fourth device to win a Spine Technology Award. Orthopedics This Week recognized its 3D-printed CASCADIA Interbody Systems in 2016; its MESA® Deformity Cricket and SERENGETI® Minimally Invasive Retractor System were recognized in 2010 and 2009 respectively.

For more information about the MOJAVE PL 3D Expandable Interbody System and K2M and Balance ACS, visit www.K2M.com and www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn and YouTube.

Forward-Looking Statements

The foregoing contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements.  These forward-looking statements include statements relating to the expected timing, completion and effects of the proposed merger, as well as other statements representing management’s beliefs about, future events, transactions, strategies, operations and financial results, including, without limitation, our expectations with respect to the costs and other anticipated financial impacts of the merger; future financial and operating results of K2M Group Holdings, Inc. (“K2M”); K2M’s plans, objectives, expectations and intentions with respect to future operations and services; required approvals to complete the merger by our stockholders and by governmental regulatory authorities, and the timing and conditions for such approvals; the stock price of K2M prior to the consummation of the transactions; and the satisfaction of the closing conditions to the proposed merger.  Such forward-looking statements often contain words such as “assume,” “will,” “anticipate,” “believe,” “predict,” “project,” “potential,” “contemplate,” “plan,” “forecast,” “estimate,” “expect,” “intend,” “is targeting,” “may,” “should,” “would,” “could,” “goal,” “seek,” “hope,” “aim,” “continue” and other similar words or expressions or the negative thereof or other variations thereon.  Forward-looking statements are made based upon management’s current expectations and beliefs and are not guarantees of future performance.  Such forward-looking statements involve numerous assumptions, risks and uncertainties that may cause actual results to differ materially from those expressed or implied in any such statements.  Our actual business, financial condition or results of operations may differ materially from those suggested by forward-looking statements as a result of risks and uncertainties which include, among others, those risks and uncertainties described in any of our filings with the Securities and Exchange Commission (the “SEC”).  Certain other factors which may impact our business, financial condition or results of operations or which may cause actual results to differ from such forward-looking statements are discussed or included in our periodic reports filed with the SEC and are available on our website at http://www.k2m.com under “Investor Relations.” You are urged to carefully consider all such factors.  Although it is believed that the expectations reflected in such forward-looking statements are reasonable and are expressed in good faith, such expectations may not prove to be correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only to expectations as of the date of this communication.  We do not undertake or plan to update or revise forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections, or other circumstances occurring after the date of this communication, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized.  If we make any future public statements or disclosures which modify or impact any of the forward-looking statements contained in or accompanying this communication, such statements or disclosures will be deemed to modify or supersede such statements in this communication.

Additional Information and Where to Find It

This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval.  This communication relates to a proposed acquisition of K2M by Stryker Corporation.  In connection with this proposed acquisition, K2M plans to file one or more proxy statements or other documents with the SEC.  This communication is not a substitute for any proxy statement or other document K2M may file with the SEC in connection with the proposed transaction.  INVESTORS AND SECURITY HOLDERS OF K2M ARE URGED TO READ THE PROXY STATEMENT AND OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.  Any definitive proxy statement(s) (if and when available) will be mailed to stockholders of K2M.  Investors and security holders will be able to obtain free copies of these documents (if and when available) and other documents filed with the SEC by K2M through the website maintained by the SEC at http://www.sec.gov.  Copies of the documents filed with the SEC by K2M will be available free of charge on K2M’s internet website at http://www.k2m.com or upon written request to: Secretary, K2M Group Holdings, Inc., 600 Hope Parkway, SE, Leesburg, Virginia 20175, or by telephone at (703) 777-3155.

Participants in Solicitation

K2M, its directors and certain of its executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction.  Information regarding the persons who may, under the rules of the SEC, be deemed participants in such solicitation in connection with the proposed merger will be set forth in the proxy statement if and when it is filed with the SEC.  Information about the directors and executive officers of K2M is set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the SEC on March 1, 2018, its proxy statement for its 2018 annual meeting of stockholders, which was filed with the SEC on April 20, 2018, its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2018 and June 30, 2018, which were filed with the SEC on May 2, 2018 and August 2, 2018, respectively, and its Current Reports on Form 8-K or Form 8-K/A, which were filed with the SEC on January 8, 2018, January 9, 2018, February 28, 2018, March 29, 2018, May 1, 2018, June 11, 2018, June 14, 2018, June 18, 2018, August 1, 2018 and August 30, 2018.

These documents can be obtained free of charge from the sources indicated above.  Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.

K2M Group Holdings, Inc.
600 Hope Parkway, SE
Leesburg, Virginia 20175
Tel. (703) 777-3155
www.k2m.com

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Captiva Spine Adds TirboLOX-C Titanium Cervical Cage to 3D Printed Dual Layer Lattice Structure Offering

Jupiter, FL – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-C 3D Printed Titanium Cervical Cages.

TirboLOX-C Titanium Cervical Cages

TirboLOX-C Titanium Cervical Cages were created following the principles of biomimicry.   The titanium alloy interbody fusion devices with a dual layer organic lattice structure are formed using advanced 3D printing technologies. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture.  Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony on growth, in growth and vascularization. TirboLOX-C’s open architecture is designed to reduce radiographic presence for clear imaging.  TirboLOX-C’s high coefficient of friction creates immediate bidirectional fixation.

Dale Mitchell, President and Founder of Captiva Spine said, “Our design development, incorporating substantial surgeon design input, including dual layer porous 3D printed titanium cages, dates back several years.  The timing for commercialization is excellent, as surgeons’ apparent growing preference for porous 3D printed titanium cages is substantial.  In addition, the recently announced industry acquisitions, that include 3D cage technology, may limit independent distributors’ access to this critical growth technology.  Likewise, we are pleased to make our complete line of TirboLOX 3D printed titanium cages available to support their surgeons’ needs.”  Captiva Spine is able to deliver TirboLOX Cervical’s unique dual layer organic lattice structure with numerous geometries and sizes satisfying a wide range of surgeon preferences.

Captiva Spine’s TirboLOX-C Titanium Cervical Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angeles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality.  They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

This Press Release can be found at PRWeb.com

Solvay’s Ixef® PARA enables Intelligent Implant Systems to pioneer a new single-use instrument kit for anterior cervical fusion procedures

Alpharetta, Ga., September 26, 2018 — Solvay, a leading global supplier of specialty polymers, announced today that the high stiffness, strength, gamma sterilization resistance and biocompatibility of its Ixef® polyacrylamide (PARA) resin helped enable a new single-use instrument kit for anterior cervical fusion procedures. Developed by Intelligent Implant Systems, a medical device company specializing in solutions for spinal surgery, the MEDIANT™ Anterior Cervical Plating System leverages Solvay’s advanced polymer to help boost operating room (OR) efficiency, eliminate onsite sterile processing and reduce infection risk.

“The primary benefit of Solvay’s Ixef® PARA in this application is its metal-like strength, which gives our single-use surgical instruments a very high level of performance without incurring the costs associated with machining metal and repeated steam sterilization,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “Although PEI also offered viable options for our surgical tool kit, we specified Ixef® GS-1022 PARA because its superior stiffness and moldability was essential for the kit’s instruments.”

Ixef® GS-1022 PARA forms the awl and pin-screwdriver handles, measuring caliper, and locking plier handles in Intelligent Implant Systems’ kit. The polymer’s excellent impact resistance also eliminated the need for a metal strike plate that had been part of the awl’s early designs. This reduced the cost and simplified the manufacture and assembly of the instrument, further supporting the economics of single-use instruments.

Ixef® GS-1022 PARA provides excellent aesthetics, including an attractive surface finish. The material is available in a range of gamma-stabilized colors, including the signature green of the MEDIANT™ System’s tools. Together, these properties of Ixef® PARA ensure Intelligent Implant Systems’ single-use instruments retain their visual appeal after they are gamma sterilized and packaged for delivery. Solvay’s PARA polymer has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which helped streamline the MEDIANT™ kit’s navigation through regulatory approvals.

“Solvay was an early advocate of the healthcare industry’s shift toward single-use surgical instruments, and we sought to support customers by proactively developing a broad portfolio of biocompatible polymer alternatives to metal – complete with gamma-sterilized colors and master access files,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Yet while the industry’s growing adoption of our advanced polymers validates this early insight, we derive much greater satisfaction in working closely with innovators like Intelligent Implant Systems to help achieve unique new designs for improving patient results.”

Intelligent Implant Systems will feature the MEDIANT™ Anterior Cervical Plating System at Booth #1905 during The North American Spine Society (NASS) meeting in Los Angeles, Sept. 26-29. For related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay

™ MEDIANT is a trademark of Intelligent Implant Systems

Intelligent Implant Systems is based in Charlotte, NC. Founded in 2007, the company aims to develop and market innovative surgical solutions for orthopedics and both fusion and non-fusion applications of the spine. Since its inception, the company has been granted multiple U.S. patents with foreign and additional U.S. patents pending to protect its core technology. Innovation is truly part of what Intelligent Implant Systems brings to patients, surgeons, hospitals and ambulatory surgery centers. Learn more at www.intelligentimplantsystems.com.

Media Relations

Marla Witbrod
Solvay Specialty Polymers
+1 770 772 8451
marla.witbrod@solvay.com

Dan McCarthy
AH&M Marketing Communications
+1 413 448 2260 Ext. 470
dmccarthy@ahminc.com

Enrico Zanini
Solvay Specialty Polymers
+39 338 603 4561
enrico.zanini@solvay.com

Alan Flower

Industrial Media Relations

+32 474 117 091

alan.flower@indmr.com

 

 

 

 

 

 

Surgio and SimplyRFID Announce Partnership For Fully-Automated Visibility into the Medical Device Supply Chain in Healthcare

Surg.io™, an emerging leader in software solutions for the management of orthopedic instrument and implant inventory as well as hospital sterile processing and perioperative solutions, has partnered with SimplyRFID, a veteran leader in tracking technology and inventory visibility solutions, announce an exclusive healthcare partnership to provide a fully integrated inventory management system that brings real-time visibility, tracking, and analytics to the entire hospital supply chain.

The medical device supply chain is inherently complex and full transparency has remained elusive for the majority of the healthcare industry. Hospitals and manufacturers alike have difficulty gaining oversight of even their highest-dollar assets.

Recent studies and surveys show that 80% of hospitals still manage their inventory via manual processes. Without tracking, up to 30% of their inventory expires on the shelves and hundreds of thousands – and often millions – of dollars in charges go uncaptured and unnecessary purchasing practices continue unabated.

The agreement combines two technology platforms that enable real-time location tracking plus artificial intelligence to reduce the potential for human error while increasing supply chain efficiencies. Surg.io and Simply RFID have jointly created the most advanced software/hardware solution to provide transparency and actionable analytics to the orthopedic & spine clinical arenas.

The new partners plan to launch the products in Los Angeles this week at the North American Spine Society’s Annual Convention on September 26-19 (Booth 1135). “We are excited to see how the partnership of Surg.io and SimplyRFID takes both platforms to new heights that were previously impossible. It is a real ‘1 plus 1 = 10’ scenario.” Jeff Claeson, Surg.io’s Co-Founder & Chief Technology Officer.

Carl Brown, President/Founder of SimplyRFiD said: “It’s a perfect match! Surgio makes healthcare supply chain management simple. We make supply chain tracking simple. By bringing these two technologies together – a trusted hospital scheduling / management product from Surgio and an accurate tracking system from SimplyRFiD – we give hospitals the best solution for managing their resources. Together, we create the complete solution that improves healthcare for everyone.”

About Surg.io

Surg.io is a complete inventory tracking system created for the orthopedic and spine industry. ERP systems were not built to effectively facilitate the fast-paced logistical environment of medical device supply chains. They are complex and often rely on tribal knowledge of each system to manage effectively. Healthcare suppliers and institutions rely on Surg.io to streamline communication between disparate teams to ensure continuity. By offering a user-friendly and intuitive interface, you don’t have to be a power user to manage inventory. Leverage Surg.io to enhance processes and optimize supply chain strategy.

About SimplyRFID

Since its founding in 2003, SimplyRFID has been at the forefront of developing tracking technology software. With over 100 million tags shipped and thousands of systems deployed worldwide in industries ranging from defense to healthcare, SimplyRFID is the expert industry leaders turn to for tracking solutions. Its largest deployment was developed in support of a major pharma group, which chose SimplyRFID due to its 15+ years of industry-leading expertise in RF-data capture solutions.  The deployment created a solution with unmatched reliability, accuracy, and scalability, enabling real-time tracking of tagged pharmaceutical items in hospitals and at healthcare providers worldwide.

 

Medacta Appoints General Manager for U.S. Spine Business and Announces Full-Market Release of Customizable MySpine MC Surgical Guides for Posterior Lumbar Fusions

LOS ANGELES–(BUSINESS WIRE)–Medacta® International, the family-owned global leader in innovative joint replacement and spinal technologies, announces today the appointment of long-time commercial leader Daniel Abromowitz as General Manager, Spine Division for Medacta USA. In addition, the company announced its MySpine Midline Cortical Pedicle Screw Placement Guide (MySpine MC), a patient-matched technology for posterior lumbar fusions, is now generally available and will be on display at the North American Spine Society (NASS) 2018 Annual Meeting, held Sept. 26-29, 2018 in Los Angeles, at Booth #2323.

“Daniel is a welcomed addition to the management team, bringing an innovative management approach and broad engineering and supply chain experience,” said Eric Dremel, President of Medacta USA. “Most importantly, Daniel’s track record of sustained commercial success and relentless customer focus will allow the potential of our Spine Division to be fully realized.”

A respected business leader, Abromowitz brings to Medacta USA a history of building high-performing, results-driven teams, with more than a decade of experience supporting and leading early-stage and emerging companies in the medical device and health care marketplaces. After nine years with spinal implant company X-spine Systems, Inc., Daniel was the Vice President of Sales when the company was acquired by Bacterin in 2015. Since, he has held senior leadership positions at Xtant Medical (formerly X-spine), Aerobiotix and most recently, Captiva Spine.

“As a passionate supporter of collaborative worldwide innovation, Medacta International offers an incredible growth opportunity for spine in the U.S. market. My goal is to build on the successful foundation of Medacta’s joint division here in the U.S. to support our key stakeholders in spine: surgeons, patients, facilities and agents,” Abromowitz said. “By utilizing the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, Medacta surgeons are never alone. I hope to expand on these peer-to-peer training programs for spinal surgeons here in the U.S., as we build Medacta USA Spine into an innovative leader for the U.S. market.”

MySpine MC – Offering a new approach to posterior lumbar fusion

The patient-matched, 3D-printed MySpine MC, first announced in May 2018, guides pedicle screws to a trajectory that evolved from the well-established cortical bone trajectory (CBT). The MySpine MC technique, however, has a more caudomedial entry point than traditional pedicle screw trajectories and a less extreme caudal-cranial angle than CBT to avoid interference with the cranial facet joints and to accommodate larger screw diameters and lengths, precisely supported by 3D pre-operative planning. As an accurate and reliable muscle-sparring approach, MySpine MC is designed to encourage faster patient recovery and is suitable for both inpatient and outpatient surgery settings.

MySpine MC will be on display at NASS 2018 at Booth #2323 along with the rest of Medacta’s spine product portfolio. For more information on MySpine MC, visit Medacta’s MySpine MC webpage, where the new MySpine MC video is available.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient-matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

SurGenTec’s ALARA™ Access Needle Awarded Best Spine Technology for 2018

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec ® LLC, a South Florida based medical device company has been awarded the 2018 Orthopedics This Week Spine Technology Award and will be formally receiving their award during the 2018 North American Spine Society meeting. This year’s meeting will be held Sept. 26th -28th in Los Angeles, CA. The awarded technology from SurGenTec’s product line is the unique and innovative ALARA ™ access needle. The access needle will be offered in multiple variations including with and without a depth stop. When combined with their patented fully adjustable extension handle the user can maintain superior target needle manipulation while also reducing radiation exposure. The extension handle allows users to maintain maximum source-to-skin distance between their hands and the primary x-ray beam without sacrificing precision and control. A white paper study revealed a reduction in radiation exposure of 293 times less than standard needle manipulation and 15 times less than using a Kocher Clamp. The ALARA access needle is set for release in Mid-October.

Travis Greenhalgh, CEO of SurGenTec stated in a recent interview, “Although its often overlooked in the industry, many surgeons reach dangerous levels of radiation exposure annually and SurGenTec is on a mission to decrease those numbers and raise awareness.”

SurGenTec, LLC is a medical device company based in Boca Raton, FL that strives to bring the next level of technology to the spine and orthopedic industry. SurGenTec develops and manufactures innovative products with patient and surgeon safety at the heart of everything they develop. SurGenTec has already made their presence known with the GraftGun® Universal Graft Delivery System which launched earlier this year and are excited to add the awarded ALARA to their portfolio. SurGenTec will also be showcasing their pre-filled MIS cartridge options at NASS, including ViBone® viable bone matrix. SurGenTec partnered with Aziyo® Biologics to provide ViBone next generation bone graft in an MIS cartridge to reduce thawing time, cross contamination, and delivery issues. SurGenTec has multiple products in their pipeline set for release over the next year.

www.surgentec.com
7601 N Federal Hwy., Suite 150A
Boca Raton, FL 33487
561-990-7882 / customerservice@surgentec.com

Contacts

SurGenTec ® LLC
Ricki Goldman, 561-990-7882
customerservice@surgentec.com

Synergy Biomedical Announces FDA Clearance of BIOSPHERE® FLEX

September 25, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX. Based on Synergy’s patented BioSphere® Technology, BIOSPHERE® FLEX is a strip-format bone graft product composed of porous, bioactive glass that is dimensionally integrated within a collagen and sodium hyaluronate scaffold. The porosity of the BIOSPHERE® FLEX bone graft was specifically designed for optimized absorption of bone marrow aspirate. BIOSPHERE® FLEX is presently in final preparation for commercial launch in the 4th quarter of 2018.

“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “The BioSphere® product line provides surgeons with a full spectrum of bone graft forms that can be tailored to a variety of surgical techniques while leveraging the proven advantages of Synergy’s core bioactive technology. These options include BIOSPHERE® PUTTY (a robust bone graft material that can be used alone or combined with autograft), BIOSPHERE® MIS PUTTY (with a delivery system specifically designed for targeted graft placement in minimally invasive surgery), and now BIOSPHERE® FLEX (developed to be used by surgeons who prefer the characteristics of a flexible strip form and the ability to augment with bone marrow aspirate).”

“The addition of BIOSPHERE FLEX to the product portfolio provides Synergy increased coverage of the bone graft market,” stated Kevin Booth, VP of Sales. “With the BioSphere® product line, surgeons have access to next-generation bone graft technology that is compatible with a variety of bone grafting techniques.”

BIOSPHERE® FLEX utilizes Synergy’s patented BioSphere® Technology which is based on an innovative spherical form of bioactive glass that allows for ideal and precise control over the osseous healing process. The BioSphere® granules utilized in BIOSPHERE® FLEX have a unique and innovative bonded sphere structure that provides an optimal porosity for bone growth through the granules. BIOSPHERE® FLEX has one of the highest bioactive glass contents on the market due to its increased granule density compared to other porous bone graft sheets. Additionally, the use of a specifically formulated collagen and sodium hyaluronate carrier in BIOSPHERE® FLEX permits the implant to become flexible and moldable when hydrated with bone marrow aspirate. This aids in graft placement, and enables the implant to conform to irregular bone surfaces for maximum graft continuity and healing potential.

BIOSPHERE® FLEX utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a next-generation bone graft material with the working characteristics of a flexible strip that is designed to absorb and hold bone marrow aspirate in direct contact with porous bioactive glass granules.

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere® Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com