Life Spine Announces FDA Clearance of PLATEAU®-LO Insert and Rotate Spacer System

March 20, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the PLATEAU-LO Insert and Rotate Spacer System.

“PLATEAU-LO is my go-to spacer for micro-invasive lumbar interbody fusions. The oblique lordosis and vast array of footprints cater to the wide variety of patient anatomies I see in my practice. I also find that the bulleted tip allows for very simple insertion, and the insert and rotate feature allows for restoration of disc height. These features are essential for good patient outcomes,” said Rebecca Kuo, MD of Joliet, IL.

“PLATEAU-LO is another great addition to our already robust interbody platform. By combining PLATEAU-LO with our AVATAR® Percutaneous Screw System and the CENTRIC®-T Pedicle-Based Retractor System it shows our keen interest in innovation around micro-invasive procedures and providing our customers with multiple options for optimal patient care,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine.

PLATEAU-LO is available in PEEK material and is offered in 7° and 12° lordosis and multiple footprints options.

Key Features and Benefits of the system are:

  • Chamfered corners allow for ease of insertion and distraction
  • Oblique lordosis to better match patient anatomies and pathologies
  • Bullet tip simplifies insertion
  • Large, open graft windows maximize visibility and bone graft containment
  • Aggressive tooth pattern prevents graft migration

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

March 20, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. These liners are designed to work in conjunction with the Novation® Crown Cup® Acetabular System including InteGrip® printed, 3-D porous material.

The advanced bearing material in the new XLE liners is designed for low wear and contains vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopaedic implant polyethylene. Vitamin E, a natural antioxidant, is blended into the raw material of Novation XLE liners to mitigate oxidative effects both before and after implantation.

This product complements Exactech’s Hip product family, which also includes the Alteon® HA Femoral StemTapered Wedge Femoral StemNeck Preserving Stem and Monobloc Revision Stem.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

Smith & Nephew Supports AAFAO Courses with Donation of More Than $3M of Equipment to The Podiatry Institute

LONDONMarch 19, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE:SN), the global medical technology business, today announces the donation of more than $3M of trauma plates and screws, external fixation implants and instruments to The Podiatry Institute (PI). This equipment will be used to support ongoing educational courses conducted at the PI through the American Academy of Foot and Ankle Osteosynthesis (AAFAO).

Smith & Nephew has been the sole sponsor of the comprehensive and advanced educational courses conducted by the PI and AAFAO for the past four years, contributing to resident education for nearly 1600 participants. The company not only provided the surgical equipment and personnel support for these courses, but also hosted the event at its world class Innovation Center in Memphis, Tenn.

“Smith & Nephew has always been proud to support this important training. We view this donation as an important business need for podiatric resident training and their future patients,” said John Clausen, Vice President Global Marketing, Trauma and Extremities. “Along with this donation of surgical equipment, we will also continue to provide support with the appropriate Smith & Nephew personnel.”

The AAFAO was founded in 2014 for the sole purpose of training podiatric residents in the techniques and skills of skeletal fixation, trauma and reconstructive surgery of the foot and ankle. Courses are led by some of the best podiatrists in the profession with curriculum covering application of the principles and techniques for current and novel approaches to reconstructive surgery on the foot and ankle. This donation allows the AAFAO and PI to host these courses multiple times a year while opening up opportunities for multiple sponsors.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward- looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com

Orthofix Announces Agreement to Acquire Spinal Kinetics

March 15, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced that it has entered into a definitive agreement to acquire Spinal Kinetics Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs. Terms of the agreement include $45 million in cash closing consideration plus up to $60 million in contingent milestone payments related to U.S. Food and Drug Administration approval of the M6-C cervical disc and the achievement of trailing twelve-month sales targets of $30 million and $50 million.

“The Spinal Kinetics M6 artificial discs will further strengthen Orthofix’s product portfolio by filling a strategic gap in our Spine Fixation product line. This technology is a significant advancement in mimicking the natural motion of the spine, which we believe will be very beneficial to patients and well received by our surgeon customers,” said Orthofix President and Chief Executive Officer, Brad Mason. “This acquisition is very well aligned with our value creation strategy of accelerating topline growth by investing in faster growing market segments in our core businesses. In addition, we expect this news will energize our sales force and be attractive to potential new sales talent.”

Spinal Kinetics manufactures and distributes the M6-C cervical and M6-L lumbar artificial discs for patients suffering from degenerative disc disease (DDD) of the spine. These unique discs are designed to mimic the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus. This allows for six degrees of motion, similar to a natural disc.

“Artificial disc replacement is increasingly being indicated as the superior surgical solution to the traditional spinal fusion because it maintains normal motion of the spine and in many cases lessens the chance of future surgery. However, the designs of the first-generation artificial discs, much like total hip replacement, were based on the ball-and-socket concept which does not take into account the natural compression of the native disc,” said Dr. Richard D. Guyer, orthopedic spine surgeon and Chairman of the Texas Back Institute Research Foundation in Dallas and an investigator in the “Restore” U.S. clinical trial sponsored by Spinal Kinetics. “The M6 disc is designed out of materials to mimic the biomechanics of a normal disc including axial compression, flexion-extension, lateral bending, translation and axial rotation in order to provide patients with a more natural range of motion.”

The M6 artificial discs currently have CE Mark approval for distribution in the European Union and other international geographies. They are not available for commercial distribution in the U.S. Spinal Kinetics has submitted a PMA to the U.S. Food and Drug Administration in order to gain U.S. market approval for the M6-C cervical disc to treat single level cervical DDD. Internationally, there have been more than 54,000 implants of the M6-C and M6-L since the products were first launched in 2006.

“We look forward to becoming a part of the Orthofix team,” said Tom Afzal, President and CEO of Spinal Kinetics. “Joining forces gives us the opportunity to bring together Spinal Kinetics’ proven innovative technology with Orthofix’s regulatory, market development, distribution and commercial expertise as we work to broaden the availability of these devices and ultimately prepare for U.S. commercialization.”

Orthofix estimates the artificial disc market in 2017 to be over $325 million worldwide and $200 million in the U.S., with double-digit growth expected for many years. Also, Orthofix anticipates that the momentum created from the addition of the M6 disc to the Orthofix spine fixation portfolio will generate pull-through revenue of other Orthofix products and position the company for market share gains in the $5.4 billion U.S. spine hardware market.

The transaction is anticipated to close in the second quarter of 2018, subject to customary closing conditions. Orthofix expects the acquisition to not only add revenue in 2018, but also increase its organic revenue growth rate in 2019 and beyond. The company also expects the deal to be slightly accretive to the Company’s non-GAAP diluted earnings per share and adjusted EBITDA within 12 months of PMA approval in the U.S. and further accretive thereafter.

In connection with the transaction, Canaccord Genuity is acting as a financial advisor to Spinal Kinetics.

Orthofix Conference Call

Orthofix will conduct a conference call on Thursday, March 15 at 4:00 p.m. Central time (5:00 p.m. Eastern time). An overview of the transaction will be provided during the call. The investor presentation is viewable on Orthofix’s U.S. corporate home page or ir.orthofix.com. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 7493218. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 7493218.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

About Spinal Kinetics Inc.

Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to the unique biomechanical properties that replicate the motion of a natural disc and the positive clinical outcomes for patients. The company is located in Sunnyvale, California. For more information about Spinal Kinetics or the M6 Artificial Disc, please visit spinalkinetics.com.

Forward Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the estimates, projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, Spinal Kinetics and their respective companies’ product portfolios, are based on Orthofix management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks, including the possibility that the deal might not close, difficulties commercializing Spinal Kinetics’ products and integrating their product lines into Orthofix’s business, inaccuracies in Orthofix’s estimates and projections of future product sales, including the current and future size of the worldwide and U.S. artificial disc market, FDA and regulatory approval risks, and other risks described in the “Risk Factors” section of our 2017 Annual Report on Form 10-K, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Stryker Spine Division’s Tritanium® C Anterior Cervical Cage Gains Momentum With Surgeons

March 15, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has been implanted by 311 surgeons in more than 1,770 procedures across the U.S. since its introduction in late October. The company has sold more than 3,188 Tritanium C implants to date.

The Tritanium C Anterior Cervical Cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3

“As more spine surgeons gain experience using Tritanium cages, they are becoming believers in Tritanium Technology, which is designed to mimic the porosity of cancellous bone,” said Bradley Paddock, president of Stryker’s Spine division. “We are thrilled by the positive feedback the Tritanium C Anterior Cervical Cage is receiving from our surgeon customers.”

“The Tritanium C Anterior Cervical Cage is another great product by Stryker that brings revolutionary technology to the operating room,” said Dr. Lance Smith, Orthopedic Surgeon at McBride Orthopedic Hospital, Oklahoma City. “With many product sizes and lordosis options, I feel like I can match the anatomy and needs of the patient with the implant. I look forward to using the Tritanium C Cage product in more spinal surgeries.”

“I was intrigued by Tritanium because of the idea of bone in-growth as opposed to the on-growth of competitive products,” said Dr. Scott Kutz, Texas Back Institute, Plano, Texas. “I found the large graft window and imaging characteristics of Tritanium to be favorable versus other metal implants I’ve used.”

Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.4 This “precise randomization”4 of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that create a uniform lattice structure, as well as cages offering porosity that is only present on the surface. Tritanium Cages feature an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment.

The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and was introduced to surgeons during the North American Spine Society conference Oct. 25–28, 2017. Full commercial launch occurred on Dec. 10, 2017. For Indications for Use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com and www.stryker.com/builttofuse/. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491

Drs. Smith and Kutz are paid consultants of Stryker. Their statements represent their own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Content ID: TRICC-PR-3_16579

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

K2M Launches Next-Generation YUKON™ OCT Spinal System at AANS/CNS 2018

LEESBURG, Va., March 14, 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 the commercial launch of the YUKON™ OCT Spinal System at the 34th Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS), occurring March 14-17 in Orlando, FL (Booth #200). At the meeting, the Company will also showcase Balance ACS® or (BACS®), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for spine patients.

The YUKON OCT Spinal System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in September 2017, was developed to help surgeons restore cervical sagittal balance through posterior fixation in the occipito-cervico-thoracic regions of the spine. It features a newly designed top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters. The screw provides 60 degrees of angulation for 60 degrees of coronal swing “60 for 60” to aid in screw placement, providing up to 105 degrees of polyaxial angulation.

“We are pleased to launch our next-generation YUKON OCT Spinal System, an important addition to our growing complex spine portfolio, at this year’s AANS/CNS meeting,” said K2M Chairman, President, and CEO Eric Major. “K2M is committed to realizing the theme of this year’s meeting—restoring alignment in an era of global change—as evidenced by this latest commercial milestone and through our comprehensive Balance ACS platform.”

YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium to accommodate construct rigidity based on degenerative or deformity corrections. The system’s advanced, streamlined reduction instruments allow for intraoperative flexibility and ease of use. A Pistol Grip Rod Reducer provides up to 20 mm of reduction, while the Sequential Reducers deliver up to 15 mm of controlled reduction and correction.

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.

For more information about the YUKON OCT Spinal System and K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit 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

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

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

CTL Introduces MATISSE(TM) Ti-PEEK ACIF Cage Implant

DALLAS, TX / ACCESSWIRE / March 13, 2018 / CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance and approval to market its new MATISSE™ Ti-PEEK ACIF Cage System with TiCro™ technology in the practice of spine fusion surgery.

The MATISSE™ Ti-PEEK ACIF Cage with CTL Medical’s proprietary TiCro™ surface technology offers the increased bone ingrowth of Titanium and the post-op fusion visibility of PEEK. Like its predecessor, the MATISSE™ Titanium ACIF Cage with TiCro™, the updated Ti-PEEK interbody device offers surgeons a 200 percent greater endplate contact surface area, as well as geometric surface morphology for increased mechanical locking at the cage and bone interface. The implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“The MATISSE™ Ti-PEEK Cage with TiCro™ represents several improvements over earlier models,” stated Rose Moore, vice-president of marketing for CTL Medical Corporation. “The MATISSE™ device line now offers 3 material options to satisfy surgeons and their patients ever changing needs. As with previous models, the Matisse Ti-PEEK system offers streamlined instrumentation and a variety of footprints, heights, and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE™ Ti-PEEK Cage with TiCro™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE™ Ti-PEEK Cage with TiCro™ is to be used with supplemental fixation, such as CTL Medical’s VAN GOGH™ Anterior cervical plating system, which has been cleared for use in the cervical spine.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

AboutCTL Medical Corporation

CTL Medical Corporation is a fully integrated, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talents, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Media Contact:

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

SOURCE: CTL Medical Corporation

Solvay’s Zeniva® PEEK enables durable all-polymer knee implant from Okani Medical Technology

Alpharetta, Ga., March 5, 2018 — Solvay, a leading global supplier of specialty polymers, announced that Okani Medical Technology, a China-based pioneer in artificial joint applications, has developed an all-polymer knee implant based on Solvay’s Zeniva® polyetheretherketone (PEEK). Okani’s novel ORGKnee™ implant offers a longer service life at a lower cost than traditional metallic implant systems. Solvay’s booth at AAOS 2018 will feature the ORGknee™ implant in multiple sizes.
Okani evaluated Zeniva® PEEK’s suitability for the femoral and tibial tray components of its knee implant according to ISO 14243-1:2009, which simulates normal walking behavior over 10 years. The findings, which Okani will present at the Orthopaedic Research Society (ORS) 2018 Annual Meeting next week, indicate that the ORGKnee™ implant made of Zeniva® PEEK exhibited 50 percent less wear versus a metal implant as measured by material loss over 3 million cycles.
Okani selected Zeniva® PEEK for its ORGKnee™ implant due, in part, to the material’s success in spinal implant applications. Unlike implants made of cobalt chrome or titanium alloys, those molded from Zeniva® PEEK exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime due to significantly reduced wear of the total knee-joint prosthesis.
PEEK’s injection molding capability makes large-scale production of ORGKnee™ implants possible in a fraction of the time and cost it takes to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment,” said Zhonglin Zhu, chief technology officer for Okani.
Another motivation that prompted Okani’s decision to work with Solvay was the polymer supplier’s reputation for partnering with highly innovative medical device companies.
Okani’s implant is not only a perfect showcase for the unique properties of Zeniva® PEEK, but also for Solvay’s open innovation business model, which takes a collaborative approach to helping medical device customers foster innovation and optimize their technology,” said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit.
Okani’s ORGKnee™ implant enters pre-clinical trials this April before undergoing standard clinical trials by China’s Food and Drug Administration (CFDA) in September, 2018. The company plans to commercially launch its ORGKnee™ solution in 2020 after CFDA approvals are complete.
For more information about this application and related news about specialty polymers for healthcare, please go to solvayhealthcarenews.com.
® Zeniva is a registered trademark of Solvay
™ ORGKnee is a trademark of Okani Medical Technology

Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that address key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its light-weighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 24,500 employees in 61 countries. Net sales were €10.1 billion in 2017, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Paragon 28® launches the industry’s most robust screw and instrumentation system for addressing Charcot arthropathy – Joust™ Beaming Screw System

ENGLEWOOD, Colo.March 9, 2018 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results benefitting both the surgeon and patient.

The Joust Beaming Screw System offers surgeons 220 unique beam options to address Charcot foot deformity.

The system is made up of 5.0, 5.5, and 7.2 mm, solid and cannulated beams. The beams are Type II Anodized Ti-64AI-4V for improved fatigue strength. All beams have a sharp tip for ease of insertion and are offered headless to minimize prominence. The 7.2 mm beams are available in 65-185 mm in length to address varying patient anatomy and to aid in allowing surgeons to place a medial column beam into the posterior aspect of the talus. The 5.0 and 5.5 mm beams are offered in 50-120 mm lengths to accommodate varying patient anatomies and to allow for increased bone capture. The system offers partially threaded and fully threaded options to allow for compression or increased thread purchase depending on the surgical requirements and anatomy.

The system includes instrumentation designed to facilitate placement of a K-wire down the center of the intramedullary canal of the medial column. The patent pending PRECISION® Guide aids in positioning of the K-wire simplifying placement which may reduce intraoperative fluoroscopy time. All instrumentation is designed to assist in the surgeons preferred approach, cannulated or solid.

Finally, the system allows surgeons to buttress the medial column beam with a 2.0 mm thick Gorilla® Straddle Plate to further reinforce the construct.  Surgeons may utilize the PRECISION® Guide in conjunction with the Straddle Plate and medial column beam to avoid interference between the plate screws and the beam.

Product Page:
http://www. paragon28.com/products/joust-beaming-screw-system/

Contact:
Jim Edson, 1-971-400-7193, jedson@paragon28.com

 

SOURCE Paragon 28

Related Links

http://www.paragon28.com

Alphatec Spine Disrupts Market with Acquisition of SafeOp Surgical, ~$50M Equity Financing, and Strategic Leadership Appointments

CARLSBAD, Calif., March 08, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” 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, announced today that it has acquired SafeOp Surgical, Inc. (“SafeOp”).  SafeOp is a privately-held provider of advanced neuromonitoring technology designed to prevent the intraoperative risk of nerve injury with automated assessment that obviates the need for a technician or other neuromonitoring professional in most surgeries.  The Company also announced a $50 million capital raise, the proceeds of which were used, in part, to fund the acquisition.

Additionally, the Company announced several leadership updates. Pat Miles has assumed the role of Chief Executive Officer. Terry Rich has been appointed President and Chief Operating Officer.  Both will retain their existing Board positions.  Dr. Luiz Pimenta has been appointed Chief Medical Officer.

SafeOp Acquisition

SafeOp has developed patented technology that automates SSEP’s (Somatosensory Evoked Potentials), designed to provide surgeons with unprecedented, objective feedback during surgery.

“This strategic acquisition of SafeOp marks a transformational moment for the new ATEC,” said Pat Miles. “Our answer to the need for better neuromonitoring is investing in technology that automates information to enable objective clinical decision making and eradicate non-critical operating room personnel. The integration of this key technology into our spine procedures will address unmet clinical needs and improve surgical outcomes in spine.  We expect the combination to accelerate our business by increasing procedural revenue and driving pull-through across our entire portfolio.”

In consideration for SafeOp, Alphatec will pay $15 million in up-front cash, a $3 million convertible note, and the issuance of 3.3 million shares of common stock and warrants to purchase 2.2 million shares of common stock at an exercise price of $3.50 per share.  SafeOp will be eligible to receive an additional 1.3 million shares of common stock, subject to the achievement of performance milestones.  The issuance of the shares of common stock in the merger, including at closing, upon achievement of milestones, conversion of the notes and exercise of the warrants is subject to limitations until required stockholder approval is obtained in accordance with the NASDAQ Global Select Market rules.

Leadership and Board Appointments

The Company also announced the following leadership and board appointments.

Dr. Luiz Pimenta will advise Alphatec as Chief Medical Officer.  Pimenta is a world-renowned spine surgeon with over 30 years of expertise, and is widely credited with pioneering innovative surgical techniques and developing new technologies to improve spine surgery.  His broad contributions have been commercialized via numerous industry partners.  Dr. Pimenta will enhance the ATEC strategy by focusing on spine innovation and medical education.

Miles continued, “I am honored and thrilled to work again with Dr. Pimenta. His decision to assume a key role in our mission is pivotal.  It speaks volumes of the surgical community’s perception of ATEC’s visceral dedication to improved outcomes through eXtreme innovation.”

Richard O’Brien, M.D., and Robert Snow, the scientific principals of SafeOp, with over 50 years of combined neurophysiology expertise will join Alphatec as executives. Prior to serving as Vice President of Development and Chief Medical Officer of SafeOp, Dr. O’Brien, a renowned inventor and neurologist, was Medical Director of Impulse Monitoring, Inc., a neuromonitoring provider. Before joining Impulse Monitoring, O’Brien spent over two decades in the neurophysiology field, as both a physician and consultant. Mr. Snow, a neurophysiologist, was SafeOp’s Vice President, Marketing for 5 years, following an 11-year tenure as co-founder and Senior Vice President of Marketing at Impulse Monitoring.

“I could not be more excited to join the ATEC family and to engage in the creation of automated tools that provide objective information for better clinical decision making,” said O’Brien.

The SafeOp development and integration effort will be led by Jim Gharib, an electrical engineer with more than 20 years of experience in the field of neurophysiology. Gharib was the technical lead of NuVasive’s neurophysiology platform from the company’s inception to its achievement of billion-dollar revenue levels. Gharib is a named inventor on more than 20 patents in the fields of neuromonitoring, spine surgery, IV infusion, and blood chemistry.

“I am exceptionally pleased to work again with Rob, Richard, and Jim, the new leaders of our adjunctive technology team,” said Terry Rich, President and Chief Operating Officer of Alphatec.  “They each have a proven history of successfully creating value in the neurophysiologic and spine marketplace. I look forward to working with each of these new leaders as we evolve into a leading spine market player.”

Three new members have joined the Alphatec Board of Directors, in connection with the above transactions:

  • James Tullis, the founder and Chief Executive Officer of Tullis Health Investors, a healthcare investment firm, has over 40 years of experience in healthcare-focused investments.  Prior to establishing his firm in 1986, Tullis served as an award-winning healthcare investment research analyst and Principal at Morgan Stanley, focusing on pharmaceuticals and medical devices.
  • Jason Hochberg a partner with L-5 Healthcare Partners, and the Founder and CEO of SJS Beacon, an investment company, has over 20 years of business and legal experience.  Prior to founding SJS Beacon, Hochberg held various leadership roles throughout a 15-year tenure at LS Power, an energy investment and innovation company, serving most recently as Chief Operating Officer and as a Principal in LS Power’s private equity fund advisor.  He started his professional career at the law firm of Latham & Watkins in 1996.
  • Evan Bakst, a partner with L-5 Healthcare Partners, and the Founder of and Portfolio Manager at Treetop Capital, a healthcare investment firm. He has over 25 years of experience in healthcare-focused investments.  Prior to founding Treetop Capital, Bakst was a partner for 7 years at Tremblant Capital, an equity hedge-fund manager, where he led the global healthcare group and held various other leadership roles.

Equity Financing Transactions

The Company announced that it has entered into financing transactions to raise an aggregate of $50 million, through a private placement of Series B Convertible Preferred Stock and warrants exercisable for common stock, and a warrant exchange agreement with a holder of an existing warrant for an aggregate consideration of $4.8 million. The private placement was led by L-5 Healthcare Partners, LLC, a healthcare-dedicated institutional investor, and included certain directors and executive officers of Alphatec, as well as other new and existing institutional and independent investors.  The Company used a portion of the net proceeds from the private placement and warrant exercise to fund the $15 million cash purchase price for SafeOp, and expects to use the remainder for general corporate purposes.

Raymond James & Associates, Inc., is acting as placement agent in connection with the private placement and financing advisor in connection with the SafeOp acquisition.

Additional information and legal disclosures about the transaction are contained in the Company’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission.

The securities to be sold in the private placement will not have been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alphatec has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock purchased in the private placement and the shares of common stock underlying the warrants and issuable upon conversion of the Series B Convertible Preferred Stock.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

Inducement Award 

As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has also approved an award, collectively, to these new additions of 45,000 restricted stock units (RSUs) and 45,000 stock options (Options).

The RSUs and options will be granted following registration of the common stock underlying the RSUs and Options.  The RSUs will vest in equal annual installments on each of the first four anniversaries of date of employment, and the options will vest 25 percent on the first anniversary and in equal monthly installments of 1/36th of the balance of the Options, provided the recipient remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs and Options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to Alphatec’s 2016 Employment Inducement Award Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective March 6, 2018.

Investor Conference Call

Alphatec will hold a conference today at 1:30 p.m. PT / 4:30 p.m. ET to discuss the strategic acquisition, in conjunction with fourth quarter and full year 2017 results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 7887979. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, 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 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.

Additional information can be found at www.atecspine.com.

About Safe-Op Surgical

SafeOp is a privately-held provider of automated neuromonitoring technology.  The Company’s EPAD device was approved by the FDA in January 2014, intended for use in monitoring neurological status by automating & recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).  Functionality, including free run EMG and triggered EMG will be added later this year.

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 Alphatec 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 uncertainties regarding the Company’s ability to recognize the expected synergies and other benefits of the SafeOp acquisition; the difficulties in the integration of SafeOp post-closing; the diversion of management time to address transaction-related issues; the uncertainties related to litigation involving the acquisition of SafeOp or the private placement or limitations or restrictions imposed by regulatory authorities; the uncertainties related to unanticipated integration costs or undisclosed liabilities assumed; the uncertainties related to the acceptance of the SafeOp acquisition and its products by third parties; 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 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 fourth 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. Alphatec 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:

Carol Ruth
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

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