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

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

 

Phoenix Spine Announces Participation in the INTRACEPT Study for the Treatment of Chronic Low Back Pain

SCOTTSDALE, Ariz.March 8, 2018 /PRNewswire/ — Phoenix Spine today announced participation in a clinical study comparing the Intracept Procedure, developed by Relievant Medsystems, to conservative care for patients with chronic low back pain (CLBP). Phoenix Spine will be among 20 centers across the U.S. participating in the INTRACEPT study with up to 150 patients enrolled.

The INTRACEPT study’s primary efficacy endpoint is the mean change from baseline to 3 months post- treatment in the Oswestry Disability Index (ODI). This study will build on the recently presented results of the Level I SMART trial, which demonstrated significant improvements in function and pain, and reduction of opioid consumption.

“Low back pain—whether coming from the disc or the vertebral body— can be agonizing and debilitating,” said Dr. Dan Lieberman, a neurosurgeon and Medical Director of Phoenix Spine Surgery Center. “Surgery has previously been the only real treatment available to these patients who fail conservative treatment. At Phoenix Spine, our goal is to treat back pain in the least invasive way possible. I look forward to participating in the INTRACEPT study and am hopeful that the outcomes of the Intracept procedure will compare favorably to conservative care and will provide appropriate clinical context for patients and physicians seeking options for the treatment of chronic low back pain.”

The Intracept System is based on ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in transmitting low back pain from the vertebral body endplates. The procedure uses a transpedicular, minimally invasive approach to reach the BVN near the center of the vertebral body and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals.

Patients will undergo the procedure in an ambulatory surgery setting and return home the same day of the surgery.  The procedure uses image guidance and does not require stitches or general anesthesia.

For more information on the INTRACEPT study, please visit http://intraceptstudy.com.

If you or someone you know is interested in joining the study, please call the Phoenix Spine Surgery Center at (602) 644-9107.

About Phoenix Spine
Phoenix Spine specializes in treating back pain with a patient-centered approach using ultra-minimally invasive options including Direct Visual Rhizotomy. For more information, visit https://www.phoenixspine.com.

About Relievant Medsystems
Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the BVN.  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for CLBP.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact: Stan Miele, 602-256-2525, stan@phxspine.com

 

SOURCE Phoenix Spine

Related Links

http://www.phoenixspine.com

Benvenue Medical to Present Positive Luna 3D Interbody Fusion System Data at Spine Summit 2018

March 08, 2018

SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for spine repair, today announced that positive interim results of a retrospective analysis of its Luna® 3D Multi-Expandable Interbody Fusion System will be presented at the Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (Spine Summit) taking place March 14-17 in Orlando. The single center minimally invasive study evaluated the safety and efficacy of the Luna device when placed from a standard minimally invasive transforaminal lumbar interbody fusion (TLIF) approach.

“The brilliance of Luna is its ability to engage the disc space through a minuscule annulotomy, and then expand to cover the greatest expanse of any intervertebral device available,” said Richard Fessler, M.D., study investigator and professor of neurosurgery at Rush University. “In our analysis, minimally invasive TLIF placement of the Luna device was shown to be safe and effective, improving pain and disability scores as well as consistently restoring disc height, reducing spondylolisthesis and increasing lumbar lordosis.”

The retrospective analysis evaluated 31 patients treated with the Luna 3D System who had at least six months of post-operative follow up. All but one patient experienced improvement in pain scores from baseline, and disability scores improved for all patients. When present, spondylolisthesis was reduced significantly. No instances of graft subsidence or hardware failure occurred.

“These safety and efficacy results lay the groundwork for our ongoing evolution of the Luna 3D Interbody Fusion System,” said Robert K. Weigle, CEO of Benvenue Medical. “We are currently developing a 2.0 version of the system that leverages our original platform and vision, improves the user experience and is designed to be minimally invasive to improve outcomes for patients and for use in the growing, emerging outpatient ambulatory spinal surgery center setting. We expect to submit for FDA clearance on Luna 2.0 later this year.”

“Minimally invasive spinal surgery and procedures in the outpatient setting are forecasted to grow considerably in the near term, and we see Luna as an important technological advancement in advancing patient care, quality and economic outcomes for the patient suffering from degenerative disc disease,” said Luke Düster, managing director and partner at CRG, an investor in Benvenue Medical.

Dr. Fessler will present the analysis, “Minimally invasive transforaminal lumbar interbody fusion with a multi-directional expandable device,” in the sponsored What’s New 2 session on Thursday, March 15, from 2:52-3:02 p.m. Benvenue is also exhibiting at Spine Summit in booth #311.

About the Luna 3D Interbody Fusion System

The Luna 3D Interbody Fusion System is one of the largest footprint yet least invasive devices for posterior lumbar interbody spinal fusion. The Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint, second in height and third in lordosis, allowing surgeons to effectively restore sagittal balance and height via a MIS posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate an interbody fusion.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by CRG. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.

About CRG LP

CRG is a premier healthcare-focused investment firm that has committed over $3.0 billion of capital across more than 50 investments. The firm seeks to commit between $20 to $300 million in each company and invests across the healthcare spectrum, including: medical devices, biopharmaceuticals, tools and diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address large, unmet medical needs. The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, Houston and New York. For more information, visit www.crglp.com.

Contacts

MEDIA CONTACT:
Merryman Communications
Betsy Merryman, 310-560-8176
betsy@merrymancommunications.com

joimax® Presents Its New Generation 4K Camera Light Source and Documentation Command System, Camsource® LED, and Vitegra® at AAOS

March 08, 2018

KARLSRUHE, Germany–(BUSINESS WIRE)–joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, presents its newest combined 4K resolution camera and LED light source system, Camsource® LED, and its fully integrated documentation and command system, Vitegra® Docu and Command. Both systems are introduced for the first time at the Annual Meeting of the American Association of Orthopedic Surgeons (AAOS), currently taking place in New Orleans, LA, where joimax® is represented at booth no. 4020.

The Vitegra® Docu and Command system opens a new era of documentation, control and hospital integration. The device comes with numerous flexible control options including a wireless tablet PC, live video streaming and a live voice commenting option, in-surgery image and video review function, voice control capabilities and easy data export solutions. The Vitegra® offers with its command mode to control all other devices that are part of the joimax® endoscopic tower. An optimized monitoring of the endoscopic devices during the surgical procedures by live review and control of all important device parameters is also provided. An initial, limited market launch is planned for Q2/2018 within European and U.S. markets.

“Our new 4K LED Visualization Systems are the next important components of our steadily growing endoscopic product portfolio. These developments demonstrate our continued leading position in the fast-growing endoscopic spine surgery market worldwide,” states Wolfgang Ries, Founder and CEO of joimax®.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® (for facet and sacroiliac joint treatment) or with EndoLIF® and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press Contact USA :
joimax® Inc.
Melissa Brumley
Melissa.brumley@joimaxusa.com
001 949 859 3472

(Graphic: Business Wire)

Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System, Addition of VP of Sales & Business Development and HyperLOX™ Posterior Cervical System

Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System; the well-timed addition of Vice President of Sales and Business Development, Daniel Abromowitz; the addition of a new posterior cervical system – HyperLOX™.

Captiva Spine’s thoughtful solutions for the entire spinal column will be on display at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting March 7-9, 2018 in New Orleans at booth 4213.

TransFasten Posterior SI Fusion System

The first cases using the company’s proprietary TransFasten Posterior SI Fusion System were successfully completed across the USA starting in December 2017. TransFasten’s use of a favorable posterior approach will potentially reduce operative time and neurovascular complications. With proprietary QuadraCentric joint preparation, TransFasten provides multiple implant contact points for biomechanical stability during fusion. An initial TransFasten surgeon, Dr. Pedro Ramirez, M.D. of Central Florida Neurosurgery Institute, stated “the intuitive TransFasten instrumentation allows me to place the implant accurately, utilizing a safe posterior approach while obtaining a true biologic fusion of the sacroiliac joint.” Over the past several years there has been a resurgence in the recognition of the SI Joint as a potential source of low back pain as treatment options for SI Joint dysfunction have advanced. Captiva Spine is committed to launch devices that align clinical and economic outcomes on behalf of all key stakeholders. TransFasten is on a track for completion of its alpha launch, and Captiva Spine will be training additional surgeons on this posterior SI approach nationwide as early as the end of March 2018.

Hired: VP Sales & Business Development, Daniel Abromowitz

In supporting Captiva Spine’s commitment towards continuous growth and business development, the addition of Daniel Abromowitz to Captiva Spine’s leadership team and business is significant. Dale Mitchell, Captiva Spine’s Founder and CEO, stated, “We have been looking forward to expanding our leadership team and increasing business presence throughout the USA. Daniel is a welcome addition as a strategic business leader with a proven record of profitably building high-performing sales teams in the spinal device and healthcare marketplaces.”

Introducing: HyperLOX Posterior Cervical System

The commercial launch of the HyperLOX Posterior Cervical System provides Captiva Spine a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. HyperLOX can be constructed into a multitude of configurations based on individual patient anatomy. Offering exceptional versatility and ease-of-use, HyperLOX features a wide range of hyper-angulating top loading polyaxial screws, hooks (straight, angled, and offset), offset connectors, multiple rod-to-rod connector configurations, cross connectors, and transitional rods. Inquiries from tenured professionals looking to partner with a company to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

Discover Strength Through Connections at www.captivaspine.com.

About Captiva Spine, Inc.

Captiva Spine is 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, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. Captiva Spine operates as a family of industry professionals that take 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.

Life Spine Announces First Clinical Use of SENTRY™ 2 Lateral Plating System

March 07, 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 the first clinical use of SENTRY 2 Lateral Plating System with Dr. Tien Le of Tampa, Florida.

SENTRY 2 lateral plating system joins Life Spine’s full lateral procedural offering, which consists of PLATEAU-X Lateral Spacer System, LONGBOW Expandable Spacer System, CENTRIC® Expandable Retractor System, as well as the graft delivery system OSTEO-LINE. The SENTRY 2 Lateral Plating System offers a simple yet comprehensive stabilization solution designed to provide supplemental fixation from a lateral single position approach. SENTRY 2, along with SENTRY 4 Lateral Plating System, provides the surgeon the ability to perform a complete stabilization and fixation procedure while the patient is in the lateral decubitus position. This single approach concept negates the time and cost usually associated with the need for patient repositioning for posterior fixation, while providing ample stability. Additionally, the narrow profile of SENTRY 2 allows the surgeon to minimize retraction and trauma to the psoas and lumbar plexus, as well as providing a surgical solution when exposure is limited by the iliac crest or ribs.

“The SENTRY 2 Lateral Plating System provided me great stability in a challenging revision procedure, minimizing the cost, time and impact to the patient due to repositioning for posterior fixation, as well as the challenges associated with revision of a previous posterior fusion” stated Tien Le, MD, Spinal Neurosurgeon at NeuroSpine Center in Tampa, FL. “Single approach surgery with SENTRY 2 provides a true medical economic advantage, as well as reducing risks associated with patient repositioning and preparation. In my hands, the system provided the stability and security required for a minimally invasive lateral procedure. SENTRY 2 has a variety of plate and screw configurations to accommodate even the most challenging patient anatomies.”

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.

Contacts

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

Solvay’s high-strength Ixef® PARA enables next-generation Cervical-One™ single-procedure surgical instrument kit from ECA Medical Instruments

Alpharetta, Ga., March 6, 2018 — Solvay, a leading global supplier of specialty polymers, announced that its high-performance Ixef® polyarylamide (PARA) resin enabled ECA Medical Instruments to develop its Cervical-One™ single-use surgical instrument set for use in one- and two-level cervical spine implant procedures.

The novel Cervical-One™ kit includes the full complement of robust and ergonomically designed instruments needed by surgeons for cervical plate and interbody fixation, including precision torque-limiters and drivers. In addition to removing cost from individual instruments, the semi-custom design also empowers spinal implant OEMS to cost-effectively tailor or brand their own instrument set.

Compared to reusable instrumentation, ECA’s single-use instrument system can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections.

“When developing the Cervical-One™ platform, we required an engineered polymer that could withstand torsional, tamping and axial loads applied during the procedure,” said James Schultz, executive vice president for sales and marketing at ECA Medical Instruments. “Ixef® PARA delivers the robust mechanical performance needed for fixation of both cervical plates and screws and interbody devices. We also needed the tactile feel and weight and balance surgeons expect. Solvay’s collaborative support during the design process and proactive regulatory support – trusted throughout the industry – proved critical in reducing our time to market.”

Ixef® PARA compounds offer metal-like strength, rigidity and dimensional stability, while providing an exceptional surface finish. Ixef® PARA is optimized for sterilization using high-energy gamma radiation without significant change in appearance or performance and is available in a range of gamma-stabilized colors. Solvay’s compounds have been evaluated for ISO 10993 limited duration biocompatibility and are supported by an FDA Master Access File (MAF).

This successful collaboration combines the strengths of both ECA and Solvay – the two leaders in their respective fields,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers global business unit. “As leading orthopedic device manufacturers continue their early conversions to single use systems, we are confident that our combined critical mass and industry-relevant experience will deliver real value to potential and existing customers.

For more information about this application and related news about specialty polymers for healthcare, please go to solvayhealthcare.com.

® Ixef is a registered trademark of Solvay

™ Cervical-One is a trademark of ECA Medical Instruments

ECA Medical Instruments

ECA Medical Instruments®, headquartered in Thousand Oaks, Calif., is the industry leader in designing and manufacturing precision single-procedure torque-limiting instruments and surgical fixation kits. Founded in 1979, the company has delivered over 35 million torque-limiting instruments and procedural kits to the world’s leading cardio, neuromodulation, orthopaedic and spine implant companies. Every 15 seconds of every day an ECA torque instrument or procedural kit is used to secure a medical implant—one patient at a time. ECA, a LongueVue Capital Partners company, is an ISO 13485, CE Mark certified and FDA registered firm and was named Business of the Year 2017 by LivaNova and earned the LivaNova 2017 Supplier Excellence Award. www.ecamedical.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.

 Solvay Specialty Polymers

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 and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com. 

Solvay’s high-performance Ixef® polyarylamide (PARA) resin enabled ECA Medical Instruments to develop its Cervical-One™ single-use surgical instrument set for use in one and two-level cervical spine implant procedures. Compared to reusable metal instruments, ECA’s single-use instruments can eliminate reprocessing costs, enhance operating room efficiency, streamline hospital and ASC inventory management, and play a significant role in eliminating the root causes of surgical site infections. Photo courtesy of ECA Medical Instruments.

Photo courtesy of ECA Medical Instruments.

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

Dan McCarthy
AH&M Marketing Communications
+1 413 448 2260 Ext. 200
dmccarthy@ahminc.com

Umberto Bianchi
Solvay Specialty Polymers
+39 02 2909 2127
umberto.bianchi@solvay.com

Alan Flower
Industrial Media Relations
+32 474 117 091
alan.flower@indmr.com