LEESBURG, Va., April 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (“K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, and LifeHealthcare Group Limited (ASX:LHC) (“LifeHealthcare”), a leading independent provider of medical devices and healthcare solutions in Australia and New Zealand (ANZ), today announced that the two companies entered into a new supply agreement for the distribution of K2M’s innovative spinal technologies.

The K2M/LifeHealthcare distribution partnership, which dates back to 2010, has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare have entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.

Matt Muscio, LifeHealthcare’s CEO, stated, “I am very pleased to announce our new five-year contract with K2M through 2021. K2M is a globally recognized innovator in complex spine, having led the way in deformity and now minimally invasive and 3D-printed spine solutions. Through our partnership, we have delivered highly successful product initiatives, such as the EVEREST^® MI XT and MESA^® platforms, and market leading education forums, such as Deformity Down Under, to address the needs of Australian and New Zealand clinicians and their patients. We look forward to working with Eric Major and the K2M team over the coming years to reach our shared aspiration of the number one market share position in the Australian and New Zealand spine market.”

Eric Major, K2M’s President and CEO, stated, “LifeHealthcare has been an important strategic partner of ours for many years and their established distribution presence and strong surgeon relationships have been instrumental in K2M’s strong market share growth in Australia and New Zealand. We are happy to announce our new agreement and look forward to offering innovative spinal technologies, such as our EVEREST MI XT Spinal System, our industry-leading 3D-printed CASCADIA™ Lateral Interbody System, and our comprehensive Balance ACS^™ platform focused on achieving three-dimensional spinal balance, to surgeons in this important international spine market.”

For more information about K2M, visit www.K2M.com. For more information about LifeHealthcare, visit www.lifehealthcare.com.au.

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 Facebook, Twitter, Instagram, LinkedIn, and YouTube.

About LifeHealthcare

LifeHealthcare Group Limited is a leading independent provider of healthcare solutions in Australia and New Zealand across clinically specialized therapeutic channels bringing Australian and New Zealand healthcare professionals innovative medical devices by partnering with world class companies who share the vision of innovation and making a real difference to people’s lives.

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; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; 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 in our main facility or information technology systems;  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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; 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.

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

LifeHealthcare Contact:
Kristine James				              
General Manager Corporate Development		  
+61 2 8114 1534					 
kristine.james@lifehealthcare.com.au

CARLSBAD, Calif., April 07, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC) and a provider of spinal fusion technologies, announced today that the Company has launched its new Battalion Lateral System with the Alphatec Squadron Lateral Retractor, and successfully completed initial patient surgeries including degenerative, multilevel and L4/L5 spinal segment cases.  With the launch of the Battalion Lateral System, the Company is well positioned to begin to compete in the $500M U.S. Lateral market.

“The launch of Battalion Lateral represents a significant milestone for Alphatec, opening up new commercial opportunities for us.  With this launch, we are now able to compete in the MIS Lateral market—one of the fastest growing markets in spine,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “The Battalion Lateral System includes our proprietary Squadron Retractor that is designed to enhance the surgeon’s experience and improve clinical outcomes.  Early feedback from surgeon customers has been very positive regarding the system performance, differentiated feature set and ability to successfully treat even the most complex patient cases with a minimally invasive approach.  The launch of Battalion Lateral also enables Alphatec to access new distributors with strong surgeon relationships in the Lateral space. We look forward to expanding into this new market and increasing surgeon adoption.”

Battalion Lateral System Overview

The Battalion Lateral System with the Alphatec Squadron Lateral Retractor provides surgeons with a next-generation Lateral system with innovative, unique functionality designed to improve clinical outcomes by reducing tissue creep, minimizing psoas retraction time, and achieving alignment and fusion objectives.  The Battalion Lateral System includes numerous proprietary features, including the Squadron Lateral Retractor.  The system is designed to allow surgeons to customize the access to match the patient’s unique anatomy through independent retraction of the cranial/caudal blades, DepthControl™ technology that provides in-situ height adjustment for the low-profile blades, and LevelToe™ mechanics to ensure that the blades maintain a parallel plane when toed up to 15°.  The Squadron Retractor is also fully compatible with most neuromonitoring platforms enabling access safely through the psoas. The Battalion Lateral Spacer is available in 0° and 15° lordosis with a variety of width and height options for lumbar and thoracic approaches as well as angled and offset instrumentation to provide access to the L4/L5 segment.

“Alphatec’s Battalion Lateral System provides great options for accessing and preparing the space via the retractor, but the retractor itself completes the procedure,” said Dr. Frank K. Kuwamura, a board-certified orthopedic spine surgeon, in San Antonio, Texas.  “The ability to independently raise and lower blades to accommodate the anatomy really separates this retractor from other retractors available on the market.  It saves time in the psoas and that supports better patient outcomes.”  Dr. Kuwamura was one of the first surgeons to use the system and completed the case with Alphatec’s Illico® percutaneous pedicle screws.  The patient had a previous fusion and had developed adjacent disc disease.

Michael E. Russell, II, M.D., a board-certified orthopedic surgeon in Tyler, Texas, was also one of the first surgeons to use the Battalion Lateral System in a clinical setting.  He used the system to perform a Lateral procedure at L3/L4 and instrumented posteriorly using Alphatec’s Arsenal™ Spinal Fixation System. The Squadron Lateral Retractor allowed Dr. Russell to access the disc space from an offset trajectory.

Dr. Russell commented, “The Squadron Retractor enabled me to attach to multiple attachment points giving me the flexibility to use my preferred Lateral technique.  The combination of the level toeing and the ability to lower the low-profile blades individually allowed me to successfully navigate osteophytes without the need for blade extenders.”

Battalion Lateral to be Featured at Upcoming Surgeon Conferences

The Battalion Lateral System and Squadron Retractor will be featured at the International Society for the Advancement of Spine Surgery, ISASS, April 12th through April 14th in Boca Raton, Florida and at the Annual Meeting of the American Association of Neurological Surgeons, AANS, April 24th through April 26th in Los Angeles, California for surgeon review.

About Battalion Lateral System and Squadron Retractor Lateral Access System

The Battalion Lateral System features a full array of access and disc preparation instrumentation in straight, angled, and offset orientations.  The system is recommended for use with the Arsenal Spinal Fixation System or the Illico MIS Posterior Fixation System. The Battalion Lateral implant is also cleared for use with both autograft and allograft biologic materials.
For more information, please visit:   http://alphatecspine.com/Battalion-Lateral.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, 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 delivering advancements in spinal fusion technologies. The Company markets products in the U.S. via independent sales agents and a direct sales force.

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

Forward Looking Statements  

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to compete and expand its presence within the U.S. MIS Lateral market and the size of such market; the Company accessing new distributors with strong surgeon relationships in the Lateral space and increasing surgeon adoption; and the ability of Battalion™ Lateral System to enhance the surgeon’s experience and improve clinical outcomes.  The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the uncertainty of success in developing and launching new products, including without limitation the products discussed in this press release; the Company’s ability to compete directly with the market leaders in the U.S. MIS Lateral market; the Company’s ability to gain market share in the U.S. MIS Lateral market and to benefit a vast number patients in such market; and the acceptance of the Company’s products by the surgeon community and the success of procedures by spine surgeons, including without limitation the products and procedures discussed in this press release.  Please refer to the risks detailed from time to time in Alphatec Holdings’ SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

SAN JOSE, Calif., April 7, 2017 — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the U.K.’s National Institute for Health and Care Excellence (NICE) has published their Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain.¹ The guidance recommends that MIS SI joint fusion be available to properly diagnosed patients in the U.K. National Health System (NHS).

NICE develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations. NICE’s role is to improve outcomes for people using the NHS and other public health services.²

The recommendation states that the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery, based primarily on the strong clinical evidence from the iFuse Implant, is adequate provided that standard arrangements are in place.  They also recommend that the procedure be performed by trained surgeons using a lateral transarticular approach, and that patients have been properly diagnosed with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

“Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion.  Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients,” according to W. Carlton Reckling, MD, MBA, Chief Medical Officer and Vice President Medical Affairs at SI-BONE.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth³, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9868.040617

1. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. NICE Interventional Procedures Guidance [IPG578]. April 2017. https://www.nice.org.uk/guidance/IPG578/chapter/1-recommendations

2. https://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf

3. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]