joimax® Celebrates Its 10th Anniversary with 900 Users in China and Reports a Jump in Q1-2017 Sales

April 11, 2017

IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the German-based market leader of technologies and training methods for endoscopic minimally invasive spinal surgery, recently celebrated its 10-year anniversary in China with an outstanding 3-day event in Chongqing. More than 900 surgeons out of 2,000 users in China took part in live surgeries, workshops and a scientific program on endoscopic spinal technologies including MISS fusion techniques. joimax® also organized the presentation of its latest systems like the TESSYS® ISeeU and iLESSYS® Delta in product trainings as well as its newest tools for endoscopic treatment in an exhibition hall. The program was supported by joimax® Faculty Members from Europe, USA and other countries.

During the meeting a Chinese Faculty Team, with 13 members, was inaugurated by Wolfgang Ries, Founder and CEO of joimax®, and Qin-Guang You, President of joimax® China. “Due to the growing education and training needs in the Asian region the time has come to form a local team for this important market,” explains Wolfgang Ries. “It is a great honor to lead this team and to support the further growth of joimax®,” says the head of the Faculty Team, Prof. Yue Zhou from the Third Military Medical University in Chongqing. He was awarded with the joimax® Handshake Award in Gold for his exceptional commitment, and the members of the group received the joimax® Handshake Award in Silver.

After growing sales figures in 2016 (31% growth vs. 2015), joimax® is proud to announce a jump in sales in the first quarter 2017. Consolidated figures show an increase of 60% compared to the same period of last year. “This is a very encouraging development, showing the continuing expansion and growth of the group,” 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® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF® and Percusys® for endoscopic minimally-invasive assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole 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
001 949 859 3472
Melissa.brumley@joimaxusa.com

Expanding Orthopedics Inc. to Present Clinical Information With FLXfit™ at the ISSAS Conference in Boca Raton

OR AKIVA, Israel, April 12, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that clinical experience with the FLXfit™, world’s first articulating and lordotic expandable cage, which will be presented by two distinguished surgeons at the International Society for the Advancement of Spine Surgery (ISASS) Meeting in Boca Raton, FL.

Dr. Marc Weinstein, from the Center for Spinal Disorders at the Florida Orthopaedic Institute in Tampa, will have a podium presentation “Use of a Novel 3-D Titanium Alloy Lordotic Expandable Cage Improves Segmental Lordosis after TLIF Greater than with a Static Lordotic Cage. Dr. Weinstein commented, “The FLXfit enables a unique, in-situ lordosis correction allowing to dial in the lordosis angle and to fit it to the patient’s anatomy.” Moreover, “The FLXfitTM cage effectively allows for larger cage in the interbody space once expanded.” Dr. Weinstein added, “Our study has shown significantly improved segmental lordosis was achieved using FLXfitTM with TLIF when compared to a static cage. He concludes, “We are in the midst of a clinical study which will provide a more thorough investigation of this unique device and demonstrate its clinical value for our patients.”

Dr. Raphael Roybal, from the Spine Institute at Chatham Orthopaedics, Savannah, GA., will have a poster presentation “Improvement in Sagittal Alignment and ODI Scores in Patients Treated with MIS TLIF Using a Lordotic Expandable Cage versus a Fixed Lordotic cage”. He noted, “The use of the FLXfit™ expandable cage demonstrated increased correction of the sagittal alignment post-operatively compared to a fixed angle banana cage.” Dr. Roybal added, “The combination of a large footprint device, controlled lordotic expansion and an easy to use instrumentation makes it an optimal solution for my patients.”

Mr. Ofer Bokobza, CEO of Expanding Orthopedics, said that “We are excited to present at this important ISSAS event with two renowned surgeons as Dr. Roybal and Dr. Weinstein. This continues to reinforce the clinical benefits of this novel device and its potential contribution to sagittal alignment.” Mr. Bokobza stated that, “We are excited about the momentum and growth of the FLXfitTMin the US and are continuing to monitor and collect clinical data in more US centers.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The company is led by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio of anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaïm
Vice President
Sales and Marketing
E-mail: david@xortho.com
Phone: +1(347)3219683

SOURCE Expanding Orthopedics Inc. (EOI)

Simplify Medical Announces First Patient Treated in U.S. Pivotal Trial Of MRI-Optimized Cervical Artificial Spinal Disc at Two Adjacent Levels

April 12, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc, today announced that the first patient has been treated in the device’s pivotal clinical trial studying its use in two adjacent levels of the spine as a treatment for cervical degenerative disc disease. The Simplify Disc is designed to be clearly viewed on magnetic resonance imaging (MRI) without the artifact that can result from metal used in typical spine implants, potentially protecting patients from radiation associated with computed tomography (CT) scans.

Following the first case at Texas Back Institute, Simplify Disc IDE study investigator John Peloza, MD said, “Disc implantation went smoothly and the patient is doing quite well.” Dr. Peloza, medical director of the Center for Spine Care, continued, “I look forward to studying the use of the Simplify Disc at two levels, in collaboration with the Texas Back Institute team. I believe the Simplify Disc’s anatomic design with lower heights can help minimize overdistraction, which may improve outcomes in multi-level procedures.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “We are excited to start the Simplify Disc Two-Level IDE study. The device is made of materials designed to optimize its viewing and viewing of the adjacent spinal canal on MRI without artifact. This may eliminate or minimize the use of post-operative CT scans and reduce the risk of the associated radiation to the patient.”

The prospective, randomized controlled Simplify Disc pivotal trial will encompass up to 215 patients at up to 15 centers and will compare cervical implantation of two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The composite primary endpoint includes functional improvement, pain relief and safety. The national co-principal investigators are Domagoj Coric, MD, chief of the department of neurosurgery, Carolinas Medical Center, and Dr. Guyer. For information about eligibility or enrollment in the two-level pivotal trial, please visit http://www.simplifytrial.com/.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a simple, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

“We have designed the Simplify Disc to be responsive to surgeons’ needs, providing them with the potential to improve patient outcomes,” said David Hovda, Simplify Medical Chief Executive Officer. “We are enthusiastic about moving forward with the pivotal trial.”

The Simplify Disc is also enrolling patients in a second pivotal trial comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the one-level clinical trial is available at www.SimplifyTrial.com.

The Simplify Disc has received the CE Mark and has been used to treat more than 600 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications, Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

Brian May Joins Spine Wave as Executive Vice President, Research and Development

SHELTON, CT–(Marketwired – April 12, 2017) – Spine Wave, Inc. is a fast growing, privately held company committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that Brian May has joined the Company as Executive Vice President, Research and Development.

Mr. May brings extensive experience in the orthopedics market and was most recently at Zimmer Biomet where he was one of the two directors running Product Development for the Zimmer Biomet Knee Reconstruction business. Brian is a seasoned leader with a proven track record in orthopedic product development. He joined Zimmer in 2015 via the Biomet acquisition where he spent the previous 13 years of his career. Mr. May holds a Bachelor of Science degree from University of Illinois and a Master of Science in Bioengineering from Clemson University.

As Spine Wave continues to expand its portfolio with differentiated products, Mr. May will lead the extensive research and development efforts. “I am pleased to have someone with Brian’s proven leadership ability join the Spine Wave team,” said Mark LoGuidice, Spine Wave’s Chief Executive Officer. “Biomet grew nearly tenfold during Brian’s tenure and that firsthand experience will prove invaluable to Spine Wave as we position ourselves for the next phase of significant growth.”

“I am excited to join Spine Wave, a company with a proven history of developing and commercializing innovative products,” said Mr. May. “Spine Wave has several important product launches scheduled for 2017 which will significantly broaden the company’s offering and which have the potential to generate robust and sustainable growth for the foreseeable future. I look forward to contributing to Spine Wave’s continued growth and evolution.”

About Spine Wave
Spine Wave’s vision is to leverage our intellectual property portfolio and engineering expertise to deliver a steady stream of highly differentiated spinal technologies with a particular emphasis on expandable interbody devices. Spine Wave’s portfolio of expandable products now includes the Velocity® Interbody Device, the Leva® Interbody Device and the StaXx® family of products, of which over 50,000 devices have been implanted. Other novel products in the portfolio include the Annex® Adjacent Level System, the Sniper® Spine System, which has developed a reputation as a leading MIS screw system, and the recently acquired True Position® Pivoting Spacer System which is comprised of a “crescent-style” interbody device and a unique delivery mechanism which simplifies accurate and reproducible placement of the implant. Spine Wave is committed to delivering a robust pipeline in 2017 and 2018 that will allow the company to address every major spine market segment with a highly differentiated offering.

For further information on all the Spine Wave products please visit the Company’s website at www.SpineWave.com.

Contact:
Terry Brennan
Chief Financial Officer
Email contact

203-712-1810

Texas Back Institute first in the US to provide herniated disc repair using Anchor Orthopedics’ Technology

PLANO, TX, April 11, 2017 /PRNewswire/ – Texas Back Institute continues to lead the way in spine surgery by being the first in the US to use the AnchorKnot® Tissue Approximation Kit, a novel technology for use in herniated disc repair.

Dr. Scott L. Blumenthal, board-certified orthopedic spine surgeon, physician executive with Texas Back Institute and Co-Medical Director of Center for Disc Replacement, performed a discectomy procedure on a young patient in February 2017. This patient was the first in the US to undergo herniated disc repair using the AnchorKnot® Kit.

Lumbar disc herniation is one of the most common causes for back surgery, and can occur from injury or disc degeneration.  In both cases, material from a damaged disc presses on the spinal nerve, causing many patients to experience pain, which can significantly decrease their quality of life.  A standard discectomy procedure offers effective relief; however, it commonly results in a defect that until now, has been difficult to repair without specific tools. Studies have shown that 10-15% of patients could suffer a reherniation through this defect.

The Texas Back Institute completed nearly 500 discectomy cases in 2016. Dr. Blumenthal comments that “most discectomy procedures are left to heal through the body’s scar tissue which could take 6 weeks or more, so if approximating the tissue can return patients to function and to rehab earlier then this could be a real benefit to patients.”  Dr. Blumenthal indicates that there has been literature and commercial attempts in the past and “with appropriate studies and follow-up this could be a game changer for patient outcomes.”

“As an experienced medical device company, we have worked closely for numerous years with surgeons to design the AnchorKnot®Tissue Approximation Kit for use in herniated disc repair.  It is a tremendous honor for Anchor Orthopedics to have our first US clinical partner at the Texas Back Institute,” said Neil Godara, General Manager. “Our goal is to design clinically meaningful products that improve the lives of patients around the world. We look forward to offering the AnchorKnot® Tissue Approximation Kit to patients in need of a discectomy procedure, and continuing to collaborate with Dr. Blumenthal and his team at the Texas Back Institute.”

About Anchor Orthopedics

Anchor Orthopedics XT Inc., the developer of the AnchorKnot® Tissue Approximation Kit, aims to provide surgeons with novel solutions that optimize procedures in disc repair in an effort to preserve the biomechanics of the patient and improve surgical outcomes. Our mission is to work closely with surgeons on all aspects of development to create clinical solutions that serve to improve the lives of patients around the world. Anchor Orthopedics XT Inc., located in Mississauga, Canada, is a subsidiary of Baylis Medical Company Inc.

PRM-00194 EN J-1 V-1 © Anchor Orthopedics XT Inc., 2017. Anchor Orthopedics XT and AnchorKnot are trademarks and/or registered trademarks of Anchor Orthopedics XT Inc. in the USA and/or other countries. All other trademarks are the property of their respective owners. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use. The AnchorKnot Suture Passer (2-0) is an accessory of the Anchor System. The Anchor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the Anchor Endoscope and accessories are intended to aid the surgeon’s visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the Anchor System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). Patents pending and/or issued.

Media Contact Person:
Ester Kwok
Global Product Manager
ekwok@anchorortho.com
Tel: 647-484-0662 ext 388
Anchor Orthopedics XT Inc.
http://www.anchorortho.com

SOURCE Anchor Orthopedics

Safe Orthopaedics Products Listed by AP-HP Paris Hospitals

April 10, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing that its principal products for thoracolumbar spinal fusion have been listed by AP-HP (Assistance Publique – Hôpitaux de Paris, the main hospital authority serving Paris and its suburbs).

This listing with AP-HP means that Safe Orthopaedics products are available in 39 hospitals in Paris, including 15 active in spinal surgery, together accounting for around one-quarter of the French market.

To support the growing activity in the Paris region and capitalize on this listing from the outset, the Company has hired a sales manager for the Paris region, backing up the teams already covering largely south-east and south-west France.

Upon the introduction of its products, Safe Orthopaedics had initially decided to focus on development in the regions with the assistance of expert salespeople possessing very strong local roots in a bid to firmly establish its credibility. The addition of dedicated sales coverage for the Paris region represents another crucial stage in the Company’s development.

Aside from the AP-HP approval, the new sales manager for the Paris region will be able to build on the relationships already established with hospitals in the Paris region. These include Kremlin-Bicêtre teaching hospital where it has conducted a trial demonstrating the benefits of Safe Orthopaedics’ single-use instruments for spinal surgery2.

All the thoracolumbar ranges have been successfully listed with AP-HP. SteriSpine PS and SteriSpine LC can cover requirements for the bulk of trauma and degenerative surgeries performed at these hospital facilities.

“We are proud of the work done by our sales teams, which has resulted in our products being listed by AP-HP Paris hospitals. This represents a very important step forward in the expansion of our business. It will boost our sales not only in the Paris region but also in all the major public and private hospitals in France, given the value of such a listing.” said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics.

About AP-HP

AP-HP is a globally renowned and leading European hospital authority. Every year, its 39 hospitals treat 8 million sick people, providing consultations, emergency and scheduled in-patient treatment and in-home healthcare. It provides public healthcare services round-the-clock, which it regards both as a duty and a source of pride. AP-HP is the Paris region’s leading employer, with its workforce of 100,000 doctors, research scientists, paramedics, administrative and blue-collar staff. For further information: www.aphp.fr

Next Financial Release

Full-year 2016 results: April 28, 2017 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

1 Source: Safe Orthopaedics
2 See the “A Randomized Study Confirms the Benefits of Safe Orthopaedics’ Products in a Leading French Teaching Hospital” press release dated October 20, 2016.

Contacts

Safe Orthopaedics
Thierry Lambert, Tél.: +33-(0)1-34-21-50-00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél.: +33-(0)1-44-71-94-94
SafeOrtho@newcap.eu

K2M Group Holdings, Inc. & LifeHealthcare Group Limited Announce New Distribution Agreement for Australia & New Zealand

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

Alphatec Spine Launches Battalion™ Lateral System with Squadron™ Retractor to support Minimally Invasive Lateral Access Procedures

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

Alphatec Spine Adds Experienced Spine Executives to Sales Leadership Team

CARLSBAD, Calif., April 05, 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 the addition of two new sales executives with proven track records in the spine industry, naming James (Jim) Duffy as Area Vice President, U.S. Sales, South, and Greg Rhinehart as Area Vice President, U.S. Sales, East.  Drawing on their deep commercial spine experience, Messrs. Duffy and Rhinehart will be responsible for expanding the Company’s presence in the Southern and Eastern United States, respectively, including continuing to build dedicated sales agent relationships, targeting new customer and market opportunities, and providing service and support for existing surgeon customers.

“I’m excited to welcome Jim and Greg to the Alphatec family as we continue to build out a strong sales leadership team that is focused on driving sustainable growth and improving patient outcomes,” said Terry Rich, Alphatec Spine’s Chief Executive Officer. “Jim and Greg bring tremendous track records to Alphatec and they will be instrumental in recruiting and developing top distributors and sales talent to deepen our engagement with surgeons and build greater awareness and adoption of our differentiated products.  I look forward to working with both leaders as we accelerate our sales strategy and aggressively work to become the fastest growing company in spine.”

Jim Duffy Named AVP Sales, South Region

Mr. Duffy brings over 25 years of progressive spine and orthopedic sales leadership experience to Alphatec, including a proven history of building strong distributor relationships and dedicated distribution channels.  Mr. Duffy joins Alphatec from Zimmer Biomet Spine, where he was the Sales Vice President for the East region of the United States following Zimmer’s merger with Biomet, and was responsible for the strategic integration and management of the distribution channel.   Prior to Zimmer Biomet, Mr. Duffy served as the Area Vice President of Sales for Zimmer Spine.  Earlier in his career, Mr. Duffy served in a number of district and regional sales leadership roles, including at KARL STORZ Endoscopy-America, Medtronic Spinal and Biologics, and at Synthes Spine.

Mr. Duffy holds a Bachelor of Science in Business Management from Westfield State University.

Greg Rhinehart Named AVP Sales, East Region

With over two decades of spine and orthopedic sales leadership experience, Mr. Rhinehart brings significant expertise to Alphatec in developing high-performing sales organizations, and driving expansion and revenue growth.  Prior to joining Alphatec, Mr. Rhinehart was the Vice President of Sales at Medicrea.  Before that, Mr. Rhinehart held senior sales leadership roles at Globus Medical, Inc., where he most recently served as the Vice President of Sales for the Central U.S. region—a position he held for nine years.  Under his leadership at Globus, Mr. Rhinehart successfully built a new sales organization to continue Globus’ expansion in the Central U.S., significantly growing annual revenues.  Prior to joining Globus, Mr. Rhinehart held multiple sales leadership roles in spine and orthopedics at DePuy Spine, Medtronic, Sulzer-Spinetech and DePuy Orthotech.

Mr. Rhinehart holds a Bachelor of Science in Business Administration from Ohio State University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec Holdings Inc.’s 2016 Employment Inducement Award Plan (the “Plan”), on March 30, 2017, the Compensation Committee of the Board of Directors of Alphatec Holdings, Inc. approved the following inducement awards:

  • Mr. Duffy: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.
  • Mr. Rhinehart: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan.  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, which was March 31, 2017 for Mr. Rhinehart and April 4, 2017 for Mr. Duffy, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (the first date of employment). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

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 successfully expand in certain geographic regions, launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. 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 uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement.  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 its 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

Aesculap Launches Novel Spine Device Warranty on its Plasmapore®XP Surface

CENTER VALLEY, Pa., April 6, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC, a medical device company with long-standing expertise in applying biocompatible surface treatments to orthopaedic implants, announced today a new warranty program on its established portfolio of surface-enhanced interbodies for spinal fusion. This warranty announcement coincides with the launch of the TSpace®XP interbody system, treated with PlasmaporeXP surface enhancing technology. The warranty offers participating facilities a device replacement in the instance of a reoperation because of clinically-relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician’s ability to visualize adjacent anatomy. This is the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry warranting against both delamination of a surface enhancement and the ability to visualize an implant without artifact.

This new Aesculap warranty on PlasmaporeXP devices differentiates the technology from other manufacturers who have less widely studied surface coated or otherwise enhanced spinal fusion interbodies. The current U.S. spine market favors PEEK, a medical grade plastic, for fusion. However, PEEK alone may lack the biocompatible characteristics necessary to stimulate a lasting fusion. For this reason, some spinal implant manufacturers are going back to all titanium implants; however, this structural material may create intraoperative and postoperative visualization issues which may jeopardize the safety profile for patients.

Aesculap began developing its expertise in surface enhancements with its BiContact™ Universal Hip System in 1986 and was first to the U.S. spine device market with surface-enhanced PEEK-OPTIMA®* interbodies for spinal fusion applications. Aesculap’s experience, with more than 20,000 PlasmaporeXP devices implanted to date plus results from over 20 clinical studies, provided the foundation to offer the device warranty.

According to Chuck DiNardo, President of Aesculap Implant Systems, LLC, “In the consumer market, if a product does not meet expectations, the purchaser expects a money-back type of guarantee. This has not been the norm in the device market. We created a program to demonstrate to healthcare providers that we believe in our product, our clinical data and our long-standing experience and ultimately share their goal of a lasting treatment for their patients’ chronic back issues.”

As a forerunner in surface enhancing technology, Aesculap’s proprietary process applies a pure titanium surface that is porous, osteoconductive and biocompatible to the core of each PlasmaporeXP implant on the top, bottom and lateral surfaces. Based on the global success of this surface enhancing technology, Aesculap has developed a full portfolio of PlasmaporeXP devices like the newest TSpace interbody to address a variety of degenerative spinal indications and approaches.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com/xp.

*PEEK-OPTIMA is a registered trademark of Invibio Limited.

SOURCE Aesculap Implant Systems, LLC