ApiFix Surpasses 250 Scoliosis Patients Treated and Six-Year Follow-up of Earliest Cases

October 02, 2018

BOSTON–(BUSINESS WIRE)–ApiFix Ltd., a leading motion-preservation scoliosis correction company, announced today that its patented Minimally Invasive Deformity Correction (MID-C) technology has now been used to treat more than 250 young patients diagnosed with progressive scoliosis. The company also announced that the earliest treated patients have reached their six-year follow-up milestone.

ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction while retaining spine flexibility using a least invasive surgical approach. Patient recovery is relatively pain-free and is measured in days, not months. The MID-C system acts as an “internal brace” that incorporates a patented unidirectional, self-adjusting rod mechanism with motion-preserving polyaxial joints allowing additional non-invasive post-operative correction over time and is removable.

The MID-C device has been used for treatment in multiple countries, with more than 100 patients now having greater than two-year follow-up. A typical ApiFix surgical procedure takes about 90 minutes with minimal blood loss (~50cc) and short hospitalization and recovery times (1-2 days and 1-2 weeks, respectively). In contrast to fusion correction procedures, the MID-C system allows for additional deformity correction with standard post-operative exercises. Patients’ normal daily activities are unencumbered since spine flexibility and mobility are retained.

Available treatment options for progressive scoliosis in the U.S. have been limited despite continued advances in both surgical and non-surgical systems – a perspective shared by Randy Betz, MD, past president of the Scoliosis Research Society.

“Despite great recent advancements, our options to address progressive curvature in young patients today remain limited,” said Dr. Betz. “Bracing systems are required to be worn many hours per day and do not correct the deformity. Standard spinal fusions correct the deformity but have a much longer recovery time and result in a permanent loss of mobility. The introduction of a procedure that can effectively correct spinal deformity with less invasive, motion-preserving techniques will have a dramatic effect on the quality of life for these patients and their families.”

“The new ApiFix surgery is much less invasive than standard fusion procedures, allowing for a significantly shorter recovery,” said Ron El-Hawary, MD, Chief of Orthopedics, IWK Health Centre in Halifax, Canada, who has been impressed with his use of the MID-C device in patients. “We see that patients have more flexibility and they will likely have better participation in sports, dance and other activities performing at the same level or higher than previously. Based on my own experience and the overall early experience of many patients beyond two-years follow-up, I believe this device has great promise in offering a completely different option for adolescent idiopathic scoliosis patients with progressive curves.”

Paul Mraz, ApiFix CEO, is committed to establishing a new standard of care for spinal deformity treatment, generating peer-reviewed evidence, and working with the FDA to help make this new technology available for patients in the United States. The device is currently investigational in the United States and is under review by FDA in a Humanitarian Device Exemption application.

“Our review of the extensive clinical experience with the MID-C system and our ongoing collection of new data continue to underscore ApiFix’s positive results realized in patients with progressive spinal deformity,” said Mraz. “ApiFix represents a game-changing opportunity for patients and families and a viable alternative to irreversible fusion procedures. We look forward to making this technology more widely available worldwide.”

About ApiFix Ltd.

Founded in 2011, ApiFix Ltd. is a privately held medical device company based in Misgav, ISRAEL and Boston, Massachusetts, USA and a portfolio company of The Trendlines Group Ltd. (SGX: 42T; OTCQX: TRNLY). ApiFix is a leading motion-preservation scoliosis correction company developing a unique platform technology that represents a disruptive approach to spine deformity treatment. ApiFix’s Minimally Invasive Deformity Correction (MID-C) system has CE Mark approval and is available in Europe, Israel, Singapore and Canada. More information is available at www.apifix.com.

Contacts

for ApiFix Ltd.
Paul Williams, 310/569-0023
paul@medialinecommunications.com

Solvay’s Ixef® PARA offers alternative to stainless steel in Innovative Surgical Designs’ new Redi-Spine™ system for spinal fusion surgical procedures

Alpharetta, Ga., October 2, 2018  Solvay, a leading global supplier of specialty polymers, announced during NASS 2018 last week that Innovative Surgical Designs, a developer and manufacturer of orthopedic spinal systems, chose Ixef® polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spine™ kit leverages Ixef® PARA’s mechanical strength, moldability and gamma sterilizability to offer an economical alternative to reusable stainless steel instruments.

Ixef® PARA’s metal-like strength and rigidity enabled us to simplify and deliver Redi-Spine™ instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-molded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef® PARA resin, I realized how wrong I was.  We wouldn’t be able to offer the Redi-Spine™ kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.

Designed to withstand the severe torsional forces and rigors of thoracolumbar spinal fixation, Innovative Surgical Designs’ Redi-Spine™ instruments received 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August. It contains multiple disposable, handheld instruments including a T-ratchet handle, counter-torque tool and gearshift probe that are molded entirely or in part from Solvay’s Ixef® GS-1022 PARA.

Ixef® GS-1022 PARA can be sterilized with gamma ray radiation without any significant change to its mechanical properties, ultra-smooth finish or color. Solvay offers the material in a range of gamma-stabilized colors, from which Innovative Surgical Designs, Inc. chose gray for its kit. Solvay’s polymer has also been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which can help streamline regulatory approvals.

The growing adoption of single-use surgical instruments has increasingly established Solvay’s Ixef® PARA as a mainstream material for these applications,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “We continue to build on our early and proactive support of this trend by working closely with trailblazers like Innovative Surgical Designs, Inc. to help optimize their products for molding and speed to market.

Innovative Surgical Designs plans to launch the Redi-Spine™ kit during the fourth quarter of 2018. For more related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay
™ Redi-Spine is a trademark of Innovative Surgical Designs

 

Spineology U.S. Clinical Trial for Interbody Fusion

October 01, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H., Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, presented 12-month outcomes data from Spineology’s SCOUT clinical trial at the recent annual meeting of the North American Spine Society (NASS) in Los Angeles, California.

The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at ten participating study sites, and study enrollment is complete. Dr. Chi and his co-authors reported on 102 treated subjects, of whom 80 have completed 12-month postoperative follow-up and 27 have completed 24-month follow-up.

Statistically significant improvements were seen at six months, twelve months and 24 months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. At the primary fusion endpoint of 12-months 65 of 70 (93%) with available films were fused, as read on CT by two independent radiologists. Eighty nine percent (89%) of subjects reported “Excellent” or “Good” patient satisfaction at 12 months (71 of 80) and 24 months (24 of 27). Safety was excellent. There were no unanticipated adverse events and no interbody device-related serious adverse events.

“We have found this innovative minimally invasive graft containment device to be a safe and effective option for lumbar interbody fusion procedures,” said Dr. Chi. “Patient- reported outcomes are very favorable, including improved function, reduced pain, and high satisfaction rates. Combined with excellent safety and radiographic fusion, the SCOUT study is demonstrating very favorable results.”

The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Spineology’s OptiMesh® deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Spineology CEO John Booth said, “We are very pleased to know that SCOUT patients have reported these high satisfaction rates and good clinical improvements with their fusion success. We look forward to continuing patient follow-up and gaining the market clearance that will allow us to market this unique fusion device. We are grateful to Dr. Chi and all the SCOUT investigators for their commitment to this important clinical trial.”

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

4WEB Medical, TeDan Surgical Innovations and Lattus Spine Announce Exclusive Partnership To Provide Best In Class Total Lateral Solution

LOS ANGELESSept. 26, 2018 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the North American Spine Society (NASS) Annual Meeting that the company has entered into an exclusive partnership with both TeDan Surgical Innovations and Lattus Spine, LLC to market a turnkey, best in class, Total Lateral Solution.

“Today is a truly exciting day for 4WEB as we establish a premier market position with these game changing partnerships,” said Jessee Hunt, 4WEB Medical President and CEO.  “The combination of our Truss Implant Technology and the Extreme Lateral access solution offered by TeDan and Lattus, address two major components of a Total Lateral Solution that is poised to make a meaningful impact on lateral spine clinical outcomes.”

The Extreme Lateral (XL) Access platform was developed to be the most user-friendly retractor system on the market. This was accomplished by integrating proprietary design elements that mitigate performance characteristics that surgeons find problematic in competitive retractors.  While TeDan will continue to market other surgical systems and fulfill contractual obligations to its existing customers, the company will no longer manufacture & distribute its flagship XL3 retractor.  Going forward, the company’s primary focus will be the advancement of 4WEB’s Lateral Spine Truss System™ through the continued development of the Lattus XL15 retractor.

“The optimized ergonomics of the XL platform allows the surgeon to focus on implant technology rather than the access portion of the procedure,” said Danny Fishman, President of TeDan.  “After analyzing the lateral market, we believe 4WEB’s Truss Implant Technology provides the best in class implant offering necessary to be competitive with the market leaders in lateral surgery.  We are thrilled to be exclusive partners with 4WEB in our common goal to provide an industry leading Total Lateral Solution.”

4WEB’s proprietary Truss Implant Technology™ mitigates the chance of subsidence and leverages mechanobiology to stimulate an osteogenic response that facilitates the healing process in spine fusion procedures. The 4WEB Total Lateral Solution combines the most innovative implant design and access solution to successfully compete with well-established leaders in the lateral spine market.

The transaction is subject to customary closing conditions.

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology™, and the Spine Truss Systems™, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System

KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ — Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures.

In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the endpoints of freedom from adjacent level fracture and midline vertebral height restoration.  The SpineJack system also showed substantial and sustained improvement in both pain (VAS) and function (Oswestry Disability Index) over BKP.

Available in three sizes to accommodate different vertebral body sizes, the SpineJack titanium implant is inserted and expanded, and PMMA bone cement is injected at low pressure to stabilize the restored vertebral body.

The SpineJack system has been commercially available in Europe since 2008 and over 70,000 units have been implanted worldwide.  The company plans to execute a limited launch of the device for the remainder of 2018.

For more information, please visit Stryker’s booth #1401 at the annual meeting of the North American Spine Society in Los Angeles September 26th– 29th, or at www.stryker.com.

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.

Media contact
Jennifer Lentner 
jennifer.lentner@stryker.com

SOURCE Stryker

Related Links

http://www.stryker.com

Kuros Reports First Patient Treated in Randomized Controlled Trial of MagnetOs in Spinal Fusion

SCHLIEREN (ZURICH), Switzerland, Sept. 27, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study, which is entitled “A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion”. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “It is gratifying to see this important trial get underway in spinal fusion, as this area of great medical need is the focus of our commercial activities. The study is expected to generate important data that can help further differentiate MagnetOs and improve outcomes for patients.”

The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “It is a privilege to be leading this investigation of MagnetOs. MagnetOs is supported by some fantastic scientific evidence and is a treatment which has the potential to significantly improve patients’ lives. Patients own bone remains the gold standard against which all other grafts should be measured, yet very few studies have investigated synthetic alternatives side by side with autograft in a clinical setting. This study is poised to provide a level of definitive clinical evidence that surgeons have been crying out for.”

About the study
The study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will enrolled in this study. Primary endpoint is posterior spinal fusion rate after one year based on CT-scans.

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149
michael.grau@kurosbio.com hherklots@lifesciadvisors.com

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

About Kuros Biosciences AG 
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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

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

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

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

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

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

About Centinel Spine, LLC.

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

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

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

For more information, please contact:

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

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

SeaSpine Announces Launch of Regatta™ Lateral System

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About K2M

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

Forward-Looking Statements

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

Additional Information and Where to Find It

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

Participants in Solicitation

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

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

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

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

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

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

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

TirboLOX-C Titanium Cervical Cages

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

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

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

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

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

About Captiva Spine, Inc.

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

This Press Release can be found at PRWeb.com