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

Solvay’s Ixef® PARA enables Intelligent Implant Systems to pioneer a new single-use instrument kit for anterior cervical fusion procedures

Alpharetta, Ga., September 26, 2018 — Solvay, a leading global supplier of specialty polymers, announced today that the high stiffness, strength, gamma sterilization resistance and biocompatibility of its Ixef® polyacrylamide (PARA) resin helped enable a new single-use instrument kit for anterior cervical fusion procedures. Developed by Intelligent Implant Systems, a medical device company specializing in solutions for spinal surgery, the MEDIANT™ Anterior Cervical Plating System leverages Solvay’s advanced polymer to help boost operating room (OR) efficiency, eliminate onsite sterile processing and reduce infection risk.

“The primary benefit of Solvay’s Ixef® PARA in this application is its metal-like strength, which gives our single-use surgical instruments a very high level of performance without incurring the costs associated with machining metal and repeated steam sterilization,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “Although PEI also offered viable options for our surgical tool kit, we specified Ixef® GS-1022 PARA because its superior stiffness and moldability was essential for the kit’s instruments.”

Ixef® GS-1022 PARA forms the awl and pin-screwdriver handles, measuring caliper, and locking plier handles in Intelligent Implant Systems’ kit. The polymer’s excellent impact resistance also eliminated the need for a metal strike plate that had been part of the awl’s early designs. This reduced the cost and simplified the manufacture and assembly of the instrument, further supporting the economics of single-use instruments.

Ixef® GS-1022 PARA provides excellent aesthetics, including an attractive surface finish. The material is available in a range of gamma-stabilized colors, including the signature green of the MEDIANT™ System’s tools. Together, these properties of Ixef® PARA ensure Intelligent Implant Systems’ single-use instruments retain their visual appeal after they are gamma sterilized and packaged for delivery. Solvay’s PARA polymer has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which helped streamline the MEDIANT™ kit’s navigation through regulatory approvals.

“Solvay was an early advocate of the healthcare industry’s shift toward single-use surgical instruments, and we sought to support customers by proactively developing a broad portfolio of biocompatible polymer alternatives to metal – complete with gamma-sterilized colors and master access files,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Yet while the industry’s growing adoption of our advanced polymers validates this early insight, we derive much greater satisfaction in working closely with innovators like Intelligent Implant Systems to help achieve unique new designs for improving patient results.”

Intelligent Implant Systems will feature the MEDIANT™ Anterior Cervical Plating System at Booth #1905 during The North American Spine Society (NASS) meeting in Los Angeles, Sept. 26-29. For related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.

® Ixef is a registered trademark of Solvay

™ MEDIANT is a trademark of Intelligent Implant Systems

Intelligent Implant Systems is based in Charlotte, NC. Founded in 2007, the company aims to develop and market innovative surgical solutions for orthopedics and both fusion and non-fusion applications of the spine. Since its inception, the company has been granted multiple U.S. patents with foreign and additional U.S. patents pending to protect its core technology. Innovation is truly part of what Intelligent Implant Systems brings to patients, surgeons, hospitals and ambulatory surgery centers. Learn more at www.intelligentimplantsystems.com.

Media Relations

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

Dan McCarthy
AH&M Marketing Communications
+1 413 448 2260 Ext. 470
dmccarthy@ahminc.com

Enrico Zanini
Solvay Specialty Polymers
+39 338 603 4561
enrico.zanini@solvay.com

Alan Flower

Industrial Media Relations

+32 474 117 091

alan.flower@indmr.com

 

 

 

 

 

 

Surgio and SimplyRFID Announce Partnership For Fully-Automated Visibility into the Medical Device Supply Chain in Healthcare

Surg.io™, an emerging leader in software solutions for the management of orthopedic instrument and implant inventory as well as hospital sterile processing and perioperative solutions, has partnered with SimplyRFID, a veteran leader in tracking technology and inventory visibility solutions, announce an exclusive healthcare partnership to provide a fully integrated inventory management system that brings real-time visibility, tracking, and analytics to the entire hospital supply chain.

The medical device supply chain is inherently complex and full transparency has remained elusive for the majority of the healthcare industry. Hospitals and manufacturers alike have difficulty gaining oversight of even their highest-dollar assets.

Recent studies and surveys show that 80% of hospitals still manage their inventory via manual processes. Without tracking, up to 30% of their inventory expires on the shelves and hundreds of thousands – and often millions – of dollars in charges go uncaptured and unnecessary purchasing practices continue unabated.

The agreement combines two technology platforms that enable real-time location tracking plus artificial intelligence to reduce the potential for human error while increasing supply chain efficiencies. Surg.io and Simply RFID have jointly created the most advanced software/hardware solution to provide transparency and actionable analytics to the orthopedic & spine clinical arenas.

The new partners plan to launch the products in Los Angeles this week at the North American Spine Society’s Annual Convention on September 26-19 (Booth 1135). “We are excited to see how the partnership of Surg.io and SimplyRFID takes both platforms to new heights that were previously impossible. It is a real ‘1 plus 1 = 10’ scenario.” Jeff Claeson, Surg.io’s Co-Founder & Chief Technology Officer.

Carl Brown, President/Founder of SimplyRFiD said: “It’s a perfect match! Surgio makes healthcare supply chain management simple. We make supply chain tracking simple. By bringing these two technologies together – a trusted hospital scheduling / management product from Surgio and an accurate tracking system from SimplyRFiD – we give hospitals the best solution for managing their resources. Together, we create the complete solution that improves healthcare for everyone.”

About Surg.io

Surg.io is a complete inventory tracking system created for the orthopedic and spine industry. ERP systems were not built to effectively facilitate the fast-paced logistical environment of medical device supply chains. They are complex and often rely on tribal knowledge of each system to manage effectively. Healthcare suppliers and institutions rely on Surg.io to streamline communication between disparate teams to ensure continuity. By offering a user-friendly and intuitive interface, you don’t have to be a power user to manage inventory. Leverage Surg.io to enhance processes and optimize supply chain strategy.

About SimplyRFID

Since its founding in 2003, SimplyRFID has been at the forefront of developing tracking technology software. With over 100 million tags shipped and thousands of systems deployed worldwide in industries ranging from defense to healthcare, SimplyRFID is the expert industry leaders turn to for tracking solutions. Its largest deployment was developed in support of a major pharma group, which chose SimplyRFID due to its 15+ years of industry-leading expertise in RF-data capture solutions.  The deployment created a solution with unmatched reliability, accuracy, and scalability, enabling real-time tracking of tagged pharmaceutical items in hospitals and at healthcare providers worldwide.

 

Medacta Appoints General Manager for U.S. Spine Business and Announces Full-Market Release of Customizable MySpine MC Surgical Guides for Posterior Lumbar Fusions

LOS ANGELES–(BUSINESS WIRE)–Medacta® International, the family-owned global leader in innovative joint replacement and spinal technologies, announces today the appointment of long-time commercial leader Daniel Abromowitz as General Manager, Spine Division for Medacta USA. In addition, the company announced its MySpine Midline Cortical Pedicle Screw Placement Guide (MySpine MC), a patient-matched technology for posterior lumbar fusions, is now generally available and will be on display at the North American Spine Society (NASS) 2018 Annual Meeting, held Sept. 26-29, 2018 in Los Angeles, at Booth #2323.

“Daniel is a welcomed addition to the management team, bringing an innovative management approach and broad engineering and supply chain experience,” said Eric Dremel, President of Medacta USA. “Most importantly, Daniel’s track record of sustained commercial success and relentless customer focus will allow the potential of our Spine Division to be fully realized.”

A respected business leader, Abromowitz brings to Medacta USA a history of building high-performing, results-driven teams, with more than a decade of experience supporting and leading early-stage and emerging companies in the medical device and health care marketplaces. After nine years with spinal implant company X-spine Systems, Inc., Daniel was the Vice President of Sales when the company was acquired by Bacterin in 2015. Since, he has held senior leadership positions at Xtant Medical (formerly X-spine), Aerobiotix and most recently, Captiva Spine.

“As a passionate supporter of collaborative worldwide innovation, Medacta International offers an incredible growth opportunity for spine in the U.S. market. My goal is to build on the successful foundation of Medacta’s joint division here in the U.S. to support our key stakeholders in spine: surgeons, patients, facilities and agents,” Abromowitz said. “By utilizing the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, Medacta surgeons are never alone. I hope to expand on these peer-to-peer training programs for spinal surgeons here in the U.S., as we build Medacta USA Spine into an innovative leader for the U.S. market.”

MySpine MC – Offering a new approach to posterior lumbar fusion

The patient-matched, 3D-printed MySpine MC, first announced in May 2018, guides pedicle screws to a trajectory that evolved from the well-established cortical bone trajectory (CBT). The MySpine MC technique, however, has a more caudomedial entry point than traditional pedicle screw trajectories and a less extreme caudal-cranial angle than CBT to avoid interference with the cranial facet joints and to accommodate larger screw diameters and lengths, precisely supported by 3D pre-operative planning. As an accurate and reliable muscle-sparring approach, MySpine MC is designed to encourage faster patient recovery and is suitable for both inpatient and outpatient surgery settings.

MySpine MC will be on display at NASS 2018 at Booth #2323 along with the rest of Medacta’s spine product portfolio. For more information on MySpine MC, visit Medacta’s MySpine MC webpage, where the new MySpine MC video is available.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient-matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

SurGenTec’s ALARA™ Access Needle Awarded Best Spine Technology for 2018

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec ® LLC, a South Florida based medical device company has been awarded the 2018 Orthopedics This Week Spine Technology Award and will be formally receiving their award during the 2018 North American Spine Society meeting. This year’s meeting will be held Sept. 26th -28th in Los Angeles, CA. The awarded technology from SurGenTec’s product line is the unique and innovative ALARA ™ access needle. The access needle will be offered in multiple variations including with and without a depth stop. When combined with their patented fully adjustable extension handle the user can maintain superior target needle manipulation while also reducing radiation exposure. The extension handle allows users to maintain maximum source-to-skin distance between their hands and the primary x-ray beam without sacrificing precision and control. A white paper study revealed a reduction in radiation exposure of 293 times less than standard needle manipulation and 15 times less than using a Kocher Clamp. The ALARA access needle is set for release in Mid-October.

Travis Greenhalgh, CEO of SurGenTec stated in a recent interview, “Although its often overlooked in the industry, many surgeons reach dangerous levels of radiation exposure annually and SurGenTec is on a mission to decrease those numbers and raise awareness.”

SurGenTec, LLC is a medical device company based in Boca Raton, FL that strives to bring the next level of technology to the spine and orthopedic industry. SurGenTec develops and manufactures innovative products with patient and surgeon safety at the heart of everything they develop. SurGenTec has already made their presence known with the GraftGun® Universal Graft Delivery System which launched earlier this year and are excited to add the awarded ALARA to their portfolio. SurGenTec will also be showcasing their pre-filled MIS cartridge options at NASS, including ViBone® viable bone matrix. SurGenTec partnered with Aziyo® Biologics to provide ViBone next generation bone graft in an MIS cartridge to reduce thawing time, cross contamination, and delivery issues. SurGenTec has multiple products in their pipeline set for release over the next year.

www.surgentec.com
7601 N Federal Hwy., Suite 150A
Boca Raton, FL 33487
561-990-7882 / customerservice@surgentec.com

Contacts

SurGenTec ® LLC
Ricki Goldman, 561-990-7882
customerservice@surgentec.com

Synergy Biomedical Announces FDA Clearance of BIOSPHERE® FLEX

September 25, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX. Based on Synergy’s patented BioSphere® Technology, BIOSPHERE® FLEX is a strip-format bone graft product composed of porous, bioactive glass that is dimensionally integrated within a collagen and sodium hyaluronate scaffold. The porosity of the BIOSPHERE® FLEX bone graft was specifically designed for optimized absorption of bone marrow aspirate. BIOSPHERE® FLEX is presently in final preparation for commercial launch in the 4th quarter of 2018.

“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “The BioSphere® product line provides surgeons with a full spectrum of bone graft forms that can be tailored to a variety of surgical techniques while leveraging the proven advantages of Synergy’s core bioactive technology. These options include BIOSPHERE® PUTTY (a robust bone graft material that can be used alone or combined with autograft), BIOSPHERE® MIS PUTTY (with a delivery system specifically designed for targeted graft placement in minimally invasive surgery), and now BIOSPHERE® FLEX (developed to be used by surgeons who prefer the characteristics of a flexible strip form and the ability to augment with bone marrow aspirate).”

“The addition of BIOSPHERE FLEX to the product portfolio provides Synergy increased coverage of the bone graft market,” stated Kevin Booth, VP of Sales. “With the BioSphere® product line, surgeons have access to next-generation bone graft technology that is compatible with a variety of bone grafting techniques.”

BIOSPHERE® FLEX utilizes Synergy’s patented BioSphere® Technology which is based on an innovative spherical form of bioactive glass that allows for ideal and precise control over the osseous healing process. The BioSphere® granules utilized in BIOSPHERE® FLEX have a unique and innovative bonded sphere structure that provides an optimal porosity for bone growth through the granules. BIOSPHERE® FLEX has one of the highest bioactive glass contents on the market due to its increased granule density compared to other porous bone graft sheets. Additionally, the use of a specifically formulated collagen and sodium hyaluronate carrier in BIOSPHERE® FLEX permits the implant to become flexible and moldable when hydrated with bone marrow aspirate. This aids in graft placement, and enables the implant to conform to irregular bone surfaces for maximum graft continuity and healing potential.

BIOSPHERE® FLEX utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a next-generation bone graft material with the working characteristics of a flexible strip that is designed to absorb and hold bone marrow aspirate in direct contact with porous bioactive glass granules.

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere® Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

MATRIXX: First Ever Clinical Trial Evaluating 3D-Printed Titanium vs PEEK

September 24, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announces the momentous start of the MATRIXX Trial – marking the first ever clinical evaluation of novel 3D-printed lumbar interbody fusion devices relative to PEEK.

The Nexxt Matrixx® System is a collection of porous titanium spinal fusion implants that interweave highly differentiated surface texturing technology with novel 3D-printed cellular scaffolding. With the sponsorship of this trial, Nexxt Spine hopes to prove that their technology can accelerate bony ingrowth and improve clinical outcomes.

“Since we launched last October, over 1400 Nexxt Matrixx® devices have been implanted and the response from our surgeon leaders has been phenomenal,” stated Nexxt Spine President, Andy Elsbury. “While our early adopters have witnessed improved clinical outcomes first-hand, we are excited to take the industry lead and quantify the clinical merits of Nexxt Matrixx® scientifically.”

The MATRIXX Trial is a prospective randomized controlled trial that will evaluate the clinical and radiographic outcomes of the Nexxt Matrixx® System following lumbar interbody fusion. Patients will be randomized to receive either a Nexxt Matrixx® 3D-printed porous titanium cage or a traditional plastic PEEK cage routinely recognized as the current ‘gold standard.’ Data will be collected at 3, 6, 12, and 24 months in order to quantify the speed and quality of fusion relative to the two implant materials.

“Although often used in spinal surgery, plastic PEEK cages are limited as they function more like static shims holding expensive biologics as opposed to active scaffolds that enable endplate to endplate healing,” explains Alaedeen Abu-Mulaweh, Director of Engineering.

While other manufacturers have used 3D-printing to develop devices that mimic bone’s trabecular geometry, Nexxt Spine chose to ignore the marketing allure and focus instead on the core science.

“Titanium is physically incapable of biological remodeling, so using 3D-printing to directly mimic the structural randomness of bone doesn’t make a whole lot of sense,” explains Abu-Mulaweh. “Rather than simply looking like bone, Nexxt Matrixx® was designed with the vision of actively facilitating the body’s natural power of cellular healing.”

The initiation of the MATRIXX Trial is “a milestone moment for Nexxt Spine and the medical community as a whole,” says Elsbury. “We believe that our Nexxt Matrixx® technology has the potential to revolutionize the landscape of spinal fusion and are excited for the opportunity to prove it.”

About Nexxt Spine

Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The Nexxt Matrixx® family currently consists of implants available for cervical, TLIF Oblique, and TLIF procedures. Stand-Alone Cervical, Stand-Alone ALIF, and Corpectomy devices incorporating Nexxt Matrixx® technology are actively in development & testing.

Contacts

Nexxt Spine LLC
Alaedeen Abu-Mulaweh, 317-678-8424
aabu-mulaweh@nexxtspine.com

Medtronic Launches the Infinity(TM) OCT Spinal System

DUBLIN and LOS ANGELES – September 25, 2018 – Medtronic plc (NYSE:MDT) today announced the U.S. launch of the Infinity(TM) Occipitocervical-Upper Thoracic (OCT) System designed to simplify posterior cervical spine surgery. The Infinity OCT System is a complete procedural solution that integrates navigation and biologics with Medtronic’s comprehensive devices and instrumentation to create efficiency in fusion procedure workflows for the upper back and neck. The announcement was made during the North American Spine Society meeting taking place from September 26th – 29th in Los Angeles where Medtronic is exhibiting at Booth #1201.

“For more than 35 years, Medtronic has partnered with leading spine surgeons to advance new technologies with the goal of improving patient outcomes,” said Doug King, senior vice president and president of the Medtronic’s Spine division, which is part of the Restorative Therapies Group. “We engineered every component of the Infinity OCT System to perform efficiently during the most complex spine procedures, as well as to integrate seamlessly with our market-leading imaging and navigation technologies.”

The Infinity OCT System is used to immobilize and stabilize the spine while it fuses. The system features several innovative components – including a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimize cross threading, and 3.0mm and 5.5mm diameter screws for expanded patient demographics and clinical applications. The system has a full spectrum of implant materials and sizes – and when paired with the O-arm(TM) Imaging System and StealthStation(TM) Navigation System – provides a fully-enabled procedural solution designed to bring efficiency and simplicity to even the most complex posterior cervical procedures.

The Infinity OCT System is indicated for certain conditions including degenerative disc disease, instability or deformity, tumors, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury. September is Spinal Cord Injury Awareness Month and according to the National Spinal Cord Injury Statistical Center, the 2016 annual incidence of spinal cord injuries in the U.S. was approximately 54 cases per million people, or about 17,000 cases per year.1

“Some of our posterior cervical patients arrive in critical condition and their lives depend on our surgical skills and the performance of the tools we use to treat them,” said Dr. Greg Trost, neurosurgeon at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. “With Infinity, I can focus on delivering the best patient care during complex procedures knowing that every component was precisely-designed with modularity and versatility in mind. And an integrated procedural solution with Stealth navigation and Infinity was game-changing as a 3D-view of the anatomy allows me the precision to place pedicle screws with confidence and accuracy.”

The Infinity OCT System is now available in the U.S. The system will be released in geographies around the world in 2018 and 2019.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Grand View Research. Spinal Implants & Devices Market Size, Share & Trends Analysis Report By Product (Fusion Devices, Spinal Biologics), By Technology, By Surgery Type, By Procedure Type, And Segment Forecasts, 2018 – 2024. April 2018. Available at: https://www.grandviewresearch.com/industry-analysis/spinal-implants-spinal-devices-market

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Kuros Biosciences Appoints Strategic Advisory Board

SCHLIEREN (ZURICH), Switzerland, Sept. 25, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the formation of its Strategic Advisory Board (SAB). The newly-formed SAB will work closely with Kuros’ leadership team to guide the strategic direction of the company. The SAB is assembled from key-opinion-leading surgeons and academic research experts, specialized in the treatment of disorders of the Spine. The board will sit for the first time in Los Angeles, USA on September 27, 2018, to coincide with the North American Spine Society annual meeting, at which Kuros Biosciences is presenting new scientific data in support of the Company’s bone graft product, MagnetOs, which was recently launched to market.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are pleased to welcome some of the most recognized names in the field of spinal research onto our Strategic Advisory Board. Our SAB will provide the necessary input to ensure that we match our strategy to the needs of the market and continue to build value for the future.”

Strategic Advisory Board Members:

R. Todd Allen, MD, PhD – UCSD, San Diego, CA, US
Richard (Todd) Allen, MD, is board-certified orthopedic surgeon with expertise in complex adult reconstruction procedures for deformity/scoliosis and tumors. He also specializes in complex disorders of the upper cervical spine and in degenerative, traumatic, and post-traumatic conditions.  Dr. Allen utilizes both a variety of minimally invasive and open surgical procedures for these conditions, focused on optimizing patient-centered outcomes.  As an associate professor in the Department of Orthopedic Surgery, Dr. Allen is active in educating medical students, residents and fellows at UC San Diego School of Medicine.  He is Spine Fellowship Director at UC San Diego and actively performs research on spinal deformity, biologics, disc replacement, and cost-effective/quality metrics in spine.  He has been lead or contributing author to numerous peer-reviewed research publications and book chapters. He has presented nationally and internationally, including such meetings as our North American Spine Society (NASS) and American Academy of Orthopedic Surgeons (AAOS) meetings.  He is part of the NASS Basic Science and Biologics Committee and continues to be highly active in several national committees advancing spine surgery research and outcomes.

Alpesh A. Patel, MD, FACS – North Western Medicine, Chicago, IL, US
Alpesh A. Patel, MD is the Director of Orthopedic Spine Surgery at Northwestern and a spine surgeon with fellowship training in both Orthopedic Spine Surgery and Neurosurgery. Dr. Patel specializes in cervical spine surgery and minimally invasive spine surgery. His experience and research include the areas of cervical spine surgery, cervical myelopathy, herniated discs, minimally invasive surgery, spine trauma and spinal cord injuries. Dr. Patel is known for his clinical research on patient outcomes, genetics of spinal disease, and injuries of the spine and spinal cord. He is also known for his research in cost-effectiveness and value in spine care, making spine surgery at Northwestern, as well as throughout the United States and the world, safer and more effective.

Kornelis Poelstra, MD, PhD – Sacred Heart Hospital, FL, US
Kornelis Poelstra is board certified in orthopedic spine surgery. He specializes primarily in long-construct minimally invasive spine surgeries, adult spinal deformity, oncologic conditions, spinal fracture treatment and cervical disc replacements. He is one of the world leaders in Robotic Spine Surgery and has performed more than 600 complex robotic cases thus far. He has an extensive research background in implant associated wound infections, novel material sciences for both spine- as well as orthopedic implant designs and worked on stem cell implantation for spinal cord injury. The mechanical- and cellular processes salient for the formation of a stable arthrodesis and implant incorporation into the human body are of specific interest to him. He founded the Spine Center of Excellence at Sacred Heart Hospital in North-West Florida and has been directing this Institution since its inception.

Andrew A. Sama, MD – HSS, New York, NY, US
Dr. Andrew Sama is Associate Professor of Clinical Orthopedic Surgery at Weill Cornell Medical College and previously served as Director of Spine Surgery Fellowship at Hospital for Special Surgery. Dr. Andrew Sama specializes in the management of all traumatic, degenerative, and deformity-related conditions of the cervical, thoracic, and lumbosacral spine. He has received several research grants, including funding from the National Institutes of Health. Dr. Sama is involved in product development and has helped design several orthopedic implant devices. He has published articles in numerous peer-reviewed medical journals and co-edited a textbook titled ‘Lateral Access Minimally Invasive Spine Surgery’. He is on the editorial board of Current Reviews in Musculoskeletal Medicine and serves as a reviewer for the journals Spine and Clinical Orthopedics and Related Research.

Faheem Sandhu, MD, PhD – MedStar Health, Chevy Chase, MD, US
Faheem Sandhu, MD, PhD, is director of Spine Surgery at MedStar Georgetown University Hospital and professor of Neurological Surgery at Georgetown University Medical Center. He specializes in minimally invasive and complex spinal surgery. Dr. Sandhu is an innovator in the field and holds several patents. His practice includes all areas of spine conditions: degenerative, deformity, tumor, and trauma. He has special interest in minimally invasive spine surgery and applying these techniques to all aspects of spinal surgery as well as disc arthroplasty and disorders of the craniocervical junction. Dr. Sandhu has authored more than 50 peer-reviewed articles and book chapters and has presented his research at major meetings in the U.S. and abroad. He regularly teaches courses on techniques of minimally invasive spine surgery. He is a Diplomate of the American Board of Neurological Surgeons and a Fellow of the American Association of Neurological Surgeons.

Prof. Bill Walsh PhD – UNSW, Sydney, Australia 
W.R. Walsh, Ph.D. is a Professor in the Prince of Wales Clinical School, Division of Surgery at University of New South Wales in Sydney, Australia, and Director of Surgical & Orthopaedic Research Laboratories, Prince of Wales Hospital. His research lies at the interface between implanted materials, including autograft, allograft and synthetic biomaterials, and the connective tissues of the body. The foundation of his research interests center on understanding the biology and biomechanics of connective tissues during healing, age and disease; this involves research techniques from the macro to molecular level. Bill has over 385 peer reviewed journal publications, book chapters and patents. He is on several editorial boards including Biomaterials, CORR, Muscle Tendon Ligament Journal, Journal of Biomechanics, The Spine Journal and Frontiers in Surgery and Bone and Joint Research.

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.