STIM_onTrack_Phone-1.jpg

Orthofix Wins 2017 Spine Technology Award for STIM onTrack Mobile App

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

October 25, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that its STIM onTrack™ mobile app has earned the 2017 Spine Technology Award in the Cervical Care category from Orthopedics This Week, the most widely read publication in the Orthopedics industry. The award will be presented today at the North American Spine Society (NASS) annual meeting in Orlando, FL. and published in upcoming issues of Orthopedics This Week and Orthopedics This Month Spine.

The STIM onTrack technology for mobile devices was introduced in 2017 and works with the latest generation Orthofix CervicalStim™ and SpinalStim™ bone growth stimulators. The mobile app includes a first-to-market feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment, allowing them to adjust and personalize follow-up protocols to help achieve better outcomes. In parallel, the app provides patients with a daily treatment reminder and a device usage calendar to help them adhere to their prescription and take an active role in their spinal fusion recovery. The STIM onTrack app is free and available through the iTunes App Store.

The STIM onTrack technology is one of 10 medical device advancements being recognized by Orthopedics This Week that represent significant advancements in their respective categories.

“The Spine Technology Awards are intended to bring increased recognition to exemplary and innovative spine surgery products and the engineering teams and inventors who create them,” said Robin Young, Founder and Publisher of Orthopedics This Week and RRY Publications. “We are pleased to present Orthofix with this award in recognition of the STIM onTrack mobile app and its potential to facilitate therapy compliance and ultimately improve patient outcomes.”

“We are honored to accept this award on behalf of our team of dedicated people who work hard every day to develop innovative technologies like the STIM onTrack app,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “This new mobile application and our latest generation CervicalStim and SpinalStim bone growth stimulators are great examples of the merger between our products and technology advancements that are designed to improve patient outcomes. We are proud to partner with physicians to help patients redefine their recovery process through better tracking and adherence to their therapy.”

About Bone Growth Stimulators

Orthofix announced the U.S. Food and Drug Administration (FDA) and European CE Mark approval of its next-generation CervicalStim and SpinalStim bone growth stimulators in January 2017. The U.S. devices feature the STIM onTrack mobile app. These Class III medical devices use a low-level pulsed electromagnetic field (PEMF) designed to activate cellular pathways that stimulate the proliferation and differentiation of mesenchymal stem cells to augment the body’s natural healing process, providing patients with a safe, noninvasive treatment option for promoting post-operative lumbar and cervical fusion.

The SpinalStim device is the only bone growth therapy device approved by the FDA as both a lumbar spinal fusion adjunct to improve fusion outcomes and as a non-surgical treatment for spinal pseudoarthrosis. Additionally, the CervicalStim device is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment option for improving cervical fusion outcomes in high risk patients. Together, these devices are the number one prescribed bone growth stimulators for spinal fusion.

In October 2016, The North American Spine Society (NASS) issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. These evidence-based coverage policy recommendations support the use of PEMF stimulation devices as an adjunct to spinal fusion surgery.

Orthofix invites those attending the NASS Annual Meeting to visit Booth #1500, Hall WE1 to learn more about the STIM onTrack mobile app and our next-generation bone growth stimulation devices.

About Orthopedics This Week

Orthopedics This Week, a four time winner of the MORE awards for journalistic excellence, is dedicated to delivering breaking news, analysis and commentary about the Orthopedics industry. Published 40 times a year, Orthopedics This Week covers what matters most in healthcare through the distribution of unique and valuable information to professionals who get up every day and work in the orthopedic community.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and MTF Biologics. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: practices of health insurance companies and other third-party payors with respect to reimbursement for our PEMF devices and other risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
Investor Relations
markquick@orthofix.com
or
Denise Landry, 214-937-2529
Media Relations
deniselandry@orthofix.com

Read More
Fortilink-C-1.jpg

RTI Surgical® Launches Fortilink®-C IBF System, the First 3D Printed Polymer-based Interbody Device

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

October 25, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced the commercial launch of Fortilink-C IBF System with TETRAfuse® 3D Technology. The Fortilink-C system is the first in a family of devices to incorporate RTI Surgical’s TETRAfuse 3D Technology.

“TETRAfuse 3D Technology combines the best characteristics of titanium, allograft bone and PEEK – all in one package,” said Grigory Goldberg, M.D., an orthopaedic surgeon practicing in Princeton, N.J. “The Fortilink-C system represents a revolutionary new step in the future of spine surgery.”

The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device to incorporate macro, micro and nano-rough features on the entire implant surface— not just on the endplate surfaces. The Fortilink-C device is designed to allow bony ingrowth on all implant surfaces while maintaining radiolucent and bone-like mechanical properties that surgeons expect.

“The Fortilink-C system has ushered in a new beginning for cervical fusion cages – we have gone from iliac crest to cadaver bone to PEEK and titanium, and now, Fortilink-C IBF System with TETRAfuse 3D Technology,” said Richard E. Nussbaum, M.D. an orthopaedic surgeon practicing in Sherman Oaks, CA and the first surgeon to implant a Fortilink-C device. “The enhanced implant design increases the surface area and, in an animal model, shows greater circumferential bony ingrowth1.”

“Fortilink-C IBF System demonstrates RTI Surgical’s commitment to advancing technologies and delivering innovative clinical solutions that meet the demands of our customers while improving the lives of patients,” said Camille Farhat, RTI chief executive officer. “This new innovative platform will have many derivative products, and this, in addition to the map3® Cellular Allogeneic Bone Graft and our comprehensive spine hardware portfolio, brings us a step closer to a complete offering.”

® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.
1 Data on file RTI Surgical, Inc. Performance data from animal models may not be representative of performance in humans.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

 

Read More
prod_ortho_allofuse-select-cm_510x330-1.jpg

AlloSource To Highlight AlloFuse Select CM Cellular Allograft Matrix At North American Spine Society Annual Meeting

Posted On October 25, 2017 By OrthoSpineNews In Biologics /  

CENTENNIAL, Colo., Oct. 24, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cellular, cartilage, bone, skin and soft-tissue allografts to advance patient healing in surgical procedures, will highlight AlloFuse® Select CM at the North American Spine Society Annual Meeting (NASS).

AlloFuse Select CM combines osteoconductive, osteoinductive, and osteogenic properties to support the initiation and nurturing of bone growth, leading to consistent spinal fusion outcomes and delivering the benefits of autograft bone without the potential drawbacks. The product engages the body’s natural healing power and can be used in a variety of spinal, neurologic, and orthopedic procedures.

“AlloFuse Select CM represents our ongoing dedication to delivering advanced allograft solutions that help restore mobility for recipients,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “We are proud to support spine surgeons by expanding our biologics portfolio to provide a range of products that assist in patient healing.”

This cellular allograft matrix is moldable and compressible for insertion into interbody implants or placement around anatomical structures. AlloFuse Select CM enhances AlloSource’s current orthobiologic portfolio, which includes AlloStem® Cellular Bone Allograft, AlloFuse® Cortical Fibers and AlloFuse Fiber Boat, AlloFlex® Plus and AlloFuse putty, paste and gel allografts.

Surgeon experts Dr. Shay Bess and Dr. Peter Passias will be at AlloSource’s NASS booth #1033 for peer-to-peer discussion during NASS, which is taking place October 25-28, 2017 in Orlando, Florida.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

Read More
l.jpg

Alphatec Announces Preliminary Third Quarter 2017 Financial Results And Corporate Updates

Posted On October 25, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., Oct. 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced preliminary estimates of financial results for the third quarter ended September 30, 2017.  The Company also announced several corporate updates.

Preliminary, Unaudited Third Quarter 2017 Financial Results

  • Total revenue of $22.8 million to $23.1 million
  • U.S. commercial revenue of $20.4 million to $20.7 million
  • U.S. commercial gross margin of 68% to 69%
  • Total operating expenses decreased to a range of $15.7 million to $16.0 million
  • Cash burn improved to approximately $3.7 million; cash balance of approximately $15.4 million at September 30, 2017

“Third quarter revenue was down sequentially due to the impacts of the hurricanes in Texas, Florida, and Puerto Rico, and fewer selling days in the quarter,” said Terry Rich, Alphatec’s Chief Executive Officer. “In spite of the weather-related challenges, we successfully managed operating expenses and substantially decreased cash burn for a fourth consecutive quarter.  As well, with the momentum we are experiencing in our sales channel, we expect to drive sequential revenue growth in the fourth quarter.”

The Company will report final third quarter 2017 financial results and will hold a conference call on Thursday, November 9, 2017, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 4698936. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

A replay of the webcast will remain available on the Company’s website, www.atecspine.com, until the Company releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 4698936.

Ward W. Woods Appointed to Board of Directors

Alphatec has appointed Ward W. Woods to its board, adding his decades of capital markets and business expertise. Mr. Woods is former President and Chief Executive Officer of Bessemer Securities Corporation and Founding Partner of Bessemer Holdings, L.P., a private equity firm, a senior partner and member of the Management Committee of Lazard Freres & Company, and Managing Director, Partner and co-head of the Corporate Finance Department at Lehman Brothers. Mr. Woods currently serves as Chairman of the Advisory Board of the Stanford Woods Institute, as Chair Emeritus and trustee of the Wildlife Conservation Society and as a trustee of the David & Lucille Packard Foundation. He is a former Trustee of Stanford University, former Chairman of The Stanford Management Company and a former trustee of the National Fish and Wildlife Foundation. Mr. Woods has also served as former Governor and Treasurer of The Nature Conservancy, Vice-Chair and trustee of The Asia Society and a trustee of The Boys Club of New York.  Mr. Woods graduated from Stanford University.

“The new leadership team at Alphatec has begun to execute an important mission to improve patient outcomes and expand market share. I look forward to contributing to the Company’s advancement into a major spine market player,” said Woods.

Mike Plunkett, President and Chief Operating Officer Resigns

On October 18, 2017, the Company accepted the resignation of its President and Chief Operating Officer, Mike Plunkett, who is stepping down from his position to pursue other interests. Mr. Plunkett’s resignation is effective as of November 15, 2017, and it is anticipated that he will remain available to the Company in a consulting capacity through the end of 2017 to transition his duties.

Mr. Rich stated, “Mike has contributed solidly to the commencement of the Alphatec transformation.  We sincerely appreciate his years of service and leadership, and wish him the best in his future endeavors.”

Shelf Registration Filed

Alphatec has filed a shelf registration statement with the Securities and Exchange Commission (SEC).  The filing will register up to $100 million in aggregate of equity, debt, or other types of securities described in the registration statement in one or more offerings.  The terms of any future offering will be established at the time of the offering, subject to market conditions and approval by the Company’s board of directors.  Each time securities are offered and sold, the Company will provide a supplement to the registration statement with specific information about the offering and the amounts, prices, and terms of the securities. The supplement may also add, update or change information contained in the registration statement. The filing may enable the Company to offer and sell securities on an expedited basis if market opportunities present themselves.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.
Additional information can be found at www.atecspine.com.

Disclosure Regarding Preliminary Unaudited Results

The preliminary financial results presented above reflect Alphatec’s estimates based solely upon information available to it as of the date hereof, is not a comprehensive statement of its financial results or position as of or for the three months ended September 30, 2017, and has not been audited, reviewed or compiled by its independent registered public accounting firm, Mayer Hoffman McCann P.C. (“MHM”). Accordingly, MHM does not express an opinion or any other form of assurance with respect thereto. Alphatec’s actual third quarter results may differ materially from these estimates. Accordingly, investors should not place undue reliance upon these estimates

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

Read More
MOJAVE-PL-3D-1050x525-1.jpg

K2M to Feature First FDA-Cleared 3D-Printed Expandable Interbody System, Industry-Leading 3D-Printed Portfolio, & Balance ACS™ Platform at NASS 2017

Posted On October 25, 2017 By OrthoSpineNews In Spine /  

LEESBURG, Va., Oct. 24, 2017 (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 comprehensive next-generation innovations—including the MOJAVE™ PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology™, its industry-leading 3D-printed portfolio, and Balance ACS™ (BACS™) platform—at Booth #509 at the 2017 North American Spine Society (NASS) meeting, occurring October 25–28 in Orlando, FL. Favorable data on K2M’s RHINE™ Cervical Disc System* and the PALO ALTO® Cervical Static Corpectomy Cage System will be featured during scientific sessions on October 25.

“NASS is a perfect place to share, collaborate, and exchange K2M’s latest advancements in spinal surgery,” said K2M Chairman, President, and CEO Eric Major. “This year, K2M is pleased to feature our MOJAVE PL 3D Expandable Interbody System—the world’s first and only FDA-cleared, 3D-printed expandable fusion device—as well as our differentiated product portfolio consisting of our industry-leading 3D-printed solutions and Balance ACS platform. We are committed to developing next-generation technologies and strive to elevate recognition of Total Body Balance as essential to surgical success.”

K2M to Exhibit Next-Generation Innovations and Balance ACS Platform

During the meeting, Major and other members of the executive team will be onsite to showcase K2M’s differentiated spinal technologies, including the Company’s latest offerings and industry-leading, 3D-printed Lamellar 3D Titanium Technology portfolio of products.

  • MOJAVE PL 3D Expandable Interbody System: A first-to-market, FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody system, designed to allow for independent adjustment of the anterior and posterior height, that features K2M’s Lamellar 3D Titanium Technology.
  • PALO ALTO Cervical Static Corpectomy Cage System: The first and only static corpectomy cage in the world to receive a cervical 510(k) clearance from the FDA.
  • EVEREST® Minimally Invasive XT Spinal System: A comprehensive system that incorporates EVEREST screw technology with metal extensions for minimally invasive rod delivery and reduction. A low-profile XTower™ sleeve enables intraoperative functionality as an extended tab or rigid tower system based on surgeon preference.
  • YUKON™ OCT Spinal System: An advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.

K2M will also feature its Balance ACS platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. K2M will demo the BACS System—which includes BACS Preauthorization, BACS Surgical Planner, BACS Anatomical Models, and BACS Data Management—and the BACS app, a convenient portal for surgeons to access the BACS System.

The Company will host a BACS reception on Thursday, October 26, featuring discussions by Dr. Pierce Nunley and Dr. Kornelis Poelstra from 6 to 8 p.m. at Howl at the Moon (8815 International Drive, Orlando, FL).

Favorable Data Supporting K2M’s Spinal Solutions to Be Presented

Favorable data on K2M’s RHINE Cervical Disc System* will be presented during a scientific session entitled: “Biomechanical Assessment of Viscoelastic Cervical Disc Prosthesis in One- and Two- Level Constructs.” The session will be held on Wednesday, October 25 from 2:17 to 2:23 p.m. in room WF1. The RHINE Cervical Disc* is K2M’s next-generation cervical artificial disc replacement featuring proprietary molding technology designed to minimize wear between the polymer core and metal endplates.

Richard Guyer, MD, an orthopedic spine surgeon at Texas Back Institute in Plano, Texas, and lead author of the RHINE study said, “This study shows that the next-generation one-piece viscoelastic disc has the ability to maintain a motion segment’s normal COR (center axis of rotation) even if placed in a less than ideal position**.”

Further, the PALO ALTO Cervical Static Corpectomy Cage System will be featured in a scientific session entitled: “Cardinal Spine, LLC: ACCF: 30-Month Follow-Up on C-VBR.” The session will be facilitated by Frank P. Castro Jr., MD, on Wednesday, October 25 from 2:29 to 2:35 p.m. in room W230CD.

For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

*This product is intended for export and is not sold or offered for sale in the United States.
**Based on mechanical testing. May not represent clinical results.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make. 

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

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

Read More
ht_170817_serrato_pedicle_screw_800x600-1-e1508946716621.jpg

Stryker’s Spine Division to Commercially Launch Serrato Pedicle Screw at NASS 2017

Posted On October 25, 2017 By OrthoSpineNews In Spine /  

October 24, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that it will commercially launch its Serrato™ pedicle screw, a unique dual-lead screw intended for use in the non-cervical spine, at the North American Spine Society (NASS) Annual Meeting, Oct. 25-28, 2017, Orlando, Fla. (booth No. 500).

Design innovations pioneered by Stryker elevate one of the most basic spinal surgery tools, with the goal of reducing work, increasing speed, and enhancing surgical efficiency. The Serrato pedicle screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque,1 and True-Tip geometry, which allows for precise insertion and immediate bone engagement.1

“We are thrilled to announce the full commercial launch of the Serrato pedicle screw during this important spinal surgery conference,” said Bradley Paddock, President of Stryker’s Spine division. “We have been receiving exceptional feedback from our surgeon customers since the initial launch and are excited to now make Serrato more broadly available to surgeons.”

According to Alexander R. Vaccaro, MD, PhD, MBA, one of the first surgeons to integrate Serrato, “The Serrato pedicle system from Stryker has added a new level of versatility to the armamentarium that a spine surgeon has in all complex spinal procedures. The new screw design affords excellent screw purchase.”

The Serrato pedicle screw, part of Stryker’s Xia® 3 Spinal System, received 510(k) clearance from the U.S. Food and Drug Administration in May 2017. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com. Follow Stryker’s Spine division on Twitter @stryker_spine.

References

1. Serrato Claims Validation Report | DHF 0000052658

Dr. Vaccaro is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Content ID: TLSER-PR-3_15824

Contacts

Sullivan & Associates
Barbara Sullivan, 714-374–6174
bsullivan@sullivanpr.com

Read More
VerteLP-Surgical-Technique-Cover-1-e1508945531144.jpg

VGI Medical Enters Lateral Spine Market With 1st Of Its Kind Technology

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

LARGO, FLA. (PRWEB) OCTOBER 24, 2017

VGI Medical, LLC, a privately held medical device company specializing in unique spinal implants, today announced the full the commercial launch of the VerteLP® Lateral Interbody Fusion System.

VerteLP was designed to address many of clinical challenges that surgeons face such as insufficient fixation of the implant or interference with pedicle screws. The system was designed to be minimally invasive and anatomy preserving all while decreasing operating room time due to the reduction in the number of surgical steps and instruments required to insert the implant.

“We have been thrilled by the feedback and clinical outcomes during our alpha launch and we are excited to launch VerteLP to a wider audience,” said Tov Vestgaarden, president and chief executive officer of VGI Medical. “Our goal is create innovative solutions that solve clinical problems for surgeons and improve patient outcomes and we believe we have achieved that with VerteLP.”

VerteLP Advantages

  • Biomechanics – First of its kind bilateral plate fixation limits axial rotation and lateral bending, increasing stability of the segment
  • OR Efficiency – Reduction in OR time due to fewer instruments and surgical steps required to insert cage and lateral plating when compared to other lateral systems
  • Anatomy Preserving – Unlike competitive systems, the VerteLP lateral plating fixation does not compromise the endplates or vertebral bodies
  • Avoids Pedicle Screws – VerteLP lateral plating does not interfere with the placement of pedicle screws in primary cases or at adjacent levels where prior hardware is in place

VGI Medical 2017 North American Spine Society (NASS) Meeting

VGI Medical will display their flagship Sacroiliac (SI) Joint system, SiJoin® Direct Posterior Fusion, best-in-class VerteLoc® Posterolateral Fusion, and the all new VerteLP® Lateral Interbody Fusion System in Booth #1709 at the 2017 NASS Meeting held October 25-28, 2017 in Orlando, Florida.

About VGI Medical, LLC

VGI Medical (VGI), founded in 2007 based on an invention developed by Tov Vestgaarden, PhD, is an innovative medical device company focused on using its industry knowledge and creative thinking to develop and commercialize a broad range of advanced, high-performance and innovative spinal implants. VGI developed its first product, the VerteLoc® Minimally Invasive Spine Stabilization System, to overcome the limitations of currently available implants. Applying the principles of this success, VGI Medical added SiJoin® to its product line in 2013 for Sacroiliac fusion and introduced the truly unique VerteLP® in early 2016. For more information, please visit http://www.vgimedical.com.

Read More
astura-logo-e1508878175841.png

Astura Medical Appoints Steve Haayen Vice President of Commercial Operations

Posted On October 25, 2017 By OrthoSpineNews In Spine /  

CARLSBAD, CA – October 24, 2017 – Astura Medical, a high growth, innovative spine technology company, today announced it appointed Steve Haayen as its Vice President of Commercial Operations. In this role, Mr. Haayen will be reporting to Joel Gambrell, President and CEO, and responsible for the continued expansion of the Company’s commercialization strategy across the United States.

“I am excited to welcome Steve as a member of the Astura executive team,” said Mr. Gambrell. “His leadership and significant expertise in multiple aspects of the business, will be critical as we continue to scale our efforts of bringing best-in-class technology to our surgeon and distributor partners.”

Mr. Haayen brings over 11 years of spine sales and management experience to Astura. Prior to joining Astura, Mr. Haayen has held roles of increasing responsibility with Stryker Spine, Globus Medical, Biomet Spine, and most recently, as Area Vice President at Spinal Elements. Throughout his career, Mr. Haayen has consistently delivered high volume revenue growth, developed sales distribution channels, and helped establish strategic direction for organizations.

Astura Medical will be exhibiting (Exhibit 565) its full portfolio of technology, including its most recent addition, BRIDALVEIL OCT System, at the 32nd North American Spine Society (NASS) Annual Meeting, taking place in Orlando, October 24-27th. 

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

 

Media Contact:

Joel Gambrell

Astura Medical

760.814.8047

joel@asturamedical.com

Read More
download.png

Biogennix Ramps Up National Distribution for Bone Graft Substitute Products osteoSPAN and Morpheus

Posted On October 24, 2017 By OrthoSpineNews In Biologics /  

October 24, 2017

IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company which develops, manufactures, and distributes proprietary bone graft substitutes used for bone fusion procedures, announced today that it is expanding its distribution efforts for its novel bone graft substitutes, Morpheus™ and osteoSPAN™ to full national distribution.

The products are resorbable, moldable, osteoconductive scaffolds ideally suited for bone regeneration and optimal handling by surgeons.

News of Biogennix’s decision to expand its marketing of the products to a national level follows on the heels of last month’s announcement that Morpheus and osteoSPAN have now been used in more than 6000 patients.

“Our regionally focused efforts to market Morpheus and osteoSPAN bone graft products have exceeded expectations thus far,” said Scott Bauccio, Biogennix’s Vice President of Sales and Business Development. “We believe these products are fast becoming the new standard of effectiveness and ease of use when it comes to bone graft substitutes. They have been so well received by the clinician and patient communities that it makes sense that we expand our distribution on a nationwide level.”

Bauccio added that he and other key members of Biogennix’s executive team are attending the North American Spine Society (NASS) Meeting in Orlando this week, meeting with potential spine sales team members and reps as part of the growth phase.

Biogennix is a leading developer of osteobiologic products specifically designed for spine fusion and bone trauma. The company is led by a team of scientists and industry veterans committed to delivering unique products for bone regeneration. Biogennix designs, manufactures and distributes all of its products from its Irvine facilities.

Biogennix™ is a fully-integrated osteobiologic company headquartered in Irvine which develops, manufactures, and distributes proprietary bone graft substitutes used in bone fusion procedures. Learn more at biogennix.com.

Contacts

for Biogennix
Paul Williams, 310-569-0023
paul@medialinecommunications.com

Read More
TRXCellRight-01.png

CellRight Technologies to Participate in World’s Largest Spine Exhibition

Posted On October 24, 2017 By OrthoSpineNews In Biologics /  

October 24, 2017

SAN ANTONIO, Texas–(BUSINESS WIRE)–Tissue Regenix Group plc (AIM:TRX) (‘Tissue Regenix’ or ‘The Group’) the UK based regenerative medical devices company announces subsidiary CellRight Technologies (‘CellRight’) will be participating in The North American Spine Society annual meeting – NASS 2017, being held in Orlando, Florida, October 25-28 2017.

NASS is the largest spine exhibition in the world where spine care professionals from around the globe will share the latest information on new technologies, innovative techniques and procedures, and best practice.

NASS is the first conference that the Group have attended since completing the acquisition of CellRight Technologies in August. The Group will be exhibiting at booth #1343 promoting its range of products including Matrix OI® stem cell containment products, MatrixCellect 100 DBM putty, ConCelltrate Inductive Carrier Matrix and Matrix OI Cortical Fibers.

CellRight is focused on innovative product development expanding the potential of regenerative solutions in the osteobiologics field, offering surgeons and patients a biologic product portfolio.

With products that are 100% allograft bone, the innovative platform technology preserves the native Bone Morphogenic Proteins (BMPs) and growth-factors to verify osteoinductivity needed for bone regeneration, resulting in best-in-class products and ensuring superior clinical outcomes. CellRight verifies osteoinductivity for every lot post sterilization and these osteogenic bioengineered implants address indications in the spine, trauma, TJA and sports medicine fields.

The CellRight technology complements dCELL® Technology, Tissue Regenix’ patented decellularization process for soft tissues. In due course, soft tissue products for use in various orthopedics applications, with an initial focus on ligament reconstruction, will also be processed at the state-of-the-art CellRight tissue bank facility based in San Antonio, Texas.

Jesus Hernandez, CEO CellRight Technologies commented: “We are delighted to be attending NASS as part of the larger Tissue Regenix Group. This conference offers a unique opportunity to showcase our portfolio of innovative spinal products and discuss the future potential of the combined CellRight and dCELL® platforms with some of the best healthcare specialists in the world.”

###

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company’s patented decellularisation (‘dCELL®‘) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease.

Contacts

For more information:
Tissue Regenix Group plc
Caitlin Pearson
Head of Communications
Tel: 0330 430 3073
or
Racepoint Global
Jeff Stoecker, +1-617-624-3424
jstoecker@racepointglobal.com

Read More