Jupiter, FL — (PR Newswire) — Atlas Spine, Inc., a high technology spine implant company focused on the development of innovative, disruptive implants and instrumentation for spine surgery, has hired Matthew Miller as Executive Vice President of Business Development.

Miller has over 25 years in orthopedics and spine experience and has co-founded or been instrumental in the development of several high-profile orthopedic and spine companies.

In 2005 he raised over $14 million in seed capital for SpineMedica, Inc., which licensed technology a hydrogel material from The Georgia Institute of Technology and Salumedica, Inc. as an artificial disc.  In 2007 Miller co-founded MiMedx Group, Inc. with licensed technology from the University of South Florida and the Shriners Hospital for Children. Miller and his team took the company public when Pete Petit stepped in to run the public company. Most recently he was a co-founder of The Genomics Cancer Institute, a company focused on the commercialization of genomic and esoteric cancer testing in partnership with NCI-accredited hospitals.

“I’m elated and grateful for the opportunity to be part of the team at Atlas Spine, Inc. Atlas is committed to developing innovative and disruptive spine implants and surgical technology. More importantly, the talent the company has assembled is inspiring. Every team member is committed to developing the best products that serve the needs of spine surgeons and benefit patient outcomes. I couldn’t be more pleased to jump back into the spine industry than I am with Atlas Spine, Inc.”

As Executive Vice President of Business Development, “I’ll be finalizing a mezzanine financing round and working with the executive team to deploy capital to support the launch of several products we have in front of the U.S. Food and Drug Administration. I can’t talk about the products prior to their approval, which for those who know me, is very difficult. We have some game-changing products coming to market. I can’t wait.”

Atlas Spine, Inc., is a privately held spine implant company based in Jupiter, Florida. Atlas is committed to the development of innovative spine implants that benefit surgeons and provide better patient outcomes. 

Media:  Please contact Matt Miller, at 813-368-6011 or mmiller@atlasspine.com for information about the company. Interviews and photos are available upon request.

Matt Miller

EVP Business Development

Atlas Spine, Inc.

1555 Jupiter Park Dr.

Jupiter, FL 33458

Office:  561-741-1108

Cell:  813-368-6011

www.atlasspine.com

October 25, 2017

ORLANDO, Fla., Oct. 25, 2017 /PRNewswire/ — DePuy Synthes* today is launching two solutions for minimally invasive spinal fusion surgery (MIS) designed to simplify the procedure, particularly as MIS gains traction and shows reduced complications compared to open surgery in treating degenerative disc disease in the back.^1,2

Research shows the number of MIS fusion surgeries conducted in 2010 accounted for one-sixth of the total number of all spine surgeries in the United States and is expected to be more than half of all spine surgeries in 2020.³ As MIS becomes more common, there is a significant need to simplify these procedures, especially the complexity associated with degenerated disc removal and pedicle screw insertion.

The VIPER PRIME™ System combines multiple instruments into one pedicle screw inserter tool that reduces the number of instrument passes. The single-use CONCORDE^® Clear MIS Discectomy Tool allows surgeons to complete the degenerated disc-clearing process faster on average and more efficiently compared to traditional discectomy tools while increasing the amount of disc material removed.⁴ These products are being showcased here at the North American Spine Society meeting.

“As a global leader in spine, we have a responsibility to continue to innovate to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “Both the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool are examples of how we are providing differentiated technologies that simplify spine surgery and make it more reproducible for every surgeon while reducing the impact on patients.”

VIPER PRIME System Inserts Pedicle Screws with Single Instrument Pass
Currently, the MIS screw insertion technique may consist of numerous instruments, involves the use of tools like Jamshidi needles and guidewires, and requires multiple instrument passes in and out a patient’s body, all of which contribute to procedural complexity. The VIPER PRIME System combines many of these instruments into one single tool and reduces the number of instrument trays to two**. A new screw tip design and stylet that is fully controlled by the screwdriver allows surgeons to target pedicles and insert the screw in one single instrument pass. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw through an MIS technique compared to traditional techniques.⁵ Additionally, the system’s streamlined instrument set means a smaller procedural footprint that also helps reduce waste, processing costs and environmental impact.⁶

CONCORDE Clear Discectomy Tool Removes Degenerated Disc in Under Four Minutes⁴
Disc removal in spinal fusion surgery requires the surgeon to work through a small surgical field with limited visualization. It also typically requires multiple instruments and instrument passes to make sure the disc is cleared and the endplates of the vertebrae are prepped for implants, which increases the risk of nerve root injury. The CONCORDE Clear Device is a single-use instrument that uses standard operating room suction to remove the degenerated disc and prepare the endplates, a simplified approach that is faster on average and results in a reduction in tool passes and instrument exchanges compared to traditional techniques.⁴*** A clear handle enables surgeons to visualize collection of disc material.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies****, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries. MEDOS INTERNATIONAL, SARL is the legal manufacturer of the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool.
**Compared to the VIPER® 2 MIS System
***Comparing CONCORDE Clear MIS Discectomy Tool vs. traditional discectomy tools
****The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.
DSUS/SPN/1017/1674 10/17

¹ Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567.
² Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.
³ Phillips F. M., Cheng I., Rampersaud Y. R., et al. Breaking through the ‘glass ceiling’ of minimally invasive spine surgery. Spine. 2016;41, S8:S39–S43.
⁴ Araghi, A. Novel Technologies for MIS Fusion Discectomy and Expandable Interbody. ISASS Boston September 18-20 2015.
⁵ Adaptiv #103327910 (Analysis 1): Percent Reduction in Time for the Viper Prime Technique Compared to the Traditional Jamshidi/Guidewire Technique.  Bench test results may not be indicative of clinical performance.
⁶ Earthwards Scorecard Results: VIPER PRIME System.

SOURCE DePuy Synthes

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