K2M Acquires Exclusive License to Comprehensive Patent Portfolio of Expandable Spinal Implants to Increase 3D-Printed Offerings

LEESBURG, Va., Aug. 03, 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 has acquired the exclusive license to a robust portfolio of 17 issued and pending patents for expandable interbody technology. The license is another example of K2M’s focus on being a market-leading innovator and provider of expandable solutions for a diverse range of TLIF, Lateral, PLIF, and other procedures. The licensed IP is expected to provide K2M’s interbody portfolio with expansion capabilities that exceed many expandable devices currently on the market.

K2M also announced its intent to integrate its 3D printing technology, Lamellar 3D Titanium Technology™, into new products developed with this intellectual property. This will further strengthen the Company’s leadership in the 3D printing of spinal devices. K2M was the first leading spine company to market a 3D-printed spinal implant and offers the most comprehensive portfolio of 3D-printed spinal devices on the market today. The Company’s 3D-printed portfolio currently extends across three product families and provides differentiated solutions to help achieve spinal balance in complex, minimally invasive, and degenerative spine procedures.

“We are excited to have obtained the exclusive rights to this intellectual property portfolio and look forward to integrating our 3D printing technology with new expandable spinal devices as part of our effort to build a comprehensive portfolio of industry-leading, 3D-printed solutions to address the full range of spinal pathologies,” said K2M President and CEO, Eric Major. “This strategic investment to enhance our intellectual property portfolio—coupled with our recent announcements around MOJAVE™ PL 3D Expandable, SAHARA® AL Expandable, and our Balance ACS™ platform—are key milestones to drive our strategy to be the technology and market leader in the next generation of 3D-printed expandables.”

K2M recently announced two additions to its expandable portfolio. K2M received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the MOJAVE PL 3D Expandable Interbody System, a first-to-market, 3D-printed, FDA-cleared expandable posterior-lumbar interbody system featuring K2M’s Lamellar 3D Titanium Technology.  The Company also introduced the SAHARA AL Expandable Stabilization System, the only lordotic expandable interbody device with integrated screw fixation on the market to help achieve spinal balance.

Balance ACS (BACS™) 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.

For more information on K2M, as well as its expandable and 3D-printed portfolios, visit www.K2M.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

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

Bone Biologics Announces Appointment of Bret Hankey to Company’s Board of Directors

August 03, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp. (OTCQB: BBLG) announced that Bret Hankey has joined the company’s board of directors. Mr. Hankey brings more than 15 years of operating and board director experience to the BBLG board.

Since 2000, Mr. Hankey, age 40, has served in various capacities within the Hankey Group where he currently serves as President and is a member of the board of directors on all major companies that comprise the Hankey Group.

Headquartered in Los Angeles, California, the Hankey Group is comprised of seven operating companies specializing primarily in the automotive, finance, technology, real estate and insurance industries. Since 2007, Mr. Hankey has also served in various capacities with Westlake Financial Services, a member of the Hankey Group, and is currently the Vice Chairman and Executive Vice President of Westlake Financial. Westlake Financial is the largest privately held automotive finance company in the United States. Mr. Hankey graduated from the University of Southern California in 2000 with a B.S. in Business Administration and Finance.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with the three founders and select strategic partners, building on unprecedented research on the Nell-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. Nell-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

About The Hankey Group

Headquartered in Los Angeles, California, the Hankey Group is comprised of seven operating companies specializing primarily in the automotive, finance, technology, real estate and insurance industries.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTCQB; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on May 12, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

TransEnterix Announces First Senhance U.S. Innovation Center at Florida Hospital Orlando

August 03, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that it has installed a Senhance Surgical Robot at the Institute for Surgical Advancement at Florida Hospital Orlando.

The Senhance Robot is placed under a collaboration agreement with Florida Hospital ISA. Nicholson Center Orlando will be used as a facility to perform pre-clinical training and procedural development in cooperation with surgical staff from Florida Hospital. Additionally, surgeons from around the world are participating in the robotic pre-clinical activities at the innovation center.

“The selection of a U.S. innovation center is a critical milestone in the global expansion of Senhance,” said Todd M. Pope, President and CEO at TransEnterix. “We are pleased to partner with a leading institution such as Florida Hospital Orlando and the clinicians at the Institute for Surgical Advancement. Together, we will continue to usher in an expansion in the use of robotics to advance minimally invasive surgery.”

“We have created a center for the interdisciplinary development of new surgical approaches utilizing the latest technology,” said Dr. Steve Eubanks, Surgeon and Executive Director for the Institute for Surgical Advancement. “Our team is excited to be the first U.S. center to explore the clinical and training pathway for this new surgical robotic platform, and to share these programs with surgeons from across the globe.”

About Florida Hospital Institute for Surgical Advancement

The Institute for Surgical Advancement was developed to facilitate the success of physicians who have the capabilities and desires to innovate academically and through procedural and instrumentation development. Through our various resources, we facilitate and assess the needs of our physicians to help develop advancements for patient care and innovate new surgical approaches. Combining physician experience with expertise in engineering improves the early phases of design and encourages the flow of ideas. We have various resources for this process, including the brainstorming room, our prototype lab, and Florida Hospital Nicholson Center, a world leader in surgical training. For more information, visit https://www.floridahospitalisa.com.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark, and is currently under FDA review for clearance in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

About Florida Hospital Nicholson Center

For over a decade, Florida Hospital Nicholson Center has trained more than 70,000 physicians from around the globe on leading-edge clinical and surgical techniques. Utilizing state-of-the-art surgical suites, and labs, plus advanced medical simulation robotics and learning centers, medical professionals can acquire and advance their skills in a highly collaborative surgical learning environment. For more information please visit NicholsonCenter.com.

Forward Looking Statements

This press release includes statements relating to the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the partnering between TransEnterix, Florida Hospital Orlando and the clinicians at the Institute for Surgical Advancement will continue to usher in an expansion in the use of robotics to advance miniminally invasive surgery . For a discussion of the risks and uncertainties associated with TransEnterix’ s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 7, 2017 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

MiMedx Initiates Phase 3 Plantar Fasciitis Clinical Trial

MARIETTA, Ga.Aug. 2, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has initiated its Phase 3 Plantar Fasciitis clinical study.

The Company submitted a formal Investigational New Drug (IND) amendment to the Food and Drug Administration (FDA) requesting the initiation of the Phase 3 trial based on the interim results of its IND Phase 2B trial for the treatment of Plantar Fasciitis. To date, the Company has received no comments or changes to the amendment filing or the Phase 3 protocol, and the Company is moving forward with the Phase 3 trial. MiMedx anticipates enrolling the first Phase 3 patient within the next 30 to 60 days.

The Phase 3 clinical study is a prospective, double-blinded, randomized controlled trial of AmnioFix Injectable as compared to a saline placebo injection in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month. The comparison group will be treated with a 0.9% Sodium Chloride USP placebo injection. Approximately 164 patients will be enrolled in the study with an estimated enrollment period of 18 months. The primary efficacy endpoint will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

MiMedx also reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time to discuss this study as well as the progress of the Company’s numerous other clinical studies in support of its Biopharmaceutical strategy. MiMedx executives “Pete” Petit, Chairman and CEO; Bill Taylor, President and COO; Debbie Dean, Executive Vice President; Chris Cashman, EVP and Chief Commercialization Officer; and Mark Landy, Vice President Strategic Initiatives, will be presenting during the August 7th call. Also present will be Donald Fetterolf, M.D., Chief Medical Officer; Thomas Koob, PhD, Chief Scientific Officer; and other members of MiMedx senior management.

The Company expects the planned presentations to last approximately 45 minutes. After the planned presentations, the call will be open for questions and answers. The subject matter, topics and updates to be covered during the formal presentations include:

  • Update of Biopharma Transition Activities
  • Initiation Status of Plantar Fasciitis IND Phase 3 Study
  • Update on Plantar Fasciitis IND Phase 2B Study
  • Upcoming Filings for Additional IND Clinical Studies
  • Plantar Fasciitis and Pain Management Commercial Update

A listen-only simulcast of the MiMedx August 7, 2017 shareholder call will be available on-line at the Company’s website at www.mimedx.com beginning at 2:00 p.m. eastern timeAugust 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company’s website at www.mimedx.com.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

K2M Group Holdings, Inc. Reports Second Quarter 2017 Financial Results; Reaffirms Fiscal Year 2017 Outlook

LEESBURG, Va., Aug. 01, 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 reported financial results for its second fiscal quarter ended June 30, 2017.

Second Quarter 2017 Financial Summary:

  • Total Q2 revenue of $65.7 million, up 10.9% year-over-year. Total Q2 revenue increased 11.6% year-over-year on a constant currency basis.
  • Domestic Q2 revenue of $50.8 million, up 12.2% year-over-year, comprised of:
    • U.S. Complex Spine growth of 9.7% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 25.4% year-over-year
    • U.S. Degenerative growth of 9.9% year-over-year.
  • International Q2 revenue of $14.9 million, up 6.6% year-over-year, or 9.3% on a constant currency basis.
  • Net loss of $9.1 million for the three months ended June 30, 2017, compared to a net loss of $11.1 million in the comparable period last year.
  • Adjusted EBITDA of $0.6 million for the three months ended June 30, 2017, compared to Adjusted EBITDA loss of $0.3 million in the comparable period last year.

 Recent Product Introductions:

  • On May 25, 2017, the Company announced the launch of the MESA 2 Cricket, an enhancement to the Company’s innovative MESA®2 Deformity Spinal System. The MESA 2 Cricket provides surgeons the ability to efficiently complete challenging correction maneuvers in all three anatomical planes, with the goal of achieving three-dimensional balance in patients with complex spinal deformities.
  • On June 20, 2017, the Company announced the introduction of the SAHARA® AL Expandable Stabilization System, the Company’s first expandable offering within its interbody portfolio. SAHARA AL is the only lordotic expandable interbody device with integrated screw fixation on the market to help achieve spinal balance.
  • On June 22, 2017, the Company announced that its MOJAVETM PL 3D Expandable Interbody System received 510(k) clearance from the U.S. Food & Drug Administration (FDA). MOJAVE PL 3D is a first-to-market, 3D-printed, FDA-cleared expandable posterior-lumbar (PL) interbody system that features K2M’s Lamellar 3D Titanium Technology.
  • On July 6, 2017, the Company announced that its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation, received 510(k) clearance from the FDA and a CE Mark. NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct.

Recent Strategic Highlights:

  • On April 6, 2017, K2M and LifeHealthcare Group Limited announced a new distribution agreement for K2M’s innovative spinal technologies in Australia and New Zealand (ANZ). The K2M/LifeHealthcare distribution partnership dates back to 2010 and has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.
  • On April 21, 2017, K2M received key product registrations in Japan from the Pharmaceuticals and Medical Devices Agency (PMDA), which are now under its control, including the MESA and EVEREST® product lines.
  • On May 1, 2017, the Company announced that they hosted more than 100 international spine surgeons from 22 countries for its annual Meeting of Minds™ in Lisbon, Portugal, from April 28-29, 2017. Meeting of Minds is a premier, world-class curriculum in the latest approaches and techniques for the operative treatment of spinal disorders. The Company also demonstrated its Balance ACS (or BACS) platform, which applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients.
  • On May 3, 2017, the Company announced participation at the 2017 combined meeting of The European Pediatric Orthopaedic Society and The Pediatric Orthopaedic Society of North America (EPOSNA) from May 3-6 in Barcelona, Spain. The Company showcased the Balance ACS and Three-Dimensional Total Body Balance and hosted a clinical symposium in 3D spinal solutions.
  • On July 10, 2017, the Company announced the signing of a new, long-term, exclusive agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. and a prominent supplier of medical devices in Japan, for the distribution of K2M’s innovative spinal technologies. Pursuant to the agreement, Japan Medicalnext is the exclusive distributor of K2M’s spine products in Japan. The terms of the agreement include a long-term partnership of up to seven years. With more than 250 employees—including 50 orthopedic sales professionals—in seven offices located throughout the country, Japan Medicalnext has significant experience in medical device distribution, including the Japanese spinal surgery market.

“Our second quarter product launches and strategic accomplishments reflect continued progress toward our strategic goals of introducing innovative spine surgery technologies, expanding our selling presence and improving our selling productivity which, together, help K2M to increase our share of the global spine market,” said President and Chief Executive Officer, Eric Major. “Revenue growth in the second quarter was driven by double-digit growth in the U.S. and high single-digit constant currency growth outside the U.S.  During the quarter, we also made progress toward achieving profitability, generating $0.6 million in Adjusted EBITDA, compared to an Adjusted EBITDA loss of $0.3 million last year. We have reaffirmed our full year financial outlook—including constant currency revenue growth of 12%-15% year-over-year and Adjusted EBITDA of $6 million to $10 million—and continue to expect improving results over the balance of 2017.”

Second Quarter 2017 Financial Results

Three Months Ended June 30, Increase / Decrease
2017 2016 $ Change % Change % Change
($ in thousands) (as reported) (constant currency)
United States $ 50,775 $ 45,238 $ 5,537 12.2 % 12.2 %
International 14,917 13,989 928 6.6 % 9.3 %
Total Revenue: $ 65,692 $ 59,227 $ 6,465 10.9 % 11.6 %

Total revenue for the second quarter of 2017 increased $6.5 million, or 10.9%, to $65.7 million, compared to $59.2 million for the second quarter of 2016. Total revenue increased 11.6% year-over-year on a constant currency basis. The increase in revenue was primarily driven by greater sales volume from primarily domestic new surgeon users and newer product offerings, offset primarily by customer declines and lower sales in certain international direct markets as compared to last year.

Revenue in the United States increased $5.5 million, or 12.2% year-over-year, to $50.8 million, and international revenue increased $0.9 million, or 6.6% year-over-year, to $14.9 million. Second quarter 2017 international revenue increased 9.3% year-over-year on a constant currency basis. Foreign currency exchange impacted second quarter international revenue by approximately $0.3 million, representing approximately 265 basis points of 2017 international growth year-over-year.

The following table represents domestic revenue by procedure category.

Three Months Ended June 30, Increase / Decrease
2017 2016 $ Change % Change
($ in thousands)
Complex Spine $ 20,342 $ 18,535 $ 1,807 9.7 %
Minimally Invasive 8,785 7,005 1,780 25.4 %
Degenerative 21,648 19,698 1,950 9.9 %
U.S. Revenue: $ 50,775 $ 45,238 $ 5,537 12.2 %

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 40.1%, 17.3% and 42.6% of U.S. revenue, respectively, for the three months ended June 30, 2017.

Gross profit for the second quarter of 2017 increased 9.0% to $43.2 million, compared to $39.6 million for the second quarter of 2016.  Gross margin was 65.7% for the second quarter of 2017, compared to 66.9% for the prior year period. Gross profit includes amortization expense on investments in surgical instruments of $3.6 million, or 5.5% of sales, for the three months ended June 30, 2017, compared to $3.4 million, or 5.8% of sales, for the comparable period last year.

Operating expenses for the second quarter of 2017 increased $2.4 million, or 4.9%, to $51.3 million, compared to $48.9 million for the second quarter of 2016. The increase in operating expenses was driven primarily by a $2.2 million increase in sales and marketing expenses, compared to the comparable period last year.

Loss from operations for the second quarter of 2017 improved $1.1 million, to $8.2 million, compared to a loss from operations of $9.3 million for the comparable period last year. Loss from operations included intangible amortization of $2.4 million and $2.6 million for the second quarters of 2017 and 2016, respectively.

Total other expenses for the second quarter of 2017 decreased $0.8 million to $0.9 million, compared to $1.7 million last year. The decrease in other expense, net, was primarily attributable to an increase of $1.8 million in unrealized gains from foreign currency remeasurement on intercompany payable balances, partially offset by an increase in interest expense of $1.0 million from the Convertible Senior Notes issued in August 2016.

Net loss for the second quarter of 2017 was $9.1 million, or $(0.21) per diluted share, compared to a loss of $11.1 million, or $(0.27) per diluted share, for the second quarter of 2016.

Six-Months 2017 Financial Results

Six Months Ended June 30, Increase / Decrease
2017 2016 $ Change % Change % Change
($ in thousands) (as reported) (constant currency)
United States $ 96,982 $ 87,431 $ 9,551 10.9 % 10.9 %
International 30,595 28,102 2,493 8.9 % 11.8 %
Total Revenue: $ 127,577 $ 115,533 $ 12,044 10.4 % 11.1 %

For the six months ended June 30, 2017, total revenue increased $12.1 million, or 10.4%, to $127.6 million, compared to $115.5 million for the six months ended June 30, 2016. Total revenue increased 11.1% year-over-year on a constant currency basis. U.S. revenue increased $9.6 million, or 10.9%, to $97.0 million for the first six months of 2017, compared to $87.4 million last year. International revenue increased $2.5 million, or 8.9%, to $30.6 million for the first six months of 2017, compared to $28.1 million last year. International revenue increased 11.8% year-over-year on a constant currency basis.

Six Months Ended June 30, Increase / Decrease
2017 2016 $ Change % Change
($ in thousands)
Complex Spine $ 37,478 $ 34,465 $ 3,013 8.7 %
Minimally Invasive 16,657 13,886 2,771 20.0 %
Degenerative 42,847 39,080 3,767 9.6 %
U.S. Revenue: $ 96,982 $ 87,431 $ 9,551 10.9 %

Sales in our complex spine, MIS and degenerative categories represented 38.6%, 17.2% and 44.2% of U.S. revenue, respectively, for the first six months of 2017.

As of June 30, 2017, we had cash and cash equivalents of $36.5 million as compared to $45.5 million as of December 31, 2016. We had working capital of $111.3 million as of June 30, 2017 as compared to $115.9 million as of December 31, 2016.

At June 30, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $38.0 million and the capital lease obligation of $34.4 million. The Company had no borrowings outstanding on the revolving credit facility as of June 30, 2017.

2017 Outlook

The Company is reaffirming its fiscal year 2017 guidance expectations. The Company continues to expect:

  • Total revenue on an as reported basis in the range of $263.0 million to $270.0 million, representing growth of 11% to 14% year-over-year, compared to total revenue of $236.6 million in fiscal year 2016.
  • Total revenue on a constant currency basis is expected to increase 12% to 15% year-over-year in 2017.
  • The Company continues to expect mid-teens growth in its U.S. business in 2017.
  • The Company now expects mid-single-digit growth in its International business in 2017, compared to an expectation of low single-digit growth previously.
  • Total net loss of approximately $34.0 million to $31.0 million, compared to a total net loss of $41.7 million in fiscal year 2016.
  • Adjusted EBITDA in a range of $6.0 million to $10.0 million, compared to Adjusted EBITDA of $0.6 million in fiscal year 2016.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on August 1st to discuss the results of the second quarter, and to host a question and answer session. Those who would like to participate may dial 888-505-4378 (719-457-1513 for international callers) and provide access code 1117408 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 1117408. The webcast will be archived on the investor relations section of the Company’s website.

About K2M Group Holdings, Inc.

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

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, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
June 30, December 31,
2017 2016
ASSETS    
Current assets:    
Cash and cash equivalents $ 36,546 $ 45,511
Accounts receivable, net 50,092 46,430
Inventory, net 66,751 61,897
Prepaid expenses and other current assets 7,039 6,147
Total current assets 160,428 159,985
Property, plant and equipment, net 50,938 50,714
Goodwill 121,814 121,814
Intangible assets, net 18,076 22,758
Other assets, net 30,725 28,254
Total assets $ 381,981 $ 383,525
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current maturities under capital lease obligation $ 1,046 $ 973
Accounts payable 21,708 15,367
Accrued expenses 16,339 15,673
Accrued payroll liabilities 10,001 12,068
Total current liabilities 49,094 44,081
Convertible senior notes 38,003 36,894
Capital lease obligation, net of current maturities 34,392 34,933
Deferred income taxes, net 5,017 5,017
Other liabilities 1,069 1,032
Total liabilities 127,575 121,957
Stockholders’ equity:
Common stock, $0.001 par value, 750,000,000 shares authorized; 43,277,400 and
42,291,352 shares issued and 43,268,789 and 42,282,741 shares outstanding, respectively
43 42
Additional paid-in capital 485,713 474,512
Accumulated deficit (231,013 ) (211,081 )
Accumulated other comprehensive loss (203 ) (1,771 )
Treasury stock, at cost, 8,611 and 8,611 shares, respectively (134 ) (134 )
Total stockholders’ equity 254,406 261,568
Total liabilities and stockholders’ equity $ 381,981 $ 383,525
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Revenue $ 65,692 $ 59,227 $ 127,577 $ 115,533
Cost of revenue 22,522 19,631 44,001 39,235
Gross profit 43,170 39,596 83,576 76,298
Operating expenses:
Research and development 5,560 5,762 10,810 10,790
Sales and marketing 31,242 28,993 61,716 56,748
General and administrative 14,524 14,183 28,278 28,031
Total operating expenses 51,326 48,938 100,804 95,569
Loss from operations (8,156 ) (9,342 ) (17,228 ) (19,271 )
Other expense, net:
Foreign currency transaction gain (loss) 874   (972 ) 847 (552 )
Interest expense (1,731 )   (735 ) (3,463 ) (1,386 )
Total other expense, net (857 )   (1,707 ) (2,616 ) (1,938 )
Loss before income taxes (9,013 ) (11,049 ) (19,844 ) (21,209 )
Income tax expense 46 49 88 74
Net loss $ (9,059 ) $ (11,098 ) $ (19,932 ) $ (21,283 )
Basic and diluted $ (0.21 ) $ (0.27 ) $ (0.47 ) $ (0.51 )
Weighted average shares outstanding:
Basic and diluted 42,641,585 41,622,027 42,434,311 41,487,575
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 (In Thousands)
Six Months Ended June 30,
2017 2016
Operating activities
Net loss $ (19,932 ) $ (21,283 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 14,614 14,037
Provision for inventory reserves 2,192 1,876
Provision for allowance for doubtful accounts 50 (29 )
Stock-based compensation expense 2,880 3,855
Accretion of discounts and amortization of issuance costs of convertible senior notes 1,109
Other 3
Changes in operating assets and liabilities:
Accounts receivable (2,924 ) (7,733 )
Inventory (3,523 ) (7,254 )
Prepaid expenses and other assets (5,583 ) (5,796 )
Accounts payable, accrued expenses, and accrued payroll liabilities 2,929 6,270
Net cash used in operating activities (8,185 ) (16,057 )
Investing activities
Purchase of surgical instruments (6,442 ) (7,812 )
Purchase of property, plant and equipment (2,571 ) (14,275 )
Changes in cash restricted for leasehold improvements 61 4,449
Purchase of intangible assets (50 ) (1,282 )
Net cash used in investing activities (9,002 ) (18,920 )
Financing activities
Borrowings on bank line of credit 19,500
Principal payments under capital lease (469 )
Issuances and exercise of stock-based compensation benefit plans, net of income tax 8,322 876
Net cash provided by financing activities 7,853 20,376
Effect of exchange rate changes on cash and cash equivalents 369 (209 )
Net decrease in cash and cash equivalents (8,965 ) (14,810 )
Cash and cash equivalents at beginning of period 45,511 34,646
Cash and cash equivalents at end of period $ 36,546 $ 19,836
Significant non-cash investing activities
Leasehold improvements under capital lease $ $ 2,603
Additions to property, plant and equipment $ 500
Cash paid for:
Income taxes $ 131 $ 175
Interest $ 1,124 $ 171

K2M GROUP HOLDINGS, INC.
Reconciliation of GAAP to Non-GAAP Measures
(Unaudited)
 (In Thousands)

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measures of revenue in constant currency, Adjusted Gross Profit, and Adjusted EBITDA.

The Company presents these non-GAAP measures because it believes these measures are useful indicators of the Company’s operating performance.  Management uses these non-GAAP measures principally as a measure of the Company’s operating performance and believes that these measures are useful to investors because they are frequently used by analysts, investors and other interested parties to evaluate companies in the Company’s industry.  The Company also believes that these measures are useful to its management and investors as a measure of comparative operating performance from period to period.

Constant currency information compares results between periods as if exchange rates had remained constant period-to-period.  We calculate constant currency by converting the prior-year results using current-year foreign currency exchange rates.

Adjusted Gross Profit represents Gross Profit less amortization expense of surgical instruments.  The Company presented Adjusted Gross Profit because it believes it is a useful measure of the Company’s gross profit and operating performance because the measure is not burdened by the timing impact of instrument purchases and related amortization.

Adjusted EBITDA represents net loss plus interest expense, income tax expense, depreciation and amortization, stock-based compensation expense and foreign currency transaction (gain) loss.

The Company presents Adjusted EBITDA because it believes it is a useful indicator of the Company’s operating performance.  Management uses Adjusted EBITDA principally as a measure of the Company’s operating performance and for planning purposes, including the preparation of the Company’s annual operating budget and financial projections.

Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to net loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP and it should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items.  In addition, Adjusted EBITDA is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as tax payments, debt service requirements, capital expenditures and certain other cash costs that may recur in the future.  Adjusted EBITDA contains certain other limitations, including the failure to reflect the Company’s cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized.  In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments in this presentation.  The Company’s presentation of Adjusted EBITDA should not be construed to imply that the Company’s future results will be unaffected by any such adjustments.  Management compensates for these limitations by primarily relying on its GAAP results in addition to using Adjusted EBITDA supplementally.  The Company’s definition of Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

The following table presents reconciliations of gross profit to adjusted gross profit and net loss to Adjusted EBITDA for the periods presented.

Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Reconciliation from Gross Profit to Adjusted Gross Profit
Gross profit $ 43,170 $ 39,596 $ 83,576 $ 76,298
Surgical instrument amortization 3,605 3,425 7,069 6,697
Adjusted gross profit (a Non-GAAP Measure) $ 46,775 $ 43,021 $ 90,645 $ 82,995
Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Reconciliations from Net Loss to Adjusted EBITDA
Net loss $ (9,059 ) $ (11,098 ) $ (19,932 ) $ (21,283 )
Interest expense 1,731 735 3,463 1,386
Income tax expense 46 49 88 74
Depreciation and amortization 7,419 7,294 14,614 14,037
Stock-based compensation expense 1,339 1,749 2,880 3,855
Foreign currency transaction (gain) loss (874 ) 972 (847 ) 552
Adjusted EBITDA (a Non-GAAP Measure) $ 602 $ (299 ) $ 266 $ (1,379 )

The following table presents a reconciliation of net loss to Adjusted EBITDA for our 2017 guidance:

Year Ended
December 31,
2017
Net loss $ (32,450 )
Interest expense 6,700
Income tax expense 100
Depreciation and amortization 27,500
Stock-based compensation expense 6,150
Foreign currency transaction loss
Adjusted EBITDA $ 8,000

The reconciliation assumes the mid-point of the Adjusted EBITDA range and the mid-point of each component of the reconciliation, corresponding to guidance of $6.0 million to $10.0 million for 2017.

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

Globus Medical Reports Second Quarter 2017 Results

AUDUBON, Pa., Aug. 02, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions manufacturer, today announced its financial results for the second quarter ended June 30, 2017.

  • Worldwide sales were $152.4 million, an increase of 10.8% as reported, or 11.0% in constant currency
  • Second quarter net income was $28.7 million, or 18.8% of sales
  • Diluted earnings per share (EPS) were $0.29
  • Non-GAAP diluted EPS were $0.32
  • Non-GAAP adjusted EBITDA was 35.1% of sales

David Paul, Chairman and CEO said, “Our worldwide sales for the second quarter were $152.4 million, an increase of 10.8% over the second quarter of 2016.  Our adjusted EBITDA margins remained at an outstanding 35.1% and we also delivered non-GAAP EPS of $0.32.

“We are pleased with our performance during the second quarter.  We made significant progress with competitive rep hiring, further expanded our in-house manufacturing capacity, and continued to run an extremely efficient organization with best in class adjusted EBITDA margins.  During the quarter we completed the acquisition of KB Medical, an innovative robotics company out of Switzerland. This acquisition significantly bolsters our development team, intellectual property, and product portfolio. KB Medical has a tremendous team of innovative developers that share our philosophy, approach, and strategy for robotic solutions in medicine.  We remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”

Second quarter sales in the U.S. increased by 1.2% compared to the second quarter of 2016.  International sales increased by 104.5% over the second quarter of 2016 on an as reported basis and 106.6% on a constant currency basis due to the Alphatec acquisition included in the second quarter of 2017.  Sales from the Alphatec acquisition contributed $15.5 million in the quarter.

Second quarter GAAP net income was $28.7 million, an increase of 11.1% over the same period last year.  Diluted EPS for the second quarter was $0.29, as compared to $0.27 for the second quarter 2016.  Non-GAAP diluted EPS for the second quarter was $0.32, compared to $0.29 in the second quarter of 2016.

The company generated net cash provided by operating activities of $26.0 million and non-GAAP free cash flow of $12.4 million in the second quarter.  Cash, cash equivalents and marketable securities ended the quarter at $373.1 million.  The company remains debt free.

2017 Annual Guidance
The company reaffirms guidance for full year 2017 sales of $625 million and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 second quarter results with the investment community at 5:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, August 9, 2017.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 1012-6289.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provision for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs represents the change in fair value of business-acquisition-related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition- related professional fees.

In addition, for the period ended June 30, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs and the tax effects of such adjustments.  The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended June 30, 2017 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall liquidity for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP within the meaning of Item 10(e) of Regulation S-K.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended Six Months Ended
(In thousands, except per share amounts) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Sales $ 152,390 $ 137,489 $ 308,199 $ 276,753
Cost of goods sold 37,199 32,731 72,799 64,250
Gross profit 115,191 104,758 235,400 212,503
Operating expenses:
Research and development 10,713 10,594 21,379 20,624
Selling, general and administrative 64,438 53,312 131,497 107,110
Provision for litigation 243 3,056 243 3,056
Amortization of intangibles 1,809 397 3,591 789
Acquisition related costs 617 (519 ) 1,005 155
Total operating expenses 77,820 66,840 157,715 131,734
Operating income 37,371 37,918 77,685 80,769
Other income, net 2,186 418 4,286 1,178
Income before income taxes 39,557 38,336 81,971 81,947
Income tax provision 10,890 12,530 24,590 28,131
Net income $ 28,667 $ 25,806 $ 57,381 $ 53,816
Earnings per share:
Basic $ 0.30 $ 0.27 $ 0.60 $ 0.56
Diluted $ 0.29 $ 0.27 $ 0.59 $ 0.56
Weighted average shares outstanding:
Basic 96,161 95,585 96,079 95,491
Diluted 97,818 96,426 97,483 96,359
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value) June 30,
2017
December 31,
2016
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 149,669 $ 132,639
Restricted cash 478 477
Short-term marketable securities 162,520 157,673
Accounts receivable, net of allowances of $3,645 and $2,771, respectively 95,489 91,983
Inventories 111,108 112,692
Prepaid expenses and other current assets 5,879 14,502
Income taxes receivable 9,986 3,800
Total current assets 535,129 513,766
Property and equipment, net of accumulated depreciation of $181,223 and $166,711, respectively 130,123 124,229
Long-term marketable securities 60,932 60,444
Note receivable 30,000 30,000
Intangible assets, net 90,036 61,706
Goodwill 112,769 105,926
Other assets 1,051 928
Deferred income taxes 34,974 30,638
Total assets $ 995,014 $ 927,637
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 16,291 $ 17,472
Accrued expenses 41,707 46,401
Income taxes payable 1,400 1,911
Business acquisition liabilities, current 9,663 14,108
Total current liabilities 69,061 79,892
Business acquisition liabilities, net of current portion 10,676 5,972
Deferred income taxes 8,175 7,876
Other liabilities 1,802 1,819
Total liabilities 89,714 95,559
Commitments and contingencies
Equity:
Common stock; $0.001 par value.  Authorized 785,000 shares; issued
  and outstanding 96,289 and 95,930 shares at June 30, 2017 and December 31, 2016, respectively 96 96
Additional paid-in capital 224,796 211,725
Accumulated other comprehensive loss (5,872 ) (8,642 )
Retained earnings 686,280 628,899
Total equity 905,300 832,078
Total liabilities and equity $ 995,014 $ 927,637
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended
(In thousands) June 30,
2017
June 30,
2016
Cash flows from operating activities:
Net income $ 57,381 $ 53,816
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 22,935 13,698
Amortization of premium on marketable securities 1,855 2,085
Write-down for excess and obsolete inventories 4,962 4,536
Stock-based compensation expense 7,062 5,690
Allowance for doubtful accounts 958 148
Change in fair value of contingent consideration 811
Change in deferred income taxes (4,238 ) 1,625
(Increase)/decrease in:
Restricted cash (1 ) 14,884
Accounts receivable (3,172 ) 2,624
Inventories (4,652 ) (3,812 )
Prepaid expenses and other assets 8,506 1,114
Increase/(decrease) in:
Accounts payable (1,660 ) (1,707 )
Accrued expenses and other liabilities (4,497 ) (10,078 )
Income taxes payable/receivable (6,825 ) (5,796 )
Net cash provided by operating activities 79,425 78,827
Cash flows from investing activities:
Purchases of marketable securities (119,196 ) (172,886 )
Maturities of marketable securities 102,733 129,495
Sales of marketable securities 9,503 16,602
Purchases of property and equipment (25,061 ) (20,142 )
Acquisition of businesses (31,501 )
Net cash used in investing activities (63,522 ) (46,931 )
Cash flows from financing activities:
Payment of business acquisition liabilities (5,234 ) (400 )
Proceeds from exercise of stock options 5,911 3,575
Net cash provided by financing activities 677 3,175
Effect of foreign exchange rate on cash 450 119
Net increase in cash and cash equivalents 17,030 35,190
Cash and cash equivalents, beginning of period 132,639 60,152
Cash and cash equivalents, end of period $ 149,669 $ 95,342
Supplemental disclosures of cash flow information:
Interest paid 21 2
Income taxes paid $ 35,475 $ 32,214
Supplemental Financial Information
Sales by Geographic Area:
(Unaudited)   Three Months Ended Six Months Ended
(In thousands) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
United States $ 126,271 $ 124,716 $ 255,934 $ 252,276
International 26,119 12,773 52,265 24,477
Total sales $ 152,390 $ 137,489 $ 308,199 $ 276,753
Sales by Product Category:
(Unaudited)   Three Months Ended Six Months Ended
(In thousands) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Innovative Fusion $ 79,866 $ 69,442 $ 161,738 $ 139,488
Disruptive Technology 72,524 68,047 146,461 137,265
Total sales $ 152,390 $ 137,489 $ 308,199 $ 276,753
Liquidity and Capital Resources:
(Unaudited) June 30,
2017
December 31,
2016
(In thousands)
Cash and cash equivalents $ 149,669 $ 132,639
Short-term marketable securities 162,520 157,673
Long-term marketable securities 60,932 60,444
Total cash, cash equivalents and marketable securities $ 373,121 $ 350,756
Available borrowing capacity under revolving credit facility 50,000 50,000
Working capital $ 466,068 $ 433,874

The following tables reconcile GAAP to Non-GAAP financial measures.

Non-GAAP Adjusted EBITDA Reconciliation Table:
(Unaudited) Three Months Ended Six Months Ended
(In thousands, except percentages) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Net income $ 28,667 $ 25,806 $ 57,381 $ 53,816
Interest income, net (1,590 ) (602 ) (3,008 ) (1,098 )
Provision for income taxes 10,890 12,530 24,590 28,131
Depreciation and amortization 10,695 7,022 22,935 13,698
EBITDA 48,662 44,756 101,898 94,547
Provision for litigation 243 3,056 243 3,056
Stock-based compensation expense 3,571 2,920 7,062 5,690
Acquisition related costs 968 (519 ) 2,054 155
Adjusted EBITDA $ 53,444 $ 50,213 $ 111,257 $ 103,448
Net income as a percentage of sales 18.8 % 18.8 % 18.6 % 19.4 %
Adjusted EBITDA as a percentage of sales 35.1 % 36.5 % 36.1 % 37.4 %
Non-GAAP Net Income Reconciliation Table:
(Unaudited) Three Months Ended Six Months Ended
(In thousands) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Net income $ 28,667 $ 25,806 $ 57,381 $ 53,816
Provision for litigation 243 3,056 243 3,056
Amortization of intangibles 1,809 397 3,591 789
Acquisition related costs 968 (519 ) 2,054 155
Tax effect of adjusting items (840 ) (990 ) (1,766 ) (1,372 )
Non-GAAP net income $ 30,847 $ 27,750 $ 61,503 $ 56,444
Non-GAAP Diluted Earnings Per Share Reconciliation Table:
(Unaudited) Three Months Ended Six Months Ended
(Per share amounts) June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Diluted earnings per share, as reported $ 0.29 $ 0.27 $ 0.59 $ 0.56
Provision for litigation 0.03 0.03
Amortization of intangibles 0.02 0.04 0.01
Acquisition related costs 0.01 (0.01 ) 0.02
Tax effect of adjusting items (0.01 ) (0.01 ) (0.02 ) (0.01 )
Non-GAAP diluted earnings per share* $ 0.32 $ 0.29 $ 0.63 $ 0.59
* amounts might not add due to rounding
Non-GAAP Free Cash Flow Reconciliation Table:
(Unaudited) Three Months Ended Six Months Ended
(In thousands)   June 30,
2017
June 30,
2016
June 30,
2017
June 30,
2016
Net cash provided by operating activities $ 25,976 $ 23,270 $ 79,425 $ 78,827
Adjustment for impact of restricted cash 1 784 1 (14,884 )
Purchases of property and equipment (13,528 ) (10,776 ) (25,061 ) (20,142 )
Non-GAAP free cash flow $ 12,449 $ 13,278 $ 54,365 $ 43,801
Non-GAAP Constant Currency Sales Growth Comparative Table:
(Unaudited) Three Months Ended Reported
Growth
Currency
Impact on
Current Period
Constant
Currency
Growth
(In thousands, except percentages) June 30,
2017
June 30,
2016
United States $ 126,271 $ 124,716 1.2 % 1.2 %
International 26,119 12,773 104.5 % $ (275 ) 106.6 %
Total sales $ 152,390 $ 137,489 10.8 % $ (275 ) 11.0 %
(Unaudited) Six Months Ended Reported
Growth
Currency
Impact on
Current Period
Constant
Currency
Growth
(In thousands, except percentages) June 30,
2017
June 30,
2016
United States $ 255,934 $ 252,276 1.4 % 1.4 %
International 52,265 24,477 113.5 % $ (639 ) 116.1 %
Total sales $ 308,199 $ 276,753 11.4 % $ (639 ) 11.6 %
Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

First Surgical Implantation of ZIP ULTRA® MIS Interspinous Device Performed in Argentina

CARLSBAD, Calif., Aug. 02, 2017 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) announced today the first surgical implantation of the company’s ZIP ULTRA® minimally invasive interspinous device in Latin America in Buenos Aires, Argentina. This surgery is part of Aurora Spine’s efforts to expand the use of its ZIP® MIS Fusion System worldwide. The surgery was performed at the Clinique Hospital San Miguel Arcangel by the surgeon team of Prof. Santiago Cerneaz and Dr. Guillermo Segvic.

“The ZIP ULTRA MIS fusion system is a very intuitive and easy to use system that allows me to perform a short and safe surgery while avoiding the risk of nerve impact,” said Prof. Cerneaz and Dr. Segvic. “The instrumentation is very intuitive and the implantation is fast and simple via a small incision.”

“We are very excited to now offer our ZIP MIS product portfolio in Argentina,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine. The ZIP family of products is designed to be simple, safe and secure and we are convinced it will improve patient outcomes in Argentina.”

“Aurora is changing spine surgery,” said Trent Northcutt, President and CEO of Aurora Spine. “The combination of the proven ONE-STEP™ locking mechanism and our minimally invasive design allows patients in Latin America to receive the Screwless Procedure™ as an alternative to pedicle screws.”

Aurora Spine’s ZIP ULTRA MIS interspinous fixation implant for spinal fusion consists of a ONE-STEP™ locking mechanism, which eliminates the use of a set screw, articulating spikes and comes in various sizes to accommodate variations in patient anatomy.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

CONTACT INFORMATION

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

Globus Medical Announces Acquisition of Robotics Developer KB Medical

AUDUBON, Pa., Aug. 02, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (GMED), a leading musculoskeletal solutions manufacturer, today announced that the acquisition of KB Medical, SA, a robotic developer based in Lausanne, Switzerland, closed during the second quarter of 2017.

“The acquisition of KB Medical demonstrates Globus Medical’s continued commitment and enthusiasm for the potential impact of robotic technology on surgery,” said Dave Demski, President, Emerging Technologies. “The addition of KB Medical will enable Globus Medical to accelerate, enhance and expand our product portfolio in Imaging, Navigation and Robotics. KB Medical’s experienced team of technology development professionals, its strong IP portfolio, and shared philosophy for robotic solutions in medicine strengthen Globus Medical’s position in this strategic area.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

SI-BONE, Minimally Invasive SI Joint Fusion using the iFuse Implant System® Maintains Exclusive Coverage with BCBS of IL, MT,NM,OK,TX

SAN JOSE, Calif.Aug. 2, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC) and its divisions of Blue Cross and Blue Shield® (BCBS) in IllinoisMontanaNew MexicoOklahoma, and Texas have updated their coverage policy for MIS SI joint fusion and maintained their exclusive positive coverage for the iFuse Implant System.  The updated policy, which took effect July 15th, 2017, includes additional iFuse Implant System clinical publications and can be found at the link below.

 http://www.medicalpolicy.hcsc.net/medicalpolicy/activePolicyPage?lid=j4cm155u&corpEntCd=IL1

The policy specifically states that “use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFuse Implant System) is considered experimental, investigational and/or unproven.”  In other words, only the iFuse Implant System is considered a proven MIS SI joint fusion procedure and is covered by the policy.

Blue Cross and Blue Shield® (BCBS) plans of IllinoisMontanaNew MexicoOklahoma and Texas, under the umbrella of HCSC, is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, covering approximately 15 million lives. The iFuse exclusive positive coverage policy, which originally became effective January 1, 2017, is based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse ImplantsTM for SI joint fusion.  The policy has been further strengthened with additional iFuse Implant publications demonstrating the safety and effectiveness of the iFuse ProcedureTM.  The BCBS plans in IllinoisMontanaNew MexicoOklahoma and Texas join SelectHealth in Utah and Geisinger in Pennsylvania as a growing number of commercial health plans to offer exclusive positive coverage for the iFuse Implant System.

Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: “this exclusive coverage policy update by the five Blue Cross and Blue Shield plans in IllinoisOklahomaNew MexicoMontana and my home state of Texas further validates the strength of the clinical evidence supporting the iFuse Implant System as the only minimally invasive SI joint fusion device with appropriate and sufficient data to support coverage.”

About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5  Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.

SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it.  While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test.  The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.

About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint’s unique motion of nutation.  The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth6, facilitating long-term fusion of the joint.  The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.

The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9954.080217

1.

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.

2.

Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.

3.

Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.

4.

Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

5.

DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

6.

MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Titan Spine Continues Strong Sales Performance with 49% YOY Growth Rate at Mid-Year 2017

August 02, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it continues its strong revenue acceleration for the second quarter of 2017, driven by the increasing demand for the Company’s nanoLOCK® surface technology. nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1

The company reports the following for the second quarter:

  • Surpassed 50,000 implantations of its Endoskeleton® interbody fusion devices since inception
  • nanoLOCK® sales volume has increased by 42% since the close of the first quarter
  • nanoLOCK® has been utilized to date by 150 surgeons in 98 hospitals
  • Achieved 2,500 implantations of nanoLOCK® since launch

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Following a record first quarter, we continued to exceed expectations during the second quarter for a strong close to the mid-2017 mark. The significant demand for nanoLOCK® is a direct reflection of our expanded sales team’s ability to reach more surgeons and surgeons’ recognition of the advantages our surface technology provides at the nano-cellular level for helping patients heal faster following spine fusion surgery. In fact, we have more than doubled the number of surgeon customers using nanoLOCK in the second quarter compared to the first. We are pleased that our second quarter achievements demonstrate a growing confidence and continued adoption of nanoLOCK®.”

Steve Cichy, Executive Vice President of Sales of Titan Spine, added, “The demand for nanoLOCK® has certainly fueled our significant sales growth over the first half of this year. We have recently invested significant capital to beef up our instrument set and implant inventory to meet this growing demand, which will start to pay dividends over the remainder of the year and beyond.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

nanoLOCK® named the winner of Back Pain Centers of America’s 2017 Awards of Excellence for the Technology Innovation Award

1 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com