LEESBURG, Va., July 17, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark for its CAYMAN^® United Plate System following completion of its first surgical cases. CAYMAN United is designed for rigid fixation to K2M’s CASCADIA^™ Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology^™, the first and only 3D-printed cage with modular fixation capabilities. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.

“The CAYMAN United Plate System, which firmly fixates to K2M’s CASCADIA Lateral 3D implants, is a notable advancement,” said Robert Lee, FRCS (Tr&Orth), a spine surgeon at Royal National Orthopaedic Hospital NHS Trust in Stanmore, UK. “Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilizing a 3D-printed device to encourage bony integration throughout the implant.”

The CAYMAN United Plate System’s single level, 1- and 2- hole plate configurations precisely match all CASCADIA Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach. Single-level plate sizes minimize retraction required for placement and an assembly alignment feature keys into the CASCADIA implants to resist rotation. Versatile insertion options allow for plate assembly with a central assembly screw prior to implantation, or in-situ after the cage has been placed.

“We are excited to receive FDA clearance and a CE Mark for our CAYMAN United Plate System, designed to enhance our CASCADIA Lateral 3D Interbody System and making it the first and only 3D-printed cage available on the market with modular fixation capabilities,” said K2M Chairman, President, and CEO, Eric Major. “As a leading innovator of 3D-printed spinal solutions, we remain committed to developing advanced technologies that when complemented by our comprehensive Balance ACS platform, help surgeons facilitate 3D spinal balance in their patients.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the CASCADIA implants are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity.

Balance ACS^® (or BACS^®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information on the CASCADIA Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology and the CAYMAN United Plate System, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. 

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use 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 payers; 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 maintain adequate working relationships with healthcare professionals; 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 to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; 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 remediate the material weaknesses in our IT general controls; 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 associated with the exit of the United Kingdom from the European Union; 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 a fiscal 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; 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; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; 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.

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

July 10, 2018

CARLSBAD, Calif., July 09, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today the 100^th surgical implantation of the company’s ZIP ULTRA® minimally invasive interspinous device in Canada. These surgeries are part of Aurora Spine’s continuing efforts to expand the use of the Company’s ZIP® MIS Fusion System in North America.

The 100^th surgery was completed with a ZIP implant provided by Venture Medical, Ltd. and performed at False Creek Healthcare Centre in Vancouver, BC by Navraj Heran, MD, the center’s Chief of Neurosurgery.

“The Aurora Spine 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 Dr. Heran. “The ZIP device is minimally invasive and the implantation is fast and simple via a small incision.”

“We are very excited to continue offering our ZIP MIS products in Canada,” said Laszlo Garamszegi, Chief Technology Officer and VP of Engineering of Aurora Spine. “The ZIP family of products is designed to be simple, safe and secure with minimal disruption to patients and we are convinced that ZIP implants will contribute to improved patient outcomes in Canada.”

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

“We are passionate about delivering innovative, first-class products like the ZIP spinal implant to the Canadian market,” said Chris Walsh, President and CEO of Venture Medical, Ltd. “The ZIP implant device is proven to be one of the most significant, minimally invasive technology solutions in the Canadian healthcare market.”

About Dr. Heran

Dr. Navraj Heran is a locally raised and practicing neurosurgeon maintaining a very active neurosurgical profile at several hospitals in the Greater Vancouver area including Royal Columbian Hospital, Eagle Ridge Hospital and Lion’s Gate Hospital. He is specialized in minimal access techniques in neurospine, neurosurgery and endovascular neurosurgery.

About False Creek Healthcare Centre

False Creek Healthcare Centre in Vancouver, BC was founded in 1996 and has grown to become one of Canada’s most renowned independent health providers. This state-of-the-art centre is more than just a medical clinic; it offers world-class service to individuals seeking immediate access to high quality medical care in Canada, utilizing the most advanced technology and techniques available.  Learn more about False Creek Healthcare Centre at their website: https://www.centrichealthsurgical.com/location/vancouver

About the ZIP Implant

“The combination of the proven ONE-STEP™ locking mechanism and our minimally invasive design allows patients in Canada to receive a screwless fusion treatment as a pedicle screw alternative,” said Trent Northcutt, President and CEO of Aurora Spine.

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

CENTER VALLEY, Pa., July 3, 2018 /PRNewswire/ — Aesculap Implant Systems, LLC today announced that UnitedHealthcare^® has issued a new, positive medical policy for Lumbar Total Disc Replacement (TDR). UnitedHealthcare will cover Lumbar TDR for single-level degenerative disc disease. This change means that millions of patients in virtually every state in the country will now have access to the procedure, taking total commercial insurance coverage in the United States to almost 65 percent.

“I like to think my case was part of the change,” said recent activL^® Artificial Disc patient and UnitedHealthcare customer Carrie Guthrie, now of Washington state, who had her Lumbar TDR procedure in Atlanta with Dr. Tapan Daftari of the Resurgens group. Guthrie, who invested in the three-month external appeal process to fight UnitedHealthcare’s denial of her case, is now living pain free. “When the activL Patient Assistance Line helped to get the approval of the Lumbar Disc Replacement, I could not have predicted how the surgery would alter my life,” said Guthrie. “Living with severe daily pain year after year had changed my perception of life; it had dulled my ability to enjoy anything.”

Guthrie gained access to the activL Artificial Disc by leveraging her external review rights as afforded to her by the Affordable Care Act. By exercising her rights to the external review process, UnitedHealthcare had to send her case to an independent third party to determine if her case was medically necessary. Stakeholders believe that cases like Guthrie’s were an essential factor in UnitedHealthcare’s decision to overturn their negative policy.

“We are thankful for patients like Carrie Guthrie who are willing to put the evidence in front of non-covering payers and help them understand why Lumbar TDR should be an option,” said Kim Norton, who leads Aesculap’s payer policy and reimbursement efforts. “UnitedHealthcare will begin covering because patients have helped them to see that there is a demand for this procedure, and the patients do well after receiving it,” continued Norton.

“We invested in a comprehensive evidence development and payer policy strategy at Aesculap because we know how strong our long-term activL Artificial Disc outcomes are. We saw the unmet need, and we wanted to focus our resources on important initiatives like helping patients with Degenerative Disc Disease,” said Chuck DiNardo, President of Aesculap Implant Systems. “We all knew that with the evidence and through the work of our Patient Assistance Line, US payers would want to extend access to Lumbar TDR to their customers, our patients. We are pleased that payers are giving the data consideration.”

This announcement comes weeks after the US Military’s TRICARE health plan also announced coverage and after numerous BlueCross BlueShield plans have decided to cover. The remaining patients with non-covering health plans include primarily a few BlueCross BlueShield plans, as well as Aetna, a large national insurer which had a positive coverage policy for Lumbar TDR and dissolved it as part of a merger with a different plan in 2012.

The activL Artificial Disc is a third generation motion preservation device designed to more closely mimic the natural biomechanics of the healthy human spine, thereby significantly reducing the impact on adjacent level anatomy. The five-year clinical outcomes were recently presented at the North American Spine Society (Orlando, FL, October 25-28, 2017) meeting and will be presented at EuroSpine 2018 (Barcelona, Spain, September 19-21, 2018). The radiographic outcomes were published in Spine(https://journals.lww.com/spinejournal/Abstract/publishahead/Progression_of_Adjacent_level_Degeneration_After.95075.aspx).

If you are a Degenerative Disc Disease sufferer interested in understanding your spinal fusion alternative options or if you need help navigating the Lumbar TDR insurance landscape, visit https://www.soactivesofast.com/low-back/activl-artificial-disc or call 1-844-245-1140.

About Aesculap Implant Systems, LLC

Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

SOURCE Aesculap Implant Systems, LLC

Related Links

http://www.aesculapimplantsystems.com

CARLSBAD, Calif., July 02, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has appointed Dennis L. Cirino to the newly created position of Senior Vice President, Spinal Systems, effective immediately.

Mr. Cirino brings over 25 years of spine industry experience with numerous leadership roles in sales and marketing.  Prior to joining SeaSpine, Mr. Cirino spent eight years at NuVasive, Inc., where he served in roles of increasing seniority, most recently serving as vice president of market development for computer-assisted surgery. Prior to NuVasive, Mr. Cirino spent ten years at Medtronic, where he held senior marketing, development and marketing services positions focused on spinal systems, biologics, and pain stimulation. Mr. Cirino holds a Bachelor of Science in Business Administration from Duquesne University and a Master of Business Administration from the University of Notre Dame.

As Senior Vice President, Spinal Systems, Mr. Cirino will lead all aspects of the Company’s spinal implants activities and initiatives.  In this capacity, he will set direction for product innovation and development, marketing services, surgeon and sales education, and international strategy.

“Dennis’ deep experience building robust marketing programs, implementing international strategy, and driving surgeon education will serve us well as we leverage our recently launched and increasingly differentiated products, which are critical to accelerating our revenue growth,” said Keith Valentine, president and chief executive officer of SeaSpine. “His strong relationships in the spine industry further strengthen our surgeon-centric approach to product innovation and mission to deliver cost effective solutions to improve the quality of patient lives.”

“SeaSpine’s focus on innovation and clinical value coupled with its increasing investment in medical education and training has positioned the company as the spine company of choice among both surgeons and distributors,” said Mr. Cirino.  “I am thrilled to join this outstanding team and look forward to contributing to their powerful vision.”

Inducement Awards
As an inducement to accepting employment with the Company, on June 30, 2018, the Compensation Committee of the Company’s Board of Directors approved a restricted stock unit award to Mr. Cirino with respect to 39,619 shares of SeaSpine common stock, as well as restricted stock unit awards to seven new, non-executive employees with respect to an aggregate of 6,660 shares of SeaSpine common stock.  The awards are being granted under SeaSpine’s 2018 Employment Inducement Incentive Award Plan, which was adopted on June 29, 2018, and provides for the granting of equity awards to new employees of SeaSpine.  The awards will be granted effective on the date SeaSpine files a registration statement registering the common stock underlying the awards, which filing is expected to occur this month, and will vest in substantially equal installments on each of the first three anniversaries of the grant date.  The awards are intended to comply with Nasdaq Marketplace Rule 5635(c)(4).

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

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: Mr. Cirino’s ability to leverage the Company’s recently launched products to accelerate revenue growth and Mr. Cirino’s ability to strengthen the Company’s product innovation and ability to deliver cost effective solutions to improve the quality of patient lives.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients; the Company’s ability to attract new, high-quality distributors; pricing pressure; supply shortages; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

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

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