Laser Spine Institute Welcomes Board-Certified Orthopedic Spine Surgeon

March 13, 2018 (TAMPA, Fla.)  – Laser Spine Institute, the leader in minimally invasive spine surgery, is proud to welcome board-certified Orthopedic Spine Surgeon, Brett G. Menmuir, M.D. In his role, Dr. Menmuir will serve patients out of Laser Spine Institute’s Scottsdale, Ariz. facility, helping patients find lasting relief from chronic neck and back pain.

“We’re incredibly pleased to have Dr. Menmuir join our Laser Spine Institute team as the newest Orthopedic Spine Surgeon,” said Roger Cary, President and Chief Executive Officer, Laser Spine Institute. “Dr. Menmuir is an accomplished surgeon, and he has devoted his career to providing the best possible care for his patients, making him a perfect fit for the surgical team.”

From an early age, Dr. Menmuir knew his career would involve working with his hands to help those suffering from chronic pain. His focus and determination would eventually lead him to a career in orthopedic spine surgery, allowing him to use his skills to heal those in need.

After earning his degree in science from Georgetown University, Dr. Menmuir went on to earn his medical degree from Georgetown University’s School of Medicine. He then attended Louisiana State University to complete his residency in orthopedic spine surgery followed by a fellowship at Twin Cities Spine Center in Minneapolis.

Before joining Laser Spine Institute’s surgical team, Dr. Menmuir spent more than a decade at Reno Orthopedic Clinic where he was the Spine Team Leader. While there, he specialized in minimally invasive techniques for spine and sacroiliac joint fusions, motion preservation surgery, pain management and orthopedic procedures.

Dr. Menmuir is also a member of various professional associations, including American Academy of Orthopedic Surgeons, Nevada Orthopedic Society, Society of Lateral Access Surgery and AO Spine.

Laser Spine Institute’s locations are recognized as providers of the highest level of patient care by the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC).

For more information, visit

Media Contact: Maura Devetski, Edelman

Phone: 404-832-6788


About Laser Spine Institute
Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Fla.; Scottsdale, Ariz.; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has helped more than 75,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Patients often refer a friend or family member to have surgery at Laser Spine Institute; we have a patient recommendation score of 97 out of 100. Additionally, Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one operating room and nine employees, Laser Spine Institute now has nearly 1,000 corporate and health care professionals across the country.


SpineGuard Reports Full-Year 2017 Financial Results

March 15, 2018


SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, reported today its full-year 2017 financial results as approved by the Board of Directors on March 14, 2017.

€ thousands – IFRS audited Dec 31, 2017 Dec 31, 2016
Revenue 8 174 7 463
Gross Margin 6 952 6 354
Gross margin (% of revenue) 85,1 % 85,1 %
Sales, distribution & marketing 6 116 6 643
Administrative costs 2 116 2 049
Research & Development 1 267 1 295
Operating profit / (loss) -2 547 -3 633
Non recurring operating costs -415 0
Financial Result -1 163 -545
Income Tax 0 0
Net profit / (loss) -4 125 -4 178

Stephane Bette, CEO of SpineGuard said: « The full-year results demonstrate that we can achieve our goal of operational profitability by the end of 2018. We generated solid growth while launching our innovative technology platform. In 2017 SpineGuard signed 2 major strategic partnerships: for distribution in China with XinRong Medical; and an exclusive worldwide DSG™ licensing to Adin for dental implant surgery. Furthermore, the early commercial success of the DSG screw with our partner Zavation in 2017 bodes well for 2018.”

Solid growth of revenue and strong improvement of the operating profit

Full year revenue was € 8,174k, growing 10% (12% cc). The United States represented 61% of the 8,764 DSG™-enabled devices sold by Dec. 31, 2017 and 81.5% of the revenue. Sales grew in the US by 14% (cc).

Gross margin remains stable at 85.1% and grew by € 598k. This was the result of a combination of stable OUS prices, ASP increases in the USA and improvements in manufacturing costs (despite unfavorable exchange rates).

Operating expenses decreased by € 488k (4.9%) thanks to the company reorganization initiated in the second half of 2017 and to rigorous control of operational expenses.

As expected, SpineGuard greatly reduced its operating loss to € -2,547k (vs. € -3,633k), i.e. an improvement of € +1 087k (close to +30%) for the full-year with a progress of € +505k in the second half of 2017.

Non-recurring operating costs related to the reorganization amount to € 415k.

Net loss was € -4,125k (vs. € -4,178k) after taking into account the financial result impacted by the unrealized exchange rate losses and by the concurrent increase of the paid interest related to contracted loans.

Working capital requirement decreased by € 249k as the result of a reduction of the inventory dedicated to late 2016 new product launch.

At Dec. 31, 2017, cash and cash equivalents were € 1.2M, plus the secured € 2.0M of convertible bonds (OCAPI) for a total of € 3.2M.

2017: SpineGuard reached the following key milestones

In the United States, SpineGuard’s leading market, the company continued its solid progress supported by the following events:

  • The FDA cleared the DSG™ integration module for the smart screw in January. The subsequent pre-launch period enabled SpineGuard to collect the positive clinical experiences of 100 surgeries.
  • In October, Zavation and SpineGuard officially launched the Z-Direct smart screw at the annual congress of the North American Spine Society (NASS) to great acclaim.
  • Penetration of university hospitals continues to grow, with 38 centers using PediGuard® in their training process by year-end.

In the rest of the world, the company focused its marketing and training support activities toward major commercial partners and signed a major distribution agreement with XinRong Medical for China, Hong-Kong and Macao.

SpineGuard broadened the scope of its DSG™ technology platform beyond Spine with the completion of an exclusive license deal in dental implantology with the Israeli Group Adin Dental Systems, a high growth potential market.

In an area of strong interest, SpineGuard obtained the world’s first experimental validation with the laboratory Institut des Systèmes Intelligents et de Robotique of the Paris Sorbonne University that demonstrated how DSG™ technology can stop a surgical robot automatically when an impending bone breach is detected.

Promising perspectives in 2018:

  • Growing adoption by physicians and various orthopedic industry players of DSG™-enabled devices (industry partnerships, distributors, universities).
  • The commercial launch of the Z-Direct smart screw with Zavation in the USA and additional partnerships for DSG™ screw expansion.
  • A broadening of the scope of DSG™ applications: robotics, visualization module and non-spine.
  • Reaching operating profitability by the end of 2018.

Nomination of Pierre Jerome as successor of Alan Olsen as Chairman of the Board

The Board of Directors accepted Alan Olsen’s resignation from his role of Chairman of the Board during its March 14th meeting. Alan served as Chairman of the Board of SpineGuard since 2010 and will remain a Director until the term of his mandate expires on May 17, 2018. The Board of Directors sincerely thanks Alan for his unwavering support over the last nine years.

Maurice Bourlion, SpineGuard Board Director and co-inventor of DSG® technology says: “On behalf of all Board members, I sincerely thank Alan Olsen for his major contribution to SpineGuard’s progress. Since 2010, he has organized and managed the governance of the company, while also sharing his great experience with the company. Today Pierre Jerome, co-founder of the company, takes over as Chairman. With Pierre, we will be able to pursue our growth strategy and our path towards profitability”.

During the same meeting, the Board of Directors named Pierre Jérôme – co-founder of SpineGuard – as new Chairman of the board.

« I would like to warmly thank the board of directors for their vote of confidence in giving me this new responsibility, as well as Alan Olsen for his contribution to the development of SpineGuard since his nomination in 2010; I wish him all the best. The company under the leadership of Stéphane is now well on track toward profitability while continuing to demonstrate the strong potential of its DSG™ technology through sustained growth and innovation. The Chinese market, the smart pedicle screw, dental implantology and the robotic applications are now as many tangible opportunities that I will strive, along with the other board members, to help Stéphane and his team fully materialize so that our shareholders can harvest the fruit of their investment” concludes Pierre Jérôme.

Next financial press release: First Quarter 2018 revenue on April 5, 2018.

About SpineGuard®
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit


Stéphane Bette
Chief Executive Officer
Tél. : +33 (0)1 45 18 45 19
Manuel Lanfossi
Chief Financial Officer
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tél. : +33 (0)1 44 71 94 94

Stryker Spine Division’s Tritanium® C Anterior Cervical Cage Gains Momentum With Surgeons

March 15, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium® C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, has been implanted by 311 surgeons in more than 1,770 procedures across the U.S. since its introduction in late October. The company has sold more than 3,188 Tritanium C implants to date.

The Tritanium C Anterior Cervical Cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study,2* and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3

“As more spine surgeons gain experience using Tritanium cages, they are becoming believers in Tritanium Technology, which is designed to mimic the porosity of cancellous bone,” said Bradley Paddock, president of Stryker’s Spine division. “We are thrilled by the positive feedback the Tritanium C Anterior Cervical Cage is receiving from our surgeon customers.”

“The Tritanium C Anterior Cervical Cage is another great product by Stryker that brings revolutionary technology to the operating room,” said Dr. Lance Smith, Orthopedic Surgeon at McBride Orthopedic Hospital, Oklahoma City. “With many product sizes and lordosis options, I feel like I can match the anatomy and needs of the patient with the implant. I look forward to using the Tritanium C Cage product in more spinal surgeries.”

“I was intrigued by Tritanium because of the idea of bone in-growth as opposed to the on-growth of competitive products,” said Dr. Scott Kutz, Texas Back Institute, Plano, Texas. “I found the large graft window and imaging characteristics of Tritanium to be favorable versus other metal implants I’ve used.”

Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.4 This “precise randomization”4 of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that create a uniform lattice structure, as well as cages offering porosity that is only present on the surface. Tritanium Cages feature an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment.

The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and was introduced to surgeons during the North American Spine Society conference Oct. 25–28, 2017. Full commercial launch occurred on Dec. 10, 2017. For Indications for Use, please refer to the Tritanium C Anterior Cervical Cage Instructions for Use.

About Stryker

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


1. PROJ43909 Tritanium technology claim support memo
2. RD0000053710: Tritanium cell infiltration and attachment experiment
*No correlation to human clinical outcomes has been demonstrated or established
3. RD0000050927: Tritanium material capillary evaluation
4. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491

Drs. Smith and Kutz are paid consultants of Stryker. Their statements represent their own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

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

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

Content ID: TRICC-PR-3_16579


Sullivan & Associates
Barbara Sullivan, 714/374–6174

New European patent approval for Episurf Medical

MAR 14, 2018

The European patent office EPO has announced its intention to grant another European patent for Episurf Medical (NASDAQ: EPIS B). The patent, entitled “Method and node for manufacturing a surgical kit for cartilage repair, covers the medical image segmentation process used for joint damage visualisation as well as for manufacturing of Episurf Medical’s patient-specific joint implants and surgical instruments.

“A comprehensive patent portfolio supporting various aspects of our technology has for a long time been a prioritised area, and this patent forms an important part thereof. This grant follows previous approvals for this patent family in China and Australia”, comments Pål Ryfors, CEO, Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69


About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website:

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11.30 CET on 14 March 2018.


 About Us

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website:

K2M Launches Next-Generation YUKON™ OCT Spinal System at AANS/CNS 2018

LEESBURG, Va., March 14, 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 the commercial launch of the YUKON™ OCT Spinal System at the 34th Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS), occurring March 14-17 in Orlando, FL (Booth #200). At the meeting, the Company will also showcase Balance ACS® or (BACS®), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for spine patients.

The YUKON OCT Spinal System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in September 2017, was developed to help surgeons restore cervical sagittal balance through posterior fixation in the occipito-cervico-thoracic regions of the spine. It features a newly designed top-loading polyaxial screw with high angulation and the ability to accommodate rods in two diameters. The screw provides 60 degrees of angulation for 60 degrees of coronal swing “60 for 60” to aid in screw placement, providing up to 105 degrees of polyaxial angulation.

“We are pleased to launch our next-generation YUKON OCT Spinal System, an important addition to our growing complex spine portfolio, at this year’s AANS/CNS meeting,” said K2M Chairman, President, and CEO Eric Major. “K2M is committed to realizing the theme of this year’s meeting—restoring alignment in an era of global change—as evidenced by this latest commercial milestone and through our comprehensive Balance ACS platform.”

YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium to accommodate construct rigidity based on degenerative or deformity corrections. The system’s advanced, streamlined reduction instruments allow for intraoperative flexibility and ease of use. A Pistol Grip Rod Reducer provides up to 20 mm of reduction, while the Sequential Reducers deliver up to 15 mm of controlled reduction and correction.

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 about the YUKON OCT Spinal System and K2M’s complete product portfolio, visit For more information on Balance ACS, visit

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 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 and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; 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 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, 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 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 price; our lack of current plans to pay cash dividends; 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  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

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

Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery

WESTMINSTER, Colo.March 14, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced the company received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of P-15L Peptide Enhanced Bone Graft compared to autograft in transforaminal lumbar interbody fusion (TLIF) surgery for degenerative disk disease.

Spinal fusion procedures such as TLIF involve joining and stabilizing one or more vertebrae to reduce pain and nerve irritation. A bone graft, which has historically been obtained from the patient’s pelvis, is placed in the interbody space to promote fusion. P-15L Bone Graft is based on proprietary synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment and activation, and is designed to be used as a substitute for autologous bone.

“With regulatory approval to begin a new IDE study of P-15L Bone Graft in TLIF procedures, we are now in position to collect additional Level 1 human clinical data on our next-generation advanced drug-device combination bone graft,” said Glen Kashuba, chief executive officer of Cerapedics. “Several hundred thousand people in the U.S. need surgery for degenerative disk disease every year, and it is our goal to offer surgeons a safe and effective alternative to a patient’s own bone as well as address the evidence gap around commercial bone grafts often used in these procedures.”

The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. Patients will be assessed prior to surgery and six weeks, three months, 12 months, and 24 months post-surgery. The primary endpoint for the study is composite clinical success at 24 months based on several factors including the achievement of radiographic fusion (assessed by CT), at least a 15-point improvement in the Oswestry Disability Index (ODI), no new or worsening persistent neurological deficit, and no subsequent surgical intervention at the index level. Clinical investigators are permitted to use any FDA cleared static PEEK interbody device and any FDA cleared pedicle fixation system delivered through either an open or minimally invasive TLIF technique.

“We are very pleased to be on the verge of initiating this milestone study,” said Jeffrey G. Marx, PhD, president and chief operating officer of Cerapedics. “We believe the FDA approved study design should allow for rapid enrollment and clear evaluation of the safety and efficacy of P-15L Bone Graft versus local autograft. We’re assembling an outstanding team of surgeon investigators whom we are excited to collaborate with.”

“Prior research of this proprietary P-15 technology has demonstrated potential benefits in fusion rates, neurological outcomes and safety in cervical and lumbar fusions,” said Paul M. Arnold, MD, neurosurgeon and vice chair of research in the Department of Neurosurgery at the University of Kansas Medical Center and principal investigator of the IDE study. “We are pleased to participate in a new study evaluating whether similar results can be achieved in a wider range of patients with degenerative disk disease utilizing the next generation P-15L product.”

In November 2015, Cerapedics received Premarket Approval (PMA) from the FDA for the use of i-FACTOR Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming only the second PMA-approved bone graft in the spine. The company is initiating enrollment in the newly approved TLIF IDE study with the expectation that the results from the study will support a PMA application.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at

Media contact:
Adam Daley
Berry & Company Public Relations

SOURCE Cerapedics

Related Links

CTL Introduces MATISSE(TM) Ti-PEEK ACIF Cage Implant

DALLAS, TX / ACCESSWIRE / March 13, 2018 / CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance and approval to market its new MATISSE™ Ti-PEEK ACIF Cage System with TiCro™ technology in the practice of spine fusion surgery.

The MATISSE™ Ti-PEEK ACIF Cage with CTL Medical’s proprietary TiCro™ surface technology offers the increased bone ingrowth of Titanium and the post-op fusion visibility of PEEK. Like its predecessor, the MATISSE™ Titanium ACIF Cage with TiCro™, the updated Ti-PEEK interbody device offers surgeons a 200 percent greater endplate contact surface area, as well as geometric surface morphology for increased mechanical locking at the cage and bone interface. The implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“The MATISSE™ Ti-PEEK Cage with TiCro™ represents several improvements over earlier models,” stated Rose Moore, vice-president of marketing for CTL Medical Corporation. “The MATISSE™ device line now offers 3 material options to satisfy surgeons and their patients ever changing needs. As with previous models, the Matisse Ti-PEEK system offers streamlined instrumentation and a variety of footprints, heights, and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE™ Ti-PEEK Cage with TiCro™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE™ Ti-PEEK Cage with TiCro™ is to be used with supplemental fixation, such as CTL Medical’s VAN GOGH™ Anterior cervical plating system, which has been cleared for use in the cervical spine.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

For more information on CTL Medical Corporation, visit

AboutCTL Medical Corporation

CTL Medical Corporation is a fully integrated, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talents, positioning it to be a leader in medical device design and manufacturing. For more information, visit

Media Contact:

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171

SOURCE: CTL Medical Corporation

Astura Medical Reports 312% Annual Revenue Growth in 2017

CARLSBAD, CA – March 14, 2018 – Astura Medical, a high-growth, innovative spine technology company, today reported an annual revenue increase of 312% for the full year ending Dec. 31, 2017.

“Our market-leading growth rate in 2017 can be attributed to a number of factors, but it’s our rapidly increasing network of surgeon and distributor partners throughout the country that is the real validation on the quality of our technology and performance of our team,” said Joel Gambrell, President and CEO of Astura Medical.

2017 was highlighted by a number of other achievements for Astura, including the 510k approval and initial release of the BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System, several key personnel hires, and significantly increasing inventory to support the rising demand for the company’s product portfolio.

“As we look ahead, we anticipate further growth to come from the continued success of our Phase One suite of products and our recent full commercial release of Bridalveil OCT,” stated Mr. Gambrell. “Our current momentum combined with the scheduled launch of our MIS Platform later this year, which will include an MIS Percutaneous Screw System and Expandable Posterior Lumbar Interbody Cages, positions us well for a strong performance in 2018.”

About Astura Medical

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

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


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

Media Contact:

Steve Haayen

Astura Medical


Zimmer Biomet Announces Quarterly Dividend for First Quarter of 2018

WARSAW, Ind.March 12, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the first quarter of 2018.

The cash dividend of $0.24 per share will be paid on or about April 30, 2018 to stockholders of record as of the close of business on March 29, 2018. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit or follow Zimmer Biomet on Twitter at


SOURCE Zimmer Biomet Holdings, Inc.

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Paris High Court Rules in Favor of CoorsTek in Lawsuit Claiming Trademark Infringement of Ceramic Orthopaedic Hip Componets

March 07 2018

Paris, France – CoorsTek today announced that the Paris High Court has ruled in its favor in a lawsuit brought by CeramTec GmbH attempting to block the manufacture and sale of CoorsTek’s CeraSurf®-p “pink” ceramic hip components.

In its ruling, the Paris High Court stated that CeramTec sought to “indefinitely perpetuate the technical effect” of its patent covering its Biolox Delta materials—which expired at the same time CeramTec was filing for its “pink” trademarks—in order to prevent its competitors from selling products using the once patented composition. The court found that CeramTec’s actions at the time of filing the trademarks were done in bad faith. The results of this judgement are that CeramTec’s European Union trademark registrations related to the color pink as applied to ceramic implants are invalid and unenforceable throughout the European Union, and that CeramTec’s infringement action against CoorsTek was dismissed.

“CoorsTek is pleased with this decision as it supports CoorsTek’s efforts to be able to provide medical device manufacturers with additional access to high-quality, substantially equivalent implantable ceramic components,” said Jonathan Coors, Co-CEO of CoorsTek. “This ruling is one more step in opening up the implantable device market to further competition, benefitting patients and enabling CoorsTek to achieve its mission of making the world measurably better.”

The inherent pink color of CoorsTek CeraSurf®-p ceramic material is a natural result of the chromium oxide dopant used in the ceramic matrix to provide a combination of hardness and toughness. CeraSurf®-p ceramic hip implant femoral heads (hip balls) and acetabular liners (cups) demonstrate extreme durability and longevity in applications due to a combination of high-performance ceramics, metals and polymers. CeraSurf®-p ceramic femoral heads and acetabular liners have received regulatory approvals and have been distributed for clinical use as bearing surfaces for hip implant systems in South America since 2011 and Europe since 2012, and received FDA 510(k) clearance in the U.S. in 2016.

CeramTec originally brought the suit against CoorsTek in 2013, claiming the development and marketing of the pink CoorsTek acetabular liners and femoral heads was in direct violation of its now invalid European Union trademark registrations.

The Paris High Court decision follows a similar ruling in January 2017, when the U.S. District Court for the District of Colorado ruled in favor of CoorsTek in its lawsuit challenging CeramTec’s claims to the color pink for implantable ceramic components. In that ruling, the U.S. District Court stated that CeramTec does not own any trademark or trade dress rights in the color pink in the U.S. and enjoined CeramTec from interfering with the rights of CoorsTek Medical to market CeraSurf®-p ceramic components in the United States.