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Current Issues in Spine

February 2-4, 2017
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RegulatorySpineTop Stories

Nuvasive Files Lawsuit Against Patrick S. Miles To Protect Corporate Assets And Stakeholders’ Interests

October 10, 2017 OrthoSpineNews

SAN DIEGO, Oct. 10, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has filed a lawsuit in the Delaware Chancery Court against Patrick S. Miles, former vice chairman of the Company and a member of NuVasive’s Board of Directors. The lawsuit asserts that before abruptly resigning from the Company to join Alphatec Holdings, Inc. (NASDAQ: ATEC), Mr. Miles engaged in a scheme for over a year to divert corporate opportunities and then announced he would join Alphatec in violation of his contractual obligations to NuVasive. In the lawsuit, NuVasive argues Mr. Miles’ divided loyalties constituted a clear breach of his fiduciary duties to NuVasive and its stakeholders, and that he violated his non-competition and non-solicitation obligations to the Company.

NuVasive issued the following statement:

This step was not taken lightly, particularly given Mr. Miles’ history with NuVasive. Yet it is this history and Mr. Miles’ intimate knowledge of the Company and our proprietary information that makes his breach of fiduciary duties and contractual obligations so egregious and this litigation necessary.

It is not the Company’s preference to proceed down a litigation path, but it would be contrary to our own responsibilities to ignore Mr. Miles’ actions. To be clear, Mr. Miles’ conduct has precipitated this lawsuit, which we believe is necessary to protect NuVasive’s rights and interests and the interests of our stakeholders. We will continue to take all appropriate steps in this regard.

As detailed in the complaint:

  • In January 2016, NuVasive was contacted by UBS Financial Services Inc. to explore NuVasive’s interest in acquiring Alphatec. Miles was NuVasive’s president and chief operating officer at the time. Miles advised NuVasive that pursuing such acquisition was “a waste of time,” and that Alphatec had an “aged, undifferentiated portfolio.” Consistent with Miles’ comments, NuVasive passed on the opportunity.
  • Then, on March 22, 2017, Miles secretly executed a securities purchase agreement to purchase $500,000 of Alphatec stock in a private placement. Miles and Alphatec concealed this investment by purchasing shares in Alphatec through an entity called “MOM” and failing to disclose that Miles was the beneficial owner of the shares. While still an employee and a member of the NuVasive Board, Miles negotiated an offer from Alphatec to serve as its executive chairman. As part of that offer, as an inducement to his employment, Alphatec granted Miles 1,000,000 Restricted Stock Units (a market value of $3,220,000 at Alphatec’s closing price as of October 2, 2017). Miles also agreed to purchase 1.3 million shares at $2.26 per share (a $2,938,000 investment) and is to be granted warrants to purchase up to an additional 1.3 million shares of Alphatec stock upon the closing of his purchase. Miles will own about 15% of the outstanding shares of Alphatec’s stock and, with the warrants he has been granted, could potentially own up to 23% of Alphatec’s outstanding stock.
  • On Sunday, October 1, 2017, Miles notified NuVasive that he was resigning his position as vice chairman and a member of the Board effective immediately. He planned to commence employment as Alphatec’s executive chairman the next day, and he did not intend to honor his contractual commitments to refrain from: 1) working for a competitor, 2) soliciting NuVasive’s customers and 3) recruiting NuVasive’s employees.

A full copy of the complaint will be available at NuVasive’s website.

NuVasive stated it is continuing to investigate and will file further claims if warranted.

DLA Piper is serving as legal counsel to NuVasive in connection with this matter.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with the acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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SpineTop Stories

Nanovis Spine Featured in Orthopedic Design and Technology

October 9, 2017 OrthoSpineNews

Nanovis Spine CEO Matt Hedrick recently sat down to speak with ODT about our commitment to developing innovative products to improve patient care and outcomes (full article attached).

https://www.odtmag.com/issues/2017-10-01/view_features/distinguished-support-a-review-of-spinal-orthopedic-technologies/?sthash.APN1XgvK.mjjo

“With an approximately 10 percent rate of lumbar non-fusions, we feel this area is where we can do the most good. Nanovis’ deeply porous titanium scaffolded FortiCore implant systems provide high fixation strength in a short timespan compared to PEEK, plasma-sprayed PEEK, or allograft…” Hedrick said.

The advantages of FortiCore® include:

#deeply porous interconnected titanium scaffold

#intermolded PEEK-Optima® core by InVibio with benefits of modulus and imaging

#resistance to abrasion and delamination (rebar in concrete concept)

#published pre-clinical data showing statistically significant superiority vs. PEEK, Allograft, and Plasma Spray https://lnkd.in/eDjfMaR

“Our next technology upgrade for this market is a patented nanotube surface that offers the potential to further enhance the interface with bone that our entire line of spinal implants offers surgeons. Combining these technologies provides Nanovis and our distributor partners an entire portfolio of highly-advanced and highly-differentiated products.”

Nanovis is actively recruiting independent distributors to give more patients, physicians, and providers access to our science enhanced, meaningfully differentiated technology platforms.

To learn more, please contact jeff.shepherd@nanovistechnology.com, or visit us at Booth# 762 at the North American Spine Society meeting October 25-28, 2017 in Orlando.

 

 

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Spine

Stryker’s 3D-Printed Tritanium® C Anterior Cervical Cage To Be Featured at Congress of Neurological Surgeons Meeting

October 9, 2017 OrthoSpineNews

October 09, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will demonstrate its new 3D-printed Tritanium C Anterior Cervical Cage, an interbody fusion device designed for use in the cervical spine, at the Congress of Neurological Surgeons (CNS) Annual Meeting, Oct. 7-11, 2017, in Boston (booth No. 311).

The Tritanium C Anterior Cervical Cage is the latest spinal fusion implant constructed from Stryker’s proprietary Tritanium In-Growth 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* The Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.3 Tritanium is inspired by the microstructure of cancellous bone4 and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

“We look forward to showcasing the Tritanium C Anterior Cervical Cage and demonstrating its advanced capabilities at the CNS meeting,” said Bradley Paddock, President of Stryker’s Spine division. “Stryker’s Tritanium Technology is ‘engineered for bone.’ Our growing line of Tritanium implants reflects our commitment to being at the forefront of technology advances in spinal surgery, and to providing our surgeon customers with a range of options to address their preferences and meet the needs of their patients.”

According to Mohammed Faraz Khan, M.D., Hackensack University Medical Center, N.J., one of the first surgeons to use the new cage, the benefits of the Tritanium C Anterior Cervical Cage are clear. “In my opinion, this new addition is going to make all the difference in this space,” Khan said. “The inserter used with the system was super sleek and easy to use.”

The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and will be available to surgeons in Q4 2017. It features 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. Engineered for stability,5 the cage has serrations on the superior and inferior surfaces designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and to protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies.

About Stryker

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

References

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
5. PROJ44960: Coefficient of friction memo

Content ID: TRICC-PR-2_15699

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.

Contacts

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

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Spine

SI-BONE, Inc. Announces Utah’s PEHP Coverage for the iFuse Procedure™ for MIS SI Joint Fusion

October 9, 2017 OrthoSpineNews

SAN JOSE, Calif., Oct. 9, 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 PEHP Health & Benefits of Utah, a nonprofit trust providing health benefits to Utah’s public sector employees and their families, has issued a positive coverage policy for MIS SI joint fusion with iFuse.  The policy specifies positive coverage for MIS SI joint fusion using iFuse with prior authorization for CPT (current procedural terminology) code 27279 and considers open SI joint fusion with CPT 27280 experimental and investigational.  In addition, the policy considers percutaneous radiofrequency ablation/denervation of the SI joint, including pulsed, non-pulsed and cooled, experimental and investigational.

“Minimally invasive SI joint fusion using the iFuse Implant has become the method of choice to treat patients who suffer from chronic pain resulting from degenerative sacroiliitis or sacroiliac joint disruption.  With over 28,000 procedures performed and 54 peer-reviewed publications that include two Level 1 randomized controlled trials as well as numerous long-term studies including a 6-year study published in Neurosurgery, the iFuse Implant is the benchmark for SI joint fusion,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE.  “It’s very encouraging to see health plans such as PEHP of Utah provide access to the iFuse Procedure™ for its health plan members who are suffering from chronic SI joint pain who’ve failed conservative care.”

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 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

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

CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse Implant and iFuse Procedure are trademarks of SI-BONE, Inc.  ©2017 SI-BONE, Inc. All Rights Reserved. 10004.100917

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

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

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Spine

Renew Spinal Care Announces Strategic Alliance Agreement with SpineMark

October 5, 2017 OrthoSpineNews

HOUSTON, Oct. 5, 2017 /PRNewswire/ — Renew Spinal Care, Inc. announces a strategic alliance agreement with SpineMark Corporation, adding a key component to its rapidly expanding structure. The agreement with SpineMark will allow the two dynamic companies to complement one another through mutually aligned strategies that will enhance patient diagnosing, integrate operational minimally invasive spine surgery protocol and merge state-of-the-art medical technology.

Renew consists of a national network of board-certified spine surgeons who specialize in minimally invasive spine surgery (MISS). Physicians utilize innovative techniques to repair multiple levels of the spine, bilaterally, in the lumbar, cervical and even the thoracic region in one anesthetic experience. Through MISS procedures, spinal nerve impingements are released through the least invasive approaches available. In most cases, patients do not require an overnight hospital stay; rather, they leave the surgical facility on the same day with just a bandage and no stitches.

SpineMark Destination Centers are a unique, comprehensive delivery system, starting with accurate diagnosis of the origin of the pain. SpineMark advocates for holistic modalities and minimally invasive procedures and surgeries to restore patients’ abilities to live a productive life. SpineMark leads with a “first-do-no-harm” minimally invasive spine approach, with more complex surgeries, such as fusions, always considered a last resort.

SpineMark’s mission is to create a universal standard based on early intervention for the treatment of patients suffering from spinal pain with the help of physicians, industry payors and governmental agencies. SpineMark’s protocol and Renew’s network of board-certified surgeons are combining to offer Spine Centers of Excellence in an unparalleled partnership in the history of the development of MISS.

In addition to focusing on spine, the agreement integrates minimally invasive foot and ankle surgery. Both companies are in the forefront of assisting leading nationally recognized surgeons specializing in ambulatory foot and ankle surgery avoiding plates, pins and screws.

Pairing of Leading Minds on Spine Care

Sam Bailey, CEO of Renew, and Marcy Rogers, President of SpineMark, bring more than 45 years combined business experience and leadership in the development of spinal modalities. The agreement between Renew and SpineMark unites their formidable experience and relationships, forming an alliance that offers a platform for physicians to maximize their practice and healthcare consumers to benefit from the latest developments in spine surgery.

Bailey said, “I am honored and humbled to work together with Marcy and the SpineMark team. Her tireless pursuit of excellence in uniting the greatest minds in MISS is inspirational to all who know her and have had the privilege of working alongside her.”

Concerning the agreement, Rogers said, “The time is right for the mutual synergies of Renew and SpineMark to unite. Both companies are privileged to work with the greatest physician leaders in the industry. Sam and I have known each other since the early days of MISS. We believe this agreement will help change the course of medical history.”

Neurosurgeon Dr. Adam Lewis, National Medical Director for SpineMark, welcomes the opportunity to work closely with Renew. “In just five years, Renew has established its reputation as a true leader in the MISS space. As a long-time advocate of MISS, I am excited for SpineMark to help Sam and his team bring their innovative techniques to even more communities.”

Dr. Michael Keogh, National Director of Marketing for SpineMark, says the agreement between Renew and SpineMark will improve the quality of life for people nationwide. “The biggest beneficiaries of this agreement are patients,” he says. “They will gain access to the most advanced care that delivers exceptional outcomes at low costs — the type of services our healthcare system desperately needs more of.”

For Press Inquiries, contact:
Ashley@RenewSpinalCare.com
917.478.4533

SOURCE Renew Spinal Care, Inc.

Related Links

http://www.renewspinalcare.com

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Spine

Recent Studies Show Backpacks Affect the Spine in Adolescents

October 5, 2017 OrthoSpineNews
DALLAS, TX, October 05, 2017 /24-7PressRelease/ — According to Spine Journal, over 60% of adolescents aged 6 to 19 have reported that their daily backpack use caused back pain. The majority of American children carry backpacks to school every day, making it imperative that students are taught how to carry their backpacks in the correct way to result in the 60% statistic dropping. The Spine Journal puts an emphasis on the 60% percent statistic, claiming that the frequency of carrying the backpack and its position on the body is directly related to the lower back pain. Now that the school year is in full swing and the homework is piling up, it is important to help young students adopt proper carry habits to keep their spine healthy and pain free.

A separate study from SPINE (Volume 35, pp 83-88) found that the weight of backpacks significantly affected the rate of back pain in children. According to the study, carrying a loaded backpack with books, folders, and other supplies frequently caused a compression of spinal discs in the lower spine. When additional weight was added to these backpacks, children had to continually adjust their posture to carry the weight as comfortably as they could. Unfortunately, these altered positions resulted in disc pressure, causing low back pain. SPINE’s study concluded that a large portion of low back pain sufferers presented changes in their lumbar spine by MRI scan. They were carrying anywhere from 10 to 20 percent of their bodyweight.

Texas Back Institute recommends that a child’s backpack should, at maximum, weigh no more than 10-15% of their body weight before risking back pain. Likewise, it is crucial the backpack has an even distribution of weight by utilizing both straps over their shoulders. Slinging a backpack over one shoulder will force the child to lean to the side for extended periods of time under the weight of the pack. This will cause the spine to curve and increase the force on the lumbar discs, creating low back pain and discomfort.

The position and condition of the backpack is just as important. For example, backpacks should be replaced when the thick padding of the straps has worn down. The bottom of the pack should rest comfortably in the lower back’s curve and never hang too far past the waist. Helping parents and their children become aware of these crucial details will assist children in alleviating their back pain and lower the chronic low back pain statistic in adults.

About Texas Back Institute: Texas Back Institute and its team of spine surgeons, specializing in conditions from Scoliosis to Degenerative Disc Disease and Myelopathy, use experience, talent, state-of-the-art equipment, and technology to provide superior and innovative care for patients who suffer from back and neck pain, which has kept patients flying out of town to receive care from Texas Back spine surgeon in Dallas.

From its beginning in 1977, the goal to perform as a center of excellence while integrating the best of science and education with the best business practices has served Texas Back Institute well and continues to be the backbone of TBI’s success. Over 40 years later, Texas Back Institute is one of the largest freestanding multidisciplinary academic spine centers in the world. Utilizing the latest technological advancements and medical breakthroughs, leading and participating in numerous FDA trials, developing surgeons through its fellowship program and employing an expert medical team and compassionate support staff, Texas Back Institute remains dedicated to helping patients get back to life.

 

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Spine

K2M Group Holdings, Inc. President & Chief Executive Officer Eric Major Elected Chairman of the Board of Directors

October 4, 2017 OrthoSpineNews

LEESBURG, Va., Oct. 04, 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 President and Chief Executive Officer Eric Major has been elected Chairman of the Company’s Board of Directors, effective immediately. Major succeeds Dan Pelak, who will assume the role of Independent Lead Director after serving as Chairman since 2010.

“On behalf of our Board, I am pleased that Eric Major will serve as our next Chairman at a time when K2M is defining itself as a preeminent spinal device company of the future,” said Pelak. “Eric’s leadership experience, industry expertise and vision of excellence in spinal innovation make him the ideal person to lead our Board of Directors, and I look forward to supporting him in his new role.”

Major, a co-founder of the Company, has served as K2M’s President, Chief Executive Officer, and a Director since January 2004.

“It is truly an honor to succeed Dan Pelak, whose tenure as Chairman is marked by significant achievement and success at K2M,” said Major. “I have also had the great opportunity to work with our founding Chairman and present Chief Medical Officer, Dr. John Kostuik, who helped to inspire a surgeon- and patient-focused culture. I look forward to continued cross-collaboration between our executive team and our Board. Innovation remains at the core of our Company as we strive to create value for our shareholders by helping surgeons to care for patients around the world who suffer from debilitating spinal pathologies.”

About K2M

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

Forward-Looking Statements

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

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

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

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

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

 

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RegulatorySpineTop Stories

ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device

October 4, 2017 OrthoSpineNews

KNOXVILLE, TN (PRWEB) OCTOBER 04, 2017

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device.

“Additive manufacturing techniques create intricate three-dimensional implants, layer by layer, allowing a freedom in design and surface unattainable through conventional machining,” explained Stephen Ainsworth, PhD, Vice President of Research & Development, ChoiceSpine. “It revolutionizes our approach to design and the benefits we can now offer to our spine surgeon customers and their patients.”

HAWKEYE Ti offers the same complete implant portfolio as the original PEEK HAWKEYE device with the added advantage of a 3D printed, open titanium structure optimized for bone in-growth. HAWKEYE Ti is the first of many 3D printed devices being developed and commercialized by ChoiceSpine.

The HAWKEYE Vertebral Body Replacement System was designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. The portfolio contains small and large footprints that range in size from 10 to 50 mm in height with either 0° or 6° lordosis. “The breadth of this portfolio married with the new 3D printed implants provides a wide variety of options to match varying patient anatomies and surgical needs,” said KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine.

“The clearance of our first additively manufactured device is a great achievement for the ChoiceSpine R&D team and the company,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “HAWKEYE Ti allows us to meet the clinical demands of spine surgery in order to stay competitive in a dynamic market.”

About ChoiceSpine 
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

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SpineTop Stories

4WEB Medical Announces Launch of Next Generation Anterior Spine Truss System

October 4, 2017 OrthoSpineNews

DALLAS, Oct. 4, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, has announced the launch of its next generation interbody fusion product line for anterior lumbar spine procedures.  The new release of the Anterior Spine Truss System recently received FDA clearance for several impactful line extensions along with some key new indications for use and design enhancements.

“As the first ever FDA cleared additive manufactured spine implant, the original Anterior Spine Truss System paved the way for a new paradigm in implant technology,” said Jim Bruty, Sr. Vice President of Sales and Marketing at 4WEB Medical.  “The latest edition of the Anterior Spine Truss System builds upon 6 years of successful clinical use with a variety of upgrades that position it as the most advanced anterior interbody solution on the market today.”

The Anterior Spine Truss System features an array of new hyperlordotic options in 16, 20, and 25 degree angles and offset insertion functionality has been added for optimal oblique positioning of the device.  4WEB’s new clearance also includes an indication for allogenic bone graft in addition to autograft.  The key differentiator for the product remains the proprietary truss design that provides a more stimulative and stable environment for fusion than competitive annular designs across the industry.

“The hyperlordotic anterior lumbar offering demonstrates 4WEB’s commitment to further expand their market leading truss technology platform,” said Bobby Kalantar, M.D., orthopedic surgeon at Medstar Georgetown. “The new hyperlordotic footprints allow for greater anterior sagittal balance restoration while keeping the signature bi-convex truss design which has shown to increase bone interface and dramatically reduce the risk of expulsion.”

4WEB expects that the Anterior Spine Truss System will provide a considerable growth opportunity for the business as it takes the product to market in the fourth quarter.  The company’s spine business has just completed its eighth straight quarter of consecutive growth and is poised for its biggest quarter ever in Q4 with the most comprehensive portfolio of 3D printed interbody implants and the early success of its also recently released lateral product line.

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

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Spine

‘Lifelike’ 3D printed spine to help train spinal surgeons

October 4, 2017 OrthoSpineNews
Medicalxpress, October 4, 2017 – Credit: Nottingham Trent University

Researchers are 3-D printing replica human vertebrae which act and feel like real bone tissue to help train spinal surgeons before they go into live operations.

A project led by Nottingham Trent University aims to give trainee surgeons the “tactic knowledge” of how it feels to partly remove or drill into vertebrae before undertaking procedures on patients.

The models – which are created using powder printing technology to help achieve a lifelike porosity of real bone – feature hard outer layers and a softer centre.

“Consultants undertaking delicate and precise procedures like need as much knowledge and experience as possible as part of their surgical training before going into live operations,” said Professor Philip Breedon, of the university’s Design for Health and Wellbeing Group.

“One error can lead to catastrophic, life-changing consequences for a patient, so it’s imperative that surgeons can prepare themselves thoroughly.

“This research will enable clinicians to experience how performing spinal surgery feels both physically and mentally, but in a safe training environment.”

The project is in collaboration with consultant spinal surgeon Professor Bronek Boszczyk, of Nottingham University Hospitals Trust, who is a visiting professor at Nottingham Trent University.

 

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