Zimmer Biomet Announces U.S. Launch of Avenue® T TLIF Cage with Integrated VerteBRIDGE® Plating

Posted On October 3, 2017 By OrthoSpineNews In Spine, Top Stories /

WARSAW, Ind., Oct. 2, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it is officially launching in the United States the Avenue^® T TLIF Cage. Avenue T advances posterior lumbar cage technology by incorporating VerteBRIDGE^® plating, which facilitates simplified cage insertion and zero-profile, intradiscal fixation through a direct, minimally invasive surgical (MIS) approach. Avenue T is the first and only posteriorly implanted cage with integrated, anti-migration fixation, solidifying Zimmer Biomet as the first company to offer a suite of lumbar cages with integrated fixation for every fusion approach. Avenue T joins a family of cages with VerteBRIDGE plating, including ROI-C^® Cervical Cage, Avenue^® L Lateral Lumbar Cage and ROI-A^® ALIF Cage.

Dr. Craig Chebuhar, a board-certified orthopaedic spine surgeon in Atlanta, Georgia, who implanted one of the first Avenue T cages in the U.S., commented, “I regularly use Zimmer Biomet’s ROI-C Cervical Cage featuring VerteBRIDGE plating in my practice. Transforaminal lumbar surgery is another attractive application for integrated plating. For my TLIF patients, I appreciate the additional fixation VerteBRIDGE provides to the construct, all via a minimally invasive approach.”

The Avenue T Cage is a prime example of Zimmer Biomet’s commitment to the advancement of MIS surgery. The Avenue T Cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a simplified technique. The VerteBRIDGE plates are sterile packaged and pre-assembled on a PEEK cartridge. The cartridge simplifies the technique, enabling the cage and plates to be loaded simultaneously on the Inserter. Once the cage is implanted, the Impactor advances both plates at the same time, reducing implantation steps. The unique anterior column fixation provided by the plating may permit the surgeon to select from a greater array of options for supplemental fixation.

Indications: The Avenue T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

About Zimmer Biomet
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 www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Vivorté announces the commercial availability of FORTERA™ and REGENTO™ bone grafting solutions for orthopedic surgery

Posted On October 3, 2017 By OrthoSpineNews In Biologics, Top Stories /

LOUISVILLE, KY — (October 3, 2017) — Vivorté, Inc., a vertically-integrated, specialty orthopedic biomaterials company, today announced the commercial availability of a complete line of bone grafting product solutions. Joining Trabexus EB, the company’s flagship bone grafting solution, Fortera is a completely synthetic calcium phosphate cement, capable of controlled delivery through a 16-gauge cannula. REGENTO is a resorbable, particulate b-TCP bone void filler with engineered macroporosity to promote protein deposition and cell attachment.

These newly introduced products join Trabexus EB, which first received 510(k) clearance in 2015. TRABEXUS EB is a self-setting, gradually resorbable, calcium phosphate matrix enhanced with partially demineralized allograft particles. The engineered bone component is formed into “hourglass” shapes (TRABS^®) using a proprietary manufacturing process.

This novel shape provides multiple benefits, including increased “interconnectivity” of adjacent particles, creation of channels for accelerated remodeling and greater overall surface area. Further, the TRABS are partially demineralized, exposing key osteoinductive proteins, which are known to influence and direct the formation of new bone. Trabexus EB is resorbed and remodeled by the body as new bone formation occurs during the healing process.

“With the introduction of Fortera and Regento to our product portfolio, Vivorté now offers a complete line of synthetic biomaterials possessing a wide range of clinical performance attributes” said Ruth Voor, CEO of Vivorté, Inc. “Vivorté is a unique, emerging company, with multiple 510(k) cleared technologies, vertically-integrated manufacturing capability and an R&D pipeline of orthopedic biomaterials and traditional metallic implants. To date, our products have been well-received in the marketplace by orthopedic surgeons and hospitals, and we continue to expand our distribution network to reach institutions across the United States.”

According to BioMedGPS, the current market for bone graft substitute products exceeds $1.7B annually in the United States alone. Bone grafting procedures are necessary to fill defects or cavities in bone as the result of injury, reconstructive surgical procedures such as a joint replacement, or surgical excision following the removal of tumors or cysts.

Clinical considerations vary across these procedures, requiring biomaterials with differing handling characteristics, biological activity and mechanical performance. Vivorté continually seeks to understand the surgical environment in order to design and develop products that best complement each surgeon’s unique operative technique.

The Fortera and REGENTO products will be made available concurrent with the Orthopaedic Trauma Association (OTA) Annual Meeting, being held October 11-14, 2017 in Vancouver, B.C., Canada. Representatives from Vivorté will be attending the OTA meeting to further address product requests and inquiries.

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky, is a privately-held, ISO-certified orthopedic biomaterials manufacturer, focused on developing innovative and cost-effective, surgical products for the benefit of surgeons, hospitals and patients. The company’s products include TRABEXUS^® EB^™ Osteoinductive Bone Matrix, Fortera^™ Injectable Bone Graft and Regento^™ Bone Void Filler. To learn more, please visit our website at www.vivorte.com.

Contact: Therese Montano / Vivorté, Inc. / 502-714-7234 / tmontano@vivorte.com

Taking MIS TLIF to the Next Level

Posted On October 2, 2017 By OrthoSpineNews In Spine, Top Stories /

Tracey Romero/9-29-2017

Photo: PROLIFT® and Dr. Zeshan Hyder/Courtesy of Life Spine

In an arena of rapid technological advancement, it takes an innovation powerhouse to design products that have the ability to disrupt the spine industry. Life Spine, a manufacturer of spinal implants that launched 27 products in 2016, has revolutionized the TLIF taking it from a 90+ minute minimally invasive procedure to a micro-invasive procedure that has been completed in as little as 25 minutes.

Surgeons like Zeshan Hyder, D.O. of the Bone and Joint Specialists of Northwest Indiana are executing up to six of these procedures in one day. The potential benefits of a drastic reduction in procedural time are directly realized by surgeons and their patients. The system is designed to offer the benefits of: less time in the hospital and OR, reduced incision size, a safer surgery and a more reproducible procedure that caters to an ambulatory surgery center (ASC) setting.

The main benefit of the micro-invasive TLIF is less time in the operating room which typically correlates to a faster recovery.

Traditional TLIF procedures can take up to six hours. Six hours of muscle retraction, anesthesia, blood loss and fatigue to the hospital staff. Additionally, the longer the operating time, the fewer the patients a surgeon can operate on and the higher the cost of surgery.

READ THE REST HERE

K2M Receives FDA Clearance for Next-Generation YUKON™ OCT Spinal System

Posted On September 29, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

LEESBURG, Va., Sept. 29, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON^™ OCT Spinal System. YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance.

The YUKON OCT Spinal System features newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees of polyaxial angulation. YUKON OCT screw heads accept both Ø3.5 & Ø4.0 mm rods in both cobalt chrome and titanium, and accommodate construct rigidity based on degenerative or deformity corrections. Square thread set screws facilitate screw introduction and minimize the potential for cross-threading, while an updated occipital plate features integrated lateral holes with the goal of enhancing occiput fixation.

“The YUKON OCT System expands on K2M’s current offering while accounting for the challenging posterior cervical cases surgeons often treat,” said Chambliss Harrod, MD, a spine and orthopedic surgeon at the Bone & Joint Clinic of Baton Rouge. “Unlike systems that feature only highly favored angulation screw designs, YUKON OCT is a comprehensive system that offers surgeons the ability to treat a variety of spinal conditions—including routine degenerative cases, revisions, and complex cervical deformities.”

YUKON OCT’s advanced, streamlined reduction instrumentation allows for intraoperative flexibility and ease of use. The pistol grip style Rod Reducer provides 20 mm of reduction, while the Sequential Reducers deliver 20 mm of controlled reduction and correction.

“We are pleased to announce FDA clearance of the YUKON OCT Spinal System and the successful completion of its first surgical cases,” said K2M President and CEO Eric Major. “K2M is a global leader in spinal innovation and YUKON OCT is our new solution that deepens our expanding portfolio of spinal devices for the occipito-cervico-thoracic region of the spine. Accompanied by our comprehensive Balance ACS^™ platform, YUKON OCT offers a competitive surgical solution with the goal of achieving Total Body Balance for patients.”

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

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

Green Sun Medical awarded $50K for scoliosis brace at prestigious pediatric medical device competition

Posted On September 28, 2017 By OrthoSpineNews In Spine, Top Stories / 1

Fort Collins, CO – (September 28, 2017) – Fort Collins based start-up Green Sun Medical was awarded the top cash prize of $50,000 during the FDA-sponsored pediatric medical device competition at the Fifth Annual Pediatric Device Innovation Symposium in San Jose, Calif. organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

Green Sun Medical is developing a dynamic scoliosis brace that will allow physicians to remotely monitor the performance on the patients.

“We are honored to have our scoliosis brace recognized with these other pediatric device innovations,” said Jamie Haggard, CEO of Green Sun Medical. He also said that current treatments include braces developed over 40 years ago and spinal fusion surgeries.

Green Sun Medical was awarded the top cash prize of $50,000 in grant money an the pitch competition sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National and the A. James Clark School of Engineering at the University of Maryland. The competition was part of the annual symposium to foster innovation that will advance pediatric healthcare and address the unmet surgical and medical device needs for children.

“Our heartfelt congratulations to Green Sun Medical who was selected from a highly competitive field of worthy devices,” said Kolaleh Eskandanian, Ph.D., executive director of the Sheikh Zayed Institute and NCC-PDI. “In our role as a catalyst for pediatric innovation, we see this as the beginning of our relationship with Green Sun Medical.

She adds that in addition to financial support, the awardees will have access to consultation services for all phases of pediatric device development – from ideation through marketing – to help them get their devices to market faster.

During the competition, 12 finalists had five minutes to present their proposal to the judging panel, which included Susan Alpert, M.D., of SFA Consulting, a former director of the FDA Office of Device Evaluation and former senior vice president and chief regulatory officer of Medtronic; Charles Berul, M.D., of Children’s National; Andrew Elbardissi, M.D., of Deerfield Management; Rick Greenwald, Ph.D., of the New England Pediatric Device Consortium (NEPDC); James Love, J.D., of Oblon; Josh Makower, M.D., of NEA; Jennifer McCaney, Ph.D., of MedTech Innovator; Jackie Phillips, M.D., of Johnson & Johnson; and Tracy Warren of Astarte Ventures.

This competition was created to foster innovation in the pediatric device sector, which continues to lag behind adult device development and creates a host of challenges for doctors when treating children. Since inception in 2013, NCC-PDI has supported 67 pediatric devices and the companies and research labs owning these devices have collectively raised $55 million in additional funding.

To learn more about Green Sun Medical visit http://www.greensunmedical.com

# # #

Green Sun Medical was founded to transform the treatment to address Adolescent Idiopathic Scoliosis. We are developing a dynamic brace that applies continuous corrective pressure and allows the physicians to remotely monitor their patients.

Zimmer Biomet Announces Global Launch of the Persona® Partial Knee System

Posted On September 28, 2017 By OrthoSpineNews In Recon, Top Stories /

WARSAW, Ind., Sept. 11, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of the Persona^® Partial Knee System, the latest addition to its portfolio of personalized and anatomically designed knee implant systems. The launch of the Persona Partial Knee System is the first significant jointly developed new product for the Company since the Zimmer Biomet combination, and reinforces the Company’s leadership position in partial knee replacement.

“The global introduction of the Persona Partial Knee System is the combined Company’s first major product launch and fills a significant gap in our knee portfolio,” said Daniel Florin, Interim Chief Executive Officer, Senior Vice President and Chief Financial Officer. “The partial knee market continues to expand as patients demand alternatives to traditional knee replacement. The addition of the fixed-bearing Persona Partial Knee System complements the Company’s mobile-bearing Oxford^® Partial Knee, further strengthening our leadership position in this growing market.”

The Persona Partial Knee System represents the next era in personalization, equipping surgeons with a comprehensive system of implants and instruments that are designed to offer an uncompromising fit and efficiency in the operating room. The development team leveraged global experts in partial knee replacement and utilized the ZiBRA™ Anatomical Modeling System to analyze thousands of bones, both male and female, representing a diverse global population.

“The new Persona Partial Knee System has made me a better partial knee surgeon,” said Craig Della Valle, MD, a developing surgeon from Rush University Medical Center in Chicago, Illinois. “Its combination of compartment-specific implants that fit better to ergonomic instruments has made me both more accurate and efficient. The system is definitely a move forward in the right direction,” said Dr. Della Valle.

Rocci Trumper, MD, at Poudre Valley Hospital in Fort Collins, Colorado successfully performed the first surgery of the Persona Partial Knee System since the full global commercial launch on August 31, 2017. “The instruments were thoughtfully designed and the tibial component fit well,” said Dr. Trumper.

There have been more than 1,000 cases to date across centers in the U.S., EMEA and Japan, and more than 260 patients have been enrolled in a 10-year global multi-center study.

“The introduction of the Persona Partial Knee System comes at a significant time as we continue to see an increase in the demand for knee replacements,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “This innovative technology furthers our commitment to restore mobility, alleviate pain and improve the quality of life for patients around the world.”

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

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Image courtesy of Zimmer Biomet.

Providence Medical Technology Expands Offering of Posterior Cervical Fusion Solutions

Posted On September 27, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

WALNUT CREEK, Calif., Sept. 27, 2017 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced FDA 510K clearance for its ALLY™ Posterior Fixation System. The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and is compatible with the company’s flagship DTRAX® Spinal System.

DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 7,000 cases worldwide. Posterior cervical fusion is indicated for patients with symptomatic nerve root involvement and/or mechanical instability. Spinal implants are typically used as an adjunct to posterior cervical fusion cases, and the newly cleared ALLY Posterior Fixation System is the latest addition to the family of spinal fusion implants offered by Providence. Providence also offers CAVUX® Cervical Cages, ALLY Bone Screws, and ALLY Facet Screws as options for spinal instrumentation during cervical fusion procedures.

“We are encouraged by the continued adoption of our posterior cervical fusion technology. Surgeons are increasingly considering posterior cervical fusion with intervertebral cages and supplemental screw fixation when treating patients with cervical spine disorders,” said Providence CEO, Jeff Smith. “The regulatory clearance of ALLY Posterior Fixation System is an important milestone and reflects our commitment to continued innovation and expansion of our differentiated product offering.”

Providence recently announced multiple independent clinical studies supporting the safety, efficacy, and cost-efficiency of its posterior cervical fusion technology. The company will be exhibiting at the annual meeting of the North American Spine Society (NASS) in Orlando, Florida, on October 25-28, booth #1140.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

SOURCE Providence Medical Technology

Global Surgeon Experience Demonstrates AxioMed Freedom® Viscoelastic Disc Will Be Revolutionary

Posted On September 27, 2017 By OrthoSpineNews In Spine, Top Stories /

MALDEN, MASS. (PRWEB) SEPTEMBER 27, 2017

AxioMed clinical experience across continents continues to point to the benefits of the AxioMed disc replacement, as Professor Dr. Kingsley R. Chin shares his clinical assessment, stating, “I was pleased with the motion seen between the spinous processes and facets immediately after implanting the AxioMed viscoelastic cervical disc during a recent case in Kingston, Jamaica. I noted that the disc needs some time to warm to body temperature to see more compression of the disc. In this case we inspected the motion immediately after implantation while the wound was still open.”

President of AxioMed Jake Lubinski added, “Dr. Chin’s experience is being echoed by surgeons, many implanting the disc for the first time, who can’t believe how simple and natural the sizing and placement of the disc is.”

Dr. Chin emphasized how easy the surgery is, pointing out, “Surgeons who have implanted the cervical or lumbar AxioMed Freedom discs all share their amazement at how simple the discs are to implant and how well the patients do. I expect this experience will result in a revolutionary change in spinal care from fusions to viscoelastic discs.”

Dr. Kingsley R. Chin is a Bohlman trained and board certified orthopedic spine surgeon who practices at the LESS Institute in Florida.

To view the latest cervical and lumbar AxioMed cases done in the past two weeks, visit AxioMed on YouTube.

About AxioMed
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® disc through clinical studies in the U.S. and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom disc technology.

Wenzel Spine Announces Refinements and Extended Size Range of the VariLift®-C

Posted On September 27, 2017 By OrthoSpineNews In Spine, Top Stories /

AUSTIN, TX September 26, 2017 – Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced the commercial availability of the revised VariLift®-C System throughout the U.S.

VariLift-C is now available in three heights, 8mm 9mm and 10mm, allowing surgeons to implant an optimally sized device in a broader patient population. Instrumentation has been modified to reduce size and to improve usability and ergonomics.

“The new features of the VariLift-C system enhances ease of use, and reduces overall exposure and instrumentation footprint. My patients have experienced excellent symptom relief and very low complication rates. In nearly all cases, VariLift-C procedures are done as outpatient surgeries, with patients returning home same day.” said Dr. Benjamin Gelber, M.D., Chairman, Division of Neurosurgery, Bryan LGH Medical Center in Lincoln, NB and Clinical Associate Professor, Department of Neurosurgery, University of Nebraska College of Medicine. He further added “Another benefit is no separate bone graft harvest or extenders are necessary for the VariLift-C. procedure. These enhanced features contribute to a very high success rate for my patients.”

VariLift-C 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. VariLift-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone.

VariLift-C may be used with or without supplemental fixation.

Wenzel Spine’s Cervical VariLift® Stand-Alone Expandable Interbody Fusion System and the redesigned instruments are now commercially available in the U.S.

About Wenzel Spine, Inc.

Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients. For more information about the company and our products, visit www.wenzelspine.com.

Follow Wenzel Spine on LinkedIn: https://www.linkedin.com/company/wenzel-spine
Follow Wenzel Spine on Twitter: https://twitter.com/WenzelSpine
Follow Wenzel Spine on Facebook: https://facebook.com/WenzelSpine
Follow Wenzel Spine on Instagram: https://Instagram.com/wenzelspine

For further information, contact:
Chad Neely, Chief Executive Officer
(512) 469-0600

SeaSpine Announces Launch of Shoreline® Anterior Cervical Standalone System

Posted On September 26, 2017 By OrthoSpineNews In Spine, Top Stories /

CARLSBAD, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of the Shoreline Anterior Cervical Standalone (ACS) System, featuring TruProfile^™ technology.

The Shoreline ACS System is designed to deliver maximum flexibility and modularity, offering zero- and low-profile plating options, including two, three and four hole variations, as well as 10 and 15 degree lordotic implants. This selection provides surgeons the ability to intraoperatively address a wide range of anatomy, surgical situations or bone. In addition, TruProfile technology offers a low profile plate design at 1.6mm thickness, minimizing the profile on the anterior aspect of the spine and minimizing cephalad caudal encroachment of adjacent segments.

“Shoreline with TruProfile has met the challenge of combining ease of implant placement and plate fixation to allow for a more responsive approach to specific patient requirements,” stated Dr. James Bruffey, an orthopedic surgeon in San Diego, CA.

All Shoreline interbody implants feature proprietary NanoMetalene surface technology designed to provide a bone-friendly titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity like bone, and excellent radiographic visibility for post-operative imaging. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a proprietary, high-energy, low-temperature process. Unlike other titanium coating applications, this process maximizes the implant surface area that has titanium nanotopography.

“The modular design of Shoreline with TruProfile is intended to optimize operating room efficiency and maximize procedural flexibility, while NanoMetalene provides the latest in surface technology,” stated Keith Valentine, President and Chief Executive Officer of SeaSpine. “In addition, we believe the hyperlordotic and large footprint offerings enable surgeons to assemble the best construct option to match patient anatomy.”

About SeaSpine
SeaSpine 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 implant 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 implant 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 implant product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete 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 may include, but are not limited to, statements relating to: the design and other benefits of the Shoreline ACS System, TruProfile technology, and NanoMetalene; the ability of the Shoreline ACS System to optimize operating room efficiency, maximize procedural flexibility, or enable surgeons to assemble the best construct option. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in our 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) 309-5999
ir@seaspine.com

SeaSpine Holdings Corporation