3D_Balance_ACS-AOK.jpg

K2M to Showcase 3D Spinal Balance Portfolio and Balance ACS® Platform at IMAST 2018

Posted On July 10, 2018 By OrthoSpineNews In Spine /  

LEESBURG, Va., July 10, 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 it will showcase its 3D spinal balance portfolio and Balance ACS® Platform at the 25th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, CA, at Booth #29. Additionally, the Company will host four interactive workshops facilitated by distinguished leaders in spine surgery.

“K2M is excited to attend this year’s IMAST, a prestigious meeting for surgeons to explore the latest topics, technologies, and techniques in spinal deformity,” said John P. Kostuik, MD, Chief Medical Officer and Co-founder at K2M. “Over the past year, we have grown our product offering—as evidenced by our 100th product milestone and our launch of BACS Patient-Specific Rods & Rails at IMAST. We remain committed each day to inventing new solutions that help surgeons improve the lives of people living with spinal disease.”

At the meeting, K2M will showcase its comprehensive 3D spinal balance portfolio. Products include the YUKON™ OCT Spinal System, NILE® Alternative Fixation Spinal System, RAVINE® Lateral Access System, EVEREST® MI and MI XT Spinal Systems, CHESAPEAKE® Anterior-Lumbar Stabilization System, OZARK™ Cervical Plate Systems, and more.

The Company will also feature Balance ACS (BACS®), which provides solutions to help surgeons achieve 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.

K2M to Host Interactive Workshops in Diamond Salon 6

  • Techniques for Correcting Cervical Spine Deformities
    Wednesday, July 11 (4:00–6:00 p.m.)
    Christopher Ames, MD; Steven Glassman, MD; Jeffrey Gum, MD
  • Using Spinopelvic Parameters to Optimize Correction in the Adult Patient
    Thursday, July 12 (12:30–1:30 p.m.)
    Christopher Ames, MD; Shay Bess, MD; Robert Lee, BSc, FRCS
  • Alternative Fixation Using Band Technology
    Thursday, July 12 (5:15–6:15 p.m.)
    Gregory Mundis, MD; Burt Yaszay, MD
  • Hybrid Approaches to Deformity Surgery
    Friday, July 13 (12:00–1:00 p.m.)
    Robert Lee, BSc, FRCS

For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

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

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

Media Contact:

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

Investor Contact:

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

Read More
1c-PROCEDURE-step4_01220-crop-resized-12-1.png

Relievant Announces First Commercial Intracept Procedures

Posted On July 10, 2018 By OrthoSpineNews In Spine /  

MINNEAPOLIS, July 10, 2018 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), announced today the successful completion of the first commercial Intracept Procedures.  The procedures were performed by Dr. Bradly Goodman at OrthoAlabama Spine & Sports in Birmingham, Alabama and Dr. Erik Bendiks at Georgia Spine & Orthopaedics in Atlanta, Georgia.

Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, costing nearly $150 billion each year in medical treatment and lost productivity. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Existing therapies fail to provide adequate pain relief for approximately 80 percent of CLBP patients.

The Intracept Procedure is based on groundbreaking research that identified and demonstrated the role of the basivertebral nerve in transmitting low back pain. The procedure utilizes a minimally invasive approach to reach the basivertebral nerve near the center of the vertebral body and delivers radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine surgeons and interventional pain specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.

The company published the results of the SMART trial, a Level I, sham-controlled randomized controlled trial (RCT) in February 2018 and is currently enrolling patients in a second Level I RCT, the INTRACEPT study, at 20 US sites to expand the portfolio of evidence demonstrating the benefits of the Intracept Procedure.

“We are pleased to initiate the commercialization of Intracept in the United States and to offer this clinically-proven pain relief option to the large segment of chronic low back pain patients who cannot find relief from conservative care and who are not surgical candidates,” said Kevin Hykes, President and Chief Executive Officer. “The ability to intervene early in the disease continuum with this minimally invasive treatment has the potential to significantly improve quality of life and to reduce or eliminate the need for opioids. We are committed to working with patients, physicians and payors to facilitate access to this important new therapy.”

About the INTRACEPT Clinical Study
Relievant is sponsoring the INTRACEPT clinical study to compare outcomes in CLBP patients treated with the Intracept Procedure versus standard medical care. The primary efficacy endpoint is the mean change from baseline to 3 months post-treatment in the ODI, a measurement of the impact of back pain on functional status. The Intracept Procedure will also be evaluated for impact in reducing healthcare costs. The INTRACEPT study will enroll up to 150 patients at up to 20 leading medical centers across the U.S. Patients will be randomized 1:1 between the Intracept Procedure arm vs non-surgical management therapies to treat their CLBP.  Patients in the control arm will have the opportunity to receive the Intracept Procedure after 12 months.  Please visit www.intraceptstudy.com for more information.

About Relievant Medsystems
Founded in 2006 and with offices in Minneapolis, MN, and Sunnyvale, CA, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.

FDA has cleared Relievant’s Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

Contact
Chris Geyen
Chief Financial Officer
(650) 368-1000
investors@relievant.com

Read More
TitanSpine_Endoskeleton_WEB-A-1.jpg

Titan Spine Appoints Brian Burke as Chief Operating Officer

Posted On July 10, 2018 By OrthoSpineNews In Spine, Top Stories /  

July 10, 2018

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Brian Burke as Chief Operating Officer (COO). In his role, Mr. Burke will have broad cross-functional responsibility for the Company’s main business functions of sales, marketing, operations, hospital contracting, research and development, human resources, and legal, all to further support the growth of the Company and adoption of its nanoLOCK® surface technology.

nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1

Peter Ullrich, MD, Chief Executive Officer of Titan Spine, commented, “As we continue to focus on growth, we identified a need to bring on additional executive talent to the Titan Spine team. Brian has extensive experience driving effective and dynamic functional leadership, brings a wealth of experience in the medtech industry working with both privately and publicly held companies, and has demonstrated a proven track record of implementing operational efficiency. We welcome Brian and believe he will be instrumental in expanding Titan’s strategic positioning in the marketplace.”

Prior to joining Titan Spine, Mr. Burke served as General Manager for Zimmer Biomet Dental in North America where he successfully led the integration of commercial sales and marketing in the United States and Canada following the $13.4B acquisition of Biomet by Zimmer in 2015, which created the second-largest company in the dental implant and oral reconstructive surgery market. He was responsible for leading all North American sales channels that encompassed direct sales, inside sales, and specialty sales. Before Zimmer Biomet, Brian was Group Director of Latin America and Asia for Biomet 3i, where he managed all sales and marketing activities while also managing regulatory compliance and in-country manufacturing in specific global areas.

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

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

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

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

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

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

Contacts

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

Read More
335_main-1.jpg

Mainstay Medical Announces the Completion of All Implants in the ReActiv8-B Study

Posted On July 9, 2018 By OrthoSpineNews In Spine /  

July 09, 2018

DUBLIN–(BUSINESS WIRE)–Regulatory News:

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces the completion of all implants in ReActiv8-B, its US IDE clinical study.

A total of 204 patients were implanted in the study, reflecting the strength of interest in study participation. The implants were completed in accordance with the Company’s planned timeline and the Company expects to announce a full data readout towards the end of 2018.

Jason Hannon, CEO of Mainstay, said: “Completing all implants in the ReActiv8-B study is a significant step for Mainstay and represents continued momentum in our efforts to bring ReActiv8 to patients in the US. We remain on track to have full study data towards the end of 2018. I would like to thank the study participants and investigators for their participation — we look forward to announcing the results of the study later this year.”

ReActiv8-B is an international, multi-centre, prospective, randomized, sham-controlled triple-blinded study with one-way crossover, conducted under an IDE from the US Food & Drug Administration (FDA). The study is intended to gather data in support of a pre-market approval (PMA) application to the FDA, a key step towards the commercialization of ReActiv8 in the US. The study utilizes an adaptive trial design, inclusive of an interim analysis. In December 2017 the Company announced a positive outcome of the interim analysis.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (MSTY.IE).

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstaymedical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Contacts

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Jessica Hodgson, Nicholas Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
or
FTI Consulting (for Ireland):
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
or
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
or
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
or
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Image courtesy of Mainstay Medical

Read More
1-bto-1.jpg

Paragon 28® announces launch of non-sterile instrumentation to aid surgeons in collection of autogenous bone – Bone Graft Harvesting System

Posted On July 9, 2018 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., July 8, 2018 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

Today, Paragon 28 continues to honor a tradition of comprehensive and innovative solutions with the launch and release of the Bone Graft Harvesting System.

The Bone Graft Harvesting System was created to offer a means to effectively harvest autogenous bone with a straightforward technique, no matter the harvest site chosen.

Common issues that can arise while obtaining autogenous bone includes removal of graft from the harvester, difficulty controlling the amount of bone harvested, and inconsistency of the morselized bone. The Paragon 28® Bone Graft Harvester addresses these concerns by offering three convenient sizes (6 mm, 8 mm, 10 mm) to provide options when choosing the harvest site. The morselizing tip on the harvester allows for control of consistency based on the speed of the drill, while depth markings assist the surgeon with controlling the harvest volume and penetration depth. A 2.3 mm K-wire is also available in this system for use if a pilot hole is desired.

The Bone Graft Harvesting kit disposable trephine and reusable door assemblies are made from medical grades of Stainless Steel.  The Bone Graft Harvesting System is delivered in a non-sterile configuration and fits into the Paragon 28® Gorilla® R3CON Plating system.  The system is self-contained for a case and can be used in combination with other Paragon 28 systems or in isolation.

About Paragon 28, Inc.

Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. From the onset, Paragon 28 has made it our goal to re-invent the space of foot and ankle surgery. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Website:

http://www.paragon28.com/products/bone-graft-harvest-system/

Contact:

Jim Edson, Vice President of Product Management and Marketing

jedson@paragon28.com

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com

Read More
GettyImages-667599137_meniscaltear_hero-1-23-bto-1.jpg

HSS Researchers Launch Study to Look for Clues to Meniscal Healing After Surgery

Posted On July 9, 2018 By OrthoSpineNews In Sports Medicine /  

NEW YORK, July 9, 2018 /PRNewswire-USNewswire/ — Researchers at Hospital for Special Surgery in New York City are launching a new study to identify inflammatory molecules that might help improve treatment of people with certain knee injuries.

The goals of the study, which is now enrolling patients, is to find biomarkers correlated with the development of osteoarthritis of the joint after surgery to fix traumatic tears of the meniscus. This horseshoe-shaped layer of cartilage cushions the bones of the knee during weight-bearing activities like running and jumping.

More than one million Americans annually undergo meniscal surgery, making it among the most common orthopedic procedures performed in the United States. The injuries generally occur in young athletes who experience violent trauma to the knee, although older people can suffer them without such trauma, as well. However, patients who undergo the procedure often develop osteoarthritis of the joint—a painful, degenerative condition that to date has no cure or particularly effective treatment.

“The bottom line is, this is a very common orthopedic surgery and the results are not very good,” said David W. Altchek, MD, sports medicine surgeon and co-chief emeritus of HSS Sports Medicine, and medical director for the New York Mets. “It seems like the surgery makes a small number of people better, some have an indifferent response and, unfortunately, a significant number of people get worse.”

“We don’t really know much about the biology of how the meniscus heals. We kind of let pain be the guide,” added Christopher Mendias, PhD, ATC, associate scientist at HSS, who is helping conduct the study. “We want to be able to say, ‘Is it healing well, and is there a correlation between doing poorly clinically and elevated levels of pro-inflammatory biomarkers or that we can detect with advanced imaging?'”

The HSS study will have several components. Drs. Altchek, Mendias and their colleagues will take samples of synovial fluid–a viscous substance that lubricates joints–from 28 patients (14 men and 14 women) aged 18 to 45 undergoing a procedure called partial meniscectomy in which surgeons shave away frayed pieces of the cartilage. Those samples will be screened for the presence of proteins associated with inflammation, molecules such as interleukin 1 beta, which is known to play a role in osteoarthritis, as well as other previously unidentified substances.

The researchers also will use an advanced form of magnetic resonance imaging to track meniscal healing over time, and will match that information with the biomarker activity to look for patterns of protein activity that predict either successful healing or poor outcomes.

“This whole idea of precision medicine is just kind of catching on in orthopedics now,” Dr. Mendias said. Ideally, a biomarker panel could help surgeons determine which patients will be most likely to benefit from particular meniscal procedures, and what kind of rehabilitation–and even prehabilitation–routine they should undergo. “It could also help us identify therapies to block those inflammatory molecules and reduce the risks of osteoarthritis later in life,” he said.

“The hypothesis is that there is a degenerative effect afterward, as a result of the injury or the surgery, or both—and that biologic therapy might slow that down,” Dr. Altchek said. He added that there is “a tremendous amount of excitement” in the field of orthopedics about new biologic therapies, including platelet rich plasma and stem cells, that are now being used to treat tendon injuries and certain other ailments. Whether they might work to treat or even prevent the development of osteoarthritis after knee surgery is unclear. “This project is an important step in the direction” of answering that question, he said.

Scott A. Rodeo, MD, sports medicine surgeon, co-chief emeritus of HSS Sports Medicine, and co-director of the Tissue Engineering, Regeneration, and Repair Program, will be contributing patients to the study.

“A common clinical observation is that there is tremendous variability in the rate and risk of progressive degenerative changes in patients undergoing surgery for meniscus injury,” said Dr. Rodeo, who also is head team physician for the New York Giants. “Some patients will do well for decades with no further problems, while there is a subset of patients who develop relatively rapid progression of degenerative changes. In addition to biomechanical factors, it is likely that the ‘biologic milieu’ in the joint is a major factor accounting for these discrepant outcomes. In this study we will characterize inflammatory mediators, matrix degrading enzymes, and a host of other cytokines that likely play an important role in joint homeostasis. Such information will not only help us gain a better understanding of the underlying mechanism of joint degeneration in patients with meniscus injury, but, importantly, may suggest therapeutic targets to allow development of innovative treatments.”

Other HSS physicians involved include HSS sports medicine surgeons Answorth A. Allen, MD, New York Knicks team physician; and Riley J. Williams III, MD, medical director of the Brooklyn Nets.

If you have a meniscus tear and are interested in the study, or would like to serve as a healthy control subject, please contact Daniel Edon (edond@hss.edu).

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries and performed more than 32,000 surgical procedures. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 22.000 subscribing musculoskeletal healthcare professionals in 125 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care and to make world-class HSS care more accessible to more people.

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu

Read More
AEROBIOTIX-Logo-STACKED-small-1.png

Loma Linda Veterans Benefit from New Advanced Environmental Technology

Posted On July 9, 2018 By OrthoSpineNews In Biologics /  

May 25, 2018

LOMA LINDA, Calif.–(BUSINESS WIRE)–In the fight against hospital acquired infections, Veterans Administration medical centers play a critical role in protecting the health of America’s veterans. At the 159-bed Veterans Administration Loma Linda Healthcare System in California, administrators have adopted the latest technology in fighting airborne bacteria and viruses which contribute to these infections. Recently, the hospital adopted the Illuvia system by Aerobiotix, a unique technology which utilizes ultraviolet energy to eliminate airborne pathogens in the hospital environment. This includes drug resistant microbes such as MRSA. “The hardest place to kill a pathogen is inside the human body. If we can eliminate the danger in the air before it gets a chance to enter the patient, the human and economic benefits are profound,” states Dr. David Kirschman, M.D. founder of Aerobiotix, Inc.

The Veterans Administration Loma Linda has installed the Illuvia systems in ten hospital locations including operating rooms and surgical supply areas. In peer reviewed data, these systems have been shown to significantly reduce airborne bacterial and contamination levels.

About Aerobiotix Inc.

Aerobiotix, Inc. is a company driving leadership in advanced air quality products for the healthcare market. The company develops, manufactures and markets novel technologies to build better healthcare environments worldwide. Our focus is to build awareness of the contribution of air quality issues to hospital-acquired infections and provide safe, effective devices to improve the environments of care. Today, our products benefit patients and caregivers around the globe.

Contacts

Aerobiotix, Inc.
Ann Dunham
Department of Marketing
adunham@aerobiotix.com

Read More
Calcium-Phosphate-Bone-Cement-390x220-12-1.png

Bone Cement Market Outlook 2025 – Leading Key Players are DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew, DJO Global, Arthrex

Posted On July 9, 2018 By OrthoSpineNews In Financial /  

(EMAILWIRE.COM, July 09, 2018 ) Bone Cement Market

Bone cement is used for the fixation of prosthesis to the bone in various orthopedic musculoskeletal surgical procedures for the treatment of osteoporosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, severe joint destruction secondary to trauma, collagen disease, and revision of previous arthroplasty.

In our study, we have segmented the bone cement market by type, application, and end user. Based on type, global bone cement market is segmented as polymethyl methacrylate (PMMA) cement, calcium phosphate cement (CPC), glass polyalkenoate cement (GPC), and others. Based on application, the market is segmented into arthroplasty, kyphoplasty, and vertebroplasty. On the basis of end user, the market is segmented as hospitals, ambulatory surgery centers, and clinics. Geographically, the market for bone cement is segmented into North America, Europe, Asia Pacific (APAC), Middle East and Africa (MEA) and South and Central America (S&CAM).

Download Sample Copy @ http://bit.ly/2yVvDWm

The bone cement market is estimated to grow at a CAGR of 5.4% during the forecast period from 2018 to 2025. The market for bone cement is projected to reach US$ 1,414.1 Mn in 2025. The market is witnessing a potential growth rate during the past few years and is expected to witness similar trend in the coming years. Factors such as, increasing prevalence of osteoporosis, growing demand for arthroplasty procedures, and growing geriatric population are primarily contributing to the growth of this market. Additionally, major manufacturers in the market are engaged in research and development activities to develop advanced products. Furthermore, rise in umber of osteoporosis cases and increase in number of bone disease cases are expected to boost the demand for bone cement in the coming years. According to a survey conducted by International Osteoporosis Foundation, around 15-30% male and 30-50% females are at a risk of suffering from osteoporotic fracture during their lifetime. Moreover, according to the International Osteoporosis Foundation, approximately one out of five men and one in every three women over the age of 50 would suffer from a fracture owing to osteoporosis. This is expected to stimulate the demand of bone cement market in the coming years. However, availability of substitutes can hamper the growth of this market at a certain extent.

 

READ THE REST HERE

 

Read More
download-123.png

100th Surgical Implantation of ZIP ULTRA™ MIS Interspinous Device Performed in Canada

Posted On July 9, 2018 By OrthoSpineNews In Spine, Top Stories /  

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

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

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

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

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

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

About Dr. Heran

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

About False Creek Healthcare Centre

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

About the ZIP Implant

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

About Aurora Spine

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

Forward-Looking Statements

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

CONTACT INFORMATION

Aurora Spine Corporation

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

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

Read More
misonix_01-2-bto2.jpg

New Study Shows Superior Healing Outcomes Associated with Ultrasonic Debridement

Posted On July 9, 2018 By OrthoSpineNews In Extremities /  

FARMINGDALE, N.Y., July 09, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (NASDAQ:MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today the results of a new Randomized Controlled Trial (RCT), which demonstrated superior healing outcomes associated with the use of ultrasonic debridement for lower extremity wounds.

The study, “The effect of 22.5kHz low frequency contact ultrasound debridement (LFCUD) on lower extremity wound healing for a vascular surgery population: A Randomized Controlled Trial” – was published in the International Wound Journal, and compared Misonix’s SonicOne® ultrasonic debridement device to standard sharp debridement in a 70 patient study conducted by The Ottawa Hospital: Limb Preservation Program in Ottawa, Canada. It concluded that SonicOne ultrasonic debridement treatment resulted in better wound appearance, significant reduction in wound area and superior healing outcomes, compared to other patients in the study that were not treated with SonicOne.

Stavros Vizirgianakis, President and CEO of Misonix, commented, “We are very proud to partner with world class wound care facilities like The Ottawa Hospital: Limb Preservation Program. These results from their recently published study are important both because of the study’s rigor and its conclusive data, which shows marked improvement in healing rates and effectiveness of our SonicOne ultrasonic technology to positively and significantly impact patients’ lives. Wound treatment is an attractive growth opportunity for Misonix and we are confident that our best-in-class ultrasound wound treatment products will allow us to significantly grow across both existing and new markets and drive added adoption of our therapeutic ultrasonic medical devices, including SonicOne.”

Dr. Christine Murphy, lead author of the study, said, “This detailed work is strong evidence that SonicOne improves tissue quality in a challenging population facing very high risk of amputation, including more wound closures. A Randomized Controlled Trial is level one evidence and not commonly available for wound technologies, and as an assessor-blinded study, this is very powerful.”

About Misonix, Inc.
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s web site at www.misonix.com.

Contact: 
Joe Dwyer Joseph Jaffoni, Norberto Aja, Jennifer Neuman
Chief Financial Officer JCIR
Misonix, Inc. 212-835-8500 or mson@jcir.com
631-694-9555
Read More