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February 2-4, 2017

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September 1, 2016 OrthoSpineNews

WARSAW, Ind., Sept. 1, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that it will be participating in the INVESTIndiana Equity Conference at the Indianapolis Marriott Downtown on Thursday, September 15, 2016 at 1:10 p.m. Eastern Time.

A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website athttp://investor.zimmerbiomet.com.

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; spine, bone healing, 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.

About INVESTIndiana
Since 2008, the INVESTIndiana Equity Conference has given professional investors and fund managers an opportunity to interact with leading Indiana public companies.  The event features CEOs, CFOs and corporate leaders discussing important trends and their strategies to grow their companies.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com



September 1, 2016 OrthoSpineNews

KALAMAZOO, Michigan, USA, Sept. 1, 2016 /PRNewswire/ — Stryker’s Endoscopy division announced today it has acquired Ivy Sports Medicine, LLC, whose portfolio is comprised of a comprehensive minimally invasive meniscal repair platform. The addition of Ivy Sports Medicine’s portfolio enables Stryker to provide customers with a complete meniscal platform to better serve their patients.

The portfolio includes the only FDA-approved collagen meniscus implant (CMI®) on the market, a reliable and innovative all-inside repair device, as well as an inside-out meniscal suturing platform.  Ivy’s history and sole focus on advancing the treatment of meniscal injuries is also highly complementary to Stryker’s current portfolio of visualization, resection, fluid management, and ACL reconstruction platforms.

“The acquisition of Ivy Sports Medicine strengthens our capabilities and fits strategically with our current portfolio. Ivy’s complete meniscal platform, coupled with their clinical history, will allow us to provide our customers with multiple solutions to address meniscal repair,” said Matt Moreau, Vice President and General Manager of Stryker’s Sports Medicine business.  “This is an area of sports medicine where there is continued opportunity to address unmet customer needs. The Ivy portfolio provides a unique platform for us to build upon as we seek to continue advancing the treatment of meniscal injuries.”

“Ivy Sports Medicine was formed to capitalize on the unmet opportunity in meniscal repair, which we view as one of the more attractive growth opportunities in all of orthopaedics,” said Robert Pangia, CEO of Ivy Sports Medicine. “Our products provide surgeons with a complete set of tools to treat a large spectrum of meniscal repairs. We are excited about the prospects of combining these products with Stryker’s distribution channels and complementary portfolio of sports medicine products.”

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

Media Contact
Jenny Braga, Senior Communications Manager
jenny.braga@stryker.com

Logo – http://photos.prnewswire.com/prnh/20140106/PH40722LOGO

SOURCE Stryker

Related Links

http://www.stryker.com


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September 1, 2016 OrthoSpineNews

CARLSBAD, Calif., Sept. 01, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq: ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced the completion of the previously announced sale of its international operations and distribution channel to Globus Medical (NYSE: GMED), a leading musculoskeletal implant manufacturer.

With the closing of the transaction, the Company is now focused solely on the U.S. market, which Alphatec believes constitutes nearly 65% of the world’s spinal fusion market.

Over the past several years, the Company has focused its R&D programs and invested in the development of a leading, robust suite of products that are available to surgeons in the U.S. today—including Arsenal™ Degenerative, Arsenal Deformity and Battalion™ Universal Interbody.  In addition, the Company has recently obtained U.S. clearance for its new XYcor® Expandable Spinal Spacer System, which the Company plans to launch later this year.  The Company also made significant progress through its initiative to outsource its manufacturing operations—reducing capital investment in equipment, partnering with valued suppliers to provide flexible capacity, while achieving unit level cost reductions and margin improvements. As a result, Alphatec believes it is now better positioned to compete more effectively in the marketplace, accelerate growth and continue to improve profitability.

“Today marks the beginning of a new chapter for Alphatec,” said Jim Corbett, President and Chief Executive Officer of Alphatec Spine. “I am excited about the long-term prospects for the company as we pursue the U.S. spinal market with the resources we need to support continued investment in the commercialization of our robust product line. We have the right products, an exceptional team and a newly streamlined balance sheet to support our growth across the country, and we look forward to executing on our vision.”

Terms of the Transaction

Globus acquired Alphatec’s international operations and distribution channel for a purchase price of $80 million in cash. Globus will also provide Alphatec a five-year senior secured credit facility of up to $30 million. In addition, Alphatec has entered into a supply agreement through which Alphatec will supply its products to Globus for up to five years.

New Capital Structure

With the closing of this transaction, Alphatec believes that it can now establish a new capital structure that appropriately reflects the capital needs of its U.S.-focused business and positions the company for achieving future profitability. As part of the closing, Alphatec implemented the following related to this new capital structure:

  • Drew down $25M of the $30M credit facility from Globus upon closing;
  • Paid off the existing Deerfield credit facility balance and retired the credit facility;
  • Reduced the MidCap Financial term loan to a $5M balance; and
  • Reduced the MidCap Financial revolver commitment to $22.5M.

With this, Alphatec expects to have paid down approximately $66 million of existing debt and debt-related expenses.

Concurrent with this transaction, Deerfield Management Company, L.P. has utilized its cashless exercise provision under its warrant agreements, converting its warrants to purchase up to 11.45 million shares of common stock to approximately 3.2 million shares on a pre-reverse split basis. This will constitute approximately 269 thousand shares on a post-reverse split basis.  As a reminder, on August 25, 2016 the Company completed a one-for-twelve reverse stock split.

“As a result of this transaction, we are able to improve Alphatec’s forward-looking balance sheet by reducing our overall debt while providing the liquidity and reserves needed to invest in commercializing our robust product portfolio,” said Mike O’Neill, Alphatec’s Chief Financial Officer.  “The new term loan from Globus, in conjunction with a planned revolving line of credit from MidCap Financial, provides the company with credit facilities of up to $57.5 million, which will offer sufficient liquidity and appropriate financing to successfully support Alphatec’s transition to a U.S. market based company.  Upon closing, we estimate our total debt drawn will be approximately $45 million. I would like to thank Deerfield who has been an excellent partner and we appreciate the support that they have provided to the company through the years. I am also pleased that MidCap will remain as a lender and provide funding for the company going forward. I want to thank them for their continued commitment and support to Alphatec.”

The Company expects that its stronger financial foundation coupled with its strong product portfolio will support future investments in its capital instrument base each year. These investments will be used to drive the commercial expansion of its new product lines, which are expected to contribute substantially to its planned growth profile. In addition, the Company has already made substantial headway towards its goal of reducing its operating expenses by $20 million. The Company expects this to continue for the remainder of 2016 and into 2017, translating to positive cash flow and profitability in the back half of 2017.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

About Globus Medical

Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.  The Company cautions you that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the Company’s ability to compete in the U.S. marketplace, accelerate growth and continue to improve profitability, continued investment in the commercialization of the U.S. product lines and in its capital instrument base, expected capital re-structuring and expected reductions in operating expenses and the timing and likelihood of cash flow and profitability. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the Company’s ability to execute on its business plan and effectively compete in the U.S. marketplace; the Company not realizing the full economic benefit from the transaction, including as a result of indemnification claims under the definitive purchase agreement and the retention by the Company of certain liabilities associated with the international business; the Company’s ability to meet its obligations under the supply agreement and its credit facilities; the uncertainty of success in developing new products or commercializing products currently in the Company’s pipeline, including the products discussed in this press release; the Company’s ability to successfully reduce and control its costs, improve its margins and improve its profitability; claims related to the Company’s intellectual property; product liability exposure; and other risks detailed in the Company’s public periodic filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement.

CONTACT: Investor/Media Contact:

Christine Zedelmayer

Investor Relations

Alphatec Spine, Inc.

(760) 494-6610

czedelmayer@alphatecspine.com

Source: Alphatec Holdings, Inc.


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September 1, 2016 OrthoSpineNews

Submitted by

In light of the recent news that New York Mets’ third baseman David Wright elected to undergo neck surgery to repair a herniated disc, there has been a buzzing discussion on the impact of such a decision on Wright himself, the team, and the season. And most of the questions swirling distill to one: Is this the right choice given the circumstances?

Professional athlete or not, this is a question most patients grapple with when it’s time to consider spine surgery—it’s a mentally taxing topic. There are a million questions that dance around in a patient’s head.

  • Have we really exhausted all other options?
  • Will I make a complete recovery?
  • Will what I’m giving up be worth it in the end?

As a spine surgeon, I can tell you that the patient’s health and quality of life to come are the major drivers of our treatment recommendations. And though some sacrifices may have to be made, sometimes surgery may very well be the answer that will supply the best outcome. It is equally important, however, for patients to be on the same page with the course of treatment recommended—both surgeon and patient must move forward hand-in-hand.

I can say with confidence, that for almost any patient (and I’ve treated many) surgery is not something that is even considered until other treatment options have been fully exhausted and have failed to provide adequate relief. In Wright’s case specifically, his treatment team made the decision to proceed with surgery after many tests, rest and anti-inflammatory medications and injections were administered and did not sufficiently alleviate his pain or improve his ability to move his neck properly. This kind of assertive nonsurgical treatment is delivered with the hope of providing a suitable resolution of symptoms that would deem surgical intervention unnecessary. Immobilization, medications to reduce inflammation, swelling and pain, slews of diagnostic tests (X-rays, MRI’s), and intense physical therapy are all front-runner treatment options delivered with the hope to avoid the next more serious step.

 

READ THE REST HERE


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September 1, 2016 OrthoSpineNews

By JOHN GAUDIOSI • August 28th, 2016

Dr. Robert Louis, a neurosurgeon at Hoag Memorial Hospital Presbyterian in Orange County, CA, is pitched some type of new technology, gadget or medication every day. He’s shown things so often that he developed an internal filter that automatically sets expectations a lot lower than the enthusiasm of the rep. But that all changed in October 2015.

That’s when Surgical Theater reps dropped by to showcase the Surgical Navigation Advanced Platform, or SNAP. Designed by former Israeli fighter pilots, the technology uses virtual reality to allow neurosurgeons to “fly” through a patient’s brain to get a better look at tumors, nerves, blood vessels and tissue prior to surgery. Before surgery, the patient’s brain is captured and recreated as a 3D model for Dr. Louis or his colleague Dr. Christopher Duma, neurosurgeon and director of Hoag’s Brain Tumor Program, to navigate.

Hoag is currently using an Oculus DK2, but the FDA recently cleared the consumer Oculus Rift for use and that will be deployed moving forward in all medical facilities, according to Jim Breidenstein, president and COO at Surgical Theater’s SNAP division.

Louis said prior to the introduction of this technology, he’d have to reference black-and-white 2D “slices” of the brain and then use his imagination (and 20 years of surgical experience) to map out the surgical procedure in his head before entering the Operating Room.

Since SNAP is registered with both Stealth, a technology Hoag uses, and Brainlab, that 3D model of the patient’s brain is used to track the tips of the instruments as the neurosurgeon navigates the brain. It works like a GPS inside the head, allowing doctors to track their instrument in real-time.

“Instead of looking at a 2D model, I can now see the tips of the instruments on the 3D Surgical Theater System on screen and compare that to what I’m seeing through the lens of the microscope,” said Louis, who is also director of Hoag’s Skull Base and Pituitary Tumor Program.

 

READ THE REST HERE


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September 1, 2016 OrthoSpineNews

8/23/2016

CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, announced that it has established a General Services Administration partnership with Firehouse Medical Inc. to sell its line of innovative spinal implants and devices to the U.S. government. GSA contracts allow commercial companies to establish long-term, government-wide contracts and sell their products and services at volume discount pricing.

“Partnering with Firehouse Medical Inc. was a no-brainer for us. Their extensive experience working with the U.S. government is something we value, and we are thrilled to provide our products to a new customer base,” said Daniel Chon, president and CEO of CTL Medical Corporation.

Firehouse Medical Inc. is a full line distributor of medical/rescue supplies and training simulators, currently holding three long-term, fixed-price GSA contracts; a Defensive Logistics Agency Med/Surgical contract; a Distribution and Pricing Agreement with the DLA; and multiple state contracts.

“We are extremely pleased to enter into a partnership with CTL Medical Corporation,” said Brent Poole, CEO of Firehouse Medical Inc. “Because of our multiple GSA contracts, VA hospital relationships and the value of CTL Medical Corporation’s product offerings, we expect to see excellent sales penetration in the government markets we serve.”

For more information on CTL Medical Corporation visit www.ctlmed.com. For more information on Firehouse Medical Inc. visit www.firehousemedical.com.

About CTL Medical Corporation

CTL Medical Corporation was established in 2015 by Daniel Chon, former president & CEO of AccelSPINE®, with the vision of creating a fully integrated, industry leading, global medical device design, development, and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talent, further extending their position as a leader in medical device design and manufacturing.For more information on CTL Medical Corporation visit www.ctlmed.com.

About Firehouse Medical Inc.

Founded in 1995, Firehouse Medical Inc. and its subsidiary, FHM EMS Supply LLC, are headquartered in Southern California, with sales and warehousing in Huntsville, Alabama. Firehouse Medical Inc. holds three long-term, fixed-price General Services Administration contracts, a Defense Logistics Agency Med/Surgery contract, a Distribution and Pricing Agreement with the DLA, and multiple state contracts. Firehouse Medical consistently ranks in the top 200 GSA contractors in sales performance out of a total of 22,000 GSA contracting companies. For more information on Firehouse Medical Inc. visit http://www.firehousemedical.com.

 

Media Contact:

Jeff Cheatham

TrizCom PR

O: 972-247-1369

C: 972-961-6171

jeffc@trizcom.com

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September 1, 2016 OrthoSpineNews

CHICAGO–(BUSINESS WIRE)–September 1, 2016

Navigant (NCI) today announced it acquired Dymedex Consulting, LLC, a Minnesota-based firm that provides data-driven market analysis to accelerate adoption and maximize growth for medical device companies. Dymedex offers insights through global strategic market assessments, tactical geography planning, and market landscape analysis.

The addition of the experienced Dymedex team, as well as the firm’s proprietary market development tools and methodologies, expands Navigant’s capabilities in the medical technology and life sciences industries. Navigant also plans to make the Dymedex tools, methodologies and expertise available to its healthcare clients.

“In today’s medical device market, it is critical that companies create the conditions necessary to optimize growth, utilization, and adoption. Dymedex has a proven methodology to assist companies in accelerating the development of global markets,” said Eduardo Schur, managing director and Global Life Sciences practice leader, Navigant. “And while Dymedex has been successful in the medical technology field, we are excited by the opportunity to expand their methodologies into other life sciences areas such as pharmaceuticals and biotech.”

The Dymedex team, including founders Joseph Galatowitsch and Ross Meisner, will join the Navigant Life Sciences practice within the company’s Healthcare segment.

“Uncovering critical market insights and facilitating data-driven decisions is vital to the success of life science and med tech companies,” said Joseph Galatowitsch, co-founder of Dymedex Consulting and managing director at Navigant. “The combination of Dymedex’s proprietary tools and methodologies with Navigant’s deep industry expertise and global footprint will enable our clients to fully capitalize on their opportunities.”

Based in Minneapolis, Dymedex has evaluated over 100 different medical technologies for their clients and worked in nearly 20 countries around the world. With deep knowledge of the challenges clients face, Dymedex helps clients address complex problems across multiple therapeutic and clinical areas and works on a wide range of medical technologies and business models, including monitoring and diagnostic products, therapies of all types, surgical tools, disposables, capital equipment, and other complex or combination devices.

About Navigant

Navigant Consulting, Inc. (NCI) is a specialized, global professional services firm that helps clients take control of their future. Navigant’s professionals apply deep industry knowledge, substantive technical expertise, and an enterprising approach to help clients build, manage and/or protect their business interests. With a focus on markets and clients facing transformational change and significant regulatory or legal pressures, the Firm primarily serves clients in the healthcare, energy and financial services industries. Across a range of advisory, consulting, outsourcing, and technology/analytics services, Navigant’s practitioners bring sharp insight that pinpoints opportunities and delivers powerful results. More information about Navigant can be found at navigant.com.

About Dymedex

Dymedex is a market development consulting firm that helps medical technology companies reach full market potential by using data-driven market analysis and insight to improve decision-making. Dymedex has developed over 100 customized medical technology market development plans in all major markets globally. Dymedex understands the industry’s challenges, and relies on more than 80 years of combined experience that includes nearly every major disease and condition. Data-driven critical thinking, shaped by broad experience, helps us consistently deliver key insights. At Dymedex, we are driven to provide foundational scientific market analysis that organizations can rely on to move forward with confidence.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160901005264/en/


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September 1, 2016 OrthoSpineNews

LEESBURG, Va., Sept. 01, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced management will present at the following investor conferences in September:

The 2016 Wells Fargo Healthcare Conference at the Westin Boston Waterfront in Boston, Massachusetts

  • Management will present on Thursday, September 8 at 2:20 p.m. Eastern Time

The Morgan Stanley Global Healthcare Conference at the Grand Hyatt in New York, New York

  • Management will present on Monday, September 12 at 1:05 p.m. Eastern Time

Live audio webcasts of the presentations will be provided under the ‘Events & Presentations’ section of the Company’s investor relations website at http://investors.K2M.com/. It is recommended that listeners log on 15 minutes early in order to register and download any necessary software. An archive of the webcast will be available for replay following the conference.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

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, including with respect to our international distribution partners in Australia and Japan. 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; our ability to successfully demonstrate the merits of our technologies and techniques; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; the greater resources available to some of our competitors; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our 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 our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; our ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation including by the FDA; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and FDA clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; our reliance on the performance of third parties who assist us in clinical trials and pre-clinical development; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; volatility in our common stock; our current plans not to pay dividends; potential dilution due to our issuance of common stock under our incentive plans, for acquisitions or otherwise; the amount of common stock held by our pre-IPO owners; the impact of anti-takeover provisions in our organizational documents and under Delaware law; our status as an emerging growth company, our ability to use our net operating loss carryforwards; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; 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.

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


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September 1, 2016 OrthoSpineNews

Lund, Sweden, 1 September 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced the publication of a paper in The Bone and Joint Journal: Single-stage treatment of chronic osteomyelitis with a new absorbable gentamicin-loaded, calcium sulphate/hydroxyapatite biocomposite – A prospective series of 100 cases. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

The paper provides 12-34 month follow up data from the first 100 patients in a prospective study evaluating CERAMENT G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.  This is significantly lower than published results with alternative bone graft substitutes that deliver antibiotics locally.

These results highlight the essential properties of CERAMENT G in the management of chronic osteomyelitis. The very encouraging infection recurrence prevention rate is supported by CERAMENT G’s attractive local delivery properties, which enable it to provide an initial targeted ultra-high concentration of gentamicin into the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) of the bacteria that initially caused the osteomyelitis. This unique antibiotic-eluting profile helps protect the bone healing process and promote bone remodeling.

The bone healing and bone remodeling properties of CERAMENT G, when combined with gentamicin, make it an ideal solution for dead space management in patients with chronic osteomyelitis. It is able to fill the void completely due to its injectibility and to provide initial structural stability due to its self-setting properties.

The use of CERAMENT G to deliver gentamicin locally could play an important role in improving antibiotic stewardship in hospitals by increasing compliance and reducing the need for patients with chronic osteomyelitis to receive long term systemic antibiotics.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and lead author of the paper said, “The results that we have achieved with the single stage surgical procedure using CERAMENT G for the dead space management of patients with chronic osteomyelitis are a significant improvement on past experience. These results reflect CERAMENT G’s unique local antibiotic delivery profile and its attractive bone remodelling capabilities. We are increasingly using CERAMENT G in the treatment of patients with chronic osteomyelitis and infected fractures. It allows a more patient-friendly treatment, preventing repeated operations and recurrent infections. We expect it to become the mainstay of our dead space management, given the major clinical and health economic benefits that it supports.”

The paper covers the first 100 patients in a prospective cohort study utilising CERAMENT G for dead space management in a single stage surgical procedure for chronic osteomyelitis. The mean duration of chronic osteomyelitis in this patient group was 10.4 years (0.5 to 68 years). All surgeries were performed by two surgeons and were completed in a single operative session. All patients were given similar systemic antibiotic therapy and rehabilitation. Patients were followed up for at least 12 months (mean 19.5 months, range 12 -34 months) with infection recurrence, fracture rate and wound leakage rate as the primary outcome measure. The study showed that the single stage surgical procedure with CERAMENT G, was highly effective delivering a 96% infection recurrence prevention rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.

Richard Davies, CEO of BONESUPPORT said, “The results that have been published today highlight the clear clinical benefits  with CERAMENT G’s ability to deliver sustained bactericidal levels of gentamicin locally to support the eradication of underlying infections in patients with chronic osteomyelitis. By using CERAMENT G in a single stage procedure to help patients with chronic osteomyelitis return to a normal life, we can deliver significant health economic benefits to payors who are struggling to contain the significant and growing costs of treating severely debilitating bone infection.”

Reference

McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

Notes to Editor

About BONESUPPORT™

BONESUPPORT has developed CERAMENT an innovative range of radiopaque injectable bone graft substitute products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BVF addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT BVF’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden with subsidiary locations in the U.S. and Germany. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

 

Contact Information

 

Citigate Dewe Rogerson

David Dible, Andrea Bici

+44 (0)20 7282 2949/1050

bonesupport@citigatedr.co.uk

 

BONESUPPORT AB 

Richard Davies, CEO

Phone +46 46 286 53 59

Richard.Davies@bonesupport.com