Bio2 Technologies, Inc. to Present Results from Ovine Spinal Fusion Study

Posted On March 9, 2017 By OrthoSpineNews In Biologics, Spine, Top Stories /

WOBURN, Mass., March 8, 2017 /PRNewswire/ — Bio2 Technologies will present a poster at the Annual Meeting of the Orthopaedic Research Society (http://www.ors.org) in San Diego, CA on March 22, 2017 reporting the results from an ovine interbody fusion study conducted at Colorado State University comparing Bio2’s Vitrium device to an implant of similar design constructed from PEEK polymer. Autograft bone was placed in the central lumen of both devices.

Vitrium is an advanced orthobiomaterial with structural properties similar to cortical bone. It is composed of bioactive glass, a material with well-established osteostimulative properties. Bio2 has developed a proprietary manufacturing process to produce a strong, three-dimensional structure featuring interconnected pores facilitating the propagation of new bone.

The biomechanical tests (performed by mdevdev, San Francisco, CA) evaluated Vitrium’s ability to exhibit the ideal characteristics of a spinal fusion product, prospectively defined as: a) an effective, safe resorption/bone formation profile, b) stimulation of new bone formation to increase fusion rates, and c) sufficient strength to bear/share physiologic loads. Janet Krevolin, Ph.D., Bio2’s Chief Technical Officer and co-author of the poster, stated “the test results clearly demonstrated that Vitrium achieved these objectives. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place for both the Vitrium and PEEK implants. Of note, in axial compressive load to failure testing the Vitrium fusion exhibited strength in excess of the adjoining vertebral bodies, whereas the PEEK fusion failed at the fusion site. The test data show the Vitrium devices exhibited the ideal characteristics of an interbody fusion product.”

Additional information on Vitrium and the ovine spinal fusion study may be found at: http://www.bio2tech.com

SOURCE Bio2 Technologies, Inc.

Alphatec Spine Appoints Jeffrey G. Black as Chief Financial Officer

Posted On March 8, 2017 By OrthoSpineNews In Financial, Spine /

CARLSBAD, Calif., March 06, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc. (Nasdaq:ATEC), a provider of spinal fusion technologies, announced today that it continues its investment in new executive talent with the hiring of Jeffrey G. Black as Executive Vice President and Chief Financial Officer.

Mr. Black is a seasoned executive with over 25 years of experience in financial and operations management, including senior-level finance roles for six publicly-traded companies. As the CFO at Alphatec, Mr. Black will lead the finance, investor relations and accounting organizations, architecting the appropriate capital structure for the Company to execute its strategy and build a sustainable financial foundation for future growth.

“Jeff’s financial insight, capital restructuring and financing experience, as well as his open leadership style will be great enhancements to the Alphatec team,” said Terry Rich, Chief Executive Officer of Alphatec Spine. “His history of successfully leading growing organizations, his Wall Street relationships in the healthcare sector, and his strong discipline in cost and cash control make him an ideal fit for Alphatec. I look forward to partnering with Jeff as we continue to build a high-growth U.S. spine company and improve surgeons’ experiences and patient outcomes through our differentiated product offerings. We also thank Dennis Nelson, Vice President, Finance, for serving as Alphatec’s Principal Accounting Officer, and offering strong leadership of our finance and accounting organizations while we engaged in the CFO search.”

Mr. Black, 48, previously served as the Chief Financial Officer of Applied Proteomics, Inc., a company that develops novel, non-invasive diagnostics using a proteomics-based platform. Before joining Applied Proteomics, Mr. Black served as the Chief Financial Officer of AltheaDx, Inc., a molecular diagnostics company specializing in pharmacogenetic testing. Prior to AltheaDx, Mr. Black served as Chief Financial Officer of Verenium Corporation (formerly Diversa Corporation), a Nasdaq-listed pioneer in the development and commercialization of high-performance enzymes for use in industrial processes. During his nine-year tenure at Verenium/Diversa, Mr. Black played a leadership role in more than $500 million of strategic, equity, and debt financing transactions, culminating in the sale of the company to BASF in 2013. Mr. Black is a certified public accountant (inactive) and began his career with Ernst & Young LLP. He currently serves on the Board of Directors of Cellana, Inc., a privately-held algae bioproducts company.

“I am pleased to be joining Terry and his high-caliber leadership team, with a proven record of success in the spine market,” said Mr. Black. “With this new team in place, a robust product portfolio, and a rich pipeline of new products, Alphatec is well-positioned to continue on an accelerated path to improve patient lives. I am excited to be a part of the company’s transformation, with an eye toward building value for shareholders.”

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on February 21, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards to Mr. Black: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan. Collectively, the RSUs and options were granted as inducements material to Mr. Black entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of Mr. Black’s first date of employment, assuming in each case that he remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 6, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case Mr. Black remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to the Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective February 21, 2017.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

Further information regarding the Company’s appointment of Jeffrey G. Black as Executive Vice President Finance and Chief Financial Officer is set forth in a Current Report on Form 8-K that was filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2017 and is available on both the SEC’s website at www.sec.gov and the Company’s website at www.alphatecspine.com.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops 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. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.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. Alphatec Spine cautions investors 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 Company’s ability to build a high-growth U.S. spine company; ability to strengthen its position in the U.S. spine market; ability to improve surgeon’s experiences, patient outcomes and patient lives; ability to build value for shareholders; ability to architect the appropriate capital structure; ability to build a sustainable financial foundation for future growth; the potential of the Company’s pipeline of products; and the Company’s ability to achieve its strategic goals. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. 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 uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; the failure to obtain FDA clearance or approval for new products or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; claims related to the Company’s intellectual property; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Vertos Medical’s mild® Procedure Receives Broad Coverage From Centers For Medicare & Medicaid Services

Posted On March 8, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild^® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence Development (CED) Program. A clinically proven outpatient procedure performed through a portal the size of a baby aspirin, mild requires no stitches, no general anesthesia, no implants, and no overnight hospital stay.

Broad access to the mild procedure has been granted for Medicare patients via a CMS-approved claims-analysis study that will passively collect and analyze real-world data to demonstrate the role of the therapy in the continuum of care for LSS. CMS’s recent decision to expand access follows the successful completion of the company’s CMS-approved randomized controlled study, MiDAS ENCORE.¹

“Patient and physician demand for the mild procedure has grown a great deal, and I’m excited to hear that my patients and fellow practitioners will now have access to this effective, proven method for relieving pain and getting people back to doing the things that make life enjoyable,” said Nagy Mekhail, M.D., Ph.D., Director of Evidence Based Pain Medicine Research and Education at Cleveland Clinic, who is an investigator of previous clinical studies of mild and has been performing the procedure since 2010. “Neurogenic claudication related to lumbar spinal stenosis can be extremely life limiting; this first-line treatment stands to benefit the many patients currently being treated for LSS in the United States, who have no viable treatment options.”

It is estimated that roughly 10% of Americans have lumbar spinal stenosis, and that by 2021 some 2.4 million will be experiencing considerable pain as a result of the condition.

“This is great news for the thousands of people who suffer from the debilitating symptoms related to their lumbar spinal stenosis with neurogenic claudication, who have struggled to find a safe, effective, low-cost solution,” said Eric Wichems, President and CEO of Vertos Medical.

The mild procedure has been studied in more than 20 peer-reviewed publications and 12 clinical trials, and has been performed on more than 20,000 patients. Peer-reviewed clinical data has demonstrated that mild helps patients suffering from LSS stand longer and walk further with less pain.²

¹Benyamin, R., et al. (2016). mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician, 19: 229-242. ISSN 1533-3159.

² Mekhail, Nagy, et al. (2012). Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6): 417–425. doi: 10.1111/j.1533-2500.2012.00565.x.

Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include mild^®, which offers a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. mild^®treats this condition by restoring space in the spinal canal using specialized mild^® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that mild^® can help LSS patients stand longer and walk farther with less pain¹, and no major device-related complications have been reported in any clinical trial.² Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how mild^® treats LSS click here.

SOURCE Vertos Medical

Intellijoint Surgical® Announces intellijoint HIP® Anterior Application FDA Clearance

Posted On March 8, 2017 By OrthoSpineNews In Regulatory /

WATERLOO, ON, March 7, 2017 /PRNewswire/ – Intellijoint Surgical^® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP^® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP Anterior is a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, and offset to orthopaedic surgeons performing Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA).

“intellijoint HIP Anterior has been developed by a group of brilliant engineers with deep understanding of the steps involved in direct anterior hip replacement, which allows surgeons to integrate the device easily into their workflow,” said Dr. Javad Parvizi, member of Intellijoint Surgical’s Scientific Advisory Board and DAA orthopaedic specialist at Thomas Jefferson University Hospital’s Department of Orthopedic Surgery. “intellijoint HIP Anterior provides quantifiable, intraoperative measurements that allows surgeons to optimally position the components, restore limb length and offset. intellijoint HIP Anterior stands to eliminate fluoroscopy verification for cup position, leg length and offset that is often used by surgeons.”

Per bench top validation testing cleared by the FDA, 20 separate simulations were performed with intellijoint HIP Anterior accurately measuring anteversion to within 0.47°and inclination to within 0.65° when compared to radiographic scans. intellijoint HIP Anterior was intuitively designed to provide cup position measurements in relation to the supine coronal plane or Anterior Pelvic Plane, depending on surgeon’s preference.

“The low-cost fee-per-case pricing model of intellijoint HIP Anterior allows me to utilize navigation for all of my total hip replacements with the Direct Anterior Approach.” commented Dr. Michael Bradley, President/CEO of Orthopedics Rhode Island. “My DAA patients have peace of mind knowing that their hip implants are positioned exactly how I planned pre-operatively, thanks to intraoperative measurements from intellijoint HIP Anterior.”

Intellijoint Surgical will be showcasing the full intellijoint HIP suite including intellijoint HIP Anterior at AAOS 2017 Annual Meeting – Booth #5551 from March 15 – 18, 2017 in San Diego, California, USA. intellijoint HIP Anterior is currently in Limited Market Release and will be available in New York, Illinois, Rhode Island and Houston, Texas in early summer 2017.

About Intellijoint Surgical:

Intellijoint Surgical^® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP^® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

VTI Expands with 3 New International Distribution Partners

Posted On March 8, 2017 By OrthoSpineNews In Spine, Top Stories /

(March 7, 2017) VTI – Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has strengthened its distribution in Northern Europe to better serve its international customers. During this process VTI has appointed three new distributors with a strong focus on the spine market. This improved territory coverage will help increase awareness and give surgeons access to VTI’s InterFuse® modular spinal implants.

The three new distribution channels VTI will be partnering with are: Joline GmbH & Co KG, based in Hechingen, Germany: Articular, based in Helsinki, Finland and Anatomica, headquartered in Gothenburg, Sweden. All three distributors have a strong presence in all major hospitals within their respective countries.

Vice President of International Sales Ben Wasscher states “We believe that we have significantly upgraded the quality of our distribution network in Northern Europe, enabling VTI to better serve its existing surgeon customers as well as significantly expanding on this existing user base. This will bring the benefits of the InterFuse® modular interbodies to a larger patient population.”

“Anatomica’s sales force is very enthusiastic about the InterFuse® system!” says CEO Sverker Stomberg of Anatomica.

When asked about how surgeons react when seeing the InterFuse® product, Peter Kohlbecher Director of Sales & Marketing at Joline GmbH & Co KG said, “They like the fact that a large surface implant can be inserted from posterior; no need to flip the patient; no need to work with general surgeons to get access to the spine from the anterior”.

ABOUT VERTEBRAL TECHNOLOGIES, INC.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells InterFuse® modular interbody fusion devices worldwide.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.877-912-5401

Stryker’s Spine Division To Feature Novel 3D-Printed Spinal Implants at AAOS Conference

Posted On March 8, 2017 By OrthoSpineNews In Spine /

Allendale, N.J.—March 8, 2017—Stryker’s Spine division will feature its 3D-printed Tritanium Posterior Lumbar (PL) Cage and introduce a variety of new cage sizes at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 15-18, 2017, in San Diego (booth No. 3133).

Stryker’s Tritanium PL Cage launch initially included four footprint options, eight height options, and two lordosis options. The company now offers several additional sizes based on surgeon needs and requests, including a hyper-lordotic (12°) cage option, as well as two new footprints—9 x 32 mm and 11 x 32 mm.

During the conference, Stryker’s proprietary Tritanium In-Growth Technology will be featured in a virtual reality “tour,” providing surgeons with a unique perspective on how 3D printing, also known as additive manufacturing, allows the company to produce highly porous implants that would be difficult or impossible to create using traditional manufacturing techniques.

Tritanium Technology allows for the creation of porous structures designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.¹This “precise randomization”¹ of fully interconnected pores differs from other technologies featuring longitudinal channels and traverse windows that result in a uniform lattice structure, as well as cages offering porosity that is only present on the surface.

“Stryker is a pioneer in 3D additive manufacturing, investing nearly 15 years in research and development,” said Stryker’s Spine division President Bradley Paddock. “Unlike traditional manufacturing techniques, the flexibility of our 3D additive manufacturing capabilities allows us to precisely engineer and produce porous Tritanium devices. We are excited to continue growing our unique suite of Tritanium spinal products.”

Also at AAOS, results will be presented from a pre-clinical animal study that evaluated the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different materials, including the Tritanium PL Cage. Preliminary results of the study were presented at the North American Spine Society conference in October 2016. (Click here to access the Tritanium pre-clinical study summary.)

The Tritanium PL Cage features fully interconnected pores that span endplate to endplate. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray,² and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. Additional spinal implants based on Stryker’s Tritanium Technology are in development.

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. For more information, visit www.stryker.com or www.stryker.com/builttofuse.

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

Editor’s note: For images, video footage, or animation of the Tritanium PL Cage and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at bsullivan@sullivanpr.com or 714/374-6174. A backgrounder is available at www.stryker.com/builttofuse.

References

Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
Abbushi A, Cabraja M, Ulrich-Wilhelm T, Woiciechowsky C, Kroppenstedt S. The influence of cage positioning and cage type on cage migration and fusion rates in patients with monosegmental posterior lumbar interbody fusion and posterior fixation. Eur Spine J. 2009;18: 1621–1628.

Content ID: TRITA-PR-6_13360

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: AMagine, Stryker, Tritanium. All other trademarks are trademarks of their respective owners or holders.

AAEAAQAAAAAAAAJWAAAAJGI2MWI1YmU0LTljYzItNDdmOS1hZDJhLTI4YWNlYWNkZmM4OA.png

LinkSPINE Names Tom McLeer Vice President of Sales and Marketing

Posted On March 7, 2017 By OrthoSpineNews In Spine, Top Stories /

Rockaway, NJ — March 7, 2017 — LinkSPINE, a medical device company focused on the development of less invasive techniques for spine surgery, has named Tom McLeer Vice President of Sales and Marketing.

McLeer is an established medical device executive leader who has made a name in the industry by exponentially boosting sales for existing companies and leading startups through clinical approval and into full commercialization. He most recently served as Senior Vice President of US Commercial Operations for Alphatec Spine. Previously, he was CMO and General Manager of Spinal Operations for Pioneer Surgical Technology and VP of Sales and Marketing for Archus Orthopedics. Earlier in his career, McLeer was VP of Marketing and Business Development for Spinal Concepts and VP of Marketing for Interpore Cross International.

“We are excited to welcome Tom McLeer to the LinkSPINE team to lead our Sales and Marketing efforts,” sad LinkSPINE President, Dennis Farrell. “Tom’s deep leadership experience in spine and familiarity with novel technologies will be invaluable to us as we as we continue to expand our less invasive Midline Choice product portfolio.”

Farrell added that LinkSPINE remains committed to developing innovative solutions which reduce surgical morbidity and which are designed for placement with minimal fluoro and shorter learning curves than tubular MIS techniques; and that McLeer is ideally suited to help bring those solutions to the surgical community.

‘Midline Choice’ is LinkSPINE’s comprehensive midline fusion portfolio, which includes CorticaLINK and FacetLINK. A single kit houses a complete array of screws and devices, offering the surgeon the ability to intra-operatively create a less invasive fusion construct based upon each patient.

“I’m excited to be part of such a great team and I look forward to working with my existing contacts to help advance this minimally invasive procedure to a wide patient population,” said McLeer. “I was drawn to LinkSPINE’s dedicated focus on improving patient outcomes — and it’s innovative portfolio of powerful, yet simple solutions for less invasive surgery. The devices are novel, elegant and intuitive and fulfill a desire for a simple, less invasive approach to lumbar surgery, adding true value for surgeons who are tiring of long learning curves. It will be rewarding to be part of the company’s growth and success.”

McLeer and his new LINKSpine colleagues will be exhibiting the company’s technology in Booth 907 at the Spine Summit 2017 AANS/CNS Meeting in Las Vegas, from March 8-11, 2017.

LinkSPINE is a privately held medical device company focused on the development of less invasive techniques for spine surgery. LinkSPINE is a sister company of Waldemar Link GmbH of Hamburg Germany, a worldwide leader in Reconstructive Orthopedics.

Media: Interviews and photos are available upon request. Please contact Paul Williams at 310/569-0023 or via paul@medialinecommunications.com.

Paul Williams

President

MediaLine Communications

310/569-0023

Stryker’s AVAflex® Vertebral Balloon System Receives FDA 510(k) Clearance

Posted On March 7, 2017 By OrthoSpineNews In Regulatory /

Kalamazoo, Michigan, USA – March 7, 2017 – Stryker announced today that its AVAflex Balloon System has received FDA 510(k) clearance and is, for the first time, available with Stryker’s market-leading bone cements and implants and the AutoPlex Mixing and Delivery System.

“Doctors who perform vertebral augmentations are committed to the health and wellness of their patients, and Stryker is committed to empowering those doctors to provide the best possible care,” said Chad Ludwig, marketing director at Stryker Instruments. “The AVAflex Balloon System enables doctors to achieve bipedicular results with a unipedicular approach to vertebral augmentation.”

The AVAflex and AutoPlex systems are used in the treatment of vertebral compression fractures (VCF), which affect an estimated 750,000 Americans each year. VCF patients can suffer from extreme pain and are at an increased risk for serious health problems. Vertebral augmentation, including the use of a balloon system, has been shown to provide patients with significant pain relief and dramatically reduce mortality rates.^,

The AVAflex curved balloon system’s new 11-gauge size allows surgeons to achieve with one insertion and a smaller needle what had previously required two insertions, making procedures less invasive and potentially reducing the risk of patient trauma. Using a minimally invasive technique, physicians can successfully create a midline cavity for targeted cement placement by accessing one pedicle.

AVAflex is now available with Stryker’s bone cements and implants and the AutoPlex Mixer and Delivery System, an easy-to-use bone cement mixing and delivery system. The AutoPlex system provides consistent and thorough blending of components, helping eliminate human error and variability.

Stryker has furthered its mission of making health care better for physicians, hospital staff and patients with the addition of the AVAflex portfolio, which it acquired from Becton Dickinson in 2016. Stryker provides the most complete and least invasive portfolio of vertebral compression fracture treatment options.

With an unrivaled collection of balloon catheters and augmentation options, cements, automated mixers and directional delivery systems, Stryker enables care providers to tailor their approach for the treatment of vertebral compression fractures. Stryker is now the exclusive provider of automatic mixing and delivery systems and 11-gauge curved balloons.

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.

Hip Replacement Implant Market Forecast 2016 – 2024

Posted On March 7, 2017 By OrthoSpineNews In Recon /

NEW YORK, March 7, 2017 /PRNewswire/ — Hip Replacement Implant Market: Overview

Read the full report: http://www.reportlinker.com/p04760054-summary/view-report.html

Hip Replacement Implant are the artificial implant made of metal, plastics or ceramic which are replaced with the hip joint. Hip replacement procedure takes place when hip joint is damaged due to disease or injury.

A detailed overview of market dynamics, including the drivers, restraints, and opportunities of the hip replacement implant market, has been provided in this report. Market revenue for all the above mentioned segments, and their sub segments has been provided for the forecast period of 2016-2024, considering 2015 as the base year, and 2014 as the historical year, along with compound annual growth rate (CAGR %), for the forecast period of 2016-2024. Market share estimations were based on in-depth analysis and study of products, and their features, prices etc.

This report provides in-depth analysis of the hip replacement implant market. The stakeholders for this report include companies involved in the manufacturing of hip implant and its spares parts. For providing a snapshot of this market to the stakeholders, executive summary section is included in this report, which summarizes the market size, trends and competition in different regions. Market share analysis among the market players is analyzed to signify percentage share of the major players operating in the hip replacement implant market. Furthermore, the report incorporates market attractiveness analysis by geography that depicts the most attractive and significant region in the global market in 2015.

Global Hip Replacement Implant Market: Research Methodology

The research methodology is a combination of primary and secondary research. Primary research includes information collected via e-mails, and telephonic interviews of Key Opinion Leaders (KOL), and forms the bulk of our research. Secondary research includes information collected from various sources, by study of company websites, annual reports, stock analysis presentations, press releases, and various national and international databases.

Global Hip Replacement Implant Market: Segmentation

Based on product type, global hip replacement implant market is segmented on the basis of product are total hip replacement implant, partial hip replacement implant, hip resurfacing implant and revision hip replacement implant. Total hip replacement implant segment is further sub-segmented into fixed bearing hip implants and mobile-bearing total hip implants. Based on material, the hip replacement implant market are segmented into metal-on-metal, metal-on-polyethylene, ceramic-on-metal, ceramic-on-polyethylene and ceramic-on-ceramic. End users in the hip replacement implant market are, hospitals, orthopedic clinics, ambulatory surgical centers and others (long term care center, research, academics, nursing facility, etc.)

Global Hip Replacement Implant Market: Regional Outlook

Based on geography, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. The regions are further segmented into major countries which include, U.S., Canada, Germany, U.K., France, rest of Europe, China, Japan, Australia and New Zealand, Rest of Asia Pacific, Brazil, Mexico, Rest of Latin America, Saudi Arabia, South Africa and Rest of Middle East and Africa.

Key Players Mentioned in this Report are:

The report also comprises list major players in the market, their SWOT analysis, market share of these players in the hip replacement implant market, key business strategies, product portfolios, and recent developments. Key market players profiled in this report include, B. Braun Melsungen AG, Exactech, Inc., DJO Global, Inc., Johnson & Johnson, MicroPort Scientific Corporation, OMNIlife science, Inc., Smith & Nephew, Stryker Corporation and Zimmer Biomet Holdings, Inc. Zimmer Biomet Holdings, Inc.

The global hip replacement implant market has been segmented as follows:

Global Hip replacement Implant Market, by Product Type
Total Hip Replacement Implant
Fixed Bearing Hip Implants
Mobile-Bearing Total Hip Implants
Partial Hip Replacement Implant
Hip resurfacing Implant
Revision Hip Replacement Implant

Global Hip Replacement Implant Market, by Material
Metal-on-metal
Metal-on-polyethylene
Ceramic-on-metal
Ceramic-on-polyethylene
Ceramic-on-ceramic

Global Hip Replacement Implant Market, by End Users
Hospitals
Orthopedic Clinics
Ambulatory Surgical Centers
Others

Global Hip Replacement Implant Market, by Geography
North America
U.S.
Canada
Europe
Germany
France
U.K.
Rest of Europe
Asia Pacific
China
Japan
Australia & New Zealand
Rest of Asia Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East and Africa
Saudi Arabia
South Africa
Rest of MEA
Read the full report: http://www.reportlinker.com/p04760054-summary/view-report.html

About Reportlinker
ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.

http://www.reportlinker.com

__________________________
Contact Clare: clare@reportlinker.com
US: (339)-368-6001
Intl: +1 339-368-6001

SOURCE Reportlinker

Misonix, Inc. Enters into Exclusive Chinese Distribution Agreement for BoneScalpel

Posted On March 7, 2017 By OrthoSpineNews In Extremities, Spine /

FARMINGDALE, N.Y., March 7, 2017 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced that it has entered into an exclusive distribution agreement with Shandong Weigao Orthopedic Device Company Limited (“Weigao Orthopedic”), a subsidiary of Shandong Weigao Group Medical Polymer Company Limited (HKSE: 1066).Weigao Orthopedic is a medical device company in China specializing in research and development, production and sale of spine, trauma and joint orthopedic implants devices.

The terms of the distribution agreement grant exclusive rights to Weigao Orthopedic for the sale, marketing and distribution of Misonix’s BoneScalpel in the People’s Republic of China, Hong Kong, and Macau for an initial period of five years.

Mr. Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “We are pleased to enter into this distribution agreement with Weigao Orthopedic, one of the most highly regarded orthopedic and spine surgery device providers in the People’s Republic of China. They have a broad distribution network and relationships with medical institutions that will benefit from the solutions that the BoneScalpel has to offer. We look forward to a mutually beneficial relationship working with Weigao Orthopedic to introduce and embed our products throughout the PRC, Hong Kong and Macau.”

Mr. Gong Jianbo, Chief Executive Officer and Executive Director of Weigao Orthopedic, commented, “We are very pleased with this partnership and for exclusive distribution rights to BoneScalpel. We greatly appreciate the controlled cutting, sparing of soft tissue and the reduction in bleeding that the BoneScalpel provides. Misonix’s ultrasonic bone cutting technology has been quickly gaining the attention of spine surgeons around the world and our team is excited to bring this important technology to surgeons across China.”

Scott Ludecker, Senior Vice President of Global Sales and Marketing, said, “We greatly appreciate the opportunity to work with one of the leaders in the orthopedic industry in the PRC. We have conducted extensive due diligence on identifying a partner for this most important market for our leading-edge ultrasonic surgical tools. It was clear from the beginning that both companies share a common vision for the future of spine surgery and the important role that BoneScalpel plays in enabling better and safer outcomes for surgeons and the patients they treat.”

About Misonix
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.

About Shandong Weigao Group
Shandong Weigao Group and its subsidiaries are principally engaged in the research and development, production and sale of single-use medical devices. The Group has a wide range of products, which includes consumables, orthopedic materials, and blood purification consumables and equipment. The Group’s main production facilities are situated in Weihai, Shandong Province. The Group is incorporated in the People’s Republic of China and has an extensive sales network comprising 28 sales offices, 34 customer liaison centers and 222 cities with sales representatives. Shandong Weigao Group has a total customer base of 5,298 (including 3,132 hospitals, 414 blood stations, 643 other medical units and 1,109 distributors).
For more information on Shandong Weigao Group, please visit http://en.weigaogroup.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact	Investor Contact
Misonix Contact:	Joe Diaz
Joseph Dwyer	Lytham Partners
631-694-9555	602-889-9700
invest@misonix.com	info@misonix.com

SOURCE Misonix, Inc.

Our Blog