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.

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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.

OrthAlign, Inc. Announces Full Commercial Launch of UniAlign™

Posted On March 7, 2017 By OrthoSpineNews In Recon /

ALISO VIEJO, CA (PRWEB) MARCH 06, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with precision tools, announced the full commercial launch of UniAlign™, the world’s first handheld navigation device for unicompartmental knee arthroplasty (UKA).

UniAlign provides surgeons with OrthAlign’s clinically-proven handheld navigation technology, along with instruments uniquely designed to address the demanding requirements for precision of UKA procedures. To date, OrthAlign technology has successfully been used in approximately 60,000 joint arthroplasty cases, worldwide.

“UniAlign has become an invaluable tool for my practice,” said Sridhar M. Durbhakula, MD of the Washington Joint Institute in Bethesda, MD. “It delivers a more efficient operation with precise bone cuts, no CT/MRI, minimal pin site morbidity, and it gives me real-time data so that I always know exactly what I’m doing. Patients will get home more quickly because UniAlign allows for a minimally invasive surgical approach that promotes faster patient recuperation. UniAlign is the ideal way to cost-effectively offer computer assisted surgery in the outpatient setting.”

UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

“The introduction of UniAlign is just the beginning of OrthAlign’s new product rollout for 2017,” said Eric B. Timko, OrthAlign’s Chief Executive Officer and Chairman. “As OrthAlign’s biggest focus for this year is in expanding our customer reach and application pipeline, we will continue providing orthopedic surgeons and healthcare facilities with our clinically beneficial and economically friendly portfolio of products, staying true to our core design principles of ease of use, precision, and cost effectiveness.”

OrthAlign will be showcasing its full portfolio of products, including the recently launched UniAlign and Direct Anterior HipAlign® technologies at this year’s AAOS meeting in San Diego, CA, March 15-18, 2017 at booth #5615.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise the standard of care in Joint Arthroplasty surgeries by making consistent and measurable results accessible and affordable to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

Corbion full year 2016 results

Posted On March 7, 2017 By OrthoSpineNews In Financial /

March 06, 2017

Corbion reported sales of € 911.3 million in 2016, a decrease of 0.8%. Organic sales growth was -1.2%. EBITDA excluding one-off items grew by 13.2% in 2016. In Q4 2016 sales were € 226.1 million, a decrease of 1.9%. Q4 2016 EBITDA excluding one-off items increased by 6.3%. The company proposes to distribute a regular dividend of € 0.56 per share, an additional cash dividend of € 0.44 per share, and a new share buyback of € 25 million.

“In 2016 we continued to make good progress in executing our strategy and we are well on track to deliver on our 2015-2018 targets. In the past year we have made strategic choices involving our customer and product portfolios. These choices resulted in a significant margin improvement, but at the same time had an adverse, albeit temporary, impact on our top-line growth in the year. For 2017, we are confident top-line growth will return to our guidance range. A notable highlight in the second half of the year was the announcement of the PLA joint venture together with Total, a market leader with technical and marketing expertise and a leading position in polymers,” commented Tjerk de Ruiter, CEO.

Key financial highlights FY 2016

Net sales organic growth was -1.2%; volume growth was -1.2%
EBITDA excluding one-off items was € 170.1 million, an organic increase of 13.8%
EBITDA margin excluding one-off items was 18.7%, up from 16.4%
“Streamline” contributed € 20 million to EBITDA (2015: € 15 million)
One-off items at EBITDA level of € -3.2 million in 2016, mostly in connection with the closure of our Kansas powder blending plant, partly offset by the sale of the Breddo-Likwifier activities
Operating result was € 126.9 million, an organic increase of 17.5%
Free cash flow was € 72.1 million (2015: € 55.2 million)
Net debt/EBITDA at year-end was 0.6x (2015: 0.4x)
Our € 50 million share-buyback program was finalized on 28 October 2016.

Key figures

€ million	FY 2016	FY 2015	Total growth	Organic growth
Net sales	911.3	918.3	-0.8%	-1.2%
EBITDA excluding one-off items	170.1	150.3	13.2%	13.8%
EBITDA margin excluding one-off items	18.7%	16.4%
Operating result	126.9	108.6	16.9%	17.5%
ROCE	20.6%	19.2%

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/919ed3c2-7b2b-4d86-94fe-bd6dbbbedfb8

Bone Therapeutics Strengthens Clinical Development Leadership with Appointment of Dr. Miguel Forte as Chief Medical Officer

Posted On March 7, 2017 By OrthoSpineNews In Biologics /

March 06, 2017

GOSSELIES, Belgium–(BUSINESS WIRE)–Regulatory News:

BONE THERAPEUTICS (Brussels:BOTHE) (Paris:BOTHE) (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Miguel Forte, MD, PhD as Chief Medical Officer (CMO).

Dr. Forte has significant regenerative medicine and cell therapy industry experience, most recently as Chief Operating and Medical Officer at TxCell, a French biotechnology company specializing in immune cell therapy, and as Chief Commercialization Officer and Chair of the Commercialization Committee at the International Society of Cellular Therapy (ISCT). With over 20 years’ industry experience, Dr. Forte has gained broad expertise in medical and regulatory affairs, ranging from leading early and late stage clinical trials to market authorization and the launch of new biologic products for various indications.

At Bone Therapeutics, Dr. Forte will be responsible for the Company’s clinical development strategy and advancing its products to market. He will also play a key role in increasing the visibility of the Company throughout the medical community.

At TxCell, Dr. Forte was instrumental in defining the company’s regulatory strategy, design and implementation of clinical studies and completed a positive first-in-man Phase I/II study with an antigen specific T-cell therapy. Prior to TxCell, Dr. Forte held several senior positions in large pharmaceutical companies, including as Vice President, Global Medical Affairs at UCB, and various senior positions at the European Medicines Agency, Bristol-Myers Squibb, Abbott, and Wellcome Laboratories (now part of GSK).

Dr. Forte graduated in Medicine from the University of Lisbon, specializing in infectious diseases. He obtained a PhD in Immunology at the University of Birmingham and received post-graduate training in Health Economics of Pharmaceutical and Medical Technology at Stockholm School of Economics. Dr. Forte is currently Associate Professor in Health Sciences and Pharmacy at the University of Aveiro and the University of Lisbon. Dr. Forte succeeds Prof. Dr. Valerie Gangji, who will focus on her role as Head of the Rheumatology and Physical Medicine Unit at the Erasme University Hospital. Dr. Gangji will remain available to the Company during a transistion period to provide advice and support on ongoing clinical programmes.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are delighted to strengthen our clinical development team with the appointment of Dr. Forte. His vast expertise in cell therapy will be a strong asset to our company and will further drive the progress of Bone Therapeutics’ innovative pipeline. In addition to his specific experience with cell therapy products, Dr. Forte has extensive experience in interacting with regulatory bodies and establishing strong relationships with investigators and key opinion leaders. We would like to thank Valérie Gangji for her contribution to our company. She pioneered the use of differentiated bone forming cells and her work forms part of the foundation of Bone Therapeutics’ bone cell therapy products.”

Commenting on his appointment, Dr. Miguel Forte said: “I am very excited to be joining Bone Therapeutics, a leading biotechnology company in bone cell therapy products. The Company has an advanced clinical pipeline with promising products in clinical development and I am impressed with its progress to date. I look forward to working with the Bone Therapeutics team to realise the potential of its ground breaking products for the benefits of patients.”

About Bone Therapeutics

Bone Therapeutics is a leading biotechnology company specializing in the development of cell therapy products intended for orthopaedics and bone diseases. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative regenerative products containing osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.

PREOB^®, Bone Therapeutics’ autologous bone cell product, is currently in pivotal Phase IIB/III clinical studies for two indications: osteonecrosis and non-union fractures. ALLOB^®, its allogeneic “off-the-shelf” bone cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs for the development of novel product candidates.

Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics’ regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families. Further information is available at: www.bonetherapeutics.com.

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
+32 (0)2 529 59 90
investorrelations@bonetherapeutics.com
or
For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson and Hendrik Thys
+44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com
or
For French Media and Investor Enquiries:
NewCap Investor Relations
& Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
+ 33 (0)1 44 71 94 94
bone@newcap.eu

Month: March 2017

Contacts