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OMNIlife science™, Inc. Announces First Clinical Evaluations of Revolutionary OMNIBotics® Active Spacer Robotic Tissue Balancing Device

Posted On October 31, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /  

RAYNHAM, Mass., Oct. 31, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that they have begun clinical evaluations of their exclusive OMNIBotics Active Spacer robotic tissue balancing device at three U.S. sites. This technology received 510(k) clearance from the FDA on September 1, 2017.

The OMNIBotics Active Spacer, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal and a soft tissue perspective.

“I believe that the active spacer technology is the tool we have been looking for to create even better predictability and reproducibility for knee replacement surgery,“ said Jeffrey M. Lawrence, M.D. Viroqua, WI. “I’m very excited to offer this system to my patients.”

Of his early experience, John M. Keggi, MD, Middlebury, CT said, “The active spacer technology is a great step forward that brings the most advanced measurement and analysis tools directly to each patient and surgeon right in the operating room. It’s an unprecedented, real-time evaluation of the knee that optimizes each step of the procedure.”

Studies indicate that a significant percentage of knee replacement patients do not achieve full satisfaction even with well-placed implants. One potential contributing factor is sub-optimal soft tissue balancing.

“The active spacer is an amazing new technology for knee replacement. It actually shows your surgeon, in real time, how tight or loose your knee is on each side as it bends. This information is then fed into a robot, which plans how your knee is replaced on an individual basis for optimum results,” said Amber Randall, MD an orthopedic surgeon in Arizona.

OMNI, a pioneer in robotic-assisted total knee replacement, now offers the only robotic technology that quantitatively drives the total knee replacement surgical procedure with both alignment and ligament balancing. Dr. Randall continues, “I believe that this revolutionary, never before seen technology will get us not one–but several–steps closer to the Holy Grail of knee replacement: the freely moving, perfectly stable and pain free knee.”

ABOUT OMNI

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

FORWARD LOOKING STATEMENTS

Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including its plans specific to OMNIBotics systems, as well as statements using the terms “plans,” “believes” or similar expressions are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI, increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

CONTACT

Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444
cholloway@omnils.com

 

SOURCE OMNIlife science, Inc.

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Mizuho OSI® Introduces New Levó Head Positioning System for Spine Procedures

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

UNION CITY, Calif., Oct. 25, 2017 /PRNewswire/ — Mizuho OSI®, a leading manufacturer of specialty surgical tables, pressure management solutions, and table specific patient care kits, is introducing its newest technology, the Levó Head Positioning System at NASS 2017. Using an innovative electro-mechanical technology to enable the device’s motion, the Levó System introduces a new level of actuated control and precision to head positioning for all spine procedures from cervical to sacrum. The Company is unveiling the technology in booth #717 for physicians to experience the elevated positioning capabilities afforded by Levó.

Positioning patients for spine surgery is essential for optimal operating conditions and operative site exposure. The Levó System is designed to provide the surgical team with an interface that is safe, fast, and easy to engage. The technology’s unique interface places the surgeon in control, supporting initial head positioning and cervical spine corrections throughout the procedure. Various interchangeable modules that support the use of a skull clamp or face pillow comprise a versatile platform that delivers optimal utilization within each practice.

Designed to provide fluid, yet controlled motion, Levó’s functionality supports an improved workflow and enhanced surgical access. This is achieved through key modules, including the QuickConnect System, which supports the efficient attachment of a skull clamp, and the Control Handles, which allow for intraoperative adjustments.

“In designing the Levó System, we wanted to offer surgeons a seamless and flexible solution that affords them better control over patient positioning during these delicate procedures,” said Greg Neukirch, vice president of Marketing and Sales at Mizuho OSI. “We’re proud to unveil a solution we believe works to enhance clinicians’ surgical experience, providing for safe and precise care when positioning a patient’s head for all prone spine procedures.”

Mizuho OSI is offering hands-on demonstrations of the Levó Head Positioning System at NASS 2017 in Orlando, Fla. from October 25-27 in Booth #717.

About Mizuho OSI

Mizuho OSI® is a U.S. based company and the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improves patient outcomes in spine and orthopedic surgeries, a range of general surgical tables, and consumable surgical patient care products. Mizuho OSI products are sold direct in the U.S. and Germany, and by the Mizuho Corporation in Japan. Both companies sell their products and solutions worldwide through authorized international distributors. Mizuho OSI is a wholly owned subsidiary of Mizuho Corporation located in Tokyo, Japan, a leading surgical table manufacturer in Asia. The Mizuho Group also includes Trilux Medical®, a subsidiary of Mizuho OSI. Trilux Medical is a provider and manufacturer of surgical lights, surgical pendants, operating room patient integration, video management systems, and turn-key operating room solutions. Trilux Medical products and solutions are sold direct in Germany and worldwide through authorized international distributors. More information is available at www.mizuhosi.com

 

SOURCE Mizuho OSI

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Cerapedics Announces i-FACTOR™ Peptide Enhanced Bone Graft Adopted by More than 150 Leading U.S. Hospitals

Posted On October 26, 2017 By OrthoSpineNews In Biologics, Top Stories /  

WESTMINSTER, Colo., Oct. 26, 2017 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that more than 150 leading U.S. hospitals have now adopted use of i-FACTOR™ Peptide Enhanced Bone Graft. Cerapedics received Premarket Approval (PMA) for i-FACTOR bone graft from the U.S. Food and Drug Administration (FDA) in late 2015 for use in ACDF procedures in patients with degenerative cervical disc disease. The company had initiated U.S. commercial activities in June 2016 following FDA approval of final IFU labeling and additional product sizes.

“The available options including bone morphogenetic protein therapies present both safety risks and significant costs,” said Dan Peterson, MD, FAANS & FACS, neurosurgeon at Austin Brain and Spine. “Increasingly surgeons and hospitals are recognizing the advantages of the i-FACTOR Bone Graft’s synthetic small peptide (P-15) technology in helping to improve safety and outcomes.”

i‐FACTOR Bone Graft is based on proprietary P-15 technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation. It is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine backed by Level 1 human clinical data.

“We are continually hearing about development of new options to support bone regrowth and repair, including use of stem cell technologies,” said Neill Wright, MD, FAANS, Herbert Lourie Professor of Neurological Surgery at Washington University School of Medicine. “In many cases, available data do not confirm that both performance and costs are in line to deliver optimal outcomes for patients and hospitals. With i-FACTOR Bone Graft we have that data and can feel confident about both performance and cost advantages.”

In September 2017, Cerapedics announced publication of two-year follow-up data from an FDA Investigational Device Exemption (IDE) clinical trial of i-FACTOR Bone Graft. The results published in the peer reviewed journal Neurosurgeryshow i-FACTOR Bone Graft is statistically superior in overall clinical success to autograft.

“Our national commercialization and sales strategy is well positioned to meet the rapidly expanding interest in i-FACTOR Bone Graft,” said Glen Kashuba, CEO of Cerapedics. “We fully expect the rate of adoption to continue to grow rapidly in 2018 with over 100 additional hospital approvals pending as more surgeons and hospitals recognize the clear advantages of our technology over currently available options.”

About Cerapedics
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

 

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EOI Announces Initial Surgeries With the FLXfit™15, the First Articulated and Expandable Cage With 15 Degrees of Lordosis Correction

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

OR AKIVA, Israel, Oct. 26, 2017 /PRNewswire/ –Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced first surgeries with its enhanced 3D expandable cage, the FLXfit™15.  The FLXfit™15 offers enhanced performance and versatility by providing additional device sizes with the ability to further expand the device up to 4mm to achieve controlled expansion and lordosis correction of up to 15⁰.

Dr. Marc Weinstein, at the Spine Center at the Florida Orthopaedic Institute in Tampa, FL commented, “EOI’s attention to surgeons’ feedback and ability to innovate quickly is imperative in this environment”. He said, “This new higher range expansion will enable us to better treat our patients and restore segmental lordosis up to 15 degrees. This will have a tremendous impact on our ability to improve the patient’s sagittal balance and long-term surgical outcomes.” Dr. Weinstein concluded ,”This is an ideal implant for my L5/S1 fusion patients given the reduced size on entry and the need for enhanced lordosis at this level.”

Dr. Hamad Farhat, of Chicago, Illinois said, “The new 32mm length option adds great flexibility in treating patients with smaller anatomies as well as higher vertebral levels. The smaller size will allow 15 degrees of lordosis correction with additional space to pack more bone graft material”. He explained, “Expandable cages play a key role in successful MIS fusion procedures. The ability to deliver an ALIF type footprint cage with upto 15 degrees of lordosis correction through a minimal, unilateral approach is definitively a paradigm change in the MIS fusion market.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented, “We are excited with the first surgeries with the FLXfit™15. This represents our continued commitment for innovation and collaboration with our surgeons to deliver state of the art spine fusion technology designed to improve long term patients’ outcome.”  He said ,”We believe that the performance and versatility of the new FLXfit™ family will catapult EOI to gain greater share in fusion surgery both in MIS and open approaches.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:

David Elkaim
VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347) 3219683

 

SOURCE Expanding Orthopedics Inc.

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4WEB Medical Demonstrates Increased Subsidence Resistance for Lateral Spine Truss System Compared to Annular Implants

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

ORLANDO, Fla., Oct. 26, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced the results of a new study demonstrating reduced subsidence for its Lateral Spine Truss System (LSTS) as compared to annular interbody implant designs today at the annual meeting of the North American Spine Society.  The study was led by Vijay Goel, PhD at the University of Toledo, one of the country’s foremost orthopedic biomechanics institutes.

“Our biomechanical testing showed the 4WEB 18mm wide, 40mm long LSTS implant performed better in resisting subsidence than the competitive 21mm wide, 60mm long annular design lateral device.  This finding was consistent across all density foam blocks tested.   These results are indicative of the optimized load distribution that is inherent to the 4WEB truss implant technology,” said Vijay Goel, PhD at the University of Toledo.

4WEB’s proprietary open architecture truss design increases endplate to implant contact maximizing resistance to subsidence.  The additive manufacturing process for truss technology provides a hierarchal surface roughness spanning from the nano to macro scale which may contribute to stimulating an osteogenic response.

Tony Tannoury, MD, Director of Spine at Boston Medical Center, Boston University said, “Subsidence is a clinically documented occurrence in lateral fusion procedures with higher incidences being found among smaller footprint implants.  This research allows me to confidently conduct minimally invasive lateral access surgery and match the correct size implant to the patient anatomy with less concern of the cage subsiding.  The results of this study are particularly important for high risk patients with low bone density.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio for spine includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, and the Lateral Spine Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

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Zimmer Biomet Announces U.S. Launch of Vitality®+ and Vital™ Spinal Fixation Systems

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

WARSAW, Ind., Oct. 25, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the official launch of its Vitality®+ and Vital™ Spinal Fixation Systems in the United States at the 2017 North American Spine Society (NASS) Annual Meeting.

The comprehensive Vitality+ Spinal Fixation System consists of Vitality+ POWER for simple, controlled pedicle preparation and pedicle screw insertion, Vitality+ PSO for optimal pedicle subtraction osteotomy and vertebral column resection procedures, and Vitality+ HOOKS with an extensive array of additional fixation options. In addition, the Vital Spinal Fixation System offers a compact solution for degenerative thoracolumbar procedures with its convenient, intuitive and optimized two-kit pedicle screw instrument configuration.

The launch of Vitality+ POWER follows Zimmer Biomet’s recent 510(k) clearance for pedicle preparation and screw insertion under power. The addition of power offers a significant benefit to surgeons, as compared to traditional hand-driven pedicle preparation and insertion. Vitality+ POWER features the market’s first flexible drill and a blunted reamer, both of which are designed to flex off cortical bone to ensure precision during procedures. The addition of the Vitality+ PSO system provides an extensive array of intuitive instruments for complex osteotomy procedures, including specially designed curettes, osteotomes, soft tissue manipulators and nerve root retractors.  Finally, Vitality+ HOOKS offers an assortment of hooks with various throat depths, designed for sublaminar, pedicle and transverse process fixation.

Dr. David Skaggs, a board-certified orthopaedic spine surgeon in Los Angeles, Calif., commented, “The enhancements to the Vitality System are prime examples of Zimmer Biomet’s commitment to the advancement of deformity correction. The ergonomic benefit, OR efficiencies and comprehensiveness provided by POWER, PSO and HOOKS truly support spine surgeons during procedures, and especially in complex cases, all while maintaining high quality patient care.”

The Vital Spinal Fixation System is an innovative evolution to the Vitality System. The minimized two-kit configuration includes all pertinent instruments required for degenerative spine surgeries with an easy-to-follow color-coded tray layout, which is particularly beneficial to surgeons and technicians with a small OR footprint. The upgraded Vital screws incorporate one of the largest drive standards in the industry, a T27 hexalobe drive feature designed to provide 30 percent more strength than the T25 hexalobe.* The Vital System’s dual lead screws require fewer revolutions for insertion, which improves surgical efficiency by allowing them to be inserted twice as fast as comparable single lead screws, without sacrificing pull-out strength.*

Dr. Justin Smith, a board-certified neurosurgeon in Charlottesville, Va., commented, “The Vital System’s upgraded screw and consolidated kit design offer noticeable operational efficiencies for common one- and two-level degenerative posterior thoracolumbar spine procedures. The streamlined System allows me to complete cases faster, while still providing quality patient care.”

Indications:

The Vital Spinal Fixation System is a subsystem of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition, the Vitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct®Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

Vitality+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality Spinal Fixation System screws using a power surgical technique.  Pedicle and iliac screws from the Vitality Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

*Data on file at Zimmer Biomet (TPR#00184).

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

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

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

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

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Orthofix Wins 2017 Spine Technology Award for STIM onTrack Mobile App

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

October 25, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that its STIM onTrack™ mobile app has earned the 2017 Spine Technology Award in the Cervical Care category from Orthopedics This Week, the most widely read publication in the Orthopedics industry. The award will be presented today at the North American Spine Society (NASS) annual meeting in Orlando, FL. and published in upcoming issues of Orthopedics This Week and Orthopedics This Month Spine.

The STIM onTrack technology for mobile devices was introduced in 2017 and works with the latest generation Orthofix CervicalStim™ and SpinalStim™ bone growth stimulators. The mobile app includes a first-to-market feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment, allowing them to adjust and personalize follow-up protocols to help achieve better outcomes. In parallel, the app provides patients with a daily treatment reminder and a device usage calendar to help them adhere to their prescription and take an active role in their spinal fusion recovery. The STIM onTrack app is free and available through the iTunes App Store.

The STIM onTrack technology is one of 10 medical device advancements being recognized by Orthopedics This Week that represent significant advancements in their respective categories.

“The Spine Technology Awards are intended to bring increased recognition to exemplary and innovative spine surgery products and the engineering teams and inventors who create them,” said Robin Young, Founder and Publisher of Orthopedics This Week and RRY Publications. “We are pleased to present Orthofix with this award in recognition of the STIM onTrack mobile app and its potential to facilitate therapy compliance and ultimately improve patient outcomes.”

“We are honored to accept this award on behalf of our team of dedicated people who work hard every day to develop innovative technologies like the STIM onTrack app,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “This new mobile application and our latest generation CervicalStim and SpinalStim bone growth stimulators are great examples of the merger between our products and technology advancements that are designed to improve patient outcomes. We are proud to partner with physicians to help patients redefine their recovery process through better tracking and adherence to their therapy.”

About Bone Growth Stimulators

Orthofix announced the U.S. Food and Drug Administration (FDA) and European CE Mark approval of its next-generation CervicalStim and SpinalStim bone growth stimulators in January 2017. The U.S. devices feature the STIM onTrack mobile app. These Class III medical devices use a low-level pulsed electromagnetic field (PEMF) designed to activate cellular pathways that stimulate the proliferation and differentiation of mesenchymal stem cells to augment the body’s natural healing process, providing patients with a safe, noninvasive treatment option for promoting post-operative lumbar and cervical fusion.

The SpinalStim device is the only bone growth therapy device approved by the FDA as both a lumbar spinal fusion adjunct to improve fusion outcomes and as a non-surgical treatment for spinal pseudoarthrosis. Additionally, the CervicalStim device is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment option for improving cervical fusion outcomes in high risk patients. Together, these devices are the number one prescribed bone growth stimulators for spinal fusion.

In October 2016, The North American Spine Society (NASS) issued first-of-its-kind coverage recommendations for electrical bone growth stimulators. These evidence-based coverage policy recommendations support the use of PEMF stimulation devices as an adjunct to spinal fusion surgery.

Orthofix invites those attending the NASS Annual Meeting to visit Booth #1500, Hall WE1 to learn more about the STIM onTrack mobile app and our next-generation bone growth stimulation devices.

About Orthopedics This Week

Orthopedics This Week, a four time winner of the MORE awards for journalistic excellence, is dedicated to delivering breaking news, analysis and commentary about the Orthopedics industry. Published 40 times a year, Orthopedics This Week covers what matters most in healthcare through the distribution of unique and valuable information to professionals who get up every day and work in the orthopedic community.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and MTF Biologics. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: practices of health insurance companies and other third-party payors with respect to reimbursement for our PEMF devices and other risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
Investor Relations
markquick@orthofix.com
or
Denise Landry, 214-937-2529
Media Relations
deniselandry@orthofix.com

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RTI Surgical® Launches Fortilink®-C IBF System, the First 3D Printed Polymer-based Interbody Device

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

October 25, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced the commercial launch of Fortilink-C IBF System with TETRAfuse® 3D Technology. The Fortilink-C system is the first in a family of devices to incorporate RTI Surgical’s TETRAfuse 3D Technology.

“TETRAfuse 3D Technology combines the best characteristics of titanium, allograft bone and PEEK – all in one package,” said Grigory Goldberg, M.D., an orthopaedic surgeon practicing in Princeton, N.J. “The Fortilink-C system represents a revolutionary new step in the future of spine surgery.”

The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device to incorporate macro, micro and nano-rough features on the entire implant surface— not just on the endplate surfaces. The Fortilink-C device is designed to allow bony ingrowth on all implant surfaces while maintaining radiolucent and bone-like mechanical properties that surgeons expect.

“The Fortilink-C system has ushered in a new beginning for cervical fusion cages – we have gone from iliac crest to cadaver bone to PEEK and titanium, and now, Fortilink-C IBF System with TETRAfuse 3D Technology,” said Richard E. Nussbaum, M.D. an orthopaedic surgeon practicing in Sherman Oaks, CA and the first surgeon to implant a Fortilink-C device. “The enhanced implant design increases the surface area and, in an animal model, shows greater circumferential bony ingrowth1.”

“Fortilink-C IBF System demonstrates RTI Surgical’s commitment to advancing technologies and delivering innovative clinical solutions that meet the demands of our customers while improving the lives of patients,” said Camille Farhat, RTI chief executive officer. “This new innovative platform will have many derivative products, and this, in addition to the map3® Cellular Allogeneic Bone Graft and our comprehensive spine hardware portfolio, brings us a step closer to a complete offering.”

® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.
1 Data on file RTI Surgical, Inc. Performance data from animal models may not be representative of performance in humans.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical, Inc.
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

 

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VGI Medical Enters Lateral Spine Market With 1st Of Its Kind Technology

Posted On October 25, 2017 By OrthoSpineNews In Spine, Top Stories /  

LARGO, FLA. (PRWEB) OCTOBER 24, 2017

VGI Medical, LLC, a privately held medical device company specializing in unique spinal implants, today announced the full the commercial launch of the VerteLP® Lateral Interbody Fusion System.

VerteLP was designed to address many of clinical challenges that surgeons face such as insufficient fixation of the implant or interference with pedicle screws. The system was designed to be minimally invasive and anatomy preserving all while decreasing operating room time due to the reduction in the number of surgical steps and instruments required to insert the implant.

“We have been thrilled by the feedback and clinical outcomes during our alpha launch and we are excited to launch VerteLP to a wider audience,” said Tov Vestgaarden, president and chief executive officer of VGI Medical. “Our goal is create innovative solutions that solve clinical problems for surgeons and improve patient outcomes and we believe we have achieved that with VerteLP.”

VerteLP Advantages

  • Biomechanics – First of its kind bilateral plate fixation limits axial rotation and lateral bending, increasing stability of the segment
  • OR Efficiency – Reduction in OR time due to fewer instruments and surgical steps required to insert cage and lateral plating when compared to other lateral systems
  • Anatomy Preserving – Unlike competitive systems, the VerteLP lateral plating fixation does not compromise the endplates or vertebral bodies
  • Avoids Pedicle Screws – VerteLP lateral plating does not interfere with the placement of pedicle screws in primary cases or at adjacent levels where prior hardware is in place

VGI Medical 2017 North American Spine Society (NASS) Meeting

VGI Medical will display their flagship Sacroiliac (SI) Joint system, SiJoin® Direct Posterior Fusion, best-in-class VerteLoc® Posterolateral Fusion, and the all new VerteLP® Lateral Interbody Fusion System in Booth #1709 at the 2017 NASS Meeting held October 25-28, 2017 in Orlando, Florida.

About VGI Medical, LLC

VGI Medical (VGI), founded in 2007 based on an invention developed by Tov Vestgaarden, PhD, is an innovative medical device company focused on using its industry knowledge and creative thinking to develop and commercialize a broad range of advanced, high-performance and innovative spinal implants. VGI developed its first product, the VerteLoc® Minimally Invasive Spine Stabilization System, to overcome the limitations of currently available implants. Applying the principles of this success, VGI Medical added SiJoin® to its product line in 2013 for Sacroiliac fusion and introduced the truly unique VerteLP® in early 2016. For more information, please visit http://www.vgimedical.com.

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VEXIM to be Acquired by Stryker Corporation

Posted On October 24, 2017 By OrthoSpineNews In Financial, Spine, Top Stories /  

October 24, 2017

BALMA, France–(BUSINESS WIRE)–Regulatory News:

Stryker Corporation, a global leading medical technology company, acquired on October 24th, 2017 a majority of the share capital and voting rights of VEXIM, a medical device company specializing in the minimally invasive treatment of vertebral fractures listed on Euronext Growth (FR0011072602 – ALVXM).

Stryker Corporation (NYSE:SYK) has indirectly acquired 4,115,151 VEXIM shares, representing 50.7% of the share capital and 50.3% of the voting rights of the Company for a cash price of EUR 20.00 per share, and 170,745 listed warrants (“BSAAR”), representing 37.1% of outstanding BSAARs for a cash price of EUR 3.91 per BSAAR. The selling shareholders comprised funds managed by Truffle Capital, Bpifrance and Kreaxi, as well as managers of VEXIM.

The purchase price of EUR 20.00 per share represents a premium of 29.4% to the closing share price on October 23rd, 2017 of EUR 15.46, and of 34.4% and 57.6% to the volume-weighted average share prices over 6 months and 12 months, respectively (EUR 14.89 and EUR 12.69). This price represents an aggregated equity value of VEXIM on a fully diluted basis of approximatively EUR 183 million, which corresponds to an enterprise value of approximatively EUR 162 million.

“We are really excited by this transaction and enthusiastic about our future integration into Stryker’s Interventional Spine business, which we view as highly complementary to VEXIM. Stryker will significantly help us achieve our objective to become a global spine trauma leader, through consolidation of our European presence and expansion of our international footprint. We will benefit from Stryker’s broad customer base and commercial platform in back trauma surgery, enabling further acceleration in the adoption of the SpineJack® technology. Stryker is the ideal partner to lay the ground for VEXIM business on the promising US market. VEXIM’s US FDA trial is progressing well and is in line with a 510(k) filing in 2018. This landmark transaction is the recognition of our outstanding sales growth over the past five years, with net sales CAGR of 73% between 2011 and 2016, and of the strong implication and expertize of all of VEXIM employees. For the first 9 months of 2017, sales performance continued to be robust. VEXIM generated €5.4m in revenue in Q3 and we still expect a strong performance in Q4. We are reiterating our objective to reach full-year profitability on the back of a FY 2017 sales growth which remains very significant at 25%. This transaction is really beneficial to all VEXIM stakeholders: our customers, employees and shareholders. As VEXIM enters its next chapter of growth as part of Stryker Corporation, I would like to warmly thank our reference shareholders Truffle Capital, which co-founded the Company, Bpifrance and Kreaxi, all of which steadily supported VEXIM over the years,“ said Vincent Gardès, VEXIM’s CEO.

“This transaction further illustrates the power of medtech radical innovation in France,” added Philippe Pouletty, MD, CEO of Truffle Capital.

As required by applicable regulations, Stryker France MM Holdings SAS, an indirect wholly-owned French subsidiary of Stryker Corporation, will file on October 25th, 2017 a simplified all-cash tender offer (OPA simplifiée) with the Autorité des Marchés Financiers(AMF) for all VEXIM shares and BSAARs it does not already own, at the same prices per share and per BSAAR as the prices paid for the controlling blocks (the “Offer”). Following the Offer, Stryker intends to pursue a squeeze-out (retrait obligatoire) if the appropriate ownership thresholds are reached at the closing of the Offer.

The Board of Directors of VEXIM has unanimously and unreservedly approved the Offer which it considers being in the best interest of the Company, its shareholders, employees and stakeholders and recommends that all shareholders and holders of BSAAR tender their securities to the Offer.

In accordance with applicable regulations, VEXIM will file a draft response note (projet de note en réponse) which will include the reasoned opinion of the Board of Directors and the report of Associés en Finance, the independent expert appointed by VEXIM in accordance with AMF General Regulation (articles 261-1 I and II) opining on the fairness of the financial terms and conditions of the simplified tender offer and potential squeeze-out. The transaction is expected to close in the fourth quarter of 2017.

Documentation relating to the Offer will be available on the websites of the AMF (www.amf-france.org) and the Investor Relations page of VEXIM’s website (www.vexim.com).

Goldman Sachs acted as financial advisor and Dechert LLP acted as legal advisor to VEXIM on this transaction. BNP Paribas is acting as financial advisor and presenting bank and Skadden, Arps, Slate, Meagher & Flom LLP is acting as outside legal counsel to Stryker.

Update on the US FDA trial:

The VEXIM FDA trial (European, prospective and randomized multicenter study aiming to compare safety and efficacy of the SpineJack® vs balloon kyphoplasty) is intended to provide clinical data to support a 510(k) submission in the US. The FDA trial is progressing well and is in line with a 510(k) filing in 2018.

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. VEXIM has been listed on Euronext Growth Paris since May 3rd2012. For further information, please visit www.vexim.com

SpineJack®, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

About STRYKER

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
investisseur@vexim.com
Tél. : +33 5 61 48 48 38
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
vexim@alizerp.com
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94

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