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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

Related Links

http://www.4webmedical.com

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Atlas Spine Inc., Announces the Hiring of Matthew Miller as Executive Vice President of Business Development

Posted On October 26, 2017 By OrthoSpineNews In Spine /  

Jupiter, FL — (PR Newswire) — Atlas Spine, Inc., a high technology spine implant company focused on the development of innovative, disruptive implants and instrumentation for spine surgery, has hired Matthew Miller as Executive Vice President of Business Development.

Miller has over 25 years in orthopedics and spine experience and has co-founded or been instrumental in the development of several high-profile orthopedic and spine companies.

In 2005 he raised over $14 million in seed capital for SpineMedica, Inc., which licensed technology a hydrogel material from The Georgia Institute of Technology and Salumedica, Inc. as an artificial disc.  In 2007 Miller co-founded MiMedx Group, Inc. with licensed technology from the University of South Florida and the Shriners Hospital for Children. Miller and his team took the company public when Pete Petit stepped in to run the public company. Most recently he was a co-founder of The Genomics Cancer Institute, a company focused on the commercialization of genomic and esoteric cancer testing in partnership with NCI-accredited hospitals.

“I’m elated and grateful for the opportunity to be part of the team at Atlas Spine, Inc. Atlas is committed to developing innovative and disruptive spine implants and surgical technology. More importantly, the talent the company has assembled is inspiring. Every team member is committed to developing the best products that serve the needs of spine surgeons and benefit patient outcomes. I couldn’t be more pleased to jump back into the spine industry than I am with Atlas Spine, Inc.”

As Executive Vice President of Business Development, “I’ll be finalizing a mezzanine financing round and working with the executive team to deploy capital to support the launch of several products we have in front of the U.S. Food and Drug Administration. I can’t talk about the products prior to their approval, which for those who know me, is very difficult. We have some game-changing products coming to market. I can’t wait.”

Atlas Spine, Inc., is a privately held spine implant company based in Jupiter, Florida. Atlas is committed to the development of innovative spine implants that benefit surgeons and provide better patient outcomes. 

Media:  Please contact Matt Miller, at 813-368-6011 or mmiller@atlasspine.com for information about the company. Interviews and photos are available upon request.

 

Matt Miller

EVP Business Development

 

Atlas Spine, Inc.

1555 Jupiter Park Dr.

Jupiter, FL 33458

Office:  561-741-1108

Cell:  813-368-6011

www.atlasspine.com

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Medicrea Unveils New U.S. Business Development Model with Hiring of Joseph Walland as Executive Vice President of Sales and Richard Washburn as Executive Vice President UNiD™ ASI

Posted On October 25, 2017 By OrthoSpineNews In Spine /  

October 25, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence (“ASI”) technology, announced today that the Company has hired Joseph Walland as Executive Vice President of U.S. Sales, and Richard Washburn as Executive Vice President UNiD™ ASI, to support its new business development model in the United States, effective October 23, 2017.

Denys Sournac, President and CEO of Medicrea, stated, “I am pleased to welcome Joseph Walland and Richard Washburn to Medicrea. The addition of these profoundly experienced industry executives strengthens our global leadership position and accelerates our ability to execute on the Company’s strategic growth and business development model via Medicrea’s proprietary and disruptive UNiD™ ASI technology.”

Joseph Walland joins Medicrea as Executive Vice President of U.S. Sales with more than 15 years’ commercial experience in spine, most recently as the Western Area Vice President for Stryker Spine, responsible for more than $120 million in annual revenue. Mr. Walland will lead the Company’s transformation of its U.S. sales organization and accelerate the utilization of UNiD™ ASI services throughout the entire U.S. Enterprise.

Richard Washburn joins Medicrea as Executive Vice President and will head the newly-formed UNiD™ ASI division with more than 20 years of experience in new product development, operations and medical device commercialization. With a background in engineering, Mr. Washburn has held prominent leadership positions in the industry, including Director of Marketing at Globus Medical, President of Core Essence Orthopaedics, Inc., and most recently Chief Technology Officer at Trice Medical. Mr. Washburn will take a key leadership role in Medicrea’s organization charged with shaping the ground-breaking integrated service solutions of the disruptive UNiD™ ASI platform.

Mr. Washburn will work hand-in-hand with the Company’s Chief Scientific Officer, Thomas Mosnier, PhD, to align the strategic and clinical research efforts of the Company’s UNiD™ ASI technology platform, including UNiD™ LAB engineers and consultants, UNiD™ HUB intelligent surgical planning software and UNiD™ TEK patient-specific implants.

In conjunction with the appointments of Joseph Walland and Richard Washburn, Medicrea is accelerating the implementation of a new business development model in the United States. Focused around the execution of strategic commercial and innovation goals for the Company, Medicrea is poised to transform its commercial efforts in the United States to fully synchronize with the Company’s ongoing integration of its proprietary UNiD™ ASI digital healthcare platform.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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New DePuy Synthes Spine Technologies Help Simplify MIS by Enhancing Efficiency and Reducing Steps

Posted On October 25, 2017 By OrthoSpineNews In Spine /  

ORLANDO, Fla., Oct. 25, 2017 /PRNewswire/ — DePuy Synthes* today is launching two solutions for minimally invasive spinal fusion surgery (MIS) designed to simplify the procedure, particularly as MIS gains traction and shows reduced complications compared to open surgery in treating degenerative disc disease in the back.1,2

Research shows the number of MIS fusion surgeries conducted in 2010 accounted for one-sixth of the total number of all spine surgeries in the United States and is expected to be more than half of all spine surgeries in 2020.3 As MIS becomes more common, there is a significant need to simplify these procedures, especially the complexity associated with degenerated disc removal and pedicle screw insertion.

The VIPER PRIME™ System combines multiple instruments into one pedicle screw inserter tool that reduces the number of instrument passes. The single-use CONCORDE® Clear MIS Discectomy Tool allows surgeons to complete the degenerated disc-clearing process faster on average and more efficiently compared to traditional discectomy tools while increasing the amount of disc material removed.4 These products are being showcased here at the North American Spine Society meeting.

“As a global leader in spine, we have a responsibility to continue to innovate to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” said Nadav Tomer, Global Platform Leader, DePuy Synthes Spine. “Both the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool are examples of how we are providing differentiated technologies that simplify spine surgery and make it more reproducible for every surgeon while reducing the impact on patients.”

VIPER PRIME System Inserts Pedicle Screws with Single Instrument Pass
Currently, the MIS screw insertion technique may consist of numerous instruments, involves the use of tools like Jamshidi needles and guidewires, and requires multiple instrument passes in and out a patient’s body, all of which contribute to procedural complexity. The VIPER PRIME System combines many of these instruments into one single tool and reduces the number of instrument trays to two**. A new screw tip design and stylet that is fully controlled by the screwdriver allows surgeons to target pedicles and insert the screw in one single instrument pass. In one bench study, the VIPER PRIME System demonstrated a 33 percent reduction in the time required to insert a pedicle screw through an MIS technique compared to traditional techniques.5 Additionally, the system’s streamlined instrument set means a smaller procedural footprint that also helps reduce waste, processing costs and environmental impact.6

CONCORDE Clear Discectomy Tool Removes Degenerated Disc in Under Four Minutes4
Disc removal in spinal fusion surgery requires the surgeon to work through a small surgical field with limited visualization. It also typically requires multiple instruments and instrument passes to make sure the disc is cleared and the endplates of the vertebrae are prepped for implants, which increases the risk of nerve root injury. The CONCORDE Clear Device is a single-use instrument that uses standard operating room suction to remove the degenerated disc and prepare the endplates, a simplified approach that is faster on average and results in a reduction in tool passes and instrument exchanges compared to traditional techniques.4*** A clear handle enables surgeons to visualize collection of disc material.

About DePuy Synthes Companies
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies****, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries. MEDOS INTERNATIONAL, SARL is the legal manufacturer of the VIPER PRIME System and the CONCORDE Clear MIS Discectomy Tool.
**Compared to the VIPER® 2 MIS System
***Comparing CONCORDE Clear MIS Discectomy Tool vs. traditional discectomy tools
****The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.
DSUS/SPN/1017/1674 10/17

1 Jhala, Amit, et al. Minimally invasive transforaminal lumbar interbody fusion. Indian Journal of Orthopaedics 48(6) (2014 Nov-Dec); 562-567.
2 Peng, Chan Weam Benedict, et al. Clinical and Radiological Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion. SPINE Vol. 34, Number 13 (2009); 1385-1389.
3 Phillips F. M., Cheng I., Rampersaud Y. R., et al. Breaking through the ‘glass ceiling’ of minimally invasive spine surgery. Spine. 2016;41, S8:S39–S43.
4 Araghi, A. Novel Technologies for MIS Fusion Discectomy and Expandable Interbody. ISASS Boston September 18-20 2015.
5 Adaptiv #103327910 (Analysis 1): Percent Reduction in Time for the Viper Prime Technique Compared to the Traditional Jamshidi/Guidewire Technique.  Bench test results may not be indicative of clinical performance.
6 Earthwards Scorecard Results: VIPER PRIME System.

SOURCE DePuy Synthes

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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.

Related Links

http://www.zimmer.com

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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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AlloSource To Highlight AlloFuse Select CM Cellular Allograft Matrix At North American Spine Society Annual Meeting

Posted On October 25, 2017 By OrthoSpineNews In Biologics /  

CENTENNIAL, Colo., Oct. 24, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cellular, cartilage, bone, skin and soft-tissue allografts to advance patient healing in surgical procedures, will highlight AlloFuse® Select CM at the North American Spine Society Annual Meeting (NASS).

AlloFuse Select CM combines osteoconductive, osteoinductive, and osteogenic properties to support the initiation and nurturing of bone growth, leading to consistent spinal fusion outcomes and delivering the benefits of autograft bone without the potential drawbacks. The product engages the body’s natural healing power and can be used in a variety of spinal, neurologic, and orthopedic procedures.

“AlloFuse Select CM represents our ongoing dedication to delivering advanced allograft solutions that help restore mobility for recipients,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “We are proud to support spine surgeons by expanding our biologics portfolio to provide a range of products that assist in patient healing.”

This cellular allograft matrix is moldable and compressible for insertion into interbody implants or placement around anatomical structures. AlloFuse Select CM enhances AlloSource’s current orthobiologic portfolio, which includes AlloStem® Cellular Bone Allograft, AlloFuse® Cortical Fibers and AlloFuse Fiber Boat, AlloFlex® Plus and AlloFuse putty, paste and gel allografts.

Surgeon experts Dr. Shay Bess and Dr. Peter Passias will be at AlloSource’s NASS booth #1033 for peer-to-peer discussion during NASS, which is taking place October 25-28, 2017 in Orlando, Florida.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

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Alphatec Announces Preliminary Third Quarter 2017 Financial Results And Corporate Updates

Posted On October 25, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., Oct. 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced preliminary estimates of financial results for the third quarter ended September 30, 2017.  The Company also announced several corporate updates.

Preliminary, Unaudited Third Quarter 2017 Financial Results

  • Total revenue of $22.8 million to $23.1 million
  • U.S. commercial revenue of $20.4 million to $20.7 million
  • U.S. commercial gross margin of 68% to 69%
  • Total operating expenses decreased to a range of $15.7 million to $16.0 million
  • Cash burn improved to approximately $3.7 million; cash balance of approximately $15.4 million at September 30, 2017

“Third quarter revenue was down sequentially due to the impacts of the hurricanes in Texas, Florida, and Puerto Rico, and fewer selling days in the quarter,” said Terry Rich, Alphatec’s Chief Executive Officer. “In spite of the weather-related challenges, we successfully managed operating expenses and substantially decreased cash burn for a fourth consecutive quarter.  As well, with the momentum we are experiencing in our sales channel, we expect to drive sequential revenue growth in the fourth quarter.”

The Company will report final third quarter 2017 financial results and will hold a conference call on Thursday, November 9, 2017, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 4698936. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

A replay of the webcast will remain available on the Company’s website, www.atecspine.com, until the Company releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 4698936.

Ward W. Woods Appointed to Board of Directors

Alphatec has appointed Ward W. Woods to its board, adding his decades of capital markets and business expertise. Mr. Woods is former President and Chief Executive Officer of Bessemer Securities Corporation and Founding Partner of Bessemer Holdings, L.P., a private equity firm, a senior partner and member of the Management Committee of Lazard Freres & Company, and Managing Director, Partner and co-head of the Corporate Finance Department at Lehman Brothers. Mr. Woods currently serves as Chairman of the Advisory Board of the Stanford Woods Institute, as Chair Emeritus and trustee of the Wildlife Conservation Society and as a trustee of the David & Lucille Packard Foundation. He is a former Trustee of Stanford University, former Chairman of The Stanford Management Company and a former trustee of the National Fish and Wildlife Foundation. Mr. Woods has also served as former Governor and Treasurer of The Nature Conservancy, Vice-Chair and trustee of The Asia Society and a trustee of The Boys Club of New York.  Mr. Woods graduated from Stanford University.

“The new leadership team at Alphatec has begun to execute an important mission to improve patient outcomes and expand market share. I look forward to contributing to the Company’s advancement into a major spine market player,” said Woods.

Mike Plunkett, President and Chief Operating Officer Resigns

On October 18, 2017, the Company accepted the resignation of its President and Chief Operating Officer, Mike Plunkett, who is stepping down from his position to pursue other interests. Mr. Plunkett’s resignation is effective as of November 15, 2017, and it is anticipated that he will remain available to the Company in a consulting capacity through the end of 2017 to transition his duties.

Mr. Rich stated, “Mike has contributed solidly to the commencement of the Alphatec transformation.  We sincerely appreciate his years of service and leadership, and wish him the best in his future endeavors.”

Shelf Registration Filed

Alphatec has filed a shelf registration statement with the Securities and Exchange Commission (SEC).  The filing will register up to $100 million in aggregate of equity, debt, or other types of securities described in the registration statement in one or more offerings.  The terms of any future offering will be established at the time of the offering, subject to market conditions and approval by the Company’s board of directors.  Each time securities are offered and sold, the Company will provide a supplement to the registration statement with specific information about the offering and the amounts, prices, and terms of the securities. The supplement may also add, update or change information contained in the registration statement. The filing may enable the Company to offer and sell securities on an expedited basis if market opportunities present themselves.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, 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 providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.
Additional information can be found at www.atecspine.com.

Disclosure Regarding Preliminary Unaudited Results

The preliminary financial results presented above reflect Alphatec’s estimates based solely upon information available to it as of the date hereof, is not a comprehensive statement of its financial results or position as of or for the three months ended September 30, 2017, and has not been audited, reviewed or compiled by its independent registered public accounting firm, Mayer Hoffman McCann P.C. (“MHM”). Accordingly, MHM does not express an opinion or any other form of assurance with respect thereto. Alphatec’s actual third quarter results may differ materially from these estimates. Accordingly, investors should not place undue reliance upon these estimates

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions 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 references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  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 uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party 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; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; 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. 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.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec 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.

Investor/Media Contact:
Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com

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