Medacta Launches Short Humeral Diaphysis for the Medacta Shoulder System at the San Diego Shoulder Institute’s Annual Shoulder Course

June 18, 2018

SAN DIEGO–(BUSINESS WIRE)–Medacta® International, the privately held family-owned global leader in the design of innovative joint replacement and spine surgery products, today announced clearance by the U.S. Food and Drug Administration (FDA) for its Short Humeral Diaphysis, which is utilized with the Medacta Shoulder System. The company will showcase this new product at the San Diego Shoulder Institute’s (SDSI) Annual Shoulder Course, held June 20-23 in San Diego at Booth #310. Medacta will host numerous “Meet the Expert” opportunities with orthopedic surgeon designers Matthew Saltzman, M.D., and Anup Shah, M.D., throughout the conference and lead cadaveric workshops on Thursday, June 21 as a part of its M.O.R.E. Institute.

The Short Humeral Diaphysis is an implantable device that replaces the humeral side of the gleno-humeral joint and is intended for use with the Medacta Shoulder System as an alternative to the Standard Humeral Diaphysis. The Short Humeral Diaphysis is indicated for primary and reverse shoulder replacement in patients suffering from severe arthropathy or a grossly deficient rotator cuff. Through a reduction in device length, the corresponding procedure minimizes the violation of the humeral intramedullary canal (IM). The device is manufactured from titanium alloy and will be offered in 11 sizes to provide a patient-matched fit.

“Medacta is constantly looking to expand its product offerings to accommodate the largest group of unique patient anatomies as possible,” said Francesco Siccardi, Executive Vice President of Medacta International. “We’ve experienced a very positive response to our recent expansion into the shoulder market and are looking to build on that success. The addition of the Short Humeral Diaphysis to the Medacta Shoulder System means that surgeons will be able to achieve a more personalized fit for more patients, improving the patient and surgeon experience.”

Medacta Activities at SDSI’s 35th Annual Shoulder Course

Medacta will showcase this new product at Booth #310 along with the full Medacta Shoulder System and will offer various opportunities for conference attendees to experience its products and meet with members of the team. The full schedule of Medacta’s on-site offerings is listed below.

Thursday, June 21: Medacta Shoulder System Cadaveric Workshops

  • 6:30 a.m. – 7:00 p.m.

Wednesday, June 20-Friday, June 22: “Meet the Experts” Sessions with Drs. Saltzman and Shah

  • 7:00 a.m. – 5:00 p.m. each day

Conference attendees interested in scheduling “Meet the Expert” appointments or attending Medacta’s wet lab sessions should contact Amanda Earl (aearl@medacta.us.com). Additional workshops may be added to the schedule to accommodate requests, as needed.

About the M.O.R.E. Institute – “Where the surgeon is never alone”

Strongly aware of its role to provide continuing education as products and techniques evolve, Medacta International founded the M.O.R.E. (Medacta Orthopaedic Research and Education) Institute to highlight this commitment. Built on the ideal of sharing experience within the international medical community, the mission of the M.O.R.E. Institute is to provide ongoing support to Medacta partners worldwide as they strive to make an impact by learning about and adopting emerging technologies, surgical techniques and orthopaedic products. The Institute includes the AMIS Education Program for total hip arthroplasty, which has revolutionized the teaching of the anterior approach to hip replacement throughout the world, as well as platforms to impact the specialties of partial and total knee arthroplasty, total and reverse shoulder arthroplasty, sports medicine and spine surgery. The Institute relies on Medacta consultants and the healthcare provider community to create networking opportunities and hundreds of educational events, including courses, wet labs, scientific evenings, surgeon-to-surgeon visits, international symposia, guesting and hosting thousands of participants from all over the world. With a strong focus on young and promising surgeons, the M.O.R.E. Institute also supports fellowship programs worldwide.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS® system and total knee replacement with MyKnee® patient-matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International, Inc.
Emy Gruppo, 203-247-5856
Emy@torchcomllc.com

OrthoPediatrics Corp. Announces First RESPONSE Spine Surgery

WARSAW, Ind., June 18, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the first spine surgery in Japan utilizing the RESPONSE™ Spine System (“RESPONSE”) through its exclusive agreement with Tokyo-based Robert Reid Inc. The first surgery performed represents OrthoPediatrics’ expansion into the market, providing Japanese surgeons a superior solution to treat the distinct needs of pediatric patients with spinal deformities.

Mark Karshner, OrthoPediatrics’ Senior Vice President of International Sales, stated, “We are extremely pleased by the success of the first OrthoPediatrics spine case in Japan. As one of the largest medical device markets in the world, our expansion in Japan represents a significant step forward in our ability to help children all over the world. Our exclusive agreement strengthens our international market strategy, and we look forward to future procedures.”

Hideo Shitoto, President & CEO of Robert Reid, commented, “Completing the first RESPONSE case in Japan represents a significant milestone for both Robert Reid and OrthoPediatrics. We are excited by our partnership with OrthoPediatrics in order to introduce innovative and dedicated solutions to this market. We look forward to treating many more patients in Japan.”

About RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat spinal deformity. The system is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

About Robert Reid Inc.
Robert Reid Inc. is a privately-held Japanese corporation headquartered in Tokyo. The Company imports and distributes a diverse range of surgical products from the United States and Europe. Robert Reid also designs and manufactures its own original orthopedic surgical products.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

OrthoGrid Systems Announces Immediate Launch of New HipGrid® NINE for Outpatient Total Hip Replacement

SALT LAKE CITYJune 18, 2018 /PRNewswire/ — OrthoGrid Systems, Inc., a leading innovator of radiographic assessment and alignment technology for orthopedics, today announced the commercial release of its new patent-protected HipGrid® NINE System for outpatient total hip replacement.  Featuring the same clinically validated technology utilized in the original HipGrid®, OrthoGrid’s HipGrid® NINE system is designed to seamlessly integrate with C-arm systems commonly found at ambulatory surgical centers and hospitals.

“Outpatient total hip replacement procedures are growing rapidly due in large part to the potential for added convenience, reduced costs, and quicker return to home for the patient,” explained Edouard Saget, President of OrthoGrid Systems.  “Increasingly, our customers have demanded to have a HipGrid® that is compatible with 9-Inch C-arm systems commonly found in outpatient surgery centers, and so we are pleased to immediately commence shipments of this compelling new product.”

Designed with an innovative BOA® Fit Attachment System and high contrast markings, the HipGrid® NINE is controlled intra-operatively by the physician, integrates into the standard surgical workflow with no disposables or instrumentation, and can be fully utilized in conjunction with implant systems from all vendors.

Orthopedic surgeon Erik Kubiak, MD, noted that, “as the healthcare system moves away from unconstrained spending and physicians and hospitals work together to deliver higher-quality care for a reasonable cost, OrthoGrid’s HipGrid® NINE hits the mark by enabling excellent clinical value at an attractive economic price.  I will continue relying on OrthoGrid technologies for my total hip replacement patients.”

The HipGrid® NINE System is available for sale in the USA through OrthoGrid’s sales & service team.  Please visit our website at www.orthogrid.com to learn more about our company and how to schedule a free product trial of any OrthoGrid Systems technology.

About OrthoGrid Systems, Inc.
OrthoGrid Systems is a rapidly expanding global leader in intra-operative radiographic assessment and alignment technologies for orthopedics, with specialized applications available or in development for hip arthroplasty, trauma, knee replacement, and other common procedures performed over 1 million times per year in aggregate in the USA and 3 million times globally.  OrthoGrid helps to overcome the limitations of traditional low resolution, distorted imaging technology by revealing inherent image distortion, enhancing intra-operative decision making for physicians performing orthopedic procedures.  Learn more about OrthoGrid and our products by visiting our website at www.orthogrid.com.

Media Contact: Mark Carrico. Director of Marketing
Email: 197221@email4pr.com
Phone: 801-703-5866

SOURCE OrthoGrid Systems

Related Links

https://orthogrid.com

EOS imaging Launches New EOSone Private Practice Program

June 15, 2018

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the launch of EOSone, its new Private Practice Program, at Becker’s 16th Annual Future of Spine + The Spine, Orthopedic and Pain Management-Driven ASC Conference, being held June 14-16 in Chicago.

The EOSone program is designed to address the unique needs of private practices and to ensure that safe imaging is available to all patients, not just those treated in a traditional hospital environment. The program includes support to assist sites with patient communication and education about low dose, 3D imaging, and patient specific surgical planning with respect to their conditions and treatment plans.

“In the U.S., the private practice sector accounts for 73 percent of all orthopedic practices*, representing a significant opportunity for the EOS technology,” said Marie Meynadier, Chief Executive Officer of EOS imaging. “We launched the EOSone program as an option for private clinics to better inform patients interested in safe and personalized orthopedic care about our EOS platform, 3D models, and surgical planning solutions. We also include in this program customized financing options to facilitate access for private practices to our comprehensive platform.”

Because private practices are often hindered by the initial/upfront investment associated with capital equipment, the EOSone program offers sites various options to match the sites’ estimated volumes, with access to the full suite of EOS products, including 3D services, 3D surgical planning solutions, and system services, training, support, and updates for the duration of the program.

*Becker’s Spine: 11 Statistics and Facts About Orthopedics and Orthopedic Practices

About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Joanna Zimmerman
The Ruth Group
Ph: 646-536-7006
jzimmerman@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com

Zimmer Biomet Announces Quarterly Dividend for Second Quarter of 2018

WARSAW, Ind.June 14, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the second quarter of 2018.

The cash dividend of $0.24 per share is payable on July 31, 2018 to stockholders of record as of the close of business on June 29, 2018. Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About the Company

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.

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

General Meeting of Kuros Biosciences approves all resolutions

Schlieren (Zurich), Switzerland, June 14, 2018

Kuros announced that today’s General Meeting approved all resolutions proposed by the Board of Directors with a clear majority. In particular, shareholders resolved on the increases and adjustments of the conditional and authorized capital. Joost de Bruijn, Jason Hannon, Scott P. Bruder and Oliver Walker were elected as new members of the Board. A total of 24.4 % of shares were represented at the General Meeting.

The General Meeting approved the Annual Report, the Annual Financial Statements, and Consolidated Financial Statements for the year 2017 and took note of the Reports of the Auditors. Shareholders discharged the Board and the Executive Committee. Shareholders also voted in favor of the proposed appropriation of the Annual Results and approved the compensation for the members of the Board and the Executive Committee.

Clemens van Blitterswijk was elected as new Chairman as were Leanna Caron, Giacomo Di Nepi, Christian Itin and Gerhard Ries as members of the Board. Shareholders also elected Joost de Bruijn, Jason Hannon, Scott P. Bruder and Oliver Walker as new Board members. Dr. Ries and Mrs. Caron were re-elected as members of the Compensation Committee. Both the current Independent Proxy and the Auditors were confirmed for another one-year term.

Shareholders also resolved on an increase and adjustment of the authorized share capital (to 4,116,464 registered shares with a nominal value of CHF 1.00 each) and the conditional share capital for Employee Participation (to 1,141,258 registered shares with a nominal value of CHF 1.00 each) and corresponding changes to the Articles of Incorporation.

The General Meeting took place at the Company’s headquarters in Schlieren. It was attended by 48 shareholders. 2,009,953 shares or 24.4% of a total 8,232,929 shares were represented.

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

 

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

 

HSS Hip and Knee Surgeon Bradford Waddell, MD, Named Chair of Young Arthroplasty Group

NEW YORKJune 14, 2018 /PRNewswire-USNewswire/ — Bradford Waddell, MD, hip and knee surgeon at Hospital for Special Surgery (HSS), has been named chair of the Young Arthroplasty Group (YAG) Committee in the American Association of Hip and Knee Surgeons (AAHKS).

Founded in 1991, the mission of AAHKS is to advance hip and knee patient care through education and advocacy.

“About two years ago, my colleague Dr. Jeff Lange and I sought to connect recently graduated hip and knee fellows for research and collaboration,” said Dr. Waddell. “We began with 10 to 12 surgeons, creating this new informal group and then brought the idea to AAHKS, where it has now grown into a larger group and committee.”

The mission of YAG is to connect young arthroplasty surgeons (with under 5 years of practice) in order to promote collaboration and young surgeon activity within AAHKS, with a particular focus on research, leadership and advocacy.

At the inaugural YAG meeting at AAHKS’ Annual meeting in 2017, over 100 surgeons were in attendance.

Dr. Waddell has been a member of AAHKS since 2014 and began his term as chair on June 1, 2018.  Previously, as a Health Policy Fellow for AAHKS, he was charged with finding new ways to bring younger surgeons into the organization. “Bringing our informal group to AAHKS was the perfect way to fulfill this duty,” says Dr. Waddell, who also practices in CT at HSS Stamford.

The YAG Committee’s co-founder, Jeffrey Lange, MD, orthopedic surgeon at Brigham and Women’s Hospital, serves as vice-chair, with 5 liaisons to different AAHKS committees comprising the rest of the committee.

“This group recruits young arthroplasty surgeons and works to encourage and empower them to take advantage of the full benefits of the organization whether it is in research, advocacy or leadership,” added Dr. Waddell. “I’m happy to say we’ve had 250 surgeons sign up for the group to date!”

Dr. Waddell joined HSS in October 2017; however he was no stranger to the organization as he completed his fellowship at HSS. He specializes in reconstruction of the hip and knee, specifically primary and revision hip and knee replacement. Devoted to getting his patients back to an active lifestyle, Dr. Waddell currently researches patient safety, new technologies and value-based care.

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures.  People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu

Centinel Spine Announces Lumbar Total Disc Replacement coverage by TRICARE

NEW YORKJune 14, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that TRICARE, the Military Health System for almost 10 million beneficiaries world-wide, has updated its coverage policy to now cover the company’s prodisc® L Anterior Lumbar Total Disc Replacement system, the most studied total disc replacement platform in the world.  More patients globally now have access to this market leading technology, a potential alternative to spinal fusion that is designed to relieve pain, maintain spinal motion and reduce post-operative recuperation time. The TRICARE extended coverage has far-reaching impact as it applies to both active duty and retired military personnel.  “With years of total disc replacement experience, I have witnessed extreme patient recovery with this technology.  This extended coverage policy will provide more patients with access to a proven surgery that offers better mobility and faster return to an active lifestyle,” stated spine surgeon Robert Masson, M.D. (Masson Spine Institute, Orlando FL).

The coverage policy was changed in a communication published on May 8, 2018, and made effective retroactively to November 16, 2017. The bulk of the TRICARE beneficiaries are Active Duty Service Members and their family members, along with retired service members.

TRICARE has supported cervical total disc replacement for many years, but this is the first time that it has extended coverage to lumbar total disc replacement.  “I look forward to extending the access to this technology in the lumbar spine – I have had significant experience with enabling military personnel to rapidly return to active duty, and appreciate the opportunity to provide lumbar total disc replacements to other TRICARE beneficiaries,” stated spine surgeon John F. Hall, M.D. (Flagstaff Bone & Joint, Flagstaff, AZ).

prodisc L has the longest use of any lumbar total disc replacement system in the U.S. (FDA approval in 2006), and has received coverage by numerous insurance providers since FDA approval. The prodisc technology platform has been the subject of over 400 articles, which have reported on over 13,000 patients’ lives.

“The TRICARE approval is the latest in a continuing trend of positive coverage decisions by carriers, and we welcome TRICARE beneficiaries to the pool of patients that are able to benefit from this life-changing treatment option.  More patients will now have access to the most proven technology in the world, with global clinical usage of almost thirty years,” stated John Viscogliosi, CEO of Centinel Spine.

About Centinel Spine

Centinel Spine, LLC is the largest privately-held spine company, focused on anterior column reconstruction. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies, and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning

Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer

Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, LLC

Related Links

http://www.centinelspine.com

Tyber Medical Promotes Gary Thomas To Chief Operating Officer And Adds Wesley Johnson As Executive Vice President Of Product Development

BETHLEHEM, Pa.June 12, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the promotion of Gary Thomas to Chief Operating Officer and the addition of Wesley Johnson as Executive Vice President of Product Development.

Gary Thomas has been with Tyber Medical since 2017 as the Executive Vice President of Operations.  As a key member of the leadership team, his direct role is to help Tyber Medical achieve record growth through seamless execution.  He is accountable for the supply chain including customer/project management, information systems, product launches, and innovative driven solutions to optimize operational performance.  Mr. Thomas has over 28 years of experience in operations management, product development, quality, and regulatory areas.  Before joining Tyber Medical, he was the Vice President of Operations for Musculoskeletal Transplant Foundation (MTF), an orthopaedic biologic company. While there, he was responsible for multiple sites (approx. 300 employees) including: Operations, Distribution, Development, Supply Chain, and Business Unit Operations. Prior to MTF, he was the Group Vice President of Portfolio and Project Management at Biomet overseeing spine, bone healing, and microfixation. Mr. Thomas has also held top management positions for Norman Noble, Howmedica (Stryker), and Pfizer.  Mr. Thomas holds a Master’s degree in Management from NJIT and a Bachelor’s in Business Management from Ramapo College.

As the Chief Operating Officer for Tyber Medical Mr. Thomas will be responsible for management and strategic leadership over the company’s day-to-day operations as well as developing future organic operational growth.  He will be directly responsible for the business organization and strategic alignment in Operations, Inventory (SIOP) and Supply Chain Management, Customer Service, Manufacturing, Facilities, IT/Business Systems, and other customer centric services.

Tyber Medical is happy to announce the addition of Wesley Johnson to the management team as Executive Vice President of Product Development.  Mr. Johnson has an extensive background in Product Development and Business Management in the joint reconstruction, spine, trauma, and biologics fields.  Prior to Tyber Medical he was a Vice President of Research & Development at Medacta in Chicago, Illinois.  Other key management roles have included General Manager and Vice President of Arthroplasty Division at Cayenne Medical, Co-founder/President and CEO at Alexandra Research Technologies, Director of Product Development at Spine-Tech (now Zimmer Spine), and Founder of Insight Medical as well as several other management titles.  With Mr. Johnson’s knowledge and expertise, he will lead a team that is responsible for Research, Clinical, Product Development, and innovative customer focused/driven services.  He will provide guidance and mentorship to the engineering team while creating new product innovation, product launches, and product renovations to meet broad business objectives.  Mr. Johnson holds a Bachelor’s of Science Degree and a Master of Science Degree in Mechanical Engineering from the University of Minnesota, Institute of Technology.

Jeff Tyber, CEO and President of Tyber Medical commented, “We are extremely lucky to have Wes and Gary on our leadership team.  As we grow the company, we are building an organization lead by experienced orthopedic leaders to execute our customer centric growth strategies; from creating innovative products which Wes will manage, to stream-lining the production process to deliver consistent reliability and scalability which Gary will continue to oversee.”

Visit Tyber Medical’s Booth #609, at OMTEC in Chicago, IL where the company will showcase innovative products available for private labeling as well as meeting Wesley Johnson, Tyber Medical’s new Executive Vice President of Product Development.

About Tyber Medical, LLC.

Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to portfolio enhancing, regulatory approved, orthopedic implants within the spine and extremity/trauma markets.  While focusing on rapid product commercialization, the company distributes products via private labeling; releasing 14 spine and 25 extremity/trauma systems since its founding in 2012.  Tyber Medical utilizes the differentiated, bioengineered technology such as TyPEEK® osteoconductive coatings and BioTy™, a new antimicrobial nano-textured surface modification to enhance the company’s growing portfolio.

Contact:
Eric Dickson
83 South Commerce Way, Suite 310
Bethlehem PA 18017
(610) 849-1710
edickson@tybermed.com

SOURCE Tyber Medical

Wright Medical Group N.V. Announces FDA Premarket Approval for AUGMENT® Injectable Bone Graft

AMSTERDAM, The Netherlands, June 13, 2018 (GLOBE NEWSWIRE) —  Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for AUGMENT® Injectable Bone Graft for the same clinical indications as AUGMENT® Bone Graft.  AUGMENT Injectable is a combination product consisting of recombinant human platelet derived growth factor (rhPDGF-BB) and a blend of Type I collagen and Beta tri-calcium phosphate, which provides a clinically proven and safe and effective alternative to autograft for use in hindfoot and ankle fusion in an easy to use flowable formulation.

Robert Palmisano, president and chief executive officer, stated, “Building on the commercial and clinical success of AUGMENT Injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven AUGMENT franchise and meet the needs of foot and ankle surgeons in the U.S. with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site.  In addition to the significantly improved handling characteristics with AUGMENT Injectable, one of the key differentiators continues to be the strength of the clinical evidence.  Our approved PMA supplement for AUGMENT Injectable builds upon the existing body of evidence supporting the safety and effectiveness of AUGMENT Bone Graft and leverages clinical data from the U.S. and Canada for the injectable formulation.”

The U.S. launch of AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years with a gradual ramp as the injectable form is reviewed by hospital value analysis committees and physician education programs are executed.  The company will immediately start the process of finalizing its packaging carrying the FDA approved labeling and expects to begin selling product in the U.S. shortly and complete the rollout in the next four to six weeks.

Dr. Timothy Daniels, Chief of the Division of Orthopaedic Surgery of St. Michael’s Hospital and Professor at the University of Toronto in the Department of Surgery, commented, “In Canada, my colleagues and I have been using AUGMENT Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of AUGMENT Injectable provides a valuable enhancement to the existing AUGMENT product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting.”

Dr. Jeremy McCormick, Associate Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis, Missouri, added, “I adopted AUGMENT Bone Graft shortly after it launched as a clinically proven tool that has improved patient outcomes. As my confidence in the product has grown, so too has my use of AUGMENT.  Now, with the introduction of the new injectable version, delivery of the product to the fusion site will be simplified and more consistent, helping foot and ankle specialists use it more dependably in patients.”

AUGMENT Injectable is the first clinically proven injectable protein therapeutic to come to the U.S. orthopaedic market offering an alternative to autograft in ankle and/or hindfoot fusion procedures, which translates into an estimated market opportunity of approximately $300 million in the U.S. As FDA-approved alternatives to autograft in ankle and/or hindfoot fusion procedures, AUGMENT Bone Graft and AUGMENT Injectable offer a clear patient benefit by avoiding secondary surgical sites for the harvest of autograft tissue, which can result in prolonged harvest site pain and other comorbidities in some patients.

As a result of this approval, the company plans to update its 2018 annual guidance on its second quarter earnings call scheduled for August 8, 2018.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS  

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the performance, market availability and market acceptance of the company’s products. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the company’s control; competitor activities; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 28, 2018 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com