Captiva Spine Marks First Surgeries Using TransFasten™ Posterior SI Fusion System, Addition of VP of Sales & Business Development and HyperLOX™ Posterior Cervical System

Posted On March 8, 2018 By OrthoSpineNews In Spine, Top Stories /

Captiva Spine, Inc., which designs, manufactures and distributes elegant and intuitive spine device solutions, announces the first surgeries using the company’s proprietary TransFasten™ Posterior SI Fusion System; the well-timed addition of Vice President of Sales and Business Development, Daniel Abromowitz; the addition of a new posterior cervical system – HyperLOX™.

Captiva Spine’s thoughtful solutions for the entire spinal column will be on display at the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting March 7-9, 2018 in New Orleans at booth 4213.

TransFasten Posterior SI Fusion System

The first cases using the company’s proprietary TransFasten Posterior SI Fusion System were successfully completed across the USA starting in December 2017. TransFasten’s use of a favorable posterior approach will potentially reduce operative time and neurovascular complications. With proprietary QuadraCentric joint preparation, TransFasten provides multiple implant contact points for biomechanical stability during fusion. An initial TransFasten surgeon, Dr. Pedro Ramirez, M.D. of Central Florida Neurosurgery Institute, stated “the intuitive TransFasten instrumentation allows me to place the implant accurately, utilizing a safe posterior approach while obtaining a true biologic fusion of the sacroiliac joint.” Over the past several years there has been a resurgence in the recognition of the SI Joint as a potential source of low back pain as treatment options for SI Joint dysfunction have advanced. Captiva Spine is committed to launch devices that align clinical and economic outcomes on behalf of all key stakeholders. TransFasten is on a track for completion of its alpha launch, and Captiva Spine will be training additional surgeons on this posterior SI approach nationwide as early as the end of March 2018.

Hired: VP Sales & Business Development, Daniel Abromowitz

In supporting Captiva Spine’s commitment towards continuous growth and business development, the addition of Daniel Abromowitz to Captiva Spine’s leadership team and business is significant. Dale Mitchell, Captiva Spine’s Founder and CEO, stated, “We have been looking forward to expanding our leadership team and increasing business presence throughout the USA. Daniel is a welcome addition as a strategic business leader with a proven record of profitably building high-performing sales teams in the spinal device and healthcare marketplaces.”

Introducing: HyperLOX Posterior Cervical System

The commercial launch of the HyperLOX Posterior Cervical System provides Captiva Spine a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. HyperLOX can be constructed into a multitude of configurations based on individual patient anatomy. Offering exceptional versatility and ease-of-use, HyperLOX features a wide range of hyper-angulating top loading polyaxial screws, hooks (straight, angled, and offset), offset connectors, multiple rod-to-rod connector configurations, cross connectors, and transitional rods. Inquiries from tenured professionals looking to partner with a company to build a relationship for the long run are always welcome. Captiva Spine can be contacted direct by phone at 561-277-9480 or via their website www.captivaspine.com/contact-us.

Discover Strength Through Connections at www.captivaspine.com.

About Captiva Spine, Inc.

Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality; they strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships, above all else, fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

Smith & Nephew announces full commercial release of JOURNEY™ II XR Total Knee Arthroplasty

Posted On March 7, 2018 By OrthoSpineNews In Recon, Top Stories /

LONDON, March 6, 2018 /PRNewswire/ — Smith & Nephew (LSE:SN, NYSE: SNN), the global medical technology business, today announces the full commercial release of bi-cruciate retaining JOURNEY II XR total knee arthroplasty (TKA) in the United States and Japan.

JOURNEY II XR is the next step in the evolution of total knee replacement surgery. By retaining, rather than substituting, the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), JOURNEY II XR is designed to combine the greater patient satisfaction of a partial knee replacement with the long-term survivorship and reproducible principles of TKA^1-2. JOURNEY II XR accomplishes this by eliminating the past concerns of bi-cruciate retaining knees through:

An implant design that reflects more accurate replication of the knee anatomy³
A robust tibial baseplate designed for optimal fixation and fatigue strength
The application of Smith & Nephew’s VERILAST™ Technology, an advanced bearing surface designed to provide lasting survivorship⁴
The introduction of enabling technologies such as NAVIO™ robotics-assisted surgery and VISIONAIRE™ patient matched adaptive guides to help deliver highly reproducible outcomes

Mike Donoghue, Senior Vice President, Global Orthopaedic Marketing said, “The JOURNEY II XR knee offers surgeons an innovative treatment option for arthritic patients who have intact and well-functioning cruciate ligaments. The retention of the cruciate ligaments may provide patients with more normal feel and stability throughout the range of motion, and may lead to a smoother recovery, improved function, and better patient satisfaction.” ^3,6-8

JOURNEY II total knee system is designed to achieve normal shapes, position and motion. Smith & Nephew created this platform to empower patients to “rediscover normal” following total knee arthroplasty. The full commercial release of JOURNEY II XR follows a successful limited market release in both the United States and Japan with more than 70 surgeons in both countries implanting over 1,100 JOURNEY II XR knees during the last 18 months⁹. Join Smith & Nephew at the American Academy of Orthopaedic Surgeons Annual Meeting, Booth #1651 in New Orleans, LA, March 7-9 to experience the Power of Patient Satisfaction and elevate what’s possible with the JOURNEY II XR Knee system.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

1. Patient satisfaction after primary total and unicompartmental knee arthroplasty: an age-dependent analysis. Von Keudell, Sodha, Collins, Minas, Fitz, Gomoll; Knee. 2014 Jan;21(1):180-4. 2. Total knee replacement with retention of both cruciate ligaments: a 22-year follow-up study. P. Sabouret, F. Lavoie, J-M Cloutier Bone Joint J. 2013 Jul; 95-B(7): 917–922 3. Short-term Range of Motion is Increased after TKA with an asymmetric bicruciate stabilized implant. Accepted Poster Presentation, AAOS 2018 New Orleans. Kaitlin M. Carroll, Peter K. Sculco, Brian CMichaels, Richard L. Murphy, Seth A, Jerabek, David J. Mayman 4. Testing concluded at 45 million cycles, ISO 14242-1 and 14243-3 define test completion at 5 million cycles. 5. Hommel, Hagen, and Kai Wilke. “Good Early Results Obtained with a Guided-Motion Implant for Total Knee Arthroplasty: A Consecutive Case Series.” The Open Orthopaedics Journal 11 (2017): 51–56. PMC. Web. 27 Sept. 2017. 6. Kaneko, Takao et al. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range. Journal of Orthopaedics. 14. 201-206. 10.1016 7. Grieco, Trevor F., et al. “In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy.” The Journal of Arthroplasty, 2017, doi:10.1016/j.arth.2017.09.035.8. Iriuchishima, Takanori, and Keinosuke Ryu. “A Comparison of Rollback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty.” The Journal of Knee Surgery, 2017, doi:10.1055/s-0037-1604445. 9. Data on file with Smith & Nephew.

SOURCE Smith & Nephew

Globus Medical Enters Trauma Market

Posted On March 7, 2018 By OrthoSpineNews In Extremities, Top Stories /

AUDUBON, Pa., March 06, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, is pleased to announce its entry into the orthopedic trauma market. Globus Medical has become a market leader in spinal device innovation, offering differentiated products and disruptive technologies in a competitive spine market, making it one of the fastest growing companies in orthopedics. Integrating a well-known culture of speed to market and leveraging its robust product development engine, Globus Medical is poised to become a significant player in the orthopedic trauma market.

“Globus has demonstrated an unprecedented level of surgeon responsiveness resulting in the most comprehensive spinal product portfolio on the market. We aim to continue that tradition in orthopedic trauma by leveraging a dedicated product development team with a highly trained, direct sales force to bring our innovative and efficient systems along with the best support to our surgeon and hospital customers,” said Barclay Davis, Vice President, Orthopedic Trauma. “We feel we can capitalize on our strengths of innovation and speed to market to bring game changing technology in the trauma market.”

11 New Products FDA Cleared

Globus Medical will display its growing suite of technology solutions for trauma products this week at the American Association of Orthopaedic Surgeons’ annual meeting in New Orleans. To date, Globus has received FDA 510(k) clearance for 11 products, covering the major segments of the orthopedic trauma market – fracture plates, compression screws, cannulated screws, intramedullary nails, and external fixation. This product portfolio is designed to treat a wide variety of fracture patterns and accommodates varying patient anatomies in the upper and lower extremities as well as hip and long bones. Each comprehensive system is optimized to streamline procedures and increase versatility, potentially reducing procedure time and expediting patient recovery.

Globus received FDA clearance for the following systems:

Comprehensive ANTHEM Ankle Fracture System including advanced distal Fibula plates, Cannulated Screws and key Small Fragment Plating components
ARBOR External Fixator System enabling fracture stabilization using one style clamp and one instrument
AUTOBAHN Tibial Nailing System offering both infra-patellar and supra-patellar approaches and innovative locking options
ANTHEM Small Fragment Plating System for general fractures with locking and non-locking implants and radiolucent instruments
Comprehensive ANTHEM Distal Radius Fracture System for wrist fractures that includes innovative volar, dorsal, and lateral plates as well as a robust new bridge plate
ANTHEM Proximal Humerus Plating System for shoulder fractures incorporating variable angle calcar screws and radiolucent instruments to simplify intra-op visualization and optimize implant placement
AUTOBAHN Trochanteric Nailing System for efficient geriatric hip fracture reduction and fixation
Comprehensive CAPTIVATE Compression Screw System for general fracture care including headless screws and an innovative variable-length family of screws for tough-to-reduce fractures or when bone purchase is limited
Comprehensive AUTOBAHN Femoral Nailing System with Recon screw options in both Piriformis and Troch-entry style nails
ANTHEM Proximal Tibia Plating System with innovative triple kick-stand screw fixation, integrated polyaxial rafting screws, and a novel radiolucent aiming arm for percutaneous fixation
ANTHEM Clavicle Plating System with innovative plate contours optimized for clinically-based fracture zones

“It has been impressive watching Globus move from design to development to deployment of their comprehensive trauma solutions line,” said Dr. Andrew N. Pollak, Chief of Orthopaedics at the University of Maryland Medical System. “I have been very impressed with the ability of Globus’ engineers to translate surgeon ideas and concepts into functional and easy to use implants for a wide variety of fracture patterns.”

Discover Globus Medical’s orthopedic trauma product line at the American Association of Orthopaedic Surgeons’ annual meeting in New Orleans, March 6- 11^th in Booth 4371 or visit www.globusmedical.com/trauma.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

MicroPort Orthopedics Celebrates 20 Years of Stability with its Medial-Pivot Total Knee System

Posted On March 6, 2018 By OrthoSpineNews In Recon, Top Stories /

March 06, 2018

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting-edge joint replacement implants designed to help patients achieve full function faster, is celebrating 20 years of market experience with its medial-pivot total knee system. Since launching in 1998, over 550,000 patients have benefited from MicroPort’s medial-pivot technology, which touts compelling long-term clinical results.

“The medial-pivot knee system has now stood the test of time at 20 years demonstrating impressive survivorship and excellent patient satisfaction,” said C. Lowry Barnes, MD, Chair of Orthopedic Surgery at the University of Arkansas for Medical Sciences. “It is important to recognize that this isn’t just one single publication. Over the years, the Advance® and Evolution® Medial-Pivot Knee Systems have been included in over 90 peer-reviewed publications that validate its long-term durability and functionality.”

For many years, orthopedists have clung to the concept of a hinge-like knee design with multiple radii. However, studies show that on average, 20% of patients are not satisfied with the outcome of their total knee replacement. Challenging these traditional knee designs, pioneers such as J. David Blaha, MD, Mr. Michael Freeman, MD, and Richard Komistek, PhD provided kinematic and radiographic evidence supporting medial-pivoting kinematics and stability of the knee, paving the way for the release of MicroPort’s medial-pivot knee system.

“I began using MicroPort’s medial-pivot knee system in May of 1998,” said Joost Lagast, MD, Orthopedic Surgeon at Maria Middelares Hospital Ghent. “At the time, I was not 100% satisfied with my results and was looking for something new. I attended a meeting with Professor Blaha at AAOS and was very impressed with the medial-pivot concept. During my first case, it was love at first sight – the stability and natural motion were unlike anything I’d seen in my practice. Over the last 20 years, I’ve performed nearly 4,000 knee replacement surgeries using the system, and I’m still fantastically in love with it today.”

The Evolution® Medial-Pivot Knee System features medial ball-in-socket articulation and a mobile lateral compartment that pivots about the medial side, enhancing stability, providing high flexion, and allowing the prosthesis to replicate the natural feel and motion of the knee. Additionally, the medial stability of the Evolution® knee substitutes for both the ACL and PCL, allowing for normal quadriceps function and increased proprioception.

Former NFL quarterback and Hall-of-Famer, Terry Bradshaw, underwent total knee replacement surgery with the Evolution® Medial-Pivot Knee. “My knee was causing me all kinds of problems. I couldn’t sleep at night, I couldn’t take the stairs, and worst of all, I had a hard time playing with my granddaughter,” said Bradshaw, now 69 years old. “I underwent surgery on a Tuesday, left the hospital two days later, and was walking without assistance in two weeks. Today, I can do anything I want to do – walking down stairs, squatting, fishing, and golfing. The medial-pivot technology has been life changing for me. It feels just like my knee!”

“MicroPort Orthopedics is proud to celebrate the 20^th anniversary of our medial-pivot knee system,” said Aurelio Sahagun, President, MicroPort Orthopedics. “When we launched the system back in 1998, there was nothing else like it on the market – it challenged the basis of traditional designs. Change does not happen often in orthopedics, but at the time, we knew that the medial-pivot concept had the capability to revolutionize total knee replacement. 20 years later, clinical results have proven that this design delivers better outcomes for patients and surgeons. It is incredibly gratifying to offer a best-in-class knee replacement option, and we are looking forward to another 20 years of innovation as we expand the medial-pivot technology into the revision market.”

About MicroPort Orthopedics

Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific

MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements

Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Contacts

MicroPort Orthopedics
Alex Piersiak, 617-909-5022
Alex.piersiak@ortho.microport.com

Vivorté Continues Transformation with Announcement of Mark Wagner as Chief Executive Officer

Posted On March 5, 2018 By OrthoSpineNews In Biologics, Top Stories /

LOUISVILLE, KY — (March 5, 2018) — Vivorté, Inc., a vertically-integrated manufacturer and marketer of Performance Biologics™ including TRABEXUS®, FORTERA™ and REGENTO™ announced today that Mark Wagner will assume the role of CEO to spur the company through its next phase of exponential growth.

Wagner has extensive experience leading commercial organizations within the orthopedics sector and broader medical device industry. Prior to joining Vivorté, Wagner was Senior Director of Sales and Marketing at DCI Donor Services, leading the commercialization of a diverse product line servicing the orthopedics, spine and wound care market segments.

“It is a critical time in Vivorté’s history and we are excited to announce this transition”, said Robert Saunders, Vivorté Chairman. “Over the last several months, Vivorté has been actively implementing a variety of strategic initiatives that are beginning to bear fruit. As we continue to focus on commercial execution, we look forward to continued progress and growth under Mark’s direction. Additionally, the board of directors would like to acknowledge Ruth Voor, whose wealth of contributions include leading the Vivorté organization through the product development and regulatory clearance of Trabexus and establishment of the Company’s current portfolio of products.”

Wagner joined Vivorté in October 2017 and has made a significant impact by implementing new branding / marketing initiatives and energizing the company’s sales channels. Prior experience includes leadership positions at AmerisourceBergen, Angiotech Pharmaceuticals and RTI Surgical. Wagner holds a Master of Business Administration from the Kellogg School of Management at Northwestern University and a Bachelor of Arts from Dartmouth College.

“I’m excited to become Vivorté’s CEO at this pivotal point in the company’s history,” said Wagner. “Vivorté already has the two most important ingredients for success – great products and great people. The company is focused on delivering our game-changing products to the orthopedic marketplace and sharing the clinical product efficacy results we are now seeing from our early adopters.”

Representatives from Vivorté will be attending the upcoming American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, held March 6-10, 2018 in New Orleans, Louisiana to address corporate inquiries.

About Vivorté, Inc.

Vivorté, Inc., headquartered in Louisville, Kentucky is a privately-held, vertically-integrated manufacturer and marketer of Performance Biologics™. Vivorté is committed to developing innovative and cost-effective surgical products for the benefit of surgeons, hospitals and patients. The Company’s product portfolio includes Trabexus® Trabecular Osteoinductive Biocement, Fortera™ Fortifying Osteoconductive Biocement and Regento™ Regenerative Scaffold. To learn more, please visit our website at vivorte.com.

Media Contact: Therese Montano / 502-714-7234 / tmontano@vivorte.com

Conformis iTotal CR Knee Replacement System Awarded “3A” Rating from the Orthopaedic Data Evaluation Panel in the United Kingdom

Posted On March 1, 2018 By OrthoSpineNews In Recon, Top Stories /

BILLERICA, Mass., March 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) (http://www.odep.org.uk/ODEPExplained.aspx)awarded the Conformis iTotal CR knee replacement system a “3A” rating. The 3A rating is based on strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.

ODEP is an independent panel of leading orthopedic surgeons and experts in the UK that evaluates data related to use of hip and knee implant technologies and provides a rating to indicate performance in key areas including survivorship. ODEP provides the National Health Service (NHS) with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. The 3A rating (as explained in more detail at http://www.odep.org.uk/ODEPExplained.aspx#2) is based on three-year performance data. ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines. Only products that demonstrate compliance with NICE guidance are awarded a rating.

“The positive ODEP 3A rating reaffirms my experience treating patients with the Conformis iTotal CR knee replacement system, which I believe offers my patients a more natural feeling knee with improved performance and mobility,” said Mr. Ian McDermott FRCS, Senior Consultant Knee Surgeon at London Sports Orthopaedics, based at the London Bridge Hospital in London, UK. “The clinical evidence and three-year survivorship data together are consistent with the improvement I am seeing with my patients’ outcomes after knee replacement surgery using Conformis knee prostheses.”

“ODEP ratings provide a reliable, simple and independent assessment of the performance of an implant” said, Mr. Fahad G. Attar, MBChB, FRCS, Consultant Trauma & Orthopaedic Surgeon at BMI Alexandra and Whiston Hospital, St. Helens & Knowsley Teaching Hospitals, United Kingdom. “I expect that this 3A rating will now provide additional reassurance and peace of mind to my patients and reinforce the performance reputation of Conformis iTotal CR knee replacement implants that contribute to the improved clinical outcomes I am seeing in my practice.”

“The ODEP awarded the Conformis iTotal CR system a 3A rating based in part on positive implant survivorship and performance data from the UK National Joint Registry at three years’ post-surgery,” said Mark Augusti, Chief Executive Officer and President of Conformis. “This rating provides another independent verification that our design philosophy, predicated on patient conforming implants, results in performance where it counts the most, in patients. “We hope that this 3A rating also provides an opportunity for Conformis to expand our product offering to more patients receiving their healthcare in NHS facilities.”

More information on the ODEP can be found on their website at http://www.odep.org.uk/ODEPExplained.aspx

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.

MEDIA CONTACT
Kelly Wakelee
Berry and Company Public Relations
kwakelee@berrypr.com
212.253.8881

INVESTOR RELATIONS CONTACT
Oksana Bradley
Investor Relations
ir@conformis.com
781.374.5598
www.conformis.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/acfb1db3-b005-40af-8b6e-dffa8c838cfe

Diamond Orthopedic Announces New Clinical Milestone

Posted On February 28, 2018 By OrthoSpineNews In Extremities, Top Stories /

CHARLOTTE, N.C. (PRWEB) FEBRUARY 27, 2018

Diamond Orthopedic, a medical device company that is pioneering the use of an innovative faceted threadform in orthopedics, today announced that their faceted technology was successfully used in an intercalary tibial allograft.

The surgeon who utilized Diamond’s faceted bone screw noted that, “stable, durable fixation was paramount to this type of reconstruction. I chose the Diamond threadform for its superior fixation and pullout strength, and for what I like to call its ‘bone friendly’ design. The faceted threadform not only made insertion of the screws easier, but also gave me confidence that the innovative biomechanical features of this technology will help lead to a successful patient outcome.”

Diamond’s patented faceted design allows surgeons to insert faceted screws into bone with less insertional torque and lower compressive stress, which can be particularly important when working with osteopenic bone. The faceted thread design enables an improved bone-screw interface versus traditional helical threadforms.

Roy Bivens, CEO, stated, “Faceted bone screws offer unparalleled fixation that is especially valuable in compromised bone. Diamond Orthopedic was proud to support a case of this type. Better patient outcomes are our ultimate goal. This technology has the potential to change numerous paradigms within orthopedics including with plate and screw applications and with uni-cortical fixation possibilities.”

About Diamond Orthopedic
Diamond Orthopedic, LLC, headquartered in Charlotte, NC, is a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost. Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide. With proven superiority over traditional helical threadforms, Diamond Orthopedic is the new fixation standard in orthopedics.

Media Contact:
Guillaume Viallaneix
MedTech Momentum
Phone: 407-960-2994
Email: guillaume@medtechmomentum.com

Diamond Orthopedic Contact:
1600 Camden Road
Charlotte, NC, 28203
Phone: 704-585-8270
Email: info@diamondortho.com

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risk factors contain certain forward-looking statements that involve risks and uncertainties. These statements relate to the Company’s future plans, objectives, expectations and intentions. The Company’s actual results could differ materially from those discussed in these statements. It is difficult to accurately predict the impact of each of these risks on the Company due to the dependence on many factors outside the Company’s control. These risks and uncertainties include, but are not limited to, factors affecting our financial results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. It is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

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Ortho Sales Partners Announces Two Executive Additions and the Formation of Two Divisions (Orthopedics and Spine)

Posted On February 23, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce key additions allowing the formation of two separate divisions. This strategic move further demonstrates Ortho Sales Partners commitment to offer the industries most talented and experienced consultants to its clients. In advance of their presence at the American Academy of Orthopedic Surgeons annual conference (Booth 5713), Ortho Sales Partners announces the formation of two distinct divisions. One for Orthopedics and the other for Spine. Hired to lead the Orthopedic division are Jeff Chandler and Dan Darges.

Jeff Chandler, has been appointed General Manager of Orthopedics. Mr. Chandler has a rich history in commercializing products in Total Joint Reconstruction, Trauma and Sports Medicine. A key entrepreneurial career highlight featured Mr. Chandler as Founder & CEO/President of a venture capital backed medical device firm (Aquarius Medical), led the Company for six years incepting two core technologies (fluid management pump; core body thermoregulation from Stanford University OTL), and through product inventions (IP), funding, research, development, regulatory, manufacturing, commercialization, and into a successful exit.

About his joining Ortho Sales Partners, Jeff Chandler said: “I’m excited to bring a novel and cost-effective commercialization model to startup and emerging growth companies, or launching disruptive technologies for established medical device firms. In the entrepreneurial spirit of preserving expensive cash, OSP provides an attractive staged-based vehicle to deploy a multi-disciplined and highly networked senior level team in comparison to being confined by traditionally limited FTE hiring.”

Dan Darges, Vice President of Orthopedics, career started in 1997 with Smith & Nephew as a Ortho Recon/Trauma rep, Mr. Darges’ successes and reputation led him to accept an offer as a Regional Sales Director for a top Arthrex Distributorship in 2002. Working for a Distributor allowed Mr. Darges to grow skills as a leader and manager for both Arthrex and Wright Medical product lines in Multiple States. In 2007, Mr. Darges founded Bio-Surg Solutions, Inc., a Distributorship for Wright Medical. After many successful years as one of the highest growth distributorships in the country, Mr. Darges sold his Distributorship to Wright Medical in 2012 and became a Senior Director of Sales for Wright Medical’s Foot and Ankle/Biologics products.

“I am really excited to be part of the Ortho Sales Partners team” said Darges. “I feel this role allows me to use my skill sets in multiple facets for multiple companies within the orthopedic industry. I have enjoyed my time thus far as a consultant and look forward to taking on more responsibility for our clients as the Vice President of Orthopedics.”

For the spine division, Ortho Sales Partners has promoted Matt Stuttle to the position of General Manager. Mr. Stuttle has been in the medical industry for over 18 years. He began his career in spine in 2003 has held executive management positions at Kyphon (acquired by Medtronic in 2008 for $4.3B), Paradigm Spine, SpineWave and most recently Spineart.

“I feel strongly that Ortho Sales Partners is well positioned to facilitate guidance, structure, growth and scale to medical companies worldwide. Our strengths lie in our team; A world class organization of experienced executives across a broad spectrum of specialties, all designed to mitigate risk and speed execution. I’ve had the pleasure of knowing and working closely with Kevin over the last 15 years. His leadership and vast experience lends itself well to the core focus of Ortho Sales Partners; Creating immense value for our clients and their respective shareholders.”

As General Manager’s Jeff and Matt will report in to the CEO, Kevin McGann.

“We welcome Jeff and Dan to Ortho Sales Partners. As we continue to grow our business, it is important we structure and scale the organization that allows for the continued focus on our clients and positive outcomes. Having Matt and Jeff lead our Spine and Orthopedic Divisions will allow us to stay focused while utilizing their experience and leadership skills.”

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

Astura Medical Announces Initial Cases and Full Commercial Release For BRIDALVEIL OCT Stabilization System

Posted On February 22, 2018 By OrthoSpineNews In Spine, Top Stories /

CARLSBAD, CA – February 21, 2018 – Astura Medical, a high growth, innovative spine technology company, announced today the completion of the initial surgeries and full commercial release for its BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System. The first cases were successfully completed at multiple hospitals across the country, including at the University of Colorado Hospital by Dr. David Ou-Yang, Assistant Professor of Orthopedics.

“Our practice addresses a wide range of complex conditions, so I’m always looking for the most advanced technology to meet our surgical demands,” said Dr. Ou-Yang. “Bridalveil OCT has not only met those demands, but it has continued to exceed my expectations. The versatility of the instrumentation, coupled with the breadth of implants offered has enhanced our ability to treat even the most complex cases. It is the most comprehensive and one of the most user friendly posterior cervical systems I’ve used from any company, large or small.”

“We are extremely proud of the feedback and success we’ve seen with Bridalveil OCT since our initial release of the system,” said Joel Gambrell, President and CEO of Astura Medical. “It allows us to continue to expand upon our goal of providing market leading technology to our growing network of surgeon and distributor partners.”

Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system additionally provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.

About Astura Medical
Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:
Steve Haayen
Astura Medical
858.472.8825
steve@asturamedical.com

Spine Wave Launches Proficient® Posterior Cervical Spine System Implants for Complex Posterior Cervical-Thoracic Procedures

Posted On February 21, 2018 By OrthoSpineNews In Spine, Top Stories /

SHELTON, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) — Spine Wave is increasing the Proficient^®Posterior Cervical Spine System’s product offering to further serve the posterior cervical spine market. The system is gaining rapid adoption by spine surgeons, primarily due to its patented tri-lobe polyaxial screw design which offers a best in class 120 degrees of angulation. Now, the Proficient® Posterior Cervical Spine System is expanded to include a range of new implants that make the system even more versatile for complex posterior cervical-thoracic procedures.

The Proficient® Posterior Cervical Spine System is now offered with a unique translation screw that provides medial-to-lateral translation to facilitate improved rod placement in posterior cervical-thoracic fixation procedures. Other new Proficient® Posterior Cervical Spine System implants include screw-to-rod lateral connectors, rod-to-rod connectors, and smooth-shank screws as an alternative for fixation of the uppermost cervical spine levels. Taken together, these new implants make the Proficient® Posterior Cervical Spine System even more appealing for complex posterior cervical-thoracic procedures.

“The Proficient^® Posterior Cervical Spine System is an excellent alternative for spine surgeons treating complex posterior cervical-thoracic pathology,” said Peter G. Passias, M.D., FACS, Associate Professor of Orthopaedic and Neurological Surgery, NYU Health, New York, NY. “The anatomy of the cervical-thoracic junction can make posterior cervical fixation procedures crossing that junction very challenging. The Proficient® Posterior Cervical Spine System is versatile by design and these new implants make it even more so.” “In particular,” Dr. Passias continued, “the system’s new translational screw makes rod placement in these procedures faster and easier in my practice because of the unique medial-to-lateral translation capability that it offers.”

“We have been very pleased with how well the Proficient® System has been received in the marketplace. The 120 degrees of angulation has been the biggest selling point and now the system is even more versatile with the advent of the translational screws,” said Mark LoGuidice, Spine Wave CEO. “Historically, Spine Wave has focused on thoraco-lumbar technologies. The Proficient® System is our first internally developed cervical offering and our engineers and surgeon designers have done a phenomenal job with this system. In addition, we plan to launch a unique anterior cervical technology in the middle of this year. This important anterior system is currently in a limited market release and based on the early feedback, we have high expectations for this system as well.”

/EIN News/ — About Spine Wave

Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable more efficient and less invasive solutions for spine surgeons and their patients. In addition to the Proficient® Posterior Cervical Spine System, Spine Wave also offers a broad portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names. The expandable technologies can be utilized in posterior, anterior and lateral surgical approaches. To complement the expandable spacers, Spine Wave offers a comprehensive line of pedicle screws for both minimally invasive and traditional open approaches. Additionally, Spine Wave recently launched the GraftMag® Graft Delivery System which is being very well received because it is designed to make interbody bone grafting procedures faster and easier for surgeons. The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth. For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact

Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

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