July 16, 2018

ROSEMONT, Ill., July 13, 2018 /PRNewswire-USNewswire/ — Foot and ankle orthopaedic surgeon, J. Chris Coetzee, MD, MBChB, has been named president of American Orthopaedic Foot & Ankle Society (AOFAS)^®, the leading organization for lower extremity medicine and foot and ankle surgery. In addition to leading the Society as president, Coetzee will serve on the Board of Directors of the Orthopaedic Foot & Ankle Foundation.

As president of the 2,200-member Society, Coetzee will continue the mission of advocating for patients on local and national levels to ensure they receive the best and most appropriate orthopaedic foot and ankle care. He will also continue the AOFAS tradition of providing outreach to communities in need through the Orthopaedic Foot & Ankle Foundation. One of Coetzee’s other priorities during his one-year term is ensuring that orthopaedic residents are involved in the Society early on during their medical training.

“We still live in uncertain times. Belonging to an organization like the AOFAS helps me channel the uncertainties of today into creative solutions for tomorrow,” Coetzee said. “I am looking forward to continuing collaboration with peers from all over the world to work towards our goals of improved patient care, education, and outreach.”

Coetzee earned his medical degree from University of Pretoria School of Medicine in South Africa and performed his orthopaedic residency at University of Stellenbosch in Cape Town, South Africa. He also completed a fellowship in foot and ankle orthopaedics at the University of Washington Harborview Medical Center in Seattle in addition to a trauma fellowship in Davos, Switzerland. His current work is through Twin Cities Orthopedics in Minneapolis-St. Paul.

As an avid supporter of the educational mission of AOFAS, Coetzee served as program chair of the 2014 AOFAS Annual Meeting, and has chaired several other AOFAS committees. He is an assistant editor of the AOFAS peer-reviewed journal Foot & Ankle International and a reviewer for other orthopaedic journals.

Coetzee added, “My hope for all in the Society is to live by the words of Benjamin E. Mays: ‘The tragedy of life is often not in our failure, but rather in our complacency; not in our doing too much, but rather in our doing too little; not in our living above our ability, but rather in our living below our capacities.'”

About Foot and Ankle Orthopaedic Surgeons  

Foot and ankle orthopaedic surgeons are medical doctors (MD and DO) who specialize in the diagnosis and treatment of musculoskeletal disorders and injuries of the foot and ankle. Their education and training consists of four years of medical school, five years of postgraduate residency, and a fellowship year of specialized surgical training. These specialists care for patients of all ages, performing reconstructive surgery for deformities and arthritis, treating sports injuries, and managing foot and ankle trauma.

About the AOFAS 

The American Orthopaedic Foot & Ankle Society (AOFAS) mobilizes our dynamic community of foot and ankle orthopaedic surgeons to improve patient care through education, research, and advocacy. As the premier global organization for foot and ankle care, AOFAS delivers exceptional events and resources for continuous education, funds and promotes innovative research, and broadens patient understanding of foot and ankle conditions and treatments. By emphasizing collaboration and excellence, AOFAS inspires ever-increasing levels of professional performance leading to improved patient outcomes. For more information visit the American Orthopaedic Foot & Ankle Society online at aofas.org.

SOURCE American Orthopaedic Foot & Ankle Society

Related Links

http://www.aofas.org

PORTLAND, ORE. (PRWEB) JULY 12, 2018

A recent study published in the Journal of Clinical Biomechanics examined a comparison of Acutrak 2®–4.7 mm fully threaded headless compression screws and 4.0 mm partially threaded cancellous screws and found Acutrak was the potentially favorable option for the fixation of medial malleolus fractures.

The investigator-initiated biomechanical study was led by Robin Z. Cheng of the University of California Davis Medical Center. Additional contributors were from UC Davis and the Stanford University School of Medicine. The work was funded in part by Acumed.

The study utilized 18 synthetic tibiae, each cut 18 cm from the tibial plafond, to simulate medial malleolar fractures. Each tibia was then randomly assigned fixation with either two Synthes parallel, partially threaded, unicortical 4.0 mm cancellous screws or two parallel, fully threaded Acutrak 2–4.7 mm headless compression screws, with nine tibiae in each group. To simulate tensile force on the fracture fragment, a single steel slotted spring pin was inserted through the fragment and attached to a steel cable hooked to a test machine actuator. Force was applied with an initial 50N then pulled at a rate of 10 mm per minute. Distal and lateral movement was measured to failure via spherical markers placed on the anterior portion of the medial malleolus and monitored with a CCD camera. Clinical failure was defined as 2 mm of intrarticular fragment displacement, with construct stiffness measured in both distal and lateral directions.

All tests resulted in both distal and lateral displacement of the medial malleolar fragment. Construct stiffness results for Acutrak 2–4.7 mm screws were significantly greater than the 4.0 mm cancellous screws, with mean stiffness results at:

Proximal–Distal:
4.0 mm Cancellous Screws: 668 N/mm
Acutrak 2–4.7 mm Screws: 1,699 N/mm

Medial–Lateral:
4.0 mm Cancellous Screws: 281 N/mm
Acutrak 2–4.7 mm Screws: 604 N/mm

It is important to note that synthetic tibiae were used in this study rather than cadaveric bone. The Acutrak 2 screws, however, were noted by the authors as having a larger diameter than the 4.0 mm screws, which would engage more bone and potentially result in lower bone and screw stress.

Additionally, artificially simulated axial loading in a single loading mode was observed in this study as a means to demonstrate the force exerted by the deltoid ligament on the medial malleolus without taking other soft tissue structures into account. And the tensile stress was modeled as a singular force, rather than cyclical loading, which would model stress over time.

Key findings of the Cheng et al study were in favor of using Acutrak 2–4.7 mm screws in medial malleolar fractures:

“When subjected to a single load to failure, the headless compression screw construct provides over two times greater stiffness in both the proximal-distal and medial-lateral directions. Additionally, the headless compression screw construct sustains higher forces prior [to] reaching 2 mm lateral displacement, with 2 mm of displacement defined as clinical failure.”1

“…our findings suggest that a headless compression screw construct provides a stiffer construct than a parallel unicortical cancellous screw construct. The headless compression construct sustains higher load prior to reaching clinical failure in the lateral direction.”1

“The increased resistance to both axial and shear loading, greater interfragmentary compression, and low-profile design of the Acutrak 2 headless compression screw may decrease the rate of clinical failure and reduce the need for revision surgeries, thus being a potentially improved option for fixation of horizontal medial malleolus fractures.”1

About Acumed 

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With 30 years of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. Acumed was founded in 1988 by Randy and Mary Huebner and became a member of the Colson Associates group of companies in 1999. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported worldwide.

1. Cheng RZ, Wegner AM, Behn AW, Amanatullah DF. Headless compression screw for horizontal medial malleolus fractures. Clin Biomech. 2018;55:1–6.

WARSAW, Ind., July 11, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the full-scale launch of the Pediatric Nailing Platform|FEMUR (“PNP|FEMUR”), OrthoPediatrics’ newest rigid intramedullary nailing system. The initial beta launch surgical cases, utilizing this innovative system, have received very positive surgeon feedback and have reinforced OrthoPediatrics’ confidence in the full-scale US launch of this best-in-class offering.

The Pediatric Nailing Platform|FEMUR system features two distinct child and adolescent implant offerings optimized for pediatric-specific anatomy. The system also includes a full suite of new instrumentation. The system’s enhanced child nail offering ranges from 7-9mm, while the new adolescent nails range from 9-12mm. In combination with the novel Carbon-Fiber targeting arm, and other high precision instruments, the PNP|FEMUR system can effectively address both trauma and deformity correction procedures alike.

Greg Odle, Executive Vice President, stated, “The early feedback on PNP|FEMUR has been tremendous!  This truly represents the first ever pediatric nailing platform the market has ever seen, and will be the foundation of our intramedullary technology going forward. It is the result of a very thoughtful and intentional development process, understanding the needs of the pediatric surgeons who treat femoral fractures and deformities. It’s another example of what OrthoPediatrics does; focusing ALL of our resources on helping children with orthopedic problems.”

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

AMSTERDAM, The Netherlands, July 11, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced that it will highlight new innovations at the American Orthopaedic Foot & Ankle Society (AOFAS) 2018 Annual Meeting taking place at the Hynes Convention Center in Boston, Massachusetts, from July 11-14, 2018.  Wright will feature its full range of lower extremities and biologic solutions at exhibit booth #907, including the PROstep™ Minimally Invasive Surgery System and AUGMENT^® Injectable Bone Graft.

Specifically designed for foot and ankle surgery, the PROstep system provides a minimally invasive, procedurally integrated solution that features specifically designed implants and instrumentation for percutaneous surgery of the foot.  The PROstep System can be used to treat a variety of forefoot and hindfoot pathologies, including one of the most common, Hallux Valgus, commonly known as bunions, a painful foot deformity that is prevalent in approximately 23% in adults aged 18-65 years and 35.7% in elderly people aged over 65 yearsⁱ.  Compared to a traditional open surgery, the PROstep System has been shown to get patients back on their feet faster, with less pain and an improved cosmetic result.  More information on PROstep can be found at www.ProstepMIS.com.

“With the PROstep Minimally Invasive Surgery approach to bunion and other foot and ankle deformities, my patients experience far less post-operative pain and experience a faster return to function much more quickly than traditional open surgery,” said Dr. Peter Mangone, EmergeOrtho: Blue Ridge Division, Asheville and Hendersonville, N.C.  “This could mean returning to sports, wearing their shoe of choice or just walking pain free in a very short period of time.”

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.  The launch of AUGMENT Injectable provides 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, while eliminating the need for autograft and the associated morbidities of autograft harvest.  More information on AUGMENT can be found at www.augmentbonegraft.com.

Robert Palmisano, president and chief executive officer, commented, “We have continued to expand our best-in-class foot and ankle product portfolio to meet the needs of orthopaedic surgeons and patients and further enhance our leadership position in the fast-growing lower extremities and biologics markets.  The launch of our PROstep Surgery System is a key new product launch for our core foot and ankle business and highlights our ability to help physicians provide a minimally invasive procedure option to patients to reduce pain and provide a more rapid recovery time, ultimately resulting in higher patient satisfaction.  The U.S. launch of PMA-approved AUGMENT Injectable expands our proven AUGMENT franchise to 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.  AUGMENT Injectable is expected to deliver sustained growth in the U.S. for the AUGMENT Regenerative Solutions platform over the next several years.”

Wright also announced the achievement of a clinical milestone, surpassing 30,000 total ankle replacement (TAR) procedures globally since 2008.  Wright offers a complete continuum of care from primary through revision TAR procedures including the INBONE™ Total Ankle System, the INFINITY™ Total Ankle System, the INVISION™ Total Ankle Revision System and the PROPHECY™ Preoperative Navigation System.

Other products to be featured at the AOFAS include:

SALVATION™ 2 Limb Reconstruction System – The SALVATION 2 Limb Reconstruction System is the first truly comprehensive product solution design to address limb salvage procedures in neuropathic patients.  The system is designed to help simplify this often-complex procedure, while giving surgeons the options needed to best address these challenging cases.  The external fixation system provides preassembled components, patient positioning tools and reproducible wire placement guides to streamline application and eliminate surgical steps.

INVISION™ Total Ankle Revision System with PROPHECY Preoperative Navigation – The first and only system developed specifically for total ankle revision arthroplasty with preoperative planning, the INVISION Total Ankle Revision System helps surgeons re-build bone lost through previous surgeries and provides modularity to help restore natural joint height. The introduction of INVISION with PROPHECY is an important addition to Wright’s total ankle portfolio, extending the use of the only preoperative planning system for total ankles to the entire continuum of care from primary through revision procedures.

ORTHOLOC™ Universal Anterior Ankle Fusion Plate – The Universal Anterior Ankle Fusion Plate is the latest addition to the ORTHOLOC™ Ankle Fusion Plating System, which features Wright’s innovative 3Di polyaxial locking technology.  By offering multiple points of talus fixation, the option for tibio-talar-calcaneal fusion and an external lag screw targeting guide, the Universal Anterior Ankle Fusion Plate provides surgeons with a versatile, intraoperative solution for patients requiring ankle fusion.

For more information about Wright Medical’s portfolio of foot and ankle products, visit:  www.totalankleinstitute.com

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 quality of life for patients worldwide and is a recognized leader of surgical solutions for the upper extremity (shoulder, elbow, wrist and hand), lower extremity (foot and ankle) and biologics markets, three of the fastest growing segments in orthopedics.  For more information about Wright, visit www.wright.com.

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 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.

ⁱ https://jfootankleres.biomedcentral.com/articles/10.1186/1757-1146-3-21

Investors & Media:

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

SUWANEE, GA, July 11, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce a partnership with HyperMed in Memphis, TN to sponsor a continuing clinical investigation on Diabetic Foot Ulcers (DFUs).  This investigational work is expected to begin in August 2018.  An initial case series will be conducted at two sites, the primary site being the Vascular and Wound Care Center at University Hospital, Rutgers NJMS in Newark, NJ with Dr. Oscar Alvarez as the Principal Investigator, and the second site at Olive View-UCLA Medical Center with Dr. Aksone Nouvong leading the efforts. The intent of this trial is to quantify the level of increased perfusion and oxygenation during and after treatment with the dermaPACE® System.

Previous animal studies and clinical work using the dermaPACE® System has shown that treated tissue exhibits increased perfusion to the area, as measured by doppler imaging, and an increase in venule and arteriole diameters, indicating increased red blood cell velocity.  This case series will utilize HyperMed’s Hyperview spectral imaging device to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using TcPO2 values as a control.

As a result of Dr. Alvarez’s leadership and case work, he will be able to provide SANWUAVE with valuable, measurable data to continue to expand our understanding of the dermaPACE® System’s mechanism of action.  Dr. Nouvong has already performed and published extensive research using the HyperView spectral imaging device.  These two renowned investigators and practitioners in wound care, with their combined expertise, will expand the already extensive clinical data associated with dermaPACE®.  Both researchers participated in previous dermaPACE® DFU trials.

Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board and Chief Executive Officer, said, “We are very excited about this next opportunity to investigate the effects that the dermaPACE® System has on improving perfusion and oxygenation in treated tissue.  This case series will enable us to quantify the increases and help us to better understand how dermaPACE® improves patients’ quality of life, leading to future research and improvement of clinical protocols for the treatment of Diabetic Foot Ulcers and other skin conditions.  We are another step closer to Healing Today, Curing Tomorrow.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.SANUWAVE.com.

CONTACT INFORMATION

Millennium Park Capital LLC

Christopher Wynne

312-724-7845

cwynne@mparkcm.com


SANUWAVE Health, Inc.

Kevin Richardson II

Chairman of the Board

978-922-2447

investorrelations@sanuwave.com

BETHLEHEM, Pa., July 11, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for rapid commercialization and advancing the science of bioengineered surfaces, announces the allowance for US Patent Application (No. 15/213,935) of TyFix™, an all-in-one extremity joint fixation system.

The TyFix™ sterile system delivers increased operating room efficiency and serial procedural flow by combining an intramedullary implant to the driver, drill, and broach instruments.  The all-in-one instrument/implant design, combined with the recently released Sterile Handle Kit, is designed to reduce procedure steps and total operative time, while delivering an implant construct capable of maintaining the holding power of a 3.0 Screw.

ENGLEWOOD, Colo., July 8, 2018 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

Today, Paragon 28 continues to honor a tradition of comprehensive and innovative solutions with the launch and release of the Bone Graft Harvesting System.

The Bone Graft Harvesting System was created to offer a means to effectively harvest autogenous bone with a straightforward technique, no matter the harvest site chosen.

Common issues that can arise while obtaining autogenous bone includes removal of graft from the harvester, difficulty controlling the amount of bone harvested, and inconsistency of the morselized bone. The Paragon 28® Bone Graft Harvester addresses these concerns by offering three convenient sizes (6 mm, 8 mm, 10 mm) to provide options when choosing the harvest site. The morselizing tip on the harvester allows for control of consistency based on the speed of the drill, while depth markings assist the surgeon with controlling the harvest volume and penetration depth. A 2.3 mm K-wire is also available in this system for use if a pilot hole is desired.

The Bone Graft Harvesting kit disposable trephine and reusable door assemblies are made from medical grades of Stainless Steel.  The Bone Graft Harvesting System is delivered in a non-sterile configuration and fits into the Paragon 28® Gorilla® R3CON Plating system.  The system is self-contained for a case and can be used in combination with other Paragon 28 systems or in isolation.

About Paragon 28, Inc.

Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. From the onset, Paragon 28 has made it our goal to re-invent the space of foot and ankle surgery. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Website:

http://www.paragon28.com/products/bone-graft-harvest-system/

Contact:

Jim Edson, Vice President of Product Management and Marketing

jedson@paragon28.com

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com