SANUWAVE Announces Cooperation with Ortho-Medico in Europe on a New 100 Subject Trial Treating Patients with Diabetic Foot Ulcers In-Home Care Using Dermapace

SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe.

Ortho-Medico has long been SANUWAVE’s partner in the European Union. With their strength, experience, and knowledge of the orthopedics and wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the Company’s core products, dermaPACE, and orthoPACE systems.

Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers.” Added Jo Schops, General Manager of Ortho-Medico, “Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU’s. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (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 CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. 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.

About Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

MTF Wound Care’s AmnioBand® and AlloPatch® Pliable Receive the American Podiatric Medical Association Seal of Approval

EDISON, N.J., Dec. 14, 2016 /PRNewswire/ – After evaluating each MTF Wound Care allograft in several areas – including safety, quality and effectiveness – a panel of podiatric physicians from the American Podiatric Medical Association (APMA) has granted MTF Wound Care their Seal of Approval for its AmnioBand® family of placental allografts and AlloPatch® Pliable tissue forms.

MTF Wound Care, a division of the Musculoskeletal Transplant Foundation (MTF), is a non-profit organization offering highly advanced, safe, clinically proven and cost-effective allograft solutions.

“Receiving the APMA Seal of Approval gives podiatrists and clinicians the confidence that AmnioBand and AlloPatch Pliable are beneficial in healing patients’ wounds,” said Kim Rounds, Vice President, MTF Wound Care. “Placing our tissues through the APMA’s detailed evaluation demonstrates our commitment to be a partner of choice. We are proud of this notable accomplishment that recognizes the strength of our portfolio.”

As a primary resource for foot and ankle health information, the American Podiatric Medical Association (APMA) is the nation’s leading and recognized professional organization for doctors of podiatric medicine (DPMs).

“Podiatrists play a critical role in healing life- and limb-threatening wounds in patients with diabetes,” said APMA President R. Daniel Davis, DPM. “We depend on cutting-edge products, devices, and treatments to help us deliver outstanding care and reduce amputations and hospitalizations. APMA is pleased to award its Seal of Approval to MTF’s AlloPatch Pliable and AmnioBand tissue forms.”

Evaluation Process

The APMA Seal of Approval is granted to products that are beneficial to foot health. Companies must provide comprehensive information on each product: objective data from clinical and/or laboratory studies, intended use, patents, composition, and evidence of quality control. A detailed review is conducted by each committee member, and a recommendation is then sent to the APMA Board of Trustees, which may either accept or reject the recommendation.

About AmnioBand and AlloPatch Pliable

AmnioBand is offered in several forms, derived from dehydrated human placental tissue comprised both of the amnion and chorion layers. It is used as a scaffold for the treatment of chronic non-healing wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers. AmnioBand is aseptically processed, stored in ready to use “package to patient” configuration, and available in a variety of sizes.

AlloPatch Pliable is an acellular human dermal graft designed to support host tissue remodeling. It has an open architecture derived from a deeper layer in the dermal tissue, bringing faster graft incorporation and supporting repopulation and revascularization in host tissue. It is also aseptically processed to preserve the graft’s natural structure.

About MTF Wound Care

MTF Wound Care is a division of the Musculoskeletal Transplant Foundation, a non-profit organization based in Edison, NJ. MTF is a national consortium comprised of leading organ procurement organizations, tissue recovery organizations and academic medical institutions. For more, visit www.mtfwoundcare.org.

About the American Podiatric Medical Association

Founded in 1912, the American Podiatric Medical Association (APMA), headquartered in Bethesda, MD, is the leading resource for foot and ankle health information.  Currently, the organization represents a vast majority of the estimated 15,000 podiatrists in the country.  In addition to the national headquarters, APMA boasts 53 state component locations throughout the United States and its territories, as well as affiliated societies. For more, visit www.apma.org.

Contact: Cheri Lane
Cheri_Lane@mtf.org
732-661-3712

 

SOURCE MTF Wound Care

Related Links

http://www.mtfwoundcare.org

Orthopaedic Institute for Children Installs EOS Imaging System for the Safe and Accurate Diagnosis of Musculoskeletal Conditions

December 13, 2016

LOS ANGELES–(BUSINESS WIRE)–Orthopaedic Institute for Children (OIC) announced today that it now provides healthcare’s most precise and safest way to diagnose musculoskeletal conditions in children through the installation of the highly renowned EOS Imaging System (Euronext, FR0011191766 – EOSI). As the region’s first and only standalone ambulatory care provider with this technology, OIC will use the EOS Imaging System to more accurately diagnose and treat kids while limiting their exposure to radiation. The imaging system delivers extremely precise images of a child’s limbs and spine.

“With this technology now on site, patients and their families will have peace of mind knowing they have access to an imaging system that offers safe, low-dose and highly accurate exams,” said Anthony A. Scaduto, M.D., president and chief executive officer of OIC. “As many of these children suffer from complex conditions that often require frequent imaging exams, we are glad they won’t need to add the fear of radiation exposure to their already complex concerns.”

Born from a technology awarded the Nobel Prize for Physics to Georges Charpak, the EOS® system is the first imaging solution able to simultaneously create a 2D and 3D image of the skeleton in a natural standing position with a very low radiation dose. Specifically adapted to the needs of orthopaedic surgeons and radiologists, the EOS 2D/3D® exam allows a better accuracy of diagnosis, surgical planning, and monitoring of bone and joint diseases.

Medical imaging plays an extremely important role in the diagnosis and treatment of numerous medical conditions in children and has led to significant medical advances. There are many types (or modalities) of medical imaging procedures that are used on children – from conventional X-rays to fluoroscopy to computed tomography (CT) – and the prudent use of any is critical as children are relatively more vulnerable to radiation risks than adults. This is partly due to the fact that there is a longer life expectancy (in which to manifest potential radiation-induced health concerns) and partly because the care of children can be more complicated. EOS imaging is the pioneer in 2D/3D orthopaedic medical imaging and is the safest and most accurate technology available.

“Our entire organization is committed to delivering the best orthopaedic care to children so they can go on to lead healthy, active lives,” said OIC Medical Director Mauricio Silva, M.D. “The addition of the EOS Imaging System to our already existing technologies further provides our physicians and staff the tools they need to help make this possible.”

About Orthopaedic Institute for Children
Orthopaedic Institute for Children (OIC) was founded in 1911 as Los Angeles Orthopaedic Hospital. Focused solely on musculoskeletal conditions in children, Orthopaedic Institute for Children receives 60,000 patient visits each year. In alliance with UCLA Health and with the support of the OIC Foundation, we advance pediatric orthopaedics worldwide through outstanding patient care, medical education and research. Our locations in Downtown Los Angeles, Santa Monica, Westwood and Calexico treat the full spectrum of pediatric orthopaedic disorders and injuries. For more information, visit us at ortho-institute.org.

Contacts

Orthopaedic Institute for Children
Camille Strickland, 213-742-1501
CStrickland@mednet.ucla.edu

New Orthopedic Device Technology Moves From Lab Toward Operating Room With Help From Philadelphia-Based Start-Up OrthoMend Research, Inc.

PHILADELPHIA, Dec. 9, 2016 /PRNewswire-USNewswire/ — A platform of orthopedic device technologies developed by researchers  from Temple University are moving one step closer to becoming viable options for repairing broken bones and orthopedic applications. OrthoMend Research, Inc., a start-up company from Philadelphia, PA., recently acquired the exclusive license for these novel absorbable bone fixation and regenerative repair technologies and plans to develop them for commercial use. The company has leased space within the University City Science Center.

“OrthoMend Research, Inc. has licensed exclusive commercial rights from Temple University for Nano-Diamond technology in bone fixation which has the potential to evolve current therapies to fix, repair and regenerate bones and orthopedic “drug delivery applications,” OrthoMend Research, Inc. CEO Joseph P. Connell said. “It is our desire to commercialize the technology to improve clinical outcomes, reduce costs and alleviate pain and suffering for our patients.”

“OrthoMend Research represents the important role startups have in our commercialization process by bringing together the inventors, technology and business leadership to advance this orthopedic device to patients in need,” said Stephen Nappi, associate vice president for technology commercialization and business development at Temple.

“We are very excited to begin our next phase by manufacturing and testing the devices. We plan to make considerable contributions to clinical outcomes and improve patient’s lives by repairing broken bones without leaving hardware behind in a patient’s body.” said Connell.

Peter Lelkes, chair of bioengineering and director of the Institute for Regenerative Medicine and Engineering at Temple is equally enthusiastic about the licensing agreement and the potential for collaborative research and development opportunities.

“The licensing of our invention to OrthoMend Research is an important milestone in our efforts to translate our basic research from the bench to the bedside and will, without a doubt, result in commercial products that will benefit patients around the globe,” Lelkes said.

About OrthoMend Research: OrthoMend Research, Inc. is an emerging Regenerative Orthopedic Device Company pioneering new technologies intended to revolutionize bone fixation after orthopedic, surgical and trauma situations. OrthoMend Research, Inc. is involved with commercializing technologies licensed from Temple University for an absorbable suite of bone fixation and drug delivery devices. We will develop, test and launch absorbable screws, pins and possibly plates to repair the millions of broken bones occurring each year. We are steadfast to be the leader in orthopedic devices delivering real-world technologies to impact the lives of those in need. For more information, visit www.orthomend.com

About Temple University’s Department of Bioengineering: Founded in January 2012, the Dept. of Bioengineering in the College of Engineering has grown significantly in the past four years to about 300 undergraduate students, nearly 50 graduate students, 11 core faculty members and two dozen affiliated faculty from across the entire university. The Department is the home of a first-rate, nationally and internationally recognized bioengineering research enterprise that is supported by extramural funds from NIH, NSF, DoD and others. Its newly renovated, state-of-the-art research facilities (ca. 20,000 square feet) attract graduate students, postdocs, visiting scientists and scores of undergraduate students who pursue exciting basic and translational bioengineering research.

News media contacts:
Joseph P. Connell
CEO, OrthoMend Research, Inc., 910-233-0806jpconnell1@gmail.com

 

SOURCE Temple University

Related Links

http://www.orthomend.com
http://www.temple.edu

 

Arthrosurface Names Industry Veteran Joe Darling as Executive Chairman

FRANKLIN, Massachusetts, Dec. 7, 2016 /PRNewswire/ –Arthrosurface®, an orthopedic medical technology company focused on the orthopedic upper and lower extremities markets, has named Joe Darling as the Company’s Executive Chairman. Mr. Darling will join the company in this newly created position shaping the future strategic direction with respect to, and overseeing and directing, the company’s commercial activities and business operations. The company has added Mr. Darling to their Board of Directors.

Mr. Darling’s business career spans both the pharmaceutical and medical device markets including senior management positions with Abbott Laboratories, Wyeth Pharmaceuticals, and executive level positions with Baxter International as Vice President of Marketing and Health Systems, Senior Vice President and General Manager of Smith and Nephews Sports Medicine and Biologics business, Global President of Linvatec Corporation, and Executive Vice President, Corporate Commercial Operations with CONMED Corporation, and most recently as Chief Operating Officer with Interventional Spine, Inc.

Joe’s proven leadership skills have spanned many functional areas in general management including sales, marketing, R&D, operations, regulatory and quality, finance and human resources. “Mr. Darling is well known within the orthopedic market and brings a vast knowledge of the industry to Arthrosurface. We are excited to have Joe on board,” said Dana Callow, Managing General Partner of Boston Millennia Partners. “Joe’s depth of experience and leadership skills will provide the Arthrosurface team with the strategic direction and experience necessary to accelerate the global profitable growth of the company.”

“Joe has deep experience in the global development and launch of innovative orthopedic products and we are excited to have him join the Arthrosurface team,” said Steve Ek, CEO and Founder. “We look forward to utilizing Joe’s deep understanding of the orthopedic markets along with his extensive relationships across the industry.”

“I am pleased to join Arthrosurface and look forward to working with the Arthrosurface team as we reshape the strategic direction of the company” Mr. Darling said.

About Arthrosurface


Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and biologics designed to preserve and restore the joints so patients can maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years.

 

© 2016 PR Newswire

 

Integra LifeSciences Announces Key Executive Appointments

PLAINSBORO, N.J., Dec. 05, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced key executive appointments effective December 1, 2016.

  • Robert T. Davis, Jr., corporate vice president and president, Specialty Surgical Solutions (SSS), has been named corporate vice president and president, Orthopedics and Tissue Technologies.
  • Dan Reuvers, corporate vice president and president, International, will assume the role of corporate vice president and president, SSS.
  • Glenn Coleman, corporate vice president, chief financial officer and principal accounting officer, in addition to his current responsibilities, will assume oversight of the international business. A leader for the international business will be later named reporting into Mr. Coleman.

All three executives will continue to be members of the Integra executive leadership team, reporting to Peter Arduini, Integra president and chief executive officer.

“These key leadership appointments reflect the depth and strength of our management team, enabling us to promote executives from within the company,” said Peter Arduini. “Bob, Dan and Glenn are proven leaders who have demonstrated exemplary management capabilities over the years and a track record of accomplishments that have contributed to our strong business performance.”

Robert T. Davis, Jr. brings more than 25 years of executive management experience in the global healthcare industry. He joined Integra in 2012 as president of the global neurosurgery business and was appointed corporate vice president in December 2012 and president of the SSS division in 2014.

Dan Reuvers has more than 25 years of experience in the medical technology field, including holding various executive level positions in sales, marketing and general management. Mr. Reuvers joined Integra in 2008 as vice president of marketing and product development for Integra’s surgical business. He was promoted to president of the acute surgical business in 2010 and appointed president of the instruments business in 2011.  Mr. Reuvers was named corporate vice president in 2012 and became president of the international business in 2013.

Glenn Coleman joined Integra as corporate vice president, chief financial officer and principal accounting officer in 2014, bringing 25 years of experience in financial management with leading global corporations. Mr. Coleman has been a certified public accountant in New Jersey for more than 20 years.

About Integra

Integra LifeSciences Holdings Corporation, a world leader in medical technology, is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Angela Steinway
609-936-2268
angela.steinway@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media
Laurene Isip
609-750-7984
laurene.isip@integralife.com

Moximed: First Patient Treated in US Study of Atlas® System for Unicompartmental Knee Osteoarthritis

November 29, 2016

HAYWARD, Calif.–(BUSINESS WIRE)–Moximed®, Inc. announced today that the first patient has been treated in an FDA-approved IDE study for its latest generation unicompartmental unloading implant, the Atlas System. The Atlas System builds on the company’s eight years of clinical success with joint unloading implants for medial knee osteoarthritis (OA).

“I’m pleased to treat the first patient in the Atlas IDE study. I see in my practice a tremendous number of younger, early OA patients who are seeking an alternative to arthroplasty that will allow them to maintain a highly active lifestyle,” noted Andreas Gomoll, M.D., Associate Professor of Orthopaedic Surgery at Harvard Medical School and Director of the Orthopaedic Program at the Brigham and Women’s Hospital Center for Regenerative Medicine. “Load distribution plays an important role in early osteoarthritis, and these patients could potentially benefit from a joint unloading procedure.”

The Principal US Investigator of the previous Moximed clinical study (KineSpring System), Jack Farr, M.D., Director of the OrthoIndy Cartilage Restoration Center of Indiana and the OrthoIndy Sports Medicine Fellowship Program remarked, “The Atlas System provides the same 30 lbs. of joint unloading with a significantly smaller implant and anatomically-guided surgical technique. Patients intuitively understand the concept of a shock absorber and are excited about a procedure that preserves their own anatomy without the bone cuts associated with joint replacement.” He went on to say, “I am looking forward to enrolling my first patients in the Atlas Study.” His site in Indianapolis, Indiana is now open and recruiting patients.

“Beginning a US study with the Atlas System is a noteworthy accomplishment for the company,” stated Moximed CEO Kevin Sidow. “Following on the maturing data from the pivotal study of our previous generation device, we are now excited to study the Atlas System for US patients in the clinical setting. We anticipate the Atlas IDE study will reproduce the positive outcomes and safety data presented from the first international studies of the device.”

About Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a degenerative disease affecting the hands, knees, hips, feet and spine. According to the Centers for Disease Control and Prevention (CDC), OA affects 27 million adults in the US. It is caused by changes in cartilage, the soft tissue that cushions and protects bone, leading to pain and changes in the shape of the joint. In knee OA, as the cartilage wears away, the bone ends may begin to rub against each other, causing severe pain. While often regarded as a disease of the elderly, there are more symptomatic knee OA patients under 65 years of age than over 65 years and an annual incidence of knee OA more than five times higher in individuals under 65 years of age than over 65 years.

About Moximed

Moximed, Inc. is dedicated to improving the standard of care for patients with osteoarthritis (OA). OA, the most common form of arthritis, leads to a breakdown of the joint’s cartilage and often results in joint pain and loss of motion. Moximed is supported by world-leading venture investors including New Enterprise Associates (NEA), Vertex Venture Holdings Ltd., Gilde Healthcare Partners, Morgenthaler Ventures, and GBS Venture Partners. More information can be found at www.moximed.com.

About the Atlas System

The Atlas System is designed as an implantable joint unloader for patients with medial knee osteoarthritis. Placed subcutaneously alongside the knee joint, the Atlas System incorporates advanced biomaterials designed to provide a clinically beneficial 30 lbs. of unloading. Importantly, the Atlas System absorbs excess joint load rather than transfer load to otherwise healthy areas of the joint. The Atlas System features a streamlined surgical technique that uses the patient’s own anatomy and allows the surgeon to visually confirm device function during the procedure. Finally, the Atlas System is joint preserving, and patients maintain all future treatment options should their osteoarthritis become more severe.

The Atlas System is CE Marked in Europe and is currently only being made available to select centers. The Atlas System is an investigational device in the United States, where it is limited by US law to investigational use.

Contacts

Moximed, Inc.
Keith Fong
Director of Marketing
Office: +1 510 887 3324
Cell: +1 650 245 4272
kfong@moximed.com
or
Halsin Partners
Mike Sinclair
Partner
Office: +44 (0)20 7318 2955
Cell: +44 (0)7968 022075
msinclair@halsin.com

EOS imaging Announces the Opening of the First EOS® Site in South Korea

November 28, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today the official opening of the first EOS site in South Korea, the third largest market in Asia, at the Konyang University Hospital. The University Hospital serves an adult and pediatric population of 7 million outpatients and 25 million inpatients on average per year.

The University Hospital has a strong orthopedics department for surgical and non-surgical treatment of the spine and joints. Patients of the specialized spine clinic will benefit from the low dose, full body images and weight-bearing, 3D analysis that EOS provides for deformative and degenerative spine conditions. In addition, the joint replacement clinic will use the EOS images and 3D torsion and alignment measurements to improve the planning of arthroplasty surgeries and control post-operative outcomes.

Prof Kim Sang Beom, Chief of the Spine Centre and Orthopedics Department and Board Member of the Korea Spine Surgeon Association, commented, “EOS is a real innovative technology with low dose biplanar 2D/3D radiography that’s approved by NECA. We are happy to be able to extend our services and care to our patients with this technology, including beginning to screen children and students utilizing the applicable Micro Dose option. The Konyang University Hospital uses the most advanced technology for better patient outcome. EOS will be the gold standard for musculoskeletal treatment in the near future.”

Marie Meynadier, CEO of EOS imaging, commented, “The Konyang University Hospital will be a strong reference center for the EOS platform in South Korea. Together with the Innovative Technology status obtained from the NECA Center for New Health Technology earlier this year, this will fuel adoption in the important South Korean market. We look forward to serving more Korean hospitals, healthcare professionals and patients with our low dose 2D/3D technology.”

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

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

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

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot
CFO
Ph: +33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Valentine Brouchot
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

Now Enrolling Patients for a Research Study Examining the Feasibility of Treating Osteoarthritic Knee with Autologous Bone Marrow Concentrate

CHICAGO, ILLINOIS (PRWEB) NOVEMBER 25, 2016

This study is a prospective, open label, non-randomized study to be conducted at the Weil Foot-Ankle and Orthopedic Institute. Twenty patients meeting the study inclusion and exclusion criteria and categorized as Osteoarthritis Grade 2 to Grade 3 by the K-L scale will be enrolled.

Dr. Sheinkop will be injecting concentrated bone marrow-derived stem cells and growth factors into the knee joint, the latter consisting of the intraarticular space between the femur and tibia, as well as into the tibia bone adjacent to the joint. Patients will be followed for one year, and they will be scheduled for periodic follow-up visits over the entire year to measure improvements in pain relief and function.

Current options for treating patients with knee osteoarthritis have been limited to pain medication, steroids, hyaluronic acid injections, physical therapy, chiropractic care, or any combination thereof; ultimately, a knee replacement. While these options may provide temporary symptom relief, they do not provide a long-lasting healing effect for the osteoarthritic knee nor is there a possibility of avoiding a major surgical procedure. Bone marrow-derived stem cells and growth factors offer regenerative potential when injected both into the joint and into the bone supporting the joint. Studies have shown that concentrated bone marrow-derived stem cells and growth factors have the potential to slow the degenerative process and, at times, reverse it, and they may eliminate or significantly delay the need for surgical intervention.

The importance of this study is to, for the first time, scientifically document what has been suggested by an emerging awareness about arthritis of joints, namely the articular cartilage of the joint, which might be better dealt with by considering the adjacent bony elements along with the soft tissue degradation. The role of mesenchymal stem cells and growth factors residing within the adjacent bone marrow compartments have been highlighted through the work of Dr. Philippe Hernigou (Chief, Department of Orthopaedic Surgery, Henri Mondor Hospital, University of Paris, France). The use of a patient’s own bone marrow concentrate to treat both the soft tissue, cartilage, and subchondral bone marrow could play a significant role in improving outcomes in osteoarthritic knees.

For questions about the clinical study, please contact Andrea Leon of Weil Foot-Ankle and Orthopedic Institute at aleon(at)weil4feet(dot)com or call 312-475-1893.

Dr. Mitchell B. Sheinkop is a Board-Certified Orthopedic Surgeon, former director of the joint replacement program and Professor Emeritus at Rush University Medical Center. He is a leading authority on the treatment of patients with complex hip and knee disorders, and he is well known for his pioneering use of computer-assisted navigation, minimally-invasive technologies, and hip resurfacing techniques. During his 37-year joint replacement surgical career, the integration of his clinical practice with his research played a role in the emergence of evidence-based orthopedics. Dr. Sheinkop retired from his active surgical practice six years ago to assume a pioneering role in the new subspecialty of Cellular Orthopedics. Over the past four and a half years, he has performed over 500 Interventional Orthopedic procedures.

Orthofix to Present at Piper Jaffray Healthcare Conference

November 17, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Piper Jaffray Healthcare Conference on Wednesday, November 30, 2016 at 9:10 a.m. Eastern Time in New York, NY.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix

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

Contacts

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