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Mazor Robotics Ltd. Expands Leadership Organization

Posted On June 19, 2017 By OrthoSpineNews In Robotics /  

June 19, 2017

CAESAREA, Israel–(BUSINESS WIRE)– Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, today announced leadership additions and organizational steps to position the company for its next phase of growth.

According to Mr. Ori Hadomi, CEO of Mazor Robotics Ltd., “In 2016, we announced and set in motion a plan to accelerate growth with the signing of strategic agreements and the launch of the transformative Mazor X platform. The new hires complement the capabilities of the existing team, positioning Mazor for additional growth opportunities as well as leading our more than 200 employees. I believe that our expanded leadership team maximizes Mazor’s near and long term potential.”

The Company has formed an integrated Product Development Group combining the current R&D and Product groups into a unified department. The newly formed Product Development group creates operational synergy to address market needs and to continue development of innovative spine products and future product enhancements. The department is to be headed by Oren Zarchin, Ph.D. who joins Mazor in the role of Vice President, Product Development. Dr. Zarchin’s most recent position was as Director at Philips Healthcare leading multi-disciplinary R&D teams and product platforms. This change is effective August 1, 2017.

In addition, Mazor has established the Advanced Technology Group and Mr. Eli Zehavi is appointed Executive Vice President of Advanced Technologies. Mr. Zehavi is a co-founder of Mazor and has served as the company’s Executive Vice President, Research and Development and Chief Operating Officer, since the company’s founding. The Advanced Technology Group is expected to leverage Mazor’s vast experience and expertise in software and precision guidance to develop non-spine patient focused innovations. This change is effective August 1, 2017.

Mazor has also created a new position, Vice President of Operations and Service, and recruited Mr. Joshua Belkar, an industry veteran with more than 20 years of experience in the medical device industry including a long tenure at Medtronic (Given Imaging) as Director of Operations. Mr. Belkar’s experience implementing and leading operations processes that directly impact quality will contribute to the increase in effective production as demand for Mazor systems and products rises. He will also lead the effort to expand and solidify Mazor’s first tier global service organization with a strong emphasis on global responsiveness and customer satisfaction. This change is effective July 16, 2017.

The Company also announced expanded roles and responsibilities for Ms. Sharon Levita, Chief Financial Officer and Mr. Christopher Prentice, CEO of Mazor Inc. (US Subsidiary). Ms. Levita, in addition to her CFO responsibilities has been named CFO & Vice President, Business Operations, and is overseeing a finance and additional business teams that provides enabling services to the corporation. Mr. Prentice has been named Chief Commercial Officer, consolidating the global commercial activity of the Company. These two changes are effective immediately.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the anticipated benefits and impact of the Company’s organizational steps and new hires, the Company’s growth prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170619005443/en/

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com
or
Financial Media Contact
Tom Gibson, 201-476-0322
tom@tomgibsoncommunications.com

 

Source: Mazor Robotics Ltd.

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SANUWAVE Health Appoints Maj-Britt Kaltoft to its Board of Directors; Extensive International and Strategic Partnership Strength Added

Posted On June 16, 2017 By OrthoSpineNews In Biologics /  

SUWANEE, GA–(Marketwired – Jun 16, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) today announced the appointment of Maj-Britt Kaltoft to its Board of Directors. Dr. Kaltoft brings 20 years of international specialization in development and successful execution of business development strategies, contractual structures and alliance management within all sectors of the life science industry. Dr. Kaltoft currently heads the business development and patent functions at the Danish State Serum Institute, an institution under the Danish Ministry of Health. She has obtained outstanding results in the areas of business development, licensing and alliance management in the pharmaceutical and biotech industry at Lundbeck, Nycomed, EffRx and Novo Nordisk. With this appointment, the Company’s Board of Directors has expanded to five members.

“We are delighted to welcome Dr. Kaltoft to our Board of Directors,” said Kevin A. Richardson II, CEO and Chairman of the Board of Directors of SANUWAVE Health, Inc. “Dr. Kaltoft’s international experience will prove invaluable as we continue our international expansion in Europe, Southeast Asia, Middle East and recently South America. Her extensive network in the life science industry and senior experience with alliances, joint ventures, and partnerships will help us navigate the numerous opportunities we have on our plate currently, and in the future.”

Dr. Kaltoft is a Danish citizen. She holds a MSc in Biochemistry and PhD in Protein chemistry and Molecular biology from the University of Copenhagen and a Master in International Business Administration from Seattle University.

Commenting on her appointment, Dr. Kaltoft said, “I am very excited to join SANUWAVE’s Board of Directors at this pivotal time. I am impressed with SANUWAVE’s commitment in researching and developing new approaches to treating cumbersome medical conditions and non-medical opportunities, especially in industrial biofilms. An exciting opportunity to grow internationally and in the United States awaits the FDA approval of dermaPACE®. Through the establishment of global alliances, the availability of the SANUWAVE’s technology could provide an improvement in quality of life to diabetic patients.”

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 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 de novo petition 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.

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

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Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation

Posted On June 16, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

June 16, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received FDA 510(k) Clearance and performed first surgeries with PASS® TULIP top-loading fixation including world-first patient-specific hybrid constructs.

Top-loading fixation is the global standard for posterior spinal instrumentation. Medicrea’s PASS® TULIP provides a procedurally-integrated solution for surgeons to benefit from the Company’s UNiD™ ASI technology, a scientific, data-driven model for personalized spine care. The PASS® TULIP components are fully compatible with Medicrea’s PASS LP® to provide a unique hybrid approach in complex indications. The first-ever patient-specific hybrid spine surgery was successfully performed by Dr. Frank Schwab, Chief of Spine, at the Hospital for Special Surgery in New York.

“By using two compatible implant designs in a hybrid application, I am able to personalize a patient’s operation in a whole new way. The increased flexibility and precision help me to best achieve the patient’s optimal spinal alignment targeted by Medicrea’s patient-specific implants,” stated Dr. Schwab, who uses UNiD™ ASI technology to strategically plan cases supported by the UNiD™ LAB team. “Having these additional tools to achieve my surgical strategy translates to better alignment post-operatively and that’s clearly been shown to correlate with patient satisfaction and with long-term benefits of surgery.”

Denys Sournac, President and CEO, stated, “We are pleased to extend our distinctive Lifetime Warranty covering UNiD™ Rod constructs to include associated PASS® TULIP components.” Mr. Sournac continued, “The addition of PASS® TULIP to our comprehensive implant range will open new doors for Medicrea to gain market share for our UNiD™ ASI technology by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

PASS® TULIP components are differentiated from traditional top-loading implants by a thoughtful proprietary design that allows a single implant to perform multiple clinical functions through a simple one-step maneuver. The anticipated result is increased surgical efficiency in implant placement as well as a reduction in the inventory required for a case and associated processing costs.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France, housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: Medicrea.com.

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

Medicrea is listed on
ALTERNEXT Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

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

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Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence

Posted On June 16, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

June 16, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, a data-driven digital portal for the Company’s Adaptive Spine Intelligence.

“It is our belief that data science and analytics are critical components of improved patient outcomes and efficiencies. For that reason, Medicrea has stepped into a space unoccupied by traditional device manufacturers: Software development and Artificial Intelligence,” stated Denys Sournac, President and CEO of Medicrea. “The UNiD™ HUB represents Medicrea’s ability to lead the Spine industry with breakthrough innovations by offering a unique forward-thinking and holistic approach to personalized spinal surgery.”

The UNiD™ HUB is designed to support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery. The UNiD™ HUB software also serves to enhance the existing proprietary IT utilized by Medicrea’s UNiD™ ASI platform for digital surgical planning to create a seamless communication channel between the Company’s UNiD™ LAB biomedical engineers and Surgeon users to deliver UNiD™ TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3D printing techniques.

The digital communication portal opened with the introduction of UNiD™ HUB instantly creates a sticky, user-friendly environment for surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses and dialogue with a dedicated biomedical engineer in real time. Future functionalities will become available alongside the software’s wide release planned in October of 2017, for Eurospine in Dublin, Ireland on the 11-13 October and at the annual meeting of the North American Spine Society, held 25-28 October in Orlando, Florida.

Mr. Sournac continued, “As a media tool for surgeons, we have received very positive feedback from our UNiD™ ASI customers who have seen beta versions of the software and we are now ready to make the UNiD™ HUB digital portal immediately available to them. The software integrates well with their clinical habits and enhances their experience with UNiD™ ASI technology.” Mr. Sournac added, “This new generation of software will be more than a communication tool for surgeons – It will grant surgeons access to the same data analytics and machine learning technology that is curated by our data scientists to use the UNiD™ HUB as an unparalleled research engine and networking platform.”

UNiD™ HUB has been developed in desktop and mobile applications and is accessible from medical offices as well as on the go. For a first look at the UNiD™ HUB, a video preview is available for viewing here.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: Medicrea.com.

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

Medicrea is listed on ALTERNEXT Paris ISIN: FR 0004178572 Ticker: ALMED

Contacts

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

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Bundled payments are gaining momentum in orthopedics, but can they work in other specialties?

Posted On June 16, 2017 By OrthoSpineNews In Financial /  

By CHASE HENSEL, MedCity News – June 15, 2017

Despite pressure on hospitals to reduce readmissions and studies showing that patients who are supported after leaving the hospital are better equipped to self-manage, care continues to be disjointed, leading to poor outcomes for patients, and higher costs for hospitals.

Can bundled payments serve as a solution? For certain conditions, yes. Orthopedics is pioneering this new kind of payment model and if proven successful, other complex conditions and diseases could apply these best practices to improve health and reduce costs, too.

Bundled payments to initiate better coordinated care

The Bundled Payments for Care Improvement initiative (BPCI) was launched by Centers for Medicare & Medicaid Services (CMS) to support the transition to value-based care by developing a Medicare payment system that emphasizes quality instead of quantity. Essentially, this system links payments for a myriad of services patients receive during an episode of care, as opposed to making separate payments to providers for a single illness or courses of treatment.

Holding the provider financially accountable for patient outcomes leads to higher quality of service and increased collaboration between care teams. According to CMS, “Research has shown that bundled payments can align incentives for providers—hospitals, post-acute care providers, physicians, and other practitioners—allowing them to work closely together across all specialties and settings.” The hope is that this leads to lower spending, improved care and a better overall experience for patients.

As the transition to value-based care advances, bundled payments are gaining momentum, particularly in orthopedics where the CMS instituted the Comprehensive Care for Joint Replacement (CJR) initiative? A mandatory bundled payment program for total hip/knee replacements that is pioneering more innovative payment and healthcare delivery models. Risk-sharing models for example, which reimburse based on the success of treatment goals, provide an incentive for all stakeholders including the device manufacturer to work cohesively throughout the entire episode of care. Creating mutual accountability for benchmarks (such as reduced costs and improved patient outcomes) ensures all parties are working towards the same endgame.

 

READ THE REST HERE

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Image Stream Medical and Olympus introduce MedPresence™, the first Virtual Medical Presence Solution for the Hospital Enterprise

Posted On June 16, 2017 By OrthoSpineNews In Financial, Top Stories /  

CENTER VALLEY, Pa. and LITTLETON, Mass., June 12, 2017 /PRNewswire/ — Olympus Corporation of the Americas (OCA) and Image Stream Medical, Inc. today announced the medical industry’s first enterprise virtual presence solution, MedPresence™. The system enables surgical and interventional clinicians to virtually connect and collaborate in ways that have not been possible, practical, or cost-effective before.

Specifically designed to help improve the delivery of patient care, MedPresence™ provides real-time sharing of procedural imagery, applications, and in-room frame of reference to create a context-rich, immersive experience. The system is intended to empower surgical and care teams to quickly and securely connect to clinical specialists, technicians, trainers, or manufacturer’s representatives from across the organization or around the world, and at any time – virtually.

“Our mission at Image Stream Medical is about innovating to create simple ways for clinicians to connect with each other and sources of visual insight. Our flagship EasySuite® product helps improve the workflows of in-room clinicians by connecting them with imaging sources and patient information. MedPresence™ is the next step in care team efficiency improvement, allowing hospitals to assemble teams of experts, no matter where they are located,” said Eddie Mitchell, Image Stream Medical CEO. “Leveraging virtual experts elevates care team expertise, and protects the patient care environment by reducing room crowding, eliminating security and access concerns, and lowering a patient’s infection risk. And we’ve taken a great deal of care to ensure that all MedPresence™ participants can interact and communicate naturally with one another in the same kinds of ways that they would with an in-room colleague. We know that supporting natural ways of interacting is key to improving teamwork and efficiency.”

The release of MedPresence™ follows the June 1 acquisition of Image Stream Medical, Inc. by Olympus Corporation of the Americas. The completion of this acquisition, along with the release of MedPresence™, marks the start of new collaborations from the two companies.

“Directly on the heels of Image Stream Medical joining the Olympus family, the release of MedPresence™ is a testament to the strength of their innovation. We believe MedPresence™ has the potential to dramatically improve the efficiency and level of expertise of surgical teams by enabling hospitals to assemble highly collaborative teams with virtual experts to support a host of clinical and operational scenarios such as remote clinical consultations, tele-mentoring, care standardization programs, in-case application support, and new equipment training,” said Todd Usen, president, Olympus Medical Systems Group, United States. “We are delighted to have Image Stream Medical on board and look forward to continuing to improve both hospital efficiency and patient care through technologies like MedPresence™.”

Validated by an independent, nationally recognized security firm, MedPresence™ protects the integrity of sensitive information, featuring a fully encrypted, end-to-end security architecture. The patent-pending technology offers innovative features like automated masking of PHI, “on air” indicators, and one-button privacy mode enables real-time collaboration, while safeguarding patient and clinician privacy, as well as ensuring HIPAA compliance.

MedPresence™ and applications for advanced integration in procedure room environments will be on display in the Image Stream Medical booth #415 at the OR Manager Conference on October 2-4 in Orlando, FL.

About Image Stream Medical
Image Stream Medical is a leader in clinical visual collaboration solutions and focused on a single mission: to improve healthcare by connecting providers with the visual information and collaborative insight they need to deliver exceptional patient care. Since its founding in 1999, Image Stream Medical has achieved that goal by innovating healthcare environment integration solutions that make powerful capabilities easy to use. The result is a clinical workflow experience that is more intuitive, natural and efficient. Image Stream Medical, Inc. is a wholly owned subsidiary of Olympus Corporation of the Americas.

For more information, visit Image Stream Medical at www.imagestreammedical.com.

About Olympus Corporation of the Americas
Olympus Corporation of the Americas is a precision technology leader, designing and delivering innovative solutions in Medical and Surgical Products; Scientific Solutions; and Cameras and Audio Recorders. Our expertise in optical, digital and precision technologies provides the foundation for our innovations which look inside the human body to help prevent, diagnose and treat illness; further scientific research; and capture images of the world. Throughout our nearly 100-year history, Olympus has been recognized as a pioneer and innovator focused on contributing to society by making people’s lives healthier, safer and more fulfilling. Olympus Corporation of the Americas —a wholly owned subsidiary of Olympus Corporation in Tokyo, Japan—is headquartered in Center Valley, Pennsylvania and employs more than 5,000 employees throughout locations in North and South America.

For more information, visit Olympus at www.olympusamerica.com.

 

SOURCE Olympus Corporation of the Americas

Related Links

http://www.olympusamerica.com/

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Acelity Names Tracy Jokinen as Chief Financial Officer

Posted On June 16, 2017 By OrthoSpineNews In Financial /  

June 12, 2017

SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc., a leading global advanced wound care company, today announced the appointment of Tracy Jokinen as Executive Vice President and Chief Financial Officer.

Jokinen has 25 years of financial accounting, reporting, planning and analysis experience. She is the former CFO of G&K Services, a leading provider of uniform and facility services that was acquired by Cintas earlier this year. Prior to her role at G&K, Jokinen spent more than 20 years at Valspar Corporation where she held a number of leadership roles within the global finance organization.

“Tracy has a dynamic combination of skill and experience that is uniquely suited to the needs of Acelity and the next stage of growth for the company,” said R. Andrew Eckert, President and CEO of Acelity. “She brings a strategic mindset and fresh perspective that will help accelerate our objectives, not only on behalf of Acelity, but also the many patients around the world that we serve.”

Jokinen holds a bachelor’s degree in accounting from St. Cloud State University in St. Cloud, Minn. Interim CFO Todd Wyatt will transition into a new leadership role as part of the Acelity senior management team. Acelity wishes to acknowledge Todd’s indispensable leadership and service as Interim CFO.

About Acelity

Acelity L.P. Inc. and its subsidiaries are a global advanced wound care company that leverages the strengths of Kinetic Concepts, Inc. and Systagenix Wound Management, Limited. Available in approximately 90 countries, the innovative and complementary ACELITY™ product portfolio delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Headquartered in San Antonio, Texas, Acelity employs nearly 4,800 people around the world.

Contacts

Acelity L.P. Inc.
Cheston Turbyfill, +1-210-515-7757
Corporate Communications
cheston.turbyfill@acelity.com
or
Investor Relations
Caleb Moore, +1-210-255-6433
caleb.moore@acelity.com

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Scientific And Clinical Review Confirms Potential Of MiMedx dHACM Allografts For Regenerative Applications In Orthopedics

Posted On June 16, 2017 By OrthoSpineNews In Biologics /  

MARIETTA, Ga., June 15, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed scientific and clinical review article of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts has been electronically published in the journal  Techniques In Orthopaedics.

The paper entitled “Dehydrated Human Amnion/Chorion Membrane Allografts as a Therapy for Orthopedic Tissue Repair“ was authored by Jennifer Lei, PhD; Lauren B. Priddy, PhD; Jeremy J. Lim, PhD; and Thomas J. Koob, PhD. The electronic publication in Techniques In Orthopaedics can be found at http://journals.lww.com/techortho/Abstract/publishahead/Dehydrated_Human_Amnion_Chorion_Membrane__dHACM_.99929.aspx. The article will also be published in a special Symposium issue of Techniques in Orthopaedics on “Emerging and Evolving Materials for Orthopaedics.” Guest Editors for this Symposium issue are David L. Safranski, PhD (MedShape, Inc., Atlanta, GA) and Ken Gall, PhD (Duke University, Durham, NC).

Over 226 growth factors and bioactive proteins have been identified to date in dHACM allografts, and these collective proteins have been shown to regulate activity of a variety of cell types, including stem cells that are critical for orthopedic repair. An independent comparison by a contract research organization demonstrated that micronized MiMedx PURION® Processed dHACM has significantly higher content of growth factors and bioactive proteins than two other commercially available placental-derived flowable products: FloGraft® FREEDOM (Applied Biologics) cryopreserved amnion and amniotic fluid product and PX50® (Skye Biologics) placental tissue matrix. Therefore, dHACM retains high levels of growth factors, cytokines, and chemokines.

In addition to an established history in promoting healing of chronic wounds, amniotic membrane allografts have recently been used in various orthopedic applications to reduce pain, prevent scar tissue formation, and promote healing. MiMedx PURION Processed dHACM (EpiFix® and AmnioFix®) allografts have been used in various orthopedic applications, including tendon and ligament repair, treatment of cartilage and joint space disorders, and spine procedures. The general outcomes achieved by physicians for these applications include:

  • Tendon and Ligament Repair:
    • dHACM reduced pain and improved function following treatment of plantar fasciitis, anterior cruciate ligament (ACL) reconstruction, supraspinatus and infraspinatus tendon (rotator cuff) injury, common extensor tendon tear, lateral epicondylitis (tennis elbow), patellar tendon tear, and Achilles tendinopathy.
  • Cartilage and Joint Space Disorders:
    • dHACM increased production of hyaluronic acid by human fibroblast-like synoviocytes in vitro, including in cells derived from osteoarthritis and rheumatoid arthritis donors.
    • In a rat model of osteoarthritis, injection of micronized dHACM into the knee joint space attenuated cartilage degeneration with a significant reduction in lesions, erosions, and proteoglycan loss.
  • Spine Procedures:
    • dHACM has been successfully used during transforaminal lumbar interbody fusion (TLIF) to minimize postlaminectomy epidural adhesions and scarring, resulting in significantly lower patient pain scores.

Parker H. Petit, Chairman and CEO, stated, “The outcomes that physicians have reported they are achieving when utilizing our dHACM allografts in orthopedic procedures are very impressive. We wanted to support those clinical outcomes with a comprehensive scientific and clinical review of orthopedic applications using dHACM.”

Study Background and Conclusions:

Amniotic membrane allografts are composed of extracellular matrix components such as collagen, fibronectin, and laminin, and contain a vast array of diverse growth factors and cytokines. dHACM allografts have been shown in randomized clinical trials to be effective therapies to enhance healing, and have demonstrated the ability to recruit the migration of stem cells to the site of injury in vitro and in vivo. The regenerative properties of dHACM include the ability to reduce scar tissue formation, modulate inflammation, and enhance healing, and these properties suggest that dHACM may be an effective therapy to promote healing within a variety of orthopedic tissues.

In this scientific review, the basic structure, function, and components of dHACM are discussed, and its current in vitro, in vivo, and clinical usages in orthopedic tissue repair applications are summarized as follows:

  • The delivery of growth factors, cytokines, and protease inhibitors by dHACM allografts modulates the three main phases of healing including inflammation, proliferation, and remodeling.
  • Current research and clinical cases for repairing orthopedic tissues have shown that dHACM allografts have promising results in repairing injured and diseased tissues due to their ability to reduce scar tissue formation, modulate inflammation, and enhance healing.
  • dHACM allografts have been evaluated for repair of tendon and ligament, attenuation of cartilage and joint space diseases, and prevention of scarring and adhesion formation in spinal fusion procedures.
  • Therefore, the use of dHACM allografts has great potential for regenerative applications in orthopedics.

Bill Taylor, President and COO, said, “Clinical usage in orthopedic repair is rapidly growing. We have numerous clinical trials ongoing in the area of orthopedics to evaluate the clinical efficacy of dHACM allografts in plantar fasciitis treatments, Achilles tendon repair, lumbar decompression and microdiscectomy, and total knee arthroplasty. We look forward to sharing the results of these studies when completed.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the results of clinical use of MiMedx products in various procedures and the significance of growth factor and protein content in various products.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that individual physician and patient clinical experiences may vary, other studies may show different or less favorable results,   and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016 and its most recent 10Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

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http://www.mimedx.com

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Powerful Imaging Technology Generates New Evidence on ATTUNE® Knee System

Posted On June 16, 2017 By OrthoSpineNews In Recon /  

WARSAW, IN – June 15, 2017 – When it comes to evaluating a knee replacement’s long-term performance, registry data is extremely important, but not the only tool. Another well-established, but less universally-known, technique is Radiostereometric Analysis (RSA), an imaging technique that precisely measures implant migration and can help predict implant survivorship.1-3

Given the increasing utilization of, and demand for, RSA evidence in many countries, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, made the decision in 2013 to incorporate RSA into its ATTUNE® Knee Evidence Generation Program strategy, and today announced results of the first and recently-completed two-year investigator-initiated study that evaluated the implant fixation of the ATTUNE Knee tibial base using RSA.4

In this study, conducted by the Canadian RSA Network, tiny beads of less than 1 mm were inserted into the bone surrounding the ATTUNE Knee implant at the time of surgery. These beads, made of tantalum, a metal that is well tolerated by the body, served as markers by which X-rays were used to detect 3D changes in the position of the tibial base relative to the bone over time (implant fixation). This particular study included 30 patients, which is a statistically appropriate sample size in RSA research.

Results of this study, presented at the Canadian Orthopaedic Association Annual Meeting (June 15-18, 2017, Ottawa, CA)4, showed that the ATTUNE Knee tibial base migrated an average of 0.02 mm in the superior-inferior (up and down) direction over 24 months, with an average maximum total point motion of 0.21 mm. Applying published criteria which helps interpret how RSA data can help predict future revision rates1,3, this study’s 2-year RSA results showed that the ATTUNE Knee tibial base achieved stable fixation by demonstrating average micromotion of 0.17 mm between one and two years. This is consistent with implants that have acceptable revision rates due to aseptic loosening.1

“These results are another component of the breadth of data that continue to be generated around the ATTUNE Knee,” said Kim Dwyer, Ph.D., Clinical Research Director, Knees, DePuy Synthes Joint Reconstruction. “The importance of RSA is that it can help predict an implant’s long-term performance while larger and longer survivorship studies are underway.”

Dwyer added that the importance of RSA continues to move from its well-established roots in the Nordic countries of Europe to other parts of the world, including North America. RSA Networks like the Canadian RSA Network can play a pivotal role in enhancing evidence-generation timelines, standardizing methodologies, increasing diversity by including more patients at different sites, and meeting the needs of stakeholders who value fixation evidence.

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

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

©DePuy Synthes 2017. All rights reserved.
DSUS/JRC/0617/2182
June 2017

  1. Ryd L, Albrektsson BE, Carlssson L, Dansgård FHerberts P, Lindstrand A, Dansgård, Regner L, toksvig-Larsen S, Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br 1995;77:377-83.
  2. Kärrholm, J, Gill, RHS, and Valstar, ER, The History and Future of Radiostereometric Analysis. Clin Orthop Rel Res, 2006: 448, 10-21.
  3. Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG, Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop 2012;83:614-24.
  4. Richardson, G, Turgeon, T, Gascoyne, T, Laende, E, Bohm, E, Dunbar, M. Stability assessment of a new knee replacement product using radiostereometric analysis. Poster Presentation at the Canadian Orthopaedic Association Meeting, Ottawa, Ontario, 15-18 June 2017.
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‘Cool’ New Knee Procedure Eases Arthritis Pain Without Surgery

Posted On June 15, 2017 By OrthoSpineNews In Extremities, Sports Medicine /  

by LAUREN DUNN and FELIX GUSSONE, MD

A new, non-invasive knee procedure could bring some relief for patients suffering from debilitating chronic pain, for whom surgery is not an option.

The treatment, recently approved by the Food and Drug Administration, is called “cooled radio frequency ablation” and is a less drastic option for people with moderate to severe osteoarthritis pain who are not ready to have knee replacement surgery, or who have health conditions that don’t make them a good candidate for surgery.

Marketed as “Coolief”, the procedure uses radio frequency to target and mute the nerves responsible for sending pain signals from the arthritic knee to the brain. Coolief doesn’t repair arthritis in the knee, but eases the pain, helping patients go back to activities without discomfort and fewer medications.

“What we’re changing is the wiring of the knee — so we’re taking away the pain signal and interrupting it,” Dr. Amin Sandeep, a pain specialist at Rush University Medical Center in Chicago who performs the procedure, told NBC News.

One 2016 study compared Coolief to popular cortisone injections, with patients reporting greater, longer-lasting pain relief with the new treatment than injections. Coolief reduces pain for about to 6 to 12 months, depending on how fast the nerves in the knee regenerate.

 

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