Medovex Corp Initiates Forward Integration-Direct Sales Ops Strategy on Heels of Initial Strong Sales Opportunity in Key German Market

Posted On September 14, 2017 By OrthoSpineNews In Spine, Top Stories /

September 14, 2017

ATLANTA, GA–(Marketwired – Sep 14, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced that it has formed a direct Medovex sales operation in Germany with a direct sales force. This new sales structure which will allow it to go direct in Germany, a large key market opportunity that has seen strong initial sales interest, and offers great dedicated reimbursement.

Dennis Moon, Medovex Executive Vice President, stated, “Initial sales of the DenerveX System in Germany, our most important market outside of the U.S., have been encouraging. While we continue to go narrow and deep, in a very controlled manner, early rollout procedure results have exceeded expectations. Being able to take control of our distribution through our new direct presence is expected to gain us numerous strategic advantages, not limited to better product control, increased selling focus and greater sales force accountability.”

The Company previously recently announced it had received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DenerveX System allowing the Company to market the device in Australia, the first country in the Asia Pacific region. Ahead of schedule, this paves the way for entry into an important area globally, Asia Pacific. Australia is a highly regarded market by many in the global medical community for the quality of care and delivery of the latest technology for the treatment of chronic disease such as Facet Joint Pain.

The Company also announced it had received its first order for the DenerveX System from Australia. On September 17, 2017, the Company expects to conduct sales and product training with its Australia distributor with anticipated initial procedures to be conducted shortly thereafter, following receipt of first shipments of the product.

Recently, the Company also provided a 30 day post procedure update on one of the first cases using its DenerveX System. It has also now received a five week post procedure update from Dr. Chris Dare on his first patient in the UK.

The first case was conducted on July 15, 2017 and results were assessed via visual analog scale (VAS) at 30 days post procedure. According to the VAS score, the patient reported a 70% reduction in pain. The second patient was recently assessed five weeks post procedure, reporting an 80% reduction in pain. The Company continues to secure additional patient testimonials which it intends to make available to shareholders upon completion.

Videos of leading spine surgeon Dr. Vik Kapoor talking about FJS and the DenerveX Device may be viewed at the following links:

https://youtu.be/6Q7hpEsF2mg
https://youtu.be/GIgPaIenXp4

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

image1_0_high_quality.png_full_jpegtran_q95-e1505410341929.jpg

Bodycad Announces First Use of Its Unicompartmental Knee System in Patients

Posted On September 14, 2017 By OrthoSpineNews In Recon, Top Stories /

QUEBEC CITY, Sept. 14, 2017 /PRNewswire/ — Bodycad has announced that the first personalized restoration procedures using its Unicompartmental Knee System in patients have been successfully performed.

Bodycad’s revolutionary system is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy, resulting in a better fit and the potential for improved clinical results and patient satisfaction.

“The personalized restoration enabled me to perform the procedure in an exact manner with minimal bone resection,” said Dr. Brian Hamlin, Co-Director of the Bone and Joint Center of Magee-Womens Hospital of University of PittsburghMedical Center, one of two orthopaedic surgeons to perform the procedure. “The reconstruction resulted in a well balanced knee with optimized tracking while avoiding overcorrection.”

Bodycad uses proprietary imaging algorithms to produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient, rapid, and highly automated process is the only one of itskind in the world that is impeccably integrated between software and modern manufacturing such as 3D printing.

“I was involved throughout the production of the personalized restoration,” said Prof. Werner Siebert of Vitos Orthopedic Clinic Kassel and incoming President of the German Orthopaedic Society, who also performed the procedure. “I provided patient imaging, consulted with a Bodycad PREP Tech on the resulting rendering, and then reviewed and approved the final design. The result was an exceptional fit for the patient.”

“Everyone’s anatomy is unique and that’s why standardized implants have limitations,” says Jean Robichaud, President and Founder of Bodycad. “These recent procedures reinforce a growing body of evidence that demonstrates the benefit of personalized restorations.”

Earlier this year, the company received US and European clearance for its Unicompartmental Knee System and is working collaboratively with practitioners to offer this personalized approach to orthopaedics.

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedic restorations. They are the only company in the world to have a seamlessly integrated, purpose-built, CAD/CAM platform. Its proprietary approach offers patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Contact

Andy McLeod
2035 rue du Haut-Bord
Quebec, Quebec, Canada
G1N 4R7
(418) 527.1388
info@bodycad.com

SOURCE Bodycad

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

Posted On September 13, 2017 By OrthoSpineNews In Regulatory, Top Stories /

WASHINGTON, Sept. 13, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce that it has been chosen to lead three separate training sessions with the FDA. These three training sessions will take place during the months of September and November of 2017 and will be focused on the areas of clinical trials, reimbursement, and innovation.

The Experiential Learning Program (ELP) is a program designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH) better understand real-world experience as it relates to the design, manufacture and use of medical devices. The ELP program aims to collaboratively explore device technology and obtain the necessary knowledge to enhance the review process and support communication between sponsors and the CDRH review staff.

MCRA’s experts will provide insights and case studies on key strategic considerations in the important areas of technology development as it relates to industry, and the related impact of timing and cost in creating both value and mitigating risk. Additionally, as reimbursement and healthcare economics is becoming increasingly more important, MCRA will address how procedure labeling affects reimbursement coding and how Health Technology Assessment Groups and payers determine the increasing clinical evidence requirements that FDA regulates, which increases the investment required for successful commercialization of both new and existing technology.

Speaking on the impact of programs like ELP, MCRA’s General Manager, David Lown said, “MCRA is proud to be selected by FDA to participate in its ELP program. It confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally. Our hope is that FDA benefits from our CRO’s shared knowledge in the areas of regulatory affairs, reimbursement, quality assurance and compliance”

For more information on MCRA, please visit www.mcra.com.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and medical device industries. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves over 500 clients globally.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

MiMedx Recognized as Number 5 on Fortune Magazine’s List of the 100 Fastest Growing Public Companies

Posted On September 13, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Sept. 12, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been recognized by Fortune Magazine as the fifth ranked company in Fortune’s 2017 list of the top 100 fastest growing public companies.

The methodology utilized by Fortune Magazine for its ranking of the top 100 fastest growing public companies includes the company must be listed on a major U. S. stock exchange; have a minimum market capitalization of $250 million and a stock price of at least $5 on June 30, 2017; and have been trading continuously since June 30, 2014. These companies must have revenue and net income for the four quarters ended on or before April 30, 2017 of at least $50 million and $10 million, respectively; and have posted an annualized growth in revenue and earnings per share (EPS) of at least 15% annually over the three years ended on or before April 30, 2017.

Companies that meet these criteria are ranked by revenue growth rate, EPS growth rate, and three-year annualized total return for the period ended June 30, 2017. Fortune determines the overall rank based on the sum of the three ranks. Once the 100 companies are identified, they are then re-ranked within the 100, using these three equally weighted variables.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are pleased to be among the top 100 companies in this prestigious group, and we are extremely honored to be ranked number 5. This recognition is a tribute to the outstanding employees who comprise the MiMedx team and the remarkable healing capabilities of the regenerative medicine products we offer. We are pleased that our dehydrated human amnion chorion membrane (dHACM) allografts are playing an expanding role in helping the healthcare community to improve clinical outcomes and reduce costs.”

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with 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 1,000,000 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.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the remarkable healing capabilities of the regenerative medicine products the Company offers and the expanding role played by the Company in helping the healthcare community improve clinical outcomes and reduce costs. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the healing capabilities of the Company’s products may not continue to have the same results and the Company may not continue to play an expanding role in helping the healthcare community improve clinical outcomes and reduce costs. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Todd J. Albert, MD, Named President of Scoliosis Research Society

Posted On September 13, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Sept. 12, 2017 /PRNewswire-USNewswire/ — Todd J. Albert, M.D., surgeon-in-chief and medical director of Hospital for Special Surgery (HSS) was inducted as the 48^th president of the Scoliosis Research Society (SRS) at the 52^ndAnnual Meeting Course in Philadelphia, Pennsylvania on Saturday, September 9.

With over 1,000 members, SRS is an international society that was founded in 1966 with only 37 members. Current membership includes the world’s leading spine surgeons, researchers, physician assistants and orthotists who are involved in the research and treatment of spinal deformities.

Dr. Albert began his one-year term as president effective September 9. He has been a member of SRS since 1994 and has served in leadership positions including the chair of the Program Committee and the International Meeting of Advanced Spinal Techniques.

“I’m truly honored to lead this organization that has been a driving force in the field of spinal deformity,” said Dr. Albert. “As we continue to evolve into a global society, I hope to further advance the research, education and training that is necessary to bring high quality care to every patient with a spinal deformity.”

Dr. Albert joined HSS as surgeon-in-chief in 2014 and is also the Korein-Wilson Professor of Orthopaedic Surgery. Specializing in the field of orthopedic spine surgery, Dr. Albert focuses on disorders of the cervical spine. Additionally, he has an interest in minimally invasive surgical techniques and image guided technologies. He is the author of seven books and more than 40 book chapters and has published 300 peer-reviewed and non-peer-reviewed articles.

As president, Dr. Albert will travel both nationally and internationally to lecture and teach fellow spine surgeons. He will also oversee administration and the organization’s major meetings.

Outside of the OR, Dr. Albert loves biking, has a penchant for history and enjoys traveling. Dr. Albert lives in Manhattanwith his wife Barbara and has three adult children.

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2018), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New York, New Jersey and Connecticut.
www.hss.edu

SOURCE Hospital for Special Surgery

Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A

Posted On September 12, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance is the second received during this quarter, and continues to strengthen Xtant Medical’s focus in providing a more comprehensive portfolio focused on regenerative care for the patient.

Xtant Medical’s Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The current product line offers a titanium and PEEK composite implant, with the additional option of a titanium plasma coating for improved osseointegration with the spinal endplate, all with 8° or 12° of lordosis for alignment with the curvature of the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16°, 20°, and 24°, providing the surgeon with a wider variety of choices to correct the patient’s loss of lordosis and to improve sagittal balance. The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical’s patented OsteoSponge, proprietary 3Demin, or OsteoVive viable cell allograft.

“The clearance of the additional footprints, including hyperlordotic options, further enhances our lumbar product portfolio in response to our customer’s needs,” said Gregory Juda, Chief Scientific Officer. “We continue to execute on our focus of combining our hardware and biologics technologies, strengthening our position as a comprehensive supplier for spine surgeons and their patients.”

The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. It is intended for anterior spinal fusion procedures at one or two contiguous levels of the lumbosacral spine (L2-S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

Xtant Medical estimates the US market for standalone anterior lumbar interbody fusion market to be approximately $230 million and growing. The US market for Demineralized Bone Matrix (DBM) is estimated at $410M. The additional Irix-A interbody implants are intended to be available to customers later this year.

About Xtant Medical

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

Implanet Announces Clearance of the New JAZZ™ Passer

Posted On September 12, 2017 By OrthoSpineNews In Spine, Top Stories /

September 12, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received FDA clearance to market the new JAZZ™ Passer.

JAZZ™ Passer comprises new passer instruments and a variation of the JAZZ™ Band braid, the JAZZ™ Passer Band. The latter is 100% compatible with all JAZZ™ platform implant connectors, and replicates the mechanical performances of the innovative JAZZ™ Band braid, highlighted in numerous scientific publications.

JAZZ™ Passer facilitates placing the band around anatomical structures, representing a breakthrough in terms of flexibility and ease of use. This simplified system should drive surgeon adoption of JAZZ™ band technologies.

This comprehensive system was designed in direct response to surgeon feedback. Implanet addresses an ever-expanding list of therapeutic indications, given the characteristics and performance of the JAZZ™ Platform. By effectively covering all degenerative, scoliosis-deformity and trauma-tumor pathologies in adolescents and adults, the Company competes in a market segment estimated at over 2 billion dollars.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “This project’s challenge lay in the need to retain our JAZZ™ technology’s proprietary performance characteristics. Our goal was also to develop simple instrumentation that provides the surgeon tactile feel when passing the braid around bony structures. Our valued surgeon advisors confirm that this twofold objective has been achieved, with the combination of the new braid and passers making it even easier to use JAZZ™, notably in the areas of degenerative and complex spine surgery, which account for most spine operations.”

Regarding this new product launch, Nicolas Marin, Implanet’s Chief Marketing Officer, adds: “The JAZZ™ Passer systems enables us to reach a new milestone in the adoption of our technology and the frequency of its use by surgeons. With 20% market share in pediatric deformity surgery in France, we feel that the use of JAZZ™ band technologies has become standard of care and will be part of the therapeutic arsenal of many surgeons in the rest of the world. JAZZ™ Passer represents the most appropriate response to the various problems encountered by spine surgeons that only our technology makes it possible to truly address, illustrated by the conversion of new user surgeons, particularly in the United States.”

Next financial press release: H1 2017 results, on September 19, 2017 after market closes

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ™ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ™ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013. IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net

Proven 10-year Excellence in HemiCAP® Joint Replacement for Hallux Rigidus

Posted On September 12, 2017 By OrthoSpineNews In Extremities, Top Stories /

FRANKLIN, Mass., Sept. 12, 2017 /PRNewswire/ — Arthrosurface, Inc. announced today the publication of long-term HemiCAP® data in The Journal of Foot and Ankle Surgery, “10 Year Follow-Up of Metatarsal Head Resurfacing Implants for Treatment of Hallux Rigidus.” The study reported excellent pain relief, functional improvement, high patient satisfaction, a low reoperation rate and no serious complications.

Hallux Rigidus describes a painful condition which affects the big toe at the first metatarsal joint. Osteophytes, or bone spurs, develop on the dorsal surface of the bones involved, which limit motion and cause pain. Advanced disease may also include degenerate cartilage on the joint surfaces, which can contribute to patient pain.

Historically, arthrodesis, or joint fusion, was the standard of care to address patients’ symptoms in advanced stages, however, with eliminated joint motion, patients have shown difficulties with rising on their toes, kneeling or taking a full stride when walking. Other complications include non-union of the fusion site in about 10% of the procedures.

The proprietary HemiCAP® Implant System is designed to maximize implant stability through a strong threaded fixation component and optimizes the fit with a range of implant curvatures. As an active alternative to joint fusion, the HemiCAP® System allows physicians to provide patient specific solutions with hemiarthroplasty of the first and lesser toes, as well as total joint replacement of the big toe. The motion preserving platform provides a complete solution for primary and revision surgery, while maintaining an exit into joint fusion. To date more than 33,000 implants have been used.

“Patients today want to maintain their toe mobility to stay active, whether it is playing golf, performing yoga or being able to continue to live independently,” said Lisa Donnelly VP of Marketing. “We see tremendous traffic on our website from patients inquiring how to find a physician who is trained on our technologies. We have recently launched a new physician locator covering a nationwide network of approximately 1,000 foot and ankle surgeons to help assist them.”

“It is very satisfying to see the AOFAS score of 90.6 at the 10-year follow-up and the high degree of patient satisfaction,” said Steve Ek, President & CEO of Arthrosurface. “We hope this data continues to drive the clinical and patient communities to question the role of motion sacrificing procedures in the first MTP joint, as has happened over time in multiple other joints”.

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 orthobiologics designed to preserve and restore the joints so patients can regain and 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. For more information, please go to our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

First Spinal Cord Stimulator Implant Placed in Northern California by Dr. Goldthwaite

Posted On September 12, 2017 By OrthoSpineNews In Neuro, Spine, Top Stories /

PLANO, Texas, Sept. 11, 2017 (GLOBE NEWSWIRE) — Noel Goldthwaite, MD, senior surgeon and founding member at SpineCare Medical Group, Inc., is the first physician in northern California to implant Nuvectra’s Algovita^® Spinal Cord Stimulation System, which successfully treated a local injured veteran’s chronic pain and led to his significant reduction in opioid use. The Nuvectra Algovita SCS System is a powerful and versatile spinal cord stimulation system that includes the smallest patient controller on the market. Algovita is FDA approved as a treatment for chronic, intractable pain.

“Following injuries sustained in the line of duty, this particular patient had multiple surgeries that led to unmanaged and intense chronic back pain prior to the placement of Algovita,” Dr. Goldthwaite explains. “The smaller volume paddle lead and ability to steer it using a stylet eased the navigation of significant scar tissue during the procedure. These features allowed me to place the paddle and stimulation exactly where the patient needed it, which helped to alleviate his pain right from the start. Furthermore, after the procedure, the Algovita system differs from other SCS systems in its easy to use keychain patient controller that allows the patient, in conjunction with our medical staff, to customize the amplitude, frequency, and pulse width of the stimulation and toggle between therapy settings. The results have been outstanding! When he initially came to see me, he was severely depressed and in a wheelchair due to his pain. Now he walks into my office upright with a smile on his face and a sparkle in his eye – he’s a totally different person.”

Chronic pain affects over 100 million Americans according to the Institute of Medicine, more than diabetes, cancer, and heart disease combined. Chronic pain is difficult to treat, but one potential treatment option is spinal cord stimulation, or SCS. SCS works by masking or interrupting pain signals as they travel up the spinal cord to the brain. A small, rechargeable battery is implanted under the patient’s skin and connected to thin wires, called leads, which stimulate the nerves sending pain signals. The stimulation “overrides” the pain signals, and instead of feeling pain, patients may feel a tingling sensation known as paresthesia.

Dr. Goldthwaite also discussed the opioid dependency epidemic occurring among our veterans, stating that, “SCS is a powerful non-drug tool that can be used to control pain relief for these patients. Non-drug pain control helps them function, focus, and sleep better and more effectively deal with other related conditions, including PTSD.”

Algovita gave near immediate pain relief to this patient, enabling him to reduce his opioid usage by over 90% in the 6 months since his surgery, which he had become dependent on to keep the pain at bay. Now, he leads what he calls a life of conscious living, being able to enjoy time with his family and help other veterans who have returned from active duty.

The Algovita SCS System was designed to help physicians improve their outcomes and better manage their patients’ pain today and into the future. Algovita offers a number of unique features not available with other systems on the market. With the broadest range of capabilities and fine-tuned control, Algovita provides physicians with the tools to address the individual and changing nature of pain. In addition, Algovita’s leads cover the longest span of the spinal nerves, allowing for additional coverage options as pain moves and changes. As the only stretchable leads on the market, Algovita’s leads are designed to bend and stretch with body movement to help sustain the therapy long-term. Since pain can change throughout the day and with different activities, Algovita also features a small, wireless, key-fob patient controller so stimulation can be easily and discreetly managed.

For more information about Nuvectra and the Algovita Spinal Cord Stimulation system, visit www.nuvectramed.com.

About Dr. Goldthwaite

Dr. Noel Goldthwaite was a founding member of SpineCare Medical Group in 1988. He has performed more than 12,000 spinal operations including more than 350 spinal cord stimulator system implantations and revisions both for the lumbar spine and the cervical spine. He lectures and teaches nationally and internationally. He has a special interest in treating patients who have already had unsuccessful spine surgeries. He understands very well that inadequately treated spine problems, especially failed surgeries with chronic pain, are devastating for the patient, the patient’s family, the patient’s friends, and for society. He is prepared to address all those issues.

NuVasive Announces Acquisition Of Vertera Spine

Posted On September 7, 2017 By OrthoSpineNews In Spine, Top Stories /

SAN DIEGO, Sept. 7, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the acquisition of Vertera Spine, a privately-held medical device company developing and commercializing highly innovative interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology. Terms of the acquisition were not disclosed.

The acquisition of Vertera Spine reflects NuVasive’s continued commitment to pursue strategic opportunities as it builds out its advanced materials science portfolio to complement the Company’s position as the innovation leader in spine. As a result of this acquisition, NuVasive is now the only medical device company to offer porous interbody technology across both PEEK and titanium materials, thereby addressing the spectrum of surgeons’ needs and preferences for interbody implants. Vertera Spine’s technology provides a unique three-dimensional porous PEEK architecture to help elicit and encourage bone ingrowth based on pre-clinical studies, a key factor in improved patient outcomes in spinal fusion procedures, using a proprietary processing method that retains strength and durability.

“With the addition of porous PEEK technology, NuVasive takes the next step in building out its advanced materials science technology focused on delivering the highest level of scientifically driven properties for best spinal fusion rates, including porosity, visualization, surface and structure. This in turn helps to create more predictable, improved outcomes for patients undergoing spine surgery,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Our go-to-market plans include adding Vertera Spine’s FDA-cleared products to NuVasive’s commercial offerings, as well as applying the porous PEEK technology to our innovation roadmap as we further build out our pipeline of highly differentiated products to increase our market penetration.”

Chris Lee, chief executive officer of Vertera Spine, said, “Vertera Spine is excited to join NuVasive to further proliferate our game-changing material technology, as they bring to bear the industry’s leading product innovation capability as well as the scale and resources necessary to realize our full potential. Since founding the company in 2013, our goal has been to help reach more surgeon customers and their patients with this disruptive technology. Together, we will now be able to better serve the market and change the lives of patients around the world.”

Ken Gall, chair of Mechanical Engineering and Materials Science at Duke University, said, “The development of porous PEEK was a breakthrough discovery based on nearly ten years of scientific research. The end result of this fundamental materials work was the first load bearing porous polymer scaffold used in the human body that is both high-strength and finely tuned to promote bony attachment.”

Vertera Spine’s existing interbody product lines will be added to NuVasive’s portfolio for U.S. commercial sale and distribution including:

COHERE^® Cervical Interbody Fusion Device: COHERE is FDA-cleared and recently received a new ICD-10 code, issued by the Center of Medicare & Medicaid Services (CMS), effective October 1. COHERE is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using porous PEEK.
COALESCE^TM Lumbar Interbody Fusion Device: COALESCE recently received FDA 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. Additional extensions for the device are planned for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with the integration of Vertera Spine into the Company’s business, acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.