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New Senate Bill to Replace ACA Gives More Power to States

Posted On September 13, 2017 By OrthoSpineNews In Regulatory /

Robert Lowe – September 13, 2017

A group of Senate Republicans today introduced yet another bill that would largely repeal and replace the Affordable Care Act (ACA), this time around by giving block grants to states to enact their own healthcare reforms.

The money for the block grants would come from what the federal government now spends on the ACA.

The legislation goes by the names of its four sponsors ― Sen. Bill Cassidy, MD, (R-LA); Sen. Lindsey Graham (R-SC); Sen. Dean Heller (R-NV), and Sen. Ron Johnson (R-WI).

“If you believe repealing and replacing Obamacare is a good idea, this is your best and only hope,” said Graham at a press conference today. “Everything else has failed except this approach.”

Graham warned that if Republicans fail to pass his bill, a single-payer system like the kind proposed by Sen. Bernie Sanders (I-VT) and Democratic allies was inevitable.

The block grants under the Graham-Cassidy-Heller-Johnson bill would replace current ACA expenditures on Medicaid expansion, premium subsidies for health plans bought on insurance exchanges, cost-sharing subsidies, and the so-called Basic Health Program for low-income individuals that some states have adopted. States could use the block grants to contract with insurers to encourage their participation in the exchanges, subsidize premiums and out-of-pocket costs for individuals, pay physicians and hospitals, support their Medicaid programs, and create high-risk and reinsurance pools.

READ THE REST HERE

Spineology® Secures $5 Million Investment from Hermed Capital

Posted On September 13, 2017 By OrthoSpineNews In Financial /

September 13, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving surgery™, is pleased to announce that Hermed Capital, a private equity fund located in Shanghai, China, has made a $5 million investment in the form of a convertible debenture. The proceeds from this financing are expected to fund additional commercialization, product development, and clinical research efforts for the company.

“We believe the Spineology investment is a very exciting opportunity,” stated Dr. Jerry Xiao, Managing Director of Hermed Capital. “Spineology possesses a very novel product portfolio in an otherwise very homogeneous market. We look forward to working with them as they grow in the U.S. and hope to be able to leverage our resources as they begin to explore global opportunities.”

“The Hermed investment comes at a very opportune time for Spineology,” said John Booth, CEO for Spineology. “With the recent approvals of Rampart One and Duo we are poised to dramatically expand our procedure base into additional market segments.”

The Duo System significantly reduces the surgical access required for lateral procedures while providing a large conforming device footprint.

The Rampart One System minimizes the exposure requirements associated with anterior spinal fusion procedures and is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

About Hermed Capital Co. Ltd.
Hermed Capital Co., Ltd is a venture capital investment firm specializing in growth capital investments in the healthcare industry including biotech, pharma. medical device and diagnostics projects globally, which is based in Shanghai China. With its abundant China resources, Hermed capital adds in values to those portfolio companies by leveraging its expertise and networks.

Contacts

Spineology Inc.
Dan Walsh, 651-256-8500
dwalsh@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

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

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NuVasive Announces Commercial Launch Of LessRay System Designed To Significantly Reduce Radiation Exposure

Posted On September 13, 2017 By OrthoSpineNews In Spine /

SAN DIEGO, Sept. 13, 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 commercial launch of its LessRay® software technology system. The LessRay system, comprised of a propriety software algorithm and hardware components, is designed to help address over exposure to radiation in hospital operating rooms (O.R.), particularly in the case of minimally invasive spine surgery (MIS).

“The launch of LessRay is a significant milestone for NuVasive, as we begin to sell capital equipment and bring technology advancements into the hospital O.R.,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “With LessRay’s ability to dramatically reduce radiation exposure, as well as its enhanced imaging capability, we are now executing on our imaging and navigation strategy to improve spine surgery productivity and ultimately predictability. Given the healthy pipeline of interest from customers already, the strong demand demonstrates a critical need for a solution like LessRay to address a major safety issue related to radiation facing surgeons and hospital administrators.”

LessRay Benefits
Studies show spine and orthopedic surgeons can receive their lifetime occupational radiation limit within the first 10 years of their career.¹ As a result, cancer rates and contraction of cataracts associated with radiation exposure are nearly double that of other surgery practices. LessRay’s proprietary image enhancement technology improves low-dose, low-radiation fluoroscopy (or x-ray) images to have similar diagnostic capabilities as conventional full-dose fluoroscopy images, thereby reducing radiation emission and exposure in the O.R while retaining the high resolution of a full radiation dose shot. Additionally, LessRay has other features to help reduce the number of fluoroscopic shots needed, thus decreasing the overall radiation even further. Results of a recent prospective study²conducted with patients randomized to which surgical intervals were performed with standard-dose fluoroscopy or fluoroscopy using LessRay, which measurement of radiation emission and exposure showed that radiation exposure of healthcare professionals in the O.R. was between 62 percent and 84 percent lower in the LessRay group compared to the conventional fluoroscopy group.

In addition, radiation exposure and limited imaging capabilities have been barriers to widespread spine MIS adoption, compared to general orthopedic MIS. By dramatically reducing these limitations, LessRay supports the increased adoption of MIS spine surgery and enables the well-documented patient benefits including less blood loss, lower risk of infection, faster recovery time and more. Additional hospital economic benefits include no disruption to current surgical workflow and no additional surgery time needed.

More about LessRay
NuVasive acquired the LessRay propriety software algorithm and technology system in September 2016, and has since improved upon its design. The Company completed robust alpha and beta testing in more than a dozen hospitals where spine surgery is performed, and incorporated trial feedback from surgeons and hospital staff. LessRay units will be sold as a capital sale or lease purchase, with a focus on selling into O.R.’s dedicated to spine surgery first and then proliferating the technology across additional areas of the hospital where this technology also solves a significant need.

Additional LessRay system benefits for spine surgeons and staff that help increase O.R. efficiency include:

C-arm tracking: Simplifies localization and target anatomy quickly, accurately and without the unnecessary fluoroscopy time and scouting images.
Image stitching: Minimizes surgical workflow interruption by quickly stitching together fluoroscopic images of any spine segment.
Angle finder: Minimizes O.R. steps required to obtain crisp endplate shots with fewer fluoroscopic images than traditional C-arm scouting.
Alternate view: Improves visualization by making metal instruments invisible or semi-transparent by fading out their obstruction.

“LessRay’s ability to reduce radiation usage is so compelling because it benefits not only the surgeon but also the patient and everyone in the operating room,” said Dr. Stephen Ryu, neurosurgeon at Palo Alto Medical Foundation in Palo Alto, Calif. “LessRay’s additional features that augment the capability of conventional fluoroscopy provide really useful tools for even the simplest surgeries. LessRay’s capability to assist accurate localization of spine levels alone is worth it.”

¹UI Haque M, Shufflebarger HL, O’Brien M, et al, Radiation exposure during pedicle screw placement in adolescent idiopathic scoliosis: is fluoroscopy safe? Spine 2006;31(21):2516-20.

²Wang TY, Farber SH, Perkins SS, et al. An internally randomized control trial of radiation exposure using ultra-low radiation imaging (ULRI) versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.

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 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.

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com; OR Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

This information is being sent to you by:
NuVasive, Inc.
7475 Lusk Boulevard, SAN DIEGO, CA, 92121, United States
http://www.nuvasive.com

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

Titan Spine Appoints Chad Kolean as Chief Financial Officer

Posted On September 12, 2017 By OrthoSpineNews In Financial, Spine /

September 12, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Chad Kolean as the Company’s Chief Financial Officer (CFO). In his role, Kolean will oversee Titan’s Finance Team and work to build forward-looking financial preparedness as the Company continues to experience rapid growth following the launch of its nanoLOCK® surface technology.

Prior to joining Titan, Mr. Kolean served as the CFO for Cellectar Biosciences, a life sciences company, where he drove a management restructuring and raised substantial funds resulting in uplisting to the NASDAQ Capital Market. Previously, he served as the CFO at Pioneer Surgical Technologies, providing the organization with leadership strategy, development and execution, Board support, investor relations, budgeting, forecasting, operations and regulatory due diligence. Kolean is a certified public accountant and earned his B.A. in Business Administration from Hope College.

Mr. Kolean commented, “I am thrilled to join the team at Titan Spine, particularly at such an exciting time for the company. We are well-positioned for continued financial growth that capitalizes on a strong first half of 2017. Titan Spine is making substantial progress addressing the key needs for both patients and surgeons, and the company’s growth is a direct reflection of the increased demand surgeons have for the advantages of our nanoLOCK® surface technology.”

Peter Ullrich, Chief Executive Officer of Titan Spine, added, “Chad’s appointment as our CFO validates and reflects our rapid expansion as we continue to disrupt our industry and redefine the role of interbody devices in the fusion process. The growing demand for our technology and our strong sales team has led to significant growth, especially in the first half of this year, and we believe Chad will help drive our continued progress, further benefiting patients at the nano-cellular level to heal faster following spinal fusions.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate

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Researchers at HSS Receive Grants to Study Bone Stress Injuries

Posted On September 12, 2017 By OrthoSpineNews In Financial, Sports Medicine /

NEW YORK, Sept. 12, 2017 /PRNewswire-USNewswire/ — Two research teams at Hospital for Special Surgery (HSS) have been awarded grants by the NBA and GE Healthcare Orthopedics and Sports Medicine Collaboration. This strategic partnership between NBA and GE Healthcare was launched to collaborate with leading clinical researchers to address the prevention, diagnosis and treatment of musculoskeletal injuries affecting NBA players and everyday athletes.

A team led by Brett Toresdahl, MD, primary care sports medicine physician at HSS, received a grant of nearly $300,000that will go towards investigating the use of ultrasound imaging to monitor healing and guide readiness of return to play in athletes with bone stress injuries.

Bone stress injuries of the lower leg and foot are common among elite basketball players and can require a long period of rest in order to fully recover. Determining when a player is ready to return to play has historically been difficult as it relies primarily on a player’s symptoms since signs of healing are not reliably seen with standard imaging (such as MRI and X-ray).

“There is little known about the connection between ultrasound findings, symptoms, and readiness for return to sport for athletes with bone stress injuries,” said Dr. Toresdahl, principle investigator of the study. “Our goal is to evaluate the use of serial ultrasound to assess bony healing to optimize treatment and more accurately predict readiness for return-to-play.”

The investigators will recruit adults between 18 and 50 years of age who have a bone stress injury in the lower leg or foot as a result of sport or exercise and diagnosed by MRI.

Participants will receive standard treatment of rest and crutches, splint and/or walking boot. An ultrasound will be performed every two weeks for 12 weeks at the site of the injury. Simultaneously, patients will be tracking their pain, activity and return to activity. A radiologist will grade the amount and appearance of bony callus formation and then a repeat MRI will be performed at 12 weeks.

“Our findings could provide doctors with a new way to guide athletes to safely return to play after a bone stress injury with a minimal risk of re-injury,” added Dr. Toresdahl.

The Athlete’s Foot

The other grant received by HSS went to a team led by Martin O’Malley, MD, foot and ankle surgeon at HSS. This $100,000 grant will be used to assess risk factors and intervention strategies for fifth metatarsal stress fractures, the most common type of stress fractures for basketball players. These fractures can be difficult to treat, leading to long-term consequences for an elite basketball player.

“Currently, there is limited knowledge on how to identify athletes who are at a high risk for a fifth metatarsal stress fracture,” said Dr. O’Malley, principle investigator of this study. “Additionally, we don’t have a clinical understanding on how to intervene before such injury occurs.”

This research will utilize data from the screening of collegiate and professional basketball players to identify factors of foot structure that are common in those who sustained a fifth metatarsal injury. The investigators will employ a specialized robotic device that will stimulate walking and jumping in cadavers to find features that increase the mechanical burden on this bone.

Testing will also be done to assess the ability of intervention strategies to reduce this mechanical burden and thus, the risk of injury.

“We hope to gain objective biomechanical evidence that will rationalize intervention strategies such as orthotic devices and targeted muscle activation in order to reduce risk of injury and re-injury,” added Dr. O’Malley.

SOURCE Hospital for Special Surgery

Month: September 2017

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