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UK based medical device company announces two new patents granted by the US Patent and Trademark Office

Posted On January 26, 2017 By OrthoSpineNews In Regulatory /  

SIRAKOSS Ltd., a UK-based medical device company developing innovative bone grafting solutions for the $3 billion global orthopaedic market, has announced that the United States Patent and Trademark Office (USPTO) has granted two  patents for its bone graft technologies.  SIRAKOSS‘ patent portfolio encompasses advanced synthetic bone graft technologies which  form the company’s product pipeline designed to address the significant clinical need for a fully-synthetic, standalone bone void filler.  SIRAKOSS’ technologies provide consistently effective bone regeneration without the established risks found by using either autograft or therapeutics-based products such as BMP’s.

The two new granted patents are important additions to SIRAKOSS’ intellectual property estate and significantly enhance the company’s technology and product pipeline.  Patent US 9,492,591 describes novel formulations of putty products, where the SIRAKOSS core technology may be combined with modified resorbable polymer carriers to produce a bone graft with improved handling characteristics and enhanced efficacy. The second patent (US 9,492,585) describes a range of bone graft technologies with specific microstructural properties that expands the potential products that SIRAKOSS can develop. These two new patents add to SIRAKOSS’ robust existing granted patents in Europe, Japan, Australia and China, and to the company’s core IP estate in the USA, Japan and Australia.

These patent grants occur as SIRAKOSS is advancing the development of its lead technology in Europe toward market.

The company’s proprietary technology is entirely synthetic, containing no human tissue and can be manufactured in consistent, high quality batches.  Surgeon feedback on pre-clinical performance data and handling properties of the SIRAKOSS bone graft substitutes, when compared to currently available products, has been very encouraging. The alternative approach against which all other options are measured is autograft – the ‘gold standard’ – where healthy bone is harvested from the patient’s hip and replanted at the defect site. The amount of bone that is available for grafting is limited, particularly in children, and requires two invasive operative procedures, increasing the risk for the patient and the cost for the hospital.  Other alternatives have seen products derived from cadaver bone, but these can be inconsistent in their performance.

Brian Butchart, CEO of SIRAKOSS, said “The granting of these two patents endorses the breadth of our technology and provides SIRAKOSS further protection for its unique product offerings in the largest single market for bone graft substitutes.”

Investor director, Sinclair Dunlop, Managing Partner at Epidarex Capital, said “this welcome expansion of SIRAKOSS’ global IP estate furthers the competitiveness of the company’s core technology and its potential for meeting a large market, driven by patient needs”

Synthetic bone grafts are used in trauma, spinal and dental surgery to fuse bones together to correct congenital or degenerative conditions (such as curvature of the spine) or following a traumatic injury where the bone fails to heal.

About SIRAKOSS Ltd.

SIRAKOSS Ltd is a medical device company that is developing synthetic bone graft technologies that will compete in a $3 billion global market. Bone graft substitutes are utilised in various orthopaedic and dental surgical procedures. SIRAKOSS is developing a number of products that will offer surgeons solutions to challenges that exist with current technologies, and are progressing these towards commercialisation. SIRAKOSS‘ patent portfolio provides protection for different types of synthetic bone grafts that form a product pipeline with products that have different properties related to new bone formation. This broad scope of technologies enables SIRAKOSS to develop a range of synthetic bone graft substitutes with significantly enhanced bone growth properties.  This provides the opportunities to develop products that would perform against other bone graft approaches, namely autograft, processed allografts and other synthetic bone graft substitutes. www.sirakoss.com

About Epidarex Capital

Epidarex Capital invests in early-stage, high growth life science and health technology companies in under-ventured markets within the UK and US. Epidarex was created to meet the need for more sector-specific risk capital for young companies, including spin-outs from leading research universities. The fund’s international management team has a track record of successfully partnering with top scientists and entrepreneurs to develop highly innovative products for the global healthcare market. For further information please visit www.epidarex.com.

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OrthAlign, Inc. Announces FDA Clearance for Direct Anterior Approach HipAlign

Posted On January 26, 2017 By OrthoSpineNews In Regulatory /  

Aliso Viejo, CA – January 25, 2017 – OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its Direct Anterior Approach HipAlign® system. The handheld computer provides surgeons with critical measurements they need to optimize the outcomes of their direct anterior approach total hip replacement surgeries. This is accomplished with cup placement accuracy data and measurement changes in leg length and joint offset.

Based on FDA cleared bench test data, HipAlign technology provides cup placement accuracy of ±3°, with at least 97% confidence. The system accounts for pelvic tilt when measuring the abduction and anteversion angles of the acetabular cup. Additionally, the system measures changes in leg length and joint offset, within 3mm or less, with at least 97% confidence.

“The required surgical technique for Direct Anterior HipAlign is so simple and intuitive. One of the biggest value props is that I can now eliminate the need for intraoperative radiation exposure by getting fluoro out of the operating room. I can’t emphasize how game-changing that is…,” said E. Matthew Heinrich, MD of Orthopedic Specialists of Austin, in Austin, TX. “OrthAlign technology has been one of the most cost-effective, mobile, and accurate technologies in the orthopedic market since I started my practice over 15 years ago. I use KneeAlign® technology for all of my knees and will be using HipAlign for all of my hips.”

Recent statistics have shown that the direct anterior approach, despite being a more challenging surgery, is growing in popularity amongst surgeons as it arguably leads to quicker recovery, less pain, and more normal function for patients after a hip replacement. HipAlign for the Direct Anterior Approach was designed specifically to help surgeons more easily make the transition from posterior to direct anterior, while providing more clinically relevant positioning for cup placement, leg length, and joint offset. HipAlign is an open platform, so it can be used with any THA implant system. The technology does not require any pre-operative imaging, intraoperative fluoroscopy, or any additional personnel in the operating room to control components outside of the sterile field.

“There are three key principles that OrthAlign focuses on in product development: ease of use, precision, and cost-effectiveness,” said James Young Kim, OrthAlign’s Global Vice President of Marketing. “We are so proud of our newest application Direct Anterior Approach HipAlign. Our engineers set out to create a product that will enhance the surgical experience for direct anterior hip replacements and drive better accuracy for the best outcomes, all while fitting in the surgeon’s common workflow. Best of all, especially in this cost-conscious healthcare environment, OrthAlign technology is a fraction of the cost of competing technologies. There are no upfront capital expense requirements, no software costs, and no annual service contracts.”

OrthAlign will be showcasing its full portfolio of products, including the recently approved Direct Anterior HipAlign technology at this year’s AAOS meeting in San Diego, CA, March 15-18, 2017 at booth #5615.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN® and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

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Implanet Announces Global Marketing Clearance of the New JAZZ FRAME®

Posted On January 26, 2017 By OrthoSpineNews In Regulatory /  

January 25, 2017

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has been given the green light by the American and European authorities, through FDA 510k clearance and CE marking, to market its new Jazz Frame® implant.

JAZZ Frame® is a system of connectors, the final link in the JAZZ Band® technological platform dedicated to the hybrid surgical technique. Implanet now offers surgeons the possibility of defining and optimizing a global strategy to reduce major deformities, thus maximizing long-term clinical outcomes.

“Since we have been using sublaminar braid implants to reduce and stabilize scoliotic deformities, we have been able to show significantly greater reductions than we previously obtained with our all-screw or hook-and-screw assemblies”, says Professor Keyvan Mazda, MD, Ph.D, Robert Debré Hospital, APHP, adding: “Using the JAZZ Frame® facilitates the restoration of both frontal and sagittal balance, thanks to the simultaneous reduction of both thoracic curves. This is most notable in the case of the most complex deformities where shoulder imbalance is common. The result of years of clinical experience and of close collaboration with Implanet, JAZZ Frame® allows us to be even more efficient and quick for the sole benefit of patients.”

Ludovic Lastennet, CEO of Implanet, adds: “We continue to strictly adhere to, and execute our business plan. The rapid marketing clearance in Europe and the United States is a real source of satisfaction, innovation that maximizes the clinical value of our technology. Optimized for implementation of the “frame” technique, we expect this implant to be rapidly adopted by our partner surgeons, pediatric and adult deformity specialists alike. The marketing release of JAZZ Frame® in our various markets is scheduled for the first quarter of 2017.”

Next financial press release: 2016 annual results, on March 28, 2017
Implanet will participate in the Invest Securities Biomed Event, on January 26 in Paris.

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 Compartment C of the Euronext™ regulated market in Paris.

Contacts

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

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AdvaMed Names New Head of Orthopedics Sector

Posted On January 25, 2017 By OrthoSpineNews In Financial, Regulatory /  

By Advanced Medical Technology Association | January 24, 2017

The Advanced Medical Technology Association (AdvaMed) has announced that Juan-José Gonzalez, president, U.S. DePuy Synthes, part of the Johnson & Johnson Family of Companies, has been named head of the organization’s Orthopedics Sector. In this role, Gonzalez will help lead and coordinate the regulatory and reimbursement ad-vocacy priorities that particularly impact AdvaMed’s orthopedic member companies.

As head of U.S. DePuy Synthes, Gonzalez leads a more than $5 billion orthopedic business and is responsible for all strategic and commercial activities. In his decade at Johnson & Johnson, he has held a number of management roles of increasing responsibility, most recently serving as president, DePuy Synthes Europe, Middle East and Africa (EMEA), where he led the team driving innovation and growth across the EMEA region by leveraging a broad port-folio to address customer needs in the changing market environment. Gonzalez also has a passion and successful track record for driving talent development within his organization and serves as an ongoing mentor to many within Johnson & Johnson.

Gonzalez has an engineering degree from the University of Lima, Peru; an M.B.A. in marketing and corporate finance from the University of Notre Dame; and a master’s degree in technology from Columbia University.

“With his breadth of experience and knowledge of global markets, Juan-José is an excellent choice to lead AdvaMed’s Orthopedics Sector and to advocate worldwide for patient access to needed mobility technologies,” said AdvaMed senior vice president Tara Federici, staff lead for the sector.

Priority issues for the association’s Orthopedic Sector include:

  • Working with key stakeholders on the design, devel-opment and maintenance of an effective orthopedic device registry in the U.S.; and
  • Ensuring the value of orthopedic implants is captured in new payment methodologies.

– See more at: http://www.odtmag.com/contents/view_breaking-news/2017-01-24/advamed-names-new-head-of-orthopedics-sector#sthash.ek3eb20Q.dpuf

 

 

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AMA: Court Order in Aetna-Humana Merger Halts a Bad Deal for Elderly Patients

Posted On January 25, 2017 By OrthoSpineNews In Regulatory /  

Statement attributed to: Andrew W. Gurman, M.D., President, American Medical Association

“Elderly patients were the big winners today as a federal court imposed an injunction on Aetna’s $37 billion acquisition of Humana. The court ruling halts Aetna’s bid to become the nation’s largest seller of Medicare Advantage plans and preserves the benefits of health insurer competition for a vulnerable population of seniors.

“Aetna’s strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility and affordability of health care for millions of seniors. The AMA applauds the extraordinarily well documented, comprehensive, fact-based ruling of U.S. District Judge John D. Bates, which acknowledged that meaningful action was needed to preserve competition and protect high-quality medical care from unprecedented market power that Aetna would acquire from the merger deal. Importantly, Judge Bates further concluded that the merger would unlawfully restrain competition in the sale of individual commercial insurance on the public exchanges in three counties in Florida identified in the complaint.

“The court’s ruling sets a notable legal precedent by recognizing Medicare Advantage as a separate and distinct market that does not compete with traditional Medicare. This was a view advocated by the AMA, as well as leading economists. AMA also applauds the decision for protecting competition on the public exchanges.

“The AMA’s stand against this anticompetitive merger shows again that when doctors join together, the best outcome for patients and doctors can be achieved. Given the troubling consolidation trends in health insurance industry, the AMA will continue to advocate on behalf of patients and physicians to foster more competitive health insurance markets.”

 

Media Contact:

Robert J. Mills

AMA Media & Editorial

(312) 464-5970

robert.mills@ama-assn.org

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Arthroscopy market to surpass $5.7 billion by 2023 as sports injuries are on the rise, says GlobalData

Posted On January 25, 2017 By OrthoSpineNews In Financial, Sports Medicine /  

25 January 2017

The arthroscopy market, which covers 39 countries and includes implant and capital equipment, is set to rise from $4.19 billion in 2016 to $5.73 billion by 2023, representing  a compound annual growth rate (CAGR) of 4.6%, according to research and consulting firm GlobalData.

The company’s latest report states that this growth will be driven by the rising prevalence of sports injury, which is growing at a CAGR of 6.3% and is primarily caused by intense and repetitive training in major markets like the US and China. Other drivers include rising obesity rates, an aging population and the trend towards more innovative minimally-invasive techniques, reducing cost and recovery time for patients.

Tobe Madu, MSc, GlobalData’s Analyst covering Medical Devices, explains: “Sports medicine technology is built on minimally-invasive arthroscopic implants and equipment, and these will continue to drive the market, as well as other orthopedic segments. As both a technique-driven and an implant-based field, there are arthroscopic products continuously entering the market for difficult-to-access joints, and smaller implants for smaller repairs.

“Materials development has been a key interest for physicians, as they look for more durable and biocompatible implant materials. For example, knee cartilage injuries have driven the development of products for meniscal repair, while anterior cruciate ligament and posterior cruciate ligament injuries have inspired biocomposite and bioresorbable interference screws.”

While healthcare spending as reflected by reimbursement rates is expected to go down globally, the market outlook remains strong in western countries, as substantial growth in new indications will drive up procedure numbers. Meanwhile, countries such as Brazil, China, and India, will continue to see adoption of arthroscopic products as surgeon training improves and newer economical products are introduced in the market, according to GlobalData.

Madu continues: “As disposable surgical products turn into commodities, buyer decision will become increasingly price sensitive. Despite this development, market leaders such as Arthrex and Stryker, who maintain a culture of innovation and service while delivering cost-effective products, will stay ahead of competitors.

“The most significant area of growth is in hip arthroscopy, where global revenue is expected to increase by a CAGR of 14.5% during the forecast period.”

 

Editor’s notes

– Comments provided by Tobe Madu, MSc, GlobalData’s Analyst covering Medical Devices.

– Information based on GlobalData’s report: MediPoint: Sports Medicine – Global Analysis and Market Forecasts.

– This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts. The 39 major markets include the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, India, South Korea, Australia, Canada, Mexico, Russia, Austria, Belgium, Czech Republic, Denmark, Finland, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland, Turkey, Taiwan, New Zealand, Argentina, Chile, Egypt, Israel, Saudi Arabia, South Africa, and the United Arab Emirates.

– For guidelines on how to cite GlobalData, please see: https://healthcare.globaldata.com/media-center/quoting-globaldata

About GlobalData

GlobalData is a leading global research and consulting firm offering advanced analytics to help clients make better, more informed decisions every day. Our research and analysis is based on the expert knowledge of over 700 qualified business analysts and 25,000 interviews conducted with industry insiders every year, enabling us to offer the most relevant, reliable and actionable strategic business intelligence available for a wide range of industries.

For more information

Please get in contact if you have any questions about this or other GlobalData products. Analysts are available to comment. Contact the GlobalData press office +44 (0)161 359 5822 or email pr@globaldata.com

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DePuy Synthes Announces Exclusive Co-Promotional Agreement with Pacira Pharmaceuticals, Inc.

Posted On January 25, 2017 By OrthoSpineNews In Recon, Spine /  

RAYNHAM, Mass., Jan. 25, 2017 /PRNewswire/ — DePuy Synthes Companies today announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) to co-promote EXPAREL®, a long-lasting, non-opioid, local analgesic administered at the orthopaedic surgical site. The agreement allows DePuy Synthes to promote EXPAREL across its joint reconstruction, spine, sports medicine, and trauma businesses to help with postsurgical patient pain. This will further enhance the company’s portfolio and reach in the operating room while also helping hospital customers better achieve their Triple Aim goals of improving clinical outcomes, reducing costs and enhancing patient satisfaction.

Drug overdose is the leading cause of accidental death in the U.S., with opioid addiction driving this epidemic, including more than 20,000 overdose deaths related to prescription pain relievers in 20151. While opioids have typically been used for the management of orthopaedic postsurgical pain, EXPAREL provides targeted, non-opioid pain control by working right at the site of surgery, allowing for long-lasting pain relief. Reduced pain allows the opportunity for earlier weight bearing and mobilization immediately following surgery, and more patients discharged to home rather than interim care facilities.

“There are millions of orthopedic procedures performed in the U.S. market today where we can improve patient care and the surgical experience by offering a long acting, intra-operatively delivered local anesthetic infiltration solution,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “As part of our focused approach to help bring value at every point along the care pathway, we are thrilled to be able to further our offerings through partnering with Pacira and together provide a differentiated solution for our customers to help improve patient outcomes.”

DePuy Synthes has extensive reach in the orthopaedics and spine space, positioning the company to bring EXPAREL to joint reconstruction, spine, sports medicine, and trauma patients in the U.S. for in-hospital and outpatient procedures.  Our suite of products and solutions help to drive improved clinical outcomes, reduced complication rates and improved recovery time.

DePuy Synthes is expected to begin co-promoting EXPAREL in Q1 2017.

EXPAREL® is a long acting local anesthetic indicated for single-dose infiltration into the surgical site to produce post-surgical analgesia. The U.S. Food and Drug Administration (FDA) confirmed that EXPAREL has been approved for administration into the surgical site to produce postsurgical analgesia in a variety of surgeries.2

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, 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.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to an exclusive agreement in the U.S. with Pacira Pharmaceuticals Inc. to co-promote EXPAREL®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes Sales Inc., the DePuy Synthes Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; the ability of DePuy Synthes to successfully execute strategic plans; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations; changes in behavior and spending patterns of purchasers of health care products and services; global health care reforms and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. DePuy Synthes Companies and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

©DePuy Synthes 2017. All rights reserved.

1 Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2015 on CDC WONDER Online Database, released December, 2016. Data are from the Multiple Cause of Death Files, 1999-2015, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed at http://wonder.cdc.gov/ucdicd10.html. 2010 were four times those in 1999.

2 http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2122491

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/depuy-synthes-announces-exclusive-co-promotional-agreement-with-pacira-pharmaceuticals-inc-300396181.html

SOURCE DePuy Synthes Companies

Related Links

http://www.depuysynthes.com

Iris D. Shaffer

director 

APCO Worldwide
30 S. Wacker Drive, Suite 1270

Chicago, IL 60606

(t) 312.368.7544
(m) 202.257.2876
ishaffer@apcoworldwide.com

@apcoworldwide

@irisd

www.linkedin.com/in/irisshaffer

www.apcoworldwide.com

 

A majority woman-owned business 

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Aurora Spine Announces New Chief Financial Officer

Posted On January 25, 2017 By OrthoSpineNews In Spine /  

CARLSBAD, CALIFORNIA–(Marketwired – Jan 25, 2017) – Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSX VENTURE:ASG) announced the appointment of Sarina Mason as their Chief Financial Officer (CFO), effective February 6, 2017.

Ms. Mason will help guide and oversee the company’s continued market leadership and financial growth. She brings more 16 years of experience to Aurora Spine.

Prior to joining Aurora Spine, Ms. Mason was Director of Accounting & Finance at International Stem Cell Corp., a publically traded company.

Ms. Mason began her career with Ernst and Young working primarily in the Assurance and Advisory Business Services group. Ms. Mason earned a Bachelor of Science in Accounting from San Diego State University.

Former CFO Eric Fronk has resigned from the Company effective February 6, 2017 to pursue other opportunities.

“We are very pleased to have someone with Sarina’s skills and experience join Aurora Spine,” said Trent J. Northcutt, President and CEO of Aurora Spine. “Sarina has a wealth of expertise in financial management as well as proven leadership capabilities that will be a great asset as we capitalize on the opportunities that lie ahead of us.” He added, “I would like to thank outgoing CFO Eric Fronk for his substantial contributions to the Company.”

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

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InVivo Therapeutics Announces Sixth Patient Conversion in The INSPIRE Study of the Neuro-Spinal Scaffold™

Posted On January 25, 2017 By OrthoSpineNews In Biologics, Neuro /  

CAMBRIDGE, Mass.–(BUSINESS WIRE)–

InVivo Therapeutics Holdings Corp. (NVIV) today announced that the patient enrolled in December in the INSPIRE study of the Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between discharge and the one-month evaluation. This is the sixth out of the eleven patients (54.5% conversion rate) in follow-up to have had an AIS grade improvement. Two patients who have not yet converted are early in follow-up, with conversion possible before the six-month endpoint. The INSPIRE conversion rate is considerably higher than rates observed in a range of SCI natural history databases.

Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, said: “I have been encouraged by the data generated to date in the INSPIRE study, including the two conversions in patients that I have implanted with the Neuro-Spinal Scaffold.” Dr. Coric, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee performed the implantation with his partner at Carolina Neurosurgery and Spine Associates, Samuel Chewning, M.D.

“The AIS conversion rate observed thus far in the INSPIRE study has exceeded expectations,” CEO and Chairman Mark Perrin said. “We look forward to following this patient’s progress, and we’re hopeful that we will continue to observe positive INSPIRE results as we work towards completing enrollment.”

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the timing of additional enrollments, and the expectation for application for an HDE. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170124005502/en/

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Stryker reports 2016 results and 2017 outlook

Posted On January 25, 2017 By OrthoSpineNews In Financial /  

GlobeNewswire•

Kalamazoo, Michigan – January 24, 2017 – Stryker Corporation (SYK) reported 2016 operating results for the fourth quarter and full year and 2017 outlook:

Fourth Quarter Highlights
Net sales grew 16.2% to $3.2 billion (16.8% constant currency)

Orthopaedics 5.3 % or 5.7% constant currency
MedSurg 31.1 % or 32.1% constant currency
Neurotechnology and Spine 8.7 % or 8.6% constant currency

Reported net earnings per diluted share decreased 2.9% to $1.34
Adjusted net earnings per diluted share(1) increased 14.1% to $1.78

Full Year Highlights
Net sales grew 13.9% to $11.3 billion (14.3% constant currency)

Orthopaedics 4.7 % or 5.1% constant currency
MedSurg 25.6 % or 26.3% constant currency
Neurotechnology and Spine 9.9 % or 9.8% constant currency

Reported net earnings per diluted share increased 15.1% to $4.35
Adjusted net earnings per diluted share(1) increased 13.3% to $5.80

“I am pleased with our performance in both the fourth quarter and the full year 2016,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “Fourth quarter organic sales growth of 6.7% versus a strong prior year is impressive and was balanced across Orthopaedics, MedSurg and Neurotechnology and Spine. In addition, we executed well on acquisitions and delivered leveraged adjusted earnings gains. We enter 2017 with good momentum across our businesses and look forward to building on this success.”

Sales Analysis

Consolidated net sales of $3.2 billion and $11.3 billion increased 16.2% and 13.9% as reported in the quarter and full year and 16.8% and 14.3% in constant currency, as foreign currency exchange rates negatively impacted net sales by 0.6% and 0.4%. Excluding the 10.1% and 7.9% impact of acquisitions, net sales increased 6.7% and 6.4% in constant currency, including 8.2% and 7.8% from increased unit volumes partially offset by 1.5% and 1.4% in lower prices. The acquisitions of Sage Products LLC and Physio-Control International, Inc., contributed $258 million and $740 million to our consolidated net sales in the quarter and full year.

Orthopaedics net sales of $1.2 billion and $4.4 billion increased 5.3% and 4.7% as reported in the quarter and full year and 5.7% and 5.1% in constant currency, as foreign currency exchange rates negatively impacted net sales by 0.4% in both periods. Excluding the 0.4% and 0.3% impact of acquisitions, net sales increased 5.3% and 4.8% in constant currency, including 7.8% and 6.9% from increased unit volumes partially offset by 2.5% and 2.1% in lower prices.

MedSurg net sales of $1.4 billion and $4.9 billion increased 31.1% and 25.6% as reported in the quarter and full year and 32.1% and 26.3% in constant currency in the quarter and full year, as foreign currency exchange rates negatively impacted net sales by 1.0% and 0.7%. Excluding the 23.8% and 19.1% impact of acquisitions, net sales increased 8.3% and 7.2% in constant currency, including 8.9% and 7.8% from increased unit volumes partially offset by 0.6% in lower prices in both periods.

Neurotechnology and Spine net sales of $526 million and $2.0 billion increased 8.7% and 9.9% as reported in the quarter and full year and 8.6% and 9.8% in constant currency, as foreign currency exchange rates positively impacted net sales by 0.1% in both periods.  Excluding the 1.9% and 1.4% impact of acquisitions, net sales increased 6.7% and 8.4% in constant currency, including 8.1% and 9.8% from increased unit volumes partially offset by 1.4% in lower prices in both periods.

Earnings Analysis

Reported net earnings decreased 2.3% in the quarter to $510 million and increased 14.5% to $1.6 billion in the full year. Reported net earnings per diluted share decreased 2.9% in the quarter to $1.34 and increased 15.1% to $4.35 in the full year. Reported net earnings includes charges for the amortization of purchased intangible assets, restructuring-related activities, Rejuvenate and ABG II recall, acquisition and integration related activities and certain tax matters. The effect of each of these matters on reported net earnings and net earnings per diluted share appears in the reconciliation of actual results to adjusted results. Excluding the impact of these charges increases gross profit margin in the quarter from 66.1% to 66.3% and for the full year from 66.2% to 66.6% and increases operating income margin in the quarter from 20.9% to 27.7% and for the full year from 19.1% to 25.5%.

Excluding the impact of the items described above, adjusted net earnings(2) of $675 million and $2.2 billion increased 14.2% and 12.6%, in the quarter and full year. Adjusted net earnings per diluted share(1) of $1.78 and $5.80 increased 14.1% and 13.3% in the quarter and full year.

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