Alphatec Holdings Announces Board and Executive Leadership Changes

CARLSBAD, Calif., Dec. 12, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced that its Board of Directors has appointed Terry M. Rich as the Company’s Chief Executive Officer, effective December 10, 2016.  Mr. Rich, who has also been appointed to the Company’s Board of Directors, will replace Leslie H. Cross, who has served as interim Chief Executive Officer since September 2016. The Company also announced today that its Board of Directors has appointed Mortimer Berkowitz III, a current member of the Company’s Board of Directors, as Chairman of the Board effective December 10, 2016, replacing Mr. Cross, who will step down as Chairman, but will remain on the Company’s Board of Directors.  As a result of this transition, the Board will no longer have a Lead Independent Director.  Finally, the Company announced new members of its commercial leadership team and equity inducement awards being granted to three new key employees.

Terry M. Rich Named CEO
With over 25 years of orthopedic, spine and medical device business experience, Mr. Rich has a successful track record of leading global business units, driving sales execution and commercial turn-arounds.  In addition, Mr. Rich has demonstrated experience managing both direct and distributor sales channels.  Most recently he served as President, Upper Extremities at Wright Medical Group N.V. (Nasdaq:WMGI), following Wright’s merger with Tornier, N.V. Prior to this, Mr. Rich served as the Senior Vice President, U.S. Commercial Operations, at Tornier and prior to Tornier, Mr. Rich held senior sales leadership positions in the spine industry at Nuvasive and DePuy Spine.

New Sales Leadership Appointed
In conjunction with Mr. Rich’s appointment, the Company also announced the following additions to the Company’s commercial leadership team:

  • Jon Allen has accepted a newly created position as the Company’s Executive Vice President, Commercial Operations.  In this role, Mr. Allen will be responsible for all aspects of sales, sales training, national accounts, healthcare economics and value creation.
  • Amy Ables, Ph.D., has accepted a newly created position as the Company’s Vice President, Corporate Education & Performance.  In this role, Dr. Ables will be responsible for all aspects of training and development for surgeons, sales representatives, distributors and employees.  Dr. Ables will also drive efforts for an integrated process to involve and align Alphatec’s teams to accomplish the Company’s strategic goals and objectives.

With these appointments, the Company is investing in strengthening its sales leadership in order to improve sales execution and drive future revenue growth.

Tim Berkowitz, Chairman of the Alphatec Board of Directors, said, “This leadership transition is the next step in connecting surgeons and patients in the U.S. with Alphatec’s new and robust spinal fusion products. We are excited to bring in Terry Rich as CEO to lead the next phase of the Company’s transformation and drive superior performance for Alphatec. Terry’s deep experience in the U.S. spine and orthopedics markets and his demonstrated history as an executive leader make him ideally suited for the CEO position.  We are equally excited about the additions of Jon and Amy to the commercial leadership team.  Together, Terry, Jon and Amy were senior executives at Tornier and were instrumental in repositioning Tornier’s U.S. commercial business and positioning the company for a successful merger with Wright Medical in 2015.  Their combined experience and exceptional leadership will be invaluable as we move to unlock the potential of our product portfolio across the U.S. spine market.”

Mr. Berkowitz added, “The Board offers our sincerest thanks to Les Cross for his dedication and contributions to Alphatec as Chairman of the Board for the last five-plus years.  We appreciate his guidance and leadership and we are very pleased that he will continue to serve on the Company’s Board.”

Mr. Rich said, “I am thrilled with the opportunity to lead Alphatec through this pivotal point in the Company’s transformation and aggressively pursue the large U.S. market opportunity we have in front of us. With a new, robust portfolio of spinal fusion products, an improved capital structure and a strengthened senior leadership team, we are well positioned to drive towards future profitability and growth. I look forward to engaging with the talented Alphatec employees, our surgeon customers, our distributors and sales agents, our suppliers and our shareholders as we embark on this new chapter.”

Terry M. Rich Background

With over 25 years of experience in the orthopedic and spine industry, Mr. Rich, 49, is an accomplished leader with a breadth of experience across a variety of commercial roles. Mr. Rich was most recently with Wright Medical Group and Tornier and held multiple roles with increasing responsibility since 2012 in the areas of U.S. sales, global product delivery, sales training, global marketing, commercial operations, research and development, healthcare economics, business strategy, finance and human resources.  Most recently, since 2015 he served as President, Upper Extremities of Wright Medical, where he was accountable for a ~$200M annual revenue business unit. Prior to Wright, he held senior executive leadership positions at Tornier.  Within the spine industry, Mr. Rich has held sales leadership roles at Nuvasive, where he was responsible for annual regional sales of ~$250M, and was a partner in a DePuy Spine distributor in northern California.  Mr. Rich received a B.A. in Labor Relations from Rutgers University.

New Commercial Leadership Background

Jon Allen has held numerous sales leadership and sales operations positions in spine and orthopedics over his 27-year career in medical devices, including most recently Vice President, Healthcare Economics and Reimbursement, at Wright Medical where he had oversight responsibilities for corporate accounts, product positioning, and value creation.  Prior to joining Wright Medical, Mr. Allen held senior executive leadership positions with Tornier starting as Vice President, Sales Operations, and serving on Tornier’s executive committee.  Additionally, Mr. Allen held senior leadership roles within the DePuy franchise where he was responsible for developing pricing and commercial strategy, sales channel management and subsequently owning a multi-state distributorship for DePuy Spine.  Mr. Allen has a long standing reputation being on the forefront of innovative and differentiated initiatives in the spine and orthopedics industries.  In addition, Mr. Allen has served as a consultant to leading orthopedic companies working with U.S. Senators and the Senate Finance Committee in addressing anti-conflict of interest legislation in healthcare.

Dr. Amy Ables most recently served as Vice President U.S. Training and Education at Wright Medical, a position she has held since 2014.  From 2007 to 2014, she served a variety of senior leadership roles at Tornier within medical education, clinical education, sales training and product management.  Prior to this, she served as Assistant Professor for the Department of Kinesiology at the University of Texas, Arlington.  Dr. Ables holds a Ph.D. in Biomechanics from Texas Woman’s University and has published several articles, books and presentations in the area of kinesiology, sports medicine and medical devices.

Inducement Awards Granted

As an inducement to entering into employment with the Company, and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on December 10, 2016, the Compensation Committee of the Board of Directors approved the following inducement awards:

  • Terry Rich – 200,000 restricted stock units (RSUs) and an option to purchase 200,000 shares of common stock; and
  • Jon Allen – 75,000 RSUs and an option to purchase 75,000 shares of common stock; and
  • Amy Ables – 25,000 RSUs and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”).  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the grant date, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant. The stock options will vest over four years, with 25% of the options vesting on the anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to the Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective December 10, 2016, to accommodate the foregoing awards.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.
Additional information can be found at www.alphatecspine.com.

Forward Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include references to the Company’s: product development pipeline and product portfolio; ability to transform its operations and achieve superior performance; ability to maintain and take advantage of an improved capital structure; ability of the senior leadership team to successfully implement the Company’s strategy; and ability to accelerate its revenue growth or grow its revenues at all.   Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:
Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Axiomed is Raising Interest from Silicon Valley

Aditya Humad, Acting CFO of AxioMed and Managing Partner of KICVentures, is pleased to announce that in addition to Australia, Europe, and the United States, Axiomed is now gaining interest from Silicon Valley. “It was satisfying to complete the due diligence required to assure interest in this technology.”

Mr. Humad went on to say that, “We expect interest to continue to rise as AxioMed completes its cleanroom assembly to begin manufacturing the cervical and lumbar viscoelastic disc for international distribution to meet an anticipated high demand.” AxioMed completed its IDE in August 2016 and is preparing a submission to the FDA for the clearance of its viscoelastic lumbar disc.

Dr. Kingsley R. Chin, Acting CEO of AxioMed and Managing Partner at KICVentures has been spending more time in Silicon Valley and is quoted as saying, “I feel I share a lot in common with the entrepreneurs in Silicon Valley. I have a tremendous respect for their accomplishments in a broad range of technologies and I feel they have a lot of respect for my knowledge, track record, and experience in health technology. Experts in Silicon Valley have expressed the importance of the potential disruption the seems eminent within healthcare. Time and time again, I get the feedback that AxioMed’s viscoelastic technology seems intuitive over all other existing technologies for spine surgery. They also feel that the clinical and biomechanical results so far are very convincing. I expect interest to build as we demonstrate continued progress.”

About AxioMed
Founded in 2001, AxioMed (http://www.axiomed.com/) began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.

William Rhoda Joins SeaSpine as General Manager of Process Innovation and Development

CARLSBAD, Calif., Dec. 08, 2016 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that William Rhoda has joined the Company as General Manager of Process Innovation and Development.

In this newly created position, Mr. Rhoda will establish and lead a small, focused office in eastern Pennsylvania that will provide additional product development and process improvement resources and bring even more focus to surgeon and patient needs.  This office will also serve as a local training and education site for surgeons and distributors in the Eastern United States. Mr. Rhoda will report directly to Keith Valentine, President and Chief Executive Officer.

Mr. Rhoda has more than 20 years of experience in the spinal implant market. He started his career in orthopedics with Synthes Spine and later became a founding member of Globus Medical, where he served as the Vice President of Product Development.  While at Globus, he conceived and implemented a rapid product development process that dramatically shortened the time from concept to market introduction of new products.

“SeaSpine is a dynamic organization that has dramatically improved its product development process through both quality and output during the past year,” said Mr. Rhoda.  “I am excited to join the team and leverage my experience to further reduce the time to market as we continue to drive innovation and put SeaSpine firmly on the map of innovators in the spine market.”

“I am excited to welcome Bill to our leadership team and look forward to his contributions to drive faster innovation at SeaSpine,” said Keith Valentine.  “I am confident that he will be instrumental in adding energy and responsiveness to our engineering effort and keeping us laser-focused on the needs of the surgeon and our sales team.”

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: Mr. Rhoda’s ability to shorten time-to-market, drive faster innovation and position SeaSpine as an innovator in the spine market.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: Mr. Rhoda’s ability to transition in a timely manner, if at all, and to integrate into SeaSpine’s existing infrastructure, including his ability to collaborate successfully with SeaSpine’s existing product development team; Mr. Rhoda’s ability to conceive and implement a rapid product development process at SeaSpine and his ability to shorten the time from concept to market introduction of new products; surgeons’ willingness to adopt new products resulting from such process, including as a result of failure to demonstrate adequate safety or efficacy, whether as a result of rapid development or otherwise; unexpected expense associated with the new Pennsylvania office; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

Medicrea to Host Key Opinion Leader Breakfast in New York City for Investors Focused on Advances in the Personalized Spine Market

December 08, 2016

LYON, France & NEW YORK–(BUSINESS WIRE)–The MEDICREA Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it will host a Key Opinion Leader breakfast in New York City for investors focused on advances in the personalized spine market at 8:00 am Eastern Time on Thursday, December 15, 2016.

The meeting will feature keynote presentations by spine surgeon KOLs Nicholas Qandah, DO, from the Mohawk Valley Health System, and Themistocles Protopsaltis, MD, from NYU Langone Medical Center, Bellevue Hospital, who will provide an overview of the complex spine market and discuss current and novel approaches to treating complex spinal conditions.

Members of the Medicrea management team will provide an overview of the Company’s UNiD™ personalized spinal technology platform of analytical services and patient-specific implants for the complex spine market, which received the first ever FDA Clearance for a personalized spinal treatment modality.

Dr. Nicholas Qandah is a complex spine specialist and the Director of Neurosurgery at the Mohawk Valley Health System in New Hartford, NY. Dr. Qandah was previously the Director of the Complex Spine Program for Neurosurgery and an Assistant Professor of Neurosurgery for the Residency Program at Virginia Tech Carilion Clinic in Roanoke, VA. In addition to general neurosurgery, Dr. Qandah treats patients with back and neck pain, degenerative disc disease, spinal stenosis, and herniated discs. He has special interest and expertise in minimally invasive spine surgery, complex spine surgery, and surgery for scoliosis. Dr. Qandah is a Fellow of the American College of Osteopathic Surgeons and a member of the Association for Collaborative Spine Research. Dr. Qandah completed his Neurosurgical Residency training at the Virginia Tech Carilion Clinic and was subsequently awarded the AO Complex Spine Fellowship in Orthopedics and Neurosurgery at the prestigious Harborview Medical Center at the University of Washington in Seattle, WA.

Dr. Themistocles Protopsaltis is an orthopedic spine surgeon at NYU Langone Medical Center and the Hospital for Joint Diseases. He serves as Director of Adult Spinal Deformity Surgery and Director of the Orthopaedic Spine Service at Bellevue Hospital Center in New York, NY. He is also an Assistant Professor in the Department of Orthopedic Surgery at NYU School of Medicine. Dr. Protopsaltis is board certified in orthopedic surgery and is actively involved in many research areas. Some of his interests include cervical and thoracolumbar spinal deformity, cervical spondylotic myelopathy surgical outcomes, and proximal junctional kyphosis avoidance in adult scoliosis patients. He is a member of the International Spine Study Group, comprised of leading physicians from multiple academic centers studying cervical and thoracolumbar spinal deformity surgery. He is also a fellow of the American Academy of Orthopaedic Surgeons. Dr. Protopsaltis earned his medical degree at the Columbia University College of Physicians and Surgeons and completed his orthopedic surgery residency at New York Presbyterian Hospital. He has completed a spine surgery fellowship at NYU Langone Hospital for Joint Diseases.

The event is intended for investors, analysts, investment bankers, and business development professionals only. If you would like to attend in person, please contact Mac MacDonald at 212-915-2567 or via e-mail at Mac@LifeSciAdvisors.com to reserve a place.

A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20161215/reg.jsp and within the Investors section of the Company’s website at www.medicrea.com.

About MEDICREA (www.medicrea.com)

MEDICREA specializes in bringing pre-operative digital planning and pre and post-operative analytical services to the world of complex spine. Through the lens of predictive medicine, MEDICREA leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, MEDICREA is an SME with 150 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient- specific implants.

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

For further information, please visit: medicrea.com.

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

MEDICREA is listed on ALTERNEXT Paris ISIN: FR 0004178572 – Ticker: ALMED

Contacts

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

RTI Surgical® Fills the Void in Anterior Cervical Discectomy and Fusion (ACDF) Procedures

ALACHUA, Fla. (December 8, 2016) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced today that its C-Plus™ Peek* IBF System is now indicated for use with allograft, including its proprietary map3® cellular allogeneic bone graft.

“This indication is important news because it now gives surgeons options that they didn’t have before,” noted Brian Hutchison, RTI president and chief executive officer. “Previously, the C-Plus Peek IBF System was indicated for use with only autograft, but now surgeons have more options and can tailor treatment to each individual patient’s needs.”

The map3 cellular allogeneic bone graft supports the body’s innate healing mechanisms and provides the scaffold and signals to support bone growth. The implant contains the three essential elements of bone formation (cortical cancellous bone chips supply an osteoconductive scaffold, demineralized bone matrix demonstrates verified osteoinductive potential and MAPC®-class cells, a specific type of stem cell provide osteogenic and angiogenic signals to support the bone healing process). The C-Plus Peek IBF System is a PEEK interbody fusion system that offers multiple options and features designed to provide stability and anatomic restoration, facilitating fusion, when used with autogenous bone graft, and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft, in anterior cervical discectomy and fusion (ACDF) surgery.

“We are pleased to have received this indication for the C-Plus system, which expands our product portfolio that can be used with one of our key product innovations, map3 cellular allogeneic bone graft,” Hutchison said. “We can now offer surgeons an all-inclusive RTI portfolio with C-Plus implants, map3 allograft and the Aspect® Anterior Cervical Plate (ACP) System, proving once more our commitment to providing surgeons with integrated offerings to help their patients.”

*PEEK-OPTIMA® from Invibio® Biomaterial Solutions
® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Paradigm Spine, LLC Announces Publication Of ISASS Guidelines Recommending Coverage Of Interlaminar Stabilization®

NEW YORK, Dec. 6, 2016 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis (LSS) announces publication of the International Society for the Advancement of Spine Surgery (ISASS) Policy Statement on November 10, 2016 by Richard Guyer, M.D., et al of “ISASS Recommendations/Coverage Criteria for Decompression with Interlaminar Stabilization – Coverage Indications, Limitations, and/or Medical Necessity” in the International Journal of Spine Surgery, a high-quality peer-reviewed journal published on behalf of ISASS.  Please find a link to the article here:  http://dx.doi.org/10.14444/3041.

Per the Policy Statement, lumbar decompression with interlaminar stabilization is recommended for coverage in carefully selected LSS patients without gross instability or in which the decompression procedure itself may create iatrogenic instability. The Policy Statement accurately notes that “there exists a population of patients who present with moderate to severe stenosis, with concomitant back pain, where decompression alone does not adequately address back pain.”  Interlaminar stabilization after direct decompression is a non-fusion surgical option that can provide the additional stability over decompression alone without the rigidity of an instrumented fusion.  The Policy recognizes the benefits of coflex compared to fusion and further states, “In select patients within the LSS continuum, decompression with interlaminar stabilization has proven to provide equivalent outcomes with a reduced cost compared to decompression plus fusion.”

As the only spine product that has achieved FDA Premarket Approval (PMA) for up to a Grade I spondylolisthesis with a concomitant decompression, the coflex® Interlaminar Stabilization® non-fusion device maintains motion, reduces both leg and back pain, and preserves foraminal height.  Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, “We are excited to have the recognition and support of ISASS in this publication.  The policy statement supports our goals of improving patient access, building awareness among physicians, payors and policy makers, making coflex a compelling covered treatment option for patients with stenosis.”

Hallett Mathews, M.D., MBA, EVP & CMO of Paradigm Spine, LLC  commented “We are very happy that ISASS has issued these important guidelines and are confident that it will be immensely helpful to all physicians and patients. Surgeons, health insurers and policy makers rely on publications issued by societies for current information on leading industry developments, clinical advancements and for guidance in making choices on various treatment methods for their patients.  As the publication appropriately states, with the growing population in the US, there is a rising incidence of LSS and varying options of therapeutic pathways.  Therefore, it is becoming increasingly important for the new treatment alternatives available for LSS to be supported by strong clinical data from long term studies, as coflex has recently published its own five-year study results.  Over the last four years, more than 1,000 physicians in the US have treated nearly 20,000 patients and now with these published guidelines by ISASS and having its own new CPT code becoming effective January 1, 2017, using coflex for interlaminar stabilization after a decompression is quickly becoming the preferred choice of treatment by many physicians in both an in-patient and out-patient setting.”

About Paradigm Spine, LLC
Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company’s signature product is the coflex® Interlaminar Stabilization® device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

Implanet Presents JAZZ Band Clinical Results in Hypokyphotic Idiopathic Scoliosis Patients

December 06, 2016

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, announces the publication of a new White Paper entitled “Correction of Adolescent Idiopathic Scoliosis in hypokyphotic patients using JAZZ sublaminar bands: preliminary results of a multricentric study using 3D reconstruction”, which presents clinical results from a group of adolescents suffering from hypokyphotic thoracic scoliosis treated with JAZZ sublaminar implants.

This study, co-authored by the Departments of Pediatric Orthopedic Surgery at the Robert Debré (Paris), La Timone (Marseille) and Purpan (Toulouse) hospitals in France, represents a key stage in the JAZZ system’s clinical validation and confirms both safety and efficacy in the treatment of hypokyphotic idiopathic scoliosis. The study followed a 35 patient consecutive series for an average of 34-months.

“These results confirm the efficacy of combining the posteromedial translation technique with rigid chrome-cobalt rods, enabling sagittal alignment to be restored in hypokyphotic patients suffering from idiopathic scoliosis”, says Prof. Brice Ilharreborde, MD, PhD, adding: “The use of JAZZ sublaminar bands should be considered for these patients to reduce complication rates and, in particular, the risk of intra-operative failure of the concave screws as a result of pulling from the bone. Furthermore, the reduced number of implants used to adequately treat these deformities allows the cost of surgery and the risk of medullary complication to be reduced.”

Ludovic Lastennet, CEO of Implanet, adds: “The results of this major study confirm that the JAZZ implant offers surgeons a safe and efficient alternative to traditional techniques, with excellent clinical results documented an average of 34 months postoperatively, in patients suffering from complex hypokyphotic thoracic scoliosis.”

Although many surgeons still advocate using constructs consisting entirely of screws for this type of patient, the results of this study show that the JAZZ system should be a recommended front line treatment, in particular when treating hypokyphotic pathologies.

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 2015 sales of €6.7 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

Aurora Spine Launches Mobile App

CARLSBAD, CALIFORNIA–(Marketwired – Dec 5, 2016) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today the launch of its new Aurora Spine Mobile App, designed to bring information regarding the new and exciting products being offered by Aurora Spine straight to your mobile device. The App is currently available for Apple, Android, and iPad devices.

“We’re very excited to be entering into a new era for the company in how we get information to our customers. Anyone interested in our products or anyone interested in connecting with us through social media can now do so through our App,” said Nick Feretich, 3D Graphic Artist and Marketing Advisor for Aurora Spine.

“We really want to stress how important it is to us that we are able to educate those who work with, or distribute our products, and our new App is the perfect way to do that. Our entire product line, as well as accompanying surgical technique guides, is available in its entirety on your mobile device,” said Feretich.

The Aurora Spine mobile App currently offers detailed 3D models, surgical technique guides, and comprehensive sets of features regarding each individual implant. The user can also check up on Aurora through Facebook, Twitter, and YouTube. With this new App, Aurora Spine looks to continue its trend of bringing new and innovative products to the medical industry as well as educating those involved on all it has to offer.

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.

AxioMed Continues International Push with Visit to German Surgeons to Discuss Viscoelastic Total Disc Replacement Technology

(PRWEB) DECEMBER 05, 2016

 

In anticipation of AxioMed’s exclusive cleanroom manufacturing facility in Woburn, MA to soon resume cervical and lumbar disc production, company President, Jake Lubinski will be traveling to Germany on December 6th. Mr. Lubinski will meet with surgeons who are implanting the AxioMed disc in Cologne and Karlsruhe to discuss the benefits of a viscoelastic total disc replacement.

AxioMed received its CE mark in 2009 and is the only truly viscoelastic next-generation disc replacement to restore height, cushioning, stability, and lordosis.

Mr. Lubinski will be meeting with Dr Pflugmacher, who has implanted the AxioMed disc in several patients. Dr. Pflugmacher has commented on AxioMed’s disc, saying “This prosthesis is the best prosthesis, it is easy to use and I get excellent results, it’s a very straightforward disc.”

About AxioMed
Founded in 2001, AxioMed (http://www.axiomed.com/) began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology

FIREFLY Spinal Navigation Guides receive universal clearance from FDA

Mighty Oak Medical is a medical device incubator that continues to focus on novel surgical solutions to solve problems for patients and surgeons. Our goal is to make spinal surgery safer, faster, and more efficient, by offering more intuitive solutions to the existing challenges surgeons face every day. While navigation is gradually becoming a standard of care in spinal surgery, it remains very burdensome with its cost and complexity. Adoption has been slow. FIREFLY Navigational Guides represent a cutting edge alternative to the complex and costly existing forms of intraoperative navigation in spinal surgery. FIREFLY Technology is a patented platform joining pre-surgical planning with the accuracy and patient specificity of additive manufacturing to offer improved solutions for navigating spinal procedures. FIREFLY Guides are  3D printed, patient specific and anatomically matched drill guides created by our technicians to implant pedicle screws in the spine with far greater accuracy, speed, and safety than conventional forms of navigation.

Mighty Oak Medical announces that FIREFLY Guides have now been FDA cleared for universal use with any compatible pedicle screw system, and within their cleared indications.

This universal clearance allows FIREFLY to expand its growing alignment with many well known and successful pedicle screw systems currently available to surgeons worldwide.