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Namal Nawana appointed Chief Executive Officer of Smith & Nephew

Posted On April 4, 2018 By OrthoSpineNews In Recon, Top Stories /  

4 April 2018

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces the appointment of Namal Nawana as Chief Executive Officer. He will join the Company and be appointed to the Board as an Executive Director on 7 May 2018.

Most recently, Namal was Chief Executive Officer of medical diagnostics company Alere Inc, where he led the successful turnaround of this global business and oversaw its $5.3 billion acquisition by Abbott in 2017. He joined Alere as Chief Operating Officer in December 2012.

Prior to Alere, Namal spent more than 15 years at Johnson & Johnson, primarily in its Medical Devices & Diagnostics segment, in a number of progressively senior commercial leadership roles across markets including in the USA, Asia and Europe. In 2011 he became Worldwide President of DePuy Synthes Spine, where he oversaw a transformation programme including substantial margin improvement and the integration of Synthes following its acquisition in 2012.

Namal will succeed Olivier Bohuon, who will step down from the Board on 7 May. During his notice period, Olivier will be available in an advisory capacity to provide advice and assistance to Namal in his new role, to help ensure a smooth transition.

Roberto Quarta, Chairman of Smith & Nephew, commented:

“In Namal I am delighted that we have secured an exceptional new chief executive with a proven record within the medical device industry. He has the experience as a CEO of a major listed company in the healthcare sector, and has demonstrated that he can energise businesses to deliver better performance and greater value to shareholders. We are looking forward to him joining our Board and driving Smith & Nephew to the next level of success.”

“I would also like to thank Olivier for his service. In his seven years as chief executive, Smith & Nephew has undergone important and necessary change and he has significantly strengthened the foundations of our Company. This has delivered strong value to shareholders, almost doubling the share price and materially outperforming the FTSE100, whilst also increasing the dividend distribution by more than 100%. On behalf of the Board and all of Smith & Nephew I wish him a happy retirement and all the best for the future.”

Namal Nawana commented:

“I am passionate about the medical devices industry where I have worked all my life and it is an honour to become the new Chief Executive of Smith & Nephew, a company I greatly admire. I am most excited by its portfolio of innovation which I believe gives an excellent platform from which to drive the business forward into its next exciting chapter.”

Mr Nawana is an independent member of the Board of Hologic, Inc. No further disclosure obligations arise under paragraphs (1) to (6) of LR 9.6.13 R of the UK Listing Authority’s Listing Rules in respect of this appointment.

Remuneration

Mr Nawana will be paid in accordance with the Remuneration Policy approved by shareholders on 6 April 2017, as set out in the Annual Report:

  • He will be employed on our standard US executive contract.
  • He will receive a base salary of $1,540,000 per annum (£1,100,000 converted using average exchange rates for Q1 2018) and will be paid at that dollar amount going forward.
  • He will participate in the Annual Incentive Plan (cash and equity) and the Performance Share Plan. Awards for 2018 will be pro-rated to reflect time served during the year.
  • He will be eligible to join those US defined contribution pension plans available to our US executives: Executive Plus Plan, 401k and 401k plus savings. Collectively, the Company contributions to these plans total 21.47% of salary.
  • He will receive standard US Executive benefits, which are not materially different in nature or value relative to the incumbent CEO.
  • His notice period will be six months, with the Company required to provide 12 months.
  • Mr Nawana will receive no sign-on or buy-out award associated with joining the Company.

Up until his retirement from the Company on 6 November 2018, Mr Bohuon will be paid in accordance with the Company’s Remuneration Policy and the terms of his service agreement:

  • He will continue to receive his salary, benefits and a payment in lieu of pension during his notice period.
  • He will also participate in the 2018 Annual Incentive Plan for the period up until his retirement.  Any Annual Incentive Plan payment, which is dependent on performance, will be determined by the Remuneration Committee in February 2019.
  • In accordance with the Plan Rules, on his retirement from the Company all unvested Equity Incentive Awards will vest in their entirety.
  • Also in accordance with the Plan Rules, the outstanding Performance Share Plan awards granted will be pro-rated for service and will, subject to the performance conditions being satisfactorily met at the end of the three-year performance period, vest on the original vesting dates on the third anniversary of the respective dates of grant. He will be required to retain any vested shares, net of tax, in relation to the 2017 award for a further two-year period after the vesting date.  In light of his anticipated retirement, no Performance Share Plan award was made in 2018.

Enquiries

Investors  
Ingeborg Øie +44 (0) 20 7960 2285
Smith & Nephew
   
Media  
Charles Reynolds +44 (0) 20 7401 7646
Smith & Nephew  
Ben Atwell / Debbie Scott +44 (0) 20 3727 1000
FTI Consulting  

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

◊ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

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RTI Surgical Reaches Global Milestone of Providing 8 Million Biologic Implants with Zero Confirmed Incidence of Implant-Associated Infection

Posted On April 4, 2018 By OrthoSpineNews In Biologics /  

April 04, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global provider of surgical implants, celebrates a significant global milestone of providing more than 8 million biologic implants processed through RTI’s proprietary sterilization processes with zero confirmed incidence of implant-associated infection. In 2017 alone, RTI distributed more than 600,000 biologic implants—helping surgeons serve patients in nearly 50 countries.

RTI celebrates these milestones and marks its 20th anniversary of delivering trusted surgical implants during National Donate Life Month in April. RTI has a proud, 20-year history of “firsts” in biologic surgical implants. It is recognized for initiating and elevating standards for the tissue banking industry, including being the first to introduce tissue-specific validated sterilization processes — the BioCleanse® Tissue Sterilization Process, the Cancelle® SP DBM Sterilization Process and the Tutoplast® Tissue Sterilization Process. It was also the first to offer precision-shaped bone implants and assembled technologies. Our world-class facilities in the U.S. and Europe provide a combined 250,000+ square feet of manufacturing for these advanced technologies.

“For 20 years, RTI has led the way in tissue safety for biologic implants in our industry, always keeping the patient in mind,” said Camille Farhat, President and CEO, RTI Surgical. “Our commitment to tissue safety is evident by our redundant safeguards and proprietary, validated sterilization processes, allowing us to achieve more than 8 million biologic implants with zero confirmed incidence of implant-associated infection. We celebrate these milestones in honor of the healthcare professionals and patients we serve globally and with appreciation for the gifts of life that make such healing and restoration possible.”

RTI’s tissue-based implants are used in surgical procedures such as anterior cruciate ligament reconstruction, meniscus transplantation, fracture repair, rotator cuff repair, wound coverings, post-mastectomy breast reconstruction and abdominal wall repair for hernias.

“RTI Surgical continues to raise the bar as a trusted provider of patient-centered biologic solutions with a proven track record for advancing science, safety and innovation,” said Peter Indelicato, M.D., professor emeritus and physician with the University of Florida Department of Orthopaedics and Rehabilitation’s Sports Medicine, Orthopaedics and Sports Surgery division. Dr. Indelicato has been a consultant with RTI since its inception. “RTI was instrumental in developing groundbreaking sterilization technology with proven effectiveness and safety, such as BioCleanse, and continues to drive innovation today with its portfolio of biologic implants. As the former Head Team Physician for the University of Florida Gator football team, I often relied on RTI implants to help restore our athletes to health.”

Ryanne Wilkes is a labor and delivery nurse and one among the millions of patients whose lives have been restored by receiving an RTI biologic implant. “I do not think I could have made it as far in my nursing career with my hip in the awful shape it was in,” Ryanne said. “The gift of donated tissue and the biologic implant created from that gift changed my life and will also touch the lives of the many patients I care for throughout my career.”

RTI joins Donate Life America in celebrating National Donate Life Month and encouraging Americans to save and restore lives by registering as organ, eye and tissue donors at www.registerme.org.

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 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 Statements

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, gaining market share 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.

Contacts

RTI Surgical, Inc.
Media Contacts
Erin Morton, +1-352-519-8351
emorton@rtix.com
or
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
Investor Contact
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

 

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NN, Inc. Announces Definitive Agreement To Acquire Paragon Medical

Posted On April 4, 2018 By OrthoSpineNews In Financial /  

JOHNSON CITY, Tenn., April 3, 2018 /PRNewswire/ — NN, Inc., (NASDAQ: NNBR) a diversified industrial company, today announced that it has entered into a definitive agreement to acquire PMG Intermediate Holding Corporation, the parent company of Paragon Medical, Inc. for $375 million in cash.  Paragon Medical is a medical device manufacturer which focuses on the orthopedic, case and tray, implant and instrument markets. NN anticipates the transaction will close in the second quarter of 2018 and is subject to customary closing conditions and regulatory approval.  Additional information about the transaction can be found in the supplemental deck on NN’s website, www.nninc.com. SunTrust Robinson Humphrey is acting as the financial advisor to NN, and Bass, Berry & Sims PLC is serving as the legal advisor to NN.

Paragon Medical creates partnerships with its customers by providing premier engineering from inception of a project to its completion.  Paragon works with customers in the development of value engineered products that meet the demands of a changing global market.

Tobias Buck, President, CEO and Founder of Paragon Medical commented, “Combining our great franchise with NN under their Life Sciences division is an exciting opportunity for Paragon’s customers and associates.  NN’s focus on delivering engineered solutions that help their customers bring new products to market aligns perfectly with Paragon’s core mission and values.  The combined company creates a dynamic portfolio that meets our customers’ needs across a broad platform of end markets and product offerings.”

Richard Holder, President and CEO of NN commented, “I look forward to welcoming the Paragon team to the NN family.  The acquisition of Paragon Medical fits perfectly with our strategic plan and stated goal of expanding our life sciences portfolio.  Paragon strengthens our technical abilities, expands our product and finished device offerings, and adds key talent across our organization that will help us continue to drive growth in our end markets.”

NN, Inc., a diversified industrial company combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis.  NN has 44 facilities in North America, Western Europe, Eastern Europe, South America and China.

Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These, and similar statements, are forward-looking statements concerning matters that involve risks, uncertainties and other factors which may cause the actual performance of NN, Inc. and its subsidiaries to differ materially from those expressed or implied by this discussion. All forward-looking information is provided by the Company pursuant to the safe harbor established under the Private Securities Litigation Reform Act of 1995 and should be evaluated in the context of these factors. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “assumptions”, “target”, “guidance”, “outlook”, “plans”, “projection”, “may”, “will”, “would”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “potential” or “continue” (or the negative or other derivatives of each of these terms) or similar terminology. Factors which could materially affect actual results include, but are not limited to: general economic conditions and economic conditions in the industrial sector, inventory levels, regulatory compliance costs and the Company’s ability to manage these costs, start-up costs for new operations, debt reduction, competitive influences, risks that current customers will commence or increase captive production, risks of capacity underutilization, quality issues, availability and price of raw materials, currency and other risks associated with international trade, the Company’s dependence on certain major customers, and the successful implementation of the global growth plan including development of new products. Similarly, statements made herein and elsewhere regarding pending and completed transactions are also forward-looking statements, including statements relating to the future performance and prospects of an acquired business, the expected benefits of an acquisition on the Company’s future business and operations and the ability of the Company to successfully integrate recently acquired businesses or the possibility that the Company will be unable to execute on the intended redeployment of proceeds from a divestiture, whether due to a lack of favorable investment opportunities or otherwise.

For additional information concerning such risk factors and cautionary statements, please see the section titled “Risk Factors” in the Company’s periodic reports filed with the Securities and Exchange Commission, including, but not limited to, the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements make in this press release, whether as a result of new information, future events or otherwise.

SOURCE NN, Inc.

Related Links

http://www.nninc.com

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Paradigm Spine Announces Company Activities And Three Podium Presentations Highlighting coflex® Interlaminar Stabilization® At ISASS 2018

Posted On April 3, 2018 By OrthoSpineNews In Spine /  

NEW YORK, April 3, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced its Company activities and scientific podium presentations on coflex® Interlaminar Stabilization® at the upcoming 2018 International Society for the Advancement of Spine Surgery (ISASS), being held April 11-13 in Toronto, Canada. coflex® is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe spinal stenosis.

“Now backed by two sets of Level I Evidence, coflex is the leading lumbar device shown to significantly maintain foraminal height, increase walking distance, and lower risk of secondary intervention, while still allowing patients a natural range of movement,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. “These proven long-term and durable results indicate that surgeons can be more confident when backing up their decompressions for spinal stenosis patients and when additional stabilization is required. We are pleased to be demonstrating the unique capabilities of coflex during three podium presentations, an industry symposium and an interactive workshop at this year’s meeting.”

Paradigm Spine Company Activities:

  • Interactive Bioskills Experience: Demo Workshop for Posterior Lumbar Motion Preservation with coflex
    Date and Time:      Wednesday, April 11th, 6:00 – 8:30 p.m. EDT
    Location:                Hall G, Theater Red

    This interactive demo workshop will be “come and go” style, and provide a closer look at coflex surgical pearls. Those interested in attending can RSVP on www.paradigmspineresources.com, email rsvp@paradigmspine.com or sign up at Paradigm booth #300. Walk-ins are also welcome.

  • Lunch Symposium: Extending the Durability of Decompression with the Exclusive Posterior Lumbar Motion Preservation Solution: Level I Evidence from Two Prospective Randomized Controlled Studies
    Date and Time:      Thursday, April 12th, 12:00 – 1:30 p.m. EDT
    Location:                Room 801B

    Paradigm Spine will host a Lunch Symposium with a panel of speakers, featuring ESCADA author Dr. Joerg Frankeand U.S. IDE Investigator Dr. Hyun Bae, discussing the results of the ESCADA 2-year trial results (European Study of coflex And Decompression Alone), for which researchers concluded decompression with coflex extends the durability and sustainability of a decompression procedure. Those interested in attending can RSVP on www.paradigmspineresources.com, email rsvp@paradigmspine.com or sign up at Paradigm booth #300 as space will be limited.

Paradigm Spine Podium Presentations:

  • General Podium Presentation: Abstract 162 “5-year Follow-up of Interlaminar Stabilization Surgery in the ≤ 65 Year Old Patient: More Value, Less Cost”
    Speaker:                 A.T. Brecevich
    Date and Time:       Wednesday, April 11th, 11:38 – 11:41 a.m. EDT
    Location:                 Hall F
  • Lightning Podium Presentation: Abstract 527 “Medical Cost Savings for Lumbar Spinal Stenosis Treated with Decompression and Interlaminar Stabilization as an Alternative to Fusion”
    Speaker:                 S.R. Golish
    Date and Time:       Wednesday, April 11th, 5:32 – 5:33 p.m. EDT
    Location:                 Room 801B
  • Lightning Podium Presentation: Abstract 341 “Comparison of Decompression with Interlaminar Stabilization vs. Decompression with Fusion in Patients Requiring Surgical Treatment for Spinal Stenosis Grade I Spondylolisthesis at 5 Year Follow-Up”
    Speaker:                 C. Dowe
    Date and Time:       Wednesday, April 11th, 5:47 – 5:48 p.m. EDT
    Location:                 Room 802B

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company 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 is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

 

SOURCE Paradigm Spine, LLC

Related Links

http://www.paradigmspine.com

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Exactech Knee Research Honored with Orthopaedic Research Society’s Best Implant Poster Award

Posted On April 3, 2018 By OrthoSpineNews In Recon /  

April 03, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that its research, “Total Knee Arthroplasty Using a Contemporary Computer-Assisted Surgical System: A Review of Resection Alignment on 8,000 Clinical Cases,” received the Orthopedic Implant Section Best Poster Award at the 2018 Orthopaedic Research Society (ORS) Annual Meeting in New Orleans, La.

The study was based on a large collection of technical reports on all the total knee arthroplasty cases performed in the entire application history of ExactechGPS®, Exactech’s surgeon-controlled computer-assisted surgery for improved reproducibility and efficiency in total joint arthroplasty. The results demonstrated high accuracy and precision in resection alignment with the use of the system by users with varying levels of experience.

Two additional posters, featuring the Truliant® Knee System’s femoral and patellar designs, were recognized as poster finalists in the same category. According to Co-Author H. Morton Bertram III, MD, “Truliant’s new design has had a very positive impact. I find that I can improve coverage of the native bone with the more anatomic patella.”

“The recognition from ORS is an incredible achievement that shows our commitment to research and surgeon input to deliver a clinically engineered system that addresses surgeons’ needs for reproducibility in total knee arthroplasty,” said Vice President of Knee Marketing Joseph Pizzurro. “We are pleased to receive such a positive response to Truliant’s comprehensive platform, including its state-of-the-art ExactechGPS knee applications and anatomical implant design.”

In the shoulder and orthopedic implant categories, the Equinoxe® Shoulder System was also recognized as a finalist for two different posters. The research featured a comprehensive outcome study of nearly 1,600 patients, the analysis of which provided surgeons a new threshold to quantify outcomes after total shoulder arthroplasty; this work was also recently published in the Journal of Shoulder and Elbow Surgery.

Exactech was well represented at the meeting with a total of 23 scientific posters and presentations featuring its latest innovations for shoulder, knee, hip and biologics.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

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SpinalCyte Announces MRI Evidence of Disc Regeneration Following Phase 1/Phase 2 Clinical Trial of CybroCell™ Dermal Fibroblasts

Posted On April 3, 2018 By OrthoSpineNews In Biologics, Top Stories /  

April 03, 2018

HOUSTON–(BUSINESS WIRE)–MRI analysis of patients who received intradiscal injections of human dermal fibroblasts (HDFs) shows significant improvement in disc height after six months. This is the latest evidence from SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using HDFs. This suggests there is a quantifiable regenerative process stimulated by its new cell-based therapy, CybroCell, which is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.

The landmark Phase 1/Phase 2 clinical trial, which is still enrolling, includes 24 patients with chronic lower back pain caused by degenerative disc disease. The patients are randomly assigned to one of three groups and receive intradiscal injections from one to three discs. The first group receives placebo in the form of saline only; the second group receives 10 million HDFs and the third group receives 10 million HDFs in combination with platelet-rich plasma (PRP).

Preliminary six-month MRI data on 18 patients has been completed with an independent radiological expert providing MRI analysis. Patients who received CybroCell or CybroCell with PRP demonstrated superior outcomes versus the control group. Of patients treated with CybroCell, 83 percent demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients. More than half (52 percent) of CybroCell-treated discs showed either increased disc height or no change (a clinically relevant outcome) versus only 38 percent of control discs.

“We are encouraged by the superior radiographic analysis of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “We have demonstrated clinically relevant outcomes which include increased disc height for those patients who received treatment injections.”

This data suggests CybroCell possesses tangible benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical alteration in the degenerated disc.

Over 50 percent of patients treated with CybroCell in the trial reported significant therapeutic improvement. Preclinical animal studies demonstrated that intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine.

“MRI evidence of disc regeneration is the most important clinical validation to explain the reduction in pain of our study patients,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “This study provides real evidence of pain reduction and disc regeneration at only six months. The CybroCell product has the ability to change the quality of life for these chronically diseased patients and eliminate the need for opioid use in patients suffering from chronic back pain. CybroCell can address an urgent public need and impact the national opioid crisis in the U.S.”

SpinalCyte’s Phase 1/Phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts that would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

Photo available for download: https://www.dpkpr.com/files/701/

Photo credit: Dr. Torsten Wittmann/Science Photo Library/Getty Images

SpinalCyte Youtube Channel: https://www.youtube.com/channel/UC0MaC2QPyqAsFJ-JGoStSAA

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in biologics. Visit www.spinalcyte.com.

Contacts

SpinalCyte, LLC
Investor Contact:
281.461.6211
info@spinalcyte.com
or
Media Contact:
Dan Keeney, APR, 832.467.2904
dan@dpkpr.com

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Amedica Announces Patent Grant for Silicon Nitride and Other Ceramic Materials

Posted On April 3, 2018 By OrthoSpineNews In Regulatory /  

SALT LAKE CITY, March 30, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, is pleased to announce the issuance of a key material and process patent.  US patent 9,925,295 was issued to Amedica March 27, 2018, covering “Ceramic and/or glass materials and related methods.” The patent covers various methods for improving the antibacterial, osteoconductive, and osteoinductive characteristics of silicon nitride and other ceramic materials, particularly to make them more suitable for use in manufacturing a variety of biomedical implants. Amedica now has 59 US patents and 6 foreign patents.

“This patent reflects the scientific inquiry and accomplishments in which Amedica has invested heavily during the past few years. Other biomaterials usually require surface textural engineering to make them suitable for applications such as spinal fusion. Silicon nitride is unique in having a favorable nanostructure in the “as-fired” state already. Therefore, our focus has been to move beyond surface topography toward engineering the precise surface chemistry of silicon nitride through thermal, chemical, and/or mechanical treatments to achieve a broad-based material platform that has applications throughout the biomedical space. The innovative strength of this patent has attracted several potential developing partnerships with other companies, both in spine and outside. From an intellectual property standpoint, this patent alone contributes to the lasting and refreshed value in Amedica, specifically our scientific knowledge and our ability to modify and control the material toward specific, desired product applications.” said Dr. Sonny Bal, CEO and Chairman at Amedica.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, there can be no assurance that this patent will attract several potential developing partnerships with other companies, both in spine and outside.  Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC.  Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Amedica IR 
801-839-3502
IR@amedica.com
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NuVasive Portfolio Now Includes ALIF Retractor Platform For Lateral And Supine Approaches

Posted On April 2, 2018 By OrthoSpineNews In Spine /  

SAN DIEGO, April 2, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the launch of ALIF (Anterior Lumbar Interbody Fusion) Access, the Company’s first-ever MAS® (Maximum Access Surgery) ALIF retractor platform for both lateral and supine spine surgery approaches.

The retractor system’s features help retain the characteristics of a traditional ALIF while giving surgeons options for either a lateral or supine approach based on patient need.

For lateral entry, the Lateral ALIF Access System enables single-position surgery for multilevel cases when integrated with the NuVasive XLIF® procedure, increasing O.R. efficiency by reducing the number of times a patient has to be repositioned and expanding the benefits of lateral surgery to more spinal levels.

“Accessing L5/S1 laterally has historically had its shortcomings, specifically because the existing systems on the market were not designed from the ground up for these approaches,” said Dr. J. Alex Thomas MD. “Access systems used in the past were lacking in various clinically necessary areas. NuVasive has addressed these clinical concerns with their new ALIF Access platform, whether it is a traditional supine approach or as the surgeon moves towards single-position surgery, they’ve created a real game changer for ALIF approaches.”

For the exposure surgeon, the NuVasive ALIF Access platform supports the traditional supine ALIF approach with features to enhance imaging and direct visualization of the spine and goes a step further by offering new opportunities for access from the lateral decubitus position. The learning curve for accessing L5/S1 from the lateral position mimics that of a supine approach, minimizing adoption hurdles for access surgeons. NuVasive has streamlined access for both approaches by creating a flexible platform which fluently translates between the surgeon’s desired approach, based on patient anatomy and pathology.

“ALIF Access exemplifies our commitment to innovation and providing relevant solutions to meet the diverse and evolving needs of our surgeons,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “XLIF is the foundation on which NuVasive is built, and the Lateral ALIF Access System empowers the surgeon to take XLIF to another level by incorporating a single-position protocol for a better all-around surgeon and patient experience. NuVasive remains laser-focused on delivering game-changing, procedural solutions and systems to market with the tools and training required to create the best clinical outcomes for the patient.”

Regardless of the approach, either lateral or supine, ALIF Access is fully compatible with the NuVasive anterior implant portfolio and comprises a carbon fiber frame for strength and radiolucency as well as customizable retractor blade size and positioning for optimum flexibility.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, 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 over $1 billion in revenues, NuVasive has an approximate 2,400 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.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Zimmer Biomet Announces FDA Clearance of the Comprehensive® Augmented Baseplate for Shoulder Reconstruction

Posted On April 2, 2018 By OrthoSpineNews In Regulatory, Top Stories /  

WARSAW, Ind., April 2, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Comprehensive®Augmented Baseplate, which received FDA clearance on January 3, 2018. The case was performed by John W. Sperling, M.D., an orthopaedic surgeon at Mayo Clinic, who specializes in shoulder surgery. The Comprehensive Augmented Baseplate complements the Company’s Comprehensive® Reverse Shoulder System by offering an alternative to bone grafting and eccentric reaming for patients with glenoid defects undergoing shoulder reconstruction.

This newly cleared baseplate boasts a simplified circular design at three augment heights (3mm, 5mm and 7mm buildup), allowing for augment placement in any orientation to accommodate various unique bone anatomies. Its circular design also allows bone ingrowth into the rim of the baseplate for optimal fixation.

The Comprehensive Augmented Baseplate is a component of the Comprehensive Reverse Shoulder System, a next-generation reverse shoulder prosthesis engineered to offer high-quality intraoperative flexibility and clinically proven technologies. The system aims to minimize the potential challenges of removing well-fixed humeral stems by allowing conversion to a reverse shoulder using any of the existing Comprehensive stems. Additionally, the Comprehensive Augmented Baseplate leverages Mayo Clinic’s patented methodology for the optimization of shoulder arthroplasty components developed by Dr. Sperling at Mayo Clinic, Rochester, Minn., to provide relevant sizing for a conservative approach to bone removal in order to preserve bone stock if a future revision procedure is necessary.

“The new Augmented Baseplate rounds out Zimmer Biomet’s Comprehensive Shoulder portfolio and provides solutions that help surgeons with difficult glenoid deformity cases,” said Orsa Britton, Vice President and General Manager of Zimmer Biomet’s global Extremities business.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZBH-Corp

 

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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