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Meta-Analysis Reveals LIPUS as Alternative to Surgery for Established Nonunion Fractures

Posted On June 5, 2017 By OrthoSpineNews In Extremities /  

June 05, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Low-intensity pulsed ultrasound (LIPUS) treatment can be an effective alternative to surgery for nonunions, which are fractures that fail to heal. This according to a systematic review and meta-analysis of 13 published studies that describe nonunions treated with LIPUS. The findings were published in the May 15, 2017 issue of Injury available at http://www.injuryjournal.com/article/S0020-1383(17)30341-8/fulltext.

Nonunions occur in approximately 5% of patient fracture cases each year. Nonunions have little expectation of spontaneous healing and can be corrected with revision surgery, however such procedures typically pose technical challenges and an increased potential for complications. When surgery is optional and patients want to avoid its associated risks, choosing LIPUS has demonstrated a positive healing effect more than 80% of the time, which is comparable to the success rate for surgical treatment.

“This meta-analysis revealed that LIPUS is a viable alternative to surgery for established nonunions,” said Dr. R. Grant Steen, Manager of Medical Affairs, Bioventus. “The heal rate across all primary studies included was 82% and increased to 84% for nonunions that were eight months or older.”

The review and meta-analysis was funded by Bioventus and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were considered eligible for review if LIPUS was used as an alternative to surgery for non-healing fractures and if the treatment was applied at least three months after the last surgical procedure. In addition, at least one outcome of interest (heal/fail) was required and a clear definition of delayed or nonunion was included.

Authors of this study include Ross Leighton, MD, Dalhousie University; J. Tracy Watson, MD, Saint Louis University School of Medicine; Peter Giannoudis, MD, University of Leeds; Costas Papakostidis, MD, Chapel Allerton Hospital; Andrew Harrison, PhD, Bioventus and R. Grant Steen, PhD, Bioventus.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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Medtronic, GlaxoSmithKline team up in $40M equity deal for back-pain startup

Posted On June 5, 2017 By OrthoSpineNews In Financial, Neuro /  

By kgrayson@bizjournals.com – May 30, 2017

Medtronic has joined in a $40 million round of equity financing for Saluda Medical, a med-tech company with operations in the Twin Cities.

Saluda is developing an implantable medical device to treat chronic back pain and other conditions using electrical pulses. The Australia-based company expanded into the United States two years ago, starting a seven-employee clinical research team in Bloomington, Minn.

The company plans to expand its Twin Cities operation following the round of funding, Saluda Medical Senior Vice President Dan Brounstein said in an email. “It is the place to start a medical device company and we are dedicated to continued growth.”

Action Potential Venture Capital, a venture arm of GlaxoSmithKline, led the round of funding. Medtronic was a return investor.

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First Choice Announces Share Repurchase Plan

Posted On June 5, 2017 By OrthoSpineNews In Financial, Top Stories /  

MELBOURNE, FL–(Marketwired – Jun 2, 2017) – First Choice Healthcare Solutions, Inc. (OTCQB: FCHS) (“FCHS,” “First Choice” or the “Company”), one of the nation’s only non-physician-owned, publicly traded healthcare services companies focused on the delivery of total musculoskeletal solutions with an emphasis on Orthopaedics and spine care, today announced that its Board of Directors unanimously approved a program to repurchase up to one million shares of the company’s common stock.

The authorized repurchases will be made from time to time in either the open market, block transactions, or through privately negotiated transactions. The timing, volume and nature of share repurchases will be at the sole discretion of management, dependent on market conditions, applicable securities laws, and other factors, and may be suspended or discontinued at any time.

“The stock repurchase plan demonstrates our confidence in the strength of our business and commitment to delivering shareholder value,” said Chris Romandetti, President and CEO of First Choice. “We believe our valuation is attractive relative to industry peers and given the company has sufficient cash on hand to support our expansion plans, adding the flexibility to repurchase shares was prudent.”

No assurance can be given that any particular amount of common stock will be repurchased. This repurchase program has no expiration date and is subject to the company’s blackout periods. The program may be modified or terminated by the Board of Directors at any time. The Company will report the repurchases in its periodic reports filed with the U.S. Securities and Exchange Commission.

As of March 31, 2017, First Choice reported approximately $3.9 million in cash with an additional $1.4 million available on a credit facility. First Choice intends to use available cash and future cash flows from operations to fund the repurchase program.

About First Choice Healthcare Solutions, Inc.
Headquartered in Melbourne, Florida, First Choice Healthcare Solutions (FCHS) is implementing a defined growth strategy aimed at expanding its network of non-physician-owned medical centers of excellence, which concentrate on treating patients in the following specialties: Orthopaedics, Spine Surgery, Neurology, Interventional Pain Management and related diagnostic and ancillary services in key expansion markets throughout the Southeastern U.S. Serving Florida’s Space Coast, the Company’s flagship integrated platform currently administers over 100,000 patient visits each year and is comprised of First Choice Medical Group, The B.A.C.K. Center and Crane Creek Surgery Center. For more information, please visit www.myfchs.com, www.myfcmg.com, www.thebackcenter.net and www.cranecreeksurgerycenter.com.

Safe Harbor Statement
Certain information set forth in this news announcement may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of First Choice Healthcare Solutions, Inc. Such forward-looking statements are based on current expectations, estimates and projections about the Company’s industry, management beliefs and certain assumptions made by its management. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Information concerning factors that could cause the Company’s actual results to differ materially from those contained in these forward-looking statements can be found in the Company’s periodic reports on Form 10-K and Form 10-Q, and in its Current Reports on Form 8-K, filed with the Securities and Exchange Commission. Unless required by law, the Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise to reflect future events or circumstances or reflect the occurrence of unanticipated events.

CONTACT INFORMATION

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EOI Expands the FLXfit Family of 3D Cages, Launches the FLXfit15 With 15 Degrees of Lordosis Correction

Posted On June 5, 2017 By OrthoSpineNews In Regulatory, Spine /  

OR AKIVA, Israel, June 5, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced CE mark of the FLXfit™15, enhancing the already successful FLXfit™ 3D expandable cage. The FLXfit™15 expands up to 4mm and enables controlled lordosis correction of up to 15⁰. There are two linear length options; a 40mm and a 32mm version.

The higher range expansion will enable surgeons to better treat their patients and restore lordosis angle up to 15⁰. The 32mm length option will offer great flexibility in treating patients with smaller anatomies. The ability to deliver the largest, in-class, TLIF, expandable cage with 4mm height expansion and 15 degrees of lordosis correction through a small unilateral tube is a paradigm change in the MIS fusion market.

Ofer Bokobza, CEO of Expanding Orthopedics, commented “Expandable cages are gaining market momentum and play a key role in successful MIS fusion procedures. The FLXfit™ 3D expandable cage introduced a new paradigm with expandable cages and is already making a significant traction in the market place. We are thrilled with the release of the FLXfit™15 as it represents our continued commitment for innovation and ability to deliver state-of-the-art spine fusion solutions.” He concluded, “We believe that the versatility of the new FLXfit™ family will help EOI gain a greater share in the fusion surgery market both in MIS and open approaches.”

The FLXfit™15 is the subject of a pending 510k and is not available for sale in the US.

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.
Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-3219683

SOURCE Expanding Orthopedics Inc.

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Interspinous Spacer Market Driven by Increasing Prevalence of Spinal Stenosis Due to Aging, Arthritis, Heredity

Posted On June 5, 2017 By OrthoSpineNews In Spine, Top Stories /  

Albany, NY — (SBWIRE) — 06/05/2017 — Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability.

Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.

Obtain Report Details @ http://www.transparencymarketresearch.com/interspinous-spacer-market.html

The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.

The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions.

The Interspinous spacer market is segmented as device type, end user and geography. The product type segment is further divided in two type’s statics or compressible and dynamic or non-compressible respectively. The examples of static devices include X STOP, ExtenSure and Wallis implants. These are made up of non-compressible material such as bone, metal or synthetics. The devices produce constant amount of distraction between the spinous processes due to their non-compressible nature. Dynamic Interspinous spacer devices have a degree of compressibility.

 

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NuVasive Magnetic, Non-Invasive Platforms Featured In The Journal Of Orthopaedic Trauma Supplement

Posted On June 5, 2017 By OrthoSpineNews In Extremities /  

SAN DIEGO, June 5, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the PRECICE® system and PRECICE UNYTE™ platform from NuVasive Specialized Orthopedics (NSO) are featured in the June 2017 supplement of the Journal of Orthopaedic Trauma (JOT), which demonstrates a lower complication rate, greater patient comfort and faster healing in comparison to traditional treatments1.

NSO, a NuVasive division focused on the design and innovation of disruptive orthopedic solutions, developed a proprietary platform of magnetically adjustable implant systems that include:

  • The PRECICE system is an intramedullary device that once implanted utilizes an External Remote Controller (ERC) to non-invasively lengthen the femur and tibia. Through propriety magnetic technology, the PRECICE ERC lengthens the PRECICE device with precision rate control. Each patient’s lengthening is customized based on a physician directed program.
  • PRECICE UNYTE is an intramedullary solution for stabilizing and treating difficult to heal fractures and non-unions. It leverages clinically validated technology based on the proven principles of compression and distraction osteogenesis and uses the ERC magnetic technology to apply non-invasive customized treatment for proper bone healing and restoring natural bone length.

“Our groundbreaking, non-invasive technology platforms from NSO have disrupted the spine and orthopedic markets,” said Gregory T. Lucier, NuVasive chairman and chief executive officer. “The positive outcomes from our early clinical experience with PRECICE UNYTE demonstrate that we are able to treat complex fractures with our magnetic technology, which will help transform the lives of patients that previously lacked a formidable solution.”

PRECICE system and PRECICE UNYTE are featured in the June JOT Supplement, “Intramedullary Limb Lengthening and Compression for Orthopedic Trauma Surgeons“, with five articles authored by leading surgeons Robert Rozbruch, M.D., Mitchell Bernstein, M.D., Stuart Green, M.D., Austin Fragomen, M.D., and Tracy Watson, M.D.

“I’m honored to report on the success of PRECICE UNYTE intramedullary compression implant and share the positive results of our early clinical experience,” said Dr. Green, University of California, Irvine, Department of Orthopaedic Surgery. “The future of this technology is clearly evident in the JOT supplement, which highlights the key role engineering research plays in developing medical device innovation. Patients around the globe will greatly benefit from the new technology created by the collaboration effort of NSO and the surgeon community.”

PRECICE UNYTE WEBINAR

The Company is hosting a webinar on June 6, 2017 titled, “Treating Challenging Fractures and Nonunions,” featuring Austin Fragomen, M.D. from the Hospital for Special Surgery, New York. The webinar will look at traditional treatment options and highlight new technologies in intramedullary compression and distraction devices. Click here for more information and to register.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery and beyond with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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.

1 Fragomen, Austin T. J Orthop Trauma; Volume 31, Number 6 Supplement, June 2017; S7-S13

 

SOURCE NuVasive, Inc.

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Arthromeda Inc. Completes Successful Preclinical Studies and Closes Funding for Its ArthroSight Patient-Specific Navigation Platform

Posted On June 2, 2017 By OrthoSpineNews In Financial, Recon, Top Stories /  

LOWELL, Mass., June 1, 2017 /PRNewswire/ — Arthromeda, Inc., a developer of intelligent orthopedic navigation systems, closed its Series D financing to take the ArthroSight-PS Hip Alignment System (ArthroSight-PS) through commercial regulatory approvals and clinical validation.  This was achieved following a series of successful cadaver labs conducted by surgeon Daniel Ward, MD (New England Baptist Hospital, Boston, MA) at the Cincinnati Children’s Hospital and Medical Center translational research lab (Cincinnati, OH).  The cadaveric studies confirmed that the ArthroSight- PS is an intuitive All-in-One system for accurate and precise implant positioning, providing real-time position angles (inclination and anteversion), leg length and femoral offset difference measurements.  Videos from the labs can be found in Arthromeda’s newly released clinician and patient focused website www.arthromeda.com.

Accurate hip implant positioning is an extremely important factor for patients, physicians, regulators and device companies. In recent years, the number of hip surgeries has skyrocketed with increasing numbers of younger adults getting the procedure according to popular press reports.  Over the 10 years of the study, the number of procedures more than doubled, from 138,700 in 2000 to 310,800 in 2010. The number grew by 92 percent, to 80,000, among those aged 75 and older. It jumped by 205 percent in those aged 45 to 54, to 51,900. Due to the aging baby boomer population, the magnitude of the problem is projected to increase dramatically – doubling by 2030.

“Patient-specific solutions in surgery that are individualized to patients at an affordable cost are important. I am delighted to support Arthromeda in its game-changing mission to help patients undergoing hip arthroplasty experience superior outcomes,” commented Edgar D. Jannotta, Jr., Arthromeda Director and lead investor.

Elsa Chi Abruzzo, RAC, FRAPS, chief operating officer of Arthromeda, commented, “I am grateful to our founder and executive chairman, Mr. PJ Anand, for his clear strategic vision and leadership.  I also appreciate the technical insight of our cofounder and Chief Technical Officer, Mehran Aghazadeh, MD.  We are excited to execute on the next phase of development of this elegant solution for real-time, accurate, acetabular cup positioning and leg length and femoral offset adjustments, without the expensive capital investments or increased procedure time associated with robotic and imaged-based systems.”

Foley Hoag LLP, led by Life Sciences Practice chair Jeffrey Quillen and Patrick Connolly, represented Arthromeda in the financing.  Mr. Quillen & Connolly have represented Arthromeda since its founding in 2011.

About Arthromeda, Inc.

Founded in 2011, Arthromeda, Inc. is a private medical device company focused on developing intuitive, real-time, sensor based, intelligent technologies to improve surgical outcomes for patients undergoing joint replacement procedures.  As part of its extensive patent protected intellectual property portfolio, Arthromeda has created two distinct, yet complimentary, technology platforms to reduce operating room time, improve patient outcomes, and reduce the cost burden associated with early implant failure.   More information can be found at www.arthromeda.com

Contact:
Jennifer Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org

 

SOURCE Arthromeda, Inc.

Related Links

http://www.arthromeda.com/

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RTI Surgical® Partners in New Manufacturing USA Institute

Posted On June 2, 2017 By OrthoSpineNews In Biologics, Financial, Top Stories /  

June 02, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, is part of a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (ARMI). Headquartered in Manchester, New Hampshire, ARMI is the twelfth Manufacturing USA institute. It brings together a consortium of nearly 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.

Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.

Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading advanced manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue biofabrication technology in order to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.

“We need to develop twenty-first century tools for engineered tissue manufacturing that will allow these innovations to be widely available – similar to how a fifteenth century tool (the printing press) allowed knowledge to spread widely during the Renaissance,” said inventor Dean Kamen, ARMI’s chairman.

ARMI’s efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.

“RTI Surgical is pleased to participate in the ARMI consortium,” said Todd Goede, Global Vice President of Research and Development. “We look forward to providing the regenerative manufacturing resources and knowledge that we use every day to help patients – undoubtedly, the lives of many will benefit from the innovations this initiative will create.”

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.

About ARMI

The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.

Contacts

RTI Surgical
Roxane Wergin, Phone: 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

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NuVasive Appoints Skip Kiil As Executive Vice President, International

Posted On June 2, 2017 By OrthoSpineNews In Spine, Top Stories /  

SAN DIEGO, June 1, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Skip Kiil is joining the Company as executive vice president, International. In this role, Mr. Kiil will oversee the Company’s international operations, reporting to NuVasive’s chairman and chief executive officer, Gregory T. Lucier, and serving on the Company’s executive leadership team.

Mr. Kiil brings to NuVasive more than 15 years of experience as a global medical technologies and life sciences business leader. He joins NuVasive from Alcon, a division of Novartis Corporation, where he most recently served as surgical head, Europe, Middle East, Africa and Russia.

“I am excited to welcome Skip as a member of the NuVasive executive leadership team,” said Mr. Lucier. “Skip has led complex, global commercial enterprises in Europe, the Middle East, Africa, Japan, Asia Pacific and the United States within the healthcare and spine technology industries. He brings significant strategic and operational expertise in market entry and development and proficiency in maintaining P&L responsibility, both of which are key elements as we scale and expand our high-growth international channels. We are pleased to have a global leader of Skip’s caliber join NuVasive’s world-class leadership team at this time as we accelerate past $1 billion in revenue, enhance our international operations and continue to change patients’ lives around the world.”

Mr. Kiil’s career includes extensive corporate experience in global markets. Prior to joining Alcon, Mr. Kill spent more than 12 years with Stryker Corporation, most recently as vice president and general manager, Medical Surgical Group, based in London and Rome. In that capacity, he was responsible for commercial operations for six strategic business units, including Neuro Spine/ENT, Surgical Instruments, Endoscopy, Sports Medicine and General Surgery/Visualization. Previously, as a senior leader at Stryker, Mr. Kill was general manager, MedSurg Japan, based in Tokyo. Prior to that, he had increasing corporate development, sales and marketing roles for Stryker in the United States. Mr. Kiil received a Bachelor of Science in Kinesiology from California State University, Fullerton and a Masters of Business Administration from University of Michigan.

NuVasive is the third largest global spine technology company with significant momentum to drive global growth and expansion as the Company seeks to double its international market share in the coming years. NuVasive is targeting international revenue growth at 20 percent or higher annually and scaling international operations to support the Company’s profitability expansion goals. The Company’s share-taking strategy and innovative product introductions drove growth across all of its international geographies including Europe, the Middle East, Asia Pacific and Latin America in the first quarter of 2017, leading to a 34% year-over-year increase on a reported basis in international revenues, excluding the impact of currency.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. 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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Prosidyan Receives FDA Clearance of Its FIBERGRAFT BG Putty for Postero-Lateral Spinal Fusion

Posted On June 2, 2017 By OrthoSpineNews In Regulatory, Spine /  
Warren, NJ, June 01, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it has received FDA 510(k) clearance of FIBERGRAFT BG Putty – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Putty is the second generation product in the company’s FIBERGRAFT line of bioactive glass based products. FIBERGRAFT BG Putty leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary bioactive carrier, OSSIGLIDE.

FIBERGRAFT BG Putty – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Dr. Babak Barcohana MD of the Southern California Orthopedic Institute commented, “I have had outstanding clinical results with FIBERGRAFT BG Morsels over the last three years and look forward to continued clinical success with this next generation product from Prosidyan.”

Dr. Stephen Tolhurst MD of the Texas Back Institute commented, “FIBERGRAFT BG Putty is backed by great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”

Dr. Brian Kwon MD from New England Baptist Hospital called FIBERGRAFT BG Putty “The most intelligent bone graft on the market and your best bone graft decision in the OR.”

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 7,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.
Contact Information
Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com
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