NuVasive Appoints Dale Wolf To Lead Ohio Manufacturing Facility

SAN DIEGOAug. 16, 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 appointment of Dale Wolf as vice president, Manufacturing, who will oversee the Company’s West Carrollton, Ohio manufacturing facility.

Mr. Wolf will fill a newly created role emphasizing the importance of the company’s goal to become a world-class manufacturer. He will manage the 180,000 square foot manufacturing operations, and focus on optimizing output, advancing the insourcing strategy and streamlining processes, reporting directly to Steve Rozow, executive vice president, Global Process Transformation. With accelerated improvements over the second half of 2018, the manufacturing facility is expected to produce 70 percent of its spinal implant products by year-end. The NuVasive insourcing effort represents a tremendous opportunity to control costs and implant quality, along with overall positive margin expansion.

With nearly two decades at General Electric (GE), Mr. Wolf has extensive experience in medical device manufacturing operations. He has held various leadership roles managing GE Healthcare manufacturing facilities, streamlining new product introductions, implementing Lean Six Sigma processes, supporting high-performance work teams and operating with the philosophy of continuous improvement. Most recently, Mr. Wolf led GE Healthcare’s Florence, South Carolina plant producing magnetic resonance imaging (MRI) components for the past four years. There, he led a site of more than 400 employees, and directed all supply-chain operations supporting $1 billion in revenue and $60 million in inventory.

“Dale brings a dynamic pedigree of experience in medical device manufacturing to NuVasive that will be instrumental in scaling our insourcing output,” said Steve Rozow. “His knowledge and expertise of managing complex operations will be integral in driving growth for our business as our manufacturing efforts continue to expand. Dale is a proven leader who will be a great addition to the robust manufacturing talent we are cultivating at NuVasive.”

Mr. Wolf earned a bachelor of science in Mechanical Engineering from the University of Wisconsin-Madison, and holds a Six Sigma Green Belt certification.

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

HSS Ranked No. 1 in Orthopedics by U.S. News & World Report for Ninth Consecutive Year

NEW YORKAug. 14, 2018 /PRNewswire/ — For the ninth consecutive year, Hospital for Special Surgery (HSS) has been ranked the No. 1 hospital in the nation for orthopedics by U.S.News & World Report “Best Hospitals 2018-2019” survey. HSS was also recognized as a leader in the field of rheumatology, maintaining the No. 3 ranking in the country. This is the 27th consecutive year HSS has been among the top rated hospitals.

“We are fully committed to our singular focus on musculoskeletal health which allows us to not only provide the highest quality of care and value but also to be a leader in the field through innovation,” said Louis A. Shapiro, president and CEO of HSS. “We are invested in helping people move better so they can live better.”

For the 2018-19 rankings, U.S. News evaluated more than 4,500 medical centers nationwide in 25 specialties, procedures and conditions. In the 16 specialty areas, 158 hospitals were ranked in at least one specialty.

“Whether it’s a routine or complex case, our patients benefit from highly specialized physicians with the shared goal of delivering an unmatched level of personalized care to each patient,” said Todd J. Albert, MD, surgeon-in-chief and medical director of HSS. “It is truly an honor to be a part of such a dedicated, patient-centric medical staff.”

In 2017, HSS cared for over 135,000 pediatric and adult patients surgically and non-surgically for conditions including joint pain, trauma and sports injuries, osteoarthritis, rheumatoid arthritis, back pain and spinal disorders, and conditions of the hand and upper extremity, and foot and ankle.

“Rheumatic and autoimmune diseases often present as diagnostic puzzles, and medical management can be challenging,” said Mary K. Crow, MD, physician-in-chief and chief of the Division of Rheumatology. “The chronic nature of these disorders requires sustained attention and a personal approach to care. I am regularly impressed at the level of specialized expertise that our outstanding rheumatologists provide for these complex patients and the coordinated teamwork and commitment of our HSS staff that optimizes patient outcomes and quality of life.”

HSS also provides care to elite, professional and collegiate athletes and organizations around the world, including USABasketball, Fédération Internationale de Football Association (FIFA), UFC, the Brooklyn Nets, New York Giants, New York Knicks, New York Mets and New York Red Bulls, among others.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Centinel Spine Announces that UnitedHealthcare Will Now Cover prodisc L Anterior Lumbar Total Disc Replacement

NEW YORKAug. 7, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that UnitedHealthcare®, the nation’s second largest commercial insurer, has issued a positive medical policy for Lumbar Total Disc Replacement (TDR).  This decision affects over 16 million patients covered through UnitedHealthcare, and means that three out of the four largest US commercial providers now have positive policies for the company’s prodisc® L Anterior Lumbar Total Disc Replacement system.

This is the second major policy change for Lumbar TDR since May 2018, and follows the recent TRICARE® policy change that added 9.5 million covered lives.  These combined decisions provide over 25 million additional patients with access to this life-changing technology.  This trend of positive coverage decisions is bolstered by the long-term clinical outcomes and economic value that TDR provides to both patients and the healthcare system.

prodisc is the most studied Total Disc Replacement technology in the world, with over 400 publications demonstrating its long-term effectiveness in over 125,000 patients.  This recent decision by UnitedHealthcare is the culmination of over 30 years of clinical evidence generated by Centinel Spine and its originators, multiple FDA studies, and long-term clinical success supporting the effectiveness of the prodisc technology. This recent coverage change further solidifies Centinel Spine as the worldwide leading company addressing spinal disease through anterior access to the spine.

“The impending positive coverage decision by UnitedHealthcare will soon allow millions of Americans access to lumbar disc replacement, a technology that has proven itself over the past 30+ years globally. High-level scientific evidence from FDA studies in the US have clearly shown the safety, effectiveness, decreased adjacent level degeneration, and durability of improvement when properly-selected patients are implanted with a lumbar disc replacement instead of having a fusion, ” stated spine surgeon Jack Zigler, M.D., Texas Back Institute, Plano, TX.

“We believe the recent TRICARE and UnitedHealthcare policy decisions further validate the clinical outcomes of lumbar total disc replacement.  These positive decisions provide millions of additional patients with access to a proven, life-changing technology.  Centinel Spine remains focused on providing surgeons and patients with the widest breadth of technology platforms to address spinal disease by an anterior approach.  To that end, we plan to continue to invest in motion-preserving solutions and expand the clinical body of evidence and global adoption of lumbar disc replacement,” stated John Viscogliosi, CEO of Centinel Spine.

About Centinel Spine

Centinel Spine, LLC is the largest privately-held spine company, focused on anterior column reconstruction. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies, and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi

SVP, Corporate Finance & Strategic Planning

Centinel Spine, LLC

900 Airport Road, Suite 3B

West Chester, PA 19380

Phone: 484-887-8871

Email: v.gandhi@centinelspine.com

Wendy F. DiCicco

Chief Operating and Chief Financial Officer

Centinel Spine, LLC

900 Airport Road, Suite 3B

West Chester, PA 19380

Phone: 484-887-8837

Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine / (PRNewsfoto/Centinel Spine)

Related Links

http://www.centinelspine.com

SI-BONE, Inc. Announces 23 Commercial Health Insurance Plans Now “Exclusively” Cover Triangular iFuse Implant System®

SAN JOSE, Calif.Aug. 7, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced that 23 commercial health plans have published exclusive positive coverage policies for the triangular iFuse Implant System.  These exclusive positive coverage policies provide access to MIS SI joint fusion using the iFuse Implant System for over 35 million health plan members in the following plans:

1.    BCBS Florida

13.  BCBS-Louisiana

2.    BCBS-Illinois (HCSC)

14.  BCBS-Massachusetts

3.    BCBS-New Mexico (HCSC)

15.  BCBS-Minnesota

4.    BCBS-Oklahoma (HCSC)

16.  BCBS-Mississippi

5.    BCBS-Texas (HCSC)

17.  BCBS-New Jersey (Horizon)

6.    BCBS-Montana (HCSC)

18.  BCBS-NY (HealthNow)

7.    BCBS-Idaho

19.  BCBS-Tennessee

8.    BCBS-Kansas City

20.  BCBS-Wyoming

9.    BCBS-Independence

21.  BCBS-Capital

10.  BCBS-Regence

22.  Select Health

11.  BCBS-South Carolina

23.  AmeriHealth

12.  BCBS-Kansas

In addition to the above exclusive iFuse coverage policies, in July, eviCore healthcare, which according to their web site manages over 100 million lives, published a positive recommendation for exclusive use of the triangular iFuse ImplantTM  that takes effect October 22, 2018.  Also, on January 1, 2018, Blue Cross Blue Shield Association (BCBSA), a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico, published their “triangular only” recommendation for MIS SI joint fusion.  And on May 16th, AIM Specialty Health, which is owned by Anthem, published their exclusive iFuse policy that became effective July 1, 2018.

“Payers continually tell us that long-term outcomes data from well-designed, well-executed randomized controlled trials are critically important when determining coverage for new procedures or technologies,” said Jeffrey Dunn, President, CEO and Chairman of SI-BONE.  “The threshold for positive coverage includes a reliable diagnostic algorithm combined with a broadly adoptable treatment that is safe and clinically effective with a low revision rate and is cost-effective.  The iFuse Implant, that’s been available in the U.S. since 2009,  has been the subject of 58 peer-reviewed publications demonstrating safety, effectiveness, biomechanical and economic benefits, including 2 randomized studies.1,2  Based on this extensive body of published evidence, many payers have concluded that the iFuse Implant is the only SI joint fusion device that meets the evidence threshold and have established exclusive coverage.  We remain committed to continued investments in education and clinical evidence development in order to further expand access to all those who can benefit from surgical treatment of SI joint disorders.”

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain3-6, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.7  SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test8, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by image-guided diagnostic injections to confirm the diagnosis.  The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment.

About iFuse

The iFuse Implant™, available since 2009, is the only SI joint fusion device known to be supported by multiple prospective clinical studies, including two randomized controlled trials, showing that the device improves pain, patient function and quality of life.  The extensive body of peer-reviewed published clinical evidence, unique to the iFuse Implant, has enabled government and private payors to establish positive coverage exclusive to the iFuse triangular implant.  There are over 55 peer-reviewed publications supporting the safety, effectiveness, biomechanical and economic benefits of this iFuse Implant. (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10218.080718

  1. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028
  2. Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, Van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017;20:537-550.
  3. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  4. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  5. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  6. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  7. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  8. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

RTI Surgical® and Aziyo® Biologics Announce Exclusive Agreement to Distribute ViBone® for Spine and Other Orthopedic Procedures

August 01, 2018

ALACHUA, Fla. & SILVER SPRING, Md.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, and Aziyo Biologics, Inc., a fully integrated regenerative medicine company, today announced the signing of an agreement under which Aziyo will provide ViBone to RTI Surgical for exclusive distribution in the U.S.

ViBone is a bone repair product designed to perform and handle more closely to autograft in a variety of orthopedic proceduresViBone is processed using a proprietary method optimized to protect and preserve the health of native bone cells to potentially enhance new bone formation.

“ViBone is a next generation bone graft product that meets the diverse needs of surgeons with high potential for improved outcomes for patients,” said Camille Farhat, President and CEO, RTI Surgical. “ViBone will join RTI’s existing biologic portfolio as another important option for surgeons.”

RTI’s company strategy centers on organic and acquisitive growth focused on differentiated products supported by clinical data. RTI’s commercial team will integrate ViBone into its sales and growth strategy in the U.S., effective immediately. Together, RTI and Aziyo will initiate new research on ViBone in the coming months to build on the characterization and other data currently available.

“We are excited to partner with RTI Surgical, a recognized leader in spine and tissue-based implants, to bring this innovative option to more surgeons, and to further investigate the value it provides to patients,” said Ron Lloyd, President and CEO, Aziyo Biologics. “This agreement provides a platform for RTI and Aziyo to mutually grow and expand in the spinal fusion and orthopedic markets in service to more patients.”

About ViBone

ViBone is a next generation viable bone matrix that was designed to perform and handle more like high quality autograft. Aziyo’s proprietary manufacturing process was designed to optimally protect the tissue environment with less disruption. ViBone is based on science that brings bone grafting closer to meeting the surgeon and patient’s needs and provides a better option for bone repair. To learn more about ViBone, visit www.Aziyo.com/ViBone/.

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 and trauma 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.

About Aziyo Biologics, Inc.

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the Company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular and other medical specialties. For more information, visit www.Aziyo.com.

Contacts

RTI Media Contact
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
RTI Investor Contact
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com
or
Aziyo Media Contact
Courtney Guyer, +1-510-730-7896
PR@aziyo.com

Conformis Announces the first 3D Total Hip Replacement Surgeries performed at JFK Medical Center in Florida

BILLERICA, Mass., Aug. 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers patient conforming joint replacement implants, today announced completion of the first two Conformis Hip System implants. The Conformis Hip System is the first ever 3D designed primary total hip replacement system. The first surgeries were performed by Gregory Martin, M.D., Joint Fellowship Trained Orthopedic Surgeon and founder of Personalized Orthopedics of the Palm Beaches, and took place at a leading HCA Facility, JFK Medical Center in Atlantis, Florida on July 31, 2018.

“Partnering with our expert surgeon design team and leveraging our extensive experience in automated 3D printing and additive manufacturing enabled us to bring a revolutionary new hip replacement system to market. Our 3D implant design process provides surgeons with interactive input and improves operational efficiencies compared to 2D templating. The design process produces specific individualized pre-navigated cutting guides and implants. A groundbreaking acetabular reaming system has also been developed,” said Mark Augusti, chief executive officer and president of Conformis. “With this launch, we expect to lead the way in innovative solutions for the $7B hip replacement market by providing surgeons with game-changing operative solutions to better serve them and their patients both in hospitals and ambulatory surgical settings.”

Similar to the design process for the Conformis Knee technologies, the Conformis Hip System uses proprietary advanced imaging and design software, to design, manufacture and deliver the suite of FDA-cleared patient conforming Knee and Hip replacement implants. After each patient’s CT scan is converted into a 3-dimensional computer model, the unique measurements of each patient’s anatomy are transformed into a comprehensive, individualized, pre-operative surgical plan that is delivered to the surgeon well in advance of the operation. Surgeons are able to collaborate with Conformis during the planning process in order to design the optimal Hip System for each patient based on surgeon preferences.

“The Conformis Hip System is designed to address many of the short comings of primary hip replacement today. For the first time, orthopedic surgeons have a fully-guided system designed to address the wide variations in anatomy presented across our cases,” said Dr. Martin M.D*, a member of the surgeon design team. “The Conformis system builds upon traditional methods for hip replacement surgery with proven materials and components which, today, are offered in only limited standard configurations. Due to the accuracy of the personalized pre-operative surgical plan, the 3D printed patient conforming cutting guides and hip implant components, my hope is that with the new Conformis Hip system, surgeons will be able to improve both patient outcomes and operational efficiencies.”

Each component of the Conformis Hip System is pre-navigated to fit the patient, with certain components designed specifically for that patient. The Conformis Hip System is delivered directly to the hospital or surgery center in a single patient-labeled kit, eliminating the need for excess inventory. Patient conforming, single-use, 3D printed cutting guides are also included, limiting the need for the vast amount of reusable instruments required for a standard off-the-shelf total hip replacement.

The first two Conformis Hip System surgeries were conducted as part of a limited launch. Timing for a complete commercial launch is expected to be announced in 2019.

The global hip joint reconstruction market is projected at over $7B, and about 400,000 total hip replacements are performed in the United States each year.

*Gregory Martin, MD is a consultant to Conformis, Inc.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems and a hip system that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses over 400 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints. In clinical studies, Conformis iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You should not place undue reliance on our forward-looking statements. Actual results could differ materially from the expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Media Contact:

Kelly Wakelee

kwakelee@berrypr.com

(212)-253-8241

Investor Contact:

Oksana Bradley

ir@conformis.com

(781) 374-5598

A photo accompanying this announcement is available at: http://www.globenewswire.com/NewsRoom/AttachmentNg/e52cfbc4-fc9b-4c4d-b337-1990354e34a7

The photo is also available via AP PhotoExpress.

Source: Conformis, Inc.

This article appears in: News Headlines

Referenced Stocks: CFMS

 

OrthoPediatrics Announces Expanded Indication for FIREFLY® Pedicle Screw Navigation Guides

WARSAW, Ind., July 31, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that FIREFLY® Pedicle Screw Navigation Guides (“FIREFLY”) received additional FDA 510(k) clearance for an expanded indication to include S2AI [screw] trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries, including scoliosis. When applied to the challenging S2AI trajectory, the precise and personalized mechanical guidance enabled by FIREFLY minimizes complexities associated with crossing the sacral-iliac joint while eliminating the need for excessive radiation/fluoroscopy.

OrthoPediatrics is the exclusive distributor of FIREFLY technology in children’s hospitals in the US. FIREFLY is FDA-cleared for use in adult and pediatric populations and is manufactured by Mighty Oak Medical.

The patient-specific, 3D printed FIREFLY Pedicle Screw Navigation Guides are a novel solution to complex and costly navigation systems. This patented navigation technology is designed to increase OR efficiency and eliminate the need for intraoperative radiation, making it the optimal choice in more complicated spinal construct cases, such as those involving the S2AI trajectory.

David Bailey, Executive Vice President of OrthoPediatrics, commented, “We are pleased our partners at Mighty Oak Medical have received additional FDA clearance for this enhancement of the FIREFLY technology. This signifies another pediatric patient segment that surgeons now can treat efficiently and effectively. Ensuring our customers and their patients have access to this novel technology is one more way we continue leading innovation in pediatric orthopedics.”

About Mighty Oak Medical
Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

The global bone grafts and substitutes market size is expected to reach USD 3.9 billion by 2025

LONDONJuly 31, 2018 /PRNewswire/ — Bone Grafts and Substitutes Market Size, Share & Trends Analysis Report By Material Type (Natural, Synthetic), By Application Type (Spinal Fusion, Craniomaxillofacial, Long Bone), By Region, And Segment Forecasts, 2018 – 2025.

Download the full report: https://www.reportbuyer.com/product/5479697 

The global bone grafts and substitutes market size is expected to reach USD 3.9 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to register a healthy CAGR of 5.5% during the forecast period. Demand for bone grafts and substitutes is increasing due to adoption of newer technologies and increasing demand for minimally invasive procedures.

Availability of advanced products in varied shapes and sizes providing high osteoconductive and osteoinductive properties is supporting market growth.Moreover, growing adoption of minimally invasive procedures is spurring demand for bone grafts and substitutes.

In minimally invasive procedures, large incisions and damage to muscles surrounding repair area can be significantly avoided.These techniques also reduce the duration of hospital stay and support rapid wound healing with lesser pain and surgical wounds.

Minimally invasive total joint replacement and spine surgeries are some of the newly adopted procedures. Some of the companies in the bone grafts and substitutes market are DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.

Further key findings from the study suggest:

• Increasing number of orthopedic surgeries and rising demand for minimally invasive surgeries are primary factors driving market growth

• By material type, allografts accounted for the largest market share within the natural segment in 2016, mainly due to properties such as immediate structural support and osteoconductivity. Moreover, allografts do not require another surgery to harvest the bone, which results in reduced surgery time and wound healing, thus, attributing toward segment growth

• North America is the leading regional market, followed by Europe. Rising awareness regarding commercially available products, higher healthcare expenditure, and availability of advanced healthcare infrastructure are prime factors responsible for the region’s expansion

• Key players in the market include DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.


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CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA

HERZELIYA, IsraelJuly 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue, minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing.  Additionally, the CarboClear Pedicle Screw System offers enhanced follow up abilities due to minimal CT/MRI artifact.

Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, said of his clinical experience with the CarboClear® system: “This unique material provide us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients.”

About CarboFix Orthopedics LTD.

CarboFix Orthopedic Ltd, is recognized as the world’s leading company in developing, manufacturing and marketing innovative carbon fiber orthopedic solutions. CarboFix Orthopedics’ headquarters and manufacturing are located in Herzeliya, Israel, with additional manufacturing for the Asia market in Guangzhou, China. CarboFix is working in the United States through its subsidiary CarboFix Inc. and in the rest of the world through a network of distributors. The company’s products are approved by the FDA, CE and other regulatory bodies.

For more information, please visit www.Carbo-fix.com, or reach out directly to 

Ron Szekely

Int’l V.P., Sales & Marketing

Ron@carbo-fix.com

SOURCE CarboFix Orthopedics LTD.

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NuVasive Unveils Spine’s First Integrated Surgical Automation Platform

SAN DIEGOJuly 27, 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 Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s ecosystem enabling better surgery. Pulse introduces 2D- and 3D-navigation and smart imaging capabilities while integrating the Company’s leading neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. This single platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centers.

“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation in Palo Alto, Calif. “Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

Pulse’s FDA clearance marks a major milestone in the Company’s commitment to introduce 2D- and 3D-navigation technology built on a platform of the Company’s NVM5® nerve monitoring systemLessRay®Bendini® and Integrated Global Alignment® (iGA®) systems. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimized workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilize various modules in parallel and further drive OR efficiencies.

“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

To help surgeons overcome frequent visualization challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimized procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.

NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting held September 26-29, 2018 in Los Angeles, Calif.

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.

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