SANTA CLARA, Calif., Aug. 27, 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 iFuse will be added to the List of Refundable Products and Services in France (Liste des Produits et Prestations Remboursables – LPPR), meaning that the French National Healthcare System will cover the iFuse Procedure^TM.  Reimbursement, which is exclusive to the iFuse Implant^TM, has been established following the favorable opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS), begins September 6, 2018 and is effective for an initial period of five years.

The CNEDIMTS concluded, in its opinion of December 5, 2017*, that the iFuse Procedure’s observed outcomes, including improvements in quality of life and work status, are sufficient to include iFuse on the list of Products and Services provided for in Article L.165-1 of the Social Security Code. The Commission recommends brand name registration for the iFuse Implant System with the following indications: second-line treatment of sacroiliac joint dysfunction caused by sacroiliac joint disruption or degenerative sacroiliitis in patients who fail to respond to conservative treatment. Before treatment with iFuse, a diagnosis of unilateral or bilateral SI joint dysfunction must have been confirmed with positive responses to at least three out of the five SI joint provocative maneuvers (iliac wing spacing test (distraction), iliac wings approximation test (compression), the vertical compression test of each SI joint (thigh thrust), the sacral test (Faber) and the shear test of the two supine SI joints (Gaenslen), and a positive response to palpation of the SI joint. Patients who meet the above criteria may experience relief from diagnostic injections with anesthetics and/or corticosteroid injections in the sacroiliac joint. If the clinical response to an anesthetic injection is significantly positive, the sacroiliac joint may be considered as the source of the pain, and treatment with iFuse is indicated absent any contraindications.

The commission recommends reserving the use of the iFuse Implant device to surgeons who are accustomed to using image-guided surgery and who have received specific training on the iFuse Procedure.

The iFuse Implant System® implant is included in the LPPR list under the code 3147413, the corresponding act is NEDB454 “Arthrodesis of the Sacro-iliac joint by transparietal way, with radiological guidance”.

*https://www.has-sante.fr/portail/upload/docs/application/pdf/2018-01/ifuse_5_decembre_2017_5386_avis.pdf

The iFuse Implant^TM, available in Europe since 2010, is the only SI joint fusion device believed 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 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 the iFuse Implant. (www.si-bone.com/results).

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 pain^1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁵ Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating. 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 Test⁶, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and is believed to be the last to have a proven surgical treatment.

About SI-BONE, Inc.

SI-BONE, Inc. (Santa Clara, California) is a leading medical device company that developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. In the United States, 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. 10217.082718

1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3. 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.
4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
6. 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

NEW YORK, Aug. 23, 2018 /PRNewswire/ — Centinel Spine, LLC announced today that it has completed initial cases with three different implant portfolios within their FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction.

FLX devices are 3D-printed, all-titanium implants which feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, as compared to solid titanium implants.  The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.  Centinel Spine received FDA-clearance for multiple cervical and lumbar interbody fusion device families in May of this year.

“FLX offers me another great material choice to add to my fusion armamentarium,” says Dr. Jason Garber, a Neurosurgeon with Las Vegas Neurosurgical Institute, implanting STALIF C FLX™ Cervical Integrated Interbody and STALIF M FLX™ Lumbar Integrated Interbody devices. “With STALIF® implants made from PEEK, titanium-surfaced PEEK, and now 3D-printed titanium, I have the unique opportunity to provide my patients with optimal care options for their individual and specific needs.”

STALIF FLX Integrated Interbody devices offer a unique advantage over other all-titanium implants—as they are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

Dr. Stelios Koutsoumbelis, Chief of Division of Orthopedic Surgery at South Nassau Communities Hospital, performing the first ACTILIF C FLX Cervical Interbody implantation comments, “The FLX implant offers an open bone graft window optimizing graft volume and allowing bone growth throughout the trabecular matrix structure.  The open configuration also allows for CT visualization post-operatively to assess fusion.”

“The initial implantations of these FLX products represent a significant milestone in the evolution of our interbody technologies and advanced material platforms.  Our FLX products merge the proven benefits of the STALIF design with a truly novel, all-titanium lattice technology.  This provides surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology,” says Centinel Spine Chairman & CEO, John Viscogliosi.

Centinel Spine—the pioneer of the No-Profile®, Integrated Interbody—has a 30-year global clinical history of success behind these devices for the treatment of degenerative disc disease.  The FDA clearance of the FLX platform is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.

About Centinel Spine, LLC.

Centinel Spine, LLC is a privately-held spinal device company leading the development and commercialization of the No-Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc® Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the company’s website 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 reconstruction 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, LLC

(PRNewsfoto/Centinel Spine, LLC)

Related Links

http://www.CentinelSpine.com

SALT LAKE CITY, Aug. 21, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, is pleased to announce the successful completion of the first spine fusion surgery using the Valeo C+CSC with Lumen Interbody Fusion Device.

The first surgery was performed by Dr. Tarek Elalayli of Nashville, TN. “The implant, consisting of a novel combination of solid and porous silicon nitride, is well-designed, and the surgical implantation was straight forward. The benefits of this new device include the potential for bone in-growth as well as on-growth, while a central lumen gives the surgeon flexibility to add bone graft, if needed. The device and underlying technology are a step toward spine fusion without the need for bone graft additives; with the advantages of good radiographic visualization, and inherent antibacterial properties of silicon nitride. No other spinal fusion implant combines all these properties.” said Dr. Elalayli.

The Valeo C+CsC with Lumen is Amedica’s newest spinal implant that received FDA clearance earlier this year. The device is a composite silicon nitride implant that combines different densities of Amedica’s proprietary medical grade silicon nitride ceramic. A solid, outer shell of nanostructured silicon nitride is manufactured around an inner porous layer, called CsC (“cancellous structured ceramic). CsC is approved for clinical use in Europe, and published clinical data from the CASCADE clinical trial have shown that it achieves spinal fusion without added bone grafts or fillers, at rates similar to those achieved by bone autograft.

“Several of our published reports have challenged the existing dogma that the surface texture of a biomaterial alone affects bone healing. Instead, we have shown that surface microchemistry also plays a critically important role in promoting bone healing. In the case of silicon nitride, we can precisely engineer both the surface nanostructure, as well as the surface microchemistry of an implant in order to stimulate bone-forming cells, speed up bone fusion, and discourage bacterial adhesion. The Valeo C+CsC with Lumen device captures these advantages by manufacturing different material densities into one smart, bioactive implant that is already optimized for spinal fusion. In contrast, competing implants made of inert metal and plastic usually require enhancement with cost-added bone fillers, surface texturing, or related gimmicks” said Dr. Sonny Bal, Chairman of Amedica. “Unlike any other biomaterial available for spinal fusion today, silicon nitride is in a class by itself,” added Dr. Bal.

The Valeo C+CsC with Lumen Interbody Fusion Device is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. Additional information about Amedica’s complete line of products can be found at www.amedica.com.

About Amedica Corporation

Amedica is focused on the development and application of medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and 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. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can 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. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR 
801-839-3502
IR@amedica.com

SAN DIEGO, Aug. 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