Spine – Page 57 – Selby Spine

New Orleans, Louisiana – July 25, 2017 – LongueVue Capital (“LVC”) is pleased to announce it has partnered with management to acquire Zavation Medical Products (“Zavation” or the “Company”) and provide capital for growth. Zavation is a designer and manufacturer of high quality spinal implants, instruments, and biologics. Zavation expands LVC’s healthcare portfolio and is the second medical device business LVC has partnered within the past 18 months.

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, and minimally invasive surgery. Founded in 2010 with its first sale in 2012, Zavation has experienced exceptional growth and created a national network of 100+ distributors across approximately 35 states. The Company has commercialized over 10 product families since inception, with 10 additional novel products expected to launch over the next two years. Zavation operates a 24,000 square foot vertically integrated facility with approximately 50 employees.

“Zavation has demonstrated exceptional growth and is a perfect cornerstone to our expanding healthcare portfolio. This is our fourth healthcare platform investment and our third in the past 18 months,” said Ryan Nagim, Principal and deal lead at LVC. “Furthermore, we believe the Company is at an inflection point and has the opportunity to become a market leader in the spinal implant sector, as management has shown an incredible ability to execute. As such, we look forward to our partnership with Zavation’s management team and driving significant growth, both organically and through acquisitions of unique technologies.”

“Zavation fits well within LVC’s investment strategy,” added Rick Rees, Founder and Managing Partner of LVC. “We love partnering with entrepreneur owned businesses at inflection points that have proven management teams willing to invest meaningfully alongside LVC. The Company’s rapid growth is a testament to management’s ability to capitalize on compelling demographics and other industry tailwinds favoring smaller, more agile, and customer focused OEMs. Lastly, although we are geographically agnostic, it is always great to partner with entrepreneurs in our back yard, the Gulf South. As such, we are incredibly excited to partner with management and welcome Zavation into the LVC family.”

“The management team at Zavation chose LVC due to their entrepreneur-friendly investment approach to value creation and their knowledge and expertise in growing middle market companies at inflection points like ours. With a shared vision and culture, we are confident Zavation will remain focused on its core values of excellent customer service and quality products,” said Jeffrey Johnson, President and CEO of Zavation. “LVC’s financial and operational resources will allow us to introduce new products, meet and exceed distributor and surgeon expectations, expand our market presence, and take market share at an even faster and more deliberate speed. We are excited for our Company, our distributors, our surgeons, and our LVC partners.”

Robert W. Baird & Co.’s healthcare team, led by Robert Andrews and Manish Gupta, served as exclusive financial advisor to LVC on the transaction. Abacus Finance Group, LLC provided the senior debt financing to Zavation Medical Products in support of the transaction. LVC’s legal counsel was provided by McGuireWoods, LLP.

To learn more information about Zavation and its products, visit www.zavation.com

About LongueVue Capital:
LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented equity and debt investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions and growth. LVC currently has $425 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

For inquiries, please contact lvc@lvcpartners.com or call 504-293-3600.

ATLANTA, July 25, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCE™ Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine’s novel proprietary porous PEEK biomaterial and is the second porous PEEK device to receive FDA clearance behind Vertera Spine’s COHERE® Cervical Interbody Fusion Device. Vertera Spine will be launching COALESCE for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations later this year.

COALESCE combines the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. Unlike metal-coated PEEK implants that can delaminate, COALESCE’s porous PEEK architecture is grown directly out of the implant’s solid PEEK base and has an interfacial strength stronger than the shear strength of vertebral trabecular bone. Furthermore unlike 3D-printed metal implants, porous PEEK behaves mechanically similar to bone under compression, essentially eliminating any stress shielding effects, and does not produce any imaging artifacts enabling accurate visual assessment of fusion.

Vertera Spine’s porous PEEK was first clinically introduced in May 2016 with the launch of the COHERE device for anterior cervical discectomy and fusion (ACDF) procedures. To date, over 2,000 implants have been successfully implanted with early successful clinical outcomes already reported in a peer-reviewed publication.¹

“Based on the initial success with the COHERE Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications,” said Chris Lee, Vertera Spine CEO. “We are pleased to have received FDA clearance for COALESCE and look forward to further serving surgeons’ clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging.”

“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the COHERE device,” said Gurvinder Deol, MD, an early COHERE adopter from WakeMed Health and Hospitals in Raleigh, NC. “However, I believe porous PEEK’s true value will be demonstrated with the COALESCE device in lumbar procedures where the biologic fusion environment can be more challenging, and the biomechanics more demanding on fusion devices.”

Prior studies have demonstrated the importance of adding porosity to implants to create a strong bone-to-implant interface and more stable union.² Supported by extensive research at Duke University and the Georgia Institute of Technology, COALESCE’s porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores. Dr. Ken Gall, Ph.D., Chair of Mechanical Engineering and Materials Science at Duke University, will be presenting new benchtop and clinical research on porous PEEK at the upcoming NASS Summer Spine Meeting this week in San Diego, Ca.

According to Dr. Gall, “Our latest results show that porous PEEK is able to effectively osseointegrate by forming a mechanical and biological interface with bone. Our next steps are to translate what we have learned in animal models to the clinical setting by assessing this bony ingrowth into porous PEEK on X-Ray and CT.”

About Vertera Spine:
Vertera Spine is a privately-held medical device company that develops, markets, and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.comor call 678.705.9039.

COALESCE is a trademark of Vertera Spine. COHERE is a registered trademark of Vertera Spine.

¹Smith KE, Burkus JK, Gall K, et al. Getting PEEK to Stick to Bone: The Development of Porous PEEK for Interbody Fusion Devices. Techniques in Orthopaedics (accepted, in press).
²Svehla M, et al. Morphometric and mechanical evaluation of titanium implant integration: Comparison of five surface structures. J Biomed Mater Res, 2000.

Media Contact:
Jenn Pratt
Carabiner Communications
678.655.2273
jpratt@carabinercomms.com

Company Contact:
Lindsay Larson
Vertera Spine
571.758.3783
info@verteraspine.com

SOURCE Vertera Spine

OR AKIVA, Israel, July 25, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that Dr. Grant Skidmore of Chesapeake Regional Medical Center has reported promising results with the FLXfit™ 3D Expandable TLIF Cage. Dr. Skidmore noted that “I take a lot of precautions in preserving the patient’s spinal anatomy and bony structure. My focus is on relieving the patient’s pain but also restoring his balance to assure a long term clinical outcome.” He said “With the FLXfit™, I finally have the ability to offer my patients the ultimate outcome thanks to the cage’s unique articulation and lordotic expansion feature.”

Dr. Grant Skidmore, Chesapeake Regional Medical Center, Norfolk, Virginia, explained “I am big believer of offering my patients immediate, robust and long term stability but was always puzzled how I could achieve this through a single and minimal posterior incision while preserving the spinal anatomy”. He concluded “our initial 30 patients’ series demonstrates the capability to place a large footprint cage at the front of the disc space, expand it lordotically in a controlled manner to achieve unique, anatomical fit, customized per patient.”

Ofer Bokobza, CEO of EOI, says that “we are excited to collaborate with such a skillful surgeon as Dr. Skidmore. His initial 30 patients’ series show very encouraging results and confirm the FLXfit™’s unique ability to restore lordosis and positively impact the patient’s sagittal balance.” Ofer emphasizes that “EOI recognizes the need for continuous clinical data collection through collaboration with leading surgeons. We believe that the FLXfit™ represents a new breed of expandable devices providing customized, anatomical fit solution that could lead to better patients’ outcome and new standard of care.”

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 seasoned management team, and is advised by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through MIS approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)3219683

SOURCE Expanding Orthopedics Inc.

July 25, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Spinal Kinetics, Inc., the designer and manufacturer of the innovative M6^© artificial disc, today announced total implantations of the company’s M6-C Cervical and M6-L Lumbar discs have now exceeded 50,000 throughout the international markets where the M6 is commercially available. Since the launch of the M6-C in 2006 and the M6-L in 2010, this “natural,” artificial disc design has consistently established itself as a technology of choice among spine surgeons for both cervical and lumbar disc replacement. With this strong surgeon preference, as well as patient demand for the next generation artificial disc technology, the M6 has become an industry leader in the rapidly growing artificial disc market. Additionally, the company is preparing its Pre-Market Approval (PMA) application to the FDA to obtain United States approval to treat single level cervical degenerative disc disease with the M6-C. The M6-C IDE study enrollment has been completed, and the PMA application is scheduled to be submitted to the FDA later this year.

The M6 artificial disc is designed to help patients suffering from degenerative disc disease of the spine; a common cause of chronic neck and back pain. The M6 technology provides an alternative to spinal fusion and is designed to restore natural and physiologic motion to the spine. Preserving motion with the M6 artificial disc provides an opportunity to restore biomechanical function at the treated level after native disc removal, as well as the possibility to reduce subsequent degeneration of adjacent segments. The M6 is the only physiologically designed artificial disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus in its design. Like a natural disc, this unique construct of the M6 allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements. Extensive biomechanical studies at world renowned institutions have continuously confirmed the M6’s ability to replicate natural physiologic motion.

“We are extremely proud as an organization to reach the 50,000 implant level and are appreciative of the spine surgeon community in adopting the M6 technology,” states Tom Afzal, President and CEO of Spinal Kinetics. “We believe this milestone continues to validate the market demand for more advanced artificial disc technologies that are designed to closely mimic a natural disc’s motion characteristics, ultimately benefiting patient outcomes. Disc replacement in the cervical and lumbar spine is not solely about how much motion an artificial disc provides, but more importantly, the quality of that motion and how that motion can affect other surrounding structures like facets and adjacent segments. The M6’s ability to replicate a natural disc’s quality of motion and biomechanics is what continues to differentiate it against all other artificial discs in the market.”

About Spinal Kinetics, Inc.

Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to the unique biomechanical properties that replicate the motion of a natural disc and the positive clinical outcomes for patients. The company is located in Sunnyvale, California.

For more information on Spinal Kinetics or the M6 Artificial Disc, please visit www.spinalkinetics.com. Spinal Kinetics, M6-C, M6-L are trademarks or registered trademarks of Spinal Kinetics, Inc.

CAUTION–Investigational device. Limited by Federal (or United States) law to investigational use.

Contacts

Spinal Kinetics, Inc.
Mike Gandy, 408-636-2557
mgandy@spinalkinetics.com

Walter Eisner • Thu, July 20th, 2017

Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product.

In a June 27, 2017 10K filing with the SEC, the company announced the agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing.

The company had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December 2016, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. That trial could have opened sealed internal documents that could have been used in other trials.

According to the Minneapolis Star Tribune, the company paid at least $85 million in a settlement to shareholders in 2012 to resolve allegations that it failed to reveal that most sales of Infuse were for off-label surgeries. In 2014, Medtronic said it paid $22 million to 950 injured Infuse patients. The company denied wrongdoing in each settlement.

Remaining Investigations

While the announcement settles private claims, the company is still under investigation by various state attorneys general who have issued subpoenas or document requests in Massachusetts, California, Oregon, Illinois, and Washington seeking more information regarding the Infuse device.

READ THE REST HERE

July 18, 2017 / By Family Health Team

If you’ve struggled with lumbar spinal stenosis (LSS), you know it can impact your life. People with severe LSS often can’t stand longer than a few minutes or walk more than a few hundred feet without feeling severe pain.

Bulging disk and/or enlargement of the ligaments in your spine can cause LSS. When the spinal canal narrows, it causes nerve compression. When someone with LSS stands or walks, the spinal canal narrows even more, causing low back and leg pain that is relieved with sitting or bending forward.

Until a few years ago, the only treatment options available were either of two extremes: conservative therapies or open spine surgery.

Weighing treatment options for LSS

However, conservative treatments, such as NSAIDS, physical therapy and epidural steroid injections, only work for a fraction of people. Also, when they do work, the effect is often not sustained and requires repeated treatments.

Open spine surgery, on the other hand, works to relieve pressure on spinal nerves, but surgery and anesthesia may carry increased risk in older patients.

Now, there’s a new outpatient option called mild®, which stands for minimally invasive lumbar decompression. It is only an option for patients who have significant LSS due to thickening of the ligamentum flavum, or ligaments of the spine.

READ THE REST HERE

JULY 19TH, 2017/DATA BRIDGE MARKET RESEARCH

The North America spinal implants devices market is estimated at USD 4.7 billion in 2016 and is projected to reach USD 7.0 billion by 2024, at a CAGR of 5.1% during the forecast period from 2017 to 2024. The new market report contains data for historic year 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

The North America spinal implants market is segmented based on product type, surgery type, procedure type, end-user and geography.

On the basis of product the market is segmented into into spinal fusion, vertebral compression fracture treatment devices and spinal non-fusion. The spinal fusion segment is divided into cervical fusion and thoraco-lumbar fusion. spinal non-fusion devices market is segmented on the basis of product types into dynamic stabilization devices, artificial discs, annulus repair devices and nuclear disc prosthesis. The vertebral compression fracture (VCF) treatment devices are further segmented into two product type balloon kyphoplasty devices and verteboplasty devices.

The North America spinal implants market is also segmented based on procedure type into open surgery and minimally invasive surgeries.

READ THE REST HERE

OVERLAND PARK, KANSAS (PRWEB) JULY 19, 2017

Spinal Simplicity, a medical device company developing innovative solutions to treat complex spinal and orthopedic problems, announces Richard Grant has agreed to serve as an Advisor and will join the Company’s Board of Managers.

Richard Grant brings a wealth of experience to Spinal Simplicity as an accomplished medical device executive with over 30 years in the spinal and orthopedic medical industries. As President, CEO and Co-Founder of Breakaway Imaging, LLC, Mr. Grant successfully developed new imaging technology (the O-Arm), incorporating 2-D (fluoroscopy) and 3-D (CT) imaging, in a mobile platform optimized for orthopedic and spinal surgeries. Mr. Grant orchestrated the sale of Breakaway Imaging, LLC to Medtronic, Inc. in June 2007.

Mr. Grant also has extensive experience with early-stage medical device companies as evidenced by his work as President and CEO of TheraCell, Inc., in Northridge, CA, specializing in stem cell harvesting and processing for orthopedic applications, and, as President of Bonovo Orthopedics in Phoenix, AZ, a US-based company that manufactures and distributes spine and orthopedic instrumentation and implants in China. Mr. Grant currently serves on the Board of Directors of two medical device companies, an orthopedic bracing company and an ortho-biologic company, while also serving as the Chairman of the Board of a company specializing in computer-assisted total knee solutions. Notably, Mr. Grant also served on the Board of Directors of Excelsius Surgical (sold to Globus Medical), Nocimed (partnering with Nuvasive), and Angstrom Medica (sold to Pioneer Surgical).

Todd Moseley, CEO of Spinal Simplicity, applauded Mr. Grant’s significant industry experience stating, “Rich is an admired executive in the spine and orthopedic medical device world. Spinal Simplicity will benefit mightily from Rich’s knowledge and experience navigating early-stage companies from initial innovation to becoming market leaders. Our Company will have the unique advantage of calling upon Rich’s experience as we bring the Minuteman G3-R to the minimally-invasive spine market to enhance posterior supplemental fixation and fusion, as well as to introduce our ground-breaking Wolff’s Law™ plating technology to the spinal and orthopedic extremities market.”

Mr. Grant agreed that this is an extraordinary time for Spinal Simplicity, “As the Company experiences the positive responses being lauded by physicians to its revolutionary technology, it becomes more and more evident that the spinal and orthopedic markets are ready for innovative medical devices. The time is ripe to get the word out about the innovation being unveiled by Spinal Simplicity.”

Spinal Simplicity’s Minuteman® family of sterile-packed, posterior, non-pedicle supplemental fusion and fixation devices for use in the non-cervical spine (T1-S1) provides an alternative to traditional fixation, such as pedicle screws. The Minuteman® family of devices consists of a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor.

About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, Kansas, is dedicated to the creation of simple solutions for the treatment of complex spinal and orthopedic problems. Spinal Simplicity has regulatory clearance for the Minuteman® system in the US, Europe, and Canada. Our vision is to be the leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com.

ATLANTA, GA–(Marketwired – Jul 19, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), a developer of medical technology products, today announced the first human cases performed using its recently launched DenerveX™ System and first revenue events.

The DenerveX System which has recently received CE Mark approval and clearance for commercialization in the European countries, is a new and novel device designed for enduring relief of Facet Joint Syndrome related to lower back pain.

Jarrett Gorlin, Medovex CEO stated, “Our first human use cases for the DenerveX System which took place in Manchester, England recently with very encouraging initial procedural success. We anticipate performing up to as many as 30 plus additional procedures by the end of August. This is the beginning of delivering on our goal of ‘proof of principle’ in the adoption of the technology in this very sizable market.” Gorlin concluded, “We are also pleased to have also reached our first revenue events in the EU with others soon to expected to follow.”

The DenerveX System offers a fast and simple way to perform a safe Facet Joint Syndrome treatment.

Patrick Kullmann, Medovex President and COO., added, “With the DenerveX™ System, we can offer surgeons and pain management specialists the ability to attain precise treatment of the Facet Joint pain. The DenerveX treatment uses ‘Rotacapsulation™,’ a combination of high heat and rotational capsular tissue shaving, in a minimally invasive posterior procedure for the treatment of Facet Joint Syndrome. The DenerveX System offers an alternative to existing treatments only providing temporary relief.”

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

CONTACT INFORMATION
Medovex Corp.
Jason Assad
470-505-9905
Email Contact

July 19, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced the closing of a Series B financing of $21 million. LSP (Life Sciences Partners) led the round, with additional investment from Sectoral Asset Management and returning investor M.H. Carnegie. The new funds will be used to complete two ongoing U.S. pivotal clinical trials of the Simplify Disc studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease.

“We are gratified by the confidence investors are showing in our Simplify Disc, which is designed to be clearly viewed on MRI without the artifact that can result from metal used in typical spine implants. By avoiding the radiation that would otherwise accompany a computed tomography (CT) scan, we intend to minimize patient exposure to unnecessary radiation risk,” said Simplify Medical Chief Executive Officer David Hovda. “The new funds will enable us to develop the rigorous evidence that gets us one step closer to availability for U.S. patients in need.”

“We are very impressed with the intelligence of the Simplify Disc technology,” said LSP General Partner Dr. Fouad Azzam. “With hospitals being held to higher standards relative to complications and post-operative costs, it is important that innovations minimize patient risk. Not only does the Simplify Disc avoid substantial radiation exposure, it also avoids metal wear that has been problematic for other orthopedic devices. In addition, it offers the lowest-profile device available, opening up a broader patient population for the technology.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 15 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. For information about eligibility or enrollment in either pivotal trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and has been used to treat more than 700 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

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Current Issues in Spine

LongueVue Capital, in Partnership with Management, Completes Investment in Zavation Medical Products, LLC

Vertera Spine Announces FDA Clearance of COALESCE™ porous PEEK Lumbar Interbody Fusion Device

Dr. Skidmore Reports Promising Results on a 30 Patients’ Series with EOI’s 3D Expandable FLXfit™ Cage

Spinal Kinetics Surpasses 50,000 Implants of its M6© Artificial Disc Since Launch

Contacts

Medtronic Announces Infuse Settlements

Walter Eisner • Thu, July 20th, 2017

If You Have Lumbar Spinal Stenosis, There’s an Exciting New Option

Weighing treatment options for LSS

North America Spinal Implants Market CAGR of 5.1% 2024

Richard Grant joins Spinal Simplicity, LLC as an Advisor and to serve on the Board of Managers

Medovex Announces First Human Cases Using Its DenerveX Device and First Revenue Events

CONTACT INFORMATION

Simplify Medical Closes $21 Million Series B Financing to Support Innovative Cervical Artificial Disc

Contacts

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Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

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