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June 26, 2018 OrthoSpineNews

AUDUBON, Pa., June 26, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today a new clinical milestone with the successful implantation of over 3,000 screws using ExcelsiusGPS®,  the company’s revolutionary robotic guidance and navigation system. Since the launch of ExcelsiusGPS® in late 2017, orthopedic and neurosurgeons have used the system with three compatible imaging modalities (preoperative CT, intraoperative CT, and fluoroscopic imaging) across a variety of spine surgery procedures to minimize radiation exposure, streamline workflow, and assist in screw placement.  A recent white paper comparing robotic-assisted versus conventional screw placement demonstrates some of the benefits of this technology.

“Having completed installations and surgeon training programs through the first half of 2018, we see surgeons using this technology in open and minimally invasive spine procedures including posterior cervical fusion, sacroiliac joint fusion, and thoracolumbar fusion with posterior and single position lateral approaches,” said Chief Executive Officer Dave Demski. “Surgeons are realizing the benefits of the ExcelsiusGPS® platform and the potential to significantly improve surgical techniques as demonstrated in the recent cadaveric study.”

The study, led by Dr. Alexander R. Vaccaro, MD, Ph.D, M.B.A and performed by 10 board certified surgeons in a simulated surgical environment, evaluated pedicle screw placement time, accuracy, and radiation dose for ExcelsiusGPS® in open and MIS approaches compared to conventional surgical techniques. Results demonstrated the ExcelsiusGPS® robotic navigation significantly improved pedicle screw accuracy, allowed placement of larger screw diameters and lengths than conventional techniques, and reduced radiation exposure to the clinician.  Additionally, ExcelsiusGPS® significantly reduced screw insertion time compared to the conventional MIS technique.

To learn more about the benefits of ExcelsiusGPS®, visit globusmedical.com/ExcelsiusGPS

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:  investors@globusmedical.com
www.globusmedical.com


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June 26, 2018 OrthoSpineNews

FREMONT, Calif. – June 26, 2018 – Ceterix Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced the issuance of U.S. Patent No. 10,004,492 related to the company’s method of placing a suture around a tear to repair a damaged meniscus, adding to the company’s already expansive intellectual property portfolio.

Ceterix’s new patent further protects the company’s technology enabling surgeons to arthroscopically repair soft tissue injuries in the knee using minimally invasive techniques. This is the second set of method claims describing Ceterix’s proprietary Circumferential Compression Stitch (CCS), a suture method that provides uniform, anatomic compression of meniscus tears that was not possible to do previously given the tight constraints of the knee.

“Whether you are setting a broken bone or suturing a laceration, injuries heal best when the tissue edges are perfectly lined up and repaired without gaps,” says Dr. Justin Saliman, founder and chief medical officer of Ceterix. “For the first time, orthopaedic surgeons can now apply this principle to meniscus tears with NovoStitch® Meniscal Repair Systems. We believe that by enabling simultaneous compression of the femoral and tibial sides of meniscus tears, the Ceterix technology can provide surgeons with greater confidence to repair tears that would have previously been considered non-repairable.”[i],[ii]

“The invention of delivering a Circumferential Compression Stitch within the tight constraints of the knee may be the biggest innovation in meniscal repair in the last 15 years,” says John McCutcheon, president and CEO of Ceterix. “We are committed to expanding options for surgeons to preserve the meniscus and protect normal knee function in their patients.”

 

READ THE REST HERE

 


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June 26, 2018 OrthoSpineNews

Stamford, CT, June 26, 2018 (GLOBE NEWSWIRE) — Dr. Brad Waddell is the first surgeon in Connecticut to offer HipAlign® for direct-anterior total hip replacement. HipAlign is a sensor-based navigation technology that helps surgeons perform precise and accurate hip replacement surgeries. The HipAlign system allows Dr. Waddell to offer his patients one of the most advanced surgical technologies available in Connecticut.

The HipAlign technology acts as a GPS for surgeons, using micro-electromechanical sensors like accelerometers and gyroscopes to guide hip replacement surgery, to ensure accuracy and alignment. All of this happens in a phone-like device that sits in the surgeon’s hands, and on their surgical instruments.

“Using HipAlign technology allows for accurate placement of the hip prosthesis by using patient’s individual pelvic anatomy,” said Dr. Waddell, Orthopedic Surgeon at Hospital for Special Surgery. “Cost-effective navigation and smart instrumentation like HipAlign is the future of technology in orthopedic surgery. It’s important in that the technology allows me to combine my clinical experience and decision making along with real-time data about my patient. The resulting precision may lead to improved outcomes for my patients.” Dr. Waddell works with OrthAlign in a personal capacity.

The HipAlign technology (manufactured by OrthAlign, Inc. a California-based company) launched in 2018, building on the legacy of KneeAlign®, a technology that has powered more than 75,000 surgeries to date.

To learn more about the HipAlign surgical procedure, visit www.orthalign.com. 

ORTHALIGN, INC.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

Attachment

Adam Simone
OrthAlign
asimone@orthalign.com

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June 26, 2018 OrthoSpineNews

26th June 2018

US spine care providers have a brand new tool to measure and improve patient care: a diagnosis-based clinical data registry that tracks patient care and outcomes.  Launched by the North American Spine Society (NASS), this web-based platform will allow health care providers to collect and analyse their spine care data and compare it to the de-identified data in the entire registry. Because it is diagnosis-specific, not procedure-specific, the NASS Spine Registry will enhance understanding of spine care treatments, their outcomes, and examine the natural history of spine disorders.

“In order to prove or disprove the effectiveness of spine treatments, the spine field needs to gather evidence,” says Zoher Ghogawala (Lahey Hospital & Medical Center, Burlington, USA), NASS research council director. “With its national reach and comprehensive nature, the NASS Spine Registry will help the spine care field make substantial progress on improving quality, developing best practices, and closing the gaps in medical evidence for spine care.”

From the initial idea to the implementation of a pilot program, the NASS Spine Registry was developed over the past eight years. NASS has made every effort to minimise potential barriers to participation, including cost, privacy concerns, administrative burden, and institutional review board (IRB) participation, a press release states.

“The really exciting and unique thing about the NASS registry is that it is multidisciplinary,” says Daniel Resnick (University of Wisconsin, Madison, USA), NASS president and chair of the NASS Registry Committee. “Despite the fact that more than 90% of spine care is managed without surgery, most existing registries are focused around surgical specialties or procedures. Thanks to the comprehensive nature of this registry, we will be able to see what care approaches are actually helping patients restore their function and reduce pain.”

 

READ THE REST HERE

 


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June 26, 2018 OrthoSpineNews

NESS ZIONA, IsraelJune 26, 2018 /PRNewswire/ —

CollPlant (NASDAQ: CLGN) (TASE: CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human collagen) technology for tissue repair products, today announced that it has received grant approval from the Israel Innovation Authority (IIA) to finance continued development of the Company’s proprietary rhCollagen-based formulations intended for use as BioInk for the 3D printing of tissues and life savings organs. The total approved project budget is approximately $1.2 million (NIS 4.2 million), of which the Israel Innovation Authority will finance 30%, subject to certain conditions. The terms of the grant require, among other things, CollPlant to pay royalties to the IIA on future sales of any technology developed with these funds, up to the full grant amount.

“In addition to providing immediate non-dilutive funding, this grant from the Israel Innovation Authority represents an important validation of our BioInk technology and its market potential,” said Yehiel Tal, Chief Executive Officer of CollPlant. “With the recent opening of our new cGMP production facility in Rehovot, Israel, we are well positioned to meet growing demand for our BioInk and tissue repair products. We are grateful to the IIA for this recognition.”

About the Israel Innovation Authority

The Israel Innovation Authority, formerly known as the Office of the Chief Scientist of the Ministry of Economy (& MATIMOP), is an independent and impartial public entity that operates for the benefit of the Israeli innovation ecosystem and Israeli economy, as a whole. Its role is to nurture and develop Israeli innovation resources, while creating and strengthening the infrastructure and framework needed to support the entire knowledge industry.

About CollPlant

CollPlant is a regenerative medicine company focused on 3D bioprinting of tissues and organs, developing and commercializing tissue repair products for orthobiologics, and advanced wound care markets. The Company’s products are based on its rhCollagen (recombinant human collagen) that is produced with its proprietary plant-based genetic engineering technology.

CollPlant’s products address indications for diverse fields of organ and tissue repair and are ushering in a new era in regenerative medicine. The Company’s flagship BioInk product line provides an ideal building block for 3D bioprinting of tissues and organs, and its unique Vergenix line of rhCollagen products includes a soft tissue repair matrix for treating tendinopathy and a wound repair matrix to promote a rapid optimal healing of acute and chronic wounds.

For more information, visit http://www.collplant.com

Safe Harbor Statement

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company’s history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company’s expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen-based BioInk, VergenixSTR, and VergenixFG; the Company’s ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen-based BioInk, VergenixSTR, and VergenixFG, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company’s rhCollagen-based BioInk, VergenixSTR, and VergenixFG; the Company’s ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third-party distributors and resellers; the Company’s ability to establish and maintain strategic partnerships and other corporate collaborations; the Company’s reliance on third parties to conduct some aspects of its product manufacturing; the scope of protection we are able to establish and maintain for intellectual property rights and the Company’s ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company’s strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading “Risk Factors” included in CollPlant’s most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant’s current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at CollPlant:
Eran Rotem
Deputy CEO & Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com

IR Contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

SOURCE CollPlant


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June 26, 2018 OrthoSpineNews

SALT LAKE CITY, June 26, 2018 – Innovasis provided a business update related to recent organizational milestones.

Leadership Team Expansion

Innovasis is pleased to announce the recent expansion of their leadership team. Mike Wheelock was hired as Vice President of Sales and David Oka as Director of Business Development and Clinical Affairs.

“The addition of experienced industry veterans like David and Mike ensures Innovasis continues developing world-class distribution and supports our commitment to collect compelling clinical evidence for our evolving HA PEEK enhanced interbody platform,” said Innovasis President Mike English. “We are excited and honored to have them join our rapidly expanding team.”

Headquarters Groundbreaking

With continued company growth, Innovasis is excited to announce the groundbreaking of new headquarters in Salt Lake City, Utah. The 50,000 sq. ft. facility will include a two-station cadaver lab, in house manufacturing, and corporate offices.

“This move will allow us to train our surgeon and distribution partners in an extraordinary setting, expand our manufacturing capabilities, and create operational efficiencies crucial to remain competitive in this market,” commented English.

36th Humanitarian Trip Completed

Innovasis completed their 36th humanitarian trip to Lima, Peru. This is the second humanitarian trip the company has completed in 2018. “Our humanitarian mission the past six years includes a total of total of 60 surgeon participants and over 200 spine and cranial cases completed. We are grateful for the expert staff, surgeons, and nurses that make it possible for Innovasis to continue improving patient healthcare in Peru,” said English.

About Innovasis

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.


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June 25, 2018 OrthoSpineNews

June 25, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal products and therapies, today announced the realignment of its strategic business units and the promotion of Brad Niemann to President of Global Orthofix Spine, which includes the BioStim, Spine Fixation, Spinal Kinetics and Biologics businesses. The Extremity Fixation business, which will now be referred to as “Orthofix Extremities” will continue to be led globally by Davide Bianchi as the President of Global Orthofix Extremities. This alignment structures Orthofix around two pillars: Spine and Extremities.

“In 2013, Orthofix segmented its business into four strategic business units to gain better strategic and management focus and drive needed performance improvements,” said Orthofix President and Chief Executive Officer, Brad Mason. “This strategy has proved very successful over the last several years and resulted in each business performing well with solid leadership, execution and growth.

“Today we are announcing these organizational changes as part of an overall strategy to position the Company for growth acceleration and to realize opportunities that can only be achieved by leveraging our full portfolio of spine solutions,” Mason continued. “As we expand our product offerings and integrate new technologies, such as the M6® disc, we believe the time is right to further optimize our structure to better serve our surgeon customers through a two-pillar approach of a consolidated Spine group and a focused Extremities business. We are fortunate to have two extremely talented executives to lead these organizations.”

“I am excited to have the opportunity to lead the Spine group and look forward to working more closely with the current management teams from all the spine product areas,” said Brad Niemann, President of Global Orthofix Spine. “This structure will foster better collaboration and alignment by bringing these teams together under one umbrella to help ensure we make the most of our many opportunities in the market.”

Orthofix will continue to report its financial performance according to the current four strategic business unit structure until completion of this transition, which is expected to be at the beginning of 2019. Subsequently, the Company will evaluate what changes in the Company’s segment financial reporting, if any, may be required as a result of this transition. In any event, the Company will continue to provide revenue transparency into the extremities, stimulation, spine hardware, biologics and Spinal Kinetics product groups.

About Brad Niemann

Niemann joined Orthofix in 2012 as Senior Vice President, Commercial Operations and was quickly promoted to President of the BioStim strategic business unit in June 2013 where he has successfully led the efforts to expand the utilization of bone growth stimulation technology. Prior to Orthofix, he worked in a variety of management and leadership roles of increasing responsibility at DJO Global, Inc. including serving as Senior Vice President, Recovery Sciences where he led their commercial efforts. As President of Global Orthofix Spine, he will work with the leaders of the Orthofix spine businesses in the development of strategies and initiatives to advance the Company’s worldwide spine business.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in over seventy countries via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com


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June 25, 2018 OrthoSpineNews

BILLERICA, Mass., June 25, 2018 (GLOBE NEWSWIRE) — Conformis Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell patient specific joint replacement implants designed to fit each patient’s unique anatomy, today announced publication of a study showing that patients treated with the iTotal CR Knee Replacement Systems achieved better tibial fit and tibial rotational alignment compared to patients treated with three different off-the-shelf (OTS) total knee arthroscopy (TKA) products. Results of the study titled “In Vivo Tibial Fit and Rotational Analysis of a Customized, Patient-Specific TKA versus Off-the-Shelf TKA” were presented in the May 2018 issue of The Journal of Knee Surgery, a leading peer-reviewed orthopedic journal.

The study, which was conducted jointly by Greg Martin, MD in Boynton Beach, Florida and Lennart Schroeder, MD candidate Julius-Maximilians-Universitaet Wuerzburg, Germany, intraoperatively compared component fit in four tibial zones. The Conformis iTotal CR implant system and three OTS cruciate retaining TKA products including Biomet Vanguard, Zimmer NexGen and DePuy Sigma were evaluated intraoperatively in a total of 44 knees. Each implant system was evaluated intraoperatively on the same 44 knees to compare each brand’s optimal tibial fit. Component rotation was then evaluated post operation using CT-based imaging converted into computer aided design (CAD) models. Using these models, simulated surgery was performed with the OTS TKAs.

“One of the compromises and decisions we surgeons often need to make intraoperatively is the best method to achieve an optimal “fit” for the patient while maintaining proper rotational alignment,” says board certified, fellowship trained hip and knee surgeon, Gregory Martin, MD. “The real benefit that I’ve found using Conformis implants is that this compromise is completely obviated. The implants fit precisely as designed with the in-built rotation, and enough relief to allow me to fine tune my rotation based on the specific patient’s anatomy. This is borne out in our results.”

The surgeon placed all implants with proper rotational alignment and the results of this study show: 37% of OTS knees showed >3mm under-coverage compared to 18% of Conformis iTotal and 18% of OTS had an overhang of >3mm compared to 0% for iTotal. In previous studies1, component overhang of greater than 3mm was linked to significantly higher post-operative pain. Additionally, when the same 44 knees were positioned for optimal fit, 45% of OTS knees had rotational errors of >5 degrees and 4% had >10 degrees. Excessive internal tibial component rotation has been found to be one of the leading factors of residual pain in TKR and can be a source of functional deficit2. No rotational deviation was observed with the Conformis iTotal implants, which are pre-aligned rotationally to match the patient’s unique anatomy.

“This is the first study to evaluate both the fit of the tibial tray and rotation of our patient-specific designed implants compared with off-the-shelf implants,” said Mark Augusti, chief executive officer and president of Conformis. “We often hear from surgeons that when they use off-the-shelf implants they need to compromise either on fit or rotation in the operating room. The results of this new study demonstrate that the Conformis iTotal CR can help surgeons address both issues at the same time. This study adds to the growing body of evidence that the Conformis iTotal CR can lead to better outcomes for patients.”

 

READ THE REST HERE

 


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June 22, 2018 OrthoSpineNews

SAN RAMON, Calif.June 20, 2018 /PRNewswire/ — Tenon Medical, Inc., a manufacturer of minimally invasive instruments and implants for sacroiliac joint fusion surgery, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ Fixation System) specifically indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. The CAT SIJ Fixation System becomes the first patented single implant SIJ fusion system using a true posterior approach for minimal tissue disruption.

“With the FDA 510(k) clearance of the CAT SIJ Fixation System, Tenon now has the first patented single implant SIJ fusion system that allows surgeons to use either a navigated procedure or fluoroscopic imaging providing flexibility in access and visibility.  The implant is designed to allow for bone graft materials to be loaded and delivered to the SIJ before and after implant placement to promote fusion of the SIJ,” said Tenon CEO Dr. Kal Mentak. “Our unique minimally invasive approach is designed to take less time and fewer surgical steps and represents a landmark innovation for SIJ fusion surgery benefiting patients, surgeons, facilities, and payers.”

In November 2016, Tenon Medical, Inc. was granted the first US patent covering a novel minimally invasive posterior approach fusion system to stabilize the SIJ.  The company has since filed for additional compositions.

Tenon Medical, Inc. is a privately held company located in the San Francisco Bay Area.

For inquiries about the CAT SIJ Fixation System, please contact Kal Mentak, PhD at (925) 353-0533 or kmentak@tctig.com.

 

SOURCE Tenon Medical, Inc.

Related Links

http://tctig.com


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June 22, 2018 OrthoSpineNews

SAN DIEGOJune 20, 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 results of the study “Early Outcomes of Anterior Cervical Discectomy and Fusion Using Porous PEEK™ Interbody Fusion Device,” published online in the Journal of Spine & Neurosurgery, which concludes that NuVasive patented porous polyetheretherketone (PEEK) technology is a clinically viable alternative for improving osseointegration and fusion rates of interbody implants to treat degenerative cervical disc disease.1

In the study, 50 patients (31 women and 19 men) with an average age of 60 with degenerative cervical disc disease underwent anterior cervical discectomy and fusion using a Cohere® cervical interbody fusion device from NuVasive—with 100 percent of participants experiencing positive results.

Cohere provides a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth without compromising implant strength. NuVasive incorporated the technology, which had been validated with 10 years of scientific research, into its portfolio with its acquisition of Vertera Spine in September 2017.

“This interbody fusion device with Porous PEEK surface technology provided improved osseointegration and supported spinal fusion in single level and multi-level cervical fusions,” said Dr. J. Kenneth Burkus of the Hughston Clinic in Columbus, Ga. “Twelve-month clinical outcomes have demonstrated the efficacy and stability of the Cohere Porous PEEK interbody device and shown that it is a clinically viable implant alternative for achieving successful clinical and radiological outcomes in cervical spine fusion surgery, particularly in multi-level or revision surgeries where fusion rates are lower.”

During the course of the clinical study, there were 11 1-level, 23 2-level and 16 3-level fusions between C3 and C7. Patients came from all walks of life and with various comorbidities. Thirteen of them had previously had an unsuccessful anterior cervical fusion procedure. It is notable that all patients who had revision surgery with Cohere achieved fusion six months after the surgery.

At 12 months post-operative ACDF surgery, all 50 patients demonstrated improved motion, decreased neck pain and average disc height increased by more than 4 mm. In addition, each of them showed radiographic fusion.

“NuVasive is the only company in the industry able to offer Porous PEEK technology so that surgeons can deliver life-changing clinical outcomes,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “The fact that all 50 patients in the clinical study experienced fusion is a testament to the enhanced osseointegration as well as biomechanical and imaging properties of Cohere and Porous PEEK technology, the entire NuVasive Advanced Materials Science™ portfolio, which also includes Modulus® titanium interbody implants, represents the future of porous implant technologies.”

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.

1 Burkus, J. (2018). Early outcomes of anterior cervical discectomy and fusion using porous PEEK interbody fusion device. Journal of Spine & Neurosurgery. Doi: 10.4172/2325-9701.1000295

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com