MATRIXX: First Ever Clinical Trial Evaluating 3D-Printed Titanium vs PEEK

Posted On September 25, 2018 By OrthoSpineNews In Spine /

September 24, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announces the momentous start of the MATRIXX Trial – marking the first ever clinical evaluation of novel 3D-printed lumbar interbody fusion devices relative to PEEK.

The Nexxt Matrixx® System is a collection of porous titanium spinal fusion implants that interweave highly differentiated surface texturing technology with novel 3D-printed cellular scaffolding. With the sponsorship of this trial, Nexxt Spine hopes to prove that their technology can accelerate bony ingrowth and improve clinical outcomes.

“Since we launched last October, over 1400 Nexxt Matrixx® devices have been implanted and the response from our surgeon leaders has been phenomenal,” stated Nexxt Spine President, Andy Elsbury. “While our early adopters have witnessed improved clinical outcomes first-hand, we are excited to take the industry lead and quantify the clinical merits of Nexxt Matrixx® scientifically.”

The MATRIXX Trial is a prospective randomized controlled trial that will evaluate the clinical and radiographic outcomes of the Nexxt Matrixx® System following lumbar interbody fusion. Patients will be randomized to receive either a Nexxt Matrixx® 3D-printed porous titanium cage or a traditional plastic PEEK cage routinely recognized as the current ‘gold standard.’ Data will be collected at 3, 6, 12, and 24 months in order to quantify the speed and quality of fusion relative to the two implant materials.

“Although often used in spinal surgery, plastic PEEK cages are limited as they function more like static shims holding expensive biologics as opposed to active scaffolds that enable endplate to endplate healing,” explains Alaedeen Abu-Mulaweh, Director of Engineering.

While other manufacturers have used 3D-printing to develop devices that mimic bone’s trabecular geometry, Nexxt Spine chose to ignore the marketing allure and focus instead on the core science.

“Titanium is physically incapable of biological remodeling, so using 3D-printing to directly mimic the structural randomness of bone doesn’t make a whole lot of sense,” explains Abu-Mulaweh. “Rather than simply looking like bone, Nexxt Matrixx® was designed with the vision of actively facilitating the body’s natural power of cellular healing.”

The initiation of the MATRIXX Trial is “a milestone moment for Nexxt Spine and the medical community as a whole,” says Elsbury. “We believe that our Nexxt Matrixx® technology has the potential to revolutionize the landscape of spinal fusion and are excited for the opportunity to prove it.”

About Nexxt Spine

Nexxt Spine, LLC is a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions. The Nexxt Matrixx® family currently consists of implants available for cervical, TLIF Oblique, and TLIF procedures. Stand-Alone Cervical, Stand-Alone ALIF, and Corpectomy devices incorporating Nexxt Matrixx® technology are actively in development & testing.

Contacts

Nexxt Spine LLC
Alaedeen Abu-Mulaweh, 317-678-8424
aabu-mulaweh@nexxtspine.com

Medtronic Launches the Infinity(TM) OCT Spinal System

Posted On September 25, 2018 By OrthoSpineNews In Spine, Top Stories /

DUBLIN and LOS ANGELES – September 25, 2018 – Medtronic plc (NYSE:MDT) today announced the U.S. launch of the Infinity(TM) Occipitocervical-Upper Thoracic (OCT) System designed to simplify posterior cervical spine surgery. The Infinity OCT System is a complete procedural solution that integrates navigation and biologics with Medtronic’s comprehensive devices and instrumentation to create efficiency in fusion procedure workflows for the upper back and neck. The announcement was made during the North American Spine Society meeting taking place from September 26th – 29th in Los Angeles where Medtronic is exhibiting at Booth #1201.

“For more than 35 years, Medtronic has partnered with leading spine surgeons to advance new technologies with the goal of improving patient outcomes,” said Doug King, senior vice president and president of the Medtronic’s Spine division, which is part of the Restorative Therapies Group. “We engineered every component of the Infinity OCT System to perform efficiently during the most complex spine procedures, as well as to integrate seamlessly with our market-leading imaging and navigation technologies.”

The Infinity OCT System is used to immobilize and stabilize the spine while it fuses. The system features several innovative components – including a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimize cross threading, and 3.0mm and 5.5mm diameter screws for expanded patient demographics and clinical applications. The system has a full spectrum of implant materials and sizes – and when paired with the O-arm(TM) Imaging System and StealthStation(TM) Navigation System – provides a fully-enabled procedural solution designed to bring efficiency and simplicity to even the most complex posterior cervical procedures.

The Infinity OCT System is indicated for certain conditions including degenerative disc disease, instability or deformity, tumors, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury. September is Spinal Cord Injury Awareness Month and according to the National Spinal Cord Injury Statistical Center, the 2016 annual incidence of spinal cord injuries in the U.S. was approximately 54 cases per million people, or about 17,000 cases per year.¹

“Some of our posterior cervical patients arrive in critical condition and their lives depend on our surgical skills and the performance of the tools we use to treat them,” said Dr. Greg Trost, neurosurgeon at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin. “With Infinity, I can focus on delivering the best patient care during complex procedures knowing that every component was precisely-designed with modularity and versatility in mind. And an integrated procedural solution with Stealth navigation and Infinity was game-changing as a 3D-view of the anatomy allows me the precision to place pedicle screws with confidence and accuracy.”

The Infinity OCT System is now available in the U.S. The system will be released in geographies around the world in 2018 and 2019.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

¹ Grand View Research. Spinal Implants & Devices Market Size, Share & Trends Analysis Report By Product (Fusion Devices, Spinal Biologics), By Technology, By Surgery Type, By Procedure Type, And Segment Forecasts, 2018 – 2024. April 2018. Available at: https://www.grandviewresearch.com/industry-analysis/spinal-implants-spinal-devices-market

Contacts:
Sara Thatcher
Public Relations
+1-901-399-2098

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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Kuros Biosciences Appoints Strategic Advisory Board

Posted On September 25, 2018 By OrthoSpineNews In Biologics, Spine /

SCHLIEREN (ZURICH), Switzerland, Sept. 25, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced the formation of its Strategic Advisory Board (SAB). The newly-formed SAB will work closely with Kuros’ leadership team to guide the strategic direction of the company. The SAB is assembled from key-opinion-leading surgeons and academic research experts, specialized in the treatment of disorders of the Spine. The board will sit for the first time in Los Angeles, USA on September 27, 2018, to coincide with the North American Spine Society annual meeting, at which Kuros Biosciences is presenting new scientific data in support of the Company’s bone graft product, MagnetOs, which was recently launched to market.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are pleased to welcome some of the most recognized names in the field of spinal research onto our Strategic Advisory Board. Our SAB will provide the necessary input to ensure that we match our strategy to the needs of the market and continue to build value for the future.”

Strategic Advisory Board Members:

R. Todd Allen, MD, PhD – UCSD, San Diego, CA, US
Richard (Todd) Allen, MD, is board-certified orthopedic surgeon with expertise in complex adult reconstruction procedures for deformity/scoliosis and tumors. He also specializes in complex disorders of the upper cervical spine and in degenerative, traumatic, and post-traumatic conditions. Dr. Allen utilizes both a variety of minimally invasive and open surgical procedures for these conditions, focused on optimizing patient-centered outcomes. As an associate professor in the Department of Orthopedic Surgery, Dr. Allen is active in educating medical students, residents and fellows at UC San Diego School of Medicine. He is Spine Fellowship Director at UC San Diego and actively performs research on spinal deformity, biologics, disc replacement, and cost-effective/quality metrics in spine. He has been lead or contributing author to numerous peer-reviewed research publications and book chapters. He has presented nationally and internationally, including such meetings as our North American Spine Society (NASS) and American Academy of Orthopedic Surgeons (AAOS) meetings. He is part of the NASS Basic Science and Biologics Committee and continues to be highly active in several national committees advancing spine surgery research and outcomes.

Alpesh A. Patel, MD, FACS – North Western Medicine, Chicago, IL, US
Alpesh A. Patel, MD is the Director of Orthopedic Spine Surgery at Northwestern and a spine surgeon with fellowship training in both Orthopedic Spine Surgery and Neurosurgery. Dr. Patel specializes in cervical spine surgery and minimally invasive spine surgery. His experience and research include the areas of cervical spine surgery, cervical myelopathy, herniated discs, minimally invasive surgery, spine trauma and spinal cord injuries. Dr. Patel is known for his clinical research on patient outcomes, genetics of spinal disease, and injuries of the spine and spinal cord. He is also known for his research in cost-effectiveness and value in spine care, making spine surgery at Northwestern, as well as throughout the United States and the world, safer and more effective.

Kornelis Poelstra, MD, PhD – Sacred Heart Hospital, FL, US
Kornelis Poelstra is board certified in orthopedic spine surgery. He specializes primarily in long-construct minimally invasive spine surgeries, adult spinal deformity, oncologic conditions, spinal fracture treatment and cervical disc replacements. He is one of the world leaders in Robotic Spine Surgery and has performed more than 600 complex robotic cases thus far. He has an extensive research background in implant associated wound infections, novel material sciences for both spine- as well as orthopedic implant designs and worked on stem cell implantation for spinal cord injury. The mechanical- and cellular processes salient for the formation of a stable arthrodesis and implant incorporation into the human body are of specific interest to him. He founded the Spine Center of Excellence at Sacred Heart Hospital in North-West Florida and has been directing this Institution since its inception.

Andrew A. Sama, MD – HSS, New York, NY, US
Dr. Andrew Sama is Associate Professor of Clinical Orthopedic Surgery at Weill Cornell Medical College and previously served as Director of Spine Surgery Fellowship at Hospital for Special Surgery. Dr. Andrew Sama specializes in the management of all traumatic, degenerative, and deformity-related conditions of the cervical, thoracic, and lumbosacral spine. He has received several research grants, including funding from the National Institutes of Health. Dr. Sama is involved in product development and has helped design several orthopedic implant devices. He has published articles in numerous peer-reviewed medical journals and co-edited a textbook titled ‘Lateral Access Minimally Invasive Spine Surgery’. He is on the editorial board of Current Reviews in Musculoskeletal Medicine and serves as a reviewer for the journals Spine and Clinical Orthopedics and Related Research.

Faheem Sandhu, MD, PhD – MedStar Health, Chevy Chase, MD, US
Faheem Sandhu, MD, PhD, is director of Spine Surgery at MedStar Georgetown University Hospital and professor of Neurological Surgery at Georgetown University Medical Center. He specializes in minimally invasive and complex spinal surgery. Dr. Sandhu is an innovator in the field and holds several patents. His practice includes all areas of spine conditions: degenerative, deformity, tumor, and trauma. He has special interest in minimally invasive spine surgery and applying these techniques to all aspects of spinal surgery as well as disc arthroplasty and disorders of the craniocervical junction. Dr. Sandhu has authored more than 50 peer-reviewed articles and book chapters and has presented his research at major meetings in the U.S. and abroad. He regularly teaches courses on techniques of minimally invasive spine surgery. He is a Diplomate of the American Board of Neurological Surgeons and a Fellow of the American Association of Neurological Surgeons.

Prof. Bill Walsh PhD – UNSW, Sydney, Australia
W.R. Walsh, Ph.D. is a Professor in the Prince of Wales Clinical School, Division of Surgery at University of New South Wales in Sydney, Australia, and Director of Surgical & Orthopaedic Research Laboratories, Prince of Wales Hospital. His research lies at the interface between implanted materials, including autograft, allograft and synthetic biomaterials, and the connective tissues of the body. The foundation of his research interests center on understanding the biology and biomechanics of connective tissues during healing, age and disease; this involves research techniques from the macro to molecular level. Bill has over 385 peer reviewed journal publications, book chapters and patents. He is on several editorial boards including Biomaterials, CORR, Muscle Tendon Ligament Journal, Journal of Biomechanics, The Spine Journal and Frontiers in Surgery and Bone and Joint Research.


For further information, please contact:
Kuros Biosciences AG	Media & Investors
Michael Grau	Hans Herklots
Chief Financial Officer	LifeSci Advisors
Tel +41 44 733 47 47	+41 79 598 7149
michael.grau@kurosbio.com	hherklots@lifesciadvisors.com

About MagnetOs
MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

About Kuros Biosciences AG
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

RTI Surgical® Wins 2018 Orthopedics This Week Spine Technology Award for TETRAfuse® 3D Technology

Posted On September 25, 2018 By OrthoSpineNews In Spine /

September 25, 2018

LOS ANGELES–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq:RTIX), a global surgical implant company, announced its TETRAfuse^® 3D Technology won a 2018 Spine Technology Award from Orthopedics This Week, a widely read publication in the orthopedics industry. RTI will accept the award at the North American Spine Society’s (NASS) 33^rd Annual Meeting taking place September 26-29, 2018 in Los Angeles and will be featured in upcoming issues of Orthopedics This Week and Orthopedics This Month Spine.

“RTI is honored to receive this important industry recognition, which is a testament to the ingenuity and dedication of our employees,” said Camille Farhat, President and CEO, RTI Surgical. “TETRAfuse 3D Technology is one of many examples of RTI’s commitment to the development and ongoing clinical research of innovative spine-focused solutions that meet the demands of surgeons and improve patient outcomes around the world.”

TETRAfuse 3D Technology is an interbody fusion (IBF) device material, manufactured under an exclusive license with Oxford Performance Materials, designed to help drive optimal outcomes for patients undergoing spinal fusion procedures. It is the first 3D printed polymer-based IBF device material to incorporate a nano-roughⁱsurface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEK.ⁱⁱ

TETRAfuse 3D Technology is featured in RTI’s growing Fortilink® series of devices, including the Fortilink-C, -TS and -L IBF Systems. The devices are intended for use in interbody fusion procedures in patients with degenerative disc disease (DDD), an age-related condition when one or more discs between the vertebrae of the spinal column deteriorate or break down, which can lead to pain.ⁱⁱⁱ

Those attending NASS can visit Booth #1523 to learn more about the Fortilink series of devices featuring TETRAfuse 3D Technology, as well as RTI’s full line of high-quality hardware, interbody and orthobiologic spine offerings. For more information about the Fortilink IBF series of devices and TETRAfuse 3D Technology, visit www.tetrafuse3D.com.

About Orthopedics This Week

Orthopedics This Week delivers breaking news, analysis and commentary to professionals working in the orthopedics industry. Published 40 times a year, Orthopedics This Week is a four-time winner of the MORE awards for journalistic excellence. Each year, Orthopedics This Week grants the Spine Technology Awards to inventors, engineering teams, surgeons and their companies who have created the most innovative, enduring and practical products in the treatment or care of the spine. Submissions are judged by a panel of leading surgeons with extensive clinical and research experience in spinal care.

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. Connect with us on LinkedIn and Twitter.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

ⁱ Data on file at RTI Surgical, Inc.
ⁱⁱ Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans.
ⁱⁱⁱ Donally C, Dulebohn S; Lumbar Degenerative Disk Disease. StatPearls. 2017 Oct 13. Available at https://www.ncbi.nlm.nih.gov/books/NBK448134/

Contacts

RTI Surgical, Inc.
Media Contacts:
Annie Claggett, +1 312-995-2856
aclaggett@rtix.com
or
Molly Poarch, +1 224-287-2661
mpoarch@rtix.com
or
Investor Contact:
Nathan Elwell, +1 847-530-0249

nelwell@lincolnchurchilladvisors.com

Reinvent Biologics Appoints David Drez, MD as a Chief Medical Officer

Posted On September 25, 2018 By OrthoSpineNews In Biologics /

September 25, 2018

FORT WORTH, Texas–(BUSINESS WIRE)–Fort Worth-based Reinvent Biologics announced the appointment of David Drez Jr., MD as Chief Medical Officer.

As Chief Medical Officer, Drez will provide strategic leadership on all of Reinvent Biologics medical education and research activities. He will research and track current clinical trends and provide training and support to medical professionals to optimize patient outcomes with Reinvent Biologics products. He will also serve as a resource on Reinvent’s sales efforts.

With a career spanning more than 42 years, Dr. Drez is one of the nation’s leading experts in orthopedics and sports medicine. The co-author of the highly acclaimed Orthopedic Sports Medicine and co-editor of Operative Techniques in Sports Medicine, Drez was the 2017 recipient of the Jack Weakley Award of Distinction from the National Athletic Trainer’s Association for a lifetime of outstanding contributions directly impacting health care in the area of athletics, athletic training, or sports medicine. Drez served as a team physician at McNeese State University for 37 years and was inducted into the University’s Hall of Fame. The rehabilitation area of the University’s Sports Medicine Center was named in his honor.

“Dr. Drez has spent his career sharing his knowledge and experience with future generations of physicians. He is a man of great character with a passion to teach,” said Bryant Gaines, CEO of Reinvent Biologics. “Throughout his distinguished career, he has elevated the standard of care provided to the patient. With such a great amount of research coming out on regenerative medicine, Dr. Drez will put us in a position to digest the data and effectively disseminate the knowledge to our distributors and customers.”

Drez earned his undergraduate and medical degrees from Tulane University. He completed a residency in general surgery and in orthopedic surgery at Charity Hospital in New Orleans – Tulane Service. He has published a large body of peer-reviewed research that has focused primarily on athletic injuries and their prevention and treatment options, particularly injuries of the knee and shoulder. He served as a Clinical Professor of Orthopaedics at Louisiana State University School of Medicine in New Orleans and a Clinical Assistant Professor of Orthopaedic Surgery at Baylor College of Medicine in Houston.

“Working with Reinvent Biologics will give me the opportunity to connect orthopedic medicine and regenerative medicine,” said Drez. “It’s the right time to increase awareness of the true benefits of regenerative medicine.”

About Reinvent Biologics

Fort Worth-based Reinvent Biologics, LLC discovers, invents, develops, manufactures, and commercializes new and innovative products in the field of regenerative medicine. Our goal is to address serious medical conditions, across multiple and diverse therapeutic areas. We are focused on providing physicians cost effective treatment options while improving the standard of care through a complete offering of science based biologic solutions. Learn more at www.reinventbiologics.com.

Contacts

Reinvent Biologics
Joe Moore, 817-736-1557

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Artoss, Inc. Announces Hiring of William “Billy” Lapp as Director of Sales, East Coast

Posted On September 24, 2018 By OrthoSpineNews In Biologics /

September 24, 2018

Artoss, Inc. is pleased to announce the hiring of William “Billy” Lapp as Director of Sales, East Coast. In this role, Billy will be responsible for growing the sales of NanoBone^® Bone Graft in the region from Maine to South Carolina and west to Ohio and for identifying, training, and managing independent distributors in that region.

Paul Byerley, Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, said, “Billy has built a very successful sales career with small companies in the biotech industry and more recently in orthobiologics and tissue regeneration. He is uniquely trained to articulate the key advantages of NanoBone to orthopaedic and neurosurgeons. He has earned the respect of distributor partners and I know he’ll contribute to the continued growth of NanoBone sales in the US.”

“I’m excited to be joining Artoss as this stage in its development and look forward to expanding sales of NanoBone Bone Graft along the east coast.” said Billy. “It has been my dream to help build a great company delivering products that improve patients’ lives.”

NanoBone Bone Graft products have been used in Europe and the US for more than ten years in more than 100,000 clinical cases across all indications. They have been available in the United States through Artoss, Inc. since 2015.

For further information, please contact:

Artoss, Inc.

425 E Saint Germain St., Suite 106

Saint Cloud, MN 56304

320-259-4321

info@artossinc.com

Arkansas Surgical Hospital Announces New Procedure for Neck and Arm Pain

Posted On September 24, 2018 By OrthoSpineNews In Spine /

NORTH LITTLE ROCK, ARK. (PRWEB) SEPTEMBER 24, 2018

Arkansas Surgical Hospital is now offering patients who suffer from neck and arm pain a new, minimally-invasive procedure. The prodisc C Anterior Cervical Total Disc Replacement surgery uses a ball-and-socket implant designed to maintain range of motion in the spine while removing the patient’s diseased disc.

“This procedure is similar to the way we’ve been replacing hips and knee joints over the years,” said Phillip M. Porcelli, D.O., FACOS. “Applying this same technique to the spine allows us to address the patient’s back pain without impeding their mobility or range of motion. We’re able to replace a degenerated or diseased disc with an artificial implant that improves the patient’s natural spinal motion.”

The prodisc system is the most studied Total Disc Replacement System in the United States. Over 200 peer-reviewed studies have been conducted on the system. The initial prodisc C IDE clinical study evaluated the prodisc C Total Disc Replacement surgery compared to spinal fusion surgery. The study demonstrated that prodisc C surgery is a safe and effective alternative to fusion surgery for qualified patients.

“Before total disc replacement became available our options were often limited,” said Dr. Porcelli. “We would have to remove the diseased disc and fuse the vertebrae above and below together. This left the patient with reduced range of motion and increased the likelihood of more spine surgeries.”

ABOUT ARKANSAS SURGICAL HOSPITAL
Arkansas Surgical Hospital was founded in 2005 by a group of surgeons who wanted to provide high quality, patient focused care. As a physician-owned facility, the surgeons make the decisions that impact every level of patient care.

SOCIAL MEDIA CHANNELS
Facebook: https://www.facebook.com/ArkansasSurgicalHospital
Instagram: https://www.instagram.com/arksurgicalhospital/

Tobra Medical Announces National Launch of Tobra Bone Basket for Collection of Drilled Autograft Bone in Spine Surgery

Posted On September 24, 2018 By OrthoSpineNews In Spine /

WAKE FOREST, NC / ACCESSWIRE / September 24, 2018 / Tobra Medical Inc., a specialty medical device company focused on autograft bone and specimen collection, today announced the national launch of the Tobra Bone Basket, a user friendly, continuous filtration, mesh basket system that maximizes collection of autograft bone during high speed bone drilling, for use as a bone graft. The national launch of the Tobra Bone Basket coincides with the exhibit debut (Booth #1163) at this week’s North American Spine Society (NASS) meeting in Los Angeles, CA.

”During the past six-month, market focused pilot launch, spine surgeons have consistently commented that the Tobra Bone Basket is easy to use, does not interrupt their surgery, and collects a tremendous amount of autograft bone. Additionally, the handling characteristics of the collected autograft bone output are workable, moldable and manageable for spine surgeons,” said Tobra Medical Founder and President Brad Collins.

Mr. Collins continued, ”Hospitals, surgery centers, hospital networks, and group purchasing organizations have welcomed the Tobra Bone Basket due to its economic value and cost savings associated with the reduction and elimination of expensive allograft bone substitutes in use today . The Tobra Bone Basket assists the surgeon’s need for providing autologous bone to the fusion process and to the facility’s interest in reducing cost for expensive allograft bone substitutes.”

The key component of the patented Tobra Bone Basket is the unique removeable mesh basket. The size and pattern of the mesh basket has been specifically designed and tested to capture drilled bone particles, while allowing for a continuous non-stop filtration of blood and irrigation fluids. The 25mL mesh basket is removable for easy transport of autograft bone with minimal direct handling of bone output. The inversion capability of the mesh basket ensures complete retrieval of all bone particles, thus maximizing the output with little to no waste. The Tobra Bone Basket plunger helps to further assist bone particle separation when pressed by eliminating excess fluid from autograft bone and allowing for a workable output that is easy to use and manipulate.

For more information, please visit www.tobrabonebasket.com

About Tobra Medical

Tobra Medical is headquartered in Wake Forest, NC and is a specialty medical device company focused on autograft bone and specimen collection devices for use in the operating room. Founded in 2015 with a vision to innovate effective and economical autograft bone and specimen collection systems, Tobra Medical launched their first products in January 2018. Located in the Research Triangle Region of North Carolina, Tobra Medical leverages a collaboration of high performing medical engineers, surgeons, and operating room personnel to innovate solutions to improve better clinical patient outcomes. For more information, visit www.tobramedical.com or email info@tobramedical.com.

Contact:

info@tobramedical.com
(866) 777-1505

SOURCE: Tobra Medical Inc.

Gramercy Extremity Orthopedics® Receives US Patent for Variable Angle Locking Technology

Posted On September 24, 2018 By OrthoSpineNews In Extremities /

DALLAS, TX, USA, September 24, 2018 /EINPresswire.com/ — Gramercy Extremity Orthopedics (GEO®) receives US Patent No. 10,058,362 which covers a novel approach for Variable Angle Locking Technology. It provides various methods for taking advantage of the strength of machined threads in both the plate and screw by using inserts in the plate that allow the screw to be fixed at various angles and orientations. In the main embodiment, an insert can be attached to the end of a drill guide which also serves to orient and attach the insert to the plate. Once in place, the drill hole is made in perfect alignment with the screw hole in the insert. The insert contains machined threads just as a standard plate hole would, allowing a standard locking screw to be inserted at the desired orientation. The screw can also be easily removed, the insert re-oriented, and the screw replaced as desired.

“The granting of this US patent further enhances GEO’s ability to bring solutions to surgeon needs in the orthopedic marketplace”, says Michael P. Simpson, CEO and President of GEO®. “This technology will compliment future development projects while adding additional technology to the GEO CART®”

GEO® will be exhibiting at the Becker’s ASC Conference, Chicago, October 18th– October 19th, 2018. Please come see the GEO CART® and other GEO® offerings at Booth #15T.

About GEO®:

GEO® was founded on the idea that there could exist a more cost effective, user-friendly way to supply orthopedic medical implants in today’s healthcare environment. This is accomplished through the use of technology, a groundbreaking Point-of-Sale delivery system and GEO® designed sterile, single use disposable orthopedic implants and instruments. GEO is the only solution that provides a significant opportunity to lower real operating costs by creating efficiencies and controls throughout the delivery and consumption of orthopedic implants.

(www.gramercyortho.com)

Press Media Contact:

Michael Nugent
Gramercy Extremity Orthopedics
855-436-2278 x103
email us here

Distribution channels: Banking, Finance & Investment Industry, Business & Economy, Healthcare & Pharmaceuticals Industry, International Organizations, Technology

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Paradigm Spine Announces Company Activities Highlighting coflex® Interlaminar Stabilization® At NASS Annual Meeting 2018

Posted On September 24, 2018 By OrthoSpineNews In Spine /

NEW YORK, Sept. 24, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced its Company activities and scientific podium presentation on coflex^® Interlaminar Stabilization^® at the upcoming the 2018 North American Spine Society (NASS) Annual Meeting, being held September 26-29 in Los Angeles, Calif. coflex^® is the only posterior lumbar motion preservation solution with proven long-term outcomes for durable pain relief and stability for patients with moderate to severe spinal stenosis.

“The annual NASS meeting provides an optimal opportunity to directly engage with our U.S. spine surgeon audience and we look forward to demonstrating – on the podium and through our surgeon reception – the substantial results adding up from both our newly published ESCADA study and long-term findings from the U.S. FDA IDE trial supporting coflex^® against decompression alone and against fusion, respectively,” said Marc Viscogliosi, Chairman and CEO of Paradigm Spine.

Details of Paradigm Spine’s activities below:

Oral Presentation: Interlaminar Stabilization versus PLF in the ≤ 65 Year-Old Patient: Five-Year Follow-Up
Abstract: # 91
Session: Preserving Spinal Motion; Session moderated by Richard D. Guyer, MD
Date, Time: Wednesday, September 26^th at 4:41-4:47 p.m. PDT
Location: Room 403A
Presenting Author: Antonio T. Brecevich, MD
Institutions: Hospital for Special Surgery (HSS), New York, NY
Product: Coflex (Approved for this indication)

Paradigm Spine Sponsored Surgeon Reception
Date, Time: Thursday, September 27^th at 5:30-8:00 p.m. PDT
Location: GRAMMY Museum at L.A. Live
800 W. Olympic Boulevard, Los Angeles, CA 90015
(a 3-minute walk from the Convention Center)

To learn more about coflex^® Interlaminar Stabilization^® and the newly-published ESCADA results, please visit Paradigm Spine at Booth # 1429 in the Exhibit Hall.

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 60 countries worldwide. coflex^® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Author: OrthoSpineNews

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