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

Ethicon’s Novel Skin Closure System Leads To Higher Patient And Surgeon Satisfaction After Total Knee Replacement

Posted On September 24, 2018 By OrthoSpineNews In Recon /

SOMERVILLE, N.J., Sept. 24, 2018 /PRNewswire/ — Total knee replacement patients and their surgeons were more satisfied with the cosmetic results and less worried about after care and possible infections when the DERMABOND PRINEO Skin Closure System was used to close the knee’s surgical incision rather than traditional skin staples, according to a new quantitative research study conducted by Ethicon,* part of the Johnson & Johnson Medical Devices Companies,** the manufacturer of the novel skin closure device that combines a topical skin adhesive with a self-adhering patch.¹

As a replacement for sutures or staples, the DERMABOND PRINEO System provides minimally invasive closure — no holes in the skin; no sutures or staples to remove, and no dressing changes, which may potentially reduce follow-up visits and support good cosmetic results for patients.² The DERMABOND PRINEO System has been used to close the surgical incisions of more than 1 million patients.

The double-blinded quantitative study (90% CI) of 88 total knee replacement patients and 83 orthopaedic surgeons, found more patients had overall greater satisfaction with the proven DERMABOND PRINEO System (88.2% vs. 81.8%) and were happier with the appearance of their skin incision (80% vs. 71%). Fewer patients were worried about post-operative care (55% vs. 63%) or concerned about complications (56% vs. 60%) when the DERMABOND PRINEO System was used.

Orthopaedic surgeons were more satisfied with the DERMABOND PRINEO System too, but by even wider margins than their patients. Overall surgeon satisfaction was 83.7 percent compared to 56.1 percent for skin staples. Surgeons felt the System led to greater overall patient satisfaction (84% vs. 45%), better cosmetic results (88% vs. 40%) and better overall healing of the knee incision (82% vs. 52%). Surgeons were also less worried about surgical site infections (77% vs. 52%).

“I like DERMABOND PRINEO because I think it creates a water tight skin closure of the arthrotomy, which is important for addressing some of the risk factors for surgical site infections and is also nice for the patient,” said Dr. Ryan Nunley,***Associate Professor of Orthopaedic Surgery at Washington University, St. Louis MO, and orthopaedic surgeon at Barnes Jewish Hospital. “With PRINEO, the patient may start showering soon after the procedure and feel like a normal person again, and mentally I think this helps them achieve a faster recovery period. We don’t see the train track appearance of staples and don’t need to have home nurses come to the house to remove staples or do wound management, so there is the convenience factor as well, and this is also a cost savings by eliminating the home nursing visits or additional office visits as we enter into the world of bundled payments for total joint,” said Dr. Nunley.

The new research adds to a growing body of evidence showing the value of the DERMABOND PRINEO System in orthopaedic surgery. Recently, two economic analyses demonstrated that its use may be associated with improved patient outcomes and lower healthcare costs for hospitals.^3,4 Both studies were presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22^ndAnnual International Meeting in 2017.

Building on a legacy of 20 years in topical skin adhesives, Ethicon offers a comprehensive portfolio of skin closure systems for a wide variety of incision lengths and closure strength needs, including DERMABOND PRINEO Skin Closure system (42cm) – a new configuration for longer incisions to address growing customer needs in hip, knee and spine surgery. The DERMABOND family of products are the only skin closure devices backed by an extensive body of evidence, including 5,718 patients across 51 Randomized Controlled Trials (RCTs).****

For complete indications, contraindications, warnings, precautions, and adverse reactions associated with the DERMABOND PRINEO System, reference the full package insert.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies** have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopaedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon and LinkedIn.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon, LLC is the legal manufacturer of DERMABOND® PRINEO® and STRATAFIX™ Knotless Tissue Control Devices. All other trademarks are the property of their respective owners.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, interventional and specialty solutions businesses within Johnson & Johnson’s Medical Devices segment.
***Dr. Ryan Nunley is a paid consultant for Ethicon.
****Based on published literature in PubMed and SCOPUS, using only RCTs that evaluated the use of the product in a manner consistent with intended indication.

¹ Double-blinded quantitative research study comparing surgeon experience with DERMABOND PRINEO System (22 cm) and skin staples in total knee arthroplasty. N=83 Orthopaedic surgeons. 90% CI. Fielded June/July 2017.
² Ethicon Inc. DERMABOND PRINEO Skin Closure System (22cm) Instructions for Use. LAB100114233v2. 5/15
³Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
⁴ Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N. A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.

087415-180205

SOURCE Ethicon

NuVasive Expands Biologics Portfolio To Meet Clinical And Economic Needs

Posted On September 24, 2018 By OrthoSpineNews In Biologics /

SAN DIEGO, Sept. 24, 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 U.S. commercial launch of three new biologics offerings to include traditional bone allograft, amniotic membrane DS and additional form factors to the current Propel^TM DBM product line. This portfolio expansion demonstrates the Company’s strategic efforts to deliver the most differentiated biologics portfolio in the spine industry.

NuVasive’s newest biologic product lines help promote enhanced clinical outcomes for patients, improved economic outcomes for hospital systems, as well as meet the variety of handling preferences of spine surgeons:

Traditional Bone Allograft includes cancellous chips, demineralized cancellous chips, cortical cancellous chips and cancellous crushed, which all function as economical bone graft options. Traditional Bone Allograft has osteoconductive properties that provide a scaffold for bone growth, and can be packed into bony voids or gaps in a patient’s skeletal system. This product is available in a variety of grind sizes and volumes.
Amniotic Membrane DS is a double-sided layer of human amniotic membrane intended to be a biologic barrier that may help prevent adhesions and reduce scar tissue formation near adjacent muscle, nerve and fascia layer tissue. The strong, pliable properties of this biologic help it adapt to the surrounding anatomy making it easy to handle and position into place. Amniotic Membrane DS is naturally rich in growth factors and has been shown to control inflammation and reduce bacterial and viral activity at the surgical site, supporting the patient’s overall healing process.
Propel DBM product line, launched in 2017, now introduces gel, gel plus and putty plus as additional form factors with enhanced handling properties to address surgeon preferences. The gel form factor is packaged in a syringe for convenient graft delivery, while Propel DBM putty plus and gel plus contain cancellous chips for additional osteoconductive properties helping promote bone growth. With a variety of DBM form factors available, surgeons can tailor the graft selection to the clinical needs of the patient.

“The addition of these three new product lines strengthens our comprehensive spine portfolio and further positions NuVasive as a full-service provider of biologics,” said Matt Link, executive vice president, strategy, technology and corporate development for NuVasive. “NuVasive is committed to investing in innovative offerings to meet the clinical and economic needs of our patients, surgeons and hospital partners.”

About NuVasive
NuVasive, Inc. (NASDAQ :NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

SpinalCyte to Feature Fibroblast-Based Cell Therapy Results at the 2018 North American Spine Society Annual Meeting

Posted On September 24, 2018 By OrthoSpineNews In Biologics /

HOUSTON, Sept. 24, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of spinal discs using Human Dermal Fibroblasts, today announced it will be showcasing its fibroblast-based cell therapy product CybroCell at the North American Spine Society (NASS) 2018 Annual Meeting Sept. 26 – 29 in Los Angeles.

The company recently published data in The Spine Journal that suggest fibroblast cell therapies can prevent the degeneration and promote the regeneration of spinal discs. This publication is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/. The transplantation of dermal fibroblasts was found to significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged.

“The data we’re sharing at NASS demonstrate that CybroCell has the potential to fundamentally change the way back pain is treated,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “With our strong intellectual property position and ongoing Phase 1/Phase 2 trials, SpinalCyte has the potential to relieve pain and improve function for millions who currently have no viable treatment options.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact:
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Month: September 2018

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