Michelle Willard – mwillard@dnj.com – December 16, 2016

Back pain sufferers will try anything to relieve the constant pain from therapy to medications to injections before going under the knife.

That was no different for one patient at TriStar StoneCrest Medical Center in Smyrna.

Daniel Gamber had done everything short of surgery to relieve his nerve pain originating in the neck, said Dr. James Fish, an orthopedic spine surgeon affiliated with Hughston Clinic.

“Every patient that enters our doors is different, which is why TriStar StoneCrest Medical Center continues bringing alternative spine surgery options to our community,” Fish said. “We have to be able to provide the best treatment, surgical or non-surgical, for each patient based on their pathology.”

In the case of Gamber, the best option was a ground-breaking procedure, the first two level cervical disk replacement in Rutherford County.

Fish performed the disk replacement at StoneCrest. This procedure is less invasive that other surgical procedures and reduces the likelihood of additional surgical needs, especially in young patients.

“Continuing to bring alternative spinal surgery to our suburban-based hospital is exciting for TriStar StoneCrest Medical Center and Rutherford County,” Fish said about the surgery that aims to remove a damaged disc in the spine that is causing pain and replace it with an artificial disc.

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SAN JOSE, Calif., Dec. 15, 2016 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC), an independent licensee of the Blue Cross and Blue Shield Association (BCBSA), has issued a positive medical policy exclusively for iFuse for MIS SI joint fusion (SUR705.033).

HCSC is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, with approximately 15 million covered lives insured through Blue Cross and Blue Shield^® (BCBS) Plans in Illinois, Montana, New Mexico, Oklahoma, and Texas. The positive coverage policy, which becomes effective January 1, 2017, covers MIS SI joint fusion exclusively using iFuse, based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse Implants™ for SI joint fusion.  HCSC joins SelectHealth of Utah and Geisinger in Pennsylvania to become the third private insurer to issue a positive coverage policy for MIS SI joint fusion exclusively using iFuse.  In addition, the five BCBS plans within HCSC join BCBS of Michigan and BCBS of Nebraska to provide iFuse coverage for BCBS members in seven states.

The policy calls out almost 3 dozen iFuse publications, including two randomized controlled trials (RCTs) comparing iFuse to non-operative care (INSITE and iMIA), long term results from a multicenter prospective single-arm trial (SIFI), as well as data from dozens of additional scientific publications addressing safety, durable effectiveness, biomechanics and cost effectiveness.  The policy summary states “based on professional societal organizations, literature reviews, in vitro studies, surveys, and cost-effective studies showing success and/or support for treating SIJ dysfunction with minimally invasive SIJ fusion, including a 2016 retrospective study group of patient surveys greater than 3 years, the evidence is sufficient to determine the effects of the technology on health outcomes.  Therefore, minimally invasive SIJ fusion or stabilization, using titanium triangular implants or devices, for the treatment of back pain presumed to originate from the SIJ may be considered medically necessary when meeting all of the specific criteria.”  iFuse is the only SI joint fusion device in the U.S. with peer-reviewed publications detailing evidence from prospective trials, and is the only SI joint fusion device with a FDA-cleared indication citing clinical studies that demonstrate improvements in pain, patient function and quality of life.

“The quality and quantity of clinical data supporting iFuse is compelling and was obviously a key element in enabling HCSC to establish exclusive coverage for iFuse,” said Frank Phillips, MD of Midwest Orthopaedics at Rush in Chicago, IL.  “Blue Cross Blue Shield patients make up a considerable part of my practice and now, those with SI joint pain caused by SI joint degeneration or disruption will have access to this clinically proven treatment.”

Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: “this is terrific news for Blue Cross Blue Shield patients throughout the state of Texas.  I frequently see BCBS patients in my practice who have SI joint pain and now, for those who are properly diagnosed and appropriate surgical candidates, I can offer them the iFuse procedure and eliminate the need for other costly procedures that fail to provide lasting relief of their SI joint symptoms.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotation of the sacrum relative to the illium.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth, facilitating long-term fusion of the joint.  iFuse is the only commercially available SI joint fusion system in the United States with published clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  It is the only SI joint fusion system with a FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9751.121516

SOURCE SI-BONE, Inc.

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WARSAW, Ind., Dec. 13, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of PrimaGen Advanced Allograft, an autograft substitute containing the same bone healing elements as autograft, but without the risks associated with donor site morbidity or harvest site complications.  Allograft is human tissue transplanted from a donor to a patient, while autograft tissue is transferred from one part of a patient’s body to another.  PrimaGen Advanced Allograft offers a combination of demineralized cortical bone fibers with verified osteoinductivity and cancellous bone, providing a trabecular structure for natural bony in-growth with optimal handling and delivery characteristics.

Dr. Donald Kucharzyk*, Orthopaedic Surgeon at The Orthopaedic, Pediatric and Spine Institute in Crown Point, Ind., was one of the first surgeons to use PrimaGen Advanced Allograft.  “The syringe allows for easy preparation and replication of the graft consistency prior to each use,” noted Dr. Kucharzyk, who was pleased with the new delivery system, as well as the handling, moldability and stability under irrigation.

PrimaGen Advanced Allograft is designed to provide all three components essential for bone growth and healing: osteoconductivity, osteoinductivity and osteogenicity. Advanced testing of each donor tissue verifies the following:

• Cells in cancellous bone, which provides an interconnected trabecular structure, remain viable post-thaw;
• The graft contains at least 750,000 cells per cubic centimeter (cc) of cancellous tissue with at least 70 percent cell viability; and
• The cells present are able to differentiate into mature osteoblasts, which is critical for new bone formation.

“PrimaGen Advanced Allograft was developed to overcome the limitations of other bone graft substitutes and designed to offer a real alternative to autograft,” said Adam Johnson, Zimmer Biomet’s Group President of Spine, Dental, CMF and Thoracic.  “We are pleased to include within our Spine portfolio a graft that not only has desirable handling characteristics, but is simple and convenient to use.  PrimaGen Advanced Allograft recreates the Gold Standard, while reducing the co-morbidities tied to graft harvest.”

PrimaGen Advanced Allograft is indicated for use as an allogeneic bone graft substitute containing viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient’s tissue in musculoskeletal defects. These defects may be surgically created defects or defects created from traumatic injury to bone.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

*Dr. Kucharzyk is a paid consultant of Zimmer Biomet Spine.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that Alexis V. Lukianov has been named to its Board of Directors. Mr. Lukianov’s appointment expands the Board to 10 directors, 9 of whom are independent directors.

With more than 30 years’ experience, and an extensive background in orthopedics, Mr. Lukianov has held senior executive positions with companies such as Medtronic SofamorDanek and Smith and Nephew Orthopaedics, where he was the director of a business unit that brought limb lengthening technology to the United States from Russia. He was the founder of and served as the Chairman of the Board and CEO of BackCare Group, Inc., a spine physician practice management company, and from 1999-2015, Mr. Lukianov served as the Chairman and CEO at NuVasive, Inc.

“We are pleased that Alex Lukianov will join our Board of Directors. As a senior experienced executive in the med-tech industry, Alex will be a valued strategic participant as we continue to focus on developing our growth opportunities,” said Ron Matricaria, Chairman of the Board.

An entrepreneur, Mr. Lukianov has served on a variety of public, private and not-for-profit boards including the Volcano Corporation, the California Health Institute, BIOCOM, and the Medical Device Manufacturers Association (MDMA).

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161213006261/en/

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

Source: Orthofix International N.V.

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