October 14, 2016

MINNETONKA, Minn., Oct. 17, 2016 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 12-month fusion and clinical results for patients receiving SImmetry® Sacroiliac (SI) Joint Fusion with decortication. Study results were presented on Saturday morning at the 2016 Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting by Dr. William Cross, an orthopedic trauma surgeon at the Mayo Clinic in Rochester, Minn.

“Minimally Invasive SI joint fusion has been established as an effective treatment for certain patients suffering from SI joint disorders, but many technologies available today don’t follow the accepted orthopedic principles that lead to successful long-term fusion,” said Dr. Cross, the lead author and presenter at the SMISS scientific meeting. “For me, it’s common sense that SI joint fusion should include decortication and bone grafting to achieve long-term success. The results of this study provide compelling evidence that decortication and bone grafting may contribute to earlier fusion, and that the procedure provides significant pain relief at one year post-op.”

This prospective, multi-center study enrolled 19 patients at three institutions, who underwent a CT scan 12 and 24 months after receiving minimally invasive SI joint fusion with decortication and bone grafting. CT images were reviewed by a non-biased, independent radiology core laboratory to assess fusion in relation to the joint and the area of decortication. At 12 months, fusion was reported in 74% of patients, and back pain decreased from 7.9 to 2.2 (72%). Of patients in whom fusion was reported, 86% showed fusion in the area of decortication. Freedom from device- or procedure-related adverse events through 12 months was 100%. 24-month results for the study are expected in early 2017.

The SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Company will next exhibit at the 2016 North American Spine Society (NASS) meeting inBoston, Mass., October 26 – 28.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsⁱ. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointⁱⁱ.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.

ⁱ Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ⁱⁱ Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

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Logo – http://photos.prnewswire.com/prnh/20110118/CG30384LOGO

SOURCE Zyga Technology, Inc.

Related Links

www.zyga.com

OR AKIVA, Israel, October 13, 2016 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is proud to announce that Dr. Raphael Roybal from The Spine Institute at Chatham Orthopaedics, Savannah, GA., will present his clinical experience with the FLXfit™, the world’s only articulated and expandable cage with in-situ lordosis restoration, at the SMISS, Las Vegas (Oct 13-16, 2016).

Dr. Roybal, who has already implanted tens of FLXfit™ cages, “I wanted to compare lordosis correction between fixed and expandable lordotic cages using MIS TLIF approach”. And indeed, he says that “The results of an initial series with 6 months follow-up show that the use of the FLXfit™ expandable cage demonstrated increased correction of the sagittal alignment post-operatively compared to a fixed angle banana cage.” In Dr. Roybal’s eyes, “This is clearly understood by the configuration of the cage covering a wider footprint area with a more controlled expansion of the lordosis angle conforming to the unique patient’s anatomy. Additionally, the procedure is faster, easier and gentler to the patient due to the expansion mechanism.”

Dr. Roybal added, “A statistically significant improvement was noted in the group treated with the FLXfit cage vs. the fixed banana cage in all heights and lordosis measurements (p ≤0.02) and that maintenance of correction without subsidence in both groups was noted at 6 months.” He concludes that “The major advantage of the FLXfit™ over existing solutions is its ability to combine a big footprint, optimal anterior column support and significant bone graft volume while preserving the patient’s anatomy through a posterior, MIS, TLIF approach.”

Ofer Bokobza, CEO of Expanding Orthopedics, said that “We are very proud of Dr. Roybal’s achievement and honored by the selection to present at the renowned SMISS meeting.” He explains that “Dr. Roybal’s clinical results demonstrate the FLXfit™ ability to restore lordosis while maintaining it over time.” Ofer concludes that “We see a great momentum in the US market with more surgeons adopting the FLXfit™ as their preferred treatment option for their patients.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. (EOI) is a medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

October 13, 2016

October 4, 2016 – Wolters Kluwer Health: Lippincott Williams and Wilkins

The majority of U.S. National Football League (NFL) players who undergo surgery for a herniated disc in the upper (cervical) spine are able to resume their careers and perform at a high level, suggests a study in Spine, published by Wolters Kluwer.

Even players with “upper-level” cervical disc herniation (CDH) have a high return rate and can return to play with similar performance outcomes compared to their “lower-level” counterparts, according to the analysis by Dr. Harry T. Mai of the Department of Orthopaedic surgery at the Northwestern Feinberg School of Medicine, Chicago, and colleagues. The results may help guide decisions about surgery and the likelihood of returning to competition for players with these career-threatening injuries.

Good Chance of Continuing NFL Career after CDH Surgery

The researchers identified 53 NFL players who underwent surgery for a herniated disc in the cervical spine between 1979 and 2013. Forty players had confirmed data on the level of the disc injury: 15 had “upper level” CDH (involving the uppermost vertebrae of the neck) while 25 had “lower level” injuries. Forty-five percent of the players were defensive backs and linebackers.

October 5, 2016

Alpharetta, Georgia – Solvay’s medical grade KetaSpire polyetheretherketone (PEEK) and AvaSpire polyaryletherketone (PAEK) polymers enabled medical device pioneer, Shanghai Reach Medical Instrument Co., to develop a lighter, more ergonomic and highly cost-effective kit of reusable instruments for spinal surgeries.

“For decades, metal was the material of choice for medical instruments because conventional plastics could not deliver metal’s combination of high modulus, strong chemical resistance and compatibility with stringent sterilization methods,” says Xiaomin Huang, general manager of Shanghai Reach. “Today, Solvay’s broad range of specialty polymers is changing that reality – not only by offering metal-like performance, but by also enabling the fabrication of more complex and integrated parts through cost-effective injection molding.”

Shanghai Reach’s innovative kit includes six reusable instruments:  one rod bender, two pairs of distraction and compression pliers, and three awls. For the rod bender, the medical device-maker specified KetaSpire KT-880 CF 30 PEEK, a 30% carbon fiber-reinforced resin that delivers the high strength and stiffness necessary to bend implantable 5.5mm to 6.0mm titanium rods. For the pliers and awls, Shanghai Reach chose AvaSpire AV 651 GF 50 PAEK, a 50% glass fiber-reinforced resin offering a cost-effective balance of strength, stiffness and dimensional stability.

Typically, these parts would be made from stainless steel. But Shanghai Reach’s goal was to reduce instrument weight by up to 70% for improved ergonomics, yet not compromise on mechanical properties or sterilizability. In addition to lightweight strength and stiffness, Solvay’s two biocompatible polymers offer strong resistance to fatigue and are compatible with sterilization methods based on stringent chemicals, steam and even gamma radiation.

“Shanghai Reach’s innovative new kit highlights the ground-breaking value that Solvay’s advanced polymers are injecting into a healthcare market once dominated by metal,” states Jeff Hrivnak, global business development manager for healthcare at Solvay’s Specialty Polymers Business Unit. “We expect this trend to continue as we team with industry pioneers like Shanghai Reach to explore new possibilities for replacing metal medical instruments with more cost-effective, ergonomic instruments made from high-performance polymers.”

Solvay Specialty Polymers’ experience as a reliable materials supplier in the healthcare field spans more than 25 years. The company is a leading manufacturer of healthcare plastics, offering a broad range of high-performance, medical-grade plastics for orthopedics, sterilization cases and trays, medical and dental devices, as well as filtration media and housings for hemodialysis and water purification membranes. Solvay also offers a family of Solviva Biomaterials for use in a range of implantable devices.

Source: Solvay Specialty Polymers

October 06, 2016

KNOXVILLE, TN, October 5, 2016 – ChoiceSpine, a Knoxville, TN based spinal implant company, today announced it has appointed Christy Cote as Vice President of Biologics. She is a business leader with 14+ years’ experience in stem cell technology, surgical implants, and regenerative therapies. She’s had an award winning sales career and brings with her technical expertise and strategic development focused on developing a Biologics portfolio for ChoiceSpine. Prior to joining, Christy served as Vice President of Biologics of Amendia and Biologics Regional Vice President of Orthofix. She has a Bachelor of Science in Applied Biology with focus in Microbiology from The Georgia Institute of Technology.

If you would like more information about ChoiceSpine’s biologics offering please email info@choicespine.com

About ChoiceSpine
ChoiceSpine is a privately held spine company located in Knoxville, TN, and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use.

SAN JOSE, Calif., Oct. 5, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced it has submitted INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004) 2-year randomized controlled trial (RCT) data to Yale University’s Open Data Access (YODA) program as part of its ongoing effort to promote data transparency regarding its clinical trials. INSITE is a RCT of MIS SI joint fusion with iFuse compared to non-surgical management.  The trial enrolled 148 subjects at 19 centers in the U.S.  Earlier this year, SI-BONE initiated a partnership with YODA and released 2 year results from a sister study, SIFI (Sacroiliac Joint Fusion With iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion that included 172 subjects treated at 26 U.S. centers.  The goal of the partnership between SI-BONE and YODA is to make data from key clinical trials of sacroiliac joint fusion available to approved researchers to allow secondary analyses of clinical trial data and set a new standard for transparency of clinical evidence in medical devices.

SI-BONE’s iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed publications.  No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication statement that includes claims regarding improved pain, patient function and quality of life.

“Interest in clinical trial data-sharing has increased markedly, with several recent editorials in the New England Journal of Medicine on the topic. SI-BONE welcomes independent analysis of its clinical trial data, as it may shed new light on aspects of the treatment procedure. SI-BONE encourages its colleagues in both industry and academia to share their clinical trial data,” said Daniel Cher, MD, Vice President of Clinical Affairs, SI-BONE.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company develops, manufactures and markets minimally invasive products for the SI joint.  SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion.  iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). 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 product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.

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. 9734.100516 

SOURCE SI-BONE, Inc.