CTL Medical Secures FDA Clearance for Titanium Cage Device

Posted On July 26, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

DALLAS, TX – 07/25/2017 (PRESS RELEASE JET) — CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance to market its new MATISSE™ Titanium ACIF Cage implant with TiCro™ surface, used in the practice of spine fusion surgery.

The MATISSE™ Titanium ACIF Cage with CTL Medical’s proprietary TiCro™ surface technology offers 200 percent greater endplate contact surface area, as well as bone conforming geometry for increased mechanical locking at the cage and bone interface. The implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“Countless engineering hours and R&D resources went in to developing CTL Medical’s patent pending TiCro™ surface technology, which was designed to expand our current portfolio, advance fusion technologies, and offer spine surgeons numerous surgical advantages,” stated Danny Chon, president & CEO of CTL Medical Corporation. “The Matisse™ system includes streamlined instrumentation and a variety of footprints, heights and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE™ Titanium ACIF Cage with TiCro™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE™ Titanium ACIF Cage with TiCro™ is to be used with supplemental fixation, such as CTL Medical’s VAN GOGH™ Anterior cervical plating system, which has been cleared for use in the cervical spine.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

About CTL Medical Corporation
CTL Medical Corporation is a fully integrated, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talent, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

Media Contacts:

Company Name: TrizCom PR
Full Name: Jeff Cheatham
Phone: (972) 247-1369
Email Address: SEND EMAIL
Website: www.trizcom.com

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

Posted On July 26, 2017 By OrthoSpineNews In Regulatory, Top Stories /

WASHINGTON, July 26, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical device industry, today announced that it has authored a new white paper, “The Potential FDA Impact of the 2018 Presidential Budget Request”. Following the release of the 2018 budget request, MCRA looked to analyze the potential impact of funding the Food and Drug Administration (FDA) Medical Device Review Program exclusively through user fees.

As the medical device market grows due to continued innovation and changing demographics, it is imperative for industry to be able to successfully commercialize their technologies and procedures within a reasonable and definable time frame. Since its latest iteration in 2012, the Medical Device User Fee Program has helped speed up decision times. With the new proposed budget request, uncertainty is a challenge companies will have to overcome. MCRA looks to define and clarify some of that uncertainty with this white paper.

The white paper is the result of the collaboration between Vice Presidents Glenn Stiegman and Tim Hunter, Senior Director Keith Tode, and Associate Jack Kiraly. Mr. Kiraly, a recent addition to the MCRA team, had this to say: “We are concerned by the proposed budget, however, even if passed, there will still be opportunities for industry to navigate regulatory pathways to approval.” MCRA has the experience of former FDA professionals, as well as an integrated team of regulatory, clinical, quality, reimbursement, and healthcare compliance specialists.

For more information on MCRA, please visit www.mcra.com. To read the white paper click here.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

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Grossmont Orthopaedic Medical Group Performs First Meniscus Replacement in San Diego with NUsurface® Meniscus Implant

Posted On July 26, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

July 25, 2017

SAN DIEGO–(BUSINESS WIRE)–Dr. Scott A. Hacker, an expert in arthroscopic surgery, total joint replacements, sports medicine and fracture care, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedure in San Diego has been performed. Dr. Hacker is the only physician in San Diego County – and Grossmont Orthopedic Medical Group is one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the ability of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

The recipient of the implant was Justin Marchand, 40-year-old Carlsbad resident and father of six. Four years ago, Marchand tore the meniscus in his left knee while practicing Brazilian Jiu-Jitsu drills, only to suffer a second tear in the same knee in 2014 while jogging. Although he underwent two partial meniscectomies to treat the tears, he continued to suffer from constant pain and swelling in his knee. As an avid surfer for over 25 years, Marchand went from surfing every day to once per week at best – with the expense of pain flare-ups after each session. His knee became extremely vulnerable to any type of sudden movement, and he was forced to limit all sports activities, including mountain biking, skiing and hiking.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“There aren’t many great options for patients like Justin, who experience persistent knee pain following meniscus surgery but are too young for knee replacement surgery,” Dr. Hacker said. “We hope the SUN study finds that the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery. Patients routinely ask me for something simple that could be put in the joint – this is that option they have been waiting for.”

Marchand received the NUsurface Meniscus Implant on July 25 in a short operation during which the implant was placed into his left knee joint through a small incision. He will now undergo a six-week rehabilitation program, after which time he can begin to resume work, leisure and sports activities.

“For the last four years, I had resigned myself to living with knee pain and limited mobility,” Marchand said. “As a father of six children, it has been particularly heartbreaking because I have not been able to go surfing with my kids or participate in the outdoor activities we love. I am hopeful that the NUsurface Implant will help me get back to my active lifestyle and allow me to go hiking with my family without persistent knee pain.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel.

About Grossmont Orthopaedic Medical Group

Grossmont Orthopedic Medical Group is a premier Orthopedic center in San Diego caring for patients throughout southern California. The orthopedic surgeons of Grossmont Orthopaedic Medical Group, are consistently voted as top doctors in their field. As a group they have advanced training in arthroscopic surgery, total joint replacements, sports medicine and fracture care. The doctors are actively involved in many cutting edge research techniques allowing them to care for a wide range of orthopedic problems tailored to the individual and their needs. Their training, dedication, and experience are the prescription for successful orthopaedic treatment.

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

LongueVue Capital, in Partnership with Management, Completes Investment in Zavation Medical Products, LLC

Posted On July 26, 2017 By OrthoSpineNews In Spine, Top Stories /

New Orleans, Louisiana – July 25, 2017 – LongueVue Capital (“LVC”) is pleased to announce it has partnered with management to acquire Zavation Medical Products (“Zavation” or the “Company”) and provide capital for growth. Zavation is a designer and manufacturer of high quality spinal implants, instruments, and biologics. Zavation expands LVC’s healthcare portfolio and is the second medical device business LVC has partnered within the past 18 months.

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, and minimally invasive surgery. Founded in 2010 with its first sale in 2012, Zavation has experienced exceptional growth and created a national network of 100+ distributors across approximately 35 states. The Company has commercialized over 10 product families since inception, with 10 additional novel products expected to launch over the next two years. Zavation operates a 24,000 square foot vertically integrated facility with approximately 50 employees.

“Zavation has demonstrated exceptional growth and is a perfect cornerstone to our expanding healthcare portfolio. This is our fourth healthcare platform investment and our third in the past 18 months,” said Ryan Nagim, Principal and deal lead at LVC. “Furthermore, we believe the Company is at an inflection point and has the opportunity to become a market leader in the spinal implant sector, as management has shown an incredible ability to execute. As such, we look forward to our partnership with Zavation’s management team and driving significant growth, both organically and through acquisitions of unique technologies.”

“Zavation fits well within LVC’s investment strategy,” added Rick Rees, Founder and Managing Partner of LVC. “We love partnering with entrepreneur owned businesses at inflection points that have proven management teams willing to invest meaningfully alongside LVC. The Company’s rapid growth is a testament to management’s ability to capitalize on compelling demographics and other industry tailwinds favoring smaller, more agile, and customer focused OEMs. Lastly, although we are geographically agnostic, it is always great to partner with entrepreneurs in our back yard, the Gulf South. As such, we are incredibly excited to partner with management and welcome Zavation into the LVC family.”

“The management team at Zavation chose LVC due to their entrepreneur-friendly investment approach to value creation and their knowledge and expertise in growing middle market companies at inflection points like ours. With a shared vision and culture, we are confident Zavation will remain focused on its core values of excellent customer service and quality products,” said Jeffrey Johnson, President and CEO of Zavation. “LVC’s financial and operational resources will allow us to introduce new products, meet and exceed distributor and surgeon expectations, expand our market presence, and take market share at an even faster and more deliberate speed. We are excited for our Company, our distributors, our surgeons, and our LVC partners.”

Robert W. Baird & Co.’s healthcare team, led by Robert Andrews and Manish Gupta, served as exclusive financial advisor to LVC on the transaction. Abacus Finance Group, LLC provided the senior debt financing to Zavation Medical Products in support of the transaction. LVC’s legal counsel was provided by McGuireWoods, LLP.

To learn more information about Zavation and its products, visit www.zavation.com

About LongueVue Capital:
LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented equity and debt investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions and growth. LVC currently has $425 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

For inquiries, please contact lvc@lvcpartners.com or call 504-293-3600.

Vertera Spine Announces FDA Clearance of COALESCE™ porous PEEK Lumbar Interbody Fusion Device

Posted On July 25, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

ATLANTA, July 25, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCE™ Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine’s novel proprietary porous PEEK biomaterial and is the second porous PEEK device to receive FDA clearance behind Vertera Spine’s COHERE® Cervical Interbody Fusion Device. Vertera Spine will be launching COALESCE for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations later this year.

COALESCE combines the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. Unlike metal-coated PEEK implants that can delaminate, COALESCE’s porous PEEK architecture is grown directly out of the implant’s solid PEEK base and has an interfacial strength stronger than the shear strength of vertebral trabecular bone. Furthermore unlike 3D-printed metal implants, porous PEEK behaves mechanically similar to bone under compression, essentially eliminating any stress shielding effects, and does not produce any imaging artifacts enabling accurate visual assessment of fusion.

Vertera Spine’s porous PEEK was first clinically introduced in May 2016 with the launch of the COHERE device for anterior cervical discectomy and fusion (ACDF) procedures. To date, over 2,000 implants have been successfully implanted with early successful clinical outcomes already reported in a peer-reviewed publication.¹

“Based on the initial success with the COHERE Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications,” said Chris Lee, Vertera Spine CEO. “We are pleased to have received FDA clearance for COALESCE and look forward to further serving surgeons’ clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging.”

“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the COHERE device,” said Gurvinder Deol, MD, an early COHERE adopter from WakeMed Health and Hospitals in Raleigh, NC. “However, I believe porous PEEK’s true value will be demonstrated with the COALESCE device in lumbar procedures where the biologic fusion environment can be more challenging, and the biomechanics more demanding on fusion devices.”

Prior studies have demonstrated the importance of adding porosity to implants to create a strong bone-to-implant interface and more stable union.² Supported by extensive research at Duke University and the Georgia Institute of Technology, COALESCE’s porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores. Dr. Ken Gall, Ph.D., Chair of Mechanical Engineering and Materials Science at Duke University, will be presenting new benchtop and clinical research on porous PEEK at the upcoming NASS Summer Spine Meeting this week in San Diego, Ca.

According to Dr. Gall, “Our latest results show that porous PEEK is able to effectively osseointegrate by forming a mechanical and biological interface with bone. Our next steps are to translate what we have learned in animal models to the clinical setting by assessing this bony ingrowth into porous PEEK on X-Ray and CT.”

About Vertera Spine:
Vertera Spine is a privately-held medical device company that develops, markets, and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance, and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.comor call 678.705.9039.

COALESCE is a trademark of Vertera Spine. COHERE is a registered trademark of Vertera Spine.

¹Smith KE, Burkus JK, Gall K, et al. Getting PEEK to Stick to Bone: The Development of Porous PEEK for Interbody Fusion Devices. Techniques in Orthopaedics (accepted, in press).
²Svehla M, et al. Morphometric and mechanical evaluation of titanium implant integration: Comparison of five surface structures. J Biomed Mater Res, 2000.

Media Contact:
Jenn Pratt
Carabiner Communications
678.655.2273
jpratt@carabinercomms.com

Company Contact:
Lindsay Larson
Vertera Spine
571.758.3783
info@verteraspine.com

SOURCE Vertera Spine

Dr. Skidmore Reports Promising Results on a 30 Patients’ Series with EOI’s 3D Expandable FLXfit™ Cage

Posted On July 25, 2017 By OrthoSpineNews In Spine, Top Stories /

OR AKIVA, Israel, July 25, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is excited to announce that Dr. Grant Skidmore of Chesapeake Regional Medical Center has reported promising results with the FLXfit™ 3D Expandable TLIF Cage. Dr. Skidmore noted that “I take a lot of precautions in preserving the patient’s spinal anatomy and bony structure. My focus is on relieving the patient’s pain but also restoring his balance to assure a long term clinical outcome.” He said “With the FLXfit™, I finally have the ability to offer my patients the ultimate outcome thanks to the cage’s unique articulation and lordotic expansion feature.”

Dr. Grant Skidmore, Chesapeake Regional Medical Center, Norfolk, Virginia, explained “I am big believer of offering my patients immediate, robust and long term stability but was always puzzled how I could achieve this through a single and minimal posterior incision while preserving the spinal anatomy”. He concluded “our initial 30 patients’ series demonstrates the capability to place a large footprint cage at the front of the disc space, expand it lordotically in a controlled manner to achieve unique, anatomical fit, customized per patient.”

Ofer Bokobza, CEO of EOI, says that “we are excited to collaborate with such a skillful surgeon as Dr. Skidmore. His initial 30 patients’ series show very encouraging results and confirm the FLXfit™’s unique ability to restore lordosis and positively impact the patient’s sagittal balance.” Ofer emphasizes that “EOI recognizes the need for continuous clinical data collection through collaboration with leading surgeons. We believe that the FLXfit™ represents a new breed of expandable devices providing customized, anatomical fit solution that could lead to better patients’ outcome and new standard of care.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is 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 seasoned management team, and is advised by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through MIS approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)3219683

SOURCE Expanding Orthopedics Inc.

Thomas Wickiewicz, MD, Inducted Into the AOSSM Hall of Fame

Posted On July 25, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /

New York, NY—July 21, 2017

Thomas Wickiewicz, MD, sports medicine surgeon at Hospital for Special Surgery (HSS), was inducted today into The American Orthopaedic Society for Sports Medicine (AOSSM) Hall of Fame. This recognition is one of the highest honors given to an AOSSM member. Dr. Wickiewicz was presented with an award plaque during the AOSSM Annual Meeting in Toronto, Ontario.

“I am truly honored to be in the company of these extraordinary leaders in sports medicine,” said Dr. Wickiewicz. “I have focused my career on developing innovative minimally invasive surgical techniques designed to help patients get back to what they love doing most. For athletes of all levels, that is typically a return to sport.”

AOSSM Hall of Fame members are first nominated by their peers and then selected by the Hall of Fame committee. The Hall of Fame was established in 2001 to honor members of the orthopedic sports medicine community who have contributed significantly to the specialty. AOSSM is a world leader in sports medicine education, research, communication and fellowship, and includes national and international orthopaedic sports medicine leaders.

“Sports medicine is constantly evolving over the years as our research continues to advance the field,” said Dr. Wickiewicz. “Being a surgeon means being a student for the rest of your life. Education is critical to maintaining a robust medical practice over time.”

Dr. Wickiewicz joins fellow HSS sports medicine surgeon Russell F. Warren, MD, in the Hall.

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Posted On July 25, 2017 By OrthoSpineNews In Spine, Top Stories /

July 25, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Spinal Kinetics, Inc., the designer and manufacturer of the innovative M6^© artificial disc, today announced total implantations of the company’s M6-C Cervical and M6-L Lumbar discs have now exceeded 50,000 throughout the international markets where the M6 is commercially available. Since the launch of the M6-C in 2006 and the M6-L in 2010, this “natural,” artificial disc design has consistently established itself as a technology of choice among spine surgeons for both cervical and lumbar disc replacement. With this strong surgeon preference, as well as patient demand for the next generation artificial disc technology, the M6 has become an industry leader in the rapidly growing artificial disc market. Additionally, the company is preparing its Pre-Market Approval (PMA) application to the FDA to obtain United States approval to treat single level cervical degenerative disc disease with the M6-C. The M6-C IDE study enrollment has been completed, and the PMA application is scheduled to be submitted to the FDA later this year.

The M6 artificial disc is designed to help patients suffering from degenerative disc disease of the spine; a common cause of chronic neck and back pain. The M6 technology provides an alternative to spinal fusion and is designed to restore natural and physiologic motion to the spine. Preserving motion with the M6 artificial disc provides an opportunity to restore biomechanical function at the treated level after native disc removal, as well as the possibility to reduce subsequent degeneration of adjacent segments. The M6 is the only physiologically designed artificial disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus in its design. Like a natural disc, this unique construct of the M6 allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements. Extensive biomechanical studies at world renowned institutions have continuously confirmed the M6’s ability to replicate natural physiologic motion.

“We are extremely proud as an organization to reach the 50,000 implant level and are appreciative of the spine surgeon community in adopting the M6 technology,” states Tom Afzal, President and CEO of Spinal Kinetics. “We believe this milestone continues to validate the market demand for more advanced artificial disc technologies that are designed to closely mimic a natural disc’s motion characteristics, ultimately benefiting patient outcomes. Disc replacement in the cervical and lumbar spine is not solely about how much motion an artificial disc provides, but more importantly, the quality of that motion and how that motion can affect other surrounding structures like facets and adjacent segments. The M6’s ability to replicate a natural disc’s quality of motion and biomechanics is what continues to differentiate it against all other artificial discs in the market.”

About Spinal Kinetics, Inc.

Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to the unique biomechanical properties that replicate the motion of a natural disc and the positive clinical outcomes for patients. The company is located in Sunnyvale, California.

For more information on Spinal Kinetics or the M6 Artificial Disc, please visit www.spinalkinetics.com. Spinal Kinetics, M6-C, M6-L are trademarks or registered trademarks of Spinal Kinetics, Inc.

CAUTION–Investigational device. Limited by Federal (or United States) law to investigational use.

Contacts

Spinal Kinetics, Inc.
Mike Gandy, 408-636-2557
mgandy@spinalkinetics.com

Singapore launches $13M 3D printing center with focus on medical research

Posted On July 21, 2017 By OrthoSpineNews In Biologics, Top Stories /

Jul 21, 2017 | By Tess

A new 3D printing center with a focus on healthcare research was inaugurated in Singapore this morning. Called the National University of Singapore Centre for Additive Manufacturing (AM.NUS), the new facility is initially being funded by a grant of S$18 million (around $13,208,102) provided by NUS, the National Additive Manufacturing Innovation Cluster (NAMIC), and the Singapore Economic Development Board (EDB).

Researchers at AM.NUS, which was launched earlier today by Mr. Amrin Amin, a Parliamentary Secretary at the Ministry of Home Affairs and Ministry of Health, will reportedly work alongside the NUS’ Yong Loo Lin School of Medicine, as well as its Faculties of Engineering, Science, and Dentistry, and its School of Design and Environment.

The goal of establishing the new additive manufacturing center is to advance 3D printing technologies in the fields of biomedicine and healthcare and to “boost” NUS’ standing in the field of biomedical additive manufacturing.

“The NUS Centre for Additive Manufacturing will play a critical role in supporting Singapore’s vision of becoming a leading AM hub,” commented Professor Jerry Fuh Ying-Hsi, Co-Director of AM.NUS and the Thrust Lead of Restorative Repair & Implants from the Department of Mechanical Engineering at the NUS Faculty of Engineering.

“Through this inter-faculty pooling of expertise, we hope to boost technology capabilities as well as advance intellectual property development and commercialization of AM-enabled biomedical technologies.”

The new AM center will focus its research on a number of specific areas, including the development of customized 3D printed surgical instruments, simulators, and functional prosthetics; 3D printing-enabled customized medicine (i.e. personalized drug formulations, dosages, and drug release); advancing tissue repair using 3D printed scaffolds and tissue engineering; developing restorative repairs and implants with ceramic and metal 3D printing; and oral health and craniofacial applicaitons, which will be conducted with the NUS Faculty of Dentistry.

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Medtronic Announces Infuse Settlements

Posted On July 21, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

Walter Eisner • Thu, July 20th, 2017

Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product.

In a June 27, 2017 10K filing with the SEC, the company announced the agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing.

The company had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December 2016, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. That trial could have opened sealed internal documents that could have been used in other trials.

According to the Minneapolis Star Tribune, the company paid at least $85 million in a settlement to shareholders in 2012 to resolve allegations that it failed to reveal that most sales of Infuse were for off-label surgeries. In 2014, Medtronic said it paid $22 million to 950 injured Infuse patients. The company denied wrongdoing in each settlement.

Remaining Investigations

While the announcement settles private claims, the company is still under investigation by various state attorneys general who have issued subpoenas or document requests in Massachusetts, California, Oregon, Illinois, and Washington seeking more information regarding the Infuse device.

READ THE REST HERE