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Paragon 28® announces launch of JAWS™ Nitinol Staple System to address fracture and osteotomy fixation of the foot

Posted On July 26, 2017 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., July 24, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation to help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefiting both the surgeon and patient.

Paragon 28 designed the JAWSTM Nitinol Staple System for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

The JAWSTM Nitinol Staple System uses superelastic nitinol and a simple insertion method to gain rigid compression across an osteotomy site. Unlike many competitive implants, the JAWSTM Nitinol Staple System has a lightweight titanium inserter that allows the surgeon to fully seat the staple before it is released from the inserter. This allows for final placement of the staple before the staple compresses the osteotomy site.

Achieve compression upon insertion; no heating or electrical activation is required.

A low profile bridge (1.2 mm vs. competitive 1.5 mm or greater) helps minimize soft tissue irritation while the sharp-tooth geometry increases pull out resistance and helps resist migration during healing. Paragon 28 optimized the shape, angulation, and size of the staple legs to distribute compression evenly along the length of the legs. This helps eliminate plantar gapping and ensures consistent force across the osteotomy site.

All instrumentation for the JAWSTM Nitinol Staple System comes in a self-contained, disposable, sterile kit. The JAWS Nitinol Staple comes pre-loaded on the inserter to help facilitate a quick and straightforward surgery.

About Paragon 28, Inc. 
Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Product Pages: http://www.paragon28.com/products

CONTACT: Jim Edson, jedson@paragon28.com

 

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com

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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

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Providence Medical Technology Announces Regulatory Approval From Australian (TGA) For its DTRAX® Line

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

WALNUT CREEK, Calif., July 25, 2017 /PRNewswire/ — Providence Medical Technology, Inc., a developer of innovative cervical spine technology today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DTRAX line of instruments and implants used in tissue-sparing posterior cervical fusion. The TGA approval covers GL-DTRAX Spinal System, GL-DTRAX Cervical Cage-T System, GL-DTRAX Cervical Cage-B, GL-DTRAX Expandable Cage, and GL-DTRAX Bone Screw. Providence plans to submit products to the Prostheses List in August 2017 for inclusion in early 2018.

“We are excited to deliver our innovative spinal technology to the Australian market and provide patients with less disruptive options for cervical spine surgery,” said Michael Scott, VP of International with Providence. “Australiarepresents an important, strategic market as it boasts a robust healthcare system, offers established reimbursement, and has a history of embracing innovative treatments for spine surgery.”

Providence’s DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes, minimize complications, and reduce recovery times. Tissue-sparing posterior cervical fusion with intervertebral cages offers distinct advantages over traditional posterior fusion techniques. The products have seen continued, rapid adoption by spine surgeons, hospitals, and ambulatory surgery centers since their introduction and, to date, over 7,000 procedures have been performed worldwide.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits to the $2 billionworldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.

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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.

 

 

 

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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

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Painful Choices: Why The GOP Health Plan Had To Fail

Posted On July 25, 2017 By OrthoSpineNews In Regulatory /  

Published on , Forbes Healthcare Contributor

Pain is a more powerful emotion than pleasure. Loss has a far greater impact on the human psyche than gain. For these reasons, the Republican plan to “repeal and replace” the Affordable Care Act (ACA) had to fail. And if our nation fails to reform the healthcare delivery system, as well, the impact will be even more painful.

Seven years ago, not long after the ACA became law, the GOP reassured supporters that repeal would happen—that for the good of the nation it had to happen. In drafting their replacement plan, legislators embraced healthcare spending reductions as a path to lower taxes. As a result, each of the healthcare bills introduced this term would cause tens of millions of Americans to lose their health coverage.

Congressional Republicans underestimated the pain this would cause. Now, they’re the ones feeling it. With healthcare reform efforts in limbo, President Trump resolved last week to “let ObamaCare fail,” later telling White House reporters, “I’m not going to own it. I can tell you, the Republicans are not going to own it.”

No one can say when or whether those on Capitol Hill will make another attempt at repealing or replacing the ACA. But one thing is for certain. Reform or no reform, pain is coming. And for politicians, pain always has an owner.

The Source Of Pain 

Elected officials on both sides of the aisle recognize American healthcare today fails to deliver the quality and convenience patients deserve, especially given its $3 trillion annual price tag.

Healthcare today is dangerously expensive and inefficient, and will continue to be without radical change to the current system’s structure, financing and technology. For decades, these changes in care delivery have constituted the “third rail” of the debate, and few politicians have dared touch it. That’s because insurers, drug makers, national physician groups, hospitals and other institutional powers have openly, and effectively, lobbied against any legislation that would cause them financial harm.

This leaves the legislative process at an impasse. Unless care delivery is made more efficient, efforts to expand coverage, as Democrats desire, will demand higher taxes. And without delivery system reform, Republicans hoping to lower healthcare spending face the brutal reality that millions of people will lose coverage.

Photo: Mandel Ngan (AFP/Getty Images)

 

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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.

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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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Spinal Kinetics Surpasses 50,000 Implants of its M6© Artificial Disc Since Launch

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

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SpinalCyte acquires a new Japanese patent

Posted On July 24, 2017 By OrthoSpineNews In Regulatory /  

July 21, 2017

Houston – ( BUSINESS WIRE ) – SpinalCyte, LLC, a tissue engineering technology company that is based in Texas and focuses on the regeneration of the disc nucleus pulposus using human skin fibroblasts , today announced that Japan Patent 6151006 ” Method and composition for cartilage repair using body bioreactor “announced the registration.

The technique described in this patent concerns the preparation of a cell / scaffolding composition of chondrocyte or chondrocyte-like cells. In this patent, we apply human skin fibroblasts (HDF) to the scaffold and subject the fibroblasts to mechanical stress, hypoxia, intermittent hydrostatic pressure. Furthermore, this technique also describes the use of bone formation growth factor.

SpinalCyte ‘s Chief Executive Officer Pete O’Heiron says: “This new Japanese patent shows that we have independently achieved international protection on our fibroblast technology, and our international understanding to regrow cartilage using fibroblasts It will develop a property portfolio. ”

Thanks to this addition, 23 registered patents (US and overseas) directly owned by the company and 46 patents under application are owned by SpinalCyte’s portfolio.

About SpinalCyte, LLC

SpinalCyte, LLC based in Houston, Texas, as a tissue engineering technology company, has developed an innovative solution for nucleus replacement using human dermal fibroblasts. SpinalCyte currently holds 23 registered patents in the United States and overseas, and has applied for further 46 patents. SpinalCyte, which receives all of its investment from angel investors, symbolizes the advancement of next-generation medicine for biopharmaceuticals and cell therapy.

The official version of this press release is the original language version. The translated language version is provided for the convenience of the reader and has no legal effect. When using the translated language version as a document, we ask you to compare against the original language version which is the only version with legal effect.

Contacts

Investors:
SpinalCyte, LLC
Pete O’Heiron, 281-461-6211
CEO
info@spinalcyte.com
or
Media:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

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