CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA

Posted On July 27, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

HERZELIYA, Israel, July 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear system provides unique clinical advantages to spine cancer patients and their physicians. Among those advantages are: no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue, minimal attenuation of External Beam Radiation (EBRT), allowing radiation to pass through the implant with almost zero reduction in the radiation dose level; and no artifact in CT, for optimal radiation CT planning. CarboClear spinal implants also offers superior fatigue strength, beneficial for a patient population known for extended delays in healing. Additionally, the CarboClear Pedicle Screw System offers enhanced follow up abilities due to minimal CT/MRI artifact.

Dr. Stefano Boriani, head of oncological spine surgery of GSpine4 at the Galeazzi Institute Milano, said of his clinical experience with the CarboClear® system: “This unique material provide us with additional treatment options that we didn’t have in the past, and in our experience provides better clinical outcomes for the treated patients.”

About CarboFix Orthopedics LTD.

CarboFix Orthopedic Ltd, is recognized as the world’s leading company in developing, manufacturing and marketing innovative carbon fiber orthopedic solutions. CarboFix Orthopedics’ headquarters and manufacturing are located in Herzeliya, Israel, with additional manufacturing for the Asia market in Guangzhou, China. CarboFix is working in the United States through its subsidiary CarboFix Inc. and in the rest of the world through a network of distributors. The company’s products are approved by the FDA, CE and other regulatory bodies.

For more information, please visit www.Carbo-fix.com, or reach out directly to

Ron Szekely

Int’l V.P., Sales & Marketing

Ron@carbo-fix.com

SOURCE CarboFix Orthopedics LTD.

NuVasive Unveils Spine’s First Integrated Surgical Automation Platform

Posted On July 27, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

SAN DIEGO, July 27, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s ecosystem enabling better surgery. Pulse introduces 2D- and 3D-navigation and smart imaging capabilities while integrating the Company’s leading neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies. This single platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centers.

“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” said Dr. Stephen Ryu, neurosurgeon at the Palo Alto Medical Foundation in Palo Alto, Calif. “Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”

Pulse’s FDA clearance marks a major milestone in the Company’s commitment to introduce 2D- and 3D-navigation technology built on a platform of the Company’s NVM5® nerve monitoring system, LessRay®, Bendini® and Integrated Global Alignment® (iGA®) systems. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimized workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilize various modules in parallel and further drive OR efficiencies.

“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”

To help surgeons overcome frequent visualization challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimized procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.

NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting held September 26-29, 2018 in Los Angeles, Calif.

About NuVasive

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

Forward-Looking Statements

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

SOURCE NuVasive, Inc.

House Votes Overwhelmingly To Kill Obamacare’s Tax On Medical Devices

Posted On July 26, 2018 By OrthoSpineNews In Regulatory /

July 25, 2018 – Julia Cohen | Reporter

A bipartisan majority in the House voted to repeal President Barack Obama’s 2.3 percent medical device tax Tuesday.

The repeal passed 283-132, with 57 Democrats and all but one Republican voting in favor. North Carolina Republican Rep. Walter Jones was the sole Republican against the bill.

“Minnesota’s innovators can breathe easier since we’re one step closer to ending the medical device tax for good,” Minnesota Republican Rep. Erik Paulsen, the bill’s sponsor, said in a Tuesday press release. “Today’s vote shows strong bipartisan support for lifting this burden on innovators in an industry so important to Minnesota. I’m more optimistic than ever we’ll be successful in giving these job creators the certainty and predictability they need to thrive.”

The repeal will reduce federal tax revenue by about $22 million over the next 10 years, according to a Wall Street Journal article.

The tax was temporarily rolled back in 2016, and Congress extended the rollback to 2020. Paulsen’s bill makes the repeal permanent.

“This bipartisan legislation will make healthcare more affordable and ensure Americans have access to the most innovative life-saving and life-improving medical technology,” Speaker Paul Ryan tweeted Tuesday.

Good news→ The House just voted to repeal Obamacare’s Medical Device Tax. This bipartisan legislation will make healthcare more affordable and ensure Americans have access to the most innovative life-saving and life-improving medical technology — Paul Ryan (@SpeakerRyan) July 24, 2018

Despite bipartisan support, some senators are unsure if the bill will make it to the Senate floor by the end of 2018.

READ THE REST HERE

206 Ortho Secures a Core Patent for Bio-Inspired Technology that Could Eliminate the Billions Spent on Implant Removal Surgeries

Posted On July 26, 2018 By OrthoSpineNews In Regulatory /

DEERFIELD, N.H. (PRWEB) JULY 24, 2018

206 Ortho announced today that the United States Patent and Trademark Office has issued US 10,010,609 entitled “Method and Apparatus for Treating Bone Fractures, and/or for Fortifying and/or Augmenting Bone, Including the Provision and Use of Composite Implants.” This patent covers a new bio-inspired composite and implants developed by the company that could fix broken bones without the need for removal surgery. The issuance of this patent is a major step towards replacing permanent metal implants.

206 Ortho’s biocompatible composite is designed to repair load-bearing bone and then resorb leaving no trace. The company has created a high strength biodegradable material made of fibers composed of minerals naturally found in the body bound by a biodegradable polymer. These materials are already proven and in use in orthopedic implants, sutures and other medical devices.

Metal implants have been used for over 100 years to provide stability for fractured bones during healing. However, roughly 4 out of 5 patients live with pain and discomfort and ~40% of patients undergo surgery to remove the metal implant due to the pain. These implant removal surgeries significantly increase the average cost of overall treatment, adding over $12 Billion dollars to the cost of healthcare and additional patient trauma.
206 Ortho’s technology has the potential to improve patient outcomes and quality of life while eliminating the Billions of dollars spent on the removal of metallic implants.

“This patented technology adds to our existing and growing portfolio of patented biomaterials and implants capable of changing the way orthopedic injury will be treated and managed,” said Jeff D’Agostino, Founder and CEO of 206 Ortho. “We are confident that the 206 Ortho’s expanding intellectual property estate, including this newly issued patent, will impact the effectiveness and costs associated with orthopedic surgery. This is particularly important as our global healthcare system evolves to a value-based patient care model.”

With the issuance of this new patent, 206 Ortho intends to seek additional funding and potential commercialization partners for its orthopedic surgical products.

206 Ortho is a privately held company founded in 2011 through the Arthur M. Blank Center for entrepreneurship at Babson College to develop and commercialize solutions for healing bone fractures which would positively impact patients’ lives and make healthcare more affordable globally. Their goal is to help people with bone fractures get back to their lives faster without permanent implants, fewer complications, less discomfort and at a reduced treatment cost. Bringing together the best thinking from across a broad range of industries they have created and protected the optimal solution, including patent 26 filings. 206 Ortho’s resorbable composite delivers the next generation in orthopedic care.

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

Posted On July 24, 2018 By OrthoSpineNews In Regulatory, Spine /

July 24, 2018

AARHUS, Denmark–(BUSINESS WIRE)–FBC Device ApS, a medical device company focused on restoring natural alignment of the spine through innovative interbody implants, has received its first US FDA clearance for its technology, enabling access to the US market.

Professor Finn Christensen, MD, PhD and founder and CEO of FBC Device says: “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:

Regulatory approval, now in the US along with a second implant that has been CE marked since 2013.
Patents granted around the world to protect these two implant designs as well as others to follow.
Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”

The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the Company will immediately engage interested parties capable of bringing the technology to large markets across the world.

For more information, visit www.fbcdevice.com

About the FBC Technology

Each individual has different alignment requirements – it is not one size fits all. The FBC technology is a two-piece interbody fusion device that allows for in-situ adjustment from 9-21 degrees, enabling surgeons to simply adjust alignment for each patient’s need and then lock the two pieces relative to each other.

Contacts

FBC Device ApS
Prof. FB Christensen
Email – finn@fbcdevice.com

MCRA Hires Bonnie Clothier, PhD, RN, Associate Director, Payor Relations, to Further Expand Reimbursement Payor Relations Service Division

Posted On July 19, 2018 By OrthoSpineNews In Regulatory /

WASHINGTON, July 19, 2018 /PRNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization (CRO) to the medical device industry, is pleased to announce the recent hire of Bonnie Clothier, PhD, RN, as its Associate Director, Payor Relations, to further expand its medical technology reimbursement payor relations expertise and service offerings.

Ms. Clothier most recently worked for Independence Blue Cross where she was responsible for reviewing and updating medical policy coverage positions, providing clinical rationale for appropriateness of medical billing codes (ICD10, CPT and HCPCS), and analyzing utilization patterns of claims data.

In her role at MCRA, Ms. Clothier will be responsible for providing internal and customer support to help identify specific payor issues and develop plans for gaining or improving U.S. coverage with health plans for new and innovative technologies.

Ms. Clothier said, “I am honored to join a talented, dynamic firm where I can leverage my private payor experience with my clinical and research background to assist MCRA’s clients with successfully obtaining covered access to evidenced-based care.”

Tim Hunter, MCRA’s Vice President of Health Economics, Reimbursement, and Public Policy said, “MCRA has a long history of working with payors to help them understand the important role and benefits of innovative medical devices and their associated procedures. We are excited that Bonnie has joined our Payor Relations team; with her combination of clinical and commercial insurance experience she will expand our ability to provide patient access to appropriate medical care.”

For more information on MCRA, please visit www.mcra.com

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. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown

General Manager, MCRA, LLC

Phone: 212.583.0250 ext. 2111

Email: dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices

Posted On July 19, 2018 By OrthoSpineNews In Regulatory /

MARIETTA, Ga., July 18, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has appointed Mark P. Graves to the position of Chief Compliance Officer. Mr. Graves will be responsible for providing direction and oversight of MiMedx’s compliance program, including the Company’s regulatory and legal compliance matters related to the Company’s risk management, sales operations and financial reporting. Mr. Graves will report to Ed Borkowski, the Company’s Executive Vice President and Interim Chief Financial Officer on a day-to-day basis. He will also report directly to the newly formed Ethics and Compliance Committee of the Board of Directors.

“We are implementing plans to improve our corporate compliance practices in order to ensure our Company adheres to policies with the highest integrity, ethics and legal standards,” said David Coles, interim Chief Executive Officer, MiMedx. “Mark has a strong background in driving compliance strategy, risk awareness, training, and crafting effective policy. He will help MiMedx apply and execute on best-in-class compliance standards that reflect our commitment to enhancing value for all stakeholders. We are pleased to welcome him to our organization.”

Graves brings more than 20 years of pharmaceutical and biotech industry experience to MiMedx, ranging from compliance and sales management to government affairs. He most recently was the U.S. leader for the global Patient Experience & Value function in the neurology division of UCB, Inc., a biopharmaceutical company. From 2011 to 2015, he was UCB’s Deputy Compliance Officer involved in all aspects of compliance, including the implementation and management of the company’s corporate integrity agreement. Prior to that, Graves was Senior Director in the Office of Ethics and Compliance for the Pharmaceutical Products Division of Abbott Laboratories, as well as Deputy Ethics & Compliance Officer for Takeda Pharmaceuticals North America, Inc. and TAP Pharmaceutical Products, Inc. Prior to his pharmaceutical and biotech career, he practiced labor and employment law.

Graves holds a B.A. in Criminology and Law, and a J.D. from the University of Florida as well as an MBA from the University of Chicago Booth School of Business.

The Audit Committee and the Company are developing and implementing corrective measures to improve MiMedx’s accounting and internal control practices. As part of this initiative, and as noted in the Company’s June 7, 2018 press release, the MiMedx Board of Directors established an Ethics and Compliance Committee, which includes independent directors Luis A. Aguilar and Neil S. Yeston M.D. The Company also is conducting a formal search to fill the newly established positions of Chief Accounting Officer and Internal Auditor.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion

Posted On July 18, 2018 By OrthoSpineNews In Regulatory, Spine /

July 17, 2018

NASHUA, N.H.–(BUSINESS WIRE)–Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus® nanotextured¹ surface created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology.

PEEKplus® is the first and only FDA-cleared nanotextured surface on a PEEK interbody device.

Vallum’s PEEKplus® nanotextured surface is unique in the spinal device market. Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus®. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.^2,3

PEEKplus is not a coating, it is not porous, and no chemicals are infused into the PEEK.

“Technological advances to improve the performance of implantable medical devices are taking many forms,” said Prof. Elazer R. Edelman, MD, PhD, who provided the earliest advice and encouragement to Vallum’s management team. “I believe one of the most important of those technological advances is surface modification at the nano-scale, and Vallum’s FDA clearance is a significant step down that very promising path.”

While this FDA clearance is specific to Vallum, its nanotexturing technology can be inexpensively applied to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties. Exact same PEEK interbody device – only now, truly differentiated in the spine market with a PEEKplus® nanotexture.

“Our PEEKplus® is a breakthrough innovation in spinal fusion surgery and the result of a collaborative effort among surgeons, researchers, ion beam scientists, and biomedical engineers,” said Stephen M. Blinn, President and CEO of Vallum. “A substantial investment in time and capital has been made in developing our proprietary ANAB processing technology as well as the nano-processing techniques and protocols used to produce PEEKplus®.”

Eric J. Woodard, M.D., Chairman of Vallum’s Medical Advisory Board, commented, “Receiving the first FDA clearance for a PEEK interbody fusion device incorporating nanotechnology is a tremendous milestone for Vallum. It is an important demonstration of Vallum’s leadership in developing advanced nano-processing technology for the spine and potentially for other orthopedic applications. It has been shown that nano-scale surface topographies generate osteogenic responses that drive bone growth required for a solid fusion. The ability to produce a nanotextured topography into the surface of a PEEK interbody device has the potential to set a new standard in the performance of spinal fusion interbody implants.”

About Vallum Corporation
Vallum is a medical device company headquartered in Nashua, New Hampshire. It has developed advanced technology and processing protocols for nano-scale surface engineering of implantable medical devices. The company is currently focused on nano-scale surface modification of PEEK interbody fusion devices to improve their performance in spinal fusion.

The company’s management believes its advanced technology and processing protocols can ultimately be developed to improve other implantable orthopedic devices for treating disorders throughout the body. Accelerated Neutral Atom Beam (ANAB) technology and its medical applications for nano-scale surface modification, including PEEKplus®, are covered by multiple issued patents and trade secrets.

Vallum’s mission is to develop, produce and deliver innovative and disruptive nano-scale surface technologies to affordably improve implantable medical devices and thereby improve patient outcomes and quality of life. More information can be found at www.vallumcorp.com.

Upcoming Corporate Events
Vallum management will be presenting at the Medical Alley Innovation Summit being held in Minneapolis on October 2-3, 2018 at the Minneapolis Marriott City Center.

¹ ISO/TS 80004-1:2015(en): Nanoscale-length range approximately from 1 nm to 100 nm
² Ganesan Balasundaram and Thomas J. Webster. A perspective on nanophase materials for orthopedic implant applications. Journal of Materials Chemistry, Issue 38, 2006
³ Gabriel Colon. Brian C. Ward, Thomas J. Webster. Increased osteoblast and decreased Staphylococcus epidermidis functions on nanophase ZnO and TiO2. Published online 2 June 2006 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.a.30789

Contacts

Vallum Corporation
Stephen M. Blinn, 1-603-493-4457
President and CEO
sblinn@vallumcorp.com

Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody

Posted On July 16, 2018 By OrthoSpineNews In Regulatory, Spine /

ORLANDO (PRWEB) JULY 16, 2018

Acron Medical, LLC (http://www.Acron-Medical.com), part of the spineMED Group, is a spine technology organization, dedicated to developing and commercializing globally innovative spinal implants. The company is proud to announce that it has received 510(k) clearance from the FDA for its signature new technology, the ACRON TLIF Interbody system.

“The ACRON Interbody is an exciting innovation for safe & stable thoracolumbar interbody fusion,” says Christian Schawrda, Acron Medical’s Co-Founder and CEO. “The engineering behind the development of the cage makes it the gold standard for surgeons looking for solid anchorage and optimal load distribution between the implant to protect osteoporotic patients from bone subsidence. The cage is designed to be strategically placed along the outer rim of the endplates, or ring apophysis, with superior load-bearing capacity. That approach, maximizes the strength of the fusion construct, increases fusion rates and minimizes the risk of subsidence.”

The ACRON is made of PEEK-OPTIMA, a material with a proven clinical history and a modulus of elasticity similar to bone. It also comes with a graft chamber and side windows to facilitate the formation of a robust fusion column.

The system includes a full range of implant sizes and heights that are carefully designed to accommodate different types of vertebral anatomy, and to allow surgeons to address each patient’s sagittal plane requirements.

Andreas Bernegger, Acron Medical’s Co-Founder says, “The ACRON comes to the United States after 3 years of clinical validation in Austria, Germany and Switzerland. The launch of the technology in the United States is major milestone for our group. We are currently looking for distributors and strategic partners around the country.”

Acron Medical’s management team will be attending NASS in September in Los Angeles (Sep 26-29) and is looking forward to many fruitful discussions with potential partners. For more information on Acron Medical, please visit http://www.Acron-Medical.com.

About Acron Medical, LLC.
Acron Medical is the US subsidiary of the spineMED group, based in Austria. Acron Medical founded in 2017, has leveraged its Austrian DNA, 35 years of clinical experience and the core competencies of the spineMED Group to develop a range of clinical relevant spinal technologies. The ACRON TLIF, as well as all the technologies in the spineMED R&D pipeline, are designed to harmoniously combined the latest scientific advances with intuitive designs and instrumentation. Additional information is available online at http://www.Acron-Medical.com.

Ceterix Orthopaedics Awarded New Patent for Circumferential Suturing Method in Meniscus Repair

Posted On July 12, 2018 By OrthoSpineNews In Regulatory, Top Stories /

July 12, 2018

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix^® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced the issuance of U.S. Patent No. 10,004,492 related to the company’s method of placing a suture around a tear to repair a damaged meniscus, adding to the company’s already expansive intellectual property portfolio.

Ceterix’s new patent further protects the company’s technology enabling surgeons to arthroscopically repair soft tissue injuries in the knee using minimally invasive techniques. This is the second set of method claims describing Ceterix’s proprietary Circumferential Compression Stitch (CCS), a suture method that provides uniform, anatomic compression of meniscus tears that was not possible to do previously given the tight constraints of the knee.

“Whether you are setting a broken bone or suturing a laceration, injuries heal best when the tissue edges are perfectly lined up and repaired without gaps,” says Dr. Justin Saliman, founder and chief medical officer of Ceterix. “For the first time, orthopaedic surgeons can now apply this principle to meniscus tears with NovoStitch^® Meniscal Repair Systems. We believe that by enabling simultaneous compression of the femoral and tibial sides of meniscus tears, the Ceterix technology can provide surgeons with greater confidence to repair tears that would have previously been considered non-repairable.”^[i],[ii]

“The invention of delivering a Circumferential Compression Stitch within the tight constraints of the knee may be the biggest innovation in meniscal repair in the last 15 years,” says John McCutcheon, president and CEO of Ceterix. “We are committed to expanding options for surgeons to preserve the meniscus and protect normal knee function in their patients.”

The meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and is surrounded by critical nerves, arteries and cartilage. Ceterix’s NovoStitch Meniscal Repair Systems enable surgeons to work within this tight compartment to place a stabilizing circumferential compression stitch around a meniscus tear. The circumferential compression stitch is the only meniscus repair technique that treats the femoral and tibial sides of a tear simultaneously, enabling the repair of injuries that may previously have required partial or complete removal of this important structure.

Arthroscopic surgery is a minimally invasive procedure in which an orthopaedic surgeon treats the damaged joint through small incisions using specialized tools and guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually.^[iii],[iv]

About Ceterix Orthopaedics

Ceterix Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch^® Pro Meniscal Repair System has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter

[i] Brooks KR. Arthroscopy Techniques. 2017 Oct; 6(5):e1767-e1773.
[ii] Woodmass et al. Arthroscopy Techniques. 2017 Aug; 6(4):e1329-e1333
[iii] Brinker MR. O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. JBJS. 2002 Nov; 84-A (11): 1926-1932
[iv] New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006

Contacts

for Ceterix Orthopaedics, Inc.
Krysta Pellegrino
krysta@healthandcommerce.com

Regulatory

CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA

Related Links

NuVasive Unveils Spine’s First Integrated Surgical Automation Platform

Related Links

House Votes Overwhelmingly To Kill Obamacare’s Tax On Medical Devices

206 Ortho Secures a Core Patent for Bio-Inspired Technology that Could Eliminate the Billions Spent on Implant Removal Surgeries

FBC Device ApS Receives First FDA Clearance For Spinal Interbody Implant Providing Lordosis Adjustment from 9 to 21 Degrees to Aid Surgeons & Patients

Contacts

MCRA Hires Bonnie Clothier, PhD, RN, Associate Director, Payor Relations, to Further Expand Reimbursement Payor Relations Service Division

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MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices

Related Links

FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion

Contacts

Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody

Ceterix Orthopaedics Awarded New Patent for Circumferential Suturing Method in Meniscus Repair

Contacts