Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm

Posted On November 7, 2018 By OrthoSpineNews In Regulatory /

Malvern, PA | Nov 06, 2018

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Spin, a new mobile C-arm that delivers precise 3D images for intraoperative quality assurance. By enabling surgeons to perform intraoperative corrections based on 3D images and confirm their results, the Cios Spin can help surgeons work with greater precision, transform the delivery of patient care, and achieve optimal treatment results.

Capable of integrating seamlessly into the clinical routine, the Cios Spin provides 3D computed tomography (CT)-like imaging for orthopedic, trauma and spine surgery. These 3D images can help reduce the rate of revisions with intraoperative evaluation as well as the need for post-operative CT. Cios Spin provides versatility to support both 2D and 3D imaging for a wide variety of procedures, including vascular imaging. The system’s NaviLink 3D digital navigation provides easy-to-use connectivity to surgical navigation.

Cios Spin is equipped with state-of-the-art flat panel detector technology and is available with a range of optional software packages. The Easy 3D package ensures fast, efficient setup, and image acquisition. The Screw Scout package enables system software to recognize and automatically label screws in a 3D X-ray image, saving time and effort for the surgeon.

The system’s high generator power addresses the challenge of imaging large patients and dense anatomy to enable precise clinical evaluation of images. And the Cios Spin is the first commercially available mobile C-arm with an antimicrobial coating for comprehensive infection control.

“Siemens Healthineers is proud to offer the Cios Spin, a dynamic new mobile 3D C-arm that illustrates our expertise in mobile X-ray imaging,” said Robert Dewey, Vice President of Surgical Solutions at Siemens Healthineers North America. “This system will help our customers improve the quality of patient care using precision medicine as well as reduce the additional costs imposed by revision surgery.”

Contact for journalists
Jeff Bell
Phone: (484) 868-8346; Email: jeffrey.t.bell@siemens-healthineers.com

Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2017, which ended on September 30, 2017, Siemens Healthineers generated revenue of €13.7 billion and adjusted profit of €2.5 billion and has about 48,000 employees worldwide. Further information is available at www.siemens-healthineers.com.

Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology

Posted On November 5, 2018 By OrthoSpineNews In Regulatory /

HOLLAND, Mich., Nov. 5, 2018 /PRNewswire/ — Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System. This is a key addition to their expanding shoulder portfolio and another milestone for their vision to offer a complete leading technology shoulder arthroplasty product line.

The clearance covers products used for partial or total shoulder arthroplasty used in the treatment of degenerative, rheumatoid or traumatic arthritis in the shoulder. The new InSet Shoulder system provides innovative features and solutions to address potential problems encountered with current total shoulder replacement systems.

Peter Johnston, M.D. of Southern Maryland Orthopaedic and Sports Medicine said, “The strengths of the InSet Shoulder System are its streamlined instrumentation, proprietary coating technology for implant fixation with bone preservation and ability to reproduce native humeral anatomy. The system is game-changing.”

Robert Tashjian, M.D. of the University of Utah added, “The combination of the InSet Humeral Stem and Shoulder Innovation’s unique InSet glenoid implant affords a surgically simple, bone sparing option for many types of humeral or glenoid deformities associated with arthritis.”

Rob Ball, Executive Chairman of Shoulder Innovations said, “We are excited to see the fast-paced progress and results made by the team. Genesis Innovation Group has moved rapidly in developing this highly innovative new product line. It plays a pivotal role in the Shoulder Innovations strategy, and Genesis has proven to be an excellent partner in helping our company move forward.”

Shoulder Innovations has also recently announced new investments that will be used to fuel new product development, and to acquire inventory and assets to accelerate growth of its current InSet platform technology. This technology serves as a foundational platform on which many future products and systems are in development.

The long-term vision of Shoulder Innovations is to offer a complete leading technology shoulder arthroplasty product line.

About Shoulder Innovations:

Shoulder Innovations, LLC is a medical device development company which designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system.

Leveraging its breakthrough, patented, inset glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant system focused on improving outcomes related to the greatest cause of shoulder replacement failure: glenoid loosening.

The InSet technology has been shown in testing to significantly reduce glenoid implant micro-motion and simplifies the surgical technique, potentially reducing complications or increase implant longevity.

Shoulder Innovations is based in Holland, Mich.

Learn more about Shoulder Innovations and its Total Shoulder Replacement System at shoulderinnovations.com.

SOURCE Shoulder Innovations

Histogenics and FDA to Continue Discussions on NeoCart Phase 3 Clinical Trial Data and Potential Regulatory Pathway

Posted On November 1, 2018 By OrthoSpineNews In Biologics, Regulatory /

WALTHAM, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on preliminary feedback from the Type C meeting held with the U.S. Food and Drug Administration (the FDA) on October 30, 2018. At the meeting, the top-line results from the NeoCart Phase 3 clinical trial and the potential for the submission of a Biologics License Application (BLA) were discussed. Following the meeting, the FDA and Histogenics continue to discuss the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the BLA to be accepted. The FDA has not made a final decision regarding a potential BLA submission and based on expected feedback from the FDA, Histogenics intends to provide a further update on these negotiations by the end of November 2018.

About Histogenics Corporation

Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission of a BLA for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its partners expect to compete; updated or refined data based on Histogenics’ continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics’ expectations regarding its expenses and revenue; Histogenics’ ability to obtain additional debt or equity capital; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Form 10-Q for the quarter ended September 30, 2018, expected to be filed with the SEC in the fourth quarter of 2018. In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results. Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investor Relations:
Tel: +1 (781) 547-7909
InvestorRelations@histogenics.com

Medacta Unveils Two New Kinematic Alignment Options for Knee Replacement Surgery

Posted On November 1, 2018 By OrthoSpineNews In Recon, Regulatory /

November 01, 2018

CASTEL SAN PIETRO, Switzerland & DALLAS–(BUSINESS WIRE)–Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the GMK^® Sphere – Kinematic Alignment instrumentation and surgical technique for total knee replacement (TKR). The manual instrumentation and technique are components of the new Medacta Individualized Kinematic Alignment (MIKA) offering, which is based on the kinematic alignment surgical approach, an alternative to traditional mechanical alignment for TKR that has demonstrated significant benefits for appropriate knee arthroplasty patients. Medacta collaborated on the development of the instrumentation with renowned orthopedic surgeon Dr. Stephen Howell, a pioneer in kinematically aligned total knee replacement at Adventist Health Lodi Memorial (Lodi, California).

“Kinematic alignment will play a significant role in the future of total knee replacement and is an extremely effective alignment option for most patients,” said Dr. Howell, who has been practicing a version of the technique for over a decade. “This approach, which co-aligns the axes of the components with the three kinematic axes of the native knee, offers many benefits to knee replacement candidates. The kinematic alignment technique has potential for faster recovery, quicker return to normal activities, overall, more comfort with the implant itself, and high long-term implant survival. The use of the caliper technique and the recording of intraoperative checks restores the native joint lines, limb alignment, compartment forces, and laxities of the pre-arthritic knee with high reproducibility with few ligament releases. In working with Medacta, we’ve put together a program that builds on the benefits of this surgical strategy while opening it up to even more surgeons looking to learn and practice the approach.”

The kinematic alignment technique aims to restore normal knee function by resurfacing the femur and tibial articular surfaces to those of the normal or pre-arthritic state. This approach is aimed at achieving optimal patient satisfaction and function, while minimizing damage to the surrounding tissues and ligaments. Studies and patient outcomes are starting to create awareness that kinematic alignment may offer benefits for appropriate knee arthroplasty patients.

Kinematic Alignment will be an addition to Medacta’s efforts towards personalized solutions and to the GMK Sphere Total Knee System, a medially stabilized design that facilitates taking full advantage of the kinematic approach due to its intrinsic design features.

Medacta looks to change the accessibility of kinematic alignment by providing dedicated educational tools through the M.O.R.E. Institute as well as new instrumentation. In addition to traditional metal instrumentation, a dedicated planning protocol for patient-specific instruments (MyKnee^®) will allow surgeons to ease into the technique through the use of surgeon-specified parameters.

“Medacta is committed to cutting-edge medicine and new surgical approaches that advance orthopedics, focusing on personalized medicine and improving the overall patient experience,” said Francesco Siccardi, Chief Executive Officer of Medacta International. “Our success in this area stems from our steadfast dedication to surgeon education, particularly around new strategies like Kinematic Alignment. Similar to how we disseminated the anterior approach to hip surgery through our AMIS education program, the MIKA procedure will be a new discipline within our M.O.R.E. Institute, as we look to bring this promising innovation – and all of its patient benefits – into the mainstream.”

This innovation will be on display at the 2018 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting this week in Dallas and will launch more broadly in Spring 2019. Visit Medacta at Booth #215 onsite at AAHKS to see the new GMK Sphere – Kinematic Alignment instrumentation and explore the company’s full portfolio of orthopedic technologies.

About Medacta International

Medacta International is a world leading company, developer and supplier, specializing in joint replacement, spine surgery, and sports medicine solutions. Medacta’s revolutionary approach and responsible innovation, focusing on Minimally Invasive Solutions and Personalized Medicine, have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, operates in over 30 countries around the globe, and employs more than 930 people. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter and LinkedIn.

Contacts

For Medacta International
Emy Gruppo, 203-247-5856
emy@torchcomllc.com

Innovasive™ Granted FDA Clearance for DualX™ Expanding Interbody Spinal Device

Posted On October 31, 2018 By OrthoSpineNews In Regulatory, Spine /

MISSION VIEJO, CALIF. (PRWEB) OCTOBER 31, 2018

Innovasive, a privately-held spinal device company, focuses on developing and commercializing minimally-invasive, innovative spinal technologies. Today, Innovasive announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the lumbar spine.

“DualX is a unique expandable interbody that expands in two independent directions,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “First, it expands laterally to provide a wide base for stability and spinal support. DualX then expands vertically with lordosis to aide in the restoration of sagittal alignment of the lumbar spine.”

The DualX technology is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized anatomical fit for a clinically successful fusion environment.

“The ability of DualX to provide expansion in two planes is essential for achieving a successful surgical outcome. DualX accomplishes the goals of creating a biomechanically stable environment for spinal fusion, as well as supporting normal sagittal and coronal alignment; both of which are essential factors for restoring optimal spinal balance. These critical factors will help spine surgeons achieve the primary goals of performing surgeries that lead to successful, minimally invasive spinal fusion procedures.” said, Jeffrey Roh, MD, MBA, MSc, Director of Minimally Invasive Spine Surgery at the Swedish Neuroscience Institute in Seattle, WA.

“We are excited to receive FDA clearance and look forward to a successful product launch in the near future,” said Mr. Choi. DualX will be available for implantation in spinal fusion procedures before the end of this year.

About Innovasive

Innovasive, Inc. is a privately-held spinal device company located in Mission Viejo, CA. The Company focuses on developing and commercializing innovative, minimally-invasive technologies for spine surgery. Innovasive is a portfolio company of IntuitiveX, a life science innovation incubator.

Stimwave Receives FDA Clearance for World’s Only Opioid Free Pain Management Wireless System iPhone-iWatch Controllers

Posted On October 31, 2018 By OrthoSpineNews In Regulatory /

October 31, 2018

POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, today announced that it has received FDA clearance for the WaveCrest Mobile^TM iOS Platform patient controllers for opioid free pain management. This revolutionary new system now gives patients iPhone^® and Apple Watch^® mobile control over WaveMaster^TM multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for relief of chronic pain. The Freedom SCS System is the world’s first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the U.S. who endure daily chronic back and leg pain.

WaveCrest Mobile allows a patient to use an iPhone, iPod touch^®, or Apple Watch to adjust their pain relief therapy. This is the first FDA-cleared software that allows the AppleWatch to control a neuromodulation device implanted inside the body. The software is designed to be easy to use and secure. WaveCrest Mobile enables pain sufferers to fine-tune the power level, visualize battery life, and modify programs that were pre-programmed by their clinician to control pain without opioids.

“Pain suffers are rapidly migrating to the Stimwave Freedom wireless pain relief system as an opioid free option to control their pain- and now they can adjust their therapy with the swipe of their finger through their Apple Watch or iPhone/iPod Touch discretely any time as needed,” said Stimwave Chairman and CEO Laura Tyler Perryman. “Transformation of pain treatment moving from opioids and pills to interventional solutions like Stimwave can only happen as a result of empowering the masses to take control of their pain, which is now as easy as 1-2-3 with WaveCrest Mobile.”

Stimwave’s Freedom Stimulators are implanted in an outpatient procedure with no need for general anesthesia, a large surgical incision or a bulky internal battery known to lead to numerous complications from other legacy older technologies. These products are expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to opioids.

“Patients’ needs in pain management are unique and customized programming is a must. The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Dr. Ellen Lin, M.D., medical director of San Antonio’s Advanced Spine and Pain Center. “WaveCrest Mobile provides patients with a high-tech approach to controlling their pain through their mobile device and future features and upgradeability options they never had before.”

Utilizing the Stimwave Freedom System, clinicians utilize an iPad application to easily program the system using WaveMaster advanced therapy waveforms offering the ability to easily and quickly provide patients with the widest array of programming waveforms, frequencies and combinations of options to ensure long term pain relief, all selectable from the AppleWatch or iPhone controller.

Apple and iPhone are trademarks of Apple Inc. registered in the U.S. and other countries.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Contacts

GlodowNead Communications
Rosemary O’Brien, 415-394-6500
StimwavePR@GlodowNead.com

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Aetna Offers Expanded Coverage for EXPAREL® in Select Ambulatory Surgical Centers

Posted On October 30, 2018 By OrthoSpineNews In Regulatory /

PARSIPPANY, N.J., Oct. 30, 2018 (GLOBE NEWSWIRE) — Aetna has announced that they will reimburse select ambulatory surgical centers (ASCs) for the use of EXPAREL^® (bupivacaine liposome injectable suspension) as part of a pilot program in Florida and New Jersey. The purpose of the program is to incentivize the use of non-opioid therapies for postsurgical pain management in ASCs.

This expanded coverage of EXPAREL advances Aetna’s clinical strategy of supporting increased member access to non-opioid pain treatment options and encouraging reductions in inappropriate opioid prescribing. In 2017, the company began reimbursing for EXPAREL for select impacted third molar (wisdom tooth) extractions. EXPAREL provides patients prolonged pain control that can help reduce or eliminate reliance on opioids, their associated side effects and the long-term risks of addiction or dependence.

“Aetna is demonstrating its commitment to addressing the opioid epidemic by leading the way in expanding coverage of EXPAREL in the ASC setting,” said Dave Stack, chairman and chief executive officer at Pacira Pharmaceuticals. “We look forward to continuing our work with Aetna to prevent future opioid misuse or dependence by providing a safer, non-opioid option like EXPAREL for all patients undergoing surgery.”

Studies continue to show that surgery is an inadvertent gateway to persistent opioid use. According to new research examining seven orthopedic and soft tissue surgical procedures, patients were prescribed an average of 82 opioid pills to manage postsurgical pain. Approximately 9 percent of surgical patients became newly persistent users in 2017, continuing to take these opioids at least three to six months after their operation¹. Unused opioids after surgery also pose the risk of diversion, another avenue to opioid misuse or dependence.

The reimbursement for EXPAREL in the ASC setting is demonstrative of Aetna’s ongoing collaborations with Pacira to combat the opioid epidemic. Recent initiatives include Aetna’s update to its online provider directory to help members easily identify surgeons who are trained to administer EXPAREL, as well as the creation of a national program launched by Pacira, Aetna and the American Association of Oral and Maxillofacial Surgeons (AAOMS). The program aims to reduce the number of opioid tablets prescribed to Aetna patients undergoing impacted wisdom tooth extractions through the use of EXPAREL.

About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company dedicated to advancing and improving postsurgical outcomes for acute care practitioners and their patients. The company’s flagship product, EXPAREL^® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam^®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

About Aetna
Aetna is one of the nation’s leading diversified health care benefits companies, serving an estimated 38.8 million people with information and resources to help them make better informed decisions about their health care. Aetna offers a broad range of traditional, voluntary and consumer-directed health insurance products and related services, including medical, pharmacy, dental and behavioral health plans, and medical management capabilities, Medicaid health care management services, workers’ compensation administrative services and health information technology products and services. Aetna’s customers include employer groups, individuals, college students, part-time and hourly workers, health plans, health care providers, governmental units, government-sponsored plans, labor groups and expatriates. For more information, see www.aetna.com and learn about how Aetna is helping to build a healthier world. @AetnaNews

Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL. Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.

Company Contact:
Pacira Pharmaceuticals, Inc.
Amber Sears, (973) 254-3587
Amber.Sears@pacira.com

Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com

¹ Pacira. Exposing a Silent Gatewa

Aurora Spine Announces European Patent Related To ZIP Minimally Invasive Spinal Implant

Posted On October 25, 2018 By OrthoSpineNews In Regulatory, Spine /

CARLSBAD, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSXV:ASG) (“Aurora Spine” or the “Company”) announced today the grant by the European Patent Office (the “EPO”) of Aurora’s first European patent related to the ZIP®, minimally invasive spinal implant. The patent is titled “Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System”, and covers Aurora’s family of ZIP® interspinous devices, including its ZIP Ultra®, ZIP 51™, ZIP LP™ and Dyna-ZIP™ among others. The EPO has reported that no oppositions have been filed against the European patent.

“The recent European ZIP® Interspinous patent allowance is another milestone in Aurora Spine’s history. This newly issued patent features our patented ONE-STEP™ locking mechanism that eliminates the use of a set screw in Aurora’s Screwless Procedure™ surgeries,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine and Co-Inventor of the ZIP. “The ZIP technology provides Aurora Spine with opportunities to market, license and develop its products and screwless, minimally invasive implant technology further. We are very proud of the progress that we have made over the past couple of years in spinal surgery and the remarkable value that Aurora Spine`s intellectual property has added to our company`s growth.”

“Aurora is changing spine surgery, and we are thrilled that our newest patent has been issued by the EPO. This patent further validates the modern advancements of our Screwless technology and it maintains our commitment to introduce advanced minimally invasive spine surgery technologies,” said Trent Northcutt, President and CEO of Aurora Spine.

This is Aurora Spine’s first European patent. Aurora Spine has several U.S. and international patent applications pending directed to the ZIP system and its future technologies.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the Offering and the proposed use of proceeds of the Offering. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

For more information, please contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Sarina Mason
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com

OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 26th Surgical System

Posted On October 19, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis. The system represents the Company’s 26^th surgical system and is expected to launch in the fourth quarter of 2018.

The RESPONSE 4.5/5.0mm System was designed in collaboration with pediatric orthopedic surgeons focused on additional solutions for treating complex pediatric scoliosis patients. It expands the Company’s RESPONSE platform to treat smaller stature children and builds upon the successful implant and instrument technology of the RESPONSE 5.5/6.0mm System. The RESPONSE 4.5/5.0mm System offers a hybrid implant technology allowing the option of either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome material, multiple implant connector options, and innovative, new instrumentation.

OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our 4.5/5.0mm system, which allows physicians to better treat smaller statures and patients at a younger age. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring their innovative vision to life with another surgical solution for treating complex pediatric scoliosis. The addition of the new system to our scoliosis platform continues to demonstrate OrthoPediatrics’ focus and commitment to providing solutions for children with complex spinal disorders.”

Scott Luhmann, M.D., Chief of Staff at Shriners Hospital for Children-St. Louis and Associate Professor in the Department of Orthopedic Surgery and Fellowship Director of Pediatric Orthopedic Surgery at Washington University School of Medicine, commented, “The new Response 4.5/5.0mm System brings OrthoPediatrics’ expertise and passion for musculoskeletal care of pediatric patients to the area of spinal deformity. This surgeon-centric system is focused on surgical efficacy and efficiency with an elegant rod reduction tool that significantly cuts down laborious task time in the effort to provide optimal patient outcome.”

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

RESPONSE™ Spine System
Designed with a complete focus on children, the RESPONSE system offers a simple, technologically advanced system of instruments and implants to treat the distinct needs of pediatric patients with spinal deformities. The system features advanced instrument & implant technology including 1) innovative, low profile screw design including a proprietary set screw thread design for improved fixation and reduced potential for cross threading, and 2) unique pedicle screw head accepts a 5.5mm or 6.0mm rod in both cobalt chrome and titanium. Additionally, the system has versatile reduction & de-rotation capabilities with rod reducer instrument designed for easy snap on and off 2-in-1 rod reduction instrument enables each surgeon to perform reduction and de-rotation technique of choice and serves as a rod reducer and de-rotator in one.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

Centric Medical™ Announces 510(k) Clearance of the SATURN™ External Fixation System

Posted On October 18, 2018 By OrthoSpineNews In Regulatory /

October 18, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine^®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize the foot, ankle and long bone segments.

“I am excited to continue the expansion of our foot and ankle portfolio with more complex solutions like the SATURN External Fixation System. The system has a wide variety of components to allow for a unique anatomical construct for each patient. The key features were designed with the intention to reduce operating time and provide greater ease of use for the surgical team,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine and Centric Medical, “because the procedure involves so many moving pieces, it is crucial for the design to be simple, efficient and user-friendly.”

The external fixation system is the tenth 510(k) clearance for Life Spine in the last year and can be utilized for fusions, fractures, deformity reconstructions, tumors and Charcot Reconstructions.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

For Centric Medical
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Regulatory

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