DePuy Synthes Announces Exclusive Co-Promotional Agreement with Pacira Pharmaceuticals, Inc.

Posted On January 25, 2017 By OrthoSpineNews In Recon, Spine /

RAYNHAM, Mass., Jan. 25, 2017 /PRNewswire/ — DePuy Synthes Companies today announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) to co-promote EXPAREL^®, a long-lasting, non-opioid, local analgesic administered at the orthopaedic surgical site. The agreement allows DePuy Synthes to promote EXPAREL across its joint reconstruction, spine, sports medicine, and trauma businesses to help with postsurgical patient pain. This will further enhance the company’s portfolio and reach in the operating room while also helping hospital customers better achieve their Triple Aim goals of improving clinical outcomes, reducing costs and enhancing patient satisfaction.

Drug overdose is the leading cause of accidental death in the U.S., with opioid addiction driving this epidemic, including more than 20,000 overdose deaths related to prescription pain relievers in 2015¹. While opioids have typically been used for the management of orthopaedic postsurgical pain, EXPAREL provides targeted, non-opioid pain control by working right at the site of surgery, allowing for long-lasting pain relief. Reduced pain allows the opportunity for earlier weight bearing and mobilization immediately following surgery, and more patients discharged to home rather than interim care facilities.

“There are millions of orthopedic procedures performed in the U.S. market today where we can improve patient care and the surgical experience by offering a long acting, intra-operatively delivered local anesthetic infiltration solution,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “As part of our focused approach to help bring value at every point along the care pathway, we are thrilled to be able to further our offerings through partnering with Pacira and together provide a differentiated solution for our customers to help improve patient outcomes.”

DePuy Synthes has extensive reach in the orthopaedics and spine space, positioning the company to bring EXPAREL to joint reconstruction, spine, sports medicine, and trauma patients in the U.S. for in-hospital and outpatient procedures. Our suite of products and solutions help to drive improved clinical outcomes, reduced complication rates and improved recovery time.

DePuy Synthes is expected to begin co-promoting EXPAREL in Q1 2017.

EXPAREL^® is a long acting local anesthetic indicated for single-dose infiltration into the surgical site to produce post-surgical analgesia. The U.S. Food and Drug Administration (FDA) confirmed that EXPAREL has been approved for administration into the surgical site to produce postsurgical analgesia in a variety of surgeries.²

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to an exclusive agreement in the U.S. with Pacira Pharmaceuticals Inc. to co-promote EXPAREL^®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes Sales Inc., the DePuy Synthes Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; the ability of DePuy Synthes to successfully execute strategic plans; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations; changes in behavior and spending patterns of purchasers of health care products and services; global health care reforms and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. DePuy Synthes Companies and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

¹Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2015 on CDC WONDER Online Database, released December, 2016. Data are from the Multiple Cause of Death Files, 1999-2015, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed at http://wonder.cdc.gov/ucdicd10.html. 2010 were four times those in 1999.

² http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2122491

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/depuy-synthes-announces-exclusive-co-promotional-agreement-with-pacira-pharmaceuticals-inc-300396181.html

SOURCE DePuy Synthes Companies

Aurora Spine Announces New Chief Financial Officer

Posted On January 25, 2017 By OrthoSpineNews In Spine /

CARLSBAD, CALIFORNIA–(Marketwired – Jan 25, 2017) – Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSX VENTURE:ASG) announced the appointment of Sarina Mason as their Chief Financial Officer (CFO), effective February 6, 2017.

Ms. Mason will help guide and oversee the company’s continued market leadership and financial growth. She brings more 16 years of experience to Aurora Spine.

Prior to joining Aurora Spine, Ms. Mason was Director of Accounting & Finance at International Stem Cell Corp., a publically traded company.

Ms. Mason began her career with Ernst and Young working primarily in the Assurance and Advisory Business Services group. Ms. Mason earned a Bachelor of Science in Accounting from San Diego State University.

Former CFO Eric Fronk has resigned from the Company effective February 6, 2017 to pursue other opportunities.

“We are very pleased to have someone with Sarina’s skills and experience join Aurora Spine,” said Trent J. Northcutt, President and CEO of Aurora Spine. “Sarina has a wealth of expertise in financial management as well as proven leadership capabilities that will be a great asset as we capitalize on the opportunities that lie ahead of us.” He added, “I would like to thank outgoing CFO Eric Fronk for his substantial contributions to the Company.”

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 proposed use and success of the company’s products in surgical procedures. 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.

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Amendia, Inc. Leadership Strengthens – Appointment of EVP & CFO

Posted On January 24, 2017 By OrthoSpineNews In Spine /

MARIETTA, GA (PRWEB) JANUARY 24, 2017

Amendia, Inc., designer, developer, and manufacturer of spinal implant and instrument solutions, announces the appointment of Steven F. McAllister as Executive Vice President and Chief Financial Officer.

Steve has over 30 years of medical device experience in both the U.S. and international markets. Beginning his career at Howmedica, Inc., he has since served in various finance, IT, and business planning leadership roles at DePuy Spine, Biomet Spine and Bone Healing, and, most recently, InVivo Therapeutics Corporation.

At InVivo Therapeutics, Steve served as Chief Financial Officer and was responsible for leading the company to a successful IPO. Prior to that, Steve spent six years at Biomet as the Vice President of Finance and Administration for the Spine and Bone Healing Technologies division.

“We are honored to welcome Steve to the Amendia team,” said Chris Fair, Amendia’s CEO. “His global exposure, formidable leadership experience, and proven ability to deliver results make him a natural fit as our new EVP and CFO of Amendia.”

“I am excited to work with an outstanding team and look forward to finding ways to expand on the great work that Amendia has already accomplished,” said McAllister.

Mr. McAllister received a Bachelor of Science in Accounting from Fairleigh Dickinson University in New Jersey.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, and manufacturer of medical devices used in spinal surgical procedures. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes with innovative solutions. For more information, please visit http://www.amendia.com.

New Laser Spine Institute Research Proves Efficacy of Minimally Invasive Spine Surgery

Posted On January 23, 2017 By OrthoSpineNews In Spine /

January 18, 2017 (TAMPA, Fla.) – A new research analysis released recently by Laser Spine Institute, the leader in minimally invasive spine surgery, cites surgical outcomes, proclivity to return to work and self-reported pain levels of patients who underwent outpatient minimally invasive spine surgery laminotomy foraminotomy decompression (LFD). The report, titled Advantages of Minimally Invasive Decompression Through Laminotomy and Foraminotomy, evaluated 500 Laser Spine Institute patients suffering from lumbar spinal stenosis over a two-year period.

“Our analysis of minimally invasive spine surgery laminotomy and foraminotomy procedures provides evidence that our patients encounter fewer complications, resulting in improved outcomes regardless of patient demographics,” said Reginald J. Davis, M.D., FACS, Director of Clinical Research, Laser Spine Institute. “This is among the largest outpatient outcome studies of its kind, and it proves that our minimally invasive procedures are an optimal solution for patients in need of relief from chronic back pain.”

According to the report, open back surgery has traditionally been the treatment of choice for lumbar stenosis, but this procedure can lead to spinal instability, which may require repeat surgeries. Because of the smaller incision and more direct technique, minimally invasive spine surgery reduces trauma to the muscle tissue and produces sufficient decompression to reduce levels of pain and disability. Additional key findings from the report show that when compared to procedures performed by other providers, Laser Spine Institute’s minimally invasive treatment of lumbar stenosis reflected shorter operative times, less blood loss, reduction in patient pain levels following surgery, as well as facilitating patients’ return to work faster.

The findings were recently presented by Chairman, Department of Surgery, Michael C. Weiss, D.O., FAOAO, at the Society for Minimally Invasive Spine Surgery Annual Forum ’16, one of the premier conferences for the industry.

“I was excited to present evidence that our outpatient minimally invasive spine procedures result in fewer complications and improved patient outcomes,” Chairman Weiss said. “The Annual Forum is an important venue to share information and findings on minimally invasive surgery options as a more modern solution to providing relief for patients suffering from neck and back pain.”

For more information about Laser Spine Institute visit LaserSpineInstitute.com.

For additional research findings and to download the abstract, click here.

Media Contact: Hailey Fitch, Edelman

Phone: 407-377-6650

Email: hailey.fitch@edelman.com

About Laser Spine Institute

Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland; St. Louis and Cincinnati. Laser Spine Institute has helped more than 60,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Ninety-nine percent of patients say they would refer a friend or family member to have surgery at Laser Spine Institute. Additionally, Laser Spine Institute has been repeatedly recognized by Voyance Health as a National APEX Quality Award winner for outstanding patient satisfaction and reports an enterprise patient satisfaction score of 96. In 2015, the company’s Philadelphia facility received Gold-level designation for excellence in patient-centered care from Planetree, a mission-based, not-for-profit organization that partners with health care organizations around the world and across the care continuum to transform how care is delivered.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ.

7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery

Posted On January 23, 2017 By OrthoSpineNews In Regulatory, Spine /

TORONTO, Jan. 23, 2017 /PRNewswire/ — 7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada enabling the North American commercial launch of its innovative Machine-vision Image Guided Surgery (MIGS™) system for spine surgery, the 7D Surgical System.

The 7D Surgical System employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. This new technology can easily register spinal surgery patients automatically using only visible light. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new platform can achieve an incredibly fast surgical workflow for spine procedures.

“When navigating the spine, surgeons traditionally have had two time-consuming and expensive IGS options: systems that rely on intraoperative radiation emitting devices or systems that utilize laborious manual point matching techniques,” said Beau Standish, Chief Executive Officer of 7D Surgical. “We believe the inefficiencies of these systems have limited the adoption of IGS in spine procedures to less than 20%. 7D Surgical’s MIGS™ system has now removed these barriers, providing surgeons and their hospitals with a superior product option.”

The 7D Surgical System enables near-instantaneous Flash Registration™ of the patient’s anatomy. “Guided by our product philosophy of ‘surgeons designing for surgeons’, we have achieved an unprecedented entire workflow time of less than 20 seconds for de novo spinal registration, unheard of in the spinal IGS world where such registration can interrupt surgery for up to 30 minutes,” said Dr. Victor Yang, President and Chief Scientific Officer of 7D Surgical, Senior Scientist at Sunnybrook Research Institute, and Staff Neurosurgeon at Sunnybrook Health Sciences Centre in Toronto, where prototype MIGS™ technology has been used in more than 160 patients in clinical trials.

The MIGS™ navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and is manifested in simplified yet powerful software, which is controlled by the surgeon using only a foot pedal. “Our surgeons don’t rely on non-sterile personnel to operate the technology. Our surgeons are in total control,” said Yang.

“Image guided surgery technology has finally caught up to the needs of a practicing spine surgeon,” said Dr. Frank Cammisa, Chief Emeritus of the Spine Service at Hospital for Special Surgery in New York City. “7D Surgical’s new MIGS™ system appears to provide a faster, radiation-free alternative to existing options. It could be an important new tool in expanding the use of IGS in spine procedures.” He added, “The 7D Surgical System reduces the overall cost and footprint required to navigate the spine. It’s a win-win for the surgeon and the hospital.”

With both U.S. and Canadian regulatory authorization, 7D Surgical has commenced execution of its North American commercialization strategy. “We are delighted to have achieved these regulatory milestones in line with our expectations and planning,” said Standish. “We are confident that in demonstrating the speed and efficiency of our MIGS™ system, we will convince more surgeons to employ IGS in their spine procedures.”

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada approved MIGS™ system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
140332@email4pr.com

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“MIGS™”, “Flash Registration™,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical.

SOURCE 7D Surgical

Camber Spine Technologies Announces 510(k) Clearance For Their Siconus(TM) SI Joint Fixation System

Posted On January 23, 2017 By OrthoSpineNews In Regulatory, Spine /

WAYNE, Pa., Jan. 23, 2017 — (Healthcare Sales & Marketing Network) — Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconus™ SI Joint Fixation System. Siconus™ becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a complement to the Prolix™ custom machined allograft implant.

“The Siconus™ SI Fusion Screw System is an important addition to our growing portfolio of devices and completes our exclusive SI Fusion product portfolio.” said Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Siconus™ provides superior compression across the SI Joint over multiple turns of the threaded fixation implants. When used with the Prolix™ SI Joint Fusion System, the combined solution offers a direct visualization and insertion of a machined allograft spacer into the SI joint, followed by a lateral approach compression and fixation implants. The combined solution may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint.”

The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.

Siconus™ was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com. For inquiries about Siconus™ or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies’ products are proudly MADE IN THE USA.

Source: Camber Spine Technologies

SI-BONE’s iFuse Implant System® Requires Revision Surgery 5 Times Less Compared to SI Joint Fixation with Screws According to New Peer-Reviewed Clinical Publication

Posted On January 23, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., Jan. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of a single-center retrospective study of patients who underwent SI joint fusion using titanium triangular implants or SI joint fixation using cannulated screws. The study, titled Surgical Revision after Sacroiliac Joint Fixation or Fusion¹, was published in the International Journal of Spine Surgery and involved review of medical records and tailored patient follow-up contact for patients who underwent SI joint fusion or fixation between 2003 and 2015 at the site. 4-year cumulative revision rates, calculated using Kaplan-Meier survival analysis, showed a 5.7% revision rate for the 263 patients who underwent SI joint fusion with iFuse vs. a much larger 30.8% revision rate for the 36 patients who underwent SI joint screw fixation. At the longest follow-up time point, the cumulative probability of revision in the screw group was 79.8%. Subgroup analysis showed no predictors of revision other than device used (iFuse vs. screw).

“In our practice, we switched from screws to iFuse in early 2012 because we noticed that with iFuse, a much smaller proportion of patients returned to clinic with complaints of continued SI joint pain,” said Timothy Holt, MD of the Montgomery Spine Center in Montgomery, AL and senior study author. “Surgical revision was required in a large proportion of patients who underwent screw-based fixation. In contrast, the surgical revision rate with iFuse was low, similar to that reported in the literature.”

The iFuse Implant is specifically designed for SI joint fusion due to a unique triangular shape that prevents rotational motion and a porous surface that promotes bony ongrowth*. It is the only SI joint fusion device with peer-reviewed publications from prospective trials and is the only SI joint fusion device with an FDA-cleared indication citing clinical studies that demonstrate improvements in pain, patient function and quality of life.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth, facilitating long-term fusion of the joint*. iFuse is the only commercially available SI joint fusion system in the United States with published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results). It is the only SI joint fusion system with FDA clearance recognizing demonstrated improvements in pain, patient function and quality of life following treatment.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

¹Spain K, Holt T. Surgical Revision after Sacroiliac Joint Fixation or Fusion. Int J Spine Surg. 2017;11:24-30. doi: 10.14444/4005.

*Data on file: TR 300401-A and 300359-A

SOURCE SI-BONE, Inc.

SpineFrontier Enhances the MISquito Percutaneous Pedicle Screw System in Response to Growing Demand

Posted On January 20, 2017 By OrthoSpineNews In Spine /

MALDEN, MA (PRWEB) JANUARY 20, 2017

SpineFrontier, Inc., the leader in Less Exposure Surgery (LES®) Technologies, announced today the next evolution in spinal fusion, the MISquito Percutaneous Pedicle Screw System (part of the PedFuse Pedicle Screw System platform). In contrast to the competition, SpineFrontier is focused on technique driven product solutions that provide maximum efficiency and enable outpatient, same-day surgery for patients. The MISquito’s advanced instrumentation and technique reduces exposure to fluoroscopy and eliminates the complexity of inserting of pedicle screws, pedicle rods, and locking caps in multilevel constructs.

Learn More About The Making of MISquito by Watching this Video:
https://www.youtube.com/watch?v=7IRdcLhkt4s

Dr. Chin, orthopedic spine surgeon and CEO of SpineFrontier, says, “Almost every week I now use the MISquito for percutaneous lumbar fixation in an outpatient setting. The instrumentation makes it easy to perform fusions in a lateral position and for multilevel fusions from T2 to the sacrum with ease. I first started designing percutaneous pedicle screws in 2003 with the MANTIS and now 14 years later the MISquito is very advanced in its efficiency and simplicity. With the rise in number of fusions being performed, it is critical that we make these progressive leaps forward with our systems. We are now working on leveraging the design for scoliosis.”

The MISquito System continues to advance under the leadership and expertise of Dr. Chin, SpineFrontier’s rapidly expanding surgeon base, and their relationship with SpineFrontier’s accomplished Engineers and Designers who are trained to perform this surgery in the onsite cadaver lab. This extensive knowledge network ensures that no use scenario goes unexplored and ensures the instrumentation, in conjunction with the technique, overcome the limitations and intricacies of the competition.

Michael Emery, SpineFrontier Product Manager and Engineer of SpineFrontier’s Pedicle Screw platform “It’s exciting to continue to see the effective results of our Technique based Technologies through the relationship between our surgeons and engineers. The system boasts a first in-class implant engineered to accommodate a wide range of patient anatomy, bone density, and deformities. We accomplished this with our various screw offerings, built in reduction capability with superior tab strength, and progressive screw thread.”

SpineFrontier has enhanced the MISquito System to increase the ease and simplicity of putting in percutaneous screws and rods over multiple levels.

The flat blade dilator is designed to create a minimal incision size ideal for screw and rod insertion without excess tissue damage.
The locking screw inserter eliminates any toggle between the implant and instrument making it feel like one device. The locking mechanism ensures the screw is fully retained and does not unintentionally disassemble from the inserter.
A new implant configuration called REspond-XL that incorporates extended break off tabs with significant reduction threads for easy rod reduction
The threaded rod pusher allows for fully seating the pedicle rod into the saddle of the tulip
The new GEN II Rod Inserter was developed to ensure a rigid connection between instrument and implant to allow for rod and tulip manipulation in-situ during insertion. The mechanism allows for effortless insertion into the anatomy without the need for an additional incision.
The system also has a percutaneous compressor/distractor system that is less complex than competitor systems and fits into the technique flawlessly.

Indications:
The PedFuse Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, the PedFuse Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1).

About SpineFrontier Inc.
SpineFrontier Inc. (http://www.spinefrontier.com) is a growing medical technology company that designs, develops and markets both implants and instruments for spine surgery based on the Less Exposure Surgery (LES®) Philosophy. These technologies are designed to allow for outpatient surgery due to minimal disruption of normal tissues. SpineFrontier believes LESS is more: LESS time in treatment and recovery is more time in action for patients and surgeons. The LES Techniques drive the design process under the leadership and expertise of Dr. Chin, our surgeon experts, and engineering team that have access to our training lab and state of the art manufacturing facility to ensure that every use scenario is explored and design limitations are overcome. SpineFrontier is headquartered in Malden, MA. It was founded in 2006, and released its first products in 2008. SpineFrontier is a KICVentures portfolio company and the leader in LES technologies and instruments.

Contact
Phone: (978) 232-3990
Media: contact(at)spinefrontier(dot)com
Sales: sales(at)spinefrontier(dot)com
Engineering: MikeEmery(at)spinefrontier(dot)com

Rumor Mill: Is Stryker about to purchase NuVasive?

Posted On January 20, 2017 By OrthoSpineNews In Spine / 1

This is a rumor that has long been discussed, but is this about to happen? It makes sense that Stryker would be very aggressive after the LDR splash made by Zimmer Biomet in 2016. Use the comment section below to leave your thoughts and if you have any intel on this potential blockbuster deal.

NuVasive to Resume XLIF Procedures in Japan in First Quarter 2017

Posted On December 30, 2016 By OrthoSpineNews In Spine /

SAN DIEGO, CA–(Marketwired – December 29, 2016) – NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced it received approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Recent guidance from the MHLW requires dilators and associated components used in lateral access spine surgical procedures to be classified in Japan as Class III medical devices. NuVasive’s dilator, which is used in XLIF procedures, was originally approved in Japan as a Class II device in August 2011 with additional sizes approved in January 2014. As previously disclosed, NuVasive submitted its dilator and associated components for reclassification as Class III medical devices, and surgeons had temporarily stopped performing XLIF procedures in Japan while the reclassification was pending.

With this approval from the MHLW, XLIF procedures in Japan will resume in the first quarter of 2017. In connection with the MHLW approval, NuVasive has agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.

“We’ve worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan,” said Jason Hannon, NuVasive’s president and chief operating officer. “Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013. As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again. We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need.”

XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies. There are over 350 peer-reviewed global journal articles reporting on the XLIF procedure over the last 11 years, which detail the positive outcomes and benefits of a lateral approach to the spine compared to traditional posterior and anterior approaches.

The Company intends to provide preliminary guidance for 2017 revenue on January 9, 2017 at the J.P. Morgan Healthcare Conference.

About NuVasive

NuVasive, Inc. (NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 2,200 person workforce in more than 40 countries around the world. 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.

Spine

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