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August 31, 2017 OrthoSpineNews

DENVERAug. 31, 2017 /PRNewswire/ — Fifty-six of Colorado’s top orthopedic physicians, across seven practices, have united under a common vision of improving outcomes, efficiency, cost, and quality to form Orthopedic Centers of Colorado, LLC (OCC). With 19 offices across the Denver metro area, the combined practice is the largest provider of orthopedic and musculoskeletal care in the state.

The seven practices coming together as Orthopedic Centers of Colorado, LLC are:

  • Advanced Orthopedic & Sports Medicine Specialists P.C.
  • Colorado Orthopedic Consultants, P.C.
  • Denver Spine Surgeons, LLC
  • Denver-Vail Orthopedics, P.C.
  • Hand Surgery Associates, P.C.
  • Orthopedic Associates, LLC
  • Peak Orthopedics & Spine, PLLC

In a market where just 33 percent of physicians work in independent practice, down from 48 percent in 2012, this formation represents a physician-driven commitment to the private-practice model of medicine.

“The private-practice model has proven to deliver a higher level of quality at a more competitive price,” said Davis Hurley, MD, president of Orthopedic Centers of Colorado. “Patients will continue to benefit from the more personalized approach that private practice delivers to accommodate each patient’s needs.”

As a physician-driven organization, OCC will remain nimble enough to adapt to the ever-changing healthcare landscape, and emerge as pioneers in improved patient outcomes and reduced costs, while maintaining strong personal relationships with the patients from the communities we serve.

The seven practices will begin operating as Orthopedic Centers of Colorado on September 1, 2017. Patients of the practices will see no interruption in their care and services and will begin to see the OCC name on patient communications.

About Orthopedic Centers of Colorado, LLC
The number one choice for orthopedic, hand and spine health in Colorado and the Rocky Mountains, Orthopedic Centers of Colorado is an independent group of 56 physicians focused on patient specific care, quality outcomes, value and continuous improvement. We’ve assembled the best doctors across nearly 30 areas of expertise including Colorado’s best sports medicine and orthopedic physicians. Patients can visit any of our 19 convenient locations for care from doctors who believe quality patient care starts with a great patient experience. Learn more at orthocentersco.com

 

SOURCE Orthopedic Centers of Colorado, LLC


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August 30, 2017 OrthoSpineNews

AUDUBON, Penn., Aug. 29, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that, the Board of Directors has named David M. Demski as the Company’s Chief Executive Officer, effective immediately.  Mr. Demski will report to David C. Paul, the Company’s founder, Chairman of the Board, and Chief Executive Officer since its inception in 2003.  Mr. Paul will remain in the role of Executive Chairman.

Mr. Demski has been a Globus Medical senior executive since 2003, serving initially as Chief Financial Officer from 2003 until 2008.  In 2008, he became President and Chief Operating Officer of the Company, responsible for all of its domestic and international commercial operations, including sales, marketing, manufacturing, and finance.  During Mr. Demski’s tenure as President and COO, Globus Medical consistently delivered above-category growth and profit margins, culminating in the Company’s successful initial public offering in 2012.  In 2015, Mr. Demski became President, Emerging Technologies, and assumed responsibility for overseeing the Company’s expansion into the areas of imaging, navigation, and robotics, as well as orthopedic trauma, both of which are expected to contribute to the Company’s growth over the next decade.

Mr. Paul will continue to focus on strategic initiatives and will spend less time on day-to-day operational matters.  The Company reported that the timing of these management changes was designed to allow Mr. Paul to recover from a health condition. Mr. Paul is expected to make a full recovery over the next several months and plans to remain actively involved with the Company both during his recovery and thereafter.

“No one is or could be more well suited to be CEO of Globus Medical than Dave,” said David Paul.  “He has been with us since the very start of this Company, has led virtually every aspect of its operations, and has been a significant contributor to the Company’s success to date.  During the seven years when Dave served as President, among his many responsibilities were direct leadership of both our domestic and international sales forces.  During that time, and as he took over responsibility for our Emerging Technologies division, Dave honed a talent for optimizing sales team performance and developing and commercializing new products.  His skill set is precisely what we need to continue our focus on profitable growth.

“With Dave taking over day-to-day management of the Company, I can focus on the things I am most passionate about and the areas in which I can bring the most value to our shareholders: strategy and technology innovation.  Globus Medical was built on delivering groundbreaking solutions to surgeons and their patients, and we will not stray from our core mission.  We have built a strong company and will move forward with the same vision and passion for which we are known. I look forward to being part of the Company’s continued success.”

Conference Call Details:
Globus Medical will hold a teleconference to discuss the press release with the investment community at 5:30 p.m. Eastern Time. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-216-562-0337 International Participants

There is no passcode for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at www.globusmedical.com/investors.

The call will be archived until Tuesday, September 5, 2017. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 7826-9364.

About Globus Medical, Inc.                                      
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms and specifically include statements regarding Mr. Paul’s medical prognosis. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, changes in Mr. Paul’s medical condition, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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August 29, 2017 OrthoSpineNews

WARSAW, Ind., Aug. 28, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics and Mighty Oak Medical are pleased to announce a navigation partnership that can provide unsurpassed screw placement accuracy in the pediatric population.  Mighty Oak Medical is the manufacturer of FIREFLY® Pedicle Screw Navigation Guides, which are 3D printed and patient-specific at each planned vertebral level. FIREFLY® Guides address the clear market need for a navigation solution that does not rely on intraoperative radiation, and is ideally suited for longer construct cases. OrthoPediatrics regards scoliosis surgeries as an excellent application of FIREFLY® Technology, and has been granted the exclusive distribution rights for FIREFLY® Pedicle Screw Navigation Guides in pediatric hospitals in the United States. The FIREFLY® Pedicle Screw Navigation Guides can be used with any Spinal Deformity Correction system, including the OrthoPediatrics RESPONSE Spinal Deformity System.

David Bailey, Executive Vice President of OrthoPediatrics, said, “Our partnership with Mighty Oak Medical is one more way OrthoPediatrics is advancing the field of pediatric orthopedics.  The FIREFLY® Technology will be a valuable addition to our spine portfolio, and we are pleased to partner with another company that is Leading Innovation in Pediatric Orthopedics!”

“This distribution relationship is going to highlight the stark differences between robotic and optical navigation systems, which can cost up to a million dollars and are highly complex and radiation heavy, with the 3D printed patient-specific disposable solution of FIREFLY®.  In the capable hands of the OrthoPediatrics team, we believe the FIREFLY Guides’ validated 99.7% accuracy, combined with ease of use, should quickly bring a safe and reliable navigation tool to pediatric facilities across the United States”, stated Heidi Frey, President of Mighty Oak Medical.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is the only 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 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States.
Investor Contacts: The Ruth Group, attn: Zack Kubow; (646) 536-7020  zkubow@theruthgroup.com.

About Mighty Oak Medical
Mighty Oak is a medical device incubator and a leader in patient-specific solutions for the spine. Our robust patent portfolio, both US and worldwide, and pipeline of patient-specific devices for the spine, is unparalleled. By combining the talents of experienced spine surgeons and biomedical engineers, spine surgeries can be made safer and more efficient. Our mission is to improve surgical outcomes in a manner that is both cost-effective and patient-centered. We have the freedom to focus on innovative solutions, and our team is developing many exciting and disruptive products that meet these objectives. For more information, please contact info@mightyoakmedical.com.


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August 29, 2017 OrthoSpineNews

SAN DIEGOAug. 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the expansion of its San Diego global headquarters, including the creation of an innovation center of excellence where surgeons from around the world will be educated and trained on the latest NuVasive spine technology and procedures designed to drive clinical predictability and improve patients’ lives.

NuVasive, founded in 1997 as a local San Diego medical technology startup, pioneered minimally invasive, lateral spine surgery and earned its reputation as one of the most innovative spine companies in the industry. Today, the Company ranks third in the global spine market and anticipates surpassing the $1 billion revenue mark at the end of this year.

As the Company continues to grow at an accelerated rate, it plans to renovate and further build out its world headquarters starting in January 2018. The Company’s growth is reflected in several areas, including training more than 500 surgeons annually on its products and procedures at its San Diego campus, a commitment to increasing its R&D spend as a percent of revenue from 5 to 7 percent over the next several years, and creating jobs, locally and globally.

NuVasive’s San Diego campus, located at 7475 Lusk Boulevard in Sorrento Valley, will increase by more than 100,000 square feet, bringing the total space to approximately 250,000 square feet. Expansion plans include renovating the current two buildings on campus and adding a third building. The newly renovated campus will include an innovation center of excellence, showcasing the Company’s state-of-the-art product and procedural offerings and highlighting its world renowned surgeon education. Additional features of the campus include:

  • an expanded surgeon education lab for onsite surgeon training and education;
  • a prototype design facility with 3D printing capabilities;
  • state-of-the art biomedical testing center; and
  • a new amenities building which will include an onsite café, fitness center and meeting space to accommodate up to 750 attendees.

“Our headquarters expansion reflects our commitment to the San Diego region where medical technology companies and the life sciences industry have significantly contributed to the growth for decades,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “Our new facility will offer NuVasive the unique opportunity to have our design facility, lab space and product development in one location where visiting surgeons and our product development teams can collaborate closely on our newest technologies. With the support of Mayor Faulconer and the San Diego Regional Chamber of Commerce, we are eager to continue our investment into the San Diego area with a facility that attracts, retains and grows the high-performing employee talent we have here at NuVasive.”

NuVasive worked closely with city and state officials to re-invest in the area and continue the commitment of bringing surgeons from around the world to train at the onsite cadaver lab.

“It’s an exciting day for NuVasive and a proud moment for San Diego,” said San Diego Mayor Kevin Faulconer. “NuVasive is a homegrown company that’s supporting our innovation economy, creating jobs for San Diegans and leading the world in transformative spinal surgeries. We will continue to create an environment in San Diego where companies like NuVasive can grow and thrive.”

Mayor Faulconer and other state and local officials visited the San Diego campus earlier this year.

San Diego’s business community applauds the expansion of the NuVasive campus,” said Jerry Sanders, San Diego Regional Chamber of Commerce’s president and chief executive officer. “NuVasive is a major contributor to San Diego’svital medical technology industry and has demonstrated an admirable commitment not only to supporting our region but to totally revolutionizing spine surgery across the world. It’s a major point of pride for San Diego to be home to such leading innovators who are growing, thriving, and hiring here.”

While San Diego serves as the Company’s global headquarters, NuVasive remains committed to expanding its global footprint. The Company recently opened its new international headquarters in Amsterdam, and finished a new 180,000 square foot manufacturing center in West Carrollton, Ohio. NuVasive’s footprint also includes a 100,000 square foot facility in Memphis, Tennessee, which serves at the Company’s central distribution hub.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, 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 $962 million in revenues (2016), NuVasive has an approximate 2,300 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.

Related Links

http://www.nuvasive.com


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August 28, 2017 OrthoSpineNews

28 Aug 2017

Allegra Orthopaedics Ltd (ASX:AMT) is continuing to make significant progress with its unique bone substitute technology “Sr-HT-Gahnite” and is aiming to progress into the production phase.

The company is an orthopaedic manufacturer and has obtained the global license to the composite biocompatible ceramic material known as Sr-HT- Gahnite from the University of Sydney.

Allegra’s tests have indicated that all the samples containing the Sr-HT Gahnite scaffolds showed promising ingrowth of bone through the scaffold and in some cases completely bridged the defect.

Importantly, there was no evidence of inflammation or formation of fibrous tissue, indicating good biocompatibility of the Sr-HT Gahnite.

The company is also studying the various commercial applications of this unique bone substitute technology, before commencing with interbody cervical spinal cages as the initial product offering.

 

READ THE REST HERE


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August 24, 2017 OrthoSpineNews

August 23, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, today has announced that it has expanded its Field of Use definition of the license agreement with the UCLA Technology Development Group on behalf of UC Regents for NELL-1. Additionally, Bone Biologics has entered into an exclusive license agreement with the UCLA Technology Development Group on behalf of UC Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer.

“Following the completion of several key milestones, Bone Biologics is pleased to include two additional indications to its portfolio,” said Stephen LaNeve, CEO and President of Bone Biologics. “In addition to the company’s work in spine fusion, this exclusive license agreement for trauma and osteoporosis, further supports the possibility of NELL-1 becoming a proprietary platform technology.”

Most current osteoporosis therapies are designed to slow bone loss and prevent it from worsening but research involving NELL-1 is being examined to systemically restore bone and prevent further loss.

About Bone Biologics

Bone Biologics (OTC: BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work and building on unprecedented research on the NELL-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. NELL-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTC; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com


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August 23, 2017 OrthoSpineNews

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, successfully completed its 1,000th TOMCAT Anterior Cervical Discectomy and Fusion (ACDF) procedure. The procedure was performed by Julian Price, MD of Athens Orthopedic Clinic, Athens, GA at St. Mary’s Hospital, also in Athens, on August 14, 2017.

“I choose to use TOMCAT for all my ACDF procedures as it provides streamlined implantation with modular instruments, self-locking retention clip and a hybrid device that eliminates difficult screw trajectories.” stated Dr. Price. “My clinical outcomes with TOMCAT are excellent as I have experienced early bone growth with the Hydroxyapatite (HA) Enhanced integrated PEEK™ spacer.”

The TOMCAT Cervical Spinal System was designed to stabilize and fuse the cervical vertebral column with no profile or low profile anteriorly. TOMCAT is available in two configurations, Zero Profile and Hybrid, both with 4° and 8° lordosis. The Zero Profile, Stand Alone TOMCAT sits within the vertebral body leaving the anterior cervical spine unchanged, which may reduce post–operative complications for good healing. The Hybrid, Stand Alone TOMCAT provides an adaptable surgical solution when previous adjacent level treatment is present. Both devices provide an optimized fusion environment with large, center chambers for bone graft and HA-enhanced PEEK that provides early bone apposition.

“This is an important milestone for TOMCAT and ChoiceSpine. The 1,000th completed TOMCAT procedure continues our successful track record of delivering products that produce quality outcomes in spine surgery,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “TOMCAT’s flexible design allows it to adapt to complex cervical anatomy providing spine surgeons with one solution to address multiple surgical challenges during ACDF procedures.”

About ChoiceSpine 
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

Contact:
KC Gilbert
Vice President Marketing & Professional Education
865-246-3333
kgilbert(at)choicespine(dot)com
choicespine.com


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August 23, 2017 OrthoSpineNews

SAN JOSE, Calif.Aug. 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 that Highmark, Inc., the nation’s 4th largest Blue Cross and Blue Shield-affiliated insurer, has established an exclusive positive coverage policy for MIS SI joint fusion using the iFuse Implant System.  Highmark, Inc., an independent licensee of the Blue Cross and Blue Shield Association, is among the top 10 largest health insurers in the United States and includes Blue Cross Blue Shield (BCBS) of Pennsylvania, BCBS of Delaware and BCBS of West Virginia.

Based on the more than 50 peer-reviewed clinical studies and publications, the policy, available at the link below, provides iFuse coverage for more than 4.5 million Blue Cross Blue Shield plan members in PennsylvaniaDelaware and West Virginia effective August 21, 2017.

https://secure.highmark.com/ldap/medicalpolicy/wpa-highmark/S-230-010.html

The Following Blue Cross Blue Shield Plans now cover iFuse:

  1. BCBS of Texas: HCSC: Exclusive to iFuse
  2. BCBS of Oklahoma: HCSC: Exclusive to iFuse
  3. BCBS of New Mexico: HCSC: Exclusive to iFuse
  4. BCBS of Montana: HCSC: Exclusive to iFuse
  5. BCBS of Illinois: HCSC: Exclusive to iFuse
  6. BCBS of Pennsylvania: Highmark: Exclusive to iFuse
  7. BCBS of Delaware: Highmark: Exclusive to iFuse
  8. BCBS of West Virginia: Highmark: Exclusive to iFuse
  9. BCBS of Michigan
  10. BCBS of Vermont
  11. BCBS of Nebraska

Over 22.5 million BCBS health plan members are now covered for MIS SI joint fusion.

“The SI joint is a common source of low back pain in many patients. I have performed over 90 procedures with the iFuse Implant System and it has been a rewarding procedure for my patients and for me as a spine surgeon.  I am very pleased to now be able to offer appropriately diagnosed Blue Cross Blue Shield patients this clinically proven SI joint fusion procedure,” said Michael Oh, MD, neurosurgeon at Allegheny General Hospital in Pittsburgh, PA.

“For almost 10 years, we have been keenly focused on building products and an effective procedure that benefits patients who have SI joint disruption and/or degenerative sacroiliitis. We are of course pleased that Highmark has decided to provide coverage based on the extensive published data demonstrating safety, clinical effectiveness, durability, low revision rates and opioid user reduction of the iFuse Implant System that has been available since 2008,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE.

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

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.  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

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9752.08232017

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com


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August 22, 2017 OrthoSpineNews

August 22, 2017

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing designer and manufacturer of spinal implant systems, announced the release of the Scaltoff™ Wire, a patent pending, stackable guide wire for its Entasis® Sacroiliac Joint Fusion System. The convertible length wire enables constant control during drilling, tapping, and insertion steps yet can be quickly shortened to accommodate the C-arm in lateral view x-rays.

“The most significant threat to patient safety in lateral SI joint fusion procedures is the possibility of the guide wire advancing into the sacral foramina and potentially damaging a nerve root,” says Dr. Donald Sachs (Neurosurgeon, Tampa, FL), “This is a good response to that common risk. Plus, with this, you don’t have to remove the wire, avoiding the frustrations of finding your path again.”

The stackable Scaltoff Wires (blunt and trocar) thread onto and off each other, end-to-end, providing adjustable length. Considered to be the stiffest on the market, the extra rigidity of these stainless steel wires further enhances control for the surgeon.

Now a little more than a year on the market, CoreLink’s Entasis© SI Joint Fusion System has seen more than 500 devices implanted. Surgeons most often cite the device’s Easy-In™ dual-pitch compression threading and the autograft self-harvesting circumferential fenestrations as the most compelling features in their choice of this device. CoreLink expects the addition of the stackable Scaltoff Wire to further accelerate the adoption of this implant system.

For more information or distribution opportunities concerning the Entasis® SI Joint Fusion System, or any of CoreLink’s other spinal implant products, please, visit www.corelinksurgical.com.

About CoreLink

CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. CoreLink leverages this expertise through collaboration and a dedication to empowering surgeons with the highest quality and most effective instruments and implants possible. That is how CoreLink came to be known as The Source.

Be a part of something. Come to The Source.

Indications for Use

The Entasis Dual-Lead Sacroiliac implant system is intended for sacroiliac joint fusions for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
Senior Director, Marketing
m.linhardt@corelinksurgical.com


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August 22, 2017 OrthoSpineNews

August 22, 2017 – JIM MCCONVILLE, Staff Writer, (Journal Photo by Ron Agnir)

MARTINSBURG — WVU Medicine Berkeley Medical Center added its first robot-neurosurgeon to its medical staff on Monday.

On Monday, BMC became the first medical center in West Virginia and the tri-state region to add the Mazor X, a robotic surgical platform, which will be used by its new Medicine Brain and Spine Center.

BMC is the first medical center in West Virginia and within a 60-mile radius from the center to employ the surgical robot technology.

Delivered to BMC on Aug. 17, the Mazor robot performed its first patient surgery Monday afternoon.

“As spinal surgery has evolved, more focus has been placed on minimizing trauma to the body during surgery and expediting a return to function through the use of minimally invasive techniques,” said Dr. John Caruso, neurosurgeon and medical director of WVU Medicine Brain and Spine at Berkeley Medical Center.

Using the the Mazor robot software, doctors can plan a spine operation procedure. During the actual surgical procedure, doctors use the precision mechanics and surgical arm to guide surgical tools and implants at the right trajectory and position, based on that surgical plan.

For patients, minimally invasive surgical procedure means less pain, less blood loss, a smaller surgical cut, a shorter hospital stay, and a shorter recovery period compared to conventional spine surgery.

 

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