Over the next decade, sales of spinal surgery implants, instruments, pharmaceuticals and other novel treatments for chronic and disabling back pain will, say the analysts on Wall Street, rise from $10 billion in 2020 to $14-16 billion by 2030. In terms of the overall economic cost of chronic back pain, economists estimate that it hit a staggering $250 billion (National Spine Health Foundation) in direct expenses and lost work time in 2020. To the extent that the future care givers can restore patient functionality and relieve back pain, the potential return on cost is a staggering 25 to 1: ($1 spent on treatment could deliver $25 in savings).
The spine treatment community is experiencing a period of rapid innovation and a new generation of key opinion leaders. The champions of instrumented internal fixation, stability via intervertebral innovations, biologically enhanced fusion and innovative surgical approaches, who still dominate the podiums at spine meetings, will soon be sharing the stage with a younger generation who speak software, big data, artificial intelligence, robotic assistance, neuromodulation, RNA-based pharmacology and multi-functional, additively manufactured, biologically interactive materials.
New terminology, new concepts, more MIS, more ASC and more reliable and affordable spine care. Hang on tight, it’s coming in hot.
Welcome to the August 10, 2021 special edition of Orthopedics This Week where we check in on both new companies and a handful of well-established suppliers (like Medtronic or Globus Medical) who are also driving the future of spine care. This is not an all-inclusive list. HOWEVER, like a good additive manufacturer process—we will add new layers of suppliers to the list in future special editions…this year!
Thank you for your support and interest. — Robin Young, Editor and Publisher, Orthopedics This Week
Biologica Technologies — Spun out of the 3-time, Orthopedics This Week – Best New Spine Technology Award winner, Advanced Biologics, Biologica Technologies was established as a separate, stand-alone company located in Carlsbad, CA in late 2015. The company’s core, patented, proprietary technology is an extremely unique process that captures the naturally occurring growth factors (GFs) found within allograft tissue (i.e., bone, tendon, adipose, dermis, etc.) and makes these GFs bioavailable. Biologica’s first product, ProteiOS® allograft growth factor, is more than just a single growth factor or peptide, it’s a cost-effective, soluble protein cocktail containing almost 1,000 naturally occurring growth factors, including, but not limited to; BMP-2,4,6,7,9, PDGF-BB, TGF-β and VEGF. It possesses the highest amount of non-recombinant growth factors on the market today with the added advantage of providing a surgeon their choice of what type of scaffold best meets their needs (i.e., handling, cost factors, etc.). Biologica will be presenting new ProteiOS clinical data at AAOS, AOFAS and NASS this fall. Carrying on the tradition of novel, orthobiologic solutions with substantial growth factors, Biologica’s latest introduction, OsseoGEN® cellular bone matrix (CBM), provides a CBM that once again possesses the highest amount of non-recombinant growth factors of any cellular bone matrix product. It is DMSO Free and has exceptional handling characteristics. For more information, contact Scott Cadotte, SVP Sales & Marketing scadotte@biologicatech.com, Jason Mattiello, Vice President – Sales jmattiello@biologicatech.com 800.677.6610 or visit us at www.biologicatechnologies.com.
CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. With a unique heritage that combines old-world craftsmanship with state-of-the-art manufacturing, they collaborate with surgeons to develop and deliver effective surgical solutions and improve the lives of patients. CoreLink is heavily investing in product development to grow their portfolio and better serve surgeon partners. “We have multiple new products featuring Mimetic Metal® technology coming this year and recently introduced new implant and instrument options for the M3 Stand-alone ALIF System. Our comprehensive lateral platform continues to exceed surgeon expectations due to the surgical efficiency it offers with the low-profile Oro™ Lateral Plate and the ability to optionally attach to either the F3D or PEEK Lateral interbodies. It is not just about the products; we are focusing on the data and science behind our innovative technologies with ongoing prospective studies on our FLXfit®15 Posterior Lumbar System and pre-clinical studies of Mimetic Metal,” said Jay Bartling, CEO of CoreLink. “We look forward to sharing our results and anticipate several additional launches in the coming months.” Mimetic Metal technology combines a lattice scaffolding and inner trabecular pores and is designed to emulate the structural, functional, and physiological properties of natural bone. FLXfit15 is designed to maximize lordosis correction with up to 15 degrees of controlled in-situ expansion. The articulating footprints streamline device insertion and maximize anterior lumbar support and endplate surface coverage. For more information, visit CoreLinkSurgical.com.
Curasan, Inc. Our team at CURASAN in the USA and around the world provides clinically relevant bone grafting products specializing in the latest advances in synthetic strip bone grafts for spine, trauma, extremities, and total joint revision. We have an excellent team established globally and are seeking to expand distributors as well as private label partnerships in key locations. As developer and provider of our CERASORB and CERACELL Foam grafts, we offer best in class handling while also demonstrating partnership with distributors, hospitals and GPOs driving value to their bottom line without sacrificing efficacy—this is key to our business. CERASORB Ortho Foam strip bone graft has been clinically shown to provide bone growth in various clinical indications with excellent results. Two options are available including moldable, important to conform in defect sites, as well as a flex form which has shape memory. We also have a 25cc version specifically designed for total joint revision and large defect sites reducing the number of packages required intraoperatively. CERACELL Ortho Foam strip contains the latest advances in silicated synthetic bone grafts specifically designed for posterolateral spinal fusion. Similarly to CERASORB Ortho Foam, CERACELL is available in moldable and flex versions designed to mimic surgeon handling preferences in posterolateral spine fusion. These synthetic bone grafts are on-market in the USA, CANADA, EUROPE, and other locations globally. Connect and contact us with any questions: USA/CAN interest: adminusa@curasan.com Tel: +1 919-941-9770 EUROPE and Rest of World interest: info@curasan.de Tel: +49 (0) 60 27409000 Website: www.curasan.com
Elevation Spine is a medical device company with a proprietary technology platform, Saber Technology, which is an advanced and differentiated approach to traditional fusion. Saber Technology was designed to improve patient outcomes while providing surgeons with a high-tech, yet simple approach to spinal fusion procedures. The first FDA cleared Saber Technology product, SABER-C™, is comprised of a zero-profile anterior cervical plate that accepts multiple spacer material and fixation options and provides a proprietary single-step integrated-fixation. Traditional fusion technologies utilize a plate and screws to fixate the spine during a fusion procedure. Alternatively, SABER-C’s robust and versatile implant offering utilizes a unique curved spike device which eliminates the large working space that a straight screw requires, therefore minimizing incision size and simplifying the surgical technique. As a result, the Elevation Spine fusion procedure is extremely efficient while remaining minimally invasive.
Esaote North America, Inc. – Weight-Bearing MRI – Why it should be considered as part of a patient care pathway? In a recent study of 163 cases of patients that were scheduled for spinal intervention, it was demonstrated that in 48% of the cases, the treatment plans have been determined or modified. According to the authors—Radiologists and Spine Surgeons—Weight-Bearing MRI provides significant information which can help to establish a proper diagnosis that then leads to a correct and appropriate intervention plan, especially for minimal invasive spine surgery (MISS). From the study: In 21% of the cases—1 out of 5 patients—the treatment plan was changed based on the information from Weight-Bearing MRI! Thanks to the added diagnostic opportunities of the Esaote Dedicated G-scan MRI, the unique ability to scan patients either in a supine position or a weight-bearing position, the clinical outcome of Weight-Bearing MRI may also have a relevance also in the medical legal field. For information on recent publications on WB-MRI by the radiology community see the Thieme publications: https://www.thieme-connect.com/products/ejournals/issue/10.1055/s-009-44894 See: https://www.esaote.com/dedicated-mri/mri-systems/p/g-scan-brio/
LifeLink Foundation is a non-profit community service organization dedicated to the recovery of lifesaving and life-enhancing organs and tissue for transplantation therapy. The Foundation works in a sensitive, diligent, and compassionate manner to facilitate the donation of desperately needed organs and tissues for waiting patients. LifeLink Tissue Bank provides quality allograft bone and tissue to patients all over the world. In addition, LifeLink is looking for strategic partners for contract allograft tissue processing. Our entire staff of business development personnel, R&D engineers, Quality engineers and Processing staff are willing to assist your company in bringing your next allograft to the marketplace. Additionally, LifeLink supports research efforts to enhance the available supply of organs and tissues for transplant patients and to improve patient clinical outcomes after transplantation and participates in partnership with organizations whose projects and objectives complement our life-saving mission. “At LifeLink, we remain focused on developing new Regenerative Medicine allografts and products, and continue looking to align with the appropriate partners to enhance our mission.” Michael Consilvio, General Manager, Executive Director of LifeLink Tissue Bank. Some of LifeLink Tissue Bank allogaft offerings are LifeGraft® ACDF Allograft Spacers which are a full line of parallel/lordotic cervical spacers with multiple footprints (11.5x14.5mm and 14x14mm), LifeFlex® Demineralized Cancellous Strips with a porous structure that provides osteoconductive scaffold and LifeFlex® Demineralized Cortical Fibers featuring optimal fiber design that provides ideal handling characteristics for fluid retention and expansion. Mike Consilvio, General Manager, Executive Director, michael.consilvio@lifelinkfound.org; Tim Ignatius, VP, Sales and Marketing, tim.ignatius@lifelinkfound.org; Brad Bassler, VP, Associate Executive Director, brad.bassler@lifelinkfound.org
M.O.R.E Spine Education Program — EXPERIENCE THE MEDACTA PLATFORM: AN UNPRECEDENTED SYNERGY FOR PERSONALIZED MEDICINE – When attempting a new procedure or working with a new technology, there’s always the challenge of the associated learning curve. This can often lead to discouragement and could even prevent perseverance or taking full advantage of the benefits offered by the new procedure or technology. The approach to new technologies in spine surgery may discourage surgeons to benefit from novel procedures and related improved patient outcomes. Two overcome surgeons’ hesitancies, Medacta’s mission is to provide them unconditional support through the M.O.R.E. Education Program. Along with the M.U.S.T. posterior fixation System and fusion devices, the MySpine patient-matched technology is capable to provide a comprehensive solution to both deformity and degenerative surgeries, while the innovative MySpine MC is a plus for MIS midline approach with cortical strong purchase. Ultimately, 360° surgery may combine anterior fusion with efficient posterior correction thanks to the unique synergy with the MectaLIF Anterior cages platform that represent an optimal solution for sagittal imbalance restoration. From the M.O.R.E Education Program, you can expect Learning centers for hands-on training from experienced surgeons around the world, reference centers with the ability to attend live surgeries, support from expert surgeons as needed with your first surgeries, and continuous education through international events and educational tools. Simply contact Dennis Ty from Medacta at dty@medacta.us.com and we will arrange an Education Program for you!
Pacira BioSciences, Inc. – Pacira is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving patient outcomes. The company is committed to pursuing innovation and providing better ways to manage pain safely and effectively. Pacira provides solutions to address unmet medical needs and improve clinical results with products that are approved to provide postsurgical pain management in patients aged six and over. Featuring a team of dedicated and highly talented professionals, the company is focused on driving enhanced recovery protocols featuring opioid-reducing strategies that can make a meaningful difference in the lives of patients, families, communities, and society. The overreliance on opioids to manage pain in the surgical setting, including after various orthopedic procedures, can have unintended downstream consequences such as addiction and dependence. Tackling the nation’s complex opioid epidemic will require a multifactorial strategy built on the innovative approach of forward-thinking companies that challenge and transform the way society thinks about—and treats—pain in the United States. Educating doctors and patients about the importance of non-opioid pain management options is central to the Pacira mission to improve patient care, from orthopedics, to pediatrics, and beyond.
SI-BONE, Inc. is a medical device company uniquely focused on providing solutions to musculoskeletal disorders of the sacropelvic space. The company pioneered minimally invasive fusion of the sacroiliac (SI) joint in 2009 with the triangular iFuse Implant System®. Since then, SI-BONE has expanded its focus to include pelvic fixation for spinal deformity and pelvic trauma through innovation, clinical evidence, education, and advocacy. Minimally invasive SI joint surgery, the core of SI-BONE’s business, is supported by more than 95 peer-reviewed publications demonstrating the safety, effectiveness, durability and biomechanical, and economic benefits of iFuse Technology®. Two-year results from a recent prospective study (SALLY) of the iFuse-3D™ implant demonstrated accelerated radiographic fusion and consistent clinical improvements compared to two prior iFuse implant RCTs. The iFuse-3D implant’s unique triangular geometry provides immediate stabilization, and the 3D-printed porous surface is designed to facilitate bone in-growth and on-growth. The fenestrated implant structure is designed to allow bone through-growth. SI joint fusion using the iFuse Implant System now has virtually universal payor coverage. There are more than 35 triangle-exclusive payor policies representing approximately one-third of all covered lives in the U.S. New applications in spinal deformity and pelvic trauma have expanded the company’s scope within the sacropelvic space. In 2019, the company launched iFuse Bedrock®, a technique where 3D-printed triangular implants are placed adjacent to S2AI screws to provide improved pelvic fixation and stabilization. Studies show a 30% reduction in SI joint motion at the base of long fusions when iFuse Bedrock is added to S2AI screws. SI-BONE’s latest innovation is iFuse-TORQ®, a 3D-printed threaded implant designed for fixation of pelvic fractures and SI joint surgery. For more information on SI-BONE, please visit www.si-bone.com or contact Tony Recupero, President of Commercial Operations – trecupero@si-bone.com
TheraCell, Inc. is a regenerative medicine company guided by a team of influential spine surgeons, regenerative medicine scientists, and experienced medical device executives. As a leading allograft solution company, TheraCell has developed the next generation of advanced technologies for orthopedic tissue repair. TheraCell has three synergistic technology platforms, namely: (i) TheraFuze DBF® demineralized bone fiber technology, which incorporates their proprietary and patented Bone Textile™ and FormLok™ technologies. The comprehensive portfolio of procedure-specific TheraFuze DBF products includes the Fiber Anchor™ for immediate enhanced screw fixation, Fiber Bullets™ for delivery through a cannula in MIS cases, the Fiber Bag™ and the Fiber Wrap™ for graft containment, and 1-, 2- and 3-level Fiber Boats™; (ii) A patented process for infusing demineralized cortical bone powder into cancellous bone to enhance the osteoinductive potential of demineralized cancellous bone grafts; and (iii) A technology platform of proprietary and patented oxygenation technologies. TheraCell has developed methodologies and obtained patent protection for applying the oxygenation technology to demineralized bone matrix products and other biologic materials. The O2ssify™ oxygenation technology has been demonstrated to supercharge bone formation and leads to improved tissue regeneration. TheraCell has licensed the base TheraFuze DBF® technology to AlloSource. The technology has also been licensed to Australian Biotechnologies for the Australian and New Zealand markets. To date, over 37,500 TheraFuze DBF products and licensed products have been delivered by TheraCell and its licensee partners. Founded in 2008, TheraCell is headquartered in Los Angeles, CA and maintains offices and laboratories in Littleton, MA. www.theracellinc.com.
Your email address will not be published. Required fields are marked *
Email Address (will not be published) *
Save my name, email, and website in this browser for the next time I comment.
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Copyright © 2020 RRY Publications, LLC. All Rights Reserved. Sitemap. Privacy Policy