Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

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April 17, 2017 OrthoSpineNews

DES MOINES, Iowa, April 17, 2017 /PRNewswire/ — Rational Surgical Solutions (RSS) will exhibit at Booth #804 at the American Alliance of Orthopaedic Executives (AAOE) Annual Conference (April 22-25, Indianapolis). RSS will showcase two videos for its Rati-Fi® Patient Engagement & Informed Consent App, total hip replacement and Total Knee Replacement. The Rati-Fi® platform helps orthopaedic practices see more patients, streamline and automate procedures, and meet MIPS criteria. The AAOE Annual Conference brings together more than 500 orthopaedic practice executives and their staff from around the country for four days of education, networking, and professional development.

“The aging baby boomer population has increased the demand for hip replacement and knee replacement surgeries. Total knee replacements will increase 673% by 2030, with total hip replacement operations growing 174% over the same period,” said Dr. Jonathan Fialkov, RSS President & Founder. “This growth, coupled with a diminishing surgeon workforce and the demands for meeting bundled care initiatives, puts practices under enormous pressure to increase patient flow and comply with the criteria needed for reimbursements.”

Fialkov explained that the Rati-Fi® Patient Engagement Platform can help practices on several levels. “Educating and engaging patients about their treatment options and follow up care significantly reduces the incidence of readmissions and improves patient outcomes. Our platform includes videos from MedSelfEd’s PreOp® and PostCare™ Centers that use medical illustrations, animations and plain language to describe medical procedures.” The application records the patient-physician consult, which patients and caregivers can review using a patient portal.

The Rati-Fi Application also improves practice efficiencies by automating routine procedures. “Practices can use the Rati-Fi System for secure patient-doctor messaging, and to text patients reminders about scheduling tests and upcoming appointments. The result is fewer patient complaints, fewer cancelled procedures, and fewer no shows,” said Fialkov.

About Rational Surgical Solutions
Rational Surgical Solutions, based in Des Moines, IA, was founded by Dr. Jonathan Fialkov, a urologist, in 2014. Dr. Fialkov’s extensive experience in his field and the healthcare industry, gives him unique insights into the challenges faced by physicians today. The company is developing a portfolio of products that will help physicians, surgeons and advanced practitioners leverage mHealth technology to improve patient care and education; revolutionize the informed consent process; increase the efficiency of healthcare providers; and reduce costs. For more information or to schedule a free demo visit: http://www.rati-fi.com.

SOURCE Rational Surgical Solutions

Related Links

http://www.rati-fi.com


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April 17, 2017 OrthoSpineNews

BROOMFIELD, Colo., April 17, 2017 /PRNewswire/ — “Interventional orthopedics in pain medicine practice” was recently published by Elsevier as a chapter in Techniques in Regional Anesthesia and Pain Management. The chapter, authored by Regenexx® founder Christopher J. Centeno, MD examines less invasive ways to treat orthopedic pain and injuries through autologous biologics, such as stem cells and platelet rich plasma (PRP), and the shift from surgical orthopedics to interventional orthopedics.

Interventional orthopedics utilizing advanced technologies, such as ultrasound and X-ray guidance, precise percutaneous injections of autologous biologics, and bone marrow concentrate, (BMC) expand nonsurgical options in the field of orthopedics. Citing the dramatic reduction in cardiac surgery rates since the adoption of the specialty interventional cardiology, the authors reveal, “We are poised on the brink of the same change in orthopedic care.” The authors also state, “The field of autologous biologics has the potential to alter the playing field of orthopedic care by allowing percutaneous injections to replace the need for more invasive orthopedic surgeries.”

The chapter covers three important tenets in the developing field that will allow Interventional Orthopedics to alter traditional orthopedic care in the future. First is the rapid expansion of injectates (material being injected), such as stem cells and PRP, that can help heal damaged tissue and that can effectively treat musculoskeletal tissues. Second is the precise image-guided placement of those injectates into those damaged tissues. And third is the development of new tools that will advance this regenerative-medicine technology. The chapter also highlights research that supports the use of bone marrow stem cells and the importance of education standards and organization, training, and retraining of physicians to meet these standards.

The full chapter “Interventional orthopedics in pain medicine practice” can be found online at http://www.sciencedirect.com/science/article/pii/S1084208X16300052.

Christopher J. Centeno, MD, is the CEO of Regenexx and an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics.  Dr. Centeno maintains an active research-based practice and has multiple publications listed in the US National Library of Medicine. He has also served as editor-in-chief of a medical research journal dedicated to traumatic injury and is one of the few physicians in the world with extensive experience in the culture expansion of and clinical use of adult stem cells to treat orthopedic injuries.

MEDIA CONTACT
Mark Testa
155014@email4pr.com
(303) 885-9630

SOURCE Regenexx


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April 17, 2017 OrthoSpineNews

April 17, 2017

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, announced a new Federal Supply Schedule contract for its NEOX and CLARIX product lines. The agreement provides the Military Health System broad access to NEOX Wound Allograft – indicated for use as a wound covering for dermal ulcers and defects – and CLARIX Regenerative Matrix – indicated for use as a surgical covering, wrap or barrier in orthopedic surgery and soft tissue repair.

The Military Health System encompasses the U.S. Department of Defense’s institutions providing health care to active duty and retired U.S. Military personnel and their dependents. This system provides healthcare coverage to 10.2 million lives. Amniox Medical is partnering exclusively with Alliant Healthcare, a verified Service-Disabled, and Veteran-Owned Small Business (SDVOSB). As an SDVOSB, Alliant is a priority provider of medical products and services to the Federal government with an extensive sales history with every VA and DoD hospital worldwide. Alliant provides customer support for the Amniox cryopreserved umbilical cord and amniotic tissue allografts to the Military Health System.

NEOX and CLARIX are available under codes FSS #V797D-50441 and DAPA #SP0200-05-H-0090.

“We are pleased to increase the availability of our unique technologies for the nation’s Veterans and Active Duty Military patients and the clinicians who deliver care to them,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Acknowledgement of the clinical benefits that our proprietary technology offers to patients continues to deepen among providers and payers, now including broad accessibility this very important patient population through this contract.”

Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. The biological components of these tissues have demonstrated regenerative properties that can provide healing benefits to patients with numerous medical conditions. In utero, wound healing occurs rapidly and with minimal scar, and this restorative ability is innate to placental tissues, including umbilical cord and amniotic membrane. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate the healing process. Amniox utilizes its proprietary CryoTek™ process, a cryopreservation technology, to preserve the biological and structural integrity of the native tissue. Published studies have demonstrated that the CryoTek process more effectively preserves the structural and biological integrity of the tissue.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; Bio-Tissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

Contacts

for AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com


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April 17, 2017 OrthoSpineNews

BOCA RATON, Fla., April 13, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) that the company achieved its largest revenue quarter to date in the first quarter of 2017.  “The mark of a truly successful orthopedic implant company is sustained quarter over quarter growth, irrespective of market seasonality or other external factors,” said Geoffrey Bigos, Vice President of Spine Sales at 4WEB Medical. “Our continued success and rapid expansion is a testament to our surgeon customers belief in the difference that 4WEB’s Truss Implant Technology makes on surgical outcomes for their patients.”

4WEB’s record breaking quarter was highlighted by strong demand for its comprehensive Posterior Spine Truss System product line for TLIF procedures. The company also expanded sales and distribution into dozens of new hospitals during the quarter, making significant investments in sales infrastructure to further its reach into new markets. The first planned U.S. surgeries with the company’s new Lateral Spine Truss System in Q2 are certain to further advance its market leading position.

“The proliferation of 3D printed titanium implants across the industry has fueled the market adoption of these devices in spine surgery,” said Jim Bruty, 4WEB’s Senior Vice President of Sales and Marketing. “4WEB’s distinct advantages over competitive 3D printed and other titanium implants are clear; increased bone implant surface interface, more volume for bone through-growth, and transference of load throughout the implant to create a mechanical environment for biological fusion to occur.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, the Lateral Spine Truss System, and the Osteotomy Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com


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April 17, 2017 OrthoSpineNews

MINNETONKA, Minn., April 13, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 24-month CT Fusion and Clinical Results for its SImmetry Sacroiliac Joint Fusion System. This prospective, multi-site study evaluated long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

The study evaluated 18 patients for radiographic evidence of fusion at 12 and 24 months following SI joint fusion with decortication and bone grafting. A systematic Computed Tomography (CT) review was predefined and performed by independent radiologists blinded to each other’s assessments. Fusion was defined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). Previously-reported results demonstrated that 79 percent of patients had evidence of bridging bone at 12 months. At 24 months post-op 94 percent of patients had evidence of bridging bone, with 83 percent categorized as Solid fusion across the SI joint. Of patients with Solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. There were no procedure- or device-related serious adverse events reported.

“Evidence is continually building to support sacroiliac (SI) joint fixation’s ability to effectively reduce pain in patients with SI joint disorders,” said Dr. William W. Cross III, an orthopedic surgeon specializing in pelvic disorders from Mayo Clinic in Rochester, MN who presented the data at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting. “This study demonstrates the ability of the SImmetry system to achieve pain reduction comparable to other systems, while providing radiographically evident fusion as early as 12 months and increased fusion rates at 24 months. By supplementing fixation with decortication and bone grafting, I can be confident that my patients have the best possible foundation for biological fusion, and long-term relief.”

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointii.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. The Company is exhibiting at the 2017 ISASS meeting in Boca Raton, Fla. until April 14. For more information, visit zyga.com.

i Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ii Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

 



April 17, 2017 OrthoSpineNews

April 13, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, publishes its sales for the 1st quarter of 2017.

(€ millions) 2016 2017 Variation
1st Quarter 7.0 7.0
Changes in exchange rates had no material impact on year to year comparison

During the 1st quarter of 2017, Medicrea continued the major corporate restructuring initiated in 2016 with the permanent closure of the original La Rochelle site and the relocation of all manufacturing operations to the new ultra-modern facility in Rillieux-la-Pape, near Lyon. The Company is now well positioned to respond to new market opportunities.

This transfer involved a large part of the Company’s resources, which were also heavily involved in two successful certification audits conducted by the FDA (Food and Drug Administration) for the marketing of implants in the United States and by LNE/G-MED (Working Group for the Evaluation of Medical Devices) for renewal of the CE marking.

Against this backdrop, Q1 sales remained stable compared to the same period of the previous year at €7 million.

Adoption of the Company’s UNiD™ technology continued over Q1 2017 with a 38% increase in surgeries utilizing patient-specific UNiD™ Rods in the United States compared to the same quarter of 2016.

Events: ISASS 2017

Medicrea will be showcasing UNiD™ Adaptive Spine Intelligence and patient-specific implants this week at Booth #420 of the 17th Annual Conference of The International Society for the Advancement of Spine Surgery (ISASS) held in Boca Raton, Florida from April 12 to 14, 2017. On Thursday, April 13th, Medicrea technology, including early clinical results with UNiD™ 3D-printed patient-specific vertebra, features twice in the conference’s official scientific program in Presentation 483 and Presentation 456. More information on the event is available here.

Next publication: Sales for the 1st half of 2017: July 11, 2017, after market.

About Medicrea (www.medicrea.com)

Medicrea specializes in bringing pre-operative digital planning and pre and post-operative analytical services to the world of complex spine. Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and deep learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: www.medicrea.com

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
ALTERNEXT Paris ISIN: FR 0004178572– Ticker: ALMED

Contacts

Medicrea
Denys SOURNAC
Founder, Chairman and CEO
dsournac@medicrea.com
or
Fabrice KILFIGER
Chief Financial Officer
fkilfiger@medicrea.com
Tel: +33 (0)4 72 01 87 87
or
Media
Russell WARD for Medicrea
russell@theconfluencegroup.com
Tel: +1 310 424 8356



April 17, 2017 OrthoSpineNews

The number of implanted devices using PEEK-OPTIMA™ polymer has now increased to around nine million, worldwide. Pioneering developments and close collaboration with device companies, as well as assembling and sharing early clinical results with the medical community, have helped medical-grade PEEK innovator Invibio to deliver this progress. The dedicated medical “International PEEK Meeting” taking place in Washington DC, USA, April 27-28, is expected to provide additional impetus through the presentation of leading-edge research in the PEEK biomaterial polymer technology and its clinical application.

“Although it has a history of over 15 years as a biomaterial, PEEK continues to be used to actively innovate in the quest for improved patient care. The meeting will focus on the latest advances in orthopedics, spine, trauma, and dentistry applications. It is important that the medical community has access to latest updates and developments”, emphasizes Steve Kurtz, Ph.D., Implant Research Center, Drexel University (Philadelphia, PA, USA), and conference organizer, in the run-up to the 3rd International PEEK Meeting.

Need to offer improved options for surgeons and ultimately patients Kurtz continues: “I think the most interesting part of the event is the combined regulatory, scientific, and clinical audience. We all need to understand not only the technical aspects about PEEK and device characteristics but to help patients and translate these advances to the clinic as quickly as possible. It is important that we understand this new type of implant biomaterial. The focus of the upcoming meeting is going to be on the clinical understanding of how PEEK performs in new applications along with additive manufacturing and composites of PEEK implants, and understanding how to address the regulatory science questions in this area.”

The Implant Research Center at Drexel University and Exponent, Inc. chairs the meeting and invited the medical community to submit abstracts, which were then evaluated by a scientific committee for inclusion in the program either as a podium presentation or poster.

PEEK polymer based solutions: may offer distinct advantages compared to metal alternatives

One of the highlight presentations for example investigated whether locking screw fixation in carbon fibre reinforced PEEK (CFR-PEEK) composite plates is mechanically equivalent to stainless steel plates.1)

The composite biomaterial CFR-PEEK is gaining popularity for fracture fixation due to its high fatigue strength, favorable modulus of elasticity, and radiolucency. This study assessed the mechanical stability of locking screws used in CFR-PEEK proximal humerus plates compared with those used in stainless steel plates. Based on this study, CFR-PEEK proximal humerus locking plates provide comparable or superior locking screw fixation strength compared to traditional stainless steel locking plates.

Over 15 years of proven history in clinical use of PEEK has made its mark on the medical world

From the initial commercial introduction of PEEK as a biomaterial Invibio Biomaterial Solutions has, for more than 15 years, pioneered advances in the application of high-performance PEEK-based implantable polymers such as PEEK-OPTIMA. Corresponding to the company´s mission to facilitate medical-device innovation by providing new solutions and support for PEEK-related research, Invibio is sponsoring this cross-sector forum for sharing and discussing those latest advances that are both independent and international in scope.

Further details on the upcoming “3rd International PEEK Meeting”

Topics

  • Advances in the additive manufacturing of PEEK and its composites
  • Innovations in orthopedic bearings
  • Bioactive PEEK composites
  • Advances in spinal rods and artificial disc applications
  • Advances in formulations for dental, trauma, and arthroscopic implants
  • Structural composites and woven-fiber applications
  • Advances in the biologic aspects of wear debris

Scientific and Organizing Committee of the 3rd International PEEK Meeting:

  • Steven Kurtz, Ph.D., Implant Research Center, Drexel University and Exponent, Inc.
  • Joanne Tipper, Ph.D., Leeds University
  • Katherine Kavlock, Ph.D., US FDA CDRH (Center for Devices and Radiological Health)
  • John Bowsher, Ph.D., US FDA CDRH

Save the date and register

  • Thursday & Friday, April 27-28th, 2017 in Washington DC at The Cosmos Club.

REFERENCES
1.    Hak, David J. et al. (2017): Is locking screw fixation in carbon fibre composite plates mechanically equivalent to stainless steel plates? Presentation during 3rd International PEEK Meeting 2017

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in ~9 million implanted devices worldwide.

INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex plc
Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy, electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With over 35 years’ experience, we develop world leading solutions in PEEK- and PAEK-based polymers, semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at http://www.victrexplc.com or http://www.victrex.com

Copyright ©2017 Invibio Ltd.


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April 13, 2017 OrthoSpineNews

Leading spinal solutions provider Amendia, Inc. is pleased to announce the acquisition of Spinal Elements, Inc., a Carlsbad, California-based corporation.

“The acquisition of Spinal Elements brings a wealth of talent and a portfolio of exciting new products to the Amendia organization,” stated Chris Fair, CEO and President of Amendia, Inc. “The combination of these two companies solidifies our position as one of the fastest growing and most comprehensive spine companies in the marketplace today,” continued Fair.

Jason Blain, President of Spinal Elements, added, “Together, the company moving forward will provide a robust portfolio of spine products featuring titanium-coated PEEK interbody technology. We are thrilled about what lies ahead.”

Spinal Elements’ clinically proven Ti-Bond® porous titanium coating and upcoming product launches of the Lucent XP expandable cage and the Clutch interspinous process device, will complement Amendia’s recent launches of the Overwatch pedicle screw system, Syzygy reduction screw system and the Ceres cervical product lines.

Media inquiries should be directed to Steve McAllister, EVP and Chief Financial Officer at 770-575-5201.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visit http://www.amendia.com.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefitting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit http://www.spinalelements.com.


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April 13, 2017 OrthoSpineNews

LITTLE SILVER, N.J., April 13, 2017 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed Locking Lattice Plating System, to address stabilization and fusion of fractures, osteotomies, and arthrodesis of small bones.

According to Greg Kowalczyk, President of Additive Orthopaedics, “We are excited to be one of the first companies to leverage the geometric flexibility, clinical advantages and manufacturing cost benefits of additive manufacturing in the orthopaedic plating market.  These plates can be implanted either alone with locking or non-locking screws, or in conjunction with our 3D printed bone segments through the use of a connection screw. This allows the surgeon to mix and match any wedge and plate combination for various deformities, complex revisions, or other limb salvage procedures.”

This is the Company’s third 510(k) clearance leveraging additive manufacturing and fifth product line, which includes their 3D printed core products, biologics, and customs for limb salvage and complex revision cases.  Surgeons have implanted over 300 of their individual devices since the first full commercial product launch at the end of 2016.  The Company has recently closed a Series A Round of $1M.

About Additive Orthopaedics, LLC.
Additive Orthopaedics is an early stage orthopaedic company focused on the integration of advanced manufacturing and biologics for the benefit of a better patient outcome.

Contact:
Greg Kowalczyk
732.882.6633
greg@additiveorthopaedics.com

 

SOURCE Additive Orthopaedics, LLC.


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April 13, 2017 OrthoSpineNews

Inspired Spine, a Minnesota-based spine surgery innovation company, has reached the milestone of completing 500 Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedures. This truly minimally invasive surgical technique is revolutionizing the performance of lumbar interbody fusions by delivering superior outcomes including substantially less patient recovery time and minimal blood loss, while requiring a procedure duration as short as 30 minutes.

The OLLIF procedure is a minimally invasive lumbar fusion technique that employs an incision of 15 millimeters, produces 80% less blood loss than a traditional fusion, and requires no muscle detachment to access the disc space. After a surgeon learns this technique, the procedure requires less than one third of the time required to perform a traditional fusion procedure, decreasing the patient’s anesthesia risk and increasing OR throughput efficiency.

Remarkably, many patients are ambulatory within two hours after surgery and are often discharged the same day. No infections have occurred during the first 500 procedures.

Numerous studies have been and are currently being performed during the journey to the 500th procedure. One study that has been published in the peer reviewed journal Cureus and presented at several national meetings is “Economic Performance of Oblique Lateral Lumbar Interbody Fusion (OLLIF) with a Focus on Hospital Throughput Efficiency.” This study demonstrated that due to its substantially reduced surgical time and shorter required hospital stay duration, the OLLIF procedure has saved hospitals an average of $9500 per case while improving patient outcomes.

Inspired Spine has also developed two derivative lumbar fusion techniques from the OLLIF approach: 1) MIS-DLIF and 2) MIS-DTIF. MIS-DLIF enables minimally invasive lumbar fusions to be successfully performed at L5-S1, overcoming the obstacles presented by the ala of the sacrum and the iliac crest. MIS-DTIF enables minimally invasive fusion of the thoracic levels of the spine, eliminating the risks associated with traditional thoracic approaches.

Additionally, OLLIF, MIS-DLIF and MIS-DTIF have been employed to successfully treat adult degenerative scoliosis for several of the first 500 patients.

Said Chief Medical Officer Hamid Abbasi MD, “Inspired Spine’s mission is to improve patient outcomes by substantially upgrading the surgical standard of care to that which is truly minimally invasive to deliver maximum improvements to each patient. Therefore, our team developed the capability to effectively employ the OLLIF and its derivative techniques throughout the lumbar and thoracic spine. Our data from the 500 procedures demonstrates and documents exceptional outcomes with minimal complications!”

Inspired Spine offers regular training sessions for surgeons nationwide including cadaver labs and on-site proctoring. Additionally, patients can locate an Inspired Spine Certified physician for treatment by visiting InspiredSpine.com.

About Inspired Spine

Inspired Spine, a Minnesota-based advanced minimally invasive spinal surgery technology developer, has introduced and performed over 500 procedures using revolutionary new technologies and procedures in advanced minimally invasive systems. These new procedures are transforming how spinal surgeries are approached and can replace more traditional “open” spinal fusion surgeries.

Inspired Spine is focused on the development of advanced minimally invasive surgical techniques, procedures and other health care technology to minimize or eliminate the physical and economic risks and discomfort that are created by the daily struggles of enduring back pain and its physical limitations. Learn more at http://inspiredspine.com/.

Contact for Inspired Spine:
David Greene, 602-677-8981
dgreene(at)theusleadnetwork.com