The IlluminOss system provides a simple, percutaneous surgical approach which enables surgeons to create a first-of-its-kind patient-conforming implant providing almost instant internal support of fractured bones, even those affected by cancer. Benefits observed often include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates.
IlluminOss has recently entered in to an agreement with Germany-based Orthovative to distribute the IlluminOss System in Germany. Founded in 2011 and headquartered in Tegernsee, Orthovative specializes in the distribution of innovative spine and orthopedic technology.
"We are extremely excited to be representing IlluminOss in Germany," said Rob Martin, Orthovative president and CEO. "This revolutionary technology adds a new tool for the surgeon when dealing with complicated and difficult fracture indications. Orthovative leads in Germany as a company dedicated to bringing the most innovative products to our customers and IlluminOss is a perfect fit for us. We look forward to working together and advancing orthopedics."
"Orthovative has an excellent reputation nationally and has the orthopedic market knowledge and connections to help us increase adoption of the IlluminOss System in Germany," said Manny Avila, CEO, IlluminOss. "Our technology provides surgeons with an entirely new and less invasive way to approach complex fracture repair and we are eager to make our system more accessible around the world and to keep up with growing demand via partnerships with esteemed distributors such as Orthovative."
The IlluminOss System has been used in the treatment of over a thousand patients in Europe, where it is commercially available and has been in clinical use since 2010. The company's technology is commercially available in Europe and it is currently executing on its first U.S. trial towards FDA approval.
DKOU 2015 will take place in Messe Berlin / Suedgelaende from October 20-23, 2015.
IlluminOss Medical is a privately held, commercial-stage medical device company focused on designing, developing and marketing orthopedic fracture repair products that leverage its proprietary bone stabilization technology, the IlluminOss System. This minimally invasive technology allows for fracture fixation through patient-specific intramedullary implants. The system utilizes a light-curable polymer, contained within an expandable balloon catheter, to achieve bone stabilization. The revolutionary procedure is made through a small percutaneous surgical approach, providing patients and clinicians with a fast, patient-specific method of orthopedic bone stabilization. The company currently markets its products in international countries under a CE Mark for approved clinical applications through both a direct sales force and distribution networks.
The IlluminOss products are Investigational Devices; limited by Federal law to Investigational Use and are not approved for sale in the USA.
Soft Tissue Regeneration, Inc. (STR), the developer of resorbable polymer scaffolds for the repair of soft tissue injuries, today announced it has initiated a randomized and controlled clinical study in Europe for its L-C Ligament® device for the reconstruction of a ruptured anterior cruciate ligament (ACL).
The results of this clinical study will be submitted to regulatory authorities to obtain approval (CE mark) for STR to market the L-C Ligament® in most European markets. On September 24, 2015, the first three patients of this clinical study were enrolled and treated at the Isala Klinieken in Zwolle, The Netherlands, by a team led by Dr. Kees van Egmond and supported by Drs. Peter Indelicato and Robert Stanton of the United States, both members of the STR Scientific Advisory Board. All three patients were treated successfully, including the two patients who received the L-C Ligament® device and one patient who was treated with tendon harvested from the patient’s own hamstring (autologous hamstring tendon).
“The repair of a ruptured ACL typically involves the surgical harvesting of the patient’s own hamstring or patellar tendon tissue, often resulting in pain, donor-site morbidity, impaired function, and additional operating time,” said Dr. van Egmond. “With few options to autograft available, the L-C Ligament® may fulfill a significant clinical need for a device that will regenerate a functioning ACL while avoiding the morbidity associated with autograft reconstructions and saving a considerable amount of operating time.”
Dr. van Egmond also performed the first-in-man L-C Ligament® implant procedure in June 2013, and was the primary investigator of STR’s earlier 15-patient safety and feasibility study.
The L-C Ligament® clinical trial is a prospective, multi-center, randomized controlled trial that will compare the L-C Ligament® to the hamstring autograft in 60 patients requiring a surgical reconstruction for an acute ACL injury. The primary endpoint of the study is the absence of revision surgery for graft failure and the function of the reconstruction as measured by established orthopedic evaluation scores for patients following knee surgery. The trial is being conducted in Europe to obtain a CE mark to allow STR to go to market in Europe. A larger global trial in the United States and Europe is anticipated to begin in late 2016.
“This is another major milestone for Soft Tissue Regeneration and the hundreds of thousands of people who suffer ACL injuries annually requiring surgery,” said Joseph Reilly, CEO and co-founder of STR. “It is another step that will help improve patient outcomes on so many levels. Other European sites are beginning the recruitment process and we expect up to six sites to be recruiting by year end.”
The L-C Ligament® is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery and regenerate the ACL. It is manufactured in a patented and proprietary process utilizing a clinically proven polymer called poly (L-lactic acid) or PLLA. This degradable polymer is widely used in orthopaedic implantable devices, and breaks down into naturally occurring lactic acid, which is also a byproduct of exercise.
The L-C ligament® addresses known risks and morbidity associated with allograft and autograft tissues for ACL reconstruction. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site. The L-C Ligament® is anticipated to encourage the regeneration of the patient’s own ligament tissue. To date, results from large-scale animal testing and a European safety study have demonstrated that the L-C Ligament® can successfully regenerate a native ligament in the intra-articular space.
STR is privileged to have the support of a prestigious and committed Scientific Advisory Board, two of whose members, Drs. Robert Stanton and Peter Indelicato, attended and advised on the surgeries of these first three patients enrolled in the CE Mark Study. Another member of the STR Scientific Advisory Board, Dr. Robert Arciero also has attended a patient surgery during the STR Safety and Feasibility Study. Drs. Arciero, Stanton, and Indelicato are each past Presidents of the leading academic sports medicine society, the American Orthopedic Society of Sports Medicine (“AOSSM”).
The L-C Ligament® is an investigational device and is not available for use or sale in the European Union or the United States. It is only available as part of the clinical trial.
About Soft Tissue Regeneration, Inc.
Soft Tissue Regeneration, Inc. (STR) is a medical device company whose aim is to apply its patented and proprietary technology comprised of PLLA, a degradable polymer, in orthopedic implant devices for regeneration and augmentation of soft tissue. In addition to the L-C Ligament®, STR is also leveraging its technology to develop a suite of complementary follow-on products and surgical meshes, including the STR GRAFT™, a FDA 510(k)-cleared innovative device for soft tissue augmentation, repair of tendons and ligaments and rotator cuff repair in the United States. To learn more about the company or about investing in the company, visit http://www.softtissueregeneration.com.
Ellipse Technologies Inc. on Friday filed for an initial public offering, seeking to sell $75 million worth of shares. The Aliso Viejo, Calif., medical technology company makes adjustable orthopedic implants. Underwriters include Piper Jaffray and William Blair. The company said its revenue reached $26 million in 2014, while net losses reached $3.2 million that year. Ellipse lost $3.5 million in the six months ended June 30. The company is expected to trade on the Nasdaq stock exchange under the symbol MGEC.
SUNNYVALE, Calif.,Oct. 15, 2015/PRNewswire/ -- Simplify Medical, Inc. is pioneering disc arthroplasty with the non-metal, MRI compatible Simplify™ Disc, a cervical artificial disc. The Company announced today that it received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate its two-level clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This approval allows the expansion of Simplify Medical's clinical operations.
The company plans to start its previously approved single-level study following the North American Spine Society (NASS) meeting currently being held in Chicago.
Simplify Disc is a cervical disc replacement composed of MRI compatible materials designed to eliminate invasive CT scans, reduce ionizing radiation exposure, and provide a metal-free option to patients. Simplify Disc offers disc heights as low as 4.1 mm for smaller patient anatomy.
The Simplify two-level IDE Trial is a prospective, multi-center, core lab adjudicated clinical trial evaluating the Simplify Disc at up to 14 clinical sites in the United States and Australia. The primary endpoint of the IDE trial is clinical success rate of Simplify Disc compared with ACDF.
David Hovda, CEO of Simplify Medical, said, "We have worked collaboratively with the FDA to achieve two-level IDE approval, and we look forward to starting this important study addressing a large segment of patients with cervical disc disease. We are excited to move forward with the Simplify Disc, which demonstrated promising clinical performance in an OUS clinical trial and commercial settings."
Simplify two-level IDE approval follows the recent Simplify single-level IDE approval and Simplify Disc CE Mark, allowing commercialization outside of the U.S. The company also announced it recently closed an investment by M.H. Carnegie, an Australian private equity/venture capital group. Mark Carnegie, Managing Director, commented, "Motion preservation provides patients with favorable clinical outcomes, and we believe Simplify Disc's MRI imaging capability can help reduce invasive CT scans and patients' exposure to ionizing radiation."
Simplify Cervical Disc
The Simplify Disc is a cervical artificial disc composed of MRI compatible materials utilizing advanced polymers and ceramic, designed to eliminate the need for radiation-intensive CT/Myelograms. The PEEK-on-ceramic articulation is designed for low levels of wear to optimize long-term durability, and Simplify Disc offers low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.
About the Artificial Disc Market
TheJournal of Orthopaedic Sports Physical Therapy (2008;38(9):A1-A34) reports that 22-70% of the population will have neck pain at some point in their lives with chronic neck pain of greater than 6 months duration affecting 14% of individuals with neck pain. Neck pain is second only to low back pain in annual workers' compensation costs in the U.S.
About Simplify Medical
Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located inSunnyvale, California. To learn more, visit our website atwww.simplifymedical.com.
Caution: the Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.
DUBLIN and CHICAGO - October 15, 2015 - Medtronic plc (NYSE: MDT) today announced favorable seven-year data maintaining improved clinical outcomes and patient satisfaction for the Prestige LP(TM) Cervical Disc compared to anterior cervical discectomy and fusion (ACDF). The Prestige LP Disc - indicated for single-level cervical disc disease - is designed to preserve motion in the neck at the operated disc level, unlike a fusion surgery that does not allow for motion.
The data, results of seven-year patient follow-up, were presented today by Matthew Gornet, M.D., an orthopedic surgeon at the Orthopedic Center in St. Louis, MO, at the 30th Annual Meeting of the North American Spine Society (NASS) in Chicago, IL.
"The seven-year results of this study show that patients receiving cervical disc replacement maintain motion and quality of life," said Dr. Gornet. "At 24 months, Prestige LP patients demonstrated statistical superiority in overall success, and we see that trend continue in this seven-year data."
The single-arm study compared seven-year results from 211 investigational patients and 182 historical control ACDF patients. Key findings at seven years include:
Prestige LP patients exhibited a statistical improvement in overall success (74.9%) compared to patients treated with ACDF (63.2%).i Patient-reported pain outcomes, such as Neck Disability Index (NDI), were statistically similar between the groups.
Prestige LP patients maintained 6.9 degrees of mean angular motion at the treated level.
Median return to work time for Prestige LP patients was 40 days, compared to 60 days for fusion patients.
Device-related adverse events were similar in both groups.
"Motion in the neck matters, which is why Medtronic has built the most comprehensive portfolio of cervical disc technology," said Tommy Carls, vice president of Research and Development of the Spinal business, which is part of the Restorative Therapies Group at Medtronic. "We're committed to developing meaningful innovations - like the Prestige LP Disc - that fundamentally change patients' lives."
The Prestige LP Disc is the third clinically-proven artificial cervical disc in Medtronic's portfolio. Medtronic is the only company that offers cervical discs that are proven statistically superior in overall success at 24 months for a single-level indication.
The low profile Prestige LP Disc has a ball-and-trough design and moves in a range of motions, including bending, rotation and translation. Risks of the Prestige LP Disc include, but are not limited to: bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels. The Prestige LP Disc's titanium ceramic composite design has been shown to have a lower wear rate than stainless steel in mechanical testing and produces less MRI scatter than cobalt chrome (MR Conditional at 3 Tesla).
About the Spinal Business at Medtronic
Medtronic's Spinal business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. Medtronic's Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about Spinal's therapies can be found at the business unit's patient-education website, www.back.com.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
i Overall Success is decided by combining the results from five different measurements of safety and effectiveness.
KALAMAZOO, Mich., Oct. 15, 2015 /PRNewswire/ -- The Instruments division of Stryker Corporation announced today that its Interventional Spine business unit has received clearance from The U.S. Food and Drug Administration (FDA) to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures. Stryker set a new standard in 2008 with the release of VertaPlex HV, addressing specific viscosity and working time preferences for treating vertebral compression fractures. On June 12, 2015, VertaPlex HV became the first PMMA to receive 510(k) clearance for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.
"Careful intraoperative technique and VertaPlex HV PMMA is an excellent and safe solution in the management of sacral fractures. This new FDA approved indication will benefit countless lives," said Jeffrey W. Miller, MD, Director of Neuroendovascular Surgery at Bronson Methodist Hospital in Kalamazoo, MI, and principal investigator of the Stryker sponsored study for 510(k) submission. "I have already witnessed dramatic patient improvement in my own practice by incorporating sacral vertebroplasty/sacroplasty as part of my intraoperative protocol."
Sacral insufficiency fractures are an often under diagnosed condition in the elderly population, typically presenting with severe low back pain resulting in immobility. The diagnosis can be complicated by the fact that radiographic assessment of the sacrum is difficult and lower spine (lumbar) imaging is frequently not specifically targeted at the sacrum. Sacral vertebroplasty, a procedural extension of percutaneous vertebroplasty, involves the injection of bone cement into the sacrum with the aim of alleviating pain and facilitating more rapid mobilization than conservative therapy alone allows.
Due to the inherent porosity of sacral bone and comorbidity of osteoporosis, cement extravasation may be a risk for treatment of sacral insufficiency fractures. In this porous, osteoporotic environment, higher viscosity cement can help reduce cement spreading and forming denser cement clusters1.
"As our population ages, we will see more sacral insufficiency fractures that will require intervention," said Douglas Yim, MD, Visiting Associate Professor, Associate Program Director of Interventional Radiology at Johns Hopkins School of Medicine, Baltimore, MD."Having a reliable and consistent high viscosity cement like VertaPlex HV will allow greater margin of safety for patients undergoing sacroplasty."
About Stryker Stryker is one of the world's leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine, which help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
CARMEL, Ind.,Oct. 15, 2015/PRNewswire/ -- Nanovis, a life sciences company committed to developing scientifically advanced regenerative platforms for implantable medical devices, today announced the availability of the FortiCore wedge shaped lordotic cervical cage and a transforaminal lumbar interbody fusion (TLIF) device with increased scaffolding.
Nanovis' FortiCore implants combine the benefits of PEEK and titanium creating the most scientifically advanced interbody fusion devices. The launch of the wedge shaped cervical cage and TLIF follows the completion of more than 400 FortiCore implantations by leading surgeons at hospitals throughout the United States.
FortiCore interbody fusion devices are comprised of a PEEK center with a deeply porous titanium scaffold. PEEK Optima® by Invibio is also injection molded into the scaffold for exceptional integration. This unique combination of technologies is designed to increase positive outcomes in spinal fusion procedures with the imaging capabilities preferred by surgeons.
"Hospitals that are focused on outcomes and quality of care want interbody devices that allow surgeons to improve fusion and stabilization rates. This requires a different approach. A scientifically advanced approach that is fundamentally different from legacy titanium, PEEK, and surface coated implants," saidMatt Hedrick, CEO, Nanovis. "FortiCore isn't a chip off the old block. We've layered a deeply porous titanium scaffold on PEEK creating fundamentally differentiated implants. That is uniquely FortiCore and this differentiation is only the beginning. At Nanovis, we continually invest in science that advances innovation to the surface to revolutionize implants."
Nanovis' FortiCore interbody fusion devices include cervical and TLIF implants complemented by the FortiFix pedicle screw system and FortiBridge cervical plate system. Nanovis is featuring FortiCore at the 2015 North American Spine Society (NASS) meeting inChicago, November 14-17, at the Nanovis booth (#1779).
Nanovis' mission is to develop science-enhanced, life-improving technologies. The Company's patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore line of interbody fusion devices; an advanced nano-surface technology in development; and a surface technology with anti-colonization and anti-microbial capabilities in pre-clinical studies.
For more information about Nanovis, FortiCore, FortiBridge or other proprietary Nanovis science-enhanced technologies, please visitwww.nanovisinc.com or call 1-877-907-NANO.
Kuros Biosurgery AG, a biotechnology company developing novel biomaterials and bioactive-biomaterial combination products, today announces that positive pre-clinical data assessing the potential of KUR-115 as a lumber interbody spinal fusion treatment will be presented today at the 2015 North American Spine Society (NASS) event in Chicago, Illinois, by Dr. Bryan W. Cunningham. Dr. Cunningham was lead investigator of the study which was carried out at the Orthopaedic Spinal Research Institute, University of Maryland.
The objective of the study was to evaluate and compare the efficacy of KUR-115 in various concentrations versus autograft and bone morphogenetic protein-2 (BMP-2) controls for lumbar interbody spinal arthrodesis.
The study achieved its primary objective which was the demonstration of a fusion identified at 4 and 10 months in 8/8 levels treated with the optimal concentration of KUR-115 (0.4 mg/mL) as well as the autograft and BMP-2 controls; all following a direct lateral surgical approach, complete diskectomy and endplate decortication at L2-L3 and L4-L5.
Flexion-extension and lateral bending exhibited reduced segmental motion for all treatment groups at 4 months versus the non-operative intact spine (p<0.05). By 12 months, both axial rotation and flexion-extension motion were significantly lower than the intact spine (p<0.05). Histopathology indicated no evidence of foreign body/inflammatory reaction or significant pathological changes in any specimens.
There were also no significant intra-or peri-operative complications in any cases.
Dr. Bryan W. Cunningham commented: "These positive pre-clinical results suggest that KUR-115 could be a highly effective alternative to autograft in lumbar interbody spinal arthrodesis. This study will serve as a basic scientific basis for future clinical investigations into the use and efficacy of parathyroid hormone based approaches for the treatment of a number of spinal indications."
Didier Cowling, Chief Executive Officer, said: "These positive results further highlight the significant potential of Kuros' technology platform in a broad range of spinal and orthopaedic indications. We look forward to progressing KUR-115 into clinical development and adding to the positive data generated in large Phase IIb studies by KUR-111 and KUR-113."
The pre-clinical study was performed on 32 skeletally mature sheep and randomized into post-operative time periods of 4 months (n=20) and 10 months (n=12). Treatment was administered using rectangular PEEK cages (sample size of n=8) prefilled with the following treatments per time period: 4 Month Treatments - KUR-115 at 0.2 mg/ml, 0.4 mg/ml and 0.7mg/ml in a fibrin matrix, autograft and bone morphogenetic protein-2 (BMP-2). 10 Month Treatments - KUR-115 at 0.4 mg/ml in fibrin, autograft and BMP-2.
KUR-115 is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant. The product has been developed to combine a high level of efficacy with ease of use and safety.
Kuros is focused on the development of novel biomaterials and bioactive-biomaterial combination products in therapeutic areas covering sealants and orthobiologics.
Kuros has a late stage pipeline which has generated highly encouraging data in multiple clinical studies. Its most advanced sealant product candidate is KUR-023, a sealant that has successfully completed European clinical development and is close to being CE Marked. KUR-111 and KUR-113, Kuros' most advanced orthobiologic products have both met the primary endpoints in large well controlled Phase II clinical studies and are progressing towards Phase III.
Kuros has two biomaterial technology platforms, one based on fibrin sealants and the other based on its own proprietary synthetic technology that can mimic fibrin in many of its attributes. These materials can be used alone or in combination with biologically active molecules, and can be delivered in many forms including as injectable liquids, sprays, gels, pastes or preformed implants. The incorporation of the biologically active molecules into the matrices aims to maximize their activity by retention at the site of action. Kuros has a number of methodologies to achieve the desired retention and release profiles of the biologically active molecules. The products are designed to combine ease of application with localized delivery.