Ortho Regenerative Technologies confirmed the safety profile of ORTHO-R biopolymer as well as statistical significance over standard-of-care following completion of a pivotal preclinical study in rotator cuff tear repair.
Study results indicate that use of Arthrosurface's OVO® with Inlay Glenoid Shoulder Arthroplasty System to treat glenohumeral OA yielded improved clinical outcomes, no reoperations or radiographic loosening and a high rate of return to activity.
INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.
Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.
Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.
Empirical Spine completed enrollment in the investigational arm of its U.S. IDE trial of the LimiFlex Paraspinous Tension Band with decompression to treat degenerative spondylolisthesis with lumbar spinal stenosis.
Results of a study of Arthrosurface's OVO® with Inlay Glenoid Shoulder Arthroplasty System demonstrated excellent clinical benefits, including pain relief and increased range of motion in patients with glenohumeral arthritis.
Preclinical study results demonstrated that intradiscal injection of Discogenic Cells, the active ingredient in DiscGenics' IDCT allogeneic cell therapy, may be a viable treatment for degenerative disc disease.
Results from the SAKOS pivotal trial of Stryker's SpineJack® implantable fracture reduction system successfully demonstrated non-inferiority to balloon kyphoplasty (BKP), with an excellent risk/benefit profile for up to 12 months.
Clinical studies of Benvenue Medical's Luna interbody fusion device in minimally invasive Transforaminal Lumbar Interbody Fusion (TLIF) showed improved patient outcomes and decreased back and leg pain at 12 months post-op.
Preliminary study results indicate that X-BOLT Orthopaedics' X-BOLT device for hip fracture repair demonstrated a cut-out rate of 0.8% in a population of 476 patients, and performed as well as a hip sliding screw in measures such as quality of life, mortality, revision, etc.
Kuros Biosciences gained FDA approval for its IND application to initiate a Phase IIA clinical trial evaluating Fibrin-PTH orthobiologic in single-level TLIF to treat degenerative disc disease, with autograft as comparator.
At five-year follow-up, Aesculap Implant Systems' activL® lumbar disc was found to more effectively preserve range of motion vs. first-generation lumbar total disc replacement devices to treat degenerative disc disease.
Data collected using the Comprehensive Care for Joint Replacement model suggests that if Smith & Nephew's OXINIUM bearing surface was used in all U.S. primary hip procedures in 2020, it could yield ~$296MM in savings to the nation's health system.
Results from a retrospective, multicenter study with Treace Medical's Lapiplasty® 3D Bunion Correction procedure revealed a 96.8% maintenance of 3-plane correction at 13.5-month follow-up with an early weight-bearing protocol.
RTI Surgical enrolled the first patient in FORTE, a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease. Enrollment is slated for completion in 1Q20.
CyMedica Orthopedics' e-vive app-driven muscle strengthening device demonstrated statistically significant and positive results in a clinical trial evaluating the recovery of total knee replacement patients.
Clinical studies demonstrated that Stryker's Mako Total Knee was associated with less pain and need for opiates, shorter hospital stays, improved flexion and soft tissue protection vs. manual techniques.
Results from a feasability study indicate that use of the Bridge-Enhanced® ACL Repair (BEAR®) procedure from Miach Orthopaedics resulted in similar clinical, functional and patient-reported outcomes as autograft ACL reconstruction at 24 months.
Ortho Regenerative Technologies announced that following a formal meeting with FDA, an IND can be submitted in parallel with completion of a pivotal study on Ortho-R biopolymer for rotator cuff repair.
X-Bolt Orthopaedics announced that the 1,000th patient has reached one-year follow-up in WHITE4, a randomized controlled trial comparing the X-BOLT® expanding bolt device vs. a sliding hip screw in hip fracture treatment.
Study results indicate that use of Flower Orthopedics' FlowerCube implant and instrument system in first metatarsal phalangeal joint fusion at an ASC resulted in a 33% decrease in intraoperative time and $1,300 savings in reimbursement costs, while providing equivalent clinical outcomes.
Histogenics plans to evaluate the range of potential strategic alternatives for its NeoCart® cell therapy following FDA's indication that an additional clinical trial would be required before acceptance of a Biologics License Application submission.
Results from cadaveric study of OrthoSpace's InSpace balloon spacer vs. superior capsular reconstruction in the treatment of rotator cuff tears found that InSpace effectively restored the humeral head to a nearly normal position.
Results from a randomized, controlled trial of Vertiflex's Superion® Indirect Decompression System showed an 85% decrease in the proportion of patients using opioids, 5 years after treatment for lumbar spinal stenosis.
Histogenics' Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year.
In a study comparing expandable and static LLIF devices, at 2-year follow-up, researchers observed no implant subsidence in patients treated with expandable devices, with 16% subsidence in levels treated with static spacers.
Newly-published results from a 5-year study of Aesculap Implant Systems' activL® lumbar disc indicate that, in select patients, lumbar TDR is more effective than fusion at slowing the adjacent segment degenerative cascade.
Study results demonstrated that improvements in pain and function from use of Vericel's MACI vs. microfracture in the treatment of knee cartilage defects were sustained for five years following surgery.
Study results suggest that patients who underwent medial-pivot TKA with MicroPort Orthopaedics' Evolution® system scored significantly better on the Forgotten Joint Score vs. posterior-stabilized knee recipients.
Two-year study results indicate that decompression plus use of Paradigm Spine's coflex® Interlaminar Stabilization® device may enhance the procedure's durability and sustainability vs. decompression alone.
Study results suggest that use of ConforMI's iTotal CR Knee plus patient-specific instrumentation yields more consistent mechanical alignment than use of patient-specific cutting guides and off-the-shelf implants.
Interim study results demonstrated that surgeries performed with Mazor Robotics' Renaissance Guidance System yielded a 5-fold reduction in surgical complications and a 7-fold reduction in revisions vs. freehand-based, minimally invasive lumbar fusion.
Studies indicate that Providence Medical Technology's tissue-sparing cervical fusion devices, CAVUX® Cervical and DTRAX® Expandable cages, yielded improvements in pain, with radiographic confirmation of fusion.
Phase III study results demonstrated that Anika Therapeutics' CINGAL® provided superior immediate and short term OA pain relief after injection vs. hyaluronic acid alone, and superior relief at 26 weeks vs. saline.
Studies indicate that, at 5 years, the activ-L® Artificial Disc from Aesculap Implant Systems had a protective effect on the progression of degenerative disc disease at adjacent levels in 91.2% of patients.
Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.
Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequency denervation led to worsened outcomes, while iFuse Implant patients demonstrated superior improvements.
Consensus Orthopedics and the University of Miami Health launched a collaborative clinical study to evaluate the recovery effectiveness of acute care total knee arthroplasty in patients using the TracPatch wearable device.
Five-year results from a clinical trial of the Cartiva Synthetic Cartilage Implant in the treatment of great toe arthritis demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at two years post-op.
Results of evaluation of MicroPort Orthopedics' Medial Pivot Knee demonstrated 95.0% satisfaction and 98.8% survivorship at 17 years, with patients reporting high stability and comfort during regular activity.
Zimmer Biomet announced FDA approval of an expanded 26-week efficacy claim for single-injection Gel-One® Cross-linked Hyaluronate viscosupplement for the treatment of knee pain associated with osteoarthritis.
Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE's iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.
Patients in a retrospective study of Spinal Elements' Magnum+® ALIF device with Ti-Bond® coating demonstrated a 96% success rate, with subjects achieving solid arthrodesis at an average of 7.3 ± 2.3 months.
Long-term follow-up study results indicate that patients with massive rotator cuff tears that were treated with the OrthoSpace InSpace™ system showed improvements in function and pain at 6 weeks, with effects maintained for up to 5 years.
Initial study results indicate that patients undergoing the InSpace™ procedure to treat massive rotator cuff tears experienced durable improvements in shoulder function and reductions in shoulder pain at one year.
Zimmer Biomet announced positive outcomes associated with use of Trabecular Metal™ Cups in >9,500 revision hip arthroplasty cases, as reported in data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.
Study results demonstrated a high rate of clinical success from a combination of Biomatlante's MBCP+™ synthetic bone graft plus mesenchymal stem cells, particularly in the treatment of long bone non-union fractures.
Three-month safety data from a Phase I clinical trial in China for Cellular Biomedicine's AlloJoin™ off-the-shelf allogeneic stem cell therapy in the treatment of knee osteoarthritis demonstrated a safety and tolerability profile of AlloJoin in the three doses tested, with adverse events similar to that of earlier autologous trials. The trial is slated for completion in 3Q17.
Study results indicate that Implanet's JAZZ sublaminar bands offered a safe, efficient alternative to traditional techniques at up to 34 months in the treatment of complex hypokyphotic thoracic scoliosis.
Independent study results indicate comparable clinical outcomes with the use of generic vs. conventional orthopaedic trauma implants, with savings averaging US $1,197 per case. Generic implants were provided by The Orthopaedic Implant Company.
Medovex conducted a successful live tissue test of the DenerveX™ system under the most stringent standards required by FDA and other regulatory agencies. The device is intended to treat pain associated with facet joint syndrome.
Results from a pre-clinical interbody fusion study of Stryker Spine's 3D-printed Tritanium PL Interbody Cage demonstrated statistically superior range of motion, bone in-growth and greater average construct stiffness vs. PEEK and titanium plasma-sprayed PEEK cages.
Study results indicate that the minimally invasive direct thoracic interbody fusion or MIS-DTIF approach, offered by Inspired Spine, was shown to alleviate back pain in patients with degenerative disc disease or herniation.
OSTEOGROW, an EU-funded collaborative research project, is investigating a new bone regeneration therapy based on autologous blood + BMP-6 for use in applications requiring partial bone replacement, without the need for secondary interventions.
Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BONE's iFuse yielded more rapid improvements in pain, disability and quality of life vs. non-surgical treatment.
Study results indicate that total knee patients receiving ConforMIS' iTotal® CR outperformed recipients of off-the-shelf implants in terms of length of stay, discharge within 24 hours, discharge to home vs. a SNF, etc.
Pre-clinical studies suggest that multipotent adult progenitor cells (MAPCs), such as the technology used in RTI Surgical's map3® Cellular Allogeneic Bone Grafts, exhibited a more robust angiogenic protein release profile vs. mesenchymal stem cells in vitro.
Preclinical data on adipose-derived mesenchymal stem cells in a rat model, using technology similar to AlloSource's AlloStem® Cellular Bone Allograft process, showed bone formation within a critical-sized defect in all study subjects.
Study results indicate that patients treated with Spineart's BAGUERA® C cervical disc in 1- or 2-level arthroplasty exhibited good mobility at treated and adjacent levels, disc height restoration and evidence of adjacent level preservation.
Pre-clinical study results demonstrated that BONESUPPORT's CERAMENT™, loaded with rhBMP-2 + zoledronic acid in very low doses, was able to quantitatively/qualitatively generate a high amount of mineralized bone volume.
Results from a 2-year study of SI-BONE's iFuse implant for sacroiliac (SI) joint fusion show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years.
Results from 5-year clinical study comparing cervical total disc replacement (LDR's Mobi-C) with anterior discectomy and fusion to treat 2-level degenerative disc disease indicated overall success rates of 61% and 31% for cTDR and ACDF, respectively.
Initial 12-month efficacy results from a Phase IIA trial demonstrate positive effects on pain and osteoporosis blood markers from a single administration of Bone Therapeutics' PREOB® autologous osteoblastic cell therapy.
Results from a 6-month study observing BioElectronics' ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for >90% of participants, a decrease in doctor visits, etc.
Preliminary study results indicate that the Vital 5 ReLeaf Catheter improved pain scores and reduced post-op narcotic use following orthopaedic and spinal surgeries, and may support a transition to outpatient procedures.
Study results suggest that a permanent bond may form between cartilage and the hydroxyapatite coating of Episurf's Episealer® device, suggesting that implantation may stop or significantly slow the progression to OA.
Regentis Biomaterials closed a US $15MM Series D investment round. Funds will primarily support a pivotal U.S. clinical trial of GelrinC®, a cell-free implant for the treatment of articular knee cartilage injuries.
Studies concluded that, for patients with 2-level degenerative disc disease, cervical total disc replacement appears to be highly cost-effective vs. ACDF, and supports greater quality of life at less cost.
Study results from 5-year follow-up demonstrate the long-term, sustained therapeutic effect of Paradigm Spine's coflex® Interlaminar Stabilization® vs. fusion in the treatment of lumbar spinal stenosis.
CartiHeal completed a US $15MM financing round. Funds will support ongoing manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C™ cartilage regeneration technology.