FDA’s Center for Devices and Radiological Health issued a letter to industry regarding what to expect as companies and the agency respond to the COVID-19 pandemic. In general: expect help. ... Read more »
Multiple orthobiologic companies have engaged in clinical trials in 2019, seeking to demonstrate the efficacy of their cell-based products. We've recapped announcements from six of those companies. ... Read more »
Enrollment is complete in the investigational arm of the U.S. IDE trial of the LimiFlex Paraspinous Tension Band with decompression. ... Read more »
The Canada-based company is evaluating its biopolymer matrix in the U.S. and expects to start the clinical program in 1Q20. ... Read more »
The Hospital for Special Surgery has launched a clinical trial of an experimental engineered cell therapy that aims to promote better healing of rotator cuff tears after surgery. ... Read more »
Preclinical study results demonstrate that Osteo-Pharma's OsteoActivator coated collagen membranes effectively promoted new bone formation. ... Read more »
The M6-C is a next-generation artificial cervical disc developed to replace an intervertebral disc damaged by degeneration. Its physiologic one-piece design features an artificial nucleus and annulus that mimic the biomechanical motion of a natural disc, to include axial compression or shock ab... Read more »
Approximately 117 study participants have been treated, bringing enrollment to 50% completion. ... Read more »
Histogenics expects to suspend development of NeoCart, a tissue engineered implant, after FDA indicated that an additional clinical trial would be required to accept a Biologics License Application submission.... Read more »
Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we tracked that announced completed studies in the last three months.... Read more »
We looked at funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making waves; many of these companies offer technologies that could make them acquisition or collaboration targets for large OEMs.... Read more »
The Israeli startup develops implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints; to date, 80 patients in Europe and Israel have been treated in the pivotal Agili-C IDE study.... Read more »
P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »
Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.” ... Read more »
M.M.A. Tech’s MP-1, originally developed for NASA, was recently implanted during hip and knee replacement procedures in Israel. After finalizing its clinical trials and gaining market access, the company plans to become a supplier to device companies.... Read more »
We highlight recent clinical trial results, a procedural milestone and a device launch.... Read more »
The location serves flourishing biotech and medical technology companies in the region. ... Read more »
Studies suggest potential patient benefits and specific improvements in overall pain and neurological function.... Read more »
The transaction combines extensive geographic reach in logistics plus tailored clinical trials expertise.... Read more »
Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as well as ways to manage outsourcing of the process to a partner.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
