Live trial? Do we look retarded? You don’t know this industry one bit. Try not and make it obvious if you’re gonna keep this act up.
Yes live trial, as in not a closed controlled study. A label you maybe more familiar with, Real World Evidence. When i said live trial, think of it like taking software live and then seeing how it actually performs for the masses as opposed to beta which is more of a controlled study akin to a clinical trial. Im sorry if you are overly sensitive to me using different labels to describe something.
RWE offers several advantages:
- Broader Patient Populations: RWE includes data from a wide range of patients, including those with comorbidities or characteristics that might exclude them from clinical trials. This provides a more comprehensive understanding of treatment outcomes.
- Long-Term Insights: Since RWE captures data over extended periods, it can reveal the long-term effects and safety profiles of interventions.
- Diverse Treatment Settings: RWE encompasses various healthcare settings, from academic hospitals to community clinics, reflecting the full spectrum of patient care.
- Cost-Effectiveness: Conducting RWE studies is often more cost-effective and faster than running extensive clinical trials.
So again, Si3N4 implant sales to date have been to establish real world evidence across a diverse populace, in the tens of thousands, along with long-term data at this point as the implants have been implanted for over 15 years all while generating a degree of revenue. Controlled clinical studies, however, do not bring in any revenue, just burn cash. So you can see the advantage of this approach vs a standard clinical study, which Sintx did as well.
There was a small study in Australia that did a 30 year retrospective look at Si3N4 implants from the 80s, or almost 40 years ago now, with good success. This is something Zimmer should have looked for before diving into Trabecular Metal. Maybe had it waited for longer term data like Sintx has, then it wouldnt have suffered so many lawsuits connected to TM.