FDA Clearance Achieved
Monogram Technologies received 510(k) clearance from the FDA for the mBôs TKA system. This is a major milestone for the company, representing years of effort and innovation.
Regulatory Approval in India
The company received regulatory approval from the CDSCO to initiate a multicenter clinical trial in India in collaboration with Shalby Hospitals. This marks the first clinical investigation involving autonomous saw-based robotic total knee surgeries.
Improved Cash Burn Rate
The monthly cash burn decreased from $1.1 million to $1.2 million last year to about $0.8 million this quarter, reflecting cost optimization efforts.
Strong Financial Position
Monogram has $13.3 million in cash with no traditional debt, positioning the company well for future milestones.
Propelling Forward with Pilot Placements
The company is set to begin pilot placements in the U.S., which will involve approximately four surgeons to demonstrate the clinical performance of their system.