FAQ: Monogram Technologies Inc. Secures Indian Regulatory Approval for Robotic Knee Surgery Clinical Trial

What is the significance of Monogram Technologies Inc. receiving approval from India’s Central Drugs Standard Control Organization?

The approval allows Monogram Technologies Inc. to import its mBôs TKA system and begin a 102-patient, multi-center clinical trial in India, a major milestone towards the commercial launch of its robotic total knee replacement system.

Who is Monogram Technologies Inc. partnering with for the clinical trial in India?

Monogram Technologies Inc. is partnering with Shalby Limited (NSE: SHALBY) for the clinical trial, which will evaluate the safety and effectiveness of its robotic total knee replacement system.

What will the clinical trial involve?

The trial will involve a 102-patient, multi-center study evaluating the safety and effectiveness of Monogram’s robotic total knee replacement system using a Consensus CKS implant, including three-month clinical follow-up across multiple Indian sites.

When are the surgeries expected to begin?

Surgeries are expected to begin within 90 business days following the regulatory approval.

What is the mBôs precision robotic surgical system?

The mBôs precision robotic surgical system is designed by Monogram Technologies to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants, aiming for well balanced, better-fitting bone sparing knee replacements.

Has Monogram Technologies Inc. received FDA clearance for its products?

Monogram has obtained FDA clearance for mPress implants and has applied for 510(k) clearance for its robotic products, but it is required to obtain FDA clearance before marketing its products.

Where can I find more information about Monogram Technologies Inc.?

For more information, please visit www.monogramtechnologies.com.

What are the potential benefits of Monogram’s robotic knee replacement system?

The system aims to enable more personalized knee implants for patients, resulting in well balanced, better-fitting knee replacements with bone sparing implants, potentially elevating global orthopedic standards.

What other applications are being explored for Monogram’s technology?

Other clinical and commercial applications for the mBôs with mVision navigation are being explored, beyond the initial focus on orthopedic surgery.