Welcome to our dedicated page for Monogram Orthopaedics news (Ticker: MGRM), a resource for investors and traders seeking the latest updates and insights on Monogram Orthopaedics stock.
Monogram Technologies Inc (NASDAQ: MGRM) pioneers AI-driven orthopedic solutions combining surgical robotics, 3D printing, and machine vision. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's innovative approaches to joint replacement technology.
Access timely announcements including regulatory submissions, clinical trial progress, and strategic partnerships. Our curated collection features earnings reports, product development milestones, and analyses of the company's unique robotic surgical ecosystem designed for precision implant placement.
Key updates cover advancements in autonomous surgical systems, FDA clearance processes, and collaborations with medical institutions. Bookmark this page for verified information about Monogram's integration of digital imaging analytics, and bone-sparing surgical techniques that aim to redefine orthopedic care standards.
Monogram Technologies announced a continuous public offering of up to $10 million in units, priced at $2.25 per unit. Each unit includes one share of 8.00% Series D Redeemable Convertible Cumulative Preferred Stock and a warrant to purchase one share of common stock at $3.375 per share. The offering is expected to result in net proceeds of approximately $9.25 million if all units are sold, after estimated commissions and expenses. The Series D Preferred Stock pays an annual dividend of $0.18 per share and is convertible into common stock. The company may redeem the preferred stock at a premium, which declines over time. Digital Offering, is acting as the sole managing selling agent, with the offering being conducted on a "reasonable best efforts" basis.
Monogram Technologies will host an investor and analyst day on June 20, 2024, at its headquarters in Austin, Texas. The event will feature a presentation and Q&A session by CEO Ben Sexson, Founder & Chief Medical Officer Dr. Douglas Unis, CTO Dr. Kamran Shamaei, and CFO Noel Knape. Attendees will see a product demonstration of the mBôs Precision Robotic Surgical System, designed to enhance orthopedic surgeries. The company plans to complete Verification and Validation testing for the mBôs TKA System by Q2 2024 and aims for a 510(k) submission in the second half of 2024. Monogram is also preparing for clinical trials outside the U.S. The event will include tours of the headquarters and cadaver lab, and the company recently shared its Q1 2024 financial results.
Monogram Orthopaedics announced a corporate name change to Monogram Technologies effective May 15, 2024. The AI-driven robotics company, focused on orthopedic surgery, is merging its subsidiary, Monogram Technologies, into the parent company. The ticker symbol will remain 'MGRM'. CEO Benjamin Sexson stated that the new name reflects the company’s evolution and broadening technological applications. Monogram is progressing towards a 510(k) submission for its robotic surgical system, Monogram mBôs™ TKA System, and is developing mVision navigation. The company aims to leverage its robust IP portfolio to drive growth and long-term shareholder value.
Monogram Orthopaedics (NASDAQ:MGRM) reported its Q1 2024 financial results and operational highlights. The company is advancing towards completing Verification and Validation (V&V) testing for its mBôs robot, anticipating a 510(k) submission to the FDA in the second half of 2024. They introduced mVision technology and engaged CRO for OUS clinical trials. Q1 R&D expenses rose to $2.4M from $1.9M in Q1 2023, while G&A expenses increased to $1.1M from $0.8M. Net loss improved to $3.5M from $3.9M. Cash reserves stood at $10.1M on March 31, 2024.
Monogram Orthopaedics Inc. has engaged a global Contract Research Organization (CRO) to oversee its clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System outside the U.S., aiming to accelerate its product pipeline development and commercialization opportunities. The CRO will submit the clinical trial data to local regulators and has experience with successful FDA submissions. Monogram plans to conduct a multi-center TKA clinical trial with the mBôs TKA System using the cemented version of its FDA-cleared mPress TKA implant. The company expects to complete enrollment and study execution expeditiously, leveraging the clinical data for post-launch marketing and international clearance. The clinical trial design follows FDA guidance and regulations for investigations conducted outside the U.S., ensuring compliance with GCP guidelines and other regulatory requirements.
Monogram Orthopaedics Inc. provided an update regarding its mBôs surgical system regulatory path after a meeting with the FDA, revealing accelerated 510(k) submission plans for early second half of 2024. The FDA feedback on the Q1 2023 submission was positive, supporting a least burdensome approach to clinical data acquisition. Management aims to conduct an OUS clinical trial, estimating costs at $1.5M, to support post-launch marketing. Monogram anticipates leveraging OUS clinical data and an accommodating FDA stance towards it to expedite technology pipeline development, including mVision tracking solution. Verification and Validation testing nearing completion in Q2 2024, with a 510(k) submission expected in late 2024. The company's modified mBôs system design aims to minimize the risk of FDA clinical data requests. Various tests and validations are progressing well, with strategic engagements with external partners, including MCRA, aiding in regulatory strategy execution.
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