Monogram Technologies Provides Regulatory Update on mBôs TKA System and Clinical Trial Preparation in India
Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)
Investigator Meeting and Clinical Trial Training Held at the Shalby Hospital in Ahmedabad, India
AUSTIN, TX / ACCESS Newswire / February 26, 2025 / Monogram Technologies Inc. (NASDAQ:MGRM) ('Monogram' or the 'Company'), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update regarding its 510(k) premarket filing submission to the U.S. Food and Drug Administration ('FDA') for the Company's mBôs TKA System. The Company has completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration (FDA) regarding the Additional Information Request (AIR) received on September 30, 2024. The Company does not currently anticipate further requests for information from the agency. Assuming a favorable decision by the FDA following receipt of the AIR, the next communication from them is anticipated to be a clearance decision for the mBôs™ Total Knee Arthroplasty (TKA) System. If granted, that would enable commercialization and sales of the TKA system in the United States.
In August 2024, Monogram announced a strategic collaboration with Shalby Limited (NSE:SHALBY) ('Shalby'), a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups, to conduct a multicenter clinical trial to evaluate the safety and effectiveness of the mBôs TKA System. In January 2025, the Company shipped a robot to support clinical trial training. The robot was successfully shipped as planned, and an Investigator Meeting was conducted at a Shalby Hospital in Ahmedabad, India, from January 31 to February 1, 2025. The meeting was organized by Reliance Life Sciences, a subsidiary of Reliance Industries, and attended by principal investigators, multiple surgeons, and staff. The purpose of the meeting was to review study protocols, regulatory requirements, and operational procedures.
Reliance Life Sciences, a Reliance Group company-one of India's largest private sector companies-is responsible for managing the regulatory submission and communications for the clinical trial in India. As the regulatory sponsor, Reliance Life Sciences is overseeing the submission process and engagement with India's regulatory authorities. Monogram has submitted its system for regulatory clearance to run the clinical trial and will provide updates as they occur. While regulatory timelines can be variable, the Company remains confident in its submission and the strength of its strategic partnerships with Reliance Life Sciences and Shalby to support the process.
'The Investigator Meeting was a successful milestone in the preparation for Monogram's clinical trial,' said Dr. Ajaykumar Yadav, Associate Vice President and Group Head of Clinical Research at Reliance Life Sciences. 'Bringing together key stakeholders, the meeting provided an opportunity for in-depth discussions on study protocols and a demonstration of the mBôs technology, reinforcing the collaborative approach to this clinical trial. Monogram has submitted a strong and comprehensive application, and we continue to support the regulatory process as expected. Reliance Life Sciences remains committed to advancing innovation in healthcare and looks forward to contributing to the successful execution of this study.'
Monogram team in Ahmedabad, India, with various stakeholders for clinical trial Investigator Meeting from Jan 31 to Feb 1, 2025.
Monogram continues to refine and enhance its next-gen technology in parallel with its regulatory and clinical trial preparations. The most significant advancement has been to the cutting system, which has facilitated an approximately 300% increase in feed rate. A video demonstrating these next-gen improvements is available below.
Dr. Douglas Unis, Monogram's Chief Medical Officer, commented, 'The latest advancements in Monogram's robotic system are a game changer. The new cutting system enables cutting speeds that are becoming competitive with manual surgery while maintaining the accuracy and functionality expected from robotic-assisted procedures. The performance is truly remarkable for a completely hands-free, unconstrained autonomous system. With these improvements, we are on track to deliver one of the most impressive robotic solutions on the market today.'
The Company remains focused on developing a multi-application robotic system that is time-competitive with manual surgery without compromising accuracy or safety. Monogram continues to refine its technology to improve system performance and usability as it progresses toward commercialization. The Company believes its approach to active robotic cutting offers a unique value proposition and remains committed to innovation in orthopedic robotics.
'We have completed all proposed testing with what we view to be favorable results and we remain focused on developing a robotic platform that surgeons will want to use,' said Ben Sexson, CEO. 'Our research shows that safety and uncompromised speed are the top priorities for surgeons. We have always believed that an autonomous system could be optimized to be competitive with manual surgical times. I feel confident we are starting to get there. Like our shareholders, we are eager to bring this vision to the operating room.
'We have built a system that we believe has the potential to disrupt the market. Our thesis is that fast, accurate, unconstrained autonomous cutting, eventually in many clinical applications, will help drive continued adoption of robotics. Our technology has undergone rigorous and extensive testing, and we have made every effort to try and ensure our system meets the highest standards.
'What we have accomplished-with fewer than 30 full-time employees-is a testament to the dedication and expertise of our team. I could not be prouder of what our small and highly dedicated team has achieved.'
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ:MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.
Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced, better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.
Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
To learn more, visit www.monogramtechnologies.com.
Forward-Looking Statements
This press release may contain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties.. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.
Executive Vice President
MZ North America
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
28 minutes ago
- Business Upturn
Visa Signs Football Phenom Lamine Yamal as a Global Ambassador for FIFA World Cup 26™
San Francisco, United States: With exactly one year to go until the FIFA World Cup 26™ kicks off across Canada, Mexico and the United States, Visa (NYSE: V) — a global leader in digital payments and long-standing supporter of world football — today announced that Lamine Yamal, one of the game's brightest rising stars, will serve as a global ambassador for the tournament. This press release features multimedia. View the full release here: Football phenom Lamine Yamal waves alongside headline announcing Visa signed him as a Global Ambassador for the FIFA World Cup 2026™ To celebrate the milestone and build momentum toward the largest FIFA World Cup™ in history, Visa will unlock exclusive fan experiences for cardholders — including meet-and-greet opportunities with Lamine Yamal in Barcelona and signed merchandise leading into FIFA World Cup 26™. 'As we look ahead to FIFA World Cup 26™, we're aligning with like-minded athletes and brands who share our vision for using football to uplift and unite,' said Andrea Fairchild, SVP, Global Sponsorship Strategy, Visa. 'In Lamine's case, it's about honoring the sport's legacy and giving back to the fans who power it.' Yamal is captivating the football world with record-setting performances, and his skill, speed and vision on the field have made him a breakout global star — and a symbol of where the game is heading. As its global ambassador, Lamine Yamal stated, 'Football is more than a game, it's joy and a way to connect with people around the world. I'm proud to partner with Visa to share that passion and inspire people through sport.' As an Official Payment Technology Partner of FIFA, Visa has used the power of football to drive inclusion and access around the world — from grassroots programs to global stages. Through innovative fan experiences, athlete partnerships and exclusive cardholder benefits, Visa continues to redefine what's possible for fans, players, and the future of the game. As part of its commitment to uplifting communities through the power of sport, Visa has deepened its partnership with Street Soccer USA (SSUSA) to create six community-driven soccer parks in San Francisco, Denver, Kansas City, New York City, Nashville and Atlanta. More than just fields, these parks are designed to uplift and build stronger and more connected communities — where individuals can connect, grow, and thrive. To learn more about how Visa and SSUSA are working together to offer a safe and supportive environment for communities to engage in physical activity while fostering a sense of unity and belonging through the Visa Street Soccer parks, click here. About Visa Visa (NYSE: V) is a world leader in digital payments, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories. Our mission is to connect the world through the most innovative, convenient, reliable and secure payments network, enabling individuals, businesses and economies to thrive. We believe that economies that include everyone everywhere, uplift everyone everywhere and see access as foundational to the future of money movement. Learn more at . View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Yahoo
40 minutes ago
- Yahoo
Forget This 15.3%-Yielding Stock. Consider These High-Yield Dividend Growers Instead.
AGNC Investment is a mortgage-focused real estate investment trust that offers a yield above 15% at recent prices. The mREIT offers a high yield because it's extremely sensitive to interest rate changes. A pair of real estate investment trusts that offer lower yields than AGNC Investment could outperform thanks to steadily growing dividend payouts. 10 stocks we like better than AGNC Investment Corp. › If you're looking for easy ways to pump up your passive income stream, you may have noticed some stocks out there offer dividend yields at double-digit percentages. One that gets a lot of attention is mortgage-focused real estate investment trust (mREIT) AGNC Investment (NASDAQ: AGNC). When markets opened on June 11, the stock was offering a 15.3% dividend yield. AGNC's yield is so high that you could receive your entire principal back in the form of monthly dividend payments in less than five years. Of course, that's only if the company can maintain its payout. Prologis (NYSE: PLD) and Realty Income (NYSE: O) have been offering dividend yields that aren't half as high as AGNC Investment's. Despite the lower payouts up front, there's a good chance these two will deliver more passive income over the long run. Income-seeking investors want consistency from their stocks, but not the sort of consistency they get from AGNC Investment. The mortgage REIT has lowered its dividend payout three times over the past 10 years. Instead of investing in real estate, AGNC Investment and its mREIT peers buy mortgage-backed securities (MBS). The mortgages in this mREIT's MBS portfolio are nearly always backed up by government agencies in the event of a default. Agency backing makes the portfolio somewhat resilient to economic downturns, but there isn't much the company can do about shifting interest rates. In a nutshell, mREITs borrow at relatively low short-term rates and use that capital to invest in MBS that pay higher rates over longer periods. It usually goes well, right up until the Federal Reserve rapidly alters interest rates. When interest rates rise, AGNC's short-term borrowing costs rise. At the same time, prices for existing securities in AGNC's MBS portfolio can plummet. AGNC Investment and mREITs, in general, employ a lot of leverage. When MBS values drop, the company can be forced to sell portions of its portfolio at fire-sale prices to boost liquidity and satisfy lenders. This is why, despite being a well-run business, AGNC is known for lowering its dividend payout, not raising it. Shares of Realty Income and Prologis almost never fall so low that their dividend yields reach a double-digit percentage. Long-term investors who bought shares of either of these stocks, though, have outperformed folks who bought AGNC Investment by a mile. Despite a global pandemic, relatively stable interest rates made the past decade a relatively good time to be an mREIT. However, even if we add up dividends received over the past 10 years, long-term AGNC investors realized a disappointing 65.6% total return during the 10-year period ended June 10. Realty Income's stock price rose by less than 30% over the same 10-year period. If we include Realty Income's steadily rising dividend payments, though, the stock produced a 101.3% total return. Prologis' focus on logistics real estate, which e-commerce businesses rely on, served it extremely well during the COVID-19 pandemic. The company raised its dividend payout by a whopping 152.5% during the decade ended June 10. Thanks to all those payout bumps, Prologis investors outperformed the S&P 500 (SNPINDEX: ^GSPC) with an outstanding 272.9% total return. Realty Income has been raising its dividend payout on a regular basis since it bought its first property in 1970. It became a publicly traded company in 1994, and its monthly dividend payment has risen every quarter since. Prologis doesn't have a dividend-raising streak as long as Realty Income's, but it hasn't had to lower its payout since 2009. Since 2013, its payout has grown every year like clockwork. At recent prices, it offers a 3.7% yield. Investors can confidently expect significant payout raises over the next several years from Prologis. With 95.2% of its 1.3 billion-square-foot logistics real estate portfolio rented out at the end of March, the net lease REIT won't have any trouble raising its dividend commitment in the quarters ahead. Management expects core funds from operations (FFO), a proxy for earnings used to evaluate REITs, to land in a range between $5.65 and $5.81 per share this year. That's more than enough to maintain and boost a dividend payout set at just $4.04 annually. Like Prologis, Realty Income is a net lease REIT that passes all the variable costs of building ownership to its tenants. With a retail portfolio full of convenience stores and other spaces that aren't particularly vulnerable to e-commerce, it boasted 98.5% occupancy at the end of March. At recent prices, Realty Income offers a 5.6% dividend yield that will almost certainly rise higher in the years ahead. The company expects adjusted FFO to land in a range between $4.22 to $4.28 per share this year. This is more than enough to maintain and raise a payout currently set at $3.22 per share. Prologis and Realty Income boast industry-leading credit ratings, which translates to lower borrowing costs than their peers. These REITs have been active for decades, but most companies still own most of the buildings they need to operate. With advantageous borrowing costs and a huge addressable market, these two leaders could continue their dividend-raising streaks for decades to come. Before you buy stock in AGNC Investment Corp., consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and AGNC Investment Corp. wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $649,102!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $882,344!* Now, it's worth noting Stock Advisor's total average return is 996% — a market-crushing outperformance compared to 174% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 9, 2025 Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Prologis and Realty Income. The Motley Fool recommends the following options: long January 2026 $90 calls on Prologis. The Motley Fool has a disclosure policy. Forget This 15.3%-Yielding Stock. Consider These High-Yield Dividend Growers Instead. was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
NewHydrogen's Plan to Win the Green Hydrogen Race
SANTA CLARITA, Calif., June 12, 2025 (GLOBE NEWSWIRE) -- NewHydrogen, Inc. (OTCQB: NEWH), developer of ThermoLoop™, a technology that uses water and heat to produce the world's cheapest green hydrogen, today described its plan to replace expensive electrolyzers and win the renewable hydrogen race. NewHydrogen CEO Steve Hill said, 'Today, using electrolyzers is the only commercially available way to split water to produce renewable hydrogen. Electrolyzers have dominated the headlines, but their reign may be coming to an end. The time has come to kill electrolyzers!' 'The renewable hydrogen industry's heavy bet on electrolysis is holding it back,' Mr. Hill continued. 'Why? Because electrolyzers are old tech—expensive, inefficient, and fundamentally flawed. These 200-year-old systems still depend on large amounts of electricity and face major cost and scaling challenges. Despite massive investment, they've struggled to deliver the cost reductions and reliability needed to help unlock the global hydrogen economy.' ThermoLoop is being developed to change that. Instead of electricity, ThermoLoop can use any source of heat to split water into hydrogen and oxygen, making it a fundamentally different, and a more promising approach. By addressing key limitations that have dogged electrolyzers for decades, ThermoLoop has the potential to leapfrog the current state of the art and win the green hydrogen race. At the heart of ThermoLoop is its novel materials and novel reactions that keep the process running at nearly the same temperature—eliminating the energy losses of traditional thermochemical heating and cooling cycles. The Company believes this can overcome a long-standing thermochemical challenge: how to scale without wasting energy. This approach enables continuous, 24/7 hydrogen production wherever there's heat and water. Even when using large industrial heaters powered by electricity, ThermoLoop's theoretical heat-based thermodynamic efficiency suggests it can outperform electrolyzers on a cost-per-kilogram basis. That can make ThermoLoop technology not only an alternative, but a direct threat to the electrolysis-first strategy dominating today's hydrogen buildout. Mr. Hill concluded, 'Relying on inefficient electrolyzer technology won't get us to the projected $12 trillion hydrogen economy. Other horses in the race that rely on massive tracts of land and part-time sunlight won't get us there either. In my opinion, it's ThermoLoop or bust. We believe ThermoLoop can offer a smarter path forward and has the potential to be the key to finally delivering on green hydrogen's global promise.' To watch a short explainer video about ThermoLoop™ or to learn more about NewHydrogen's mission to produce the world's cheapest green hydrogen, visit About NewHydrogen, Inc. NewHydrogen is developing ThermoLoop™ – a breakthrough technology that uses water and heat to produce the world's lowest cost green hydrogen. Hydrogen is the cleanest and most abundant element in the universe, and we can't live without it. Hydrogen is the key ingredient in making fertilizers needed to grow food for the world. It is also used for transportation, refining oil and making steel, glass, pharmaceuticals and more. Nearly all the hydrogen today is made from hydrocarbons like coal, oil, and natural gas, which are dirty and limited resources. Water, on the other hand, is an infinite and renewable worldwide resource. Currently, the most common method of making green hydrogen is to split water into oxygen and hydrogen with an electrolyzer using green electricity produced from solar or wind. However, green electricity is and always will be very expensive. It currently accounts for 73% of the cost of green hydrogen. By using heat directly, we can skip the expensive process of making electricity and fundamentally lower the cost of green hydrogen. Inexpensive heat can be obtained from concentrated solar, geothermal, nuclear reactors and industrial waste heat for use in our novel low-cost thermochemical water splitting process. Working with a world class research team at UC Santa Barbara, our goal is to help usher in the green hydrogen economy that Goldman Sachs estimated to have a future market value of $12 trillion. Safe Harbor Statement Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words "anticipate," "believe," "estimate," "may," "intend," "expect" and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive and other factors affecting the Company and its operations, markets, the impact on the national and local economies resulting from terrorist actions, the impact of public health epidemics on the global economy and other factors detailed in reports filed by the Company with the United States Securities and Exchange Commission. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Relations Contact: NewHydrogen, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
