510(k) Submission with FDA Accelerated for Early Second Half of 2024

510（k）在2024年下半年初加速向FDA提交

AUSTIN, TX / ACCESSWIRE / May 1, 2024 / Monogram Orthopaedics 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 related to the regulatory and commercialization path for its mBôs surgical system following its meeting with the U.S.

德克萨斯州奥斯汀/ACCESSWIRE/2024年5月1日/Monogram Orthopedics Inc.（纳斯达克：MGRM）（“Monogram”或“公司”），一家人工智能驱动的机器人公司，专注于改善人类健康，最初专注于整形外科手术，今天在与美国会面后，提供了与其mBôs手术系统监管和商业化路径相关的更新。

Food and Drug Administration (the 'FDA')..

美国食品和药物管理局（FDA）。。

On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission request. Subsequently, Monogram conducted a teleconference meeting with the FDA on April 24, 2024, to discuss the written feedback further and obtain feedback on the Monogram mBôs™ TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S.

2024年4月19日，Monogram收到了FDA关于该公司2023年第1季度预提交请求的书面反馈。随后，Monogram于2024年4月24日与FDA举行了一次电话会议，进一步讨论了书面反馈意见，并获得了Monogram mBôs™TKA系统验证测试计划的反馈意见，包括在美国境外提出的临床试验方案。

(OUS) target population. Management believes the feedback was comprehensive and will be advantageous for preparing a successful 510(k) submission to obtain clearance..

（OUS）目标人群。管理层认为反馈是全面的，有利于准备成功的510（k）提交以获得批准。。

The Company shared with the FDA various test protocols essential for establishing the safety and effectiveness of the Monogram mBôs™ TKA System and a synopsis of its proposed OUS clinical investigation plan.

该公司与FDA分享了各种测试协议，这些协议对于建立Monogram mBôs™TKA系统的安全性和有效性至关重要，并提供了拟议的OUS临床调查计划的概要。

Based on the feedback, management assesses that: 1) the proposed testing plan generally appears acceptable to address the technical differences identified with the proposed predicate device, and 2) for the active (also autonomous) embodiment of its product, a clinical testing plan that includes approximately 100 knee surgeries conducted on an OUS population at three sites with three months of follow-up should generally be sufficient for evaluating the safety and effectiveness of the Monogram mBôs™ TKA System.

根据反馈，管理层评估：1）拟议的测试计划通常可以接受，以解决拟议的谓词设备所确定的技术差异；2）对于其产品的主动（也是自主）实施，临床测试计划包括在三个地点对OUS人群进行约100次膝关节手术，并进行三个月的随访，通常足以评估Monogram mBôs™TKA系统的安全性和有效性。

Notably, on March 21st, the Company announced that it had modified the Monogram mBôs™ TKA System to reduce the likelihood of an FDA clinical data request with its submission..

值得注意的是，3月21日，该公司宣布已修改Monogram mBôs™TKA系统，以减少提交FDA临床数据请求的可能性。。

In their written response the FDA indicated they support a least burdensome approach to acquiring clinical data. Management anticipates running an OUS clinical trial could save the Company significant cost and time. Currently, management estimates the cost to run an OUS clinical trial as proposed to be approximately $1.5M.

FDA在他们的书面回复中表示，他们支持采用负担最小的方法获取临床数据。管理层预计，进行OUS临床试验可以为公司节省大量成本和时间。目前，管理层估计，进行OUS临床试验的成本约为150万美元。

The Company plans to run a clinical trial to support post-launch marketing irrespective of whether it will be needed for obtaining regulatory clearance with the FDA..

该公司计划进行一项临床试验，以支持上市后营销，无论是否需要获得FDA的监管许可。。

Updated Key Objectives

更新的关键目标

Given the favorable FDA feedback for using OUS clinical data, Monogram management anticipates establishing an ongoing OUS clinical strategy to support its innovation strategy. Access to an extensive OUS surgeon and hospital network and an accommodative FDA posture towards OUS data could accelerate the development and commercialization of its technology pipeline, including mVision, its novel tracking solution that aims to eliminate point based registration and tracking with large fiducial based arrays..

鉴于FDA对使用OUS临床数据的良好反馈，Monogram管理层预计将建立一个持续的OUS临床战略，以支持其创新战略。访问广泛的OUS外科医生和医院网络以及FDA对OUS数据的适应态度可以加速其技术管道的开发和商业化，包括mVision，其新颖的跟踪解决方案，旨在消除基于点的注册和使用大型基准阵列的跟踪。。

The Company recently announced that the Verification and Validation testing will be largely complete in Q2 of 2024 and anticipates a 510(k) submission to follow in the second half of 2024.

该公司最近宣布，验证和确认测试将在2024年第二季度基本完成，并预计在2024年下半年提交510（k）。

The Company's plan to aggressively accelerate 510(k) submission for its mBôs surgical system with design modifications that management believes reduce the risk of a clinical trial request is on track. The Verification and Validation testing is underway, and the Company has largely completed various mandated packaging, biocompatibility, sterilization, and cleaning validations.

该公司计划积极加速510（k）提交其mBôs手术系统，并进行管理层认为可以降低临床试验请求风险的设计修改。验证和验证测试正在进行中，该公司已基本完成了各种强制性包装，生物相容性，灭菌和清洁验证。

Except for ongoing IEC testing, most tests that rely on outside vendors are on track or largely complete. For IEC testing, the Company has largely completed various mandated radiated emissions and immunity testing. The paperwork reviews are largely complete, and various electromechanical and safety tests are starting soon.

除了正在进行的IEC测试外，大多数依赖外部供应商的测试都在进行中或基本完成。对于IEC测试，该公司已基本完成了各种强制性辐射发射和抗扰度测试。文件审查基本完成，各种机电和安全测试即将开始。

The Company believes the system will perform favorably in outstanding IEC testing based on completed internal testing and various design considerations. One of the most demanding test protocols is the Human Factors Evaluation and Design Validation, which requires at least 15 surgeons to use the system in a simulated surgery.

该公司相信，基于完成的内部测试和各种设计考虑，该系统将在出色的IEC测试中表现良好。最苛刻的测试方案之一是人为因素评估和设计验证，这需要至少15名外科医生在模拟手术中使用该系统。

The Company is using much of the data from these labs to test other aspects of the system, such as system accuracy. The Company has completed six simulated surgeries, with a significant remaining portion planned in May 2024..

该公司正在使用这些实验室的大量数据来测试系统的其他方面，例如系统的准确性。该公司已经完成了六次模拟手术，其余大部分计划于2024年5月完成。。

Monogram has engaged MCRA, a US-based Contract Research Organization (CRO), to support its regulatory strategy for submission.

Monogram已聘请美国合同研究组织（CRO）MCRA支持其提交的监管策略。

'Our team has been actively executing extensive, highly rigorous internal and external testing while diligently incorporating feedback from the FDA,' said Ben Sexson, Chief Executive Officer of Monogram. 'We continue to expect verification and validation to be largely complete in H1 2024, with a planned FDA 510(k) submission in H2 2024.

Monogram首席执行官本·塞克森（BenSexson）说，我们的团队一直在积极进行广泛、高度严格的内部和外部测试，同时努力纳入FDA的反馈我们继续预计2024年上半年将基本完成验证和验证，并计划在2024年下半年提交FDA 510（k）。

We believe an OUS clinical data strategy could become valuable for ongoing research, development, and commercialization efforts.'.

我们相信OUS临床数据策略对于正在进行的研究，开发和商业化工作可能会变得很有价值。”。

Dave McGurl, Vice President, Regulatory Affairs at MCRA, commented: 'Monogram's engagements with the FDA have been highly constructive, with the Company having incorporated the FDA's feedback into the mBôs™ TKA System design. After numerous communications with the FDA and extensive clarity provided by the Monogram team, the Company should be set up for success with the 510(k) submission to the FDA for clearance.

MCRA监管事务副总裁Dave McGurl评论道：“Monogram与FDA的合作非常有建设性，该公司已将FDA的反馈纳入mBôs™TKA系统设计。在与FDA进行了多次沟通并由Monogram团队提供了广泛的清晰性之后，该公司应该成功地将510（k）提交给FDA批准。

The Company has taken patient safety extremely seriously, which is apparent in numerous aspects of the design. The Company's verification and validation plan appears to satisfy all the FDA's stated concerns, and the FDA has been supportive of Monogram following a least burdensome approach to clinical data procurement.

该公司非常重视患者安全，这在设计的许多方面都很明显。该公司的验证和验证计划似乎满足了FDA所表示的所有担忧，并且FDA一直支持采用负担最小的临床数据采购方法进行会标。

We look forward to continuing to support Monogram through its submission and clearance.'.

我们期待着通过提交和批准继续支持Monogram。”。

Upcoming 2024 Milestones

2024年即将到来的里程碑

Largely complete mBôs system verification and validation - H1 2024

基本完成mBôs系统验证和确认-2024年上半年

Submit 510(k) application to FDA - H2 2024

向FDA提交510（k）申请-2024年下半年

Commence OUS live-patient surgery trials - H2 2024

开始OUS活体患者手术试验-2024年下半年

Expanded international relationships

扩大国际关系

About Monogram Orthopaedics

关于Monogram Orthopaedics

Monogram Orthopaedics (NASDAQ:MGRM) is working to develop a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. The Company has a robotic system that can autonomously execute optimized paths for high-precision insertion of implants in synthetic bone specimens.

Monogram Orthopedics（纳斯达克股票代码：MGRM）正致力于开发一种产品解决方案架构，其长期目标是通过将3D打印和机器人技术与先进的术前成像相结合，实现大规模优化患者的骨科植入物。该公司有一个机器人系统，可以自主执行优化路径，以便在合成骨标本中高精度插入植入物。

Monogram 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. The Company has not yet made 510(k) premarket notification submissions or obtained 510(k) clearances for its robotic products.

Monogram计划生产和销售机器人手术设备和相关软件、骨科植入物、组织消融工具、导航消耗品以及重建关节置换手术所需的其他杂项仪器。该公司尚未提交510（k）上市前通知或获得其机器人产品的510（k）许可。

FDA approval is required to market these products, and the Company has not obtained FDA approval for any of its robotic products, and it cannot estimate the timing or assure the ability, to obtain such clearances..

销售这些产品需要FDA的批准，该公司尚未获得FDA对其任何机器人产品的批准，也无法估计获得此类许可的时间或确保其能力。。

Monogram Orthopaedics is working to advance the way orthopedic surgery is done. Our system is being developed to combine personalized knee implants with precision robotic surgical assistants to hopefully give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing each year in a $19.4B market represents an enormous opportunity for us..

Monogram Orthopedics正在努力推进骨科手术的方式。我们的系统正在开发中，将个性化膝关节植入物与精密机器人手术助手相结合，有望为患者提供更适合微创手术的膝关节置换术。在194亿美元的市场上，每年有10万膝关节置换手术失败，这对我们来说是一个巨大的机会。。

To learn more, visit www.monogramorthopedics.com.

要了解更多信息，请访问www.mongomorthopedics.com。

Forward-Looking Statements

前瞻性声明

This press release may include 'forward-looking statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram Orthopaedics Inc.'s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking.

本新闻稿可能包括“前瞻性声明”如果本演示文稿中提供的信息讨论了Monogram Orthopedics Inc.的业务计划、运营结果、产品或市场的财务预测、信息或期望，或者以其他方式对未来事件进行了陈述，则此类陈述是前瞻性的。

Such forward-looking statements can be identified by the use of words such as 'should,' 'may,' 'intends,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'forecasts,' 'expects,' 'plans,' and 'proposes.'.

这种前瞻性陈述可以通过使用诸如“应该”、“可能”、“打算”、“预期”、“相信”、“估计”、“项目”、“预测”、“预期”、“计划”和“提议”等词语来识别。

Although Monogram Orthopaedics Inc. believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading 'Risk Factors' and elsewhere in the offering statement filed with the SEC.

尽管Monogram Orthopedics Inc.认为这些前瞻性声明中反映的预期是基于合理的假设，但存在一些风险和不确定性，可能导致实际结果与此类前瞻性声明存在重大差异。我们敦促您仔细审查和考虑任何警示声明和其他披露，包括在“风险因素”标题下以及提交给SEC的发行声明中的其他地方所做的声明。

Forward-looking statements speak only as of the date of the document in which they are contained, and Monogram Orthopaedics Inc. does not undertake any duty to update any forward-looking statements except as may be required by law..

前瞻性声明仅在包含它们的文件之日起生效，Monogram Orthopedics Inc.不承担任何更新任何前瞻性声明的义务，除非法律可能要求。。

Investor Relations

投资者关系

Chris Tyson

克里斯·泰森

Executive Vice President

执行副总裁

MZ North America

MZ北美

Direct: 949-491-8235

直接电话：949-491-8235

MGRM@mzgroup.us

MGRM@mzgroup.us

SOURCE: MONOGRAM ORTHOPAEDICS INC

资料来源：MONOGRAM Orthopedics INC

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿