SEATTLE--(BUSINESS WIRE)--Know Labs, Inc. (NYSE American: KNW), an emerging developer of non-invasive medical diagnostic technology, today announced interim results from its most recent clinical research study. The study assessed the accuracy of Know Labs’ proprietary radiofrequency (RF) dielectric sensor in non-invasively measuring blood glucose in participants with prediabetes and Type 2 diabetes using venous blood as a comparative reference – resulting in an overall Mean Absolute Relative Difference (MARD) of 11.1%..

西雅图--（商业新闻短讯）--非侵入性医疗诊断技术的新兴开发商Know Labs，Inc.（纽约证券交易所美国代码：KNW）今天宣布了其最新临床研究的中期结果。这项研究评估了Know Labs专有的射频（RF）介电传感器在使用静脉血作为比较参考无创测量糖尿病前期和2型糖尿病参与者血糖方面的准确性-导致总体平均绝对相对差异（MARD）为11.1%。。

Dr. Virend K. Somers of the Mayo Clinic serves as an author and co-investigator on the clinical research protocol. Dr. Somers will present the interim results of the study titled, “Non-Invasive Blood Glucose Monitoring in People with Diabetes Using an RF Sensor and Venous Blood Comparator” at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy on March 6-9, 2024..

梅奥诊所的Virend K.Somers博士是临床研究方案的作者和共同研究者。萨默斯博士将于2024年3月6日至9日在意大利佛罗伦萨举行的第17届糖尿病先进技术与治疗国际会议（ATTD）上发表题为“使用射频传感器和静脉血比较仪对糖尿病患者进行无创血糖监测”的研究中期结果。。

“Achieving this level of accuracy in the first study using a blood reference device is truly remarkable,” said Larry Ellingson, former Chair of the Board of the American Diabetes Association, Founding Member of the Diabetes Leadership Board and current member of Know Labs’ Board of Directors. “Despite significant efforts in the development of non-invasive blood glucose monitoring solutions, delivering a highly accurate, economical, FDA-cleared non-invasive continuous glucose monitor (CGM) still remains to be seen.

美国糖尿病协会董事会前主席、糖尿病领导委员会创始成员、Know Labs董事会现任成员拉里·艾林森（LarryEllingson）表示：“在第一项使用血液参考装置的研究中实现如此高的准确性真是太棒了。”。“尽管在开发无创血糖监测解决方案方面做出了重大努力，但提供高度准确，经济，FDA批准的无创连续血糖监测仪（CGM）仍有待观察。

These results from ongoing clinical research reflect the impressive and continued stability of Know Labs' novel sensor technology and algorithms, bringing the company one step closer to delivering its FDA-cleared non-invasive CGM to the masses.”.

这些来自正在进行的临床研究的结果反映了Know Labs新型传感器技术和算法令人印象深刻且持续的稳定性，使该公司离向大众提供FDA批准的非侵入性CGM更近了一步。”。

Study Design

研究设计

This is Know Labs’ first clinical research protocol involving people with diabetes and using venous blood as comparative reference. The proprietary RF sensor employed in the study measures glucose levels using dielectric spectroscopy by rapidly scanning a large range of RF frequencies and recording voltage values detected at each frequency to quantify, with trade-secret machine learning (ML) algorithms, real-time continuous blood glucose levels.

这是Know Labs第一个涉及糖尿病患者并使用静脉血作为比较参考的临床研究方案。该研究中使用的专有射频传感器使用介电光谱法测量葡萄糖水平，方法是快速扫描大范围的射频频率，并记录在每个频率下检测到的电压值，以使用商业秘密机器学习（ML）算法对实时连续血糖水平进行量化。

The sensor continuously scanned participants' forearms during 21, three-hour sessions involving a 75g Oral Glucose Tolerance Test. Venous blood samples were collected using a peripheral intravenous catheter every five minutes and analyzed using an FDA-cleared blood glucose hospital meter as a reference device..

该传感器在21个三小时的疗程中连续扫描参与者的前臂，涉及75g口服葡萄糖耐量测试。每五分钟使用外周静脉导管收集静脉血样，并使用FDA批准的血糖医院测量仪作为参考装置进行分析。。

Data was prepossessed using smoothing techniques and an 80/20 split was performed to create model training and test datasets, respectively. Know Labs trained a Light Gradient Boosting Machine model on data consisting of 520 paired RF and reference blood glucose values, then tested on 130 held-out paired values..

使用平滑技术对数据进行预处理，并进行80/20分割以分别创建模型训练和测试数据集。Know Labs根据520个成对RF和参考血糖值组成的数据训练了一个光梯度增强机模型，然后对130个保持成对值进行了测试。。

Results

结果

On the held-out test dataset, blood glucose was estimated with a MARD of 11.1 ± 2.1% relative to venous blood. Similar accuracy was observed in normoglycemic (11.0 ± 2.7%) and hyperglycemic (11.5 ± 3.1%) ranges.

在保留的测试数据集上，相对于静脉血，估计血糖的MARD为11.1±2.1%。在正常血糖（11.0±2.7%）和高血糖（11.5±3.1%）范围内观察到类似的准确性。

In previously published studies, most of the data collected was within the normoglycemic range (70 to 180 mg/dL) and glucose values from a popular CGM were used as comparative reference. By including participants with Type 2 diabetes, this study significantly increased the number of data points outside the normoglycemic range, specifically within the hyperglycemic range (>180 mg/dL).

在先前发表的研究中，收集的大多数数据都在正常血糖范围内（70至180 mg/dL），并且使用流行CGM的葡萄糖值作为比较参考。通过纳入2型糖尿病患者，这项研究显着增加了正常血糖范围之外的数据点数量，特别是在高血糖范围（>180 mg/dL）内。

Demonstrating similar accuracy across both ranges is an important milestone in Know Labs’ technology development roadmap. While many devices typically underperform outside the normoglycemic range, these results suggest that the novel RF sensor, paired with trade-secret ML algorithms, holds considerable promise for the non-invasive measurement of blood glucose..

在Know Labs的技术开发路线图中，在两个范围内证明相似的准确性是一个重要的里程碑。虽然许多设备通常在正常血糖范围外表现不佳，但这些结果表明，与商业秘密ML算法相结合的新型RF传感器在无创血糖测量方面具有相当大的前景。。

Last week, Know Labs announced the KnowU™, its wearable, non-invasive CGM that incorporates the sensor the Company plans to submit to the FDA for clearance. Know Labs will exhibit the KnowU device at the ATTD Tech Fair (Booth #30) throughout the conference and during a dedicated session presentation on Thursday, March 7 from 4:30-4:40 p.m.

上周，Know Labs宣布推出KnowU™，这是一种可穿戴的非侵入性CGM，其中包含了该公司计划提交FDA批准的传感器。Know Labs将在整个会议期间以及3月7日（星期四）下午4:30-4:40的专门会议上展示KnowU设备。

CET. Know Labs will also sponsor an invitation-only luncheon hosted by Children With Diabetes (CWD), where prominent thought leaders in the diabetes management field will discuss the latest in non-invasive glucose monitoring innovation..

大学英语四级。Know Labs还将赞助由糖尿病儿童（CWD）主办的仅限邀请函的午餐会，糖尿病管理领域的杰出思想领袖将讨论最新的无创血糖监测创新。。

These early results are part of a larger, now completed clinical trial with up to 100 participants focused on a population with diabetes and prediabetes, conducted September 2023 through February 2024. During 2024, Know Labs will also deploy the KnowU in large-scale, external clinical trials while making refinements to the device and its algorithms.

这些早期结果是2023年9月至2024年2月进行的一项规模较大、现已完成的临床试验的一部分，该试验有多达100名参与者，主要针对糖尿病和糖尿病前期人群。2024年期间，Know Labs还将在大规模的外部临床试验中部署KnowU，同时对设备及其算法进行改进。

These new studies will help determine the technology’s performance throughout continuous wear, in more real-world environments, and within more expansive glycemic ranges, including the hypoglycemic range (<70 mg/dL). To stay updated on the latest results, visit www.knowlabs.co/research-and-development..

这些新的研究将有助于确定该技术在整个连续佩戴过程中的性能，在更真实的环境中，以及在更广泛的血糖范围内，包括低血糖范围（<70 mg/dL）。要了解最新结果，请访问www.knowlabs.co/research and development。。

About Know Labs, Inc.

关于Know Labs，Inc。

Know Labs, Inc. is a public company whose shares trade on the NYSE American Exchange under the stock symbol “KNW.” The Company’s platform technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The technology can be integrated into a variety of wearable, mobile or bench-top form factors.

Know Labs，Inc.是一家上市公司，其股票在纽约证券交易所（NYSE American Exchange）以股票代码“KNW”进行交易。该公司的平台技术使用光谱学将电磁能引导穿过物质或材料以捕获独特的分子特征。该技术可以集成到各种可穿戴、移动或台式形状因素中。

This patented and patent-pending technology makes it possible to effectively identify and monitor analytes that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The first application of the technology will be in a product marketed as a non-invasive glucose monitor.

这种专利和正在申请专利的技术可以有效识别和监测以前只能通过侵入性和/或昂贵且耗时的实验室测试进行的分析物。该技术的第一个应用将是作为无创血糖监测仪销售的产品。

The device will provide the user with accessible and affordable real-time information on blood glucose levels. This product will require U.S. Food and Drug Administration clearance prior to its introduction to the market..

该设备将为用户提供可访问且价格合理的血糖水平实时信息。该产品在上市前需要美国食品和药物管理局的批准。。

Safe Harbor Statement

安全港声明

This release contains statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of Know Labs, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy; and (iv) performance of products.

本新闻稿包含的声明构成1995年《私人证券诉讼改革法案》、经修订的1933年《证券法》第27A节和经修订的1934年《证券交易法》第21E节所指的前瞻性声明。这些声明出现在本新闻稿的多个地方，包括所有不是关于Know Labs，Inc.，其董事或高管在以下方面的意图，信念或当前期望的历史事实声明：（i）融资计划；（ii）影响其财务状况或经营成果的趋势；（三）增长战略和经营战略；（iv）产品性能。

You can identify these statements by the use of the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” “potential,” and similar expressions and variations thereof are intended to identify forward-looking statements.

您可以使用“可能”、“将”、“可能”、“应该”、“将”、“计划”、“预期”、“预期”、“继续”、“估计”、“项目”、“打算”、“可能”、“预测”、“可能”、“可能”、“潜在”等词语来识别这些陈述，其类似表达和变体旨在识别前瞻性陈述。

Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond Know Labs, Inc.’s ability to control, and actual results may differ materially from those projected in the forward-looking statements as a result of various factors.

投资者应注意，任何此类前瞻性声明均不能保证未来业绩，并涉及风险和不确定性，其中许多风险和不确定性超出Know Labs，Inc.的控制能力，由于各种因素，实际结果可能与前瞻性声明中预测的结果存在重大差异。

These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended September 30, 2023, Forms 10-Q and 8-K, and in other filings we make with the Securities and Exchange Commission from time to time.

这些风险和不确定性还包括公司向美国证券交易委员会提交的文件中讨论的其他风险因素，包括截至2023年9月30日的10-K表年度报告、10-Q表和8-K表，以及我们不时向美国证券交易委员会提交的其他文件。

These documents are available on the SEC Filings sec.

这些文件可在美国证券交易委员会档案管理委员会获得。