Zynex UCSF Study Results Demonstrate Laser Technology Benefits in Resolving Racial Bias of Current LED Pulse Oximeters
Zynex UCSF Study Results Demonstrate Laser Technology Benefits in Resolving Racial Bias of Current LED Pulse Oximeters
ENGLEWOOD, Colo., Dec. 12, 2024 /PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI) ("Zynex", "ZMS", "we" or the "Company"), an innovative medical technology company specializing in the manufacture and sale of noninvasive medical devices for pain management, rehabilitation, and patient monitoring, today announced highlights from a recent study comparing its NiCO laser pulse oximeter to conventional LED pulse oximeters for the effects of skin pigmentation on SpO2 measurements conducted by the University of California, San Francisco (UCSF) Hypoxia Lab.
科羅拉多州恩格爾伍德,2024年12月12日 /PRNewswire/ -- Zynex, Inc.(納斯達克: ZYXI)("Zynex","ZMS","我們"或"公司")是一家專注於製造和銷售非侵入性醫療設備的創新醫療科技公司,主要用於疼痛管理、康復和病人監測。今天,我們宣佈了一項最近研究的亮點,該研究比較了我們的NiCO激光脈搏血氧儀與傳統LED脈搏血氧儀在皮膚色素對SpO2測量影響方面的效果,該研究由加州大學舊金山分校(UCSF)缺氧實驗室進行。
Zynex's NiCO pulse oximeter utilizes highly precise laser technology to measure blood oxygenation levels directly, as opposed to current pulse oximeter products, which only estimate oxygenation levels using an LED-based technology. LED pulse oximeters have been shown to mismeasure oxygen levels in several populations, most prominently in individuals with darker skin pigmentation.
Zynex的NiCO脈搏血氧儀利用高精度激光技術直接測量血氧飽和度,而當前的脈搏血氧儀產品僅使用基於LED的技術估算氧飽和度水平。研究表明,在多個群體中,LED脈搏血氧儀在氧氣水平測量上存在誤差,尤其是在皮膚色素較深的個體中。
A poster presentation for the study was recently accepted and presented at the ANESTHESIOLOGY 2024 Event hosted by the American Society of Anesthesiologists that took place October 18 - 22 in Philadelphia. The presentation titled, "Laser-Based Pulse Oximetry Eliminates Effects of Skin Pigmentation on SpO2 Measurements," included results from a study conducted under the supervision of Dr. Philip Bickler at the UCSF Hypoxia Lab.
該研究的海報展示最近在2024年麻醉學大會上被接受並展出,該會議由美國麻醉師協會主辦,於10月18日至22日在費城舉行。展示標題爲"基於激光的脈搏血氧監測消除了皮膚色素對SpO2測量的影響",包括在UCSF缺氧實驗室由Philip Bickler博士監督進行的研究結果。
Nine darkly pigmented and nine lightly pigmented participants were recruited for this controlled desaturation study. Four NiCO pulse oximeters and two different commercially available LED-based pulse oximeters were used on each participant. Conclusions from the study showed the NiCO pulse oximeter did not demonstrate a bias for dark pigmented participants compared to lightly pigmented participants. By comparison, conventional LED-based pulse oximeters in the present study read falsely higher on darkly pigmented participants, specifically at lower oxygen saturation levels.
此次受控去飽和研究招募了九名深色皮膚參與者和九名淺色皮膚參與者。每位參與者使用了四個NiCO脈搏血氧儀和兩種不同的商業可用LED脈搏血氧儀。研究得出的結論顯示,NiCO脈搏血氧儀對深色皮膚參與者沒有表現出偏見,而與淺色皮膚參與者相比,傳統的LED脈搏血氧儀在此次研究中對深色皮膚參與者的讀數偏高,尤其是在低氧飽和度水平下。
"The findings reconfirm the results at a recent study at Duke University that our laser-based pulse oximeter is accurate across all pigmentation levels and is expected to significantly reduce racial disparity in clinical decision making, such as the need for mechanical ventilation or how much supplemental oxygen to give a patient," said Donald Gregg, President of Zynex Monitoring Solutions. "A 2022 study led by Harvard Medical School researchers at Brigham and Women's Hospital and Beth Israel Deaconess Medical Center, published in JAMA Internal Medicine, concluded that these inaccuracies were associated with disparities in care. The researchers found that, compared to White patients, Black, Hispanic, and Asian patients treated in intensive care units had greater discrepancies between blood saturation levels detected using pulse oximeters versus levels detected in blood samples and received less supplemental oxygen than White patients.
"這些發現再一次確認了杜克大學最近一項研究的結果,表明我們的激光脈搏血氧儀在所有皮膚色素水平下都是準確的,預計將顯著減少臨床決策中的種族差異,例如機械通氣的需求或給患者提供多少補充氧氣," Zynex監測解決方案的總裁Donald Gregg說道。"2022年,由哈佛醫學院的研究人員在布拉格和女子醫院以及以色列迪肯尼斯醫療中心進行的研究結果,發佈在《JAMA內科學》上,得出這些不準確的診斷與護理差異相關的結論。研究人員發現,與白人患者相比,在重症監護病房接受治療的黑人、拉美裔和亞洲患者的血氧飽和度水平與血樣檢測的水平之間存在更大的差異,且他們所接受的補充氧氣少於白人患者。"
"We remain confident that the clinical value of NiCO's unparalleled precision, accuracy, and safety provides a game-changing solution to racial disparity as we prepare our application for FDA clearance. We look forward to additional milestones and announcements for NiCO pulse oximetry in the weeks to come," concluded Gregg.
「我們仍然相信,NiCO無與倫比的精確度、準確性和安全性所提供的臨床價值,爲解決種族差異提供了變革性的解決方案,我們正在準備向FDA申請批准。我們期待在接下來的幾周內,NiCO脈搏血氧儀的更多里程碑和公告,」Gregg總結道。
About Zynex, Inc.
關於Zynex公司
Zynex, founded in 1996, develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals. For additional information, please visit: .
Zynex成立於1996年,開發、製造、營銷和銷售用於疼痛管理和康復的醫療設備,以及用於醫院的非侵入性液體、膿毒症和激光脈搏血氧監測系統。如需更多信息,請訪問:.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.
安全港聲明
本發佈包含根據美國《1995年私人證券訴訟改革法》安全港條款的前瞻性陳述。
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The Company makes no express or implied representation or warranty as to the completeness of forward-looking statements or, in the case of projections, as to their attainability or the accuracy and completeness of the assumptions from which they are derived. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement for our products from health insurance companies, our dependence on third party manufacturers to produce our products on time and to our specifications, implementation of our sales strategy including a strong direct sales force, the impact of COVID-19 on the global economy and other risks described in our filings with the Securities and Exchange Commission including but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2023 as well as our quarterly reports on Form 10-Q and current reports on Form 8-K.
前瞻性陳述既不是歷史事實,也不是未來表現的保證。相反,它們僅基於我們對未來業務、未來計劃和策略、預測、預期事件和趨勢、經濟及其他未來控件的當前信念、期望和假設。由於前瞻性陳述涉及未來,因此它們受固有的不確定性、風險和難以預測的情況變化的影響,其中許多超出了我們的控制範圍。我們的實際結果和財務控件可能與前瞻性陳述中指示的結果有實質性差異。因此,您不應依賴於任何這些前瞻性陳述。公司對前瞻性陳述的完整性不作明示或暗示的陳述或保證,或者在預測的情況下,對其可實現性或其所基於的假設的準確性和完整性不作任何保證。可能導致實際結果與前瞻性陳述實質性不同的因素包括但不限於,新產品需要獲得CE標記、醫生和醫院對新產品以及現有產品的接受程度、具有更大財務資源的大型競爭對手、必須跟上科技變化、我們對健康保險公司對我們產品的報銷依賴、我們對第三方製造商按時生產我們產品並符合我們的規格的依賴、實施我們的銷售策略,包括強大的直接銷售團隊、COVID-19對全球經濟的影響以及在我們的證券交易委員會文件中描述的其他風險,包括但不限於截至2023年12月31日的年度報告(Form 10-k)以及我們的季度報告(Form 10-Q)和當前報告(Form 8-k)。
Any forward-looking statement made by us in this 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.
我們在本公告中所做的任何前瞻性聲明僅基於當前我們獲得的信息,並且僅在聲明作出之日有效。我們不承擔任何義務對任何前瞻性聲明(無論是書面還是口頭)進行公開更新,無論是由於新信息、未來發展還是其他原因。
Investor Relations Contact:
Brian Prenoveau, CFA
MZ Group – MZ North America
[email protected]
+561 489 5315
投資者關係聯繫:
布賴恩·普雷諾沃,CFA
MZ集團 – MZ北美
[email protected]
+561 489 5315
SOURCE Zynex, Inc.
來源 Zynex, Inc.