Empower Clinics Doubling KAI Medical Laboratory Size In Anticipation Of Test Volumes By End Of Q1. Files MDEL Application With Health Canada To Import and Sell KAI Saliva PCR Test In Canada


2021-01-23 09:22:11 CFN Media Group


EMPOWER CLINICS INC. an integrated healthcare company serving patients through clinics, a telemedicine platform, and a leading medical diagnostics laboratory processing thousands of COVID-19 specimens and developing novel COVID-19 testing protocols for CE, FDA EUA and Health Canada approval, is pleased to announce significant expansion of our KAI Medical Laboratory in Dallas, Texas in anticipation of projected growth in COVID-19 testing requirements in the U.S., Canada and international markets. In addition, Empower has filed a Medical Device Establishment Licence (“MDEL”) with Health Canada for the purposes of importing, distributing and selling our KAI Medical COVID-19 Saliva Test (“KAI Saliva”), which has experienced immediate success since it’s launch on December 15, 2020 in the United States and reported on January 7, 2021. KAI MEDICAL LABORATORY EXPANDING TO AT LEAST DOUBLE CURRENT SIZE IN ANTICIPATION OF ANTICIPATED GROWTH IN VOLUME KAI Medical Laboratory, a state-of-the-art diagnostics laboratory in Dallas, was acquired by Empower Clinics on October 6, 2020 to further advance the Company’s COVID-19 national testing programs for enterprise clients, including movie and television studios, businesses and the travel industry. KAI experienced significant growth in its first quarter under Empower, with Q4 COVID-19 test kit volumes exceeding 6,000 units, far surpassing the 1,300 total units prior to acquisition. Current run rate projections now indicate as follows: January 2021 is expected to exceed 8,000 tests, surpassing all of Q4 2020 February 2021 could see daily rates hit 1,000 tests per day March 2021 could see daily rates hit 2,000 tests per day These run rates DO NOT include the recent 25,000 unit order for KAI Saliva test kits, nor do they include any test kits from the launch of KAItests.com Empower Clinics CEO, Steven McAuley stated “Our investment in R&D is really starting to pay off for KAI Medical, starting with a new state-of-art laboratory information system to automate processes for the anticipated growth in volume. Next, we have hired three new scientists, increased administrative staff and are activating a call center to provide world-class customer support. Further, the investment in new test protocols such as the Kai Saliva test kit, combined with our Health Canada medical device licence, positions us to be a leader in the reactivation of travel for Canadians.” EMPOWER FILES MDEL APPLICATION WITH HEALTH CANADA TO IMPORT, DISTRIBUTE AND SELL KAI SALIVA Empower has filed a Medical Device Establishment Licence (“MDEL”) with Health Canada for the purposes of importing, distributing and selling our KAI Medical COVID-19 Saliva Test (“KAI Saliva”), which experienced immediate success upon it’s launch on December 15, 2020 in the United States, with an initial soft launch order of 5,000 units and an order for the next 25,000 KAI Saliva PCR Test Kits with a sales value of approximately $5.5M. The filing of the MDEL application is a very important milestone as the integrated healthcare model of the company developments in Canada. Having the MDEL licence approved by Health Canada opens up the ability for Empower to import and sell the KAI Saliva COVID-19 RT-PCR test kits to all Canadians, providing a legitimate and predictable method to solve the dilemma of travel for Canadian’s and those that want or need to travel to or back into Canada. HIGHLY VIABLE SOLUTION FOR AIRLINE PASSENGERS, BOTH DOMESTIC AND FOREIGN, TO TRAVEL TO CANADA Moreover, if successful with our application, KAI Saliva COVID-19 test kit provides travellers from around the world with a simple, yet fully compliant method to obtain an RT-PCR test and laboratory provided result prior to travel to Canada. Furthermore, if successful with our application, KAI Saliva test kits provide Canada’s major airlines, with a legitimate and viable solution for Canadian travellers who leave Canada on a round-trip but have no credible means of sourcing a compliant, self-administered COVID-19 test in a foreign country. This has become a serious challenge for travellers, leading to major losses for airlines, cruise lines, hotels and hospitality. KAI Saliva RT-PCR test kits, if successful with our application, would provide Canada’s major airlines with an ability to provide one solution for both foreign and domestic travellers by simply making a KAI Saliva test kit a part of the ticketing purchase process. Foreign travellers could receive and take the test in their home countries, while Canadian travellers could take KAI Saliva test kits with them on their trip to administer prior to return travel, then a result will be provided prior to boarding flights back to Canada. INITIAL DEMAND FOR FIRST RUN KAI SALIVA TEST KITS CAME FROM EXISTING COMMERCIAL CUSTOMERS. DIRECT TO CONSUMER CHANNEL LAUNCH HAS COMMENCED. Initial and overwhelming demand for KAI Saliva test kits stemmed from our existing customers in the commercial sector and concierge testing. Given the early and significant success of KAI Saliva since its launch on December 15, 2020, Empower is extremely confident in the continued success of KAI Saliva test kits with both existing and expanded commercial customers in this next run. To this end, the next important milestone for KAI Medical is the pending launch of our direct-to-consumer, home based KAI Saliva Tests, that will launch using our new platform www.kaitests.com. Our platform will enable consumers, businesses, private and public sector to order the test kit online, have it shipped to them for simple specimen collection, then returned to KAI Medical Laboratory for processing and provision of the test results. FDA APPROVED AT HOME/WORK SALIVA TEST IS A GAME CHANGER. DISCUSSIONS UNDERWAY WITH MAJOR CANADIAN AIRLINES IN RESPONSE TO RECENT TESTING REQUIREMENTS FOR RETURNING CANADIAN TRAVELERS KAI Saliva is the direct result of investing in scientific R&D through KAI, empowering them to deliver clinical trial data and validation. This gives Empower a strong upper hand nationally and now potentially on an international stage. The power of the Saliva Test is in its simplicity, in which users merely spit into a funnel, then close the funnel with a lid containing a liquid to be mixed with the saliva by simply shaking it for 5 seconds. This saliva-based PCR test does not require a medical technician to administer the specimen collection which can be done by the individual, a parent or an administrator. The specimen is returned to KAI Medical Labs from anywhere for processing. KAI will analyze and provide a response using its compliant IT system. This simplicity of use, yet sophistication in processing, analyzing and responding represents a viable solution for the new travel policy instituted by the Canadian government and serves as the basis for discussions that are now underway with major Canadian airlines. Specifically, every traveller to Canada over the age of five, including Canadians returning from vacation, must show a negative test result from a PCR or RT-LAMP test administered in the 72 hours before their flight’s departure. The test must be conducted in the flight’s country of origin. KAI Saliva is able to provide returning Canadians with the ability to purchase a PCR test prior to leaving for vacation, self-administer the non-invasive specimen collection from their travel destination 72 hours prior to returning to Canada and receive a result prior to departure. Foreign travelers to Canada using a major Canadian airline can order KAI Saliva directly to their home almost anywhere in the world and go through the same process. As a (CE) approved test kit, it can be sent to travellers coming from South America, Caribbean and European countries. Other types of tests – such as rapid antigen tests – will not be accepted. The government has directed airlines to turn away travellers who do not present a test result at the time of boarding. As such, the simplicity of KAI Saliva test kit represents one of the most viable solutions available anywhere on the planet and a major opportunity for Empower. GLOBAL TOURISM INDUSTRY LOSSES WILL COST OVER $1 TRILLION AND 100 MILLION JOBS In a featured story on AWS Amazon titled “Restarting the Travel and Hospitality Industry: An AI-powered Solution”, Loop Insight CEO Rob Anson stated: “There’s no doubt that the pandemic has devastated the travel and hospitality industry. A recent policy brief from the United Nations reports the COVID-19 pandemic will cost the global tourism industry over $1 trillion in losses and threaten 100 million jobs. Today, 50 countries are completely closed and another 92 are partially open with mandatory quarantine upon arrival, according to Kayak. Even as measures and lockdowns around the world ease up, many travelers are postponing their plans or canceling altogether. The complexities of reopening stretch far beyond navigating the restrictions. We need to get the world back to traveling soon, and to do that, we must prioritize both guest and operator safety.” This press release is available on the Empower Clinics Verified Forum on AGORACOM for shareholder discussion, questions and engagement with management https://agoracom.com/ir/EmpowerClinics ABOUT EMPOWER: Empower is an integrated healthcare company that provides body and mind wellness for patients through its clinics, with digital and telemedicine care, and world-class medical diagnostics laboratories. Supported by an experienced leadership team, Empower is aggressively growing its clinical and digital presence across North America. Our Health & Wellness and Diagnostics & Technology business units are positioned to positively impact the integrated health of our patients, while simultaneously providing long term value for our shareholders. ON BEHALF OF THE BOARD OF DIRECTORS: Steven McAuley Chief Executive Officer CONTACTS: Investors: Dustin Klein Director [email protected] 720-352-1398 Investors: Steven McAuley CEO [email protected] 604-789-2146 This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
EMPOWER诊所公司。作为一家综合医疗保健公司,通过诊所,远程医疗平台和领先的医疗诊断实验室为患者提供服务,该实验室处理数千份COVID-19标本,并开发符合CE,FDA EUA和加拿大卫生部批准的新型COVID-19检测协议。我们很高兴宣布,我们位于得克萨斯州达拉斯的KAI医学实验室将进行重大扩展,以满足美国,加拿大和国际市场对COVID-19检测需求的预期增长。 此外,Empower已向加拿大卫生部申请医疗器械建立许可证(MDEL),用于进口,分销和销售我们的KAI Medical COVID-19唾液测试(KAI Saliva),该测试自2020年12月15号在美国推出以来立即获得成功,并于2021年1月7号报告。 KAI医学实验室将扩大到目前规模的至少两倍,预计数量将有预期的增长 凯医学实验室位于达拉斯,是一家最先进的诊断实验室,于2020年10月6日被Empower Clinics收购,以进一步推进该公司为企业客户(包括电影和电视工作室,企业和旅游业)提供的COVID-19国家测试计划。在Empower的帮助下,KAI在第一季度取得了显著的增长,第四季度COVID-19测试套件的数量超过了6000台,远远超过了收购前的1300台。 目前的运行速度预测如下: 预计2021年1月将超过8000次测试,超过2020年第四季度的全部测试 2021年2月,每天的测试率可能达到1000次 2021年3月,日检测率可能达到2,000次/天 这些运行率不包括最近KAI唾液测试包的25,000个单位订单,也不包括Kaitests.com推出的任何测试包 Empower Clinics首席执行官史蒂文·麦考利说,我们在研发方面的投资确实开始为凯医疗带来回报,首先是一个新的最先进的实验室信息系统,为预期的数量增长自动化流程。接下来,我们聘请了三位新的科学家,增加了行政人员,并正在激活一个呼叫中心,以提供世界级的客户支持。此外,对Kai唾液检测试剂盒等新检测方案的投资,加上我们的加拿大卫生部医疗设备许可证,使我们成为重新启动加拿大人旅行的领导者。 授权文件MDEL应用程序与加拿大卫生部进口,分销和销售凯唾液 Empower已向加拿大卫生部申请了医疗设备建立许可证(MDEL),用于进口,分销和销售我们的KAI Medical COVID-19唾液测试(KAI Saliva),该测试于2020年12月15日在美国推出后立即获得成功,最初的软推出订单为5,000个单位,以及下一批25,000个KAI唾液PCR测试试剂盒的订单,销售价值约为550万美元。 MDEL申请的提交是一个非常重要的里程碑,因为整合医疗模式的公司在加拿大的发展。加拿大卫生部批准MDEL许可证后,Enpower就可以向所有加拿大人进口和销售KAI Saliva COVID-19 RT-PCR检测试剂盒,为加拿大人和那些想要或需要前往或返回加拿大的人提供了一种合法和可预测的方法来解决旅行的困境。 为国内和国外的航空乘客提供前往加拿大的高度可行的解决方案 此外,如果我们的申请成功,KAI Saliva COVID-19检测试剂盒为来自世界各地的旅行者提供了一种简单但完全符合要求的方法,以便在前往加拿大之前获得RT-PCR检测和实验室提供的结果。 此外,如果我们的申请成功,KAI Saliva测试包为加拿大的主要航空公司提供了一个合法可行的解决方案,为那些往返加拿大但在国外没有可靠途径获得符合要求的,自行管理的COVID-19测试的加拿大旅客提供了解决方案。这已成为旅行者面临的一个严重挑战,导致航空公司,游轮公司,旅馆和招待业遭受重大损失。 KAI唾液RT-PCR检测试剂盒,如果在我们的应用中获得成功,将使加拿大各大航空公司能够为国内外旅客提供一个解决方案,只需将KAI唾液检测试剂盒作为购票流程的一部分。外国旅客可在本国接受并参加检测,而加拿大旅客可在返程前携带KAI唾液检测试剂盒进行检测,结果将在登机返回加拿大前提供。 FIRST RUN KAI唾液检测试剂盒的最初需求来自现有的商业客户。直接面向消费者渠道的推出已经开始。 对KAI唾液检测试剂盒的最初和压倒性需求来自于我们在商业部门和礼宾检测方面的现有客户。鉴于KAI Saliva自2020年12月15号推出以来取得的早期和重大成功,Empower对KAI Saliva测试包在下一次运行中与现有和扩大的商业客户继续取得成功充满信心。 为此,KAI医疗的下一个重要里程碑是即将推出我们的直接面向消费者,基于家庭的KAI唾液测试,该测试将使用我们的新平台www.kaitests.com推出。我们的平台将使消费者,企业,私营和公共部门能够在线订购检测试剂盒,将其运送到他们那里进行简单的标本采集,然后返回KAI医学实验室进行处理并提供检测结果。 FDA批准的家庭/工作唾液测试是一个游戏规则的改变者。正在与加拿大主要航空公司就最近对返回加拿大旅客的测试要求进行讨论 KAI Saliva是通过KAI投资于科学研发的直接结果,授权他们交付临床试验数据和验证。这使增强权能在国内,现在可能在国际舞台上占据很大的优势。 唾液测试的强大之处在于它的简单性,使用者只需将唾液吐到漏斗中,然后用装有液体的盖子将漏斗关闭,只需摇动5秒即可将其与唾液混合。这种基于唾液的PCR检测不需要医疗技术人员管理标本采集,可以由个人,父母或管理员进行。标本从任何地方运回KAI医学实验室进行处理。KAI将使用其合规的IT系统进行分析并提供响应。 这种使用简单,但在处理,分析和反应方面却很复杂的做法,是加拿大政府制定的新旅行政策的一个可行的解决办法,也是目前正在与加拿大各大航空公司进行讨论的基础。 具体而言,凡五岁以上前往加拿大的旅行者,包括度假归来的加拿大人,必须在飞机起飞前72小时内进行PCR或RT-LAMP检测,结果呈阴性。测试必须在飞行的原产国进行。KAI Saliva能够为回国的加拿大人提供在出发度假前购买PCR检测的能力,在返回加拿大前72小时从旅行目的地自行管理非侵入性标本采集,并在出发前收到结果。使用一家加拿大主要航空公司前往加拿大的外国旅行者几乎在世界任何地方都可以直接订购KAI Saliva到他们的家,并经历同样的过程。作为一个(CE)认可的测试工具包,它可以发送给来自南美洲,加勒比海和欧洲国家的旅行者。 其他类型的检测如快速抗原检测将不予受理。政府已经指示航空公司拒绝那些在登机时没有提供检测结果的旅客。因此,KAI唾液测试试剂盒的简单性代表了地球上任何地方可获得的最可行的解决方案之一,也是Empower的一个主要机会。 全球旅游业损失将超过1万亿美元和1亿个就业机会 Loop Insight首席执行官Rob Anson在AWS Amazon网站上发表了一篇题为Restarting the Travel and Hospitality Industry:Ai Powered Solutions的专题文章: 毫无疑问,这场大流行已经摧毁了旅游业和酒店业。联合国最近的一份政策简报报告说,COVID-19大流行将使全球旅游业损失超过1万亿美元,并威胁到1亿个就业机会。据Kayak说,今天,50个国家完全关闭,另有92个国家部分开放,在抵达时实行强制检疫。尽管世界各地的措施和封锁有所缓解,许多旅客还是推迟了他们的计划,或者干脆取消了计划。重新开放的复杂性远远超出了如何驾驭这些限制。我们需要让世界尽快回归旅行,而要做到这一点,我们必须优先考虑客人和操作员的安全。 本新闻稿可在AGORACOM的Empower Clinics验证论坛上获得,供股东讨论,提问和与管理层接触https://AGORACOM.com/ir/empowerClinics 关于授权: Empower是一家综合性医疗保健公司,通过其诊所,数字和远程医疗护理,以及世界一流的医疗诊断实验室,为患者提供身心健康。在经验丰富的领导团队的支持下,Empower正在北美积极扩大其临床和数字业务。我们的健康与健康和诊断与技术业务部门定位于积极影响我们的病人的综合健康,同时为我们的股东提供长期价值。 代表董事会: 史蒂文·麦考利 首席执行官 联系人: 投资者: 达斯廷·克莱因 主任 [电子邮件受保护] 720-352-1398 投资者: 史蒂文·麦考利 首席执行官 [电子邮件受保护] 604-789-2146 本文由CFN Enterprises Inc.(OTCQB:CNFN)发表,CFN Media的所有者和运营商,CFN Media是业界领先的机构和数字金融媒体网络,致力于新兴的CBD和合法大麻行业。如需更多信息,请致电+1(833)420-CNFN。