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Empower Clinics Accelerates Growth of Research and Clinical Trials Division With Signing of Two Additional Principal Investigators at First Site in Dallas, Texas

Empower Clinics Accelerates Growth of Research and Clinical Trials Division With Signing of Two Additional Principal Investigators at First Site in Dallas, Texas

Empower Clinics在德克薩斯州達拉斯的第一個地點簽署了另外兩名首席研究員,從而加速了研究和臨牀試驗部門的發展
Accesswire ·  2023/04/25 18:30

Addition Of Seasoned Principal Investigators At First SMO Site Dramatically Expands Access to Securing Multiple Research Projects Covering Numerous Specialties

在第一個SMO站點增加經驗豐富的首席調查人員極大地擴大了獲得涵蓋多個專業的多個研究項目的渠道

VANCOUVER, BC / ACCESSWIRE / April 25, 2023 / EMPOWER CLINICS INC (CSE:EPW)(PINK:EPWCF) ("Empower" or the "Company") an integrated healthcare company with a developing research and clinical trials divisions is pleased to announce that its subsidiary EPW Curesearch LLC ("EPWC") has signed two new Research Services Agreements ("Research Agreement") with leading physicians and researchers who will act as the Principal Investigators (the "PI") supporting the provision of Pharmaceutical Research and Clinical Trials Services (the "Services") of the first site in Dallas, TX.

溫哥華,BC/ACCESSWIRE/2023年4月25日/Empower Clinics Inc(CSE:EPW)(PINK:EPWCF)(“增強能力“或”公司“)一家擁有發展中的研究和臨床試驗部門的綜合醫療保健公司高興地宣佈,其子公司EPW CuResearch LLC(”EPWC“)與領先的醫生和研究人員簽署了兩項新的研究服務協定(”研究協定“),這些醫生和研究人員將擔任首席研究員(PI),支持提供藥物研究和臨床試驗服務(”服務“)在德克薩斯州達拉斯的第一個站點。

The addition of two additional PI's brings the active count of seasoned researchers to three and paves the way to conducting multiple research projects across a variety of specialties and disease states. PI's are practicing medical doctors who are specialists or internists with previous research and clinical trials experience that are integral to the success of the Clinical Trial process, including the establishment of Empower Clinics as a Site Management Organization ("SMO").

新增的兩個PI使經驗豐富的研究人員的活躍數量增加到三個,並為在各種專業和疾病狀態下開展多個研究項目鋪平了道路。PI是執業醫生,他們是具有先前研究和臨床試驗經驗的專家或內科醫生,這些經驗對臨床試驗過程的成功是不可或缺的,包括建立作為現場管理組織(SMO)的Empower診所。

THE RESEARCH AND CLINICAL TRIALS BUSINESS CYCLE

研究和臨床試驗的商業週期

In order for shareholders to better understand both the process and the critical role played by Empower within it, we have provided the following outline:

為了讓股東更好地瞭解Empower在這一過程中發揮的關鍵作用,我們提供了以下概要:

  • Big Pharmaceutical companies conduct research and clinical trials on numerous disease states (the "Sponsor")
  • Successful new drugs that get FDA or CE approval are worth billions to the Sponsor
  • Sponsors typically outsource the management of research trials to Contract Research Organizations ("CRO")
  • Specialized physicians referred to as Principal Investigators (PI's) become researchers at sites for the purpose of enrolling patients and supporting the trial
  • The next segment of the industry is Site Management Organizations (SMO), and this is where Empower intends to operate. Specifically, Empower as an SMO enters into contracts with PI's, which in this case, is a large medical center with multiple PI's under contract
  • Empower as the SMO liaises with both the CRO and the Sponsor to create a three-way contract for research and clinical trials with the Sponsor, CRO and the PI's
  • Once the trial commences:
    • Patients enroll in a trial
    • They are seen by the PI on regular intervals
    • The PI gathers the required data
    • The data is assembled, de-identified and provided to the CRO and Sponsor
  • As the SMO, Empower oversees the process of day-to-day patient management, site management, technology management and general oversight of the process
  • Each month Empower as the SMO submits a detailed invoice to the CRO for patient management services and participation from the prior month
  • 大型製藥公司對多種疾病狀態進行研究和臨床試驗(“贊助商”)
  • 獲得FDA或CE批准的成功新藥對贊助商來說價值數十億美元
  • 贊助商通常將研究試驗的管理外包給合同研究機構(“CRO”)
  • 被稱為首席調查員(PI)的專業醫生成為網站的研究人員,目的是招募患者和支持試驗
  • 該行業的下一個細分市場是網站管理組織(SMO),這也是Empower打算運營的領域。具體地說,Empower作為SMO與PI‘s簽訂合同,在這種情況下,PI是一家大型醫療中心,合同下有多個PI
  • 授權SMO與CRO和贊助商聯繫,與贊助商、CRO和PI‘s制定研究和臨床試驗的三方合同
  • 一旦審判開始:
    • 患者參加一項試驗
    • PI每隔一段時間就能看到它們
    • PI收集所需的數據
    • 數據被組合、識別並提供給CRO和贊助商
  • 作為SMO,Empower負責監督病人的日常管理、現場管理、技術管理以及對該過程的全面監督
  • 每月授權作為SMO向CRO提交一份詳細的發票,用於前一個月的患者管理服務和參與

KEY METIRCS OF THE SITE MANAGEMENT ORGANIZATION

現場管理組織的關鍵指標

  • The key metrics that impact the success of each trial for the SMO are:
    • Patient enrolment per trial
    • Patient stickiness per trial
    • The term, length, and possible extension per trial
    • The number of active trials under management.
  • As an SMO, Empower expects to have multiple PI's managing multiple trials
  • Successful new drugs have a significant anticipated value to Sponsors, the Sponsors are motivated and incentivized to keep trials on track via timely payments
  • Contracts come with extremely detailed payout schedules for every single touchpoint and element of every project
  • Expenses and payouts follow a generally standardized formula:
    • PI's are typically paid a percentage of the contract value
    • Empower as the SMO operates with a variable cost model and far superior cash flow control than in any previous medical business model
  • Empower limits and eliminates capital expenses related to:
    • Opening a clinic
    • Buying a clinic
    • Entering into long-term leases
  • Empower anticipates much improved cash flow economics each month and quarter, which are expected to improve as scale is achieved
  • 影響SMO每一次試驗成功的關鍵指標是:
    • 每次試驗的患者登記人數
    • 每次試驗的患者粘性
    • 每次試驗的期限、持續時間和可能的延期
    • 正在管理的正在進行的試驗數量。
  • 作為一名SMO,Empower希望有多個PI管理多個試驗
  • 成功的新藥對贊助商具有重要的預期價值,贊助商有動力和激勵通過及時付款來保持試驗的正軌
  • 合同為每個專案的每個接觸點和要素都提供了極其詳細的付款計劃
  • 費用和支出遵循一個一般標準化的公式:
    • PI通常會獲得合同價值的一定比例的報酬
    • 作為SMO的授權,SMO以可變成本模式和遠優於以往任何醫療業務模式的現金流控制進行運營
  • 授權限制並消除與以下各項相關的資本支出:
    • 開設一家診所
    • 收購一家診所
    • 簽訂長期租約
  • Empower預計每個月和每個季度的現金流經濟效益都會有很大改善,預計隨著規模的擴大,現金流經濟效益會有所改善

"This model represents an entirely different and superior cash model for Empower, which runs with very low overhead and internal headcount." stated Steven McAuley, Chairman and CEO. "This absence of substantial capital requirements is not only a smarter business but is also incredibly timely given the difficulties small cap companies are facing accessing capital for operations in this challenged environment".

這種模式代表了Empower一種完全不同的卓越現金模式,它以非常低的管理費用和內部員工人數運行。董事長兼首席執行官史蒂文·麥考利表示。“這種沒有大量資本金要求的做法不僅是一項更明智的業務,而且考慮到小盤股公司在這個充滿挑戰的環境中為運營獲得資本所面臨的困難,這一點也非常及時。”

The CRO Services Market in terms of revenue was estimated to be worth $76.6 billion in 2023 and is poised to reach $127.3 billion by 2028, growing at a CAGR of 10.7% from 2023 to 2028 according to a new report by MarketsandMarkets.[1] Factors such as continuously growing pharmaceutical, biotechnology and medical device R&D pipelines and technological advancements in the clinical trials process are driving the growth of this market. In recent years, the costs associated with drug and product development have increased significantly, driving pharma, biotech, and medical device companies to look for partnerships to drive modernizations and smarter ways of conducting business.

根據MarketandMarkets的一份新報告,按收入計算,CRO服務市場在2023年估計價值766億美元,到2028年將達到1273億美元,2023年至2028年的復合年增長率為10.7%。[1]不斷增長的製藥、生物技術和醫療器械研發渠道以及臨床試驗過程中的技術進步等因素正在推動這一市場的增長。近年來,與藥品和產品開發相關的成本大幅增加,促使製藥、生物技術和醫療器械公司尋找合作夥伴關係,以推動現代化和更智慧的經營方式。

The Company also announces that it entered into debt settlement agreements with creditors on April 19th, 2023 for the settlement of debt in the aggregate amount of $202,149 CAD, which was settled through the issuance of an aggregate of 8,085,960 common shares in the capital of the Company (each, a "Share") at a deemed issue price of $0.025 per Share and the issuance of a 24 month Warrant exercisable at a price of $0.05 with an expiry date of April 20, 2025, together (a "Unit") and considered (the "Debt Settlement").

該公司還宣佈,它於4月19日與債權人簽訂了債務解決協定這是,2023年,用於清償總額202,149加元的債務,已通過發行總計8,085,960股公司股本中的普通股(每股,“股份”)和發行可按每股0.025美元的價格行使、到期日為2025年4月20日的24個月認股權證(“債務清償”)連同(“單位”)和被視為(“債務清償”)。

All Shares issued pursuant to the Debt Settlement will be subject to a statutory four month and one day hold period from the date of issue in accordance with applicable Canadian securities laws. None of the Shares will be registered under the United States Securities Act of 1933, as amended, and none may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

根據適用的加拿大證券法,根據債務清償發行的所有股票將受到自發行之日起4個月零1天的法定持有期的約束。任何股票都不會根據修訂後的1933年美國證券法進行登記,如果沒有登記或獲得適用的豁免登記要求,任何股份都不能在美國發行或出售。本新聞稿不應構成出售或邀請購買公司任何證券的要約,也不應在任何司法管轄區出售任何此類要約、招攬或出售將是非法的證券。

This press release is available on the Empower Clinics Verified Forum on AGORACOM for shareholder discussion, questions, and engagement with management

本新聞稿可在AGORACOM上的授權診所驗證論壇上獲取,以供股東討論、提問和與管理層接觸

To get enhanced access to investor information about Empower Clinics, please visit the download page to get your Empower Clinics Investor Experience Wallet Pass today.

要獲取有關Empower診所的投資者資訊,請訪問下載頁面,今天即可獲得Empower診所投資者體驗錢包通行證。

ABOUT EMPOWER:

關於授權

Empower is an integrated healthcare company with multi-disciplinary clinics, a Canadian medical device company and has launched its first clinical research site becoming a Site Management Organization (SMO) in Dallas, TX. Empower is a leader in integrated healthcare and research solutions and is reshaping the model for patient-first wellness.

Empower是一家擁有多學科診所的綜合性醫療保健公司,是一家加拿大醫療器械公司,並在德克薩斯州達拉斯推出了其首個臨床研究網站,成為網站管理組織(SMO)。Empower是綜合醫療和研究解決方案領域的領先者,正在重塑患者至上的健康模式。

ON BEHALF OF THE BOARD OF DIRECTORS:

我謹代表董事會:

Steven McAuley
Chief Executive Officer

史蒂文·麥考利
首席執行官

CONTACTS:

聯繫人:

Media:

媒體:

Steven McAuley CEO
s.mcauley@empowerclinics.com
+1 855-855-9058

史蒂文·麥考利首席執行官
郵箱:s.mcauley@empower Clinics.com
+1 855-855-9058

Investors:

投資者:

Tamara Mason
Business Development & Communications
t.mason@empowerclinics.com
+1 855-855-9058

塔瑪拉·梅森
業務發展與溝通
電子郵件:郵箱:t.mason@empower Clinics.com
+1 855-855-9058

DISCLAIMER FOR FORWARD-LOOKING STATEMENTS

對前瞻性陳述的免責聲明

This news release contains certain "forward-looking statements" or "forward-looking information" (collectively "forward looking statements") within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements can frequently be identified by words such as "plans", "continues", "expects", "projects", "intends", "believes", "anticipates", "estimates", "may", "will", "potential", "proposed" and other similar words, or information that certain events or conditions "may" or "will" occur. Forward-looking statements in this news release include statements regarding: the Company's intention to create and operate a Dallas-based SMO, with plans to evolve into multiple SMO's; the parties' intentions that the Dallas-based SMO will work with industry, patients, community doctors and researchers in North America and globally to provide clinical trial management services; the parties' intentions to identify new cities to operate additional SMOs in 2023. Such forward-looking statements are based on assumptions known to management at this time, and are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the forward-looking statements, including: that the parties will be able to negotiate and enter into the Definitive Agreement on mutually agreeable terms; that legal and financial due diligence will be completed to the satisfaction of the parties; that all necessary third party approvals will be obtained. No assurance can be given that any of the events anticipated by the forward-looking statements will occur on the terms or in the time expected, or at all, or, if they do occur, what benefits the Company will obtain from them. Readers are cautioned not to place undue reliance on the forward-looking statements in this release, which are qualified in their entirety by these cautionary statements. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities laws.

本新聞稿包含適用於加拿大證券法的某些“前瞻性陳述”或“前瞻性資訊”(統稱為“前瞻性陳述”)。除有關歷史事實的陳述外,所有陳述均為前瞻性陳述,均基於截至本新聞稿發佈之日的預期、估計和預測。前瞻性表述常常可以用“計劃”、“繼續”、“預期”、“專案”、“打算”、“相信”、“預期”、“估計”、“可能”、“將”、“潛在”、“建議”和其他類似詞語,或某些事件或條件“可能”或“將”發生的資訊來識別。本新聞稿中的前瞻性陳述包括以下陳述:公司打算創建和運營一個總部設在達拉斯的SMO,並計劃發展成多個SMO;雙方打算讓總部設在達拉斯的SMO與北美和全球的業界、患者、社區醫生和研究人員合作,提供臨床試驗管理服務;雙方打算確定新的城市,在2023年運營更多的SMO。該等前瞻性表述基於管理層目前已知的假設,受風險和不確定因素的影響,可能會導致實際結果、業績或發展與前瞻性表述中包含的內容大不相同,包括:雙方將能夠以相互同意的條款談判和簽訂最終協定;法律和財務盡職調查的完成程度將令各方滿意;將獲得所有必要的第三方批准。不能保證前瞻性陳述中預期的任何事件將按照預期的條款或時間發生,或者根本不能保證,或者如果發生了,公司將從中獲得什麼好處。告誡讀者不要過度依賴本新聞稿中的前瞻性陳述,這些前瞻性陳述完全受這些警告性陳述的限制。除適用的證券法明確要求外,公司沒有義務更新或修改本新聞稿中的任何前瞻性陳述,除非適用的證券法明確要求,無論是由於新資訊、未來事件還是其他原因。

[1] Markets and markets report March 2021 reviewed February 6, 2023

[1]市場和市場報告2021年3月審閱2023年2月6日

SOURCE: Empower Clinics Inc.

資料來源:Empower Clinics Inc.


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