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Arch Therapeutics Launches Multi-Site Clinical Study for AC5® Advanced Wound System

Arch Therapeutics Launches Multi-Site Clinical Study for AC5® Advanced Wound System

ARCH治疗公司推出AC5®高级创伤系统的多点临床研究
GlobeNewswire ·  2022/09/07 06:55

Expected to Accelerate Sales Opportunities in Doctor's Office and Wound Clinics

预计将加快医生办公室和伤口诊所的销售机会

FRAMINGHAM, Mass., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a marketer and developer of novel self-assembling wound care and biosurgical products, today announced that it has launched a multi-site clinical study (the "Study") to accelerate payor adoption and differentiate the key benefits of AC5® Advanced Wound System ("AC5") in treating challenging wounds. The Study is expected to enroll and treat up to 60 patients at six sites with a primary end point of wound closure. The launch of the Study completes the near-term commitments listed in the Company's recently announced reimbursement initiative to accelerate sales opportunities for AC5 in doctor's offices and wound care clinics.

马萨诸塞州弗雷明翰,9月2022年07日(环球社)--Arch治疗公司(场外交易代码:ARTH)(“拱形“或”公司),一家新型自组装伤口护理和生物外科产品的营销商和开发商,今天宣布,它已经启动了一项多地点临床研究(以下简称研究),以加快付款人的采用,并区分AC5的主要好处®高级创伤系统(“AC5这项研究预计将在6个伤口关闭的主要终点招募和治疗多达60名患者。这项研究的推出完成了该公司最近宣布的报销计划中列出的近期承诺,以加快AC5在医生办公室和伤口护理诊所的销售机会。

Dr. Brock Liden, a board-certified podiatrist, attending physician at the Circleville Foot & Ankle Center, and expert lecturer on wound care, podiatric medicine, surgery, and practice management, has agreed to serve as the primary investigator ("PI") for the Study. As the PI, Dr. Liden will be responsible for overseeing all critical elements of the Study. "AC5 is a new step forward in the exciting synthetic skin substitute or cellular tissue product area.  I believe it is the only flowable synthetic skin substitute on the market and offers a unique application technique for difficult-to-treat wounds. I always seek better treatment options for patients with complex acute and chronic wounds, and AC5 has shown great promise in early use. As such, I am excited and honored to serve as the Primary Investigator for this Study," stated Dr. Liden.

布鲁克·利登博士是一名获得委员会认证的足科医生,是Circleville Foot&ankle Center的主治医生,也是伤口护理、足科医学、外科和实践管理方面的专家讲师,他已同意担任这项研究的主要研究员(PI)。作为PI,Liden博士将负责监督这项研究的所有关键要素。“AC5在令人兴奋的合成皮肤替代品或细胞组织产品领域迈出了新的一步。我相信它是市场上唯一流动的合成皮肤替代品,并为难以治疗的伤口提供了一种独特的应用技术。我一直在为复杂的急慢性伤口的患者寻求更好的治疗方案,AC5在早期使用方面显示出巨大的前景。因此,我很兴奋和荣幸地担任这项研究的主要研究员,”利登博士说。

"The Study supports our near-term revenue prospects by gaining amplified exposure for AC5 Advanced Wound System in doctor's offices and wound care clinics, and our long-term revenue prospects by creating opportunities for data sharing with payors and wound care clinicians—building product awareness and demonstrating better outcomes, while potentially lowering the cost of care for the more than 7 million people in the U.S who live with a chronic wound," stated Dan Yrigoyen, Vice President of Sales of Arch Therapeutics.

Arch Treeutics销售副总裁丹·伊里戈延表示:“这项研究通过扩大AC5高级伤口系统在医生办公室和伤口护理诊所的曝光率,支持我们的近期收入前景,并通过为与付款人和伤口护理临床医生共享数据创造机会,支持我们的长期收入前景--培养产品意识并展示更好的结果,同时潜在地降低美国700多万慢性伤口患者的护理成本,”Arch Treeutics销售副总裁丹·伊里戈延说。

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company with a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma, and interventional care. Arch is developing wound care and biosurgical products based on an innovative self-assembling peptide technology platform with the goal of improving healing outcomes for patients. Arch has received regulatory clearance to market AC5® Advanced Wound System in the United States and AC5® Topical Hemostat in Europe. Arch's development stage product pipeline includes AC5-G™ for endoscopic resection of gastrointestinal tumors, AC5-V® for hemostasis during vascular surgery and AC5 Surgical Hemostat for general surgical hemostasis, among others.1,2

Arch治疗公司简介
ARCH治疗公司是一家生物技术公司,拥有一种新的方法来止血(止血)、控制泄漏(密封剂)并在手术、创伤和介入治疗中处理伤口。ARCH正在开发基于创新的自组装肽技术平台的伤口护理和生物外科产品,目标是改善患者的愈合结果。ARCH已获得上市AC5的监管许可®美国和AC5的先进创伤系统®欧洲的局部止血器。ARCH的开发阶段产品线包括用于胃肠道肿瘤内窥镜切除的AC5-G™,AC5-V®用于血管手术止血,AC5外科止血器用于普通外科止血等。1,2

1 AC5-G, AC5-V, and AC5 Surgical Hemostat are currently investigational devices limited by law to investigational use.
2 AC5, AC5-G, AC5-V and associated logos are trademarks and/or registered trademarks of Arch Therapeutics, Inc. and/or its subsidiaries.

1 AC5-G、AC5-V和AC5外科止血器目前是受法律限制的研究设备,只能用于研究用途。
2AC5、AC5-G、AC5-V和相关标识是Arch治疗公司和/或其子公司的商标和/或注册商标。

Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our ability to recruit additional field sales representatives and their effectiveness, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to produce commercial quantities of our products within projected timeframes, our ability to obtain the inclusion of our AC5® Advanced Wound System on targeted federal supply schedules, our ability to develop and commercialize products based on our technology platform, and market conditions, and our ability to establish additional commercialization partnerships and build a critical mass of field sales representatives. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations, and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations, or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.

关于前瞻性陈述的通知
本新闻稿包含“前瞻性陈述”,这一术语在修订后的1933年证券法第27A节和修订后的1934年证券交易法第21E节中有定义。本新闻稿中非纯粹历史性的陈述为前瞻性陈述,包括有关对未来的信念、计划、期望或意图的任何陈述。此类前瞻性陈述包括对新技术和方法的提及、我们招聘更多现场销售代表的能力及其有效性、我们的业务和产品发展计划和预测,或市场信息。由于许多因素,实际结果可能与任何前瞻性陈述中预测的结果不同。这些因素包括与开发新产品或技术和作为发展阶段公司运营有关的内在不确定性,我们留住管理团队重要成员和吸引其他合格人员的能力,我们筹集额外资金继续执行我们的业务和产品开发计划的能力,我们获得必要的监管批准的能力,我们在预计的时间框架内生产商业批量产品的能力,我们获得AC5的能力®我们在目标联邦供应时间表上的先进伤口系统,我们基于我们的技术平台和市场条件开发和商业化产品的能力,以及我们建立更多商业化合作伙伴关系和建立关键数量的现场销售代表的能力。这些前瞻性陈述是截至本新闻稿发布之日作出的,我们没有义务更新前瞻性陈述,也没有义务更新实际结果可能与前瞻性陈述中预测的结果不同的原因。尽管我们相信本新闻稿中包含的任何信念、计划、预期和意图都是合理的,但不能保证任何此类信念、计划、预期或意图将被证明是准确的。投资者应参考本文提供的所有信息,也应参考我们提交给美国证券交易委员会的报告和其他文件中概述的风险因素披露,这些文件可在www.sec.gov上获得。

Contact:
ARTH Investor Relations
Toll Free: +1.855.340.ARTH (2784) (US and Canada)
Email: investors@archtherapeutics.com
Website:

联系方式:
Arth投资者关系
免费电话:+1.855.340.ARTH(2784)(美国和加拿大)
电子邮件:Investors@ArchTreateutics.com
网站:

or

Michael Abrams
Chief Financial Officer
Arch Therapeutics, Inc.
Phone: 617.431.2333
Email: mabrams@archtherapeutics.com

迈克尔·艾布拉姆斯
首席财务官
ARCH治疗公司
电话:617.431.2333
电子邮件:mabram@archTreateutics.com


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