Berkshire Biomedical Corporation('Berkshire' or 'the Company'), focused on developing its proprietary drug dispensing technology to enhance patient wellness, today announced that its De Novo application for marketing authorization of its COPA™ System has been accepted for review by the U.S. Food and Drug Administration (FDA). The application will be reviewed by the FDA's Division of Health Technology 3C, and has received a target decision day in .

Berkshire Biomedical Corporation ('伯克希尔'或'公司')，专注于开发其专有的药物分发技术以提升患者健康，今天宣布其COPA™系统的De Novo市场授权申请已被美国食品药品监督管理局（FDA）接受审查。该申请将由FDA的健康技术3C部门进行审查，并已获得目标决定日期。

November 2025

2025年11月

, subject to any time the application is put on hold to address any questions.

，但需在任何时间暂停申请以解决任何问题时适用。

The intended medications and use indications for which Berkshire is seeking marketing authorization include methadone HCL oral solution (for Opioid Use Disorder (OUD), moderate to severe pain), oxycodone HCL oral solution (for moderate to severe pain) and fluoxetine HCL oral solution (for treatment of depression, anxiety, and other central nervous system disorders)..

伯克希尔公司正在寻求市场授权的拟议药物及其使用指征包括盐酸美沙酮口服液（用于阿片类药物使用障碍 (OUD)、中度至重度疼痛）、盐酸羟考酮口服液（用于中度至重度疼痛）和盐酸氟西汀口服液（用于治疗抑郁症、焦虑症和其他中枢神经系统疾病）。

COPA is a novel, oral liquid dispensing system specifically designed to deliver accurate and precise doses of controlled and non-controlled prescription medications to only an Authenticated Intended User (AIU™), upon confirmation of dual biometric identifications (fingerprint and dentition) prior to each dose, with the goal of enhancing patient wellness and providing remote monitoring.

COPA 是一种新型的口服液分配系统，专门设计用于在每次剂量前通过双重生物识别（指纹和牙齿结构）确认后，将精确剂量的管制和非管制处方药仅提供给经过身份验证的预期用户（AIU™），旨在提升患者健康水平并提供远程监控。

The device functions as an optional metered dispensing tool for specific prescribed medications where the provider determines, and the patient and/or authorized caregiver concurs, that the patient and treatment plan will benefit from the controlled access and intended user authenticated remote monitoring capabilities that the COPA offers..

该设备用作特定处方药物的可选计量分配工具，其中提供者确定，并且患者和/或授权护理人员同意，认为患者和治疗计划将从COPA提供的受控访问和预期用户经过身份验证的远程监控功能中受益。

'For providers and their patients, faced with ineffective self-managed treatment plans due to adherence challenges, yet recognizing the high expense and detrimental patient impact of professionally managed plans, a solution that bridges the gap between self-managed and professionally managed dispensing is urgently needed,' stated .

“对于提供者及其患者而言，由于依从性挑战导致自我管理的治疗计划效果不佳，同时认识到专业管理计划的高昂费用及其对患者的不利影响，迫切需要一种能够弥合自我管理和专业管理分配之间差距的解决方案，”他表示。

John Timberlake

约翰·廷伯莱克

, Chief Executive Officer of Berkshire. 'Of the 5.7 million people in the U.S. with Opioid Use Disorder, only 18% receive medication treatment. The daily requirement to travel to an Opioid Treatment Program (OTP) clinic has been shown to reduce treatment retention and deter other patients from starting treatment at all.

伯克希尔首席执行官表示：“在美国，570万阿片类药物使用障碍患者中，只有18%的人接受药物治疗。每天必须前往阿片类药物治疗项目（OTP）诊所已被证明会降低治疗的持续性，并阻碍其他患者开始治疗。”

We believe COPA has the potential to dramatically expand methadone take-home medication treatment for OUD which could not only increase patient treatment retention but may also significantly increase the number of people seeking OUD treatment.'.

我们相信，COPA有潜力大幅扩大阿片类药物使用障碍（OUD）的美沙酮带药回家治疗，这不仅可能提高患者的治疗依从性，还可能显著增加寻求OUD治疗的人数。

As previously announced, Berkshire Biomedical recently received its second Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health's (NIH) National Institute of Drug Abuse (NIDA).

伯克希尔生物医学公司最近获得了美国国立卫生研究院 (NIH) 国立药物滥用研究所 (NIDA) 的第二笔快速通道小型企业创新研究 (SBIR) 拨款，正如之前所宣布的。

'The support from NIDA demonstrates the NIH's belief in the strength of the technology behind COPA and its potential to significantly increase access to Opioid Treatment Programs for persons suffering from Opioid Use Disorder (OUD),' added Mr. Timberlake.

“NIDA的支持表明了NIH对COPA背后技术实力的信心，以及其显著增加阿片类药物使用障碍（OUD）患者获得阿片类药物治疗计划的潜力，”Timberlake先生补充道。

About the National Institute on Drug Abuse (NIDA)

关于国家药物滥用研究所 (NIDA)

NIDA is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science.

NIDA是美国卫生与公众服务部下属的国家卫生研究院的一个组成部分。NIDA支持了全球大部分关于药物使用和成瘾健康方面的研究。该研究所实施各种项目以指导政策、改进实践并推动成瘾科学的发展。

About the National Institutes of Health (NIH)

关于美国国立卫生研究院 (NIH)

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

美国国立卫生研究院（NIH）是国家的医学研究机构，包含27个研究所和中心，是美国卫生与公众服务部的一部分。NIH是主要的联邦机构，负责开展和支持基础、临床和转化医学研究，并致力于研究常见和罕见疾病的病因、治疗和治愈方法。

About Berkshire Biomedical Corporation

关于伯克希尔生物医学公司

Berkshire Biomedical Corporation is a privately held medical device company. Berkshire is pioneering the use of biometric technologies, combined with encrypted HIPAA compliant cloud-based and healthcare provider-enabled remote management systems, to provide precise and accurate personalized medication delivery to only the Authenticated Intended User (AIU)..

伯克希尔生物医学公司是一家私人持有的医疗设备公司。伯克希尔正率先将生物识别技术与加密的符合HIPAA标准的云平台及医疗机构支持的远程管理系统相结合，以向经过身份验证的预期用户（AIU）提供精确且准确的个性化药物输送。

The Company's lead product under development, the Computerized Oral Prescription Administration System (COPA), is a hand-held, automated, personalized oral liquid dispensing system designed and intended to deliver controlled and non-controlled liquid oral medications to only the AIU upon confirmation of dual biometric identification (fingerprint and dentition)..

公司正在开发的主要产品——计算机化口服处方管理系统（COPA），是一种手持式、自动化、个性化的口服液分配系统，设计用于在双重生物识别（指纹和牙齿结构）确认后，仅向AIU（特定用户）提供受控及非受控的口服液体药物。

Upon receiving regulatory authorization, the Company intends to initially seek opportunities to leverage COPA in the delivery and remote management of oral liquid medication methadone, for Medication Use for Opioid Use Disorder treatment and subsequently for the delivery of controlled medications for the treatment of pain, as those patients have the greatest need for the benefits of COPA's features..

公司在获得监管授权后，计划首先寻求利用COPA在口服液态药物美沙酮的递送和远程管理方面的机会，用于阿片类药物使用障碍治疗的药物使用，随后将其用于治疗疼痛的受控药物递送，因为这些患者最需要COPA功能带来的好处。

In addition, the Company will look to expand COPA use in broader drug therapeutic categories, clinical applications, and businesses that manage the commercialization and data analytics provided by electronic devices to improve outcomes and reduce risk.

此外，公司将寻求在更广泛的药物治疗类别、临床应用和管理电子设备提供的商业化和数据分析业务中扩展COPA的使用，以改善结果并降低风险。

. The COPA™ System has not received marketing authorization from the U.S. Food and Drug Administration and is not available for commercial sale.

COPA™ 系统尚未获得美国食品和药物管理局的上市许可，也未进行商业销售。