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Independent Laboratory Test Results Confirm Value of DermaPrecise (TM) Injection Consistency in Clinical Simulation Testing

Independent Laboratory Test Results Confirm Value of DermaPrecise (TM) Injection Consistency in Clinical Simulation Testing

独立实验室测试结果证实了DermaPrecise(TM)注射剂在临床模拟测试中的价值
Accesswire ·  2022/07/26 18:05

Independent dermatology research experts at Monasterium Laboratory GmbH tested, analyzed and validated various injection parameters using donated human tissue

Monasterium实验室的独立皮肤病研究专家使用捐赠的人体组织测试、分析和验证各种注射参数

VANCOUVER, BC / ACCESSWIRE / July 26, 2022 / RepliCel Life Sciences Inc. (OTC PINK:REPCF)(TSXV:RP)(FRA:P6P2) ("RepliCel" or the "Company"), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has now received and analyzed all data and images from independent laboratory testing of the DermaPreciseTM injector prototype and consumables evaluating the injection systems' various depths and doses in donated human skin tissue.

温哥华,卑诗省/ACCESSWIRE/2022年7月26日/RepliCel生命科学公司(场外交易代码:REPCF)(多伦多证券交易所股票代码:RP)(法兰克福证券交易所股票代码:P6P2)(以下简称RepliCel或公司)今天宣布,它已经收到并分析了DermaPrecise独立实验室测试的所有数据和图像TM在捐赠的人体皮肤组织中评估注射系统的不同深度和剂量的注射器原型和消耗品。

Monasterium Laboratory, a German-based laboratory specializing in dermatology research, tested intradermal and subcutaneous injections of different volumes to provide evidence of whether or not DermaPrecise was capable of delivering controlled and consistent injections as observed, recorded, and measured in donated, human skin tissue.

Monasterium实验室是一家总部设在德国的专门从事皮肤病研究的实验室,该公司测试了不同剂量的皮内和皮下注射,以提供证据,证明DermaPrecise是否能够像在捐赠的人体皮肤组织中观察、记录和测量的那样,提供受控和一致的注射。

Human full thickness skin biopsies were injected with marker ink with viscosity matching commonly used drugs. Post-injection, the skin was cut into sections to be stained and evaluated. The injection parameters for depth and volume showed test results meet or surpass DermaPrecise objectives for consistency of volume and depth delivery. Sample pictures accompanying this press release show the kind of imagery captured in data accumulation pertaining to the injections.

在人体全层皮肤活检组织中注入与粘度匹配的常用药物的标记墨水。注射后,将皮肤切成切片进行染色和评估。深度和体积的注射参数表明,测试结果达到或超过了DermaPrecise关于体积和深度输送一致性的目标。本新闻稿附带的样本图片显示了在与注射有关的数据积累中捕获的图像类型。

"Analysis of the tests performed, confirms the unique injection consistency of the DermaPrecise™ injection system within a specified range in the tissue. With manual injections using a standard needle and syringe there is no guaranteed consistency in terms of injection depth or volume, but with the DermaPrecise™ there is uniform injection which allows for a large area of skin to be injected with the same amount of active substance in every single injection," stated Kevin McElwee, RepliCel's Chief Science Officer.

RepliCel首席科学官凯文·麦克尔韦说:“对测试结果的分析证实了™注射系统在组织内特定范围内的独特注射一致性。使用标准针头和注射器的手动注射不能保证注射深度或体积的一致性,但对于DemaPrecise™,注射是均匀的,允许在每一次注射中向大片皮肤注射相同数量的活性物质。”

"What we are starting to see with these tests on donated human skin is evidence that the system is performing in accordance with the design, engineered functionality and intended uses of the DermaPreciseTM system," stated R. Lee Buckler, President and CEO of RepliCel Life Sciences, which developed and owns all rights to the DermaPreciseTM product portfolio and its underlying technologies. "It is intended to deliver a high level of control and consistent precision for intra-dermal and subcutaneous injections," he continued.

通过对捐赠的人体皮肤进行的这些测试,我们开始看到的是该系统正在按照DermaPrecise的设计、工程功能和预期用途运行的证据TMRepliCel生命科学公司的首席执行官R·李·巴克勒说,该公司开发并拥有DermaPrecise的所有权利TM产品组合及其底层技术。“它的目的是为皮内和皮下注射提供高水平的控制和一致的精确度,”他继续说。

"As we continue to prepare for commercial launch of the DermaPreciseTM product line, it is critical we have these kinds of independent validation of the injection parameters and our ability to deliver best-in-class precision to our end users. Testing with donated human skin samples is a valuable tool in convincing clinicians to evaluate new technologies in real clinical treatment settings."

随着我们继续为DermaPrecise的商业推出做准备TM在我们的产品线中,至关重要的是我们拥有对注塑参数的这种独立验证,以及我们向终端用户提供同类最佳精度的能力。用捐赠的人体皮肤样本进行测试是说服临床医生在真实的临床治疗环境中评估新技术的宝贵工具。“

Dermatologist and clinical researcher Dr. Rolf Hoffmann, who has been a clinical advisor for the DermaPrecise™ development, stated: "As clinicians learn more about the mechanisms and effects of the various types of substances we inject into the dermis and subcutaneous tissue - including neurotoxins, fillers, antibody therapeutics, fat-dissolving enzymes, cell therapies, and other injectables - they are increasingly realizing that precision of depth, dose and/or delivery matters more to efficacy than was often originally believed."

皮肤科医生和临床研究员罗尔夫·霍夫曼博士一直是DermaPrecise™开发的临床顾问,他说:“随着临床医生对我们注入真皮和皮下组织的各种物质的机制和效果有了更多的了解--包括神经毒素、填充物、抗体疗法、脂溶酶、细胞疗法和其他注射剂--他们越来越意识到深度、剂量和/或传递的精确度对疗效的影响比人们最初认为的更重要。”

About Monasterium Laboratory GmbH

关于Monasterium实验室有限公司

Monasterium Laboratory GmbH, located in Münster Germany, is a fast-growing, dermatological research company specialized in preclinical skin, hair, pigmentation, neuroendocrinology, immunology, and wound healing research in the human system.

Monasterium实验室有限公司位于德国明斯特,是一家快速发展的皮肤科研究公司,专门从事临床前皮肤、头发、色素沉着、神经内分泌学、免疫学和人体系统伤口愈合研究。

* Note: All experiments on human tissue are performed according to Helsinki guidelines and samples are collected after patient consent and ethics approval under relevant jurisdiction laws.

*注:所有人体组织实验都是根据赫尔辛基指南进行的,样本是在患者同意和相关司法管辖区法律下的道德批准后收集的。

About the DermaPreciseTM Injector Product Line

关于DermaPreciseTM喷油器产品线

The DermaPreciseTM Injector platform is an electronic injection system which will bring new levels of control over intra-dermal or subcutaneous injections where precision of depth, dose and/or delivery consistency matters.

真皮精品TM注射器平台是一种电子注射系统,它将把对皮内或皮下注射的控制提升到新的水平,在这些地方,深度、剂量和/或输送一致性的精确度至关重要。

About RepliCel Life Sciences

关于RepliCel生命科学

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles

RepliCel是一家再生医学公司,专注于为美学和整形外科疾病开发细胞疗法,该公司认为,在工业化国家中,大约三分之一的人会受到影响,包括老化/阳光损伤的皮肤、花纹秃顶和慢性肌腱退化。这些情况通常与衰老有关,是由正常组织愈合和功能所需的健康细胞不足引起的。这些候选细胞治疗产品基于RepliCel的创新技术,利用从患者健康毛囊中分离出来的细胞群

The Company's cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated, but is the subject of an arbitration regarding Shiseido's rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

该公司的细胞疗法产品线包括用于肌腱修复的RCT-01、用于皮肤再生的RCS-01和用于头发修复的RCH-01。RCH-01一直是成功的安全性和剂量发现临床研究的对象,现在是其第三项临床研究的对象,评估治疗雄激素性脱发引起的男性和女性脱发的疗效。这项正在进行的研究由资生堂有限公司根据一项许可协议提供资金,该协议现已终止,但该协议是关于资生堂在亚洲对该产品的权利的仲裁的对象。RepliCel为世界其他地区保留了RCH-01无可争议的权利。RCT-01和RCS-01在大中华区独家授权给YOFOTO(中国)健康公司。RepliCel和YOFOTO目前正在中国共同开发这些产品。RepliCel保留了这些产品在大中华区以外的权利。

RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit replicel.com for additional information.

RepliCel还开发了一种专有的注射设备(DermaPreciseTM)和相关消耗品,预计将改善其细胞治疗产品和某些其他注射剂的管理。YOFOTO已独家授权DermaPrecise™设备和耗材在大中华区用于皮肤科应用的商业权利,并预计在获准在美国或欧洲上市后,首先在香港推出该产品。有关更多信息,请访问Replicel.com。

Notable Facts:

值得注意的事实:

  • RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
  • RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
  • RepliCel的三种细胞治疗产品现在已经在三大洲四个国家的100多名患者中进行了测试。
  • RepliCel现在拥有关键的战略地区合作伙伴,每个合作伙伴现在都在为其市场进一步投资RepliCel产品的进一步临床测试和开发。来自每个临床项目的数据将加强RepliCel及其全球其他合作伙伴的产品开发计划。

For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com

如需更多信息,请联系:
李巴克勒,首席执行官兼总裁
604-248-8693
邮箱:Info@Replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多伦多证券交易所风险交易所及其监管服务提供商(该术语在多伦多证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

SOURCE: RepliCel Life Sciences, Inc.

资料来源:RepliCel生命科学公司


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