First Commercial Product Submission from Company's Robust Regenerative Medicine-Based Pipeline

公司基于再生医学的强大管道首次提交商业产品

CINCINNATI, OH / ACCESSWIRE / March 6, 2024 / Innoveren Scientific Inc. (OTCQB:IVRN) ('Innoveren' or the 'Company'), a life science company focused on becoming a leading biotech incubator, announced today that it has submitted a 510(k) premarket filing to the U.S. Federal Food and Drug Administration (FDA) for its SkinDiscTM Lite product..

俄亥俄州辛辛那提/ACCESSWIRE/2024年3月6日/致力于成为领先生物技术孵化器的生命科学公司Innoveren Scientific Inc.（OTCQB:IVRN）（“Innoveren”或“公司”）今天宣布，它已经向美国联邦食品和药物管理局（FDA）提交了其SkinDiscTM Lite产品的510（k）上市前申请。。

SkinDiscTM Lite provides an active and protein-rich cellular matrix that is essential for structural support and cellular attachment during the wound-healing process that can be administered in an outpatient setting. The product maintains complete wound contact and depth fill during the healing process, resulting in rapid growth of the host tissue.

SkinDiscTM Lite提供了一种活性和富含蛋白质的细胞基质，对于伤口愈合过程中的结构支持和细胞附着至关重要，可以在门诊环境中使用。该产品在愈合过程中保持完全的伤口接触和深度填充，导致宿主组织的快速生长。

SkinDiscTM Lite utilizes autologous platelet-rich plasma (PRP) and platelet poor plasma concentrate, from the patient's own body, helping to mitigate any potential rejection of the product..

SkinDiscTM Lite利用患者体内的自体富血小板血浆（PRP）和贫血小板血浆浓缩物，有助于减轻产品的任何潜在排斥反应。。

'The FDA submission for SkinDiscTM Lite represents a significant milestone for Innoveren Scientific in our journey to advance our new medical technologies in areas of unmet need across multiple indications,' said Michael Yurkowsky, Innoveren Scientific's Chief Executive Officer. 'With the use of PRP, which already has predicates in wound care cleared by the FDA, we are hopeful we will also receive clearance for SkinDiscTM Lite, allowing us to continue to advance our pipeline and submit a 510(k) submission for SkinDiscTM Ultra in the coming quarters.'.

Innoveren Scientific首席执行官迈克尔·尤尔科夫斯基（MichaelYurkowsky）说：“FDA提交的SkinDiscTM Lite是Innoveren Scientific在多种适应症未满足需求领域推进新医疗技术之旅中的一个重要里程碑。”随着PRP的使用，已经有FDA批准的伤口护理预测，我们希望我们也能获得SkinDiscTM Lite的许可，使我们能够继续推进我们的管道，并在未来几个季度为SkinDiscTM Ultra提交510（k）的提交。”。

Innoveren Scientific is prepared to submit a second 510(k) De Novo submission for SkinDiscTM Ultra should clearance be received for SkinDiscTM Lite. SkinDiscTM Ultra is an operating room-only product for limb salvage that utilizes bone marrow aspirate (BMA).

如果SkinDiscTM Lite获得许可，Innoveren Scientific准备为SkinDiscTM Ultra提交第二份510（k）从头提交。SkinDiscTM Ultra是一种仅用于手术室的产品，用于利用骨髓抽吸物（BMA）进行肢体挽救。

The Company is also making progress on advancing its BreatheEasy product, a medical device that helps patients struggling with chronic obstructive pulmonary disease (COPD), as well as other closely related diseases such as chronic bronchitis and emphysema. The Company is on track for a 510(k) De Novo submission later this year once additional clinical work has been completed..

该公司还在推进其呼吸系统产品方面取得进展，呼吸系统产品是一种医疗设备，可帮助患有慢性阻塞性肺病（COPD）以及其他密切相关疾病（如慢性支气管炎和肺气肿）的患者。一旦额外的临床工作完成，该公司有望在今年晚些时候重新提交510（k）。。

About Innoveren Scientific Inc.

关于Innoveren Scientific Inc。

Innoveren Scientific Inc., formerly known as H-CYTE, Inc. is a life science and biotech incubator company, focused on advancing new technologies in areas of unmet need across multiple indications, with the ultimate goal of improving patient lives. The company invests in and fosters innovative technologies that are supported by a strong scientific foundation, which have relatively short timelines and low costs to achieve meaningful value inflection points.

Innoveren Scientific Inc.，原名H-CYTE，Inc.，是一家生命科学和生物技术孵化器公司，专注于在多种适应症的未满足需求领域推进新技术，最终目标是改善患者生活。该公司投资并培育有强大科学基础支持的创新技术，这些技术的时间表相对较短，成本较低，可以实现有意义的价值拐点。

For more information about Innoveren, please visit www.InnoverenScientific.com..

有关Innoveren的更多信息，请访问www.InnoverenScientific.com。。

Safe Harbor Statement

安全港声明

Certain statements in this press release constitute 'forward-looking statements' within the meaning of the federal securities laws. Words such as 'may,' 'might,' 'will,' 'should,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'continue,' 'predict,' 'forecast,' 'project,' 'plan,' 'intend' or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements.

本新闻稿中的某些声明构成《联邦证券法》所指的“前瞻性声明”。诸如“可能”、“可能”、“将会”、“应该”、“相信”、“期望”、“预期”、“估计”、“继续”、“预测”、“预测”、“项目”、“计划”、“打算”或类似表达，或关于意图、信念或当前期望的陈述，都是前瞻性陈述。

While Innoveren believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those outlined in Innoveren's filings with the SEC, including but not limited to Risk Factors relating to its business contained therein.

虽然Innoveren认为这些前瞻性声明是合理的，但不应过度依赖任何此类前瞻性声明，这些声明是基于我们在本发布之日可获得的信息。这些前瞻性陈述基于当前的估计和假设，并受到各种风险和不确定性的影响，包括但不限于Innoveren向SEC提交的文件中概述的风险和不确定性，包括但不限于其中包含的与其业务相关的风险因素。

Thus, actual results could be materially different. Innoveren expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law..

因此，实际结果可能会有很大不同。Innoveren明确否认因新信息、未来事件或其他原因而更新或更改声明的任何义务，除非法律要求。。

Innoveren Investor Contact:

Innoveren投资者联系人：

Alpha IR Group

Alpha IR组

Jackie Marcus or Josh Carroll

Jackie Marcus或Josh Carroll

IVRN@alpha-ir.com

IVRN@alpha-ir.com

312-445-2870

312-445-2870

SOURCE: Innoveren Scientific Inc.

来源：Innoveren Scientific Inc。

View the original press release on accesswire.com

在accesswire.com上查看原始新闻稿