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Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

创新制药公司宣布BT BeaMedical技术公司获得FDA批准推出新的外科激光系列
GlobeNewswire ·  2022/11/28 09:05

Regulatory clearance lays key technological and regulatory foundation for BT BeaMedical's vision of revolutionizing treatment options in neurosurgery, oncology, and a wide spectrum of other clinical specialties.

监管许可铺设关键点为BT BeaMedical的愿景奠定了技术和监管基础,该愿景将彻底改变神经外科、肿瘤学和其他一系列临床专科的治疗方案。

WAKEFIELD, MA, Nov. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BT BeaMedical Technologies ("BeaMed"), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the "Company") that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022.

马萨诸塞州韦克菲尔德,2022年11月28日(Global Newswire)--通过NewMediaWire-BT BeaMedical Technologies(“Beamed”),一家为癫痫和癌症手术开发下一代激光平台的私营公司通知创新制药公司(场外交易代码:IPIX)(“该公司”),其MANTA外科激光系列产品已获得美国食品和药物管理局(FDA)的批准(K222701)。这一许可是Beamed在发展先进的激光技术方面的一个重要里程碑,该技术旨在塑造能量并使其与患者特定的解剖相匹配,这是一个正在证明是现实的新概念。2022年6月,创新制药进行了一项战略投资,收购了Beamed的少数股权。

BeaMed is the inventor and developer of the StingRay Laser System (the "StingRay System"), a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage.

比米德是黄貂鱼激光系统(“黄貂鱼系统”)的发明者和开发者,这是一种基于激光的新型热消融技术,旨在治疗以前无法手术的癫痫病例,改善结果,并为肿瘤手术提供新的治疗方案,包括治疗脑癌、前列腺癌、肝癌、乳腺癌和肺癌。黄貂鱼激光系统将利用MANTA激光系列作为其核心能量产生设备,并结合新的光纤技术,使肿瘤和癫痫焦点的精确结构与能量传递完美匹配,同时保护重要功能区域免受热损伤。

The MANTA surgical laser family was cleared by the FDA including five different wavelengths (810nm, 980nm, 1064nm, 1470nm and 1940nm) and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery.

MANTA外科激光家族被FDA批准,包括五种不同的波长(810 nm、980 nm、1064 nm、1470 nm和1940 nm)和软组织应用于非常广泛的临床专科,包括神经外科、脊柱外科、泌尿外科、胸部外科、肺部外科、妇科、普通外科、耳鼻喉科/头颈、整形外科、整形外科、关节镜、眼科、放射科和口腔外科。

BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications.

Beamed预计很快就会向FDA提交必要的申请,以批准其用于多种医疗适应症的光纤。

"We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.

创新制药公司首席执行官Leo Ehrlich评论说:“我们对Beamed在推出其新平台产品方面取得的进展感到兴奋,该产品有可能帮助全球数百万患有癫痫和癌症的多个专科患者。这份申请的执行和批准的速度充分说明了Beamed的商业化战略和监管团队的非凡能力。”

"This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more," said Gil Shapira, co-founder of BeaMed.

这对我们公司来说是一个激动人心的重要里程碑。这一许可给我们带来了两项关键成就。首先,美国市场获得了广泛的潜在激光能源,每一种都允许我们进行不同和独特的组织相互作用,这一成就将具有广泛的临床意义。第二个是非常广泛的预期用途,涵盖我们技术的许多关键潜在市场。这突显了Beamed明确的监管战略,这与我们具有广泛影响力的业务愿景齐头并进,我们希望彻底改革关键治疗方法,包括脑瘤、癫痫、肺癌、前列腺癌、乳腺癌等。

BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation ( a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology (MIT).

Beamed是由摩西·埃什科尔和吉尔·夏皮拉创立的,他们都是外科激光和医疗设备方面经验丰富的专家。Beamed和黄貂鱼系统的开发也得到了鸟儿基金会(一个支持以美合作的双边组织)的特别拨款的支持。吉尔·夏皮拉拥有26年以上的工程、产品开发和管理经验,在外科激光行业拥有超过17年的经验。GIL拥有并管理着他于2012年创立的新激光公司,并带动了收入增长和盈利,其年复合年增长率达到43%,在全球安装了1200多台设备,每年在30多个国家进行50,000多例手术。此前,吉尔领导了Omniguide的产品开发和营销,Omniguide是从麻省理工学院(MIT)剥离出来的一款成功的高增长激光医疗设备。

BeaMed company website:

Beamed公司网站:

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About Innovation Pharmaceuticals

关于创新制药公司

Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

创新制药公司(IPIX)是一家临床阶段的生物制药公司,开发一系列创新疗法,以解决多种未得到满足的医疗需求领域,包括炎症性疾病、癌症和传染病。该公司还积极评估其他潜在的投资机会,以增加价值并使其投资组合多样化。

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including without limitation that compounds and devices may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

前瞻性陈述:本新闻稿包含根据1995年《私人证券诉讼改革法》的安全港条款作出的前瞻性陈述,包括但不限于有关未来产品开发计划的陈述,包括有关特定适应症的陈述;有关黄貂鱼系统治疗潜力和能力的陈述;未来监管发展;以及除历史事实陈述之外的任何其他陈述。这些陈述涉及风险、不确定性和假设,可能导致实际结果和经验与这些前瞻性陈述中表达的预期结果和预期大不相同。在某些情况下,公司通过使用诸如“预期”、“相信”、“希望”、“估计”、“展望”、“预期”、“计划”、“打算”、“目标”、“潜在”、“可能”、“建议”以及类似的表达方式来识别前瞻性陈述。可能导致实际结果与前瞻性陈述中表述的结果大不相同的其他因素包括,与在美国和其他司法管辖区进行临床前研究和临床试验以及寻求监管和许可批准有关的风险,包括但不限于化合物和设备可能无法成功完成临床前或临床测试,或未获得在美国或其他地方销售和销售的监管批准;以前的测试结果可能不会在未来的研究和试验中复制;公司未来需要和获得大量资本来资助其运营和研发, 包括根据证券购买协议出售普通股的金额和时间;公司的被许可人可能无法成功完成临床前或临床测试,公司将不会收到里程碑式的付款。关于这些和其他风险因素的更完整的描述包括在该公司提交给证券交易委员会的文件中。其中许多风险、不确定性和假设超出了公司的控制或预测能力。您不应过度依赖任何前瞻性陈述。前瞻性陈述仅代表公司在发布之日目前掌握的信息,公司没有义务公开发布对任何此类前瞻性陈述的任何修订结果,除非适用法律或法规要求,否则这些修订可能反映本新闻稿发布之日之后的事件或情况,或反映意外事件的发生。

INVESTOR AND MEDIA CONTACTS

投资者和媒体联系

Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com

创新制药公司。
利奥·埃尔利希
邮箱:Info@ipharminc.com


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