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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

創新製藥宣佈 BT Beamical 技術獲得 FDA 許可的新手術激光家族
GlobeNewswire ·  2022/11/28 22:05

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.

監管許可鋪設關鍵點為BT BeaMedical的願景奠定了技術和監管基礎,該願景將徹底改變神經外科、腫瘤學和其他一系列臨牀專科的治療方案。

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.

馬薩諸塞州韋克菲爾德,2022年11月28日(Global Newswire)--通過NewMediaWire-BT BeaMedical Technologies(“Beamed”),一家為癲癇和癌症手術開發下一代激光平臺的私營公司通知創新制藥公司(場外交易代碼:IPIX)(“該公司”),其MANTA外科激光系列產品已獲得美國食品和藥物管理局(FDA)的批准(K222701)。這一許可是Beamed在發展先進的激光技術方面的一個重要里程碑,該技術旨在塑造能量並使其與患者特定的解剖相匹配,這是一個正在證明是現實的新概念。2022年6月,創新制藥進行了一項戰略投資,收購了Beamed的少數股權。

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.

比米德是黃貂魚激光系統(“黃貂魚系統”)的發明者和開發者,這是一種基於激光的新型熱消融技術,旨在治療以前無法手術的癲癇病例,改善結果,併為腫瘤手術提供新的治療方案,包括治療腦癌、前列腺癌、肝癌、乳腺癌和肺癌。黃貂魚激光系統將利用MANTA激光系列作為其核心能量產生設備,並結合新的光纖技術,使腫瘤和癲癇焦點的精確結構與能量傳遞完美匹配,同時保護重要功能區域免受熱損傷。

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,包括五種不同的波長(810 nm、980 nm、1064 nm、1470 nm和1940 nm)和軟組織應用於非常廣泛的臨牀專科,包括神經外科、脊柱外科、泌尿外科、胸部外科、肺部外科、婦科、普通外科、耳鼻喉科/頭頸、整形外科、整形外科、關節鏡、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預計很快就會向FDA提交必要的申請,以批准其用於多種醫療適應症的光纖。

"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.

創新制藥公司首席執行官Leo Ehrlich評論説:“我們對Beamed在推出其新平臺產品方面取得的進展感到興奮,該產品有可能幫助全球數百萬患有癲癇和癌症的多個專科患者。這份申請的執行和批准的速度充分説明瞭Beamed的商業化戰略和監管團隊的非凡能力。”

"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.

這對我們公司來説是一個激動人心的重要里程碑。這一許可給我們帶來了兩項關鍵成就。首先,美國市場獲得了廣泛的潛在激光能源,每一種都允許我們進行不同和獨特的組織相互作用,這一成就將具有廣泛的臨牀意義。第二個是非常廣泛的預期用途,涵蓋我們技術的許多關鍵潛在市場。這突顯了Beamed明確的監管戰略,這與我們具有廣泛影響力的業務願景齊頭並進,我們希望徹底改革關鍵治療方法,包括腦瘤、癲癇、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·埃什科爾和吉爾·夏皮拉創立的,他們都是外科激光和醫療設備方面經驗豐富的專家。Beamed和黃貂魚系統的開發也得到了鳥兒基金會(一個支持以美合作的雙邊組織)的特別撥款的支持。吉爾·夏皮拉擁有26年以上的工程、產品開發和管理經驗,在外科激光行業擁有超過17年的經驗。GIL擁有並管理着他於2012年創立的新激光公司,並帶動了收入增長和盈利,其年複合年增長率達到43%,在全球安裝了1200多臺設備,每年在30多個國家進行50,000多例手術。此前,吉爾領導了Omniguide的產品開發和營銷,Omniguide是從麻省理工學院(MIT)剝離出來的一款成功的高增長激光醫療設備。

BeaMed company website:

Beamed公司網站:

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About Innovation Pharmaceuticals

關於創新制藥公司

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.

創新制藥公司(IPIX)是一家臨牀階段的生物製藥公司,開發一系列創新療法,以解決多種未得到滿足的醫療需求領域,包括炎症性疾病、癌症和傳染病。該公司還積極評估其他潛在的投資機會,以增加價值並使其投資組合多樣化。

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.

前瞻性陳述:本新聞稿包含根據1995年《私人證券訴訟改革法》的安全港條款作出的前瞻性陳述,包括但不限於有關未來產品開發計劃的陳述,包括有關特定適應症的陳述;有關黃貂魚系統治療潛力和能力的陳述;未來監管發展;以及除歷史事實陳述之外的任何其他陳述。這些陳述涉及風險、不確定性和假設,可能導致實際結果和經驗與這些前瞻性陳述中表達的預期結果和預期大不相同。在某些情況下,公司通過使用諸如“預期”、“相信”、“希望”、“估計”、“展望”、“預期”、“計劃”、“打算”、“目標”、“潛在”、“可能”、“建議”以及類似的表達方式來識別前瞻性陳述。可能導致實際結果與前瞻性陳述中表述的結果大不相同的其他因素包括,與在美國和其他司法管轄區進行臨牀前研究和臨牀試驗以及尋求監管和許可批准有關的風險,包括但不限於化合物和設備可能無法成功完成臨牀前或臨牀測試,或未獲得在美國或其他地方銷售和銷售的監管批准;以前的測試結果可能不會在未來的研究和試驗中複製;公司未來需要和獲得大量資本來資助其運營和研發, 包括根據證券購買協議出售普通股的金額和時間;公司的被許可人可能無法成功完成臨牀前或臨牀測試,公司將不會收到里程碑式的付款。關於這些和其他風險因素的更完整的描述包括在該公司提交給證券交易委員會的文件中。其中許多風險、不確定性和假設超出了公司的控制或預測能力。您不應過度依賴任何前瞻性陳述。前瞻性陳述僅代表公司在發佈之日目前掌握的信息,公司沒有義務公開發布對任何此類前瞻性陳述的任何修訂結果,除非適用法律或法規要求,否則這些修訂可能反映本新聞稿發佈之日之後的事件或情況,或反映意外事件的發生。

INVESTOR AND MEDIA CONTACTS

投資者和媒體聯繫

Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com

創新制藥公司。
利奧·埃爾利希
郵箱:Info@ipharminc.com


譯文內容由第三人軟體翻譯。


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