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Innovation Pharmaceuticals Visits BeaMed; New StingRay Laser System for Epilepsy and Brain Tumors Moving Toward FDA Submission

Innovation Pharmaceuticals Visits BeaMed; New StingRay Laser System for Epilepsy and Brain Tumors Moving Toward FDA Submission

創新藥品訪問 Beamed; 用於癲癇和腦腫瘤的新型魟魚激光系統朝著 FDA 提交
GlobeNewswire ·  2023/02/23 08:06

WAKEFIELD, MA, Feb. 23, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company and minority stakeholder in BT BeaMed Technologies ("BeaMed"), is pleased to inform shareholders that development of the BeaMed StingRay Laser System (the "StingRay System") is progressing smoothly and ahead of estimated schedule. The Company's Chief Executive Officer and other financial stakeholders in BeaMed recently returned from a visit to Israel to see the StingRay System first-hand.

馬薩諸塞州韋克菲爾德,2023年2月23日(環球網)--Via NewMediaWire-Innovation PharmPharmticals(OTCQB:IPIX)(以下簡稱“本公司”)是一家臨牀階段的生物製藥公司,也是BT光束技術公司(“BEAMED”)的少數股東,該公司高興地告知股東,BEAMED黃貂魚激光系統(“黃貂魚系統”)的開發進展順利,超出了預期計劃。該公司首席執行官和Beamed的其他財務利益相關者最近從以色列訪問歸來,親眼目睹了黃貂魚系統。

The StingRay System is a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy, and for improvement of outcomes and minimally invasive surgical options for brain tumors. The first-in-class system is a comprehensive design, with planned robust safety features to constantly monitor thermal energy to minimize risk to healthy tissue. These unique features differentiate the StingRay System from other laser-based surgical technologies. 

黃貂魚系統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,並改善預後和腦腫瘤的微創手術選擇。這一一流的系統是一個全面的設計,具有計劃中的強大安全功能,以持續監測熱能,將對健康組織的風險降至最低。這些獨特的功能使黃貂魚系統有別於其他基於激光的外科技術。

Epilepsy is the most prevalent serious neurologic condition in the world, affecting about 70 million people. Unfortunately, 30%-40% of those patients are afflicted with drug resistant epilepsy, meaning they receive no relief from medication. BeaMed aims to offer new hope for this core group of patients, in addition to providing better surgical options for brain tumors.

癲癇是世界上最常見的嚴重神經系統疾病,約有7000萬人受到影響。不幸的是,這些患者中有30%-40%患有抗藥性癲癇,這意味着他們得不到藥物治療的緩解。Beamed的目標是為這一核心羣體的患者提供新的希望,此外還為腦瘤提供更好的手術選擇。

During the visit, BeaMed founders Moshe Eshkol and Gil Shapira provided updates on recent BeaMed progress, including a demonstration of data integration software, as well as a review of different fiberoptics undergoing rigorous testing in advance of final selection and planned submission to the U.S. FDA for marketing clearance. A tour of an onsite FDA-approved facility where the StingRay System is being manufactured was also conducted.

在訪問期間,Beamed創始人Mohe Eshkol和Gil Shapira介紹了Beamed的最新進展,包括數據集成軟件的演示,以及在最終選擇和計劃提交美國FDA上市批准之前對不同光纖進行嚴格測試的審查。還參觀了FDA批准的生產黃貂魚系統的現場設施。

"BeaMed is on the leading edge of developing a laser technology platform that we believe could redefine standard of care for hard-to-treat, and even previously impossible-to-treat, cases of epilepsy and brain cancer," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "I can say with confidence that everyone in attendance at the BeaMed facilities were thoroughly impressed with the StingRay System and excited about its potential. BeaMed has in place a U.S. distribution partnership with ForTec Medical, a mobilizer of surgical laser technology with access to over 2,200 hospitals in the U.S. This means BeaMed is in the enviable position for an immediate market launch upon FDA clearance, which we are optimistic is attainable in 2024."

創新制藥公司首席執行官利奧·埃爾利希表示:“Beamed處於開發激光技術平臺的領先地位,我們相信,該平臺可以重新定義難以治療,甚至以前無法治療的癲癇和腦癌病例的護理標準。”我可以很有信心地説,參加Beamed工廠的每個人都對Stingray系統印象深刻,並對其潛力感到興奮。Beamed已經與Fortec Medical建立了美國分銷夥伴關係,Fortec Medical是一家外科激光技術的動員公司,可以進入美國的2200多家醫院。這意味着Beamed處於令人羨慕的地位,可以在FDA批准後立即推出市場,我們樂觀地認為,這將在2024年實現。

Having already obtained FDA clearance for the laser component of the StingRay System, BeaMed expects soon to make additional requisite submissions to the FDA for clearance of its fiber optics and its software integration package with Siemens and GE imaging systems.

Beamed已經獲得了FDA對黃貂魚系統激光組件的批准,預計很快將向FDA提交更多必要的申請,以獲得其光纖及其與西門子和GE成像系統的軟件集成包的許可。

In other news, the Company wishes to inform shareholders that it was notified by the United States Patent and Trademark Office (USPTO) that US Patent Application 16/991812 – Host Defense Protein (HDP) Mimetics for Prophylaxis And/Or Treatment of Inflammatory Bowel Diseases of the Gastrointestinal Tract – was allowed for issuance as a patent. The claims allowed include Brilacidin treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) and Ulcerative Colitis.

在其他新聞方面,該公司希望告知股東,它已接到美國專利商標局的通知,美國專利申請16/991812--用於預防和/或治療胃腸道炎症性腸病的宿主防禦蛋白模擬物--獲準作為專利頒發。允許的聲明包括Brilacidin治療潰瘍性直腸炎/潰瘍性前乙狀結腸炎(UPS/UPS)和潰瘍性結腸炎。

Additionally, the Company and University of São Paulo (USP), Brazil, have entered into a collaborative research agreement to investigate the broad-spectrum activity and treatment potential of Brilacidin in fungal diseases. Under terms of the agreement, USP researchers are to conduct pre-clinical efficacy, mechanism, resistance and immunological studies of Brilacidin against Aspergillosis, Cryptococcus and Candida. Separate in vitro testing of Brilacidin's antifungal properties is underway by NIH/NIAID-affiliated researchers, with potential to bridge into in vivo models, formulation development support and clinical testing.

此外,該公司還與巴西聖保羅大學(USP)簽訂了一項合作研究協議,以調查Brilacidin在真菌疾病中的廣譜活性和治療潛力。根據協議條款,USP的研究人員將進行Brilacidin的臨牀前療效、機制、耐藥性和免疫學研究。麴黴病, 隱球菌念珠菌。各別體外培養NIH/NIAID的附屬研究人員正在測試Brilacidin的抗真菌特性,有可能過渡到體內模型、配方開發支持和臨牀測試。

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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 
Innovation Pharmaceuticals Inc. 
Leo Ehrlich 
info@ipharminc.com

投資者和媒體聯繫
創新制藥公司。
利奧·埃爾利希
郵箱:Info@ipharminc.com


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