Polyrizon Appoints Dr. Michal Meir as Senior Director of Regulatory and Clinical Affairs
Polyrizon (Nasdaq: PLRZ) has appointed Dr. Michal Meir as Senior Director of Regulatory and Clinical Affairs. This strategic appointment comes as the company prepares for its PL-14 clinical trial, scheduled to begin in 2025. Dr. Meir, currently a Senior Consultant at MedTech SME , brings over a decade of experience in medical device and pharmaceutical industries. Her expertise spans regulatory strategy, clinical affairs management, and product development, with previous leadership roles at Medtech SME , Keystone Heart, and Alma Lasers. The appointment aligns with Polyrizon's focus on developing innovative intranasal hydrogels and strengthening its regulatory compliance and clinical excellence capabilities.
Polyrizon (Nasdaq: PLRZ) ha nominato la Dr.ssa Michal Meir come Direttore Senior degli Affari Regolatori e Clinici. Questa nomina strategica avviene mentre l'azienda si prepara per il suo trial clinico PL-14, previsto per il 2025. La Dr.ssa Meir, attualmente Consulente Senior presso MedTech SME, porta con sé oltre un decennio di esperienza nei settori dei dispositivi medici e farmaceutici. La sua expertise comprende strategia regolatoria, gestione degli affari clinici e sviluppo del prodotto, con precedenti ruoli dirigenziali in Medtech SME, Keystone Heart e Alma Lasers. La nomina è in linea con l'obiettivo di Polyrizon di sviluppare innovativi idrogel intranasali e rafforzare le sue capacità di conformità regolatoria ed eccellenza clinica.
Polyrizon (Nasdaq: PLRZ) ha nombrado a la Dra. Michal Meir como Directora Senior de Asuntos Regulatorios y Clínicos. Este nombramiento estratégico se produce mientras la empresa se prepara para su ensayo clínico PL-14, programado para comenzar en 2025. La Dra. Meir, actualmente Consultora Senior en MedTech SME, aporta más de una década de experiencia en las industrias de dispositivos médicos y farmacéuticos. Su experiencia abarca estrategia regulatoria, gestión de asuntos clínicos y desarrollo de productos, con anteriores roles de liderazgo en Medtech SME, Keystone Heart y Alma Lasers. El nombramiento se alinea con el enfoque de Polyrizon en el desarrollo de avanzados hidrogel intranasales y en el fortalecimiento de sus capacidades de cumplimiento regulatorio y excelencia clínica.
폴리라이즌 (Nasdaq: PLRZ)은 미칼 미어 박사를 규제 및 임상 업무의 선임 이사로 임명했습니다. 이 전략적 임명은 회사가 2025년에 시작될 예정인 PL-14 임상 시험을 준비하는 가운데 이루어졌습니다. 현재 MedTech SME의 선임 컨설턴트인 미어 박사는 의료 기기 및 제약 분야에서 10년 이상의 경험을 가지고 있습니다. 그녀의 전문 분야는 규제 전략, 임상 업무 관리 및 제품 개발을 포함하며, 이전에는 Medtech SME, Keystone Heart 및 Alma Lasers에서 리더십 역할을 수행했습니다. 이 임명은 폴리라이즌의 혁신적인 비강용 하이드로겔 개발과 규제 준수 및 임상 우수성 능력 강화에 대한 초점과 일치합니다.
Polyrizon (Nasdaq: PLRZ) a nommé Dr. Michal Meir au poste de Directrice Senior des Affaires Réglementaires et Cliniques. Cette nomination stratégique intervient alors que l'entreprise se prépare pour son essai clinique PL-14, prévu pour 2025. Dr. Meir, actuellement Consultante Senior chez MedTech SME, apporte plus de dix ans d'expérience dans les secteurs des dispositifs médicaux et pharmaceutiques. Son expertise couvre la stratégie réglementaire, la gestion des affaires cliniques et le développement de produits, avec des postes de direction précédents chez Medtech SME, Keystone Heart et Alma Lasers. La nomination est en accord avec l'objectif de Polyrizon de développer des hydrogels intranasaux innovants et de renforcer ses capacités de conformité réglementaire et d'excellence clinique.
Polyrizon (Nasdaq: PLRZ) hat Dr. Michal Meir zur Senior Directorin für Regulatory und Clinical Affairs ernannt. Diese strategische Ernennung erfolgt, während das Unternehmen sich auf seinen PL-14 klinischen Test vorbereitet, der für 2025 geplant ist. Dr. Meir, die derzeit als Senior Consultant bei MedTech SME tätig ist, bringt über ein Jahrzehnt Erfahrung in der Medizinprodukte- und Pharmaindustrie mit. Ihre Expertise umfasst regulatorische Strategien, das Management klinischer Angelegenheiten und Produktentwicklung, mit früheren Führungsrollen bei Medtech SME, Keystone Heart und Alma Lasers. Die Ernennung steht im Einklang mit Polyrizons Fokus auf die Entwicklung innovativer intranasaler Hydrogele und die Stärkung seiner Fähigkeiten in Bezug auf regulatorische Compliance und klinische Exzellenz.
- Strategic appointment of experienced regulatory expert ahead of 2025 clinical trials
- Dr. Meir brings over 10 years of industry experience in regulatory strategy and clinical affairs
- Strengthens company's regulatory and clinical development capabilities
- None.
Raanana, Israel, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announce today the appointment of Dr. Michal Meir, Senior Consultant at MedTech SME Ltd., as Senior Director of Regulatory and Clinical Affairs. The appointment was made as part of the Company’s preparations towards its clinical trial for PL-14 that is expected to commence in 2025. Dr. Meir brings over a decade of experience in the medical device and pharmaceutical industries, with a proven track record in regulatory strategy, clinical affairs management and product development.
Dr. Meir has extensive experience in planning and executing clinical studies that comply with stringent regulatory requirements. Her career spans leadership roles at Medtech SME Ltd., Keystone Heart and Alma Lasers, where she successfully navigated complex regulatory landscapes and spearheaded clinical initiatives that drove innovation and market access.
"We believe that Michal’s wealth of experience in regulatory and clinical affairs will be invaluable as Polyrizon advances its mission to deliver cutting-edge solutions," said Tomer Izraeli, CEO of Polyrizon. "Her strategic insights and leadership will strengthen our capabilities and play an important role in our efforts to achieve the successful development and approval of our products."
Dr. Meir’s notable achievements include managing global regulatory submissions, developing clinical strategies for new medical devices and authoring critical regulatory and clinical documents. Her appointment reflects Polyrizon’s commitment to maintaining the highest standards of regulatory compliance and clinical excellence.
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses it belief that Dr. Michal Meir’s wealth of experience in regulatory and clinical affairs will be invaluable as Polyrizon advances its mission to deliver cutting-edge solutions, how Dr. Michal Meir’s strategic insights and leadership will strengthen the Company’s capabilities and play an important role in its efforts to achieve the successful development and approval of its products and its commitment to maintaining the highest standards of regulatory compliance and clinical excellence. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s prospectus (Registration No. 333-266745), dated October 24, 2024 and filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
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