Glucotrack Strenghtens Leadership Team with Addition of Industry Veteran as Vice President of Regulatory Affairs
Glucotrack (Nasdaq: GCTK) has appointed Ted Williams as Vice President of Regulatory Affairs, effective immediately. Williams brings nearly 25 years of experience in regulatory affairs and quality assurance for Class III medical devices, including expertise in continuous glucose monitors (CGM) and drug/device combination products.
Williams previously served as Vice President of Regulatory Affairs/Quality Assurance at Glysens Inc, focusing on implantable CGM development. His experience spans roles at Therapeutics Inc. and Cardium Therapeutics, working with various medical technologies.
The appointment aims to advance Glucotrack's human clinical trials and regulatory program for their Continuous Blood Glucose Monitor (CBGM). According to CEO Paul V. Goode, Williams' expertise will be important in navigating FDA pathways as they develop their CBGM technology for diabetes patients.
Glucotrack (Nasdaq: GCTK) ha nominato Ted Williams come Vice Presidente delle Affari Regolatori, con effetto immediato. Williams porta con sé quasi 25 anni di esperienza negli affari regolatori e nella garanzia di qualità per dispositivi medici di Classe III, compresa la sua competenza nei monitor glicemici continui (CGM) e nei prodotti combinati farmaco/dispositivo.
In precedenza, Williams ha ricoperto il ruolo di Vice Presidente degli Affari Regolatori/Garanzia di Qualità presso Glysens Inc, concentrandosi sullo sviluppo di CGM impiantabili. La sua esperienza include ruoli in Therapeutics Inc. e Cardium Therapeutics, lavorando con varie tecnologie mediche.
La nomina mira a far avanzare le sperimentazioni cliniche umane e il programma regolatorio di Glucotrack per il loro Monitor Glicemico Sanguigno Continuo (CBGM). Secondo il CEO Paul V. Goode, l'esperienza di Williams sarà importante per orientarsi nei percorsi FDA mentre sviluppano la loro tecnologia CBGM per i pazienti diabetici.
Glucotrack (Nasdaq: GCTK) ha nombrado a Ted Williams como Vicepresidente de Asuntos Regulatorios, con efecto inmediato. Williams aporta casi 25 años de experiencia en asuntos regulatorios y garantía de calidad para dispositivos médicos de Clase III, incluyendo su experiencia en monitores continuos de glucosa (CGM) y productos combinados de medicamento/dispositivo.
Anteriormente, Williams fue Vicepresidente de Asuntos Regulatorios/Garantía de Calidad en Glysens Inc, concentrándose en el desarrollo de CGM implantables. Su experiencia abarca roles en Therapeutics Inc. y Cardium Therapeutics, trabajando con varias tecnologías médicas.
La designación tiene como objetivo avanzar en los ensayos clínicos en humanos y el programa regulatorio de Glucotrack para su Monitor Continuo de Glucosa en Sangre (CBGM). Según el CEO Paul V. Goode, la experiencia de Williams será importante para navegar por las vías de la FDA mientras desarrollan la tecnología de CBGM para pacientes diabéticos.
글루코트랙 (Nasdaq: GCTK) 은 테드 윌리엄스를 규제 업무 부사장으로 즉시 임명했습니다. 윌리엄스는 클래스 III 의료 기기와 관련된 규제 업무 및 품질 보증 분야에서 거의 25년의 경험을 가지고 있으며, 지속적인 혈당 모니터(CGM) 및 약물/장치 복합 제품에 대한 전문 지식을 보유하고 있습니다.
윌리엄스는 이전에 Glysens Inc에서 규제 업무/품질 보증 부사장으로 근무했으며, 이식형 CGM 개발에 집중했습니다. 그의 경험은 Therapeutics Inc.와 Cardium Therapeutics에서 다양한 의료 기술을 다루며 폭넓습니다.
이번 임명은 글루코트랙의 지속적인 혈당 모니터(CBGM)를 위한 인체 임상 시험과 규제 프로그램을 발전시키는 것을 목표로 하고 있습니다. CEO인 폴 V. 굿(Paul V. Goode)에 따르면, 윌리엄스의 전문 지식은 당뇨병 환자를 위한 CBGM 기술 개발 과정에서 FDA 경로를 탐색하는 데 중요할 것입니다.
Glucotrack (Nasdaq: GCTK) a nommé Ted Williams au poste de vice-président des affaires réglementaires, avec effet immédiat. Williams possède près de 25 ans d'expérience dans les affaires réglementaires et l'assurance qualité pour les dispositifs médicaux de classe III, y compris une expertise dans les moniteurs de glucose continus (CGM) et les produits combinés médicament/dispositif.
Williams a précédemment occupé le poste de vice-président des affaires réglementaires/assurance qualité chez Glysens Inc, se concentrant sur le développement de CGM implantables. Son expérience comprend des rôles chez Therapeutics Inc. et Cardium Therapeutics, où il a travaillé avec diverses technologies médicales.
La nomination vise à faire avancer les essais cliniques humains et le programme réglementaire de Glucotrack pour leur moniteur de glucose sanguin continu (CBGM). Selon le PDG Paul V. Goode, l'expertise de Williams sera importante pour naviguer dans les voies de la FDA lors du développement de sa technologie CBGM pour les patients diabétiques.
Glucotrack (Nasdaq: GCTK) hat Ted Williams mit sofortiger Wirkung zum Vizepräsidenten für regulatorische Angelegenheiten ernannt. Williams bringt fast 25 Jahre Erfahrung in den Bereichen regulatorische Angelegenheiten und Qualitätskontrolle für Medizinprodukte der Klasse III mit, einschließlich Fachwissen in kontinuierlichen Glukosemessgeräten (CGM) und Kombinationen von Arzneimitteln und Geräten.
Zuvor war Williams Vizepräsident für regulatorische Angelegenheiten/Qualitätskontrolle bei Glysens Inc. und konzentrierte sich auf die Entwicklung implantierbarer CGMs. Seine Erfahrung umfasst Positionen bei Therapeutics Inc. und Cardium Therapeutics, wo er mit verschiedenen Medizintechnologien arbeitete.
Die Ernennung zielt darauf ab, die klinischen Studien am Menschen und das regulatorische Programm von Glucotrack für ihren kontinuierlichen Blutzuckermonitor (CBGM) voranzutreiben. Laut CEO Paul V. Goode wird Williams' Expertise entscheidend sein, um die FDA-Pfade zu navigieren, während sie ihre CBGM-Technologie für Diabetiker entwickeln.
- Appointment of experienced regulatory affairs executive with 25 years in medical devices
- Specific expertise in continuous glucose monitoring technology
- Strategic strengthening of leadership team during clinical trials phase
- CBGM product still in development phase, not yet commercialized
- Regulatory approval timeline uncertain
New hire set to drive clinical development and U.S. commercialization of the continuous blood glucose monitor for people with diabetes
RUTHERFORD, N.J., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced today that Ted Williams has been named Vice President of Regulatory Affairs, effective immediately.
Mr. Williams has nearly 25 years of experience and a proven track record of successful management of Regulatory Affairs and Quality Assurance for highly complex Class III medical devices including active, long term implantable continuous glucose monitors (“CGM”), drug/device combination products, in-dwelling catheter based endovascular temperature control modules and cardiovascular biopharmaceutical drug development within the 510(k), De Novo, Premarket Approval and Biologics License Application Regulatory pathways. He served as Vice President, Regulatory Affairs/Quality Assurance for Glysens Inc, a technology innovator focused on development of an implantable CGM. Prior to that, his experience includes roles with Therapeutics Inc. and Cardium Therapeutics focusing on oral and injectable drugs, biologics, medical devices and gene therapy.
“I am honored to join the Company at this pivotal time as we advance our human clinical trials and create a strategic regulatory program for the Continuous Blood Glucose Monitor (CBGM),” said Mr. Williams.
Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack, said: “Mr. Williams brings extensive knowledge and experience in navigating regulatory pathways to Glucotrack, which will be instrumental as we progress development of our CBGM through the Food and Drug Administration and beyond. We are thrilled to welcome him to the team as we work to bring this technology closer to the millions of people living with diabetes.”
For more information about Glucotrack’s CBGM, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.
About Glucotrack, Inc.
Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.
Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.
Contacts:
Investor Relations:
investors@glucotrack.com
Lisa Wilson
In-Site Communications
T: 917-543-9932
E: lwilson@insitecony.com
Media:
GlucotrackPR@icrinc.com
FAQ
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