CollPlant's Collink.3D® BioInks and Technologies Offer a Relevant and Timely Solution to FDA's Plan to Reduce Animal Testing in Preclinical Safety Studies
CollPlant Biotechnologies (NASDAQ: CLGN) has positioned its Collink.3D® BioInks as a solution aligned with the FDA's recent announcement to phase out animal testing requirements for drug development. The company's rhCollagen-based BioInk products can be used to create tissue-on-a-chip and organ-on-a-chip systems, offering alternatives to traditional animal testing methods.
These innovative systems can help bridge the gap between laboratory studies and clinical trials while being more cost-effective and reducing time to market. CollPlant has also developed Computational Modeling and Simulation (CM&S) methodologies for their regenerative breast implant development, enabling precise prediction of implant behavior and tissue interaction without animal studies.
CollPlant Biotechnologies (NASDAQ: CLGN) ha posizionato i suoi Collink.3D® BioInks come una soluzione in linea con l'annuncio recente della FDA di eliminare gradualmente i requisiti di test su animali per lo sviluppo di farmaci. I prodotti BioInk a base di rhCollagen dell'azienda possono essere utilizzati per creare sistemi tissue-on-a-chip e organ-on-a-chip, offrendo alternative ai metodi tradizionali di sperimentazione animale.
Questi sistemi innovativi possono contribuire a colmare il divario tra studi di laboratorio e trial clinici, risultando inoltre più economici e riducendo i tempi di commercializzazione. CollPlant ha inoltre sviluppato metodologie di Modellazione Computazionale e Simulazione (CM&S) per lo sviluppo di impianti mammari rigenerativi, permettendo una previsione precisa del comportamento dell'impianto e dell’interazione con i tessuti senza ricorrere a studi su animali.
CollPlant Biotechnologies (NASDAQ: CLGN) ha posicionado sus Collink.3D® BioInks como una solución alineada con el reciente anuncio de la FDA sobre la eliminación progresiva de los requisitos de pruebas en animales para el desarrollo de medicamentos. Los productos BioInk basados en rhColágeno de la empresa pueden usarse para crear sistemas tissue-on-a-chip y organ-on-a-chip, ofreciendo alternativas a los métodos tradicionales de prueba en animales.
Estos sistemas innovadores pueden ayudar a cerrar la brecha entre los estudios de laboratorio y los ensayos clínicos, siendo además más rentables y reduciendo el tiempo de comercialización. CollPlant también ha desarrollado metodologías de Modelado Computacional y Simulación (CM&S) para el desarrollo de implantes mamarios regenerativos, permitiendo una predicción precisa del comportamiento del implante y la interacción con el tejido sin necesidad de estudios en animales.
CollPlant Biotechnologies (NASDAQ: CLGN)는 최근 FDA가 동물 실험 요구 사항을 단계적으로 폐지하겠다는 발표에 맞춰 Collink.3D® BioInks를 솔루션으로 제시했습니다. 회사의 rh콜라겐 기반 BioInk 제품은 조직-온-칩 및 장기-온-칩 시스템을 만드는 데 사용될 수 있어 전통적인 동물 실험 방법의 대안이 됩니다.
이 혁신적인 시스템은 실험실 연구와 임상 시험 간의 격차를 줄이는 데 도움을 주며, 비용 효율적이고 시장 출시 시간을 단축합니다. CollPlant는 또한 재생 유방 임플란트 개발을 위해 컴퓨터 모델링 및 시뮬레이션(CM&S) 방법론을 개발하여 동물 실험 없이 임플란트의 행동과 조직 상호작용을 정확히 예측할 수 있게 했습니다.
CollPlant Biotechnologies (NASDAQ : CLGN) a positionné ses Collink.3D® BioInks comme une solution conforme à la récente annonce de la FDA visant à éliminer progressivement l’obligation des tests sur animaux pour le développement de médicaments. Les produits BioInk à base de rhCollagène de l’entreprise peuvent être utilisés pour créer des systèmes tissue-on-a-chip et organ-on-a-chip, offrant des alternatives aux méthodes traditionnelles de tests sur animaux.
Ces systèmes innovants peuvent aider à combler le fossé entre les études en laboratoire et les essais cliniques, tout en étant plus économiques et en réduisant le temps de mise sur le marché. CollPlant a également développé des méthodologies de Modélisation et Simulation Informatique (CM&S) pour le développement d’implants mammaires régénératifs, permettant une prédiction précise du comportement de l’implant et de l’interaction avec les tissus sans recourir aux études animales.
CollPlant Biotechnologies (NASDAQ: CLGN) hat seine Collink.3D® BioInks als Lösung positioniert, die mit der kürzlichen Ankündigung der FDA zur schrittweisen Abschaffung der Tierversuchspflichten bei der Arzneimittelentwicklung übereinstimmt. Die rhKollagen-basierten BioInk-Produkte des Unternehmens können zur Herstellung von Tissue-on-a-Chip- und Organ-on-a-Chip-Systemen verwendet werden und bieten Alternativen zu herkömmlichen Tierversuchsmethoden.
Diese innovativen Systeme können die Lücke zwischen Laborstudien und klinischen Studien überbrücken, sind kosteneffizienter und verkürzen die Markteinführungszeit. CollPlant hat zudem Computational Modeling and Simulation (CM&S)-Methoden für die Entwicklung regenerativer Brustimplantate entwickelt, die eine präzise Vorhersage des Implantatverhaltens und der Gewebeinteraktion ohne Tierversuche ermöglichen.
- Technology aligns with new FDA initiative to phase out animal testing
- BioInk products offer cost-effective alternative to traditional testing methods
- CM&S technology enables precise prediction of product behavior without animal testing
- None.
Insights
CollPlant's alignment with the FDA's recent animal testing phase-out initiative represents a significant strategic positioning in the evolving regulatory landscape. The timing is particularly advantageous as the agency moves toward "New Approach Methodologies" (NAMs) for drug development.
The company's Collink.3D BioInk portfolio offers a ready-to-implement solution for pharmaceutical developers who must now adapt to these new regulatory requirements. Their rhCollagen-based products enable tissue-on-chip and organ-on-chip systems that can serve as the human-relevant testing alternatives the FDA is specifically encouraging.
Most compelling is CollPlant's dual approach: not only offering the physical biomaterials (BioInks) needed for alternative testing platforms but also developing Computational Modeling and Simulation methodologies that further reduce animal testing requirements. This positions them as a full-stack solution provider rather than just a materials supplier.
The FDA's five-year timeline for phasing out animal testing creates a predictable adoption curve that could drive increasing demand for CollPlant's technologies. Importantly, this regulatory shift may accelerate pharmaceutical companies' investment in alternative testing infrastructure, expanding CollPlant's addressable market without requiring substantial new R&D investment from the company itself.
While the announcement doesn't include financial projections or partnership details, the alignment between the FDA's direction and CollPlant's existing capabilities suggests potential for market expansion as the industry adapts to these new requirements.
CollPlant's novel rhCollagen BioInks are an available solution aligned with FDA's plan announced last week to phase out the animal testing requirement for the development of monoclonal antibody therapies and other drug candidates
REHOVOT,
Yehiel Tal, CollPlant's Chief Executive Officer, commented, "The FDA's new approach to develop alternatives for use in place of traditional animal testing, often referred to as 'New Approach Methodologies', or NAMs, is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development costs, and ultimately, drug prices. CollPlant's novel rhCollagen-based Collink.3D portfolio of BioInk products supports the FDA's NAMs since they can be used in a wide variety of non-animal testing applications. For example, CollPlant's BioInk products are ideal for the biofabrication of tissue-on-a-chip or organ-on-a-chip systems used for drug discovery and regenerative medicine applications and are designed to be compatible with in-vitro human-based systems like organoids. We anticipate that our BioInks will be instrumental to enable alternatives for achieving the goal of phasing out animal testing in five years."
Mr. Tal added, "CollPlant has also developed Computational Modeling and Simulation (CM&S) methodologies to assist in the development of its regenerative breast implant product candidate. Mimicry of the implant and human body interaction using CM&S, enables precise prediction of mechanical behavior of the implants in the body, as well as provides information about degradation kinetics, tissue remodeling and interaction with the host tissue. These smart tools are reducing the need for animal studies and are accelerating the development of safer and more effective human-specific solutions. The same development tools can be applied to any other soft or hard tissue type to optimize the development of regenerative implants."
About Collink.3D BioInk
CollPlant's Collink.3D BioInk pipeline consists of the first and only line of human collagen BioInk products based on chemically modified plant-derived rhCollagen that is mass-produced with high purity and consistency.
CollPlant's BioInk Collink.3D pipeline of products are based on a methacrylated form of its rhCollagen which can be used for 3D bioprinting of tissues and organs. CollPlant's BioInk is currently being utilized for the printing of its regenerative breast implants in development. By combining biomaterials and synthetic polymers, CollPlant Collink.3D can be utilized for tissue-on-a-chip or organ-on-a-chip systems, which enable real-time, human-relevant assessment of immune responses, degradation, and tissue remodeling.
Collink.3D enables scalable and reproducible biofabrication of tissue models, tissues, and organ transplants, while perfectly mimicking the native properties of tissues and organs. Additionally, it provides the advantage of being animal-free, has the properties of optimal rheology at room temperature, supports high viability of different cell types and is biocompatible and non-immunogenic.
About the
On April 10, 2025, the FDA announced a plan to phase out animal testing as a requirement for the pre-clinical development of monoclonal antibodies and other drugs.
The FDA's statement specifies that within 3–5 years, animal testing may become the exception. Incentives and collaborative efforts across industry and government are accelerating this shift. This is intended to be the road to safer drugs, reduced development timelines and ethical research practices.
About CollPlant
CollPlant is a regenerative and aesthetic medicine company ushering in a new era of medical solutions with a focus on 3D bioprinting of tissues and organs, tissue repair and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing.
In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com
Forward-Looking Statements
This press release includes forward-looking statements. Forward-looking statements include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all, including uncertainties surrounding the methods of fundraising and the Company's preferences regarding such methods; the Company's expectations regarding the costs and timing of commencing and/or concluding pre-clinical and clinical trials with respect to breast implants, tissues and organs which are based on its rhCollagen based BioInk and other products for medical aesthetics, and specifically the Company's ability to initiate its next large-animal study for its breast implants in a timely manner, or at all; the Company's or Company's strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen-based BioInk and medical aesthetics products or product candidates including, but not limited to, acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations, including its partnership with AbbVie and its ability to continue to receive milestone and royalties payments under the AbbVie agreement; the Company's reliance on third parties to conduct some or all aspects of its product development and manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates, including, with respect to the ongoing war in
Contacts
CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@collplant.com
Investors:
LifeSci Advisors
Dan Ferry
daniel@lifesciadvisors.com
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SOURCE CollPlant
FAQ
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