CollPlant Biotechnologies Announces Positive Results from non-clinical Studies of its Photocurable Regenerative Dermal and Soft Tissue Filler
CollPlant Biotechnologies (NASDAQ: CLGN) has announced positive results from non-clinical studies of its innovative photocurable dermal and soft tissue filler. The company's breakthrough product combines hyaluronic acid with modified rhCollagen to provide both immediate and long-lasting aesthetic benefits.
The novel filler is administered as a viscoelastic gel through a fine needle, allowing precise sculpting that is then stabilized using CollPlant's proprietary illumination device. Key findings include successful one-year durability studies and positive biocompatibility assessments meeting international standards. The company is now advancing towards clinical trials and optimizing its manufacturing processes.
CollPlant Biotechnologies (NASDAQ: CLGN) ha annunciato risultati positivi da studi non clinici del suo innovativo filler dermale e per tessuti molli fotocurabile. Il prodotto di punta dell'azienda combina acido ialuronico con rhCollagen modificato per offrire benefici estetici immediati e duraturi.
Il nuovo filler viene somministrato come gel viscoelastico tramite un ago fine, consentendo una modellazione precisa che poi viene stabilizzata usando il dispositivo di illuminazione proprietario di CollPlant. I principali risultati includono studi di durabilità di un anno riusciti e valutazioni di biocompatibilità positive che soddisfano standard internazionali. L'azienda sta ora avanzando verso studi clinici e ottimizzando i suoi processi di produzione.
CollPlant Biotechnologies (NASDAQ: CLGN) ha anunciado resultados positivos de estudios no clínicos de su innovador relleno dérmico y de tejidos blandos fotocurable. El producto insignia de la empresa combina ácido hialurónico con rhCollagen modificado para proporcionar beneficios estéticos inmediatos y duraderos.
El nuevo relleno se administra como un gel viscoelástico a través de una aguja fina, lo que permite esculpir con precisión y luego se estabiliza usando el dispositivo de iluminación propietario de CollPlant. Los hallazgos clave incluyen estudios de durabilidad de un año exitosos y evaluaciones de biocompatibilidad positivas que cumplen con estándares internacionales. La empresa avanza ahora hacia ensayos clínicos y optimiza sus procesos de fabricación.
CollPlant Biotechnologies (NASDAQ: CLGN)는 혁신적인 광경화 성분의 피부 및 연조직 필러에 대한 비임상 연구에서 긍정적인 결과를 발표했습니다. 회사의 핵심 제품은 수정된 rhCollagen과 결합된 히알루로닉산을 사용하여 즉시성과 오래 지속되는 미용 효과를 제공합니다.
새로운 필러는 얇은 바늘을 통해 점탄성 젤로 주사되며, CollPlant의 독점적인 조명 장치를 사용하여 정밀하게 조형된 후 안정화됩니다. 주요 소견으로는 1년 지속성 연구가 성공적으로 수행되었고 국제 기준에 부합하는 생체적합성 평가가 양호하다는 점이 포함됩니다. 회사는 이제 임상 시험으로 나아가고 제조 공정을 최적화하고 있습니다.
CollPlant Biotechnologies (NASDAQ: CLGN) a annoncé des résultats positifs d'études non cliniques de son innovant filler dermique et tissulaire mou photocurable. Le produit phare de la société associe acide hyaluronique à du rhCollagen modifié pour offrir des bénéfices esthétiques immédiats et durables.
Le nouveau filler est administré sous forme de gel viscoélastique via une fine aiguille, permettant une sculpture précise qui est ensuite stabilisée à l'aide de l'appareil d'illumination propriétaire de CollPlant. Les résultats clés incluent des études de durabilité d'un an réussies et des évaluations de biocompatibilité positives répondant aux normes internationales. L'entreprise progresse maintenant vers des essais cliniques et optimise ses processus de fabrication.
CollPlant Biotechnologies (NASDAQ: CLGN) hat positive Ergebnisse aus nichtklinischen Studien zu ihrem innovativen photopolymersierbaren Dermal- und Weichteil-Filler bekannt gegeben. Das bahnbrechende Produkt des Unternehmens kombiniert Hyaluronsäure mit modifiziertem rhCollagen, um sowohl sofortige als auch langanhaltende ästhetische Vorteile zu bieten.
Der neue Fillern wird als viskoelastisches Gel durch eine feine Nadel verabreicht, was eine präzise Konturierung ermöglicht, die anschließend mit dem firmeneigenen Beleuchtungsgerät von CollPlant stabilisiert wird. Zu den wichtigsten Erkenntnissen gehören erfolgreiche Ein-Jahres-Dauerbarkeitsstudien und positive Biokompatibilitätsbewertungen, die internationalen Standards entsprechen. Das Unternehmen macht nun Fortschritte in klinische Studien und optimiert seine Fertigungsprozesse.
CollPlant Biotechnologies (NASDAQ: CLGN) أعلنت عن نتائج إيجابية من دراسات غير سريرية لملء جلدي ولين نسيجي ضوئي قابل للضبط. يجمع المنتج الرائد للشركة حمض الهيالورونيك مع rhCollagen المعدل لتوفير فوائد جمالية فورية وطويلة الأمد.
يُدار الملء الجديد كشبه جامد لزج عبر إبرة دقيقة، مما يسمح بالنحت الدقيق ثم يتم تثبيته باستخدام جهاز الإضاءة الخاص بالشركة من CollPlant. تشمل النتائج الرئيسية نجاح دراسات المتانة لمدة سنة وتقييمات التوافقة الحيوية الإيجابية التي تلبّي المعايير الدولية. تتقدم الشركة الآن نحو التجارب السريرية وتحسن عمليات التصنيع لديها.
CollPlant Biotechnologies (NASDAQ: CLGN) 已宣布其创新性光固化真皮及软组织填充剂的非临床研究结果积极。该公司的突破性产品将 透明质酸与改良的 rhCollagen 结合在一起，带来即时与持久的美学效果。
这种新型填充剂以黏弹胶状通过细针给药，能够实现精确雕塑，随后再使用 CollPlant 的专有照明装置进行稳定。关键发现包括成功的 为期一年的耐久性研究 以及符合国际标准的生物相容性评估。公司现正推进进入临床试验并优化其制造工艺。
- Successful completion of comprehensive non-clinical program with positive results
- Demonstrated one-year durability in in-vivo studies
- Product combines immediate contouring benefits with long-term tissue regeneration
- Biocompatibility assessments showed compliance with international standards
- Product still requires clinical trials before commercialization
- Manufacturing process needs scaling and optimization
- Regulatory approval timeline remains uncertain
Insights
CollPlant's photocurable dermal filler shows promising non-clinical results, advancing to clinical trials with potential market differentiation through its unique properties.
CollPlant's announcement represents a significant R&D milestone for their photocurable dermal filler. The technology combines hyaluronic acid with modified rhCollagen to create a dual-action product that provides both immediate aesthetic results and regenerative benefits—addressing a key limitation of current fillers.
What makes this product technically innovative is its light-activated transition mechanism. The initial viscoelastic gel can be precisely contoured by physicians and then stabilized using CollPlant's proprietary illumination device, creating a semi-solid implant resistant to gravitational and mechanical forces. This approach potentially solves the migration issue common with traditional fillers.
The non-clinical program results are particularly encouraging with a one-year in vivo study demonstrating long-term durability—a critical factor for patient satisfaction and competitive differentiation. The biocompatibility assessments showing compliance with international standards establish a safety foundation necessary for regulatory advancement.
From a development timeline perspective, CollPlant has now completed the crucial pre-clinical phase and is moving to manufacturing scale-up and optimization, typical steps before initiating clinical trials. While specific timelines aren't mentioned, the manufacturing preparation indicates the company is positioning for clinical trials in the near term.
The regenerative aspect of their technology, leveraging their proprietary non-animal recombinant human collagen platform, offers a potential advantage over traditional fillers that provide volume but limited biological integration with surrounding tissues.
CollPlant is now moving towards clinical trials and scaling and optimizing its manufacturing to ensure readiness for the upcoming clinical trials
REHOVOT,
CollPlant's formulation combines hyaluronic acid with a modified form of rhCollagen to deliver both immediate and long-lasting benefits. Administered as a viscoelastic gel through a fine needle, the filler allows physicians to sculpt precise contours, which are then stabilized using CollPlant's proprietary illumination device. Upon light activation, the gel transitions into a semi-solid, cohesive implant that withstands gravitational and mechanical forces while maintaining the desired shape.
"The successful completion of our extensive non-clinical program marks an important milestone for CollPlant allowing us to enter clinical development of our photocurable regenerative filler," said Yehiel Tal, Chief Executive Officer of CollPlant. "By harnessing the unique properties of our rhCollagen technology, we aim to redefine the standard of care in aesthetic medicine with a novel solution that not only delivers immediate contouring and support but also promotes natural tissue integration for long-lasting results. We are excited to advance this product candidate another step towards the clinic and closer to providing physicians and patients with a next-generation alternative."
CollPlant's non-clinical program included a comprehensive set of safety and performance evaluations: a one-year, in vivo study confirming long-term durability; biocompatibility assessments demonstrating compliance with international relevant standards. The combined results obtained establish a strong foundation for clinical advancement, and CollPlant is now scaling and optimizing its manufacturing process to ensure readiness for the upcoming clinical trial.
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 within 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 may include forward-looking statements. Forward-looking statements may 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; 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 it 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
+972-73-2325600
Eran@collplant.com
Investors:
LifeSci Advisors
Dan Ferry
daniel@lifesciadvisors.com
Photo: https://mma.prnewswire.com/media/2785678/CollPlant.jpg
Logo: https://mma.prnewswire.com/media/2217353/CollPlant_Logo.jpg
View original content to download multimedia:https://www.prnewswire.com/news-releases/collplant-biotechnologies-announces-positive-results-from-non-clinical-studies-of-its-photocurable-regenerative-dermal-and-soft-tissue-filler-302570620.html
SOURCE CollPlant
FAQ
What are the key features of CollPlant's new dermal filler?
What were the results of CollPlant's (CLGN) non-clinical studies for their dermal filler?
How does CollPlant's photocurable dermal filler work?
What are the next steps for CollPlant's (CLGN) dermal filler development?
How is CollPlant's dermal filler different from traditional fillers?
