MARKET WIRE NEWS

CollPlant Biotechnologies Announces Positive Results from non-clinical Studies of its Photocurable Regenerative Dermal and Soft Tissue Filler

MWN-AI** Summary

CollPlant Biotechnologies (NASDAQ: CLGN) has announced promising results from its non-clinical studies of a novel photocurable dermal and soft tissue filler, paving the way for upcoming clinical trials. This innovative filler combines hyaluronic acid and a modified form of recombinant human collagen (rhCollagen), a breakthrough that aims to deliver immediate and long-lasting aesthetic benefits. Unlike traditional fillers, CollPlant's formulation allows for precise contouring through a viscoelastic gel that transforms into a coherent implant upon light activation, offering structural support while promoting tissue regeneration.

CEO Yehiel Tal emphasized the importance of these non-clinical study results, highlighting the technology's potential to redefine aesthetic treatments by providing natural tissue integration alongside immediate improvements. The extensive safety evaluations included a one-year in vivo study demonstrating the filler’s long-term durability and biocompatibility, essential for meeting international safety standards.

As CollPlant moves toward clinical development, it is also focused on scaling and optimizing its manufacturing processes to ensure readiness for trial implementation. This progress comes on the heels of a strategic partnership with Allergan, a subsidiary of AbbVie, solidifying CollPlant's position in the competitive dermal filler market.

CollPlant's aspiration to innovate within the aesthetic medicine space is further supported by its commitment to harnessing cutting-edge technologies, such as 3D bioprinting for tissue repair and reconstruction. As the company prepares for its clinical trials, investors and stakeholders alike watch closely, recognizing the unique potential of CollPlant's technology to impact the future of aesthetic treatments significantly.

MWN-AI** Analysis

CollPlant Biotechnologies (NASDAQ: CLGN) has recently announced promising results from non-clinical studies of its photocurable regenerative dermal and soft tissue filler, indicating a significant step towards clinical trials. The company’s innovative product harnesses its proprietary recombinant human collagen (rhCollagen), paired with hyaluronic acid, to offer both immediate and long-lasting aesthetic benefits. This advancement could position CollPlant favorably within the competitive aesthetic medicine market, especially as it plans to collaborate with Allergan, an AbbVie company that holds a significant stake in this sector.

As the company moves toward clinical trials, it is essential for investors to consider the following aspects. First, the positive outcomes from the non-clinical studies establish a solid foundation for the potential clinical success of the product. With long-term durability demonstrated in a year-long study, it signals a reduction in risk associated with upcoming regulatory evaluations.

However, investors should remain cautious. The path to commercialization includes navigating both clinical trial results and necessary regulatory approvals, which can be unpredictable. Market dynamics, competitive responses, and macroeconomic factors could impact CollPlant's stock performance. The ongoing geopolitical tensions in Israel may also influence investor sentiment and operational capabilities.

CollPlant’s collaboration with Allergan offers both validation and potential market entry synergies, provided it translates into successful commercialization. Investors would do well to monitor developments closely—particularly the progression of clinical trials and any updates regarding regulatory processes.

In conclusion, while CollPlant displays significant potential in redefining aesthetic treatments, the inherent risks of clinical development and market challenges suggest a cautious investment stance. A close watch on upcoming trial results and market responses will be crucial for gauging the company's performance and stock valuation moving forward.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

PR Newswire

CollPlant is now moving towards clinical trials and scaling and optimizing its manufacturing to ensure readiness for the upcoming clinical trials

REHOVOT, Israel , Sept. 30, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetic medicine company developing disruptive technologies and products based on its proprietary non-animal recombinant human collagen (rhCollagen), today announced positive results from its non-clinical program evaluating its photocurable dermal filler, as well as plans to advance this product candidate into clinical trials. This novel filler represents a significant breakthrough in aesthetic medicine by uniquely integrating contouring precision, structural support, and tissue regeneration into a single treatment.

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 Israel , projected capital expenditures and liquidity, changes in the Company's strategy, and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant are contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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

SOURCE CollPlant

FAQ**

Given CollPlant Biotechnologies' positive non-clinical results, how might this advance Collplant Holdings CQPTY's market position in the aesthetic medicine sector, particularly in comparison to its competitors?

CollPlant Biotechnologies' positive non-clinical results could enhance its market position in the aesthetic medicine sector by strengthening its credibility and innovation appeal, potentially attracting more investors and customers compared to competitors with less promising data.

What specific steps is CollPlant taking to ensure manufacturing scalability and readiness for clinical trials of its photocurable regenerative filler, and how does Collplant Holdings CQPTY plan to address potential regulatory challenges?

CollPlant is optimizing its manufacturing processes to scale production of its photocurable regenerative filler while actively engaging with regulatory agencies to navigate compliance and address potential challenges ahead of clinical trials.

With the integration of rhCollagen in their product, how does CollPlant aim to differentiate itself in the market, and what potential advantages does this offer Collplant Holdings CQPTY over traditional dermal fillers?

CollPlant aims to differentiate itself by using rhCollagen to create a bioengineered solution that potentially offers enhanced biocompatibility, reduced allergic reactions, and longer-lasting results compared to traditional dermal fillers.

Considering CollPlant’s partnership with Allergan, how can this collaboration enhance Collplant Holdings CQPTY's commercialization strategies, and what milestones are anticipated during the upcoming clinical trials?

CollPlant's partnership with Allergan can enhance its commercialization strategies by leveraging Allergan's extensive distribution network and expertise, while anticipated milestones during upcoming clinical trials may include successful product development, regulatory approvals, and market entry timelines.

**MWN-AI FAQ is based on asking OpenAI questions about CollPlant Holdings Ltd. (NASDAQ: CLGN).

CollPlant Holdings Ltd.

NASDAQ: CLGN

CLGN Trading

0.0% G/L:

$0.625 Last:

12,762 Volume:

$0.61 Open:

mwn-link-x Ad 300

CLGN Latest News

June 03, 2025 06:42:28 pm
CLGN - Historical Earnings Price Analysis

CLGN Stock Data

$8,706,044
9,102,937
N/A
15
N/A
Biotechnology & Life Sciences
Healthcare
IL
Rehovot

Subscribe to Our Newsletter

Link Market Wire News to Your X Account

Download The Market Wire News App