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

Rhea-AI Summary

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.

Positive

• 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

Negative

• Product still requires clinical trials before commercialization
• Manufacturing process needs scaling and optimization
• Regulatory approval timeline remains uncertain

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

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SOURCE CollPlant

FAQ

What are the key features of CollPlant's new dermal filler?

CollPlant's dermal filler combines hyaluronic acid with modified rhCollagen, featuring a unique photocurable formula that allows precise sculpting and becomes a semi-solid implant upon light activation.

What were the results of CollPlant's (CLGN) non-clinical studies for their dermal filler?

The studies showed positive results including successful one-year durability in in-vivo testing and biocompatibility compliance with international standards.

How does CollPlant's photocurable dermal filler work?

The filler is injected as a viscoelastic gel through a fine needle, allowing physicians to sculpt precise contours. It's then stabilized using CollPlant's proprietary illumination device, transforming into a semi-solid implant.

What are the next steps for CollPlant's (CLGN) dermal filler development?

CollPlant is preparing for clinical trials and currently scaling and optimizing its manufacturing process to ensure readiness for the upcoming clinical studies.

How is CollPlant's dermal filler different from traditional fillers?

The filler uniquely integrates three key benefits: contouring precision, structural support, and tissue regeneration in a single treatment, while using non-animal recombinant human collagen technology.