- Study demonstrated progressive stages of tissue regeneration as
highlighted by the formation of maturing connective tissue and
neovascular networks within the implants
- No indication of adverse reaction was noted
- Promising results support continued development of
rhCollagen-based regenerative breast implants as a revolutionary
and potentially safer and more natural alternative for aesthetic
and reconstructive procedures, including postmastectomy for cancer
patients
- rhCollagen-based regenerative breast implants address
$2.5 billion global breast implant
market
REHOVOT, Israel, Jan. 4, 2023
/PRNewswire/ -- CollPlant (Nasdaq: CLGN), a regenerative
and aesthetics medicine company developing innovative technologies
and products for tissue regeneration and organ manufacturing,
announced that it has successfully completed a large animal study
for its recombinant human collagen (rhCollagen)-based 3D bioprinted
regenerative breast implants, addressing the $2.5 billion global breast implant market.
Supported by these promising results, the Company is planning to
initiate a follow-up large animal study during 2023 using
commercial-size implants to support subsequent human studies and
future product commercialization.
The objectives of the study were fully achieved, including the
evaluation of the safety and efficacy of the bioprinted breast
implants. The histological analysis of the implants demonstrated
progressive stages of tissue regeneration after three months, as
indicated by the formation of maturing connective tissues and
neovascular networks. The development of native tissue was
synchronized with the degradation process of the implant, which was
consistent with the desired outcome observed during the trial.
There was also no indication of adverse reaction noted within the
implants and the surrounding tissue.
"We are very enthusiastic with the results of the study and the
achievement of its primary objectives, including the clear
demonstration of implant replacement by newly grown, native
tissue," said Yehiel Tal,
CollPlant's Chief Executive Officer. "Our regenerative breast
implants have the potential to address the safety challenges
associated with silicone implants while providing a more natural
looking and feeling aesthetic result. We are now preparing for a
follow-up large animal study using implants that mimic existing
commercial-size products, helping us advance into human clinical
trials and then product commercialization," he added.
CollPlant's bioprinted regenerative implants aim to overcome the
challenges of existing breast procedures using silicone implants or
autologous fat transfer. According to the U.S. Food and Drug
Administration, approximately 350,000 people have reported adverse
events involving breast implants between 2009 and 2019. Reports
range from autoimmune symptoms to breast implant-associated
anaplastic large cell lymphoma (BIA-ALCL). CollPlant's regenerative
breast implants are comprised of the Company's proprietary
plant-derived rhCollagen, an ideal building block for regenerative
medicine implants attributed to better bio-functionality, superior
homogeneity, and improved safety. The printed implant is designed
to degrade over time while promoting natural tissue regeneration
and integration with host tissue. 3D bioprinting technology enables
scalable production of highly precise and repeatable constructs
which can be customized to the individual anatomy of patients.
In the product development process, CollPlant uses modeling
tools that enable an optimal design of the implant in terms of
geometry, materials, physical properties, and biological
environment. The modeling takes into consideration the internal
anatomy of the breast tissue and the implant environment
post-implantation. The implant testing is rigorous and includes
static and dynamic loading in order to mimic breast tissue behavior
under different conditions and comply with the most stringent
safety requirements. The implants are designed to withstand
physiological loads and to provide what CollPlant believes is a
safer, more natural, and long-lasting alternative to current breast
reconstruction and augmentation procedures.
About CollPlant
CollPlant is a regenerative and aesthetic medicine company
focused on 3D bioprinting of tissues and organs, 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, and are ushering in a new era in
regenerative and aesthetic medicine.
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
Safe Harbor 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 ability to continue as a going concern, and its need to
raise additional capital and its inability to obtain additional
capital on acceptable terms, or at all; the impact of the COVID-19
pandemic; the Company's expectations regarding the timing and cost
of commencing clinical trials with respect to tissues and organs
which are based on its rhCollagen based BioInk and products for
medical aesthetics; the Company's ability to obtain favorable
pre-clinical and clinical trial results; regulatory action with
respect to rhCollagen based BioInk and medical aesthetics products
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; the Company's reliance on third parties to conduct
some or all aspects of its product 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; the overall global economic environment; the impact of
competition and new technologies; general market, political, and
economic conditions in the countries in which the Company operates;
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 is 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.
Photo -
https://mma.prnewswire.com/media/1977044/CollPlant_RD_team.jpg
Contact at CollPlant:
Eran
Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@CollPlant.com
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