- rhCollagen-based regenerative breast implants address
$2.8 billion global breast implant
market with revolutionary and potentially safer new
product
- Regenerative breast implants for aesthetic and
reconstructive procedures including postmastectomy for cancer
patients
- The study is planned to be concluded within six
months
REHOVOT, Israel, June 28,
2022 /PRNewswire/ -- CollPlant (Nasdaq:
CLGN), a regenerative and aesthetics medicine company
developing innovative technologies and products for tissue
regeneration and organ manufacturing, today announced the
initiation of a study in large animals for its 3D bioprinted
regenerative breast implant program, addressing the $2.8 billion global breast implant market.
"This study is a quantum leap in the development of 3D
bioprinted regenerative breast implants," said Yehiel Tal, CollPlant's Chief Executive
Officer. "We believe that our regenerative breast implants
will address safety challenges associated with silicone implants
while also providing a more natural looking and feeling aesthetic
result. Immediately following the conclusion of this study, we are
planning to launch a second study with human size implants that
mimic commercial products. These studies will advance us to the
significant stage of human clinical trials."
CollPlant's bioprinted regenerative implants aim to overcome the
challenges of existing breast procedures that use 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 intended
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. 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.
To date, CollPlant has successfully produced prototypes of
3D bioprinted implants designed to regenerate breast tissue and
evaluated these in a series of preclinical studies. The Company is
now approaching an important milestone with the launch of a large
animal study that involves the implantation of reduced-size 3D
bioprinted implants in a clinically relevant porcine animal model.
The study, which is planned to be concluded within six months, will
evaluate adipose tissue regeneration, tissue integration,
vascularization of the implant, implant degradation rate, and host
tissue response to the implant. The study will also include
screening of compositions and optimization of the surgical
procedure, which will serve as the basis for the design of a
pivotal large study with human size implants.
In the product development process, CollPlant uses computational
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 behavior of an implant,
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.
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.
At the beginning of 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. Later in 2021, CollPlant entered a strategic
co-development agreement with 3D Systems for a 3D bioprinted
regenerative soft tissue matrix for use in breast reconstruction
procedures in combination with an implant.
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.
Contact at CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Email: Eran@CollPlant.com
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SOURCE CollPlant