3D Printed Breast implants consisting of 200cc
in volume of CollPlant’s rhCollagen-based bioinks produced on a
Stratasys’ Origin® printer to be tested
Technology innovation addresses a $3.0 billion
market opportunity
Study to focus on ability of implants to grow
natural breast tissue and completely degrade over time
In a significant step in the advancement of regenerative
medicine, CollPlant Biotechnologies (Nasdaq: CLGN) and Stratasys
Ltd. (Nasdaq: SSYS) today announced the initiation of a
pre-clinical study with 200cc commercial-sized regenerative
implants printed on a Stratasys Origin® 3D printer.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240819185837/en/
3D printed breast implant consisting of
200cc in volume of CollPlant’s rhCollagen-based bioinks produced on
a Stratasys’ Origin® printer. (Photo: Business Wire)
The collaboration between CollPlant and Stratasys is currently
focused on the development of a bioprinting solution for
CollPlant’s breast implants, in addition to finding solutions to
scale-up the implant’s fabrication process. The study is intended
to test the ability of the implants to promote the growth of
natural breast tissue and completely degrade over time.
CollPlant’s novel breast implants have been designed to
regenerate an individual’s natural breast tissue without eliciting
an immune response, and could provide a revolutionary alternative
for both reconstructive and aesthetic procedures, which represents
a significant portion of the overall $3 billion addressable breast
implant market.
“This pre-clinical study marks a significant step forward in our
effort to provide patients with care using regenerative medicine
instead of traditional implants,” said Stratasys CEO Dr. Yoav Zeif.
“CollPlant's work is truly inspiring, and our collaboration
exemplifies how Stratasys partners with customers to push the
timeline and the boundaries of innovation. Together, we are driven
by a shared mission to challenge the status quo and find new ways
to improve lives and advance healthcare.”
Yehiel Tal, CEO of CollPlant, commented, “We are extremely happy
about the progress we’ve made with our breast implants program, and
with Stratasys’ successful achievement to develop a printer that
enables us to print a commercial-size implant with high resolution
and optimal physical properties. The combined pioneering
technologies of both companies is expected to streamline the
development and production process so that we have the most
efficient means to produce our regenerative breast implants. We
believe that our rhCollagen-based regenerative implant has the
potential to overcome the challenges of existing breast procedures
that use silicone implants or autologous fat transfer, thereby
significantly improving patient outcomes.”
Stratasys is a leader in polymer 3D printing solutions and
CollPlant is a pioneering regenerative and aesthetics medicine
company developing innovative technologies and products based on
its rhCollagen for tissue regeneration and organ manufacturing.
Since announcing the collaboration in April of 2023, Stratasys
has adapted the Origin printer to print the regenerative implants,
and CollPlant successfully managed to 3D-print them at 200ccs.
CollPlant is expecting to have initial results from the study in
the first half of 2025.
Currently the global breast implant market is estimated to be
$3.0 billion,1 while breast reconstruction and augmentation
procedures represent the second most common plastic surgery
procedure performed worldwide2. The most common breast augmentation
or reconstruction procedures utilize synthetic breast implantations
made of silicone, an artificial substitution for natural
regenerated tissue with a risk of complications.
Earlier this year, CollPlant announced additional positive data
from its previous pre-clinical studies that are currently underway
which showed evidence of well-developed connective tissue
containing blood vessels (i.e., neovascularization) within the
implant. Progressing tissue ingrowth inside the implant was also
observed confirming tissue regeneration. An initial biodegradation
process was noticed, while the original structure of the 3D breast
implant was preserved. No adverse tissue reaction was present,
confirming the safety profile of this novel implant in
development.
1
https://www.thebrainyinsights.com/report/breast-implants-market-14142
2 ISAPS International Survey on Aesthetic/Cosmetic Procedures,
2021
About Stratasys
Stratasys is leading the global shift to additive manufacturing
with innovative 3D printing solutions for industries such as
aerospace, automotive, consumer products, healthcare, fashion and
education. Through smart and connected 3D printers, polymer
materials, a software ecosystem, and parts on demand, Stratasys
solutions deliver competitive advantages at every stage in the
product value chain. The world’s leading organizations turn to
Stratasys to transform product design, bring agility to
manufacturing and supply chains, and improve patient care.
To learn more about Stratasys, visit www.stratasys.com, the
Stratasys blog, X/Twitter, LinkedIn, or Facebook. Stratasys
reserves the right to utilize any of the foregoing social media
platforms, including the Company’s websites, to share material,
non-public information pursuant to the SEC’s Regulation FD. To the
extent necessary and mandated by applicable law, Stratasys will
also include such information in its public disclosure filings.
Stratasys and Origin One are trademarks or registered trademarks
and the Stratasys signet is a trademark of Stratasys Ltd. and/or
its subsidiaries or affiliates. All other trademarks are the
property of their respective owners.
About CollPlant
CollPlant is a regenerative and aesthetic medicine company
focused on 3D bioprinting of tissues and organs, and medical
aesthetics. CollPlant's products are based on its recombinant human
collagen produced with its 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, visit http://www.collplant.com
Safe Harbor for Forward-Looking Statements
This joint press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to Stratasys’ and/or CollPlant’s objectives,
plans and strategies, as well as statements, other than historical
facts, that address activities, events or developments that
Stratasys and/or CollPlant intend, expect, project, believe or
anticipate 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 the companies’ respective management’s experience
and perception of historical trends, current conditions, expected
future developments and other factors believed to be appropriate.
Forward-looking statements included in this press release include,
but are not limited to, statements regarding the following: the
companies’ ability to develop a 3D bioprinter that is based on
Stratasys’ P3™ 3D printing technology and can be used with
CollPlant's rhCollagen-based BioInk; CollPlant’s expectations
regarding the cost and timing of commencing or concluding
pre-clinical and clinical trials, with respect to breast implants,
tissues and organs based on its rhCollagen based bioinks and other
products for medical aesthetics; CollPlant’s ability to obtain
favorable pre-clinical and clinical trial results with respect to
the foregoing trials; regulatory action with respect to rhCollagen
based bioinks 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 companies’ combined 3D bioprinter
and/or future potential collaborative products involving Stratasys’
P3™ 3D printing technology and/or CollPlant's rhCollagen based
bioinks and/or CollPlant’s regenerative breast implants and/or
other medical aesthetics products; the companies’ ability to
establish sales and marketing capabilities or enter into agreements
with third parties, including third party distributors and
resellers; and the companies’ ability to establish and maintain
strategic partnerships and other corporate collaborations.
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 Stratasys’ or 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: CollPlant’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
companies’ reliance on third parties to conduct some or all aspects
of the development or manufacturing of their products; the scope of
protection the companies are able to establish and maintain for
their respective and joint intellectual property rights and the
companies’ ability to operate their respective businesses and their
joint collaboration 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
companies operate, including, with respect to the ongoing war in
Israel; projected capital expenditures and liquidity; changes in
the companies’ respective strategies; and litigation and regulatory
proceedings. More detailed information about the risks and
uncertainties affecting Stratasys and CollPlant are contained under
the heading “Risk Factors” included in Item 3.D of their most
recent annual reports on Form 20-F filed with the SEC on March 3,
2023 and March 29, 2023, respectively, and in other filings that
Stratasys and CollPlant have 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
Stratasys’ and CollPlant’s current views with respect to future
events, and the companies do not undertake and specifically
disclaim any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240819185837/en/
Media: Erik Snider, Stratasys Corporate, Global Public
Relations +972 74 745 6053 Chris Reese, Stratasys Corporate,
Americas Public Relations +1 651 357 0877 Investor
Relations: Yonah Lloyd, CCO & VP Investor Relations +972 74
745 4919 CollPlant Eran Rotem, Deputy CEO & CFO
Eran@CollPlant.com
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