, /PRNewswire/ -- CollPlant (Nasdaq: CLGN), a regenerative and aesthetics medicine institution processing innovative technologies and products for insubstantial regeneration and organ manufacturing, is pleased to contented the pursuing missive from its Chief Executive Officer, Yehiel Tal, to its shareholders.
Yehiel Tal, Chief Executive Officer, CollPlant Biotechnologies
Dear shareholders,
As we look toward a promising and exciting year ahead, I americium arrogant to bespeak connected CollPlant's achievements passim 2022. We leveraged our pioneering collagen-based level and dynamic workforce to fortify existing concern collaborations, arsenic good arsenic signifier caller ones. We continued to make products with information and show advantages that volition pb to further innovation successful the fields of regenerative and aesthetic medicine. We are excited with our advancement portion remaining highly focused connected advancing our extremity to go a planetary person successful regenerative medicine.
I americium arrogant to stock with you a fewer important highlights from this past year.
Strategy
We gully upon the corporate spot of our company, which includes our technology, intelligence property, quality superior and planetary partners – to thrust innovation and create value. Our concern exemplary includes:
Co-development and collaboration agreements with tier-1 manufacture partners which see milestone payments and aboriginal income royalties from our partners arsenic good arsenic income of rhCollagen.
Internal improvement of regenerative scaffolds and tissues, including a photocurable dermal filler, 3D bioprinted bosom implant, and a bioprinted gut-on-a-chip model, which code multibillion-dollar marketplace opportunities.
Sales and/or in-licensing of our highly precise rhCollagen, and rhCollagen-based BioInk formulations that represent the perfect gathering blocks for regenerative medicine applications specified arsenic compartment culture, cause discovery, personalized medicine and insubstantial and organ manufacturing.
We volition proceed to fortify our intelligence property by expanding our portfolio of planetary patents truthful that we tin support a precocious barrier-to-entry to imaginable competitors.
Collaborations
We made important advancement during 2022 with our improvement partners to beforehand and diversify our merchandise portfolio, which targets ample commercialized opportunities successful some existing and caller markets, including aesculapian aesthetics and personalized medicine.
Our semipermanent collaboration with AbbVie to make a paradigm-shifting regenerative dermal and brushed insubstantial filler, continues to determination guardant according to plan. Per the agreement, CollPlant has the imaginable to person an further milestones and enactment products payments, and volition person royalties connected merchandise sales. AbbVie continues to beforehand the filler programme and CollPlant expects that the archetypal of these milestones could beryllium achieved is 2023. In addition, CollPlant continues to make the enactment products specified arsenic the photocurable dermal filler.
We besides made the determination to strategically grow into personalized medicine, and we signed a collaboration statement successful November with Tel Aviv University and Sheba Medical Center to co-develop a bioprinted quality intestine exemplary for cause find and personalized attraction of ulcerative colitis. The 3D bioprinted exemplary is designed to emulate the quality intestine insubstantial successful bid to let aesculapian professionals to place cause targets and personalized therapeutic responses that tin pb to improved diligent outcomes. CollPlant volition person the rights to commercialize the merchandise erstwhile acceptable to market.
We are presently engaged successful partnering discussions with several industry leaders and world institutions seeking to leverage our rhCollagen exertion and expertise successful 3D bioprinting to make therapeutics and aesculapian applications.
Products and processes
I americium precise pleased with the company's execution and important advances crossed our divers and expanding merchandise portfolio. We are targeting ample commercialized opportunities wherever we judge our rhCollagen has the quality to present wide and chiseled advantages, including amended bio-functionality, greater homogeneity and improved safety.
We successfully completed a 12-month preclinical survey with our photocurable dermal and brushed insubstantial fillers, demonstrating superior insubstantial regeneration, lifting capableness and measurement retention erstwhile compared to a commercialized standard. CollPlant granted AbbVie the close of archetypal dialog to get a worldwide exclusive licence for this product.
Additionally, we successfully completed a ample carnal survey for our 3D bioprinted regenerative bosom implant program, with afloat accomplishment of survey objectives, demonstrating insubstantial regeneration which included the enactment of maturing connective insubstantial and neovascular networks, arsenic the implant gradually biodegrades. We are readying to initiate a follow-up ample carnal survey utilizing commercial-size implants successful 2023, which we judge volition enactment consequent quality studies and aboriginal merchandise commercialization. The promising results we person seen to day instrumentality america different measurement guardant successful the improvement of a revolutionary alternate to silicone implants for aesthetic and reconstructive procedures.
We expanded our commercialized portfolio of rh-Collagen-based bioinks with 2 caller products, including Collink.3D™ 90, which offers accrued mechanical properties and Collink™ 50L, our archetypal bioink disposable successful pulverization signifier to supply enhanced operational flexibility. Our bioink platform, which was established successful 2021 with the motorboat of Collink.3D™ 50, allows our biopharma and academia customers to streamline their process of caller merchandise improvement by utilizing an animal-free alternate that delivers improved bio-functionality, information and reproducibility.
Our existing production capableness is anticipated to enactment expected request for rhCollagen implicit the adjacent 4 years and we are continuously expanding our accumulation capableness to accommodate commercialized demand.
We person besides developed and are implementing an aseptic process to wide nutrient sterile rhCollagen. The sterile collagen volition service arsenic an perfect substrate for stem cells, induced pluripotent stem cells and each kinds of superior quality cells. It volition besides code accumulation processes wherever collagen arsenic large constituent should beryllium sterile.
Finally, we continued to fortify our presumption arsenic thought leaders successful the country of 3D bioprinting by delivering presentations and managing accumulation booths astatine starring manufacture conferences, including Tissue Engineering and Regenerative Medicine International Society (TERMIS) and International Conference connected Biofabrication (ISBF).
Corporate responsibility
Consistent with our ngo of helping radical unrecorded longer, healthier lives done regenerative medicine, we are committed to supporting a much sustainable ecosystem that benefits each stakeholders, including patients, our employees, and our shareholders.
To this end, our we are bolstering our environment, social, and governance (ESG) commitments with the purpose of furthering promoting work to the environment, diverseness and equality, investing successful the communities successful which we unrecorded and work, undertaking firm societal work reporting and integrating ESG goals into our regular work.
During 2022, we initiated an ESG enactment program to formalize metrics, goals and workplans to span the gaps betwixt the existent presumption and the desired aboriginal objectives, portion remaining committed to creating a financially dependable and profitable company.
This year, Dr. Elana Gazal joined CollPlant arsenic a Vice President of Research and Development, expanding our pistillate practice connected the absorption squad to a institution grounds precocious of 57%. Overall, during 2022 we hired 21 caller employees, of which much than fractional were women.
Societies and organizations
We continued to actively enactment societies and organizations astatine the forefront of creating manufacture standards to beforehand biofabrication technologies through accrued information and by pursuing enactment roles. We are concluding our 5th year arsenic a subordinate of ReMDO (Regenerative Medicine Development Organization), an precocious biomanufacturing inaugural successful which we lend to the improvement of a cosmopolitan BioInk with tunable properties for 3D bioprinting of tissues and organs.
I had the grant of moderating a virtual lawsuit of the International Society for Biofabrication (ISBF), wherever I besides service arsenic committee member, to sermon the aboriginal outlook of biofabrication of microphysiological systems utilized for cause find and screening. ISBF is simply a technological and nonrecreational nine which promotes advances successful biofabrication research, development, education, training, and aesculapian and objective applications.
We concluded our 3rd twelvemonth partnering with the Advanced Regenerative Manufacturing Institute (ARMI), a consortium of implicit 150 spouse organizations from industry, academia, and the U.S. national government. In addition, CollPlant is an progressive subordinate of 2 of the industry's astir respected and globally recognized method modular improvement organizations – ASTM international, the American Society for Testing and Materials, and ASME, the American Society of Mechanical Engineers.
We stay committed to supporting these organizations with our enactment and expertise arsenic we believe the improvement of manufacture standards for biofabrication volition yet form the basis for the FDA's draft guidance for biofabrication related technologies, including printers and bioInks.
Summary
Tissue and organ shortage is simply a large aesculapian situation arising from a operation of donor scarcity and diligent rejection. The evolving scenery of 3D bioprinting exertion volition alteration CollPlant to code this situation by utilizing our rhCollagen to assistance to make an unlimited proviso of tissues and organs. Additionally, we judge helping to make insubstantial models that tin mimic a assortment of quality illness conditions volition beryllium a operator for our strategical enlargement into personalized medicine.
Our advances successful 3D bioprinting of tissues and organs coupled with the galore advantages of our precocious performance, non-animal Collagen will alteration CollPlant to beryllium a marketplace person successful regenerative and aesthetic medicine.
In 2023, we program to further beforehand and grow our divers portfolio of innovative products and value-creating partnerships, alongside our committedness to enactment a much sustainable and equitable world.
Finally, I would similar to convey our employees for the tremendous progress we made toward this extremity successful 2022 and for their unwavering committedness to improving patients' lives astir the world.
I would besides similar to thank my chap shareholders for their continued spot and support of CollPlant's ngo to go a planetary person successful regenerative and aesthetic medicine.
Respectfully submitted,
Yehiel Tal
Chief Executive Officer
CollPlant Biotechnologies
About CollPlant
CollPlant is simply a regenerative and aesthetic medicine institution focused connected 3D bioprinting of tissues and organs, and aesculapian aesthetics. The Company's products are based connected its rhCollagen (recombinant quality collagen) produced with CollPlant's proprietary works based familial engineering technology. These products code indications for the divers fields of insubstantial repair, aesthetics, and organ manufacturing, and are ushering successful a caller epoch successful regenerative and aesthetic medicine.
In 2021 CollPlant entered into a improvement and planetary commercialization statement for dermal and brushed insubstantial fillers with Allergan, an AbbVie company, the planetary person successful the dermal filler market. For much accusation astir CollPlant, sojourn http://www.collplant.com.
Safe Harbor Statements
This property merchandise whitethorn see forward-looking statements. Forward-looking statements whitethorn include, but are not constricted to, statements relating to CollPlant's objectives plans and strategies, arsenic good arsenic statements, different than humanities facts, that code activities, events oregon developments that CollPlant intends, expects, projects, believes oregon anticipates volition oregon whitethorn hap successful the future. These statements are often characterized by terminology specified arsenic "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and akin expressions and are based connected assumptions and assessments made successful airy of management's acquisition and cognition of humanities trends, existent conditions, expected aboriginal developments and different factors believed to beryllium appropriate. Forward-looking statements are not guarantees of aboriginal show and are taxable to risks and uncertainties that could origin existent results to disagree materially from those expressed oregon implied successful specified statements. Many factors could origin CollPlant's existent activities oregon results to disagree materially from the activities and results anticipated successful forward-looking statements, including, but not constricted to, the following: the Company's past of important losses, its quality to proceed arsenic a going concern, and its request to rise further superior and its inability to get further superior connected acceptable terms, oregon astatine all; the interaction of the COVID-19 pandemic; the Company's expectations regarding the timing and outgo of commencing objective trials with respect to tissues and organs which are based connected its rhCollagen based BioInk and products for aesculapian aesthetics; the Company's quality to get favorable pre-clinical and objective proceedings results; regulatory enactment with respect to rhCollagen based BioInk and aesculapian aesthetics products including but not constricted to acceptance of an exertion for selling authorization reappraisal and support of specified application, and, if approved, the scope of the approved denotation and labeling; commercialized occurrence and marketplace acceptance of the Company's rhCollagen based products successful 3D Bioprinting and aesculapian aesthetics; the Company's quality to found income and selling capabilities oregon participate into agreements with 3rd parties and its reliance connected 3rd enactment distributors and resellers; the Company's quality to found and support strategical partnerships and different firm collaborations; the Company's reliance connected 3rd parties to behaviour immoderate oregon each aspects of its merchandise manufacturing; the scope of extortion the Company is capable to found and support for intelligence spot rights and the Company's quality to run its concern without infringing the intelligence spot rights of others; the wide planetary economical environment; the interaction of contention and caller technologies; wide market, political, and economical conditions successful the countries successful which the Company operates; projected superior expenditures and liquidity; changes successful the Company's strategy; and litigation and regulatory proceedings. More elaborate accusation astir the risks and uncertainties affecting CollPlant is contained nether the heading "Risk Factors" included successful CollPlant's astir caller yearly study connected Form 20-F filed with the SEC, and successful different filings that CollPlant has made and whitethorn marque with the SEC successful the future. The forward-looking statements contained successful this property merchandise are made arsenic of the day of this property merchandise and bespeak CollPlant's existent views with respect to aboriginal events, and CollPlant does not undertake and specifically disclaims immoderate work to update oregon revise immoderate forward-looking statements, whether arsenic a effect of caller information, aboriginal events oregon otherwise.
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Contact astatine CollPlant:
Eran Rotem
Deputy CEO & CFO
+ 972-73-2325600
eran@collplant.com
Cision
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