Robert Kiyosaki is not securities dealers or brokers, investment advisers or financial advisers, and you should not rely on the information herein as investment advice. Conexeu Sciences Inc. has paid Robert Kiyosaki a fee of $125,000 as consideration for marketing services to be provided over a term of 90 days. [Robert Kiyosaki is a non-arm's-length party who owns zero common shares of Conexeu Sciences Inc.] This newsletter is for informational purposes only. This does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor does it constitute investment, legal, or tax advice. Prospective investors should consult qualified legal, financial, and tax advisors before making any investment decision. The securities issued by the companies we profile should be considered high risk. If you do invest despite these warnings, you may lose your entire investment. Please do your own research before investing, including reading the companies’ SEC and SEDAR+ filings, press releases, and risk disclosures. We also recommend reviewing any applicable prospectus or offering memorandum filed by the company. The information contained in this newsletter was obtained from the company directly, as well as from SEC and SEDAR+ filings, company websites, and other publicly available sources. While we believe such information to be accurate and reliable, we cannot guarantee its accuracy and prospective investors should conduct their own due diligence.
Forward Looking Statements
This newsletter includes certain statements that may be deemed “forward looking statements”. All statements in this newsletter, other than statements of historical facts, that address events or developments that Conexeu Sciences Inc. (the “Company” or “CXU”) expects to occur, are forward looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur.
Forward-looking statements include, but are not limited to, statements regarding: the Company's plans to seek regulatory clearance or approval for its CXU™ product candidates across its target indications, including wound care, dental soft tissue regeneration, veterinary wound care, and medical aesthetics; the Company's anticipated timelines for regulatory submissions, clinical programs, and commercial market entry across its target verticals; the Company's belief that its regulatory strategy will compress timelines and reduce costs relative to alternative regulatory pathways; the Company's expectation that its CXU™ platform is designed to extend across multiple indications from one core formulation; the Company's expectation regarding the manufacturing, storage, and logistical advantages of its product format, including ambient storage capability, point-of-care reconstitution, and global scalability; the Company's beliefs, based on preclinical data, regarding the performance characteristics and clinical potential of its CXU™ product candidates; the Company's expectation regarding its competitive positioning and potential in the medical aesthetics and regenerative medicine markets; and the Company's estimates regarding the size of the total addressable markets across its target verticals.
Forward-looking statements are subject to a variety of known and unknown risks, uncertainties, and other factors that could cause actual events or results to differ from those expressed or implied. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Certain important factors that could cause actual results, performance or achievements to differ materially from those in the forward-looking statements include, among others: additional capital requirements; inability to obtain sufficient funding; no history of commercial operations; no operating revenues; global financial conditions; regulatory risks, including the risk that applicable regulatory authorities do not grant clearance or approval for the Company's product candidates on anticipated timelines or at all; risks related to research and development activities and the uncertainty of their outcomes; manufacturing and supply chain risks; intellectual property risks; commodity markets; insured and uninsured risks; health, safety and community relations; environmental risks and hazards; currency rate risk; infrastructure; competitive industry environment; government regulation; management and organizational growth; climate change and climate change regulations; risk of litigation; reliance on key personnel; internal controls; conflicts of interest; interest rate risk; credit risk; liquidity risk; risks related to commercialization of the Company's products, including market acceptance, pricing, and reimbursement risks; competition from existing and new market entrants; and uninsurable risks.
Preclinical Status
The CXU™ device candidate is investigational. Statements regarding its mechanism, performance, or potential are based on preclinical findings; clinical significance has not yet been established. The Company has applied to pursue FDA clearance through the 510(k) pathway as a Class II device. There can be no assurance that the Company will obtain clearance on its anticipated timeline, or at all.