SLIDE 1
Regenerated Organs for Transplant
NASDAQ: HART
Safe Harbor Statement
2 This presentation contains forward-looking statements within the meaning of the federal securities laws. You can identify these statements by our use
- f such words as “will,” “guidance,” “objectives,” “optimistic, “ “future,” “expects,” “plans,” “estimates,” “continue,” “drive,” “strategy,” “potential,”
“potentially,” “growth,” “long-term,” “projects,” “projected,” “intends,” “believes,” “goals,” “sees,” “seek,” “develop,” “possible,” “new,” “emerging,” “opportunity,” “pursue” and similar expressions that do not relate to historical matters. Forward-looking statements in this presentation may include, but are not limited to, statements or inferences about the Company’s or management’s beliefs or expectations, the outlook for the life sciences industry and the field of regenerative medicine, the Company’s current products or products in development, the Company’s business strategy, the Company’s anticipated regulatory approvals, future revenues and earnings, the strength of the Company’s market position, business model and intellectual property rights, opportunities or potential opportunities in the field of regenerative medicine and related markets, the success of existing treatments utilizing the Company’s products, the market demand and opportunity for the Company’s current products, or the products it is developing or intends to develop and the Company’s plans, objectives and intentions that are not historical facts. These statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause the Company’s actual results to differ materially from those in the forward-looking statements include the Company’s ability to
- btain regulatory approvals, including in the U.S. and the EU , for the Company’s products, including its HART-Trachea; the success of the Company’s
clinical trials and product development programs and the number of patients who can be treated with its products; the amount and timing of costs associated with the Company’s development of its products; the Company’s failure to comply with regulations and any changes in regulations; the Company’s ability to access debt and equity markets to raise or obtain needed funding; the Company’s failure to effectively commercialize or market
- ur products on a timely basis or at all; lack of demand or decreased demand for the Company’s products; the current size or anticipated size of the
regenerative medicine market; the existence and size of opportunities in the regenerative medicine market; the Company’s financial position and ability generate revenues and profits; unpredictable difficulties or delays in the development of new technology; the Company’s collaborators not devoting sufficient time and resources to successfully carry out their duties or meet expected deadlines; the Company’s ability to attract and retain qualified personnel and key employees and retain senior management; the Company’s inability to operate effectively as a stand-alone, publicly traded company; the actual costs of the Company’s separation from Harvard Bioscience may be higher than expected; the availability and price of acceptable raw materials and components from third-party suppliers; difficulties in obtaining or retaining the management and other human resource competencies that the Company needs to achieve its business objectives; increased competition in the field of regenerative medicine and the financial resources of the Company’s competitors; the Company’s ability to obtain and maintain intellectual property protection for its device and product candidates; the Company’s inability to implement its growth strategy; the performance of the Company’s collaborators; public perception and ethical issues surrounding the use of cell technologies; the Company’s liability exposure relating to our products; the Company’s ability to operate without infringing on others’ intellectual property; potential costs of any lawsuits to protect or enforce its intellectual property; economic, political and other risks associated with international revenues and operations and additional costs of complying with changes in regulatory rules applicable to public companies; the Company’s ability to achieve the benefits of its planned separation from Harvard Bioscience, Inc., plus factors described under the heading “Item 1A. Risk Factors”, in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2014 or described in the Company’s
- ther public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The Company may not
update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information. Except as otherwise noted herein, any forward looking statements represent our estimates as of August 14, 2014 and should not be relied upon as representing
- ur estimates as of any other date.