If Valtech is unable to commence or complete successfully its clinical trials, or if it
experiences significant delays in the successful commencement or completion of its clinical trials, Valtechs ability to obtain regulatory approval to commercialize its products, and its ability to generate revenue, will be materially
Regulatory approvals to sell Valtechs existing and future products typically require clinical trials,
which can be time consuming, unpredictable and expensive. Significant technical, bench and preclinical testing may be required prior to submitting for regulatory authorization to commence a clinical trial. The cost, timing and outcome of any of
these trials or testing may be unfavorable or may be insufficient to obtain the required approvals.
Completion of any of Valtechs
clinical trials could be delayed or adverse events during a trial could cause Valtech to amend, repeat or terminate the trial. If this were to happen, Valtechs costs associated with the trial will increase, and it will take Valtech longer to
obtain regulatory approvals and to commercialize the product, or Valtech may never obtain regulatory approvals. Valtechs clinical trials may also be suspended or terminated at any time by regulatory authorities, the data safety and monitoring
board, site investigational review boards, or by Valtech including during the closing stages of enrollment of the trial and the subsequent patient data follow-up period in the event that, for example, there should be an unacceptable level of adverse
clinical events. Any failure or significant delay in completing clinical trials for Valtechs products may materially harm Valtechs or the combined companys financial results and the commercial prospects for Valtechs products.
The completion of any of Valtechs clinical trials could be substantially delayed or prevented by several factors, including: slower
than expected rates of patient recruitment and enrollment, including as a result of study inclusion and exclusion criteria; Valtechs competitors undertaking similar clinical trials at the same time as Valtech, or having functionally comparable
products that have received approval for sale; physicians or patients preferring to use approved devices or other experimental treatments or devices rather than Valtechs devices; prevalence and severity of adverse events, such as thrombus or
stroke rates, and other unforeseen safety issues; and governmental and regulatory delays or changes in regulatory requirements, policies or guidelines.
If Valtech fails to protect its intellectual
property rights, its competitors may take advantage of its ideas and compete directly against Valtech or the combined company.
Valtechs success will depend to a significant degree on Valtechs ability to secure and protect intellectual property rights and to
enforce patent and trademark protections relating to Valtechs technology. From time to time, litigation may be advisable to protect Valtechs intellectual property position. However, these legal means afford only limited protection and
may not adequately protect Valtechs rights or permit it to gain or keep any competitive advantage. Any litigation in this regard could be costly, and it is possible that Valtech will not have sufficient resources to fully pursue litigation or
to protect Valtechs other intellectual property rights. Litigation could result in the rejection or invalidation of Valtechs existing and future patents. Any adverse outcome in litigation relating to the validity of Valtechs
patents, or any failure to pursue litigation or otherwise to protect Valtechs patent position, could have a material adverse effect on the future business, financial condition, results of operations and cash flows of Valtech or the combined
company. Also, even if Valtech prevails in litigation, the litigation would be costly in terms of management distraction as well as in terms of cash resources.
Consolidation in the health care industry could have an adverse effect on Valtechs expected revenues and results of operations.
Many health care industry companies, including health care systems, are consolidating to create new companies with greater market
power. As the health care industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions
for medical devices that Valtech plans to produce and sell.