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SEC Filings

HEARTWARE INTERNATIONAL, INC. filed this Form 10-Q on 11/02/2015
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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, Valtech’s ability to obtain regulatory approval to commercialize its products, and its ability to generate revenue, will be materially adversely affected.

Regulatory approvals to sell Valtech’s 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 Valtech’s 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, Valtech’s 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. Valtech’s 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 Valtech’s products may materially harm Valtech’s or the combined company’s financial results and the commercial prospects for Valtech’s products.

The completion of any of Valtech’s 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; Valtech’s 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 Valtech’s 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.

Valtech’s success will depend to a significant degree on Valtech’s ability to secure and protect intellectual property rights and to enforce patent and trademark protections relating to Valtech’s technology. From time to time, litigation may be advisable to protect Valtech’s intellectual property position. However, these legal means afford only limited protection and may not adequately protect Valtech’s 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 Valtech’s other intellectual property rights. Litigation could result in the rejection or invalidation of Valtech’s existing and future patents. Any adverse outcome in litigation relating to the validity of Valtech’s patents, or any failure to pursue litigation or otherwise to protect Valtech’s 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 Valtech’s 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.