The continuing development of many of Valtechs products depends upon Valtech maintaining
strong relationships with health care professionals. Notably, consolidation has occurred recently in the structural heart space as strategic players have acquired new technologies. Most of these players have greater financial resources and larger
employee pools than Holdco and Valtech.
The research, development, marketing and sales of many of Valtechs proposed products is
dependent upon Valtech maintaining working relationships with health care professionals. Valtech relies on these professionals to provide Valtech with knowledge and experience regarding the development, marketing and planned sale of Valtechs
products. Health care professionals assist Valtech as researchers, marketing and product consultants, inventors and public speakers. If Valtech is unable to maintain Valtechs strong relationships with these professionals and continue to
receive their advice and input, the development and marketing of Valtechs planned products could suffer, which could have a material adverse effect on Valtechs future earnings and financial condition.
Valtechs products are the subject of clinical trials, the results of which may be unfavorable, or perceived as unfavorable, and
could have a material adverse effect on Valtechs future business, financial condition, and results of operations.
As a part
of the regulatory process of obtaining marketing clearance or approval for new products and modifications to or new indications for existing products, Valtech conducts and participates in numerous clinical trials with a variety of study designs,
patient populations and trial endpoints. Unfavorable or inconsistent clinical data from existing or future clinical trials, or the markets or a regulatory bodys perception of this clinical data, may adversely impact Valtechs
ability to obtain product clearances or approvals in some or all geographies. Success in pre-clinical testing and early clinical trials does not always ensure that later clinical trials will be successful, and Valtech cannot be sure that later
trials will replicate the results of prior trials and studies. Any delay or termination of Valtechs clinical trials will delay the filing of product submissions and, ultimately, Valtechs ability to commercialize new products or product
modifications. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the products profile, which could inhibit further marketing and development of such products.
Valtechs success is related to managements performance.
To a large extent, Valtechs success is predicated on the ability of its management team to effectively manage Valtech and the individual
businesses that it operates. The loss of the services of a senior manager or other key employee without an adequate replacement or the inability to attract and retain new and qualified resources could have a negative impact on Valtechs
business outlook, activities and operating and financial results.
Valtechs business is dependent on its relationship with
Valtech currently manufactures its products at its own facilities or through subcontractors located in various
countries, purchasing the components and materials used to manufacture these products from various suppliers. However, specific components and raw materials are purchased from primary or main suppliers (or in some cases, a single supplier) for
reasons related to quality assurance, cost-effectiveness and availability. While Valtech works closely with its suppliers to expand capacity and ensure supply continuity, it cannot guarantee that its efforts will always be successful. Moreover, due
to the strict standards and regulations governing the manufacture and marketing of its products, Valtech may not be able to quickly locate new supply sources in response to a supply reduction or interruption, with negative effects on its ability to
manufacture its products effectively and in a timely fashion.