Presbia discloses staff reduction, search for investor or strategic partner
In a regulatory filing, Presbia said that, based on recent conversations and correspondence with the FDA, it has determined that the FDA will not be willing to grant the company's pending application for premarket approval, or PMA, for the company's microlens product based on the company's current FDA staged pivotal clinical trial for its microlens product, but is likely to require that a new, additional -- albeit potentially abbreviated -- clinical trial to be undertaken and completed prior to issuing any approval of the PMA. In light of the foregoing, on April 18, the board approved a reduction of staffing and efforts by the company in connection with its pursuit of the PMA. As previously disclosed, earlier this month, the FDA granted an extension of time through September 30 to complete the company's 36-month Clinical Study Report and provide additional safety and efficacy related information relating to the company's PMA application. Given Presbia's limited cash position, together with its lack of sources of additional capital, the company has determined that it will need an investor or strategic partner in order to continue pursuit of the trial and the PMA application. In connection with this, the board has approved a partial reduction of scope of the business of the company in the U.S., with such process to commence immediately. Approximately three employees or contractors will be retained to assist with the efforts to locate an investor or strategic partner and maintain the assets of the business and the rest will be terminated. The company is in discussion with creditors and vendors, and is making efforts to, among other things, preserve and maximize the value of its assets including all of its intellectual property and clinical data. Operations in Europe will continue for approximately three months. During the three month period, the company will pursue and evaluate opportunities to identify an investor or strategic partner in order to continue pursuit of the trial and the PMA application, or to otherwise monetize its intellectual property and related assets through a potential sale or partnering arrangement. No assurances can be provided that the company will be able to locate any interested party or enter into any transaction for a potential sale or partnering arrangement. As Presbia cannot yet determine whether its efforts to find an investor or strategic partner will be successful, or what the nature of any such transaction will be, it cannot at this time estimate any charges associated with the foregoing process.