That is interesting - huge market, but weird treatment and somewhat flaky-sounding company.
Our product, the RHEO System, is designed to improve microcirculation in the eye by filtering high molecular weight proteins and other macromolecules from the patient’s plasma. The RHEO System is used to perform Rheopheresis, which we refer to under our trade name RHEO Therapy. Rheopheresis is a blood filtration process that selectively removes molecules from plasma. The RHEO System consists of the OctoNova pump and a disposable treatment set, containing two filters, through which the patient’s blood circulates. We believe that the RHEO System is the only Dry AMD treatment to target what we believe to be the underlying cause of AMD rather than its symptoms and that, based on preliminary data, appears to demonstrate improved vision in some patients.
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We are an ophthalmic therapeutic company founded to commercialize innovative treatments for eye diseases, including AMD. The RHEO System is used to perform Rheopheresis, a procedure that selectively removes molecules from plasma, which is designed to treat Dry AMD, the most common form of the disease. Shortly after our inception, we focused on commercializing therapeutic apheresis, including the opening and operation of the Rheotherapy Center, which generated revenues of $900,200 and $1,277,800 for the fiscal years ended June 30, 1999 and 1998 respectively. In 1999, the FDA’s Office of Compliance issued a directive notifying the Rheotherapy Center that any further conducting of therapeutic apheresis would need to be conducted under the authority of an Investigational Device Exemption filed with the FDA which resulted in the closure of the Rheotherapy Center. Subsequent to the closure of the Rheotherapy Center, our focus changed primarily to conducting clinical trials and seeking regulatory approval for the RHEO System. In September 1999, we received an Investigational Device Exemption from the FDA to begin a pivotal clinical trial, MIRA-1, for the RHEO System. Between early 2000 and August 2001, we enrolled 98 patients in MIRA-1. In August 2001, due to financial constraints, we downsized and temporarily suspended the enrollment of new patients. However, we continued to follow-up with the existing patients enrolled in MIRA-1. In late 2001, with permission of the FDA, we submitted for independent third party analysis data for the 43 enrolled patients for whom we had collected complete 12-month post-treatment data sets. The results of this data analysis were used to support our efforts to secure additional financing.
In 2002 and 2003, we received a net aggregate of $5,951,870 of additional financing from Diamed, TLC Vision and other investors. As a result of this incremental funding, in October 2003, we hired new management and began screening additional patients for enrollment in MIRA-1. In addition, in 2003, we began limited commercialization of the RHEO System in three clinics in Canada.
In September 2004, we signed an agreement with Rheo Therapeutics Inc., a private Canadian company, which has agreed to purchase approximately 8,000 treatment sets, and an estimated 20 OctoNova pumps by the end of 2005, with an option to purchase up to an additional 2,000 treatment sets, subject to availability. We believe that Rheo Therapeutics plans to open a number of commercial treatment centers in various Canadian cities where RHEO Therapy will be performed. Dr. Jeffrey Machat, who is an investor in and one of the directors of Rheo Therapeutics, was a co-founder and former director of TLC Vision.
As of November 12, 2004, we have enrolled a total of 161 patients in MIRA-1. We have collected complete 12-month post-treatment data sets for 85 of these patients. Of the remaining 76 patients, 63 are in the process of treatment or follow-up and the treatment of 13 patients did not result in complete data sets. We are seeking to enroll an additional 19 patients in MIRA-1 with the goal of enrolling a total of 180 patients, from which we intend to derive the required 150 complete 12-month post-treatment data sets. We are seeking to complete enrollment for MIRA-1 by the end of 2004. We intend to submit to the FDA the first three of four modules of the PMA filing, the non-clinical portion, before the end of 2004. We intend to submit the fourth module, which consists of the follow-up clinical data, in two components. We expect that we will submit the first component following completion of our six-month data on at least 150 data sets, including the 12-month data sets for all patients for whom it is available; and that we will submit the second component following completion of our 12-month data on at least 150 data sets.
Talk about a binary company - this is either going to the moon or to crash and burn. I've not a clue which.
Peter |
