Chemistry council recognizes bisphenol A study
The American Chemistry Council (ACC; Arlington, Virginia) said it is aware of a new study on bisphenol A published in the Journal of the American Medical Association that reports a statistical association between urinary bisphenol A concentrations and medical disorders in adults.
"As with any study," said the organization, "it is critically important to understand how the design of a study can limit interpretation of the study findings."
The group said the new study is a statistical analysis "that attempts to correlate urinary concentrations of bisphenol A, which reflect very recent exposure, with the incidence of cardiovascular disease and diabetes. However, the onset and development of these diseases occurred over time periods well before the bisphenol A exposure measurements were made. Because of this and other inherent limitations, the study is not capable of establishing a cause and effect relationship between bisphenol A and these health effects."
Orthovita gives response to FDA on Cortoss study
Orthovita (Malvern, Pennsylvania), a spine and orthopedic biosurgery company, said that it recently submitted its response to the initial set of comments received from the FDA to its 510(k) application for the use of Cortoss bone augmentation material in vertebral augmentation.
After receiving the FDA's initial comment letter in March, Orthovita requested a 180-day extension from the FDA for its response in order to collect and submit additional two-year follow-up patient data from its pivotal U.S. Cortoss clinical study that was conducted under an FDA Investigational Device Exemption (IDE).
FDA granted Orthovita's request and Orthovita submitted its response to the FDA within the extension period. This response increases the number of patients in the pivotal study for whom two-year follow-up data has been submitted to approximately two-thirds of the original pivotal IDE study cohort. This data is in addition to the long-term follow-up data from Orthovita's earlier pilot studies.
Zila completes 1-for-7 stock split
Zila (Phoenix) said it has completed a 1-for-7 reverse stock split. Accordingly, every seven shares of the company's common stock have been combined into one share of common stock. Fractional shares will be issued to Zila's shareholders to the extent required by the impact of the reverse stock split.
"I am very pleased that the holders of 73% of our shares participated in the reverse stock split decision, with 93% of those that participated voting in favor of the reverse split," said Chairman/CEO David Bethune. "The company will continue with its efforts to reduce expenses and improve revenues over the coming months."
The reverse stock split affects all of Zila's outstanding common stock, as well as the number of shares issuable upon the exercise or conversion of the company's outstanding warrants, convertible notes, options and other similar rights. In addition, the number of shares of common stock that Zila is authorized to issue was reduced to 30 million in connection with the reverse stock split.
Zila is an oral diagnostic company focused on the prevention, detection and treatment of oral cancer and periodontal disease.