Orthovita submits response to FDA

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 and European investigations that was previously submitted as part of the Cortoss 510(k) application.

Encision gets Amex delisting notice

Encision (Boulder, Colorado) said it received notice from the American Stock Exchange (Amex) indicating that, due to Encision's continued failure to comply with certain of the Amex's continued listing standards, the exchange intends to immediately file a delisting application with the Securities and Exchange Commission to drop Encision's common stock from the exchange.

The Amex's notice indicates that, based on a review of the company's Form 10-KSB for the year ended March 31, Form 10-Q for the period ended June 30 and information provided by the company, the exchange has determined that the company has not made progress consistent with its plan of compliance and that there is no basis for the Amex to conclude that the company could regain compliance by the Jan. 16, 2009, deadline. The company does not intend to appeal the delisting.

Encision makes surgical devices that allow surgeons to optimize technique and patient safety during a broad range of surgical procedures.

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.

Playtex launches VentAire advanced bottle

Playtex Products (Westport, Connecticut), a subsidiary of Energizer Holdings, and the maker of Playtex Infant Care products, said it is launching the VentAire advanced bottle, in a bisphenol-A (BPA)-free material, which will begin shipping in October.

The new VentAire advanced bottle is made out of BPA-free clarified polypropylene, a durable and translucent plastic. The bottle design offers superior benefits for infants as it has been clinically shown to reduce colic, gas and spit-up better than competitors, as shown in a clinical study of over 11,000 feedings. In fact, 8 out of 10 moms in the study confirmed that their baby showed fewer signs of colic using the VentAire advanced system versus three leading brands.

"The VentAire advanced bottle was designed with a unique micro-channel bottom vent to prevent air from mixing with the liquid ensuring that infants don't ingest excess air," said John Rousso, director of research and development for Playtex Infant Care. "And its unique angled shape supports a semi-upright feeding position, which is recommended by pediatricians to help prevent ear infections."

PPD to amend cash dividend

PPD (Wilmington, North Carolina), a contract research organization, said its board of directors has amended the company's annual cash dividend policy to increase the annual dividend rate by 25%, from $0.40 to $0.50 per year, payable quarterly at a rate of $0.125 per share. PPD expects the new dividend rate will be effective beginning in 4Q08.

"PPD's board of directors, management team and employees are delighted to reward our shareholders with the third consecutive annual increase in our cash dividend rate since the adoption of the dividend policy in 2005," said CEO Fred Eshelman. "We remain firmly committed to generating long-term shareholder value through the delivery of high-quality services and the advancement of our compound portfolio strategy, and returning value to our shareholders."