CollPlant Holdings Ltd. (TASE: CLPT) today announced that the US Food and Drug Administration (FDA) is requiring the long-track premarket approval (PMA), rather than the fast-track 510K approval process for the company's Vergenex wound dressing matrix for chronic wounds. This means that the approval process will take years, rather than months.
Collplant was prepared for this scenario. In a statement today, chairman Effi Cohen-Arazi said, "The company's regulatory achievement lies in the fact that the product is registered as a medical device, not as a biological drug." He said that the company expected the PMA process, and had already begun the necessary clinical trial.
Collplant is also seeking EU CE Mark for the Vergenex wound management and Vergenix Flowable Gel for treatment of chronic wounds, which it believes has greater potential. It hopes to obtain approval for these products in a year. If it conducts additional clinical trials in Europe, it will receive payments for the treatments as part of the trials. Cohen-Arazi believes that substantial revenue from these two products will begin in 2013.
Vergenex wound management and Vergenix Flowable Gel are just two of the products in Collplant's pipeline. The company already markets its human collagen, produced from tobacco plants, to research institutes, and recently signed a large commercial distribution agreement for the product. It also has joint product development agreements with Pfizer Inc. (NYSE: PFE; LSE: PFZ), Edwards Lifesciences Inc. (NYSE: EW), and Eyegenix Inc. Cohen-Arazi says that these joint ventures are making good progress, but that the company will only see revenue from them in 2014. The company currently has no substantial revenue.
Collplant's share price was unchanged at NIS 0.50 today, giving a market cap of NIS 63 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 15, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012