PHILADELPHIA, June 19 /PRNewswire/ -- Gentis Inc., the developer of the DiscCell(TM) in-situ polymerizing spinal nucleus augmentation technology, today announced the closing of its first institutional financing. The $10 million round, co-led by Pappas Ventures (Durham, NC) and Easton Capital (New York, NY), also included significant funding from Ivy Capital Partners (Montvale, NJ) and Matignon Technologies (Paris, France). Gentis will use the funds to complete the remaining pre-clinical testing and the pilot clinical study required to file an IDE for a pivotal trial with the FDA in 2008.
“Gentis’ progress over the past year and their successful first in human implants in May demonstrated to the investor group the dedication of the Gentis team, the quality of their relationships in the spine market and the potential superiority of the DiscCell material over other technologies being investigated in the exciting and expanding market of spinal nucleus augmentation,” commented Arthur Klausner, Partner at Pappas Ventures. “The Gentis team continues to demonstrate the merits of its differentiated DiscCell technology in its clinical trial in Sao Paulo, which should lead to a dynamic pivotal trial in the US in the near future,” added Frank Garcia, Partner at Easton Capital Partners. Joining Mr. Klausner and Mr. Garcia on the Gentis Board will be Robert Pangia, Partner at Ivy Capital.
“The Gentis team welcomes the new members of the Board and looks forward to utilizing the expertise of all the investors as we move the DiscCell further into the clinic and prepare for the US pivotal trial,” stated David W. Anderson, Gentis President and CEO. “The unique skills and resources of the investors will enhance our internal resources and build upon a sound base to achieve significant milestones over the coming months,” continued Mr. Anderson.
The Gentis pilot clinical study that was begun in May is being conducted at the Hospital do Servidor Estadual in Sao Paulo, Brazil by Carlos Oliveira, MD. Dr. Oliveira commented that, “Enrollment in the study should proceed quickly since the first patient results were so good that they have become advertising for the study.” Gentis anticipates that the full study will enroll in 2007 and should lead to a submission for CE mark in 2008.
About Gentis and DiscCell(TM):
Gentis is a Pennsylvania based biomaterials and orthopaedics company that has developed and tested several proprietary device technologies that address unmet needs in musculoskeletal medicine. Gentis’s lead product, DiscCell, a proprietary, injectable, in-situ polymerizing spinal nucleus augmentation device has completed a substantial portion of pre-clinical testing and is the subject of an ongoing pilot study in patients who have undergone a discectomy. Gentis will add the results of this trial to its extensive pre-clinical package for the submission of an IDE to the FDA to allow the start of a pivotal trial in the US in 2008.
Source: Gentis, Inc.
