A Medical Device Daily

Cytori Therapeutics (San Diego) said it intends to commercialize its Celution System in Europe early next year for use in reconstructive surgery in breast cancer patients following a partial mastectomy, or lumpectomy, in advance of the original anticipated timeline.

The system automates the process that releases stem and regenerative cells locked within adipose tissue, enabling patients' own stem and regenerative cells to be obtained at the bedside in real time.

The accelerated timetable for product launch is primarily the result of Cytori receiving a favorable regulatory notice regarding the Celution System by the Competent Authority, a European medical device governing body. The notice positions it to obtain expanded therapeutic claims for the system that would comprise key clinical applications, including plastic and reconstructive surgery.

"Our decision to accelerate commercialization by approximately one year is due to our regulatory progress and three additional developments," said CEO Christopher Calhoun. "First, emerging clinical and pre-clinical experience demonstrates safety and efficacy. Second, there is strong demand from physicians to make this therapy available to their patients. Third, expansion and validation of [our] manufacturing facilities enable us to bring these products to market on an accelerated schedule."

"We are appointing independent distributors in Europe to address this market opportunity," said Bruce Reuter, senior VP of international sales, marketing and distribution. "Clinical results coupled with patient and physician demand will allow us to expand our network of surgeons and institutions in targeted regions to which we will initially sell Celution Systems. We [also] intend to broaden visibility, gain post-marketing clinical experience and use the data to help secure reimbursement for the technology."

Preliminary safety findings were reported last November from an 11-patient, investigator-initiated study using adipose-derived stem and regenerative cells to reconstruct breast tissue following partial mastectomy and radiation therapy. In the study, which took place at Kyushu Central Hospital in Japan, the cells were extracted using the Celution System. The study was subsequently expanded to include eight additional patients.

"We now have a strong indication that the technology is ready for this group of patients who currently do not have a meaningful reconstructive option," said Marc Hedrick, MD, president of Cytori.

Some 300,000 patients are diagnosed with breast cancer each year in Europe and more than 200,000 in the U.S. About 60% of those patients will be treated with lumpectomy procedures, representing a trend that is increasing with early detection.

Cytori has increased its manufacturing capabilities to supply Celution Systems to meet initial demand in Europe. Starting in late 2008, next-generation Celution Systems will be manufactured by the Olympus-Cytori joint venture.

CANADA okays Medicsight products

Medicsight (London) has been granted medical device licenses from the Therapeutic Products Directorate of Health Canada to begin marketing and selling its ColonCAD API and LungCAD API.

The computer-aided detection (CAD) products are designed to be integrated into either 3-D workstations or picture archiving and communications systems to assist radiologists in the identification of potentially fatal lesions found in the lung and polyps found in the colon.

CEO David Sumner said, "These approvals build on [our] recent ColonCAR market release in the U.S. and Europe and expands the addressable market of our CAD products for the company and its distribution partners."

He added, "ColonCAD addresses many of the difficulties faced by radiologists and has been designed to help unlock the full potential of virtual colonoscopy. Our LungCAD is designed to allow radiologists to detect and segment lung nodules at early stage, enhancing treatment options and disease management."

ColonCAD API is an image-analysis software tool designed to be used with computed tomography (CT) colonography also known as virtual colonoscopy to assist in detecting and measuring potential colorectal polyps. It has been developed using one of the world's largest CT scan databases of verified CT colonography data.

LungCAD API is a software tool designed to assist in the evaluation of pulmonary nodules on CT scans of the lung. Developed using one of the world's largest and most

MedicSight is a subsidiary of MGT Capital Investments.