Injectable filler material can restore the voice and facial fullness.(PRODUCTS)

An injectable material, based on calcium hydroxylapatite (CaHA), may prove useful in treating people with voice loss or who suffer from facial wasting.

The material, known as Radiesse, was developed by US company BioForm Medical Inc.

It is used in various cosmetic, reconstructive and ear, nose and throat (ENT) applications to augment and contour folds, depressions and vocal fold defects of the facial area.

Composed of tiny, smooth CaHA particles suspended in a water-based gel carrier, the filler material has been proven safe and biocompatible in a range of soft tissue applications.

The material also allows steady growth of collagen matrix, produces virtually instant results and lasts for one to three years, according to the manufacturer.

Vocal fold treatment

An increasing number of people suffer from a form of voice loss known as vocal fold insufficiency, a medical condition in which one or both vocal folds, or cords, lack the physical capacity to vibrate properly.

The result is poor voice quality that has the capacity to compromise a person's quality of life, according to BioForm.

A multi-centre clinical study, the results of which were presented recently at the American Association of Otolaryngology-ENT in Los Angeles, found that some 94% of the study patients had improved voice quality six months after treatment. The study involved more than 100 patients.

Lead investigator and voice specialist Dr Clark Rosen, who presented his research findings, said the results indicated that CaHA was a valuable injectable material for glottal incompetence up to the six-month time point. Glottal incompetence usually occurs due to muscle damage or muscle loss associated with ageing.

The treatment was also used in cases of paralysis of the vocal folds, in which one of the vocal cords does not move to meet the middle opening between the two vocal folds. Typically, paralysis of the vocal folds results from a medical condition such as lung cancer or neck or chest surgery

Dr Rosen is the Director of the University of Pittsburgh Voice Center.

Facial wastage treatment

BioForm carried out a multi-site study on the use of Radiesse for this problem, under an Investigational Device Exemption. The aim was to assess the safety and effectiveness of Radiesse injections for restorative treatment of HIV-associated facial lipoatrophy with a view to marketing clearance.

One hundred patients were enrolled at three sites: two centres in New York City and one in San Francisco.

All the patients reported a significant improvement in their appearance at 12 months after the treatment.The research findings were published in a special supplement of the September 2005 issue of Plastic Surgery Journal.

The study results were also presented at the recent meetings of the American Society of Plastic Surgery and American Academy of Facial Plastic and Reconstructive Surgery. Lead investigator on the study was Dr Stacey Silvers, Executive partner, Madison ENT & Facial Plastic Surgery in New York City.

For further information, contact: BioForm Inc, Corporate Headquarters, 1875 South Grant Street, Suite 110, San Mateo, CA 94402, USA; tel: +1-650-286-4000; fax: +1-650-286-4090; E-mail: info@bioformmedical.com; Internet: www.bioformmedical.com; or European Office, Everdenberg 11, 4902 TT Oosterhout (Nbr), The Netherlands; tel: +31-0-162-474-800; fax: +31-0-162-474-810.