A Medical Device Daily

Artes Medical (San Diego) said it has formed a new wholly owned subsidiary, Spheris Medical , to develop and commercialize new medical applications of its microsphere tissue bulking technology.

Artes Medical’s technology is currently incorporated in ArteFill, an FDA-approved non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds, according to the company. The company will license the non-aesthetic applications of its medical technology to Spheris Medical, which going forward will focus on the development of new product applications, enter into licensing arrangements and selected strategic partnerships.

Spheris Medical plans to apply Artes Medical’s microsphere technology to develop soft tissue augmentation products, which provide long-lasting tissue reshaping for a variety of therapeutic uses. In preclinical studies, materials produced with the Artes Medical technology have been used to provide bulking of the esophageal sphincter and the urinary sphincter to assess the possible use of the technology for the treatment of GERD gastroesophageal reflux disease (GERD) and stress urinary incontinence (SUI), the company said. Other non-company preclinical studies also have been conducted to evaluate the technology for spinal disk bulking and repair. Additional potential uses include bulking of the soft palate and respiratory tissue to treat snoring for patients with sleep apnea, adding cushioning to the bottom of the foot to treat painful foot syndrome, and treatment of fecal incontinence, Artes noted.

ArteFill was approved by the FDA in October 2006 based on data from the company’s 12-month controlled, randomized, double-masked, multi-center U.S. clinical trial, which compared outcomes for patients treated with ArteFill with those of patients treated with the leading bovine collagen-based filler. At the six-month evaluation, which was the primary efficacy evaluation period for the clinical trial, the wrinkle correction in patients treated with ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment status, the company said. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.

The company also said it recently completed a five-year follow-up study of 145 patients who were treated with ArteFill in the company’s U.S. clinical trial.

In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant improvement in patient wrinkle correction five years after the patient’s last ArteFill treatment, and a statistically significant improvement in wrinkle correction at the 5-year point compared to the 6-month evaluation period. As part of the study, physician investigators and patients were asked to provide their assessment of ArteFill treatment. More than 90% of the physician assessments were either “completely successful” or “very successful” and more than 90% of the patient assessments were either “very satisfied” or “satisfied,” according to the company. Artes Medical said it has submitted the data from the study to the FDA for review in order to enhance the product labeling for ArteFill.

An ArteFill Skin Test is required before initial treatment. The most common adverse events associated with ArteFill treatment, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site, the company noted.

ArteFill is comprised of polymethylmethacrylate (PMMA), microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles. Artes Medical said ArteFill is only available in the U.S.