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Wound-Healing Mist Device to Have U.K. Clinical Trial

An ultrasound device to heal wounds and ulcers through mist emissions will undergo a clinical trial in Britain, in the first example of the testing of medical technology to result from guidance issued by the U.K.’s health-cost agency.

The National Institute for Health and Clinical Excellence said last year that more research was needed to show the efficacy of Celleration Inc.’s MIST Therapy System before it can be approved for use in the state-run National Health Service. The technology will be tested on 40 patients to determine whether it heals wounds better than existing treatment, the London-based agency, known as NICE, said.

The trial will be carried out by Cardiff University and the Cardiff and Vale University Health Board. NICE’s Medical Technologies Advisory Committee sought the research last year after deciding there wasn’t enough evidence to recommend that the NHS pay for the treatment.

“The committee thought that the MIST system showed real promise, but there simply wasn’t the quantity and quality of evidence needed to support the case for adoption at that point,” said Carole Longson, director of NICE’s Health Technology Evaluation Center, in a statement today.

NICE will have no involvement in the testing, which Celleration is paying for. The closely held company is based in Eden Prairie, Minnesota.

“There is a small amount of evidence to suggest that ulcers treated with MIST will heal more quickly than those having usual treatment,” said Keith Harding, investigator at the Wound Healing Research Unit at Cardiff University. “This trial will enable us to generate more independent evidence to show if this is actually the case.”

The device promotes healing using low-intensity ultrasound waves delivered through saline mist, encouraging repair by stimulating cells below a wound, according to the company. The therapy reduces inflammation and provides painless treatment that makes no contact with the lesion, the company says. The device costs £7,500 ($11,900) to rent a year, and is intended to be used three times a week.

Positive guidance from NICE, which advises the NHS on the treatments that represent value for money, can accelerate a technology’s adoption in England.

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