Tuesday, December 1, 2020
Home Latest Pharma-News AVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility...

AVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility study in order to evaluate Recell system for Vitiligo

Dec 30, 2019: AVITA Medical Limited announced that the U.S. FDA has approved the company’s Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL® Autologous Cell Harvesting Device (RECELL® System) for repigmentation of depigmented lesions associated with stable vitiligo.

Vitiligo affects approximately 6.5 million people in the United States, rivalling the predominance of psoriasis. Conversely, there are limited treatment options available to patients to permanently restore skin pigmentation.

- Advertisement -

Vitiligo is a disease that causes loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition.

Currently, there is no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease.AVITA Medical will collaborate with a leading medical centre in order to conduct a pilot study with 10 patients, have vitiligo lesions that have been stable for at least one year.

Areas of the vitiligo lesion will be randomly treated with slightly altering cell suspensions prepared using RECELL to confirm response rates and best possible suspension parameters. https://www.avitamedical.com/uploads/pdf/AVH-Press-Release-Vitiligo-IDE-Approval-30DEC2019-FINAL.pdf

LEAVE A REPLY

Please enter your comment!
Please enter your name here

three × one =

Most Popular

Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

November 30, 2020: Eisai and Wren Therapeutics announced that the companies have entered into an exclusive research collaboration agreement aiming to advance...

AstraZeneca agreed to sell rights to Crestor to be divested to Grünenthal in Europe

December 01, 2020: AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the...

AstraZeneca’sForxiga approved in Japan for chronic heart failure

November 30, 2020: AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving...

Moderna Announces the EC Approval for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

November 25, 2020: "Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines...