Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) said it has resubmitted its new drug application (NDA) for a drug device that potentially offers a breakthrough in pulmonary imaging.
It has done so after discussion with the US Food & Drug Administration (FDA) following the receipt of a Complete Response Letter (CRL), which raised issues the company has now addressed.
“The entire Polarean team has worked diligently to ensure that all the points raised in the CRL were comprehensively addressed,” said chief executive Richard Hullihen.
"We look forward to completing the FDA review and approval processes necessary to bring our unique technology to market addressing the significant unmet need for our non-invasive, quantitative and cost-effective functional lung imaging."
The review by the regulator is expected to take six months.
Polarean said it is making "full use" of this time preparing for commercialisation and launch of its product.
The group has developed equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging using hyperpolarised xenon gas.