(MENAFN - ProactiveInvestors - Australia) Cyclopharm (ASX: CYC) has begun a clinical trial of its Technegas product in the U.S., enrolling the first patient in the trial that is required for market entry in the region.
The company provides radiopharmaceutical services to the medical profession including Technegas which is a gas that patients inhale prior to imaging to assist in the diagnosis of blood clots in the lungs.
Over half of the world's nuclear medicine departments are located in the U.S., representing the single biggest growth opportunity for Technegas.
The first patient study to be enrolled and imaged under the U.S. Food and Drug Administration approved protocol was conducted at the Presbyterian/Columbia University Medical Center in New York.
A total of 750 patients are required for the study, and it is expected that the multicentre trial will take up to 18 months to complete.
Investigational sites will be progressively added throughout 2012 and 2013 to meet the target of 750 patients.
Cyclopharm's product Technegas was discovered in 1984 and since that time, more than 1,000 Technegas systems have been installed in hospitals throughout the world and more than 1.7 million Technegas patient studies have been completed.
The Techengas system is a device which creates Technegas " an ultrafine dispersion of Tc99m labelled carbon used for nuclear medicine ventilation/perfusion (V/Q) exams.
V/Q imaging is the primary technique used to diagnose pulmonary embolism, a life threatening condition.
Technegas has proven to be superior compared to the typical aerosol agents including Xenon-133 gas, Krypton-85 gas and Technetium 99m.
The resultant gaseous substance is inhaled by the patient via a breathing apparatus, which then allows multiple views and tomography imaging under a gamma or single photon emission computed tomography (SPECT) camera for the diagnosis of blood clots in the lungs.
Expanding market potential
Cyclopharm continues to develop new indications for Technegas. Disease states including Chronic
Obstructive Pulmonary Disease and Lung Cancer have significant market potential for Technegas and are currently being targeted with clinical studies now underway.
The company's pursuit of an expanded indication is fuelled by the market potential, with the Chronic Obstructive Pulmonary Disease market estimated at 15 to 20 times the size of that of the pulmonary embolism market Cyclopharm currently occupies.
Underwritten capital raising
Cyclopharm will raise around A2.1 million in a fully underwritten one for four renounceable rights issue to fund Cyclopet's operations and the start of the Technegas clinical trial in the U.S.
Earlier this month the company revealed it will issue 11.6 million shares at 0.18 each.