Continence Control Systems starts first human implant recruitment

BioTech Capital (ASX:BTC) investee company Continence Control Systems International (CCS) has commenced patient recruitment for its severe urinary incontinence treatment, following completion of pre-clinical studies and human ethics approval for human implants.

CCS was formed from a collaboration between the University of Melbourne and Cochlear (ASX:COH) to commercialise a replacement bladder sphincter muscle from a ring of a patient's own muscle. Medical devices specialist Cochlear provided the electrostimulation technology platform used in its bionic ear, which stimulates the replacement muscle and allows a patient to hold or release urine from the bladder when desired.

"We use a small amount of smooth muscle obtained from the same patient, and the simulator just pulses that and that effectively replaces the sphincter," said CCS CEO Tony Stephens.

The safety and feasibility study of up to 10 subjects will be conducted at Royal Melbourne Hospital in association with Dr Helen O'Connell, said Stephens.

CCS is currently conducting further laboratory testing and once completed the first human implants are expected to occur over the coming months with preliminary clinical data expected prior to christmas.

"If those data are positive, then we would move to start considering the necessary technical, regulatory and strategic things to start seeking product registration in offshore markets," said Stephens.

CCS is also currently reviewing its funding strategy to ensure it has sufficient capital to achieve product registration. In the US alone, the management of severe urinary incontinence is thought to be a US$1 billion-a-year market.

"We have a global aspiration, we see this product as addressing a global need, and step one is to do some very preliminary work in Australia, this initial safety and feasibility study. Then with that footing, we're intending to start looking to establish studies in the US," said Stephens.

A product on the market is a minimum of three to four years away for the US and two to three years for Europe, said Stephens.

Entry into the human clinical stage by CCS triggers the drawdown of an additional AUD$2 million from BioTech Capital, following its initial $2 million investment in the company. This second tranche investment increases BioTech Capital's stake in CSS to 28 per cent.