UNISEED INVESTEE COLOCARE HOLDINGS TO MERGE WITH CONTINENCE CONTROL SYSTEMS
1 November 2007: UIIT Pty Ltd ("Uniseed") is pleased to annouce that its investee company Colocare Holdings Pty Ltd ("Colocare") has completed a merger with private Sydney-based company Continence Control Systems International Pty Ltd ("CCS").
CCS is a technology spinout from Cochlear Limited, developing bionic sphincters used for the treatment of Stress Urinary Incontinence (SUI) and is known as the UTROL™ system.A small piece of the patient's own smooth muscle tissue is used to create a ring of muscle known as a sphincter, around the urethra, the pipe from the bladder to the outside.An implanted electrical stimulator (like a cochlear implant or pacemaker) delivers electrical pulses to the bionic sphincter which causes it to contract.When the patient wishes to urinate, a small controller is used to temporarily switch off the stimulation, causing the bionic sphincter to relax and allowing the patient to urinate.CCS believes the bionic sphincter can be used in both males and females who suffer SUI.
While other surgical interventions are available for males and females suffering from SUI, CCS's technology offers some significant advantages over current surgically implanted devices that simply re-position the bladder in the pelvic space.The market for urological implantable devices is already forecast to be a significant growth area, with compound annual growth rates of surgically implanted medical devices for women already exceeding 20%.Key players in this sector include major US medical device suppliers such as Boston Scientific, Johnson and Johnson, American Medical Systems and Medtronic, each of whom manage their product portfolio by acquisition.
The combined entity provides a focus for the commercial development of related continence management technologies.It is expected that the company will pursue a public float during 2008 to provide additional capital to complete product development and commence operations in the USA.While the technologies of CCS and Colocare are different, there are significant synergies in the commercialization paths especially with respect to the regulatory, clinical and quality system frameworks required to access the USA and other international medical markets.
This merger has the immediate benefit of diversifying the company's product and technology range reducing the "single product risk" and shortening the time to market.In addition, fresh investment capital will be injected into Colocare by new institutional and high net worth investors.Colocare shareholders will be represented on the Board of CCS by Mr Crispin Marsh, an experienced patent attorney and founding Chairman of ASX-listed medical device company Sunshine Heart as well as Mr Rob Douglas the Chief Operating Officer - Sydney of ResMed Limited.
Full press release from Continence Control Systems below.
For further information, please contact Peter Devine, CEO, Uniseed Management Pty Ltd.
T: +61 7 3365 3754
M:+61 409 631 581
E:p.devine@uniseed.com
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About Colocare's Fecal Management System
The Colocare Faecal Management System was invented and designed by a mechanical engineer, who is also a colostomate. The system includes a pump, power supply, tubing and a specially designed flange/receptical, which is attached to the stoma for waste removal.
Patients can manage their waste simply and effectively by using the System to lubricate and fill the bowel with water, and then to evacuate all waste from the bowel via the stoma. This procedure, which takes less than an hour, is done once every two or three days, and eliminates the need for colostomy bags to be worn.
The Colocare FMS manages both the irrigation of the colon and the transfer of faecal matter from the stoma to the toilet. The Colocare FMS is self contained and self cleaning – no connection or assembly is necessary other than filling the reservoir with warm water, wheeling the device to the toilet, placing an evacuation chamber over the stoma and switching the device on.
When activated the Colocare FMS infuses a controlled amount of water (or other irrigation liquid) into a patient's colon. When peristalsis has been induced by this infusion, the Colocare FMS collects the ejected faecal matter in the evacuation chamber, under a light vacuum, and pumps it from that chamber into a nearby toilet bowl. Upon completion of the procedure the patient stows the evacuation chamber on a housing of the device which causes the device to enter a wash cycle during which the evacuation chamber and all other faeces contacting surfaces of the device are washed using the remainder of the water in the reservoir thereby leaving the device empty and clean.
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(Full press release from Continence Control)
Merger Targets Continence Management
Sydney, Australia 1 November 2007: Continence Control Systems International Pty Limited (CCS) and Colocare Holdings Pty Limited (Colocare) today announced the merger of the two Australian companies to form a single entity dedicated to commercializing technologies which address the challenges of an ageing population.
The merger brings synergies in commercializing medical devices in this important area.
-CCS is progressing a bionic sphincter, using implantable electrical stimulation technology developed with Cochlear Limited providing a novel approach to the large and growing problem of urinary incontinence.
-Colocare is addressing the critical independence issues of living with a stoma, a surgical opening made in the abdominal wall when the lower bowel is removed following conditions such as bowel cancer
Uniseed and Westscheme have agreed to fund the merged entity with a commitment of $1.75M, with the Company planning a listing in 2008 to complete commercial product development and commence US operations.
Following the merger, Colocare Directors Crispin Marsh, a founder and director of Sunshine Heart, and Robert Douglas, Chief Operating Officer - Sydney at ResMed Limited will join the Board of the CCS group of companies.Other members of the Board include Neville Mitchell from Cochlear and Jim Dennis, a previous CEO and Worldwide President of several US medical device companies.
Colocare Chair, Crispin Marsh said "the two technology streams, while focusing in a common area, have the potential to provide diversified revenue flow. The bionic sphincter technology, while revolutionary, will require extensive clinical studies until commercial approval can be gained.In contrast, the Colocare Fecal Management System is an external system that has the potential to be considered similar to other technologies in the USA and thus, subject to FDA approval, should follow a much shorter path to commercial approval."
CCS Group Chief Executive Officer Tony Stephens said that "the merger of the two companies will provide scale, access to complementary technologies and further funding and accelerate the time to market of both products for which there is an ever increasing need."
For more information, contact:
Tony Stephens+61 402 026 590 or
Crispin March+61 414 810 426
About the CCS Group
The driving force behind Continence Control Systems International Pty Limited (CCS) is to become the Australian continence company. As a technology spinout from Cochlear Limited, CCS is building on its inheritance by developing bionic sphincters for the control of bodily functions and in a recent merger, gained an additional technology to assist survivors of colon and/or rectal cancer in managing their bodily waste.
Fueled by the ageing baby boomer population and the increasing prevalence of obesity, the demand for products to control the loss of urine and faeces is predicted to experience phenomenal growth.A 2006 study by the Australian Institute of Health and Welfare indicates over half a million people experience severe incontinence and predicts that nearly three hundred thousand of these may require products and services to help them manage their incontinence now and in the future. Incontinence is also a significant predictor of the need for institutionalization of older persons, with over 70% of people living in residential care suffering from incontinence.CCS envisages a day when its technologies can be used to eliminate or reduce the need for incontinence pads and also prevent or delay admission into residential care for older Australians.
CCS's first technology involves a bionic sphincter which is used for the treatment of Stress Urinary Incontinence (SUI) and is known as the UTROL™ system.A small piece of the patient's own smooth muscle tissue is used to create a ring of muscle known as a sphincter, around the urethra, the pipe from the bladder to the outside.An implanted electrical stimulator (like a cochlear implant or pacemaker) delivers electrical pulses to the bionic sphincter which causes it to contract.When the patient wishes to urinate, a small controller is used to temporarily switch off the stimulation, causing the bionic sphincter to relax and allowing the patient to urinate.CCS believes the bionic sphincter can be used in both males and females who suffer SUI.
While other surgical interventions are available for males and females suffering from SUI, CCS believes its technology offers some significant advantages over current surgically implanted devices that simply re-position the bladder in the pelvic space.The market for urological implantable devices is already forecast to be a significant growth area, with compound annual growth rates of surgically implanted medical devices for women already exceeding 20%.Key players in this sector include major US medical device suppliers such as Boston Scientific, Johnson and Johnson, American Medical Systems and Medtronic, each of whom manage their product portfolio by acquisition.
In addition to its bionic sphincter technology, CCS has joined with Colocare Holdings Pty Limited, another Australian company focusing on continence management for people who have a stoma.A stoma is a surgically created opening in the abdominal wall to allow bodily waste to exit, most often required following cancer of the rectum and/or descending colon.
Today, colon or rectal cancer is the third leading cause of cancer, with the key market drivers of age and obesity.Of the estimated 210,000 people living with colostomies in the USA (known as colostomates), approximately one third are aged 25-64 years, are active in the labour force. Current management practice is most often to allow the faeces to drain into a collection bag which is attached to the stoma.This drainage cannot be controlled by the colostomate which can result in significant social consequences and can have dramatic impact on the individual's quality of life.
The Colocare Fecal Management System irrigates the bowel through the stoma allowing faecal matter to be evacuated directly into the toilet.Longer term users of this pump technology have reported that this management strategy reduces or eliminates the need for colostomy bags and they now have a sense of control over this bodily function.In addition, the safety and feasibility study already completed with the Colocare FMS reinforced that users valued the improved hygiene as they no longer need to handle, and in some cases, clean the colostomy bags, they experienced less pain and discomfort, improved self confidence and quality of life and reported greater ease of colostomy management.All patients who used the Colocare FMS considered it preferable to the previous management approach.
While the technologies are different, there are significant synergies in the commercialization paths especially with respect to the regulatory, clinical and quality system frameworks required to access the USA and other international medical markets.Unlike the UTROL™ bionic sphincter which requires a full clinical evaluation, the Colocare FMS is an external product and has the potential to be introduced to the USA market based on existing products that irrigate the bowel, which subject to Food and Drug Administration review, may enable commercial approval in a much shorter timeframe, enabling CCS to build its US presence and generate early revenues from this second technology stream. Having a shorter development cycle, the Colocare FMS has the potential for shorter time to revenues and addresses the "one product company" concern of many investors.
