The Company is developing a portable hemodialysis device for in-home use. The device is simple enough to enable the patient to operate it for treatment without professional assistance.
The technology that is being used is either already FDA compliant or will be approved during the device qualification as a normal course of FDA qualification. The science on which the device is based has been submitted to various universities in the US and Europe and is considered scientifically sound.
The Company’s Chief Technology Officer has worked with a large global provider of dialysis machines and treatments. The Company also has hired expertise in the areas of software/firmware development, FDA documentation and compliance and a medical doctor. In addition, senior management has a strong history of project, operations and financial management.
The dialysis market was estimated to be $61.6 billion in 2013 and to grow at a CAGR of 6.2% through 2018. The hemodialysis market is divided into two segments: center use hemodialysis and home use hemodialysis. The general trend in healthcare is toward in home services, which means that the in-home solution has a lower market entry threshhold and represents a growing market.
The Company’s device was declared as “innovative” by a former director of the World Health Organization (WHO). The device will be lighter and easier to use than the “best” current in-home dialysis machine and will be accepted within the treatment formulary of MediCare.
ASIT Engineering has estimated that it requires an investment need of US$2.8 million to complete engineering and produce one prototype ready for FDA qualification.
After FDA qualification is achieved, The Company will be seeking capital to initiate production and distribution of the device and the disposables.
Home Use Hemodialysis Device Development
