Medical imaging company ImExHS (ASX: IME) has received an operational boost with regards to its US operations after receiving final device classification for its Hiruko Essential software suite.
The news means ImExHS now has the all-clear to commercialise its product in the US under the country’s Code of Federal Regulations (CFR).
ImExHS says it will now begin to market and sell Hiruko Essential into the world’s largest market for PACS and RIS software, a territory with almost 40,000 accredited medical imaging facilities under the purview of the American College of Radiologists.
Hiruko Essential is a software-based device that receives digital images and data from various sources including computed tomography and magnetic resonance scanners, ultrasound systems, direct radiographic devices, secondary capture devices and imaging gateways.
The device also allows for images and data to be captured, stored, communicated, processed and displayed directly within the system as well as across computer networks at distributed locations, by using an embedded web-based viewer with image manipulation tools in addition to strong data encryption to ensure secure data transfers.
According to the medical imaging company, Hiruko Essential is designed to be deployed over conventional TCP/IP networking or cloud infrastructure utilising commercially available computer hardware platforms and operating systems.
Once upon a time in America
To begin its US-focused campaign, ImExHS said it will conduct a soft launch strategy including the enactment of a distribution agreement with IGMC and localising its Hiruko suite for the US market environment as the first step.
This also includes a five and a half-year software-as-a-service (SaaS) contract with Rad One PSC in Puerto Rico, first announced last month.
According to a report by Transparency Market Research, the total market value of the global PACS and RIS market totalled US$2.2 billion in 2015 and is projected to rise at a 7% CAGR to as high as US$3.9 billion by 2024.
The research company also claims that as a continent, North America accounted for a leading share of just under 47% in the global PACS and RIS market in 2015.
To give ImExHS additional impetus, and a further operational boost in terms of market coverage, the medical imaging company is set to benefit from a “change of procedures” by the FDA.
The US agency has agreed to amend its policies under the ‘21st Century Cures Act’, by issuing ImExHS with a formal exemption under its existing code of regulations and classifying Hiruko Essential as a Class I device, thereby “clearing the way for commercialisation in the US” according to ImExHS.
In addition to the US, there is also talk of marketing Hiruko Essential in South America.
“The receipt of the FDA clearance represents an important milestone in the history of the company and will allow ImExHS to accelerate our soft launch in the US market,” said Dr German Arango, chief executive officer of ImExHS.
“Concurrently we will be working on a more detailed market entry plan. The FDA clearance is also an important recognition for ImExHS in Central and Latin America and the timing is particularly opportune given our recent appointment of a distributor in Brazil,” said Mr Arango.
This morning’s news helped ImExHS shares to advance by over 8% up to $0.067.