by John R. Fischer
, Senior Reporter | August 13, 2018
AI software developer MaxQ-AI is expected to go public in the near future, establishing an $8 million IPO listing on the Nasdaq, according to an S-1 registration statement.
The decision to do so by the Israel-based enterprise, known for developing AI tools to aid in diagnostic imaging of the brain, is part of its initiative to assist in the FDA regulatory processes for clearance of its Accipio software portfolio, viewing such a status as essential in helping to avoid repeats of net losses suffered over the last few years. It follows the recent CE marking
of its AccipioIx intracranial hemorrhage AI platform.
“In May 2018, our AccipioIx product received CE mark approval. None of our other products have been approved for commercial sale by regulatory authorities. We will not be able to generate revenues for our other products, or generate revenues for any products in the United States, until we obtain those approvals,” MaxQ-AI said in its registration statement. We have experienced net losses since our inception and had net losses of $9.2 and $1.9 million in fiscal year 2017 and in the first quarter of 2018, respectively. Our auditors have expressed doubt about our ability to continue as a going concern unless we are able to raise equity or debt financing."
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The Accipio portfolio is composed of three solutions, including AccipioDx, a CT diagnostic tool that enables clinicians to determine the presence of strokes or traumatic brain injuries with the detection of intracranial bleeding; AccipioIx, a workflow-prioritization system that alerts clinicians to potential bleeds and their locations; and AccipioAx, designed to provide annotated images and 3D renderings of the brain based on original scans for evaluation.
Its decision comes just months after another made in April to change the company’s name
from MedyMatch Technology in an effort to bring AI clinical applications to the market.
Prior to this, the company received
Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrhage detection software.
It also engaged in a number of partnerships with Samsung Neurologica, which agreed
to integrate the ICH detection application into its 8-slice small-bore CereTom portable CT scanner; IBM Watson Health for distribution
through IBM’s vendor-neutral sales channels for integration into its other offerings; and GE Healthcare for integration
with its CT scanners.
“We believe that by leveraging the existing sales and marketing infrastructure of these channel partners, each of which is a leading medical equipment manufacturer, we will be able to achieve high market penetration and user adoption rates,” said MaxQ-AI in its statement. “We have not submitted any Accipio products for FDA approval, but we intend to do so commencing in the third quarter of 2018. We expect to receive FDA approval for AccipioIx during the fourth quarter of 2018, and we expect to receive FDA approval for AccipioDx as well as AccipioAx in 2019.”
MaxQ-AI declined HCB News’ request for comment. “We are in a quiet period right now and are unable to comment on the IPO,” Michael Rosenberg, chief commercial and financial officer for MaxQ-AI, said in an email.
In addition, the company expects CE mark approvals for AccipioAx and Dx in the first half of 2019.
Terms of the registration are not complete and subject to change.
Pricing terms were not disclosed.