Innolitics and BEACON-Neuro.AI Partner to Bring FDA Breakthrough Device BEACONPredict to Market

Innolitics and BEACON-Neuro.AI Partner to Bring FDA Breakthrough Device BEACONPredict to Market

BEACONPredict, a tool that predicts dangerous brain swelling after a stroke, went from research prototype to FDA Breakthrough Device on the first review cycle. The partnership paired Innolitics' regulatory and software work with BEACON-Neuro.AI's neurocritical-care and imaging-focused research, and a De Novo pathway to market is now underway.

Innolitics, a medical-device software and FDA regulatory services provider, and BEACON-Neuro.AI Inc., a Washington University in St. Louis startup, today announced the partnership behind BEACONPredict, AI software for predicting malignant cerebral edema risk after acute ischemic stroke. Innolitics brought the regulatory strategy and software engineering; BEACON-Neuro.AI brought the clinical science out of Dr. Raj Dhar's neurocritical-care lab at WashU Medicine. Together the two companies took BEACONPredict from a research prototype to an FDA Breakthrough Device.

Malignant cerebral edema is a life-threatening complication after a large ischemic stroke, and catching it early is one of the harder calls in neurocritical care. A team that sees it coming can escalate monitoring or move to life-saving decompressive surgery before irreversible deterioration. BEACONPredict reads early brain-imaging changes alongside clinical variables and returns a risk estimate that supports the clinician's decision-making.

"BEACON-Neuro.AI brought new science to address a clinical need nobody was serving well. Our job was to give it a route the FDA would accept, and the designation came through on the first cycle. That happens when the clinical team and the regulatory team are working off one plan instead of passing documents back and forth."
Yujan Shrestha, MD, Partner, Innolitics

BEACONPredict is pursuing a De Novo pathway as a clinical decision support tool and received FDA Breakthrough Device Designation on its first review cycle and acceptance into FDA's TAP pilot, providing enhanced FDA engagement and a potentially accelerated CMS NTAP reimbursement pathway following authorization.

"We built the science at WashU Medicine, but taking it to patients means clearing the FDA, and that is not what a research lab is set up to do. Partnering with Innolitics, BEACON-Neuro.AI took BEACONPredict from lab code to an FDA Breakthrough Device in a single submission cycle, and we are building the product together now."
Raj Dhar, MD, Co-Founder of BEACON-Neuro.AI and Professor of Neurology, WashU Medicine

BEACON-Neuro.AI is raising a $0.5M pre-seed round followed by a $2.7M seed round to advance BEACONPredict through FDA clearance and commercial launch, accelerating earlier identification and treatment of high-risk stroke patients to support improving outcomes and saving lives.

Breakthrough Device Designation is a premarket program and is not a marketing authorization; BEACONPredict is not cleared or approved for commercial distribution.

About Innolitics

Innolitics is a medical-device software and FDA regulatory services provider specializing in AI/ML software as a medical device (SaMD). The company has supported development, regulatory strategy, and FDA submissions across more than 70 medical devices since 2012. Learn more at innolitics.com.

About BEACON-Neuro.AI

BEACON-Neuro.AI Inc. is a Washington University in St. Louis startup developing AI software to support clinical decision-making in neurocritical care, beginning with prediction of malignant cerebral edema after acute ischemic stroke.

Media, Innolitics: Mekha Thomas, mthomas@innolitics.com, innolitics.com
Investor inquiries, BEACON-Neuro.AI: Richard Clark, info@beacon-neuro.ai

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