NSE-FAST Market Research

TET Medical was interested in better understanding current diagnostic stroke protocols and refining the target product profile for their lead compound, TET-NSE-FAST. TETmedical hired Biocom Consulting that conducted a total of 7 in-depth telephone interviews with U.S. experts (4 Emergency Department Chairs and 3 Neurologists) between Jan. 27th and Mar. 9th, 2023. Interviews were 1 hour in duration and the physicians were blinded to the company and compound

The Market Research Objectives were:

Understand current diagnostic stroke protocols and challenges
Determine current management of stroke cases (risks, diagnostic uncertainty, etc)
Gauge physician interest in blinded product profile and potential utility within current diagnostic protocols

Conclusions

KOLs interviewed were enthusiastic about the NSE-FAST product profile
- Consensus that the assay was highly differentiated and would provide greater diagnostic certainty, especially in uncertain cases
- Several recommended more distinct differentiation from prior assays to avoid initial confusion
There was significant interest in using the assay early, along with CT, in all acute stroke suspected cases
Sensitivity and specificity of at least 90% would be well received, with even greater confidence at higher levels
Some KOLs responded favorably to inclusion of clinically relevant data (cases missed without MRI and/or avoidance of tPA) tools provide clinical guidance but have significant limitations
When CT imaging is negative, physicians rely heavily on degree of disabling symptoms to drive diagnosis and treatment
Despite diagnostic advances, experts cited numerous clinical scenarios that are diagnostically challenging.
Experts indicated 3 major areas of unmet need in ischemic stroke: greater diagnostic certainty, improved detection in difficult cases and improved pre-hospital diagnosis.

Preliminary US Stroke Opportunities

The slide below from the report describes an annual US potential market of between $400M and $800M.

Go to Market Strategy

We do not aim to change the flow and standard of care in stroke, thus assuring fast adoption. A pilot stroke study has already been conducted at Guthrie Stroke Center. A follow up feasibility study is in progress at Weill Cornell Medicine.

Our first customers will be the clinicians in the Emergency Department. The NSE-FAST will be performed on all patients presenting with a suspicion of stroke at the same time as other STAT blood work. These patients all receive a non-contrast CT scan which is used to rule out hemorrhagic stroke. Currently the clinicians have a diagnostic challenge for patients that are negative on the CT scan but symptomatic, particularly with mild or atypical symptoms. A negative TET NSE-FAST will provide high confidence to the clinician that the patient is not having an ischemic stroke; thus reducing the risk of treating a stroke mimic with tPA. We expect to initiate the training study at 1-2 clinical centers in the fall of 2023 to set the clinical cut-off followed by a pivotal study in 3-10 centers in 2024. The data from the pivotal study will be used to support the FDA regulatory pre-market submission.