CARINA MEDICAL LLC — Department of Health and Human Services SBIR Phase II: 402
CARINA MEDICAL LLC — SBIR Phase II award from Department of Health and Human Services.
Phase II SBIR prototype / development signal
- Phase II is where Department of Health and Human Services funds deeper R&D after feasibility. Incumbents with Phase II history are serious competitors on adjacent topics.
- Use this award as past-performance context and to map customer organizations for STRATFI/TACFI-style transition planning.
- At $2,000,000, this is a large obligation for typical SBIR Phase sizing — worth reviewing for scope breadth and teaming opportunity.
- Topic code 402 links this award to a solicitation family — search the same topic stem for incumbents and recompete timing.
- Amount
- $2,000,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- 402
- Solicitation
- BAA 75N91022R00027
- NAICS
- —
- Place of performance
- VA
- Period
- —
Description
The correct determination of nodal metastatic disease is imperative for patient management in oncology, since the patient’s prognosis and subsequent treatment are inherently linked to the stage of disease. Detection/segmentation of lymph node on imaging is a tedious, highly time-consuming process that is inherently subject to intra-/inter-observer variability. Malignancy classification of the lymph node improves both the diagnostic evaluation and treatment planning. An AI software, OncoAI, was successfully developed in Phase I that automatically detects and segments enlarged lymph nodes from MRI and CT and enables fully automated RECIST measurements. The overall goal of this Phase II proposal is to further enhance the performance of the AI models for lymph node detection, segmentation, and measurements and develop additional AI models for malignancy classification leveraging multi-modality imaging. Software functionality and usability will be further improved towards seamless incorporation within the clinical workflow. Finally, a multi-institutional validation study will be conducted to demonstrate the safety and effectiveness of OncoAI in clinical practice and obtain regulatory approval. The proposed aims will set a strong technical and regulatory foundation for OncoAI and contribute to not only commercial success, but also broader impact to the clinical practice of cancer care.