SBIR-STTR Award

A novel, microfluidic device to improve collection and analysis of biopsy samples from ocular paracentesis
Award last edited on: 9/6/23

Sponsored Program
SBIR
Awarding Agency
NSF
Total Award Amount
$1,256,000
Award Phase
2
Solicitation Topic Code
BM
Principal Investigator
Richard Mental

Company Information

Visionaire Products Inc

218 Field Club Road
Pittsburgh, PA 15238
   (630) 234-8945
   visionaireproducts@gmail.com
   www.innsightech.com
Location: Single
Congr. District: 17
County: Allegheny

Phase I

Contract Number: 2051962
Start Date: 2/15/21    Completed: 7/31/21
Phase I year
2021
Phase I Amount
$256,000
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve diagnosis of eye conditions with a better tool for ocular fluid biopsies. Ocular fluid biopsies are important in diagnosis and treatment, but this procedure is under-utilized due to flaws with the current method for collecting fluid; furthermore, the fluid in the eye is isolated from the rest of the body, so blood work does not help in diagnosis. Because of this, most ocular infections are diagnosed and treated based on their clinical appearance without additional data from fluid testing. This research will advance a new tool to collect ocular fluid safely and effectively. This will aid in diagnosis of sight-threatening conditions including macular degeneration, glaucoma and ocular infections, enabling earlier diagnosis and improving patient outcomes.This Small Business Innovation Research (SBIR) I Project will advance a new medical device for ocular fluid biopsies. Ocular fluid biopsies can be used for conditions beyond infections in the eye. The proposed instrument will be designed specifically for collection of fluid from the front of the eye. Tasks include: (1) optimization of the needle to decrease the force of entry to enhance the surgeon’s control and decrease risk of injury; (2) investigation of the fluid dynamics of collection with the integration of a microfluidic chamber and specialized collection system designed to handle small fluid volumes because the current method leads to fluid loss and inaccurate results. Additional work will evaluate advanced engineering features to enhance safety for this procedure.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria

Phase II

Contract Number: 2233691
Start Date: 3/15/23    Completed: 2/28/25
Phase II year
2023
Phase II Amount
$1,000,000
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to transform current eye care by providing a novel tool for ocular fluid biopsies. The fluid in the eye is isolated from the rest of the body by a blood-ocular barrier, so obtaining blood work does not help for diagnosing most ocular problems. Testing of ocular fluid has been shown to decrease rates of blindness in cases of ocular infections. However, this procedure is under-utilized due to the flaws with the current method for collecting fluid. Because of this, ocular infections can be misdiagnosed and undertreated, which can lead to increased rates of vision loss. Additionally, ocular fluid is an untapped reservoir for emerging biomarkers which has created an unmet need for better tools to collect this fluid. This project will result in a new product that can be used to collect ocular fluid for analyses that will guide treatment of some of the most common sight-threatening conditions including macular degeneration, glaucoma, and diabetes. This technology will open a new frontier in ocular diagnosis and improve vision outcomes for patients. This Small Business Innovation Research (SBIR) Phase II project is focused on fabricating a new medical device for ocular fluid biopsies. This project will create an instrument that is specifically designed to collect of fluid from the front of the eye. The research will include optimization of the needle to decrease the force of entry. This new tool will enhance the surgeon?s control during the procedure and decrease risk of injury. This research will also investigate the fluid dynamics of collection with the integration of a microfluidic chamber and specialized collection system that is designed to handle small fluid volumes. A significant limitation of the current procedure is that the fluid volumes collected are small and the current method leads to fluid loss and inaccurate results. Additional development will evaluate advanced engineering features to connect the device for drug delivery. The expected outcome of this research is an innovative surgical tool that will enable ophthalmologists to perform ocular fluid biopsies more reliably and achieve better results.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.