F SQUARE MEDICAL LLC — Department of Health and Human Services SBIR Phase II: 100

Description

PROJECT SUMMARY Despite advances in the treatment of ocular diseases, vision-threatening disease or eye injury remain the top 10 disabilities among adults. Several of these ocular conditions require an anterior chamber paracentesis (ACP). ACP is clinically indicated to reduce acutely elevated intraocular pressure (IOP) to avoid risk of permanent vision loss and to sample aqueous humor for disease diagnostics and monitoring. Conditions requiring IOP reduction include acute angle closure glaucoma, pneumatic retinopexy to treat retinal detachments, and iatrogenic IOP elevations associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents to treat diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal vein occlusions. Conditions requiring aqueous humor sampling include endophthalmitis, uveitis, retinoblastoma and lymphoma, and aqueous biomarkers increasingly are guiding treatment selection and drug monitoring, e.g., with anti-VEGF agents. Unfortunately, there exists no instrument specifically designed for ACP, and instead tuberculin syringes with standard excessively long needles and limited operational control are used. This requires a steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope, and often requires an assistant. As a result, the ACP procedure may lead to serious complications, such as hyphema and cataract due to inadvertent trauma to intraocular structures (e.g., cornea, ciliary body, iris and lens), and the aspiration rate and aqueous volume are difficult to control and unpredictable. Unfortunately, there have been no improvements in the safety or efficiency of ACP in the past century. To overcome the limitations associated with existing antiquated techniques, F Square Medical is developing and commercializing Parasafe™, the first-ever instrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable and importantly, safe instrument for controlled, rapid, and reproducible ACP without requiring a slit lamp or an assistant. Through the completion of a successful Phase I project, F Square Medical built a functional alpha prototype and assessed its performance and usability to inform beta prototype refinement. This Phase II program will build upon the substantial Phase I data package and will focus on incorporating feedback from the Phase I end-user data to refine and lock the Parasafe design for manufacture, as well as execute on the complete array of required design control activities per 21 CFR 820.30 to advance Parasafe to FDA regulatory 510(k) submission, approval, and scalable production. The completion of the proposed Phase II project will result in the filing of a 510(k) regulatory submission to the FDA for Parasafe, an instrument with the potential to significantly reduce the risk and expand the utility of ACP, thereby advancing this transformational instrument toward commercialization and improving patient care.