F SQUARE MEDICAL LLC — Department of Health and Human Services SBIR Phase I: NEI

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 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 are used. This requires a steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope. 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 is difficult to control and unpredictable. As a result, 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 the first-ever instrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable, light-weight and importantly, safe instrument for rapid and reproducible ACP. In this Phase I SBIR proposal we will: 1) work with an experienced USA-based contract engineering and prototyping firm, Gilero, to refine the design and manufacture a Parasafe prototype, 2) conduct summative evaluation human factors studies, and 3) assess the functionality of the Parasafe with practicing ophthalmologists and an ex vivo porcine model. The completion of the proposed aims will result in verification and validation of an instrument that will significantly reduce the risk of injury associated with ACP while optimizing functionality of the procedure and advancing this transformational instrument to the next phase of commercialization.PROJECT NARRATIVE Ocular anterior chamber paracentesis (ACP) has the potential to transform the standard of care in ophthalmology. For decades ACP has saved countless patients from irreversible blindness by alleviating acutely elevated intraocular pressure, and now pioneering labs are recognizing aqueous humor as a reservoir rich in diagnostic and predictive biomarkers. Unfortunately, there is no instrument specifically designed for ACP; instead, off-the-shelf tuberculin syringes with excessively long needles and cumbersome handling are repurposed with serious risks of intraocular trauma, poorly controlled aspiration rates and unpredictable fluid volumes. To address this major and urgent unmet medical need, F Square Medical is developing and commercializing the first-ever instrument designed and optimized for ACP: ParaSafe.