100616_mxmgla13616_glaucomadevice_on_black_cropped
ly_proj_2194665

Lowering the Pressure, For You.

The Brown Glaucoma Implant

ly_proj_2194665

Lowering the Pressure, For You.

The Brown Glaucoma Implant

The Innovation Behind the Device

The Innovation Behind the Device

glaucoma-2

 

 

As one of Minnesota’s leading glaucoma specialists and highest volume practitioners, J. David Brown MD was frustrated by the inadequate treatments available, and set out to find a better way to care for his patients. Dr. Brown determined that advanced biomaterials and surface chemistries, nanotechnology, and micro-engineering and manufacturing could solve the primary limitations of existing technology. The small size, flow control, and microorganism protection utilized in this technology represent a meaningful breakthrough in normalizing intraocular pressure (IOP) by shunting aqueous humor directly to the tear film, rather than regions located inside the eye. This strategy eliminates episcleral venous pressure resistance and the risk of plugging that current technologies must overcome. Because the aqueous is shunted directly to the tear film, the micro channels (filter) are the only source of resistance to aqueous outflow. As a result, the device can be engineered to achieve the predictable, precise flow control that is required to lower intraocular pressures below 12mm Hg - the threshold necessary to HALT further damage to the optic nerve, thus representing a CURE for glaucoma. The aqueous outflow constantly bathes the cornea with lubricating, nutrient-rich aqueous humor, which is showing to be a highly effective treatment for dry eye and ocular surface disease (currently a $2.4B US market). Sixty percent of all glaucoma patients taking medicated eye drops today develop an ocular surface disease severe enough to require a separate stand-alone treatment.

The Brown Glaucoma Implant (BGI) utilizes state-of-the-art biomaterials and nanotechnology to significantly reduce size, increase safety and biocompatibility, keep bacteria and proteins from entering the device, minimize manufacturing costs, and lower intra-ocular pressure beyond any existing pharmacologic or mechanical treatment. The small size, ease of implantation, microengineering and external aqueous shunting offer less chance for infection and eliminates potential plugging failures that have been associated with existing technologies. This device is engineered to achieve trabeculectomy effectiveness, without the high rate of complications associated with that procedure. The implant procedure is minimally invasive, simple and safe – taking less than one minute in recent animal studies. Other advantages offered that differentiate the BGI from competitive devices are that concomitant cataract surgery is not a criterion for use, and patients across the glaucoma spectrum (mild, moderate and severe) can be treated.

seidel

Foundational bench and animal testing has been successfully completed. Bench testing has shown the device to be effective in stabilizing aqueous humor exit flow and maintaining sub-threshold pressures under a range of physiologic aqueous inflow rates.  Additional studies have demonstrated the micro flow channels and surface chemistries, in concert with a continuous exit flow, results in complete exclusion of pathogen entry into the device. Recent animal studies have supported the bench findings and theoretic performance calculations, with a 60-75% reduction in IOP. These implantation studies have also shown the device to be easily implantable, well tolerated, securely healed into place with no infections, and a highly biocompatible cellular response.

devicecropwbackground

Foundational bench and animal testing has been successfully completed. Bench testing has shown the device to be effective in stabilizing aqueous humor exit flow and maintaining sub-threshold pressures under a range of physiologic aqueous inflow rates.  Additional studies have demonstrated the micro flow channels and surface chemistries, in concert with a continuous exit flow, results in complete exclusion of pathogen entry into the device. Recent animal studies have supported the bench findings and theoretic performance calculations, with a 60-75% reduction in IOP. These implantation studies have also shown the device to be easily implantable, well tolerated, securely healed into place with no infections, and a highly biocompatible cellular response.

Regulatory and Reimbursement Pathway

Regulatory and Reimbursement Pathway

The MicroOptx BGI has a clear regulatory pathway. In contrast with many devices and drugs where subjective measures of performance are evaluated for efficacy, glaucoma therapy has one clear objective measure – lower intraocular pressure. Pressure is measured mechanically - as most of us have experienced in an annual eye exam. It is an instantaneous, objective measure not influenced by placebo effects. The safety profile should be positively influenced by the small size of the device, biocompatible materials utilized, and the simple one-minute implantation procedure required. This combination of enhanced performance and reduced risks offer much to patients in need. The straightforward nature of determining efficacy combined with the enormous current need and minimal risks may qualify for expedited regulatory review.

 

MicroOptx has recently initiated a final preclinical GLP-safety study, and has met with FDA to discuss an early US human feasibility study to begin in Q1-2017, and pivotal trial to support PMA approval soon after.  Current reimbursement codes for minimally invasive glaucoma surgeries (MIGs) are bundled at approximately $2,600 per procedure.

eye-with-chart
glaucoma-5
glaucoma-6

Join Us in our Pursuit of Medical History.   Contact Us>

Join Us in our Pursuit of Medical History.   Contact Us>