Sanoculis is a late-stage company with CE mark and initial commercial revenues in EU. Sanoculis develops and markets the MIMS® (Minimally Invasive Micro Sclerostomy) device and surgery for the treatment of the Glaucoma. MIMS® is simple, fast, and minimally invasive requiring no stitches, eye-patch, implant or stent. It is designed to reduce the caring costs of Glaucomatous patients through simplicity, low cost, fewer post-surgical complications and less hospitalization. The CE-approved MIMS® surgery was launched for commercial use in Europe and Israel. To date, over 300 patients have undergone successfully the MIMS® procedure with excellent results. Of these surgeries, 230 were under post-market study (with one-year follow-up) and 100 as commercial surgeries (in EU and Israel). Both standalone and combined Glaucoma-Cataract procedures were conducted. The ease of operation and the short time it takes in comparison to Trabeculectomy surgery may make the MIMS® a potential second gold standard.
During the MIMS® procedure, a sclero-corneal drainage channel is created to reduce the intra-ocular pressure (IOP), comparable to existing surgical techniques. The novelty of the solution is that the channel ensures long-lasting controlled fluid flow with minor complications. MIMS® consists of a single-patient use sterile tool (disposable) and a multi-use external machine. Its benefits are: a stent-less procedure (nothing left behind), low risk of complications, it is suitable for most Glaucoma patients, has the potential for medication reduction, can be easily combined with Cataract surgery and is a surgeon-friendly, automatic procedure with short learning curve.
The company is adding two new indications for MIMS®, in addition to the supernasal standard scelostomy: Inferonasal Sclerostomy in failed Trabeculectomy cases (for severe Glaucoma) and Nasal Trabeculostomy (for mild Glaucoma). These two new indications will triple the potential market size for Sanoculis covering almost all indications for Glaucoma surgeries.
The Company provided key opinion leaders in Europe and Israel with the MIMS® device in order to enhance its clinical data and add leading ophthalmologists to the user base of this innovative technology. Early in 2023, the Company intends to initiate a US FDA study to obtain US regulatory approval.