Company History
Due to unaffordability, millions of patients in small cities/towns in the USA, and in Europe, Asia, Africa, Latin America and Eastern Europe have virtually no access to various modern and advanced clinical treatments. Also, budget-constrained hospitals and cost-conscious physicians who often do not have flexible financial resources to purchase highly expensive, single modality, specialty medical instrumentations and the pertinent tools for specific diagnostic, therapeutic and surgical procedures are always searching for not only affordable but also superior solutions to the existing medical instrumentations/devices.
Therefore, in recognition of the cost-conscious physicians' needs and also in an effort to globally provide financially-strained patients with an access to affordable and advanced medical diagnostic and therapeutic procedures, we founded in 1997 and established as a corporation in 1999 a medical device research and development company, called Mogul® Enterprises, Inc.
Since establishing our company, we have been very enthusiastically determined and highly keen in utilizing our extensive medical device experience and vast technological expertise to convert our paper-design ideas/concepts into modern/advanced yet affordable medical devices which will inherently have superior performance with added novel, specialty features that are desired or often needed by the physicians.
Form our company's inception, we started the development of our first generation product, which is a multi-energy, multifunction, multimodality medical instrumentation that provides seven energy sources (laser, microwave, RF-ablation, RF-electrocautry, ultrasound, pneumatic and mechanical) to be used with a myriad of interfacing medical devices (catheters and probes) for ablation therapy and general and/or minimally invasive surgery. This instrumentation, during a clinical procedure, will provide to a physician a flexibility of interchanging devices of different energy types. We filed for our first patent for the instrumentation design, and were granted the patent.
We, as a contract-product developer, signed a contract with another startup medical device company, and designed and developed for them a steerable lumen catheter with an optical guide wire for interventional cardiology. This product was designed specifically for detecting chronic total/partial occlusions in the coronary arteries and for re-canalizing the occluded arteries.
Also, we designed and developed for our own company other catheter products that are used in intracardiac electrogram recording (mapping) and cardiac stimulation during diagnostic electrophysiology (EP) study of a cardiac arrhythmia. These products are 3, 4 & 5 French steerable/fixed-curve with up to ten electrodes and 6 French steerable/fixed-curve catheters with up to twenty electrodes. We submitted a 510(k) application with the FDA and received 510(k) clearance for the catheter products. Additionally, we filed for patents for the designs of these catheters and various other steerable catheters, and were granted three catheter patents.
Moreover, we designed and developed for a special CS mapping a 6 French steerable lumen diagnostic EP catheter with up to 10 electrodes, which takes a .014" guide wire. And for a full cardiac chamber or even pulmonary-vein base mapping, we designed and patented a 60--80 electrode steerable, mechanically-expandable/collapsible basket EP catheter that does not require a sheath, conforms to any cardiac chamber size, and can function as a straight steerable mapping catheter as well during the clinical procedure.
All the 3, 4, 5 & 6 French steerable diagnostic EP catheters can be (and some of them already have been) easily converted into standard therapeutic RF-ablation catheters by installing a longer tip-electrode with a single or dual temperature sensor (thermocouple or thermister). Also, we have various designs of a specialty RF-ablation catheter which has a user-controlled, on-demand, tip-cooling system for optimum RF energy deposition. These catheters can be initially custom-ordered for a preclinical research and later for clinical trials.
For cardiovascular, peripheral vascular or any other catheter-based biomedical applications, we have, beside the steering mechanism used in our FDA-cleared EP products, numerous other catheter-steering technologies and designs some of which have been patented and others are in our lab notebooks. Various steering designs address different user requirements such as, navigating a catheter or a sheath through a narrow vasculature and accessing a tortuous vessel, easily handling and maneuvering the catheter or the sheath, and reliably maintaining the tip contact and control that are needed for various interventional clinical procedures and related devices. Additionally, we have designs of cardiovascular and peripheral vascular stents and their deployment catheter systems, heart pumps (LRVADs), blood chemistry/gasses IVDs, EEG headsets and other medical devices for various clinical applications.
Over the years, to promote our company and products, we have had several press releases in the US and the overseas news media, and our founder's interviews in the respected weekly medical device magazine called "The Grey Sheet" and in an audible business news web site called "wallstreetreporter.com". Also, we have exhibited every year our company and products at the Heart Rhythm Society (formerly known as NASPE) trade show since 2002, and demonstrated our EP catheters to physicians, nurses, and distributors who gave us a very positive feedback and showed a great deal of interest in purchasing the catheters. We have gathered over 200 sales leads for the catheters at the trade shows, and signed overseas distribution agreements.