The Silicon Review
Innovations in surgical processes go a long way in improving the lives of patients and reducing the complexity of surgery and the subsequent recovery. Laparoscopic surgeries are some of the most commonly performed types of medical procedures across the world and entail the thoracic and pelvic cavities being pulled up in order to help surgeons reach the affected organ. However, due to the inherent difficulties involved in making way for the surgeons, numerous laparoscopic surgeries remain unsuccessful, endangering the life of the patient. However, a company named Dome Medical has developed a revolutionary new medical device that allows laparoscopic surgeons to lift the abdominal wall from the outside and reach the affected organ with ease.
With an extensive background in medical technologies as well as finance and management respectively, the founders of Dome Medical, Glenn Foley and Arthur Raymond Malvett seek to establish a new standard of care in laparoscopic surgical access with their innovation.
In conversation with the stalwarts behind Dome Medical, Glenn Foley and Arthur Malvett
Q. Can you elaborate on the current market scenario?
Put yourself in the shoes of a GYN or general surgeon preparing for a laparoscopic procedure. Ready with your Veress needle, you can either operate with the standard 1 cm of instrument target space to gain entry into the patient’s abdominal cavity, or you can benefit from an additional 3.7 cm space to perform the same procedure. Would you rather stay within the 1 cm boundary and amplify the risk of inadvertently injuring major organs and life-sustaining blood vessels, or eliminate any potential for error by functioning within a 4.7 cm radius?
The choice is rather easy.
The truth is, for more than 30 years, GYNs and surgeons haven’t had a choice but work within the 1 cm radius, since the laparoscopic procedure to gain the initial access into the abdominal cavity has remained unchanged. GYNs and Surgeons have been using either a Veress needle (60 percent of the market) or endoscopic trocar and through that, infuse inert gas into the abdominal cavity to create a working space, and gain visualization ability. The initial insertion of the Veress needle is a highly manual system, in which large clamps are attached to either side of the abdomen, and the abdominal wall is manually lifted. Then the Veress needle is inserted blindly through the skin and muscle of the abdomen and inert gas injected until the abdomen is sufficiently insufflated. This way, GYNs and surgeons gain separation from coming in contact with critical vessels and organs when the balance of the surgical instruments is employed.
Q. Please tell us about your product
GYNs and Surgeons had no choice when operating within the space of 1 cm. There is a reported acute complication rate and an unreported complication rate in the form of infections that do not surface for a period of time. DOME Medical Technologies has designed a revolutionary platform titled LapDome™ that offers surgeons the highly coveted additional space of 3.7 cm while penetrating the abdominal cavity. The LapDome creates said room by utilizing negative pressure suction from standard or suction systems to “lift” the skin and abdominal wall away from vital organs without the use of manual clamps. The dome shaped, polycarbonate, disposable device comes with a port for attaching a suction system and an injection for a Veress needle/endoscopic trocar. Due to negative pressure generated by the suction during surgery, surgeons gain the benefits of a secure zone of 4.7 cm to insert a Veress needle and subsequent delivery of CO2.
Q. Could you elaborate on the current issues that your company seeks to address?
The clinical benefits of the LapDome medical device are evident. They include widening out the surgical field, faster turnaround times for procedures, and reduction in the complication of treatments. According to Key Opinion Leaders in surgery, GYN, and emergency medicine, there is a 30 percent occurrence rate where a complication injury isn’t detected during surgery. In such cases, patients get “closed up” and discharged from the hospital, only to return a few days later with an unseen/unknown complication. These complications can happen when surgeons unknowingly nick something, patients suffer from highly acute infections. The mortality rate in such scenarios is very high.
LapDome eliminates such complications simply because surgeons enjoy a bird’s eye view of the patient’s abdominal cavity and are unlikely to nick a bowel, spleen, or any other organ. In simpler words, when surgeons have to land the tip of the access instruments intra-abdominally, they are almost going in blindly. If they don’t succeed in the first attempt, they have to re-stick repeatedly until gaining entry. Each time they re-stick, they are heightening the chances of damaging organs. LapDome has, thus far, enjoyed a success rate of 100%. It has been used in nearly 60 procedures without surgeons having had to re-stick. The novel technology also saves time for surgeons.
With the current methodology, the insulation of the Veress needle takes longer due to the resistance of the thick and heavy abdominal wall preventing CO2 gas from entering the area. It takes surgeons about 10 minutes to insulate, but with the LapDome, they would require no more than 1 minute 30 seconds. Considering that the Operating Room (OR) is the highest cost-center at a hospital, LapDome can save the hospital approximately $7,000 on a daily basis. By saving an hour of OR time, the hospital also has the option of doing more procedures in the same timeframe. By closing that OR door an hour earlier, we are putting $7,000 in the hospital’s CFO pocket.
Additionally, the LapDome’s ability to reduce surgery-based complications is also a huge financial gain for hospitals/medical facilities. Bear in mind, each complication-related surgery costs a hospital a minimum of $100K including additional surgeries, antibiotic therapy and a week’s stay in hospital. From a macro perspective, if a hospital can eliminate two access complications a year, LapDome will pay for itself.
To sum it up, LapDome leads to efficient ORs, reduction of surgery-related accidents, safer and faster laparoscopic surgeries, and significant savings for hospitals. The pioneering medical device is scheduled for a mid-2020 launch across the U.S. and European markets.
Q. Could you talk about your journey with Dome Medical, from its early years to this day?
My co-founder, Arthur Malvett and Iinitially set up shop in the United Kingdom to capitalize on the less rigorous regulatory barriers in Europe as opposed to the more stringent laws in the United States. We had ample access to ORs and surgeons; we could gradually develop the device by learning on the fly and implementing the clinical modifications we wanted to build into the device. We learned the best way to present the device to the medical community, the nursing staff, and other stakeholders in the medical device business.
Having garnered valuable know-how in Europe, we returned to the U.S. with ambitious plans to target a significantly larger market. The Europe experience taught us about the intellectual property process, offered us a ton of clinical learning, and flexibility in understanding the best way to develop, produce, teach, and market what we believe is THE NEXT DEVICE in laparoscopic surgery. Since returning to the U.S., we have put a capital raise in place to financially support the impending launch of the product in the U.S. and Europe.
Q. What is your company’s roadmap ahead?
While LapDome is its flagship product, DOME Medical Technologies is currently developing four other devices. The LapDome Mini will cater to laparoscopic surgical needs of the smaller patients (not necessarily infants). The company also has specially designeda-LapDome version for children, since laparoscopic surgery in pediatrics is a rapidly growing segment. One of the toughest challenges in pediatric surgery is access due to the size of the patient. This gives rise to complications. There are specific aspects to be considered, such as physiology, and bodily functions of a pediatric patient.
The third device—titled LapDome Plus— DOME Medical Technologies plans to capitalize on the burgeoning bariatric surgery market. The need for the product occurred when the standard LapDome was successfully used on a patient with a body mass index of 39. We got feedback from a GYN who felt the need for a special device for patients with extremely high amounts of fatty tissue.
The fourth device in the pipeline is LapDome 2.0. It is the next generation of LapDome and will feature a totally new design, and increase the utility, flexibility, and performance.
DOME Medical Technologies has a unique value proposition in place. Now, it’s a matter of infiltrating the market. Having forged a strategic partnership with Biomerics, a US contract manufacturer, to produce, sterilize, package, and ship LapDome on a large scale, we are relying on Biomerics to smoothen the QA and compliance-related processes. Additionally, Biomerics will serve as the device development partner for DOME.
We are following a strict two-step process to reach the promised land. The first step involves entering the U.S. market through an IDE registry under the Rapid and Positional Inflation Device Registry (RAPID). After filing for IDE, the endoscopy solution provider will shortlist 10 to 15 medical facilities across the U.S. to use as a launching pad, while simultaneously undertaking marketing/commercialization initiatives. The purpose of IDE registry is to measure safety, and speed of access of LapDome and build up data on our registry protocol.
During the second step, DOME’s team will formulate results from the IDE registry into market-driven data, which it plans to use during the product launch. We will do all this while securing FDA approval —both of which we expect by mid-2020. We plan to launch the device at a medical conference with a book full of substantiated data.
Meet the intrepid entrepreneurs behind the success of Dome Medical
Glenn Foley serves as the CEO of Dome Medical. He brings +30 years of medical device industry experience. His senior management experiences range from multi-national organizations like Medtronic Vascular as Vice-President of Global Sales & Corporate Officer, to Precision Systems and most recently as CEO of Life Care Medical Devices Limited.
Mr. Foley’s experience touches all phases of medical device operations including financial institutions & investor relations, intellectual property and corporate law to sales and marketing in over 40 countries.
Arthur Malvett serves and the COO of DOME Medical. He brings extensive and broad managerial experience in international trade and finance having successfully carried out diverse overseas assignments at Midland Bank and the World Gold Council.
As the COO, Arthur serves as the “control tower” for all financial, administrative, operational and legal components of the DOME’s activities.