Dome Medical Technologies
Broadening the Horizons for Laparoscopic Surgeons

 
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, 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. 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 still 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 General Surgeons gain separation from coming in contact with critical vessels and organs when the balance of the surgical instruments is employed.

“LapDome enhances not only the safety, speed, and efficiency of each laparoscopic surgery procedure— one of the largest medical segments worldwide—but reduces the overall operating budget of the OR as well”

GYNs and General Surgeons didn’t have a choice, until now. DOME Medical Technologies, an endoscopy solution provider, has designed a revolutionary and proprietary platform titled LapDome™ that offers GYNs and General Surgeons the highly coveted space (of 4.7 cm) while penetrating the abdominal cavity. “Operating within the target space of 1 cm, GYNs and General Surgeons may potentially commit inadvertent mistakes that can lead to acute and costly complications. We are creating space to give GYNs and General Surgeons a lot more room to work with,” explains Glenn Foley, CEO and co-founder of the New York based medical device company.

This additional working space created by LapDome was measured via CT scan*. In a 12-patient study, the increased distance between the abdominal wall and the aorta and vena cava was increased 3.69cm +/-1.0 and 3.78cm +/-1.91 respectively.

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 port for a Veress needle/ endoscopic trocar. Due to negative pressure generated by the suction during the access procedure, GYNs and General Surgeons gain the benefits of a secure zone (of 4.7 cm) to insert a Veress needle or trocar and subsequent delivery of CO2. “LapDome enhances not only the safety, speed, and efficiency of each laparoscopic surgery procedure—one of the largest medical segments worldwide—but reduces the overall operating budget of the Operation Room (OR) as well,” says Foley.

The Path that Led to LapDome

Following years of dedication to their respective crafts, Foley and Arthur Raymond Malvett, the founding members of DOME Medical Technologies, stand on the cusp of potentially setting “The New Standard of Care” in laparoscopic surgery access. But the road to LapDome was anything but conventional. While Foley hails from a pure Medtech background, Malvett has deep experience in international trade and finance. Upon joining forces, the duo initially set shop in the U.K. to capitalize on the less stringent regulatory barriers in Europe as opposed to the more stringent laws in the U.S. Foley recalls, “Since we had ample access to ORs and surgeons, we could gradually develop the device by learning on the fly, 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, the duo relocated to the U.S. with ambitious plans to target a significantly vaster market. “The European 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,” says Malvett, the COO of DOME Medical Technologies, while referring to LapDome.

Since relocating to the U.S., the company has put a capital raise in place to financially support the impending launch of the product platform in the U.S. and Europe. Additionally, DOME has begun the recruiting process for key executives and staff.

If the hospital performs eight procedures a day in the OR, LapDome is saving that hospital at least one hour of OR time a day

One thing is clear: the company didn’t take any shortcuts before developing its proprietary device. During their time in the U.K. and Europe, DOME Medical Technologies put the LapDome through more than 50 procedures across hospitals and universities. It took the pilot edition of the medical device to a long list of GYNs and General Surgeons before making necessary alterations. “When we first designed the device, surgeons noticed limitations,” admits Foley. GYNs and General Surgeons wanted angulation capabilities so as to effectively enter the abdominal cavity and backfill the negative space with CO2 gas during the process of surgery access. Foley adds, “We went back to the lab and made changes to allow surgeons to create complete angulations up to 150 degrees of the instrument’s insertion. We also provided them with 360-degree circumferential plausibility and single operator capability.”



GYNs, General Surgeons and hospital administration staff across the U.S. and Europe are getting wind of this first-of-a-kind technology. Over the course of this story, we substantiate DOME Medical Technologies’ rightful place on the cover page, while highlighting the various benefits of the LapDome technology—that extend beyond the obvious, i.e., protection of vital organs.

The Clinical Benefits

To quote a member of DOME Medical Technologies’ Advisory Board, “why hit any tissue that is not your target?” 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 complication treatments. According to studies, 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. “When GYNs and General Surgeons unknowingly nick something, patients suffer from highly acute infections. These types of complications are significantly under-reported,” says Foley.

LapDome eliminates such complications simply because surgeons enjoy a highly expanded and widened target area in the patient’s abdominal cavity and are unlikely to nick a bowel, spleen, or any other organ during initial access.” Foley explains, “Intra-abdominally, when a surgeon has to land the tip of access instruments (Veress needle or trocar), they are 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, meanwhile, enjoys a 100 percent success rate with regards to successful first stick access. Foley adds, “We’ve done almost 60 procedures, and no GYN or General Surgeon has ever needed to re-stick.”

This novel technology also saves time for GYNs and General Surgeons. In the current standard (pre-LapDome), the insufflation through the Veress needle takes longer due to the resistance of the “thick and heavy” abdominal wall preventing CO2 gas from entering the area. “With LapDome, a surgeon has already created the space, which makes the insufflation rate a lot faster,” notes Foley.

As for the degree of user-friendliness, the verdict is in, and LapDome is a hit. “The two aspects GYNs and General Surgeons have appreciated the most are the easy creation of internal space from an external position and the degree of flexibility. They are able to move the LapDome around the abdomen and choose a precise spot, such as “Palmer’s Point,” details Foley. For example, in the event of a patient undergoing repeat surgery, there is scar tissue build-up that the GYN and General Surgeon have to filter through (pre-insufflation). By using LapDome, surgeons can simply avoid the areas containing a build-up. A prideful Foley says, “Our tagline is ‘The Genius is in Its Simplicity’ and surgeons can attest to that.”

The Economic Benefits

In the current standard of laparoscopic surgery, it takes surgeons an average of 10 minutes to insufflate with the existing methodology. With LapDome, they require less than 1 minute and 30 seconds. “With each procedure, we’re saving them eight minutes. If the hospital performs eight procedures a day in the OR, LapDome is saving that hospital at least one hour of OR time a day,” says Malvett, a seasoned entrepreneur.

Considering that the OR is the highest cost-center at a hospital, LapDome can save the hospital approximately $7,000 on a daily basis.

“By closing that OR door an hour earlier, we are putting $7,000 in the hospital’s CFO pocket,” stresses Malvett. By saving an hour of OR time, the hospital also has the option of doing more procedures in the same timeframe. “It can be a profit opportunity or cost savings— directly to the bottom line of a hospital.”



Besides the daily OR time savings, 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,” reasons Malvett.

In summation, LapDome leads to efficient ORs, reduction of surgery-related accidents, safer and faster laparoscopic surgeries, and significant savings for hospitals. This pioneering medical device is scheduled for a mid-2020 launch across the U.S. and European markets.

Coming Soon: A Diverse Product Suite

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 designed LapDome 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,” says Foley, before outlining the differences in laparoscopic surgery for adults versus children. “There are specific aspects to be considered, such as physiology, and bodily functions of a pediatric patient,” he adds.



With the third device—titled LapDome Plus— DOME Medical Technologies plan 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 extreme fatty tissue,” recalls Foley. The LapDome Plus is due for a late-2020 launch.

The fourth device in the pipeline is LapDome 2.0. “The next generation of LapDome will feature a totally new design, and increase the utility, flexibility, and performance,” reveals Foley.

Penetrating Market with a Precise Plan

DOME Medical Technologies has a unique value proposition in place. Now, it’s a matter of penetrating the market. Having forged a strategic partnership with Biomerics, a US contract manufacturer, to produce, sterilize, package, and ship LapDome on a large scale, the company is relying on Biomerics to smoothen the QA and compliance-related processes. Additionally, Biomerics will serve as the device development partner for DOME.

DOME Medical Technologies is banking on a disciplined 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 Insufflation 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 the IDE registry is to measure safety, and speed of access of LapDome and build up data on our registry protocol,” explains Foley.

During the second step, DOME’s steam will formulate results from the IDE registry into market-driven data, which it plans to use during the product launch. Foley adds, “We will do all this while securing FDA approval which we expect by Q2 2020. We plan to launch the device at a medical conference with a book full of substantiated data.”

In conclusion, DOME Medical Technologies intends to grab a sizeable market share fully aware that there are deeply ingrained habits. The company also expects to win over university teaching hospitals, resident GYN and General Surgeons, fellows in the early stages of their education, and surgeons who focus on sub-specialties of endoscopy such as pediatric and bariatric. Overall, Foley remains optimistic on the current climate of the laparoscopic market. “There are 16M laparoscopic procedures done per year, and that number is growing organically at 8.5 percent. Our target market is as robust as ever. We will validate the platform and succeed. We have yet to have a GYN or general surgeon use the LapDome platform without saying ‘when can I have it?’” concludes a confident Foley.