Irena Volkov, Founder & CEO, Surgicure Technologies
The global death toll caused by the COVID-19 pandemic is staggering. Healthcare systems are handling the huge influx of patients and streamlining even the basic medical procedures under great strain. For instance, consider intubation. The importance of intubation to surgeries and medical emergencies, especially during the COVID-19 pandemic, cannot be overestimated. One in four patients undergoing COVID-19 treatment needs to be intubated, which involves inserting an endotracheal tube (ET) through the patient’s mouth into the airway to ensure breathing is not obstructed. Even though current circumstances demand fast and efficient intubation to keep pace with increasing patient volumes, the intubation process typically requires up to four personnel and the use of multiple devices. In addition, the risk of nosocomial infections if intubation equipment is not properly decontaminated greatly increases the risk of disease transmission.
To this end, Surgicure Technologies, a woman-owned biotechnology start-up headquartered in Massachusetts, has introduced an elegant intubation solution with the potential to redefine standard of care, namely, the Resting Block (RB), a disposable device that addresses complications associated with traditional intubation management methods.
Bite blocks or bite guards, which are used in intubation, are often placed between the front incisors. If not properly used, they can cause unintended damage to the patient. According to the Journal of International Oral Health, 80 percent of anaesthetists stated that dental-related injuries typically occur at the onset of intubation. Wrong placement of the bite block can cause damage to the anterior tooth. Further, endotracheal tube displacement and unplanned extubations are prevalent problems that may cause further respiratory distress such as the potential need to reintubate a patient that may cause additional inflammation.” The very devices that are needed to secure an endotracheal tube during intubation are the same ones causing additional facial trauma and inflammation, keeping patients in the hospital longer. This also increases costs for both patients and hospitals. A relevant example is the need for use of this device for burn victims who have inflamed throats from the inhalation of smoke and potentially already suffered facial damage,” mentions Irena Volkov, the Founder and CEO of Surgicure Technologies.
Irena is a Ph.D. candidate in the Harvard-MIT Health Sciences and Technology Program as well as an NSF Graduate Research Fellow. Her passionate team at Surgicure is on a mission to make a positive difference in the healthcare industry by effectively addressing the often overlooked but longstanding challenges described in the literature associated with intubation. Surgicure is dedicated to building cost-effective medical instruments to safely and effectively facilitate and support the intubation process intended for both civilian and military applications.
Solving the Intubation Puzzle
As Irena mentions, when it comes to intubation, the most common problem stems from inserting an inadequately stabilized tube down a patient’s throat. Moreover, bite blocks placed between the front incisors to keep the mouth open for the tube to be inserted can result in broken and damaged teeth. There have been numerous cases of bite blocks getting dislodged, causing the patient to swallow them. An additional challenge relates to securing the tube firmly to the patient’s face, for which straps and adhesives are used. For burn victims and geriatric patients with damaged and frail skin, this can lead to further skin injury and may even require reconstructive surgery. Because of the constant pressure and friction exerted on the face, the current securing devices and medical tape in use cannot be used for long term procedures as more often than not, they cause additional bodily damage. According to the medical literature (Titled: Long-Term Complications of Tracheal Intubation), this is especially prevalent when patients with inflamed and fluid-filled lungs, such as those with pneumonia or Acute Respiratory Distress Syndrome (ARDS), need to be placed lying in a prone position so they can breathe better.
With the endotracheal tube hanging from their mouth as they are lying face down, adhesives cannot effectively support the tube and, as a result, rub against the face causing ulcers. Patients with severe respiratory diseases must be flipped over twice a day, every day, to prevent additional facial trauma and risk infections.
An Asset to Healthcare
It’s not practical to have three, four, or five practitioners setting up multiple intubation devices. They need a device that can be easily inserted between the teeth to hold the patient’s mouth open and secure the endotracheal tube so that oxygen can be delivered immediately and efficiently
Surgicure’s patented Resting Block (‘RB’) provides the functionality of both a bite block to keep patients’ mouths open and a medical tube securing device to secure and stabilize endotracheal tubes. What’s unique about the device’s design is that it relies on the patients’ back molars for improved support. The RB device consists of a frame and adjustable rack that protrudes out of the mouth, avoiding contact with the face. By relying on molars, the RB prevents accidental extubations, biting into catheters, and dislodging of bite blocks, which could potentially suffocate the patient. The real value proposition of the bite block is its ease-of-use factor, which, in turn, enables quicker intubation. As Irena explains, “This is extremely important because if there is a patient that’s sedated whose blood oxygen levels are rapidly dropping, realistically, you have about 3-5 minutes to intubate before the heart or brain experience detrimental effects. It’s not practical to have three, four, or five practitioners setting up multiple intubation devices. They need a device that can be easily inserted between the teeth to hold the patient’s mouth open and secure the endotracheal tube so that oxygen can be delivered immediately and efficiently.” Another key differentiator of Surgicure’s bite block device is that it is disposable, which eliminates the risk of cross-contamination or infections that can arise with using reusable intubation devices that are potentially not properly sterilized between patient usage. The RB device is also ideal for long term use, especially for comatose patients who would need to be intubated for longer periods of time.
Surgicure’s ingenious, integrated device eliminates the requirement for hospitals to purchase multiple straps, adhesives, and bite blocks to administer one simple procedure. Being disposable, it also saves hospitals from having to pay extra for cleaning tools or relying on the staff to decontaminate a reusable device. “The device can help save hospital costs by approximately $41,000 per patient for every avoided extubation event as well as reduced ICU stays,” says Irena.
Rooted in Invention
The idea behind Surgicure’s innovative product was derived from research conducted by two former respiratory therapists—Brendan Beely and Gabriel Wright—at the U.S. Army Institute of Surgical Research, Burn Center, Fort Sam Houston, Texas. They prototyped the device to save burn victims from enduring the ordeal of painful intubation involving multiple straps, adhesives, and bite blocks.
The project won the prestigious “Department of Defense Hot Technologies” contest.
The device project was introduced to Irena in 2019 when she was an undergraduate in neuroscience and bioentrepreneuship at the American University in Washington D.C. Her biotechnology course coordinated with a program wherein a company called FedTech would foster student entrepreneurship by encouraging them to take up research projects that were formerly undertaken by the government or military and find ways to commercialize them. Irena quickly realized its potential as a practical solution to a vexing problem in the practice of medicine. Working tirelessly to bring this product to market, Irena has acquired a license to the patent for the device from the US Army, assembled a seasoned management team, all geared toward performing a clinical trial(s), mass production and commercial launch of the RB device, activities anticipated to occur during the 2020-2021 timeframe.
“The device can help save hospital costs by approximately $41,000 per patient for every avoided extubation event as well as reduced ICU stays”
Welcoming the Intubation Innovation
Resting Block is a FDA Class I, Exempt, device that does not require premarket approval by the US FDA. This would help the company significantly accelerate its speed to market. Surgicure is planning to perform a clinical trial at the Baylor College of Medicine to gather relevant clinical data on the device’s usage.
Surgicure is constantly in conversations with multiple hospitals across California, Texas, Washington DC, and Boston to garner feedback about its offering. “One of the most remarkable appreciations that we received is from an ICU nurse who expressed that it was extremely difficult for her in situations when a patient suddenly stops breathing, and she has to manually hold their mouth open or force a bite block in while someone else is setting up the ventilator, administering medications, performing the intubation, and attached adhesives or straps to secure the endotracheal tube. This process must occur quickly so the patient doesn’t experience additional respiratory distress or organ damage. Surgicure’s product, to this end, could truly be an improvement to the current process,” adds Irena.
Headed toward a Promising Future
At Surgicure, Irena leads a workforce that comprises both ambitious graduate and medical students and respected professionals in the healthcare industry. “I think our work culture really makes a difference because we’re not influenced by pre biases. We’re coming in with fresh minds and ideas, and are ready to learn more about this industry,” mentions Irena. “To draw on the knowledge of experienced executives in the field, we recently added a Chief Operating Office and Chief Commercialization Officer to our team that, in tandem, have substantial experience working successfully with life science companies in the areas of innovation, strategy, product development and commercialization. Additionally, between our new VP of People and Strategy and myself, we make sure that every team member’s voice is heard, that our culture is inclusive and results-oriented, and includes an ethos of being a responsible corporate citizen.”
As a part of its go-to-market strategy, the company also plans to manufacture devices for clinical trials and distribution to local hospitals. For future iterations of the device, Surgicure is looking to 3D print custom-made devices specifically suited for patients without molars or even for the ones suffering from facial deformities.
The appetite for change and innovation in medicine, especially during the COVID-19 pandemic, augurs well for Surgicure Technologies, a promising startup in the intubation space.