A San Antonio medical device company is coming out of stealth mode to launch its first product for critically ill patients with severe respiratory issues. Turn Medical is commercializing its automated hospital bed that rotates the patient safely and easily to a prone position onto their abdomen.
Prone positioning is recommended for critically ill patients with severe acute respiratory distress syndrome (ARDS), which accounts for about 10% of all admissions to intensive care units (ICUs) worldwide. Prone therapy is now considered the standard of care for those with severe ARDS to reduce lung trauma and improve outcomes, especially for those on a ventilator.
“Normally it can take anywhere from six to eight caregivers to manually flip a patient, carefully handling the patient’s critical lines and tubing — the standard of care is to reposition patients every two hours,” Psencik said. “Doing it manually takes manpower, and nurses who need to flip that patient onto their back before starting CPR don’t have that time.”
Turn Medical’s automated prone positioning system allows a single nurse to “flip a patient in 30 seconds by pushing a button on our bed,” Psencik said. The bed can also elevate the patient’s head and upper body and be set to continuously rotate the bed slowly to help prevent skin damage from lying in one position too long.
Normally, there are about 500,000 patients in the U.S. with acute respiratory distress syndrome who could benefit from automated prone positioning.
“Add in COVID-19 patients on ventilators plus nursing staff shortages and the need for this powered bed rotation system is even greater,” Psencik said. “Over 20,000 nurses annually report injuries from moving patients.”
Nurses, nursing aides, orderlies, and attendants suffer more musculoskeletal injuries than workers in any other field. Costs associated with back injuries in the health care industry total more than $7 billion annually.
The idea for the bed came from three engineers who knew each other from working together.
Turn Medical’s chief program officer Eric Barta, chief technology officer Kevin Wilson, and Chris Niederkrom, chief operations officer, worked together previously at Arjo, a Swedish medical device company, and at the medical technology-focused Kinetic Concepts Incorporated (KCI) headquartered in San Antonio. The trio launched Turn Medical in October 2018.
Psencik also worked at both companies and joined Turn Medical as its CEO in September 2020. She worked with the founding team when they were in KCI’s therapeutic support surface division that was bought by Getinge Group-Arjo in 2012. The KCI surface division sold and rented hospital beds, mattress-replacement systems, and patient-mobility units.
The company has 23 employees and six provisional patents. The hospital bed is the first product in Turn Medical’s pipeline. They are have developed a technology application called InteliDerm to use with the bed that may help prevent pressure wounds on the patient’s skin.
Over the past three years, the company has raised $6.1 million in seed funding from founders and angel investors. The company is currently building the beds at a facility near the San Antonio airport on Arion Parkway.
Turn Medical has a regulatory pathway to get the bed to market with a 510(k) exemption that states the company does not need to notify the U.S. Food and Drug Administration (FDA) of their intent to market a medical device at least 90 days in advance. When a 510(k) submission is required it means that the FDA is requesting notification, along with evidence that the medical device intended to be marketed is safe and effective, prior to a company commercializing its product. The bed is also UL certified or Underwriter Laboratories certified for safety.
“There are so many things in the hospital environment that should be automated,” Psencik said. “Fifteen percent of bedside clinicians are exiting the profession every year. This keeps me awake at night as a clinician.”
To help educate clinicians, Psencik said the company plans to debut Turn University in January 2022 to help them identify disease processes that indicate a patient is developing acute respiratory distress syndrome.
“The standard of care states patients should receive prone positioning therapy within 36 hours of symptoms,” Psencik said. “We hope to help increase awareness of the proper time for prone positioning and to provide a safe and effective way to prone patients.”
The featured photo is of Turn Medical’s hospital bed, the Pronova-O2 Automated Prone Therapy System. Courtesy photo.