HOUSTON--(BUSINESS WIRE)--Proxima Clinical Research (“Proxima CRO”), a company guiding emerging medical device and pharmaceutical companies from the earliest stages of product development through commercialization, announced today it has successfully authored and submitted a 510(k) for the EvoEndo® Model LE Single-Use Gastroscope, a device that is indicated for both pediatric and adult patients five years and older. The submission was supported through grant funding by Southwest National Pediatric Device Innovation Consortium (SWPDC.org), of which EvoEndo is a portfolio company and Proxima CRO is a service partner.
“510(k) clearance is a significant achievement in the path to commercialization, signifying that the product is a safe, effective, and legally marketed device,” says Isabella Schmitt, RAC, Director of Regulatory Affairs at Proxima CRO. “We’re excited to see a transnasal endoscope specifically designed with the comfort of the pediatric patient in mind. There are always specific challenges when bringing pediatric products to market, so finding and working with innovators who see the products through to commercialization is always exciting. We are happy to have worked with both EvoEndo and SWPDC on getting this much needed product to market.”
Areas of compliance required for a medical device 510(k) submission include: 1) labeling, claims, and intended use of products; 2) product development and manufacturing operations; 3) product safety & effectiveness; and 4) product registration, records, customer complaints, and adverse reactions.
“This is an exceptional accomplishment for our team,” says Heather Underwood, CEO, EvoEndo. “The FDA 510(k) clearance validates our commitment to offer a safer, faster, and more affordable alternative to sedated endoscopy for both pediatric and adult patients, and supports the broader adoption of safer, unsedated procedures throughout the U.S.”
EvoEndo’s Single-Use Endoscopy System (“The System”) eliminates the need for general anesthesia, or conscious sedation, during routine upper endoscopic procedures. The 510(k) was granted on February 14, 2022.
“We like nothing more than seeing our investments and assistance help improve the lives of pediatric patients, families and providers,” says Chester J. Koh, MD, Executive Director and Contact Principal Investigator of SWPDC. “This is why we exist. To bring products like this to market to make healthcare better, safer, more effective, and more accessible to children around the world.”
As a multi-institutional consortium that includes Texas Children’s Hospital and Baylor College of Medicine, Texas A&M University, Rice University, University of Houston, Fannin Innovation Studio, and other partners, SWPDC is a “free and no-strings-attached” virtual accelerator that supports pediatric device innovators throughout the pediatric device life cycle by providing device seed funding, consulting, design and engineering assistance, potential clinical collaborators, and connections to local programs and resources.
The EvoEndo System is intended for use only by medical professionals. Physicians and other medical providers interested in learning more about the EvoEndo TNE system or to schedule demonstrations and training can contact the company here. The System will be distributed through Micro-Tech Endoscopy USA with commercial sales slated to begin following completion of the first clinical cases at several pediatric facilities.
EvoEndo was founded in 2017 by Dr. Joel Friedlander, a Pediatric Gastroenterologist at Children’s Hospital of Colorado, and is led by Chief Executive Officer Dr. Heather Underwood, an experienced medical device and technology entrepreneur, and alumna of the Stanford University Biodesign Program. While traditional endoscopy requires patients to undergo general anesthesia or sedation, the EvoEndo System combines sterile, single-use, flexible endoscopes, a portable video controller, and a take-home “comfort kit” containing virtual reality (VR) goggles for patient entertainment and distraction during the procedure. The EvoEndo System ultimately enables safer and more cost-effective upper endoscopic procedures for patients, doctors, and hospitals. The FDA Clearance is the latest milestone for EvoEndo, who also announced the completion of a $10.1M equity financing round last June.
About Proxima Clinical Research
Proxima CRO provides regulatory and clinical research expertise to life sciences companies of all sizes and stages, including inventors, emerging companies, and Fortune 500. With headquarters in the Texas Medical Center (“TMC”), the largest medical center in the world, Proxima CRO brings its expertise to hundreds of medical device, pharmaceutical, biotechnology, and diagnostic companies in 17 countries across five continents to further advance the $130 billion industry. Launched in November 2017, Proxima CRO is a registered Delaware C Corporation. For more on Proxima CRO and its growing team, visit ProximaCRO.com.