BOSTON, May 8, 2024 (Newswire.com) - Freyja Healthcare, an early-stage medical device company focused on developing a robust product portfolio of highly innovative products for women’s health, today announced that its novel VereSee device received 510(k) clearance from the United States Food and Drug Administration (FDA). Clearance from the FDA marks a critical step in enabling Freyja and VereSee — the first and only 2mm, safe abdominal-access video-entry device for laparoscopic surgery — to bring further innovation in the fast-growing women’s health market. VereSee will reinvigorate a category that has not seen innovation in over three decades.
Founded by Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, Freyja’s mission is to raise the standard of women’s health in both surgical and in-office procedures, enabling physicians to deliver safe and effective care. As the company’s first novel product, the VereSee device features a proprietary design engineered to be simple for the surgeon, safe for the patient, and highly differentiated from the current standard of care. The company now has four products in advanced stages of development, 17 granted patents and 21 pending patents.
“From the beginning, I’ve been impressed with Freyja’s mission to improve gynecologic solutions for women and the providers who take care of them. With this first product, Freyja is bringing meaningful innovation to a category ready for change,” said Kim Rodriguez, longtime Freyja Executive Chairman and former CEO of Acessa Health.
There are 4.8 million laparoscopic surgeries performed annually in the United States. Abdominal entry is the most dangerous step of laparoscopic and robotic surgery in women’s health, and in all laparoscopic surgery across all specialty areas. This dangerous step results in one patient death and eight injuries in the U.S. each day[1].
“The standard of care is dangerous and outdated. Initial entry is often done blindly with Veres needles or a 5-12mm optical trocar,” said Jón Ívar Einarsson, MD, co-founder and interim CEO of Freyja. “Damaging the bowel or vasculature because of blind entry can cause significant harm, even death, if undetected.”
As a part of the FDA clearance process, Freyja performed extensive testing and documentation of the safety and efficacy of the product, validating the company’s confidence in the design of its VereSee product.
“FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” said Gaby Moawad, MD, co-founder and Board Director of Freyja. “However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Freyja.”
Freyja will soon begin initial commercialization of the VereSee device, with broad availability expected in the second half of 2024.
About Freyja Healthcare
Freyja Healthcare was founded in 2017, has four products in advanced stages of development, 17 granted patents and 21 pending patents, and is engineering a robust product portfolio focused on safe and effective surgical and in-office solutions for women. Founded by two well-respected, minimally invasive gynecologic surgeons, Jón Ívar Einarsson, MD, PhD, MPH, Past-President of AAGL, founder of the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Brigham and Women’s Hospital (BWH) and a Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, and Gaby Moawad, MD, FACOG, Associate Professor of Obstetrics and Gynecology at The George Washington University School of Medicine and Health Sciences (GWSMHS). Drs. Einarsson and Moawad are inventing and building the products they wish they had early in their careers and elevating the standards for products used in women’s health surgical and in-office care. Freyja has raised almost $8 million in seed funding from private and professional high net-worth investors. Learn more at Freyja Healthcare.
[1] Clark NV, Einarsson JI. Laparoscopic entry techniques. In: Minimally invasive surgery in gynecologic practice. De Gruyter 2020.
Contact Information:Jerry Brecher
info@freyjahealthcare.com
Original Source: Freyja HealthCare's VereSee™ Device Receives 510(k) Clearance, the First of Many Products
