Nesa Medtech receives CDSCO Manufacturing License, Marking a Milestone in Next Generation Uterine Fibroid Treatment
Jul 25, 2024
PNN
Bangalore (Karnataka) [India], July 25: Nesa Medtech, a leading medical device startup in women's health, has announced its flagship product, GYIDE, received a manufacturing license from CDSCO (Central Drugs Standard Control Organization). This approval marks a significant milestone for the company able to offer scarless treatment for uterine fibroids compared to the existing invasive solutions.
Uterine fibroids are a common medical condition that affects women. They often cause symptoms such as heavy menstrual bleeding, pelvic pain, and infertility. This is a significant issue, as 1 in 4 women are affected by uterine fibroids. Only a small percentage of patients find relief from symptoms using medications. The majority of patients are recommended for surgical solutions, including open surgery or minimally invasive procedures such as laparoscopy or hysteroscopy. The most common surgery offered is hysterectomy, which involves the removal of the uterus.
GYIDE enables a scarless, no-cut, and no-suture procedure to treat symptomatic uterine fibroids. Its novelty is its guidance system, which can deliver ablation under real-time ultrasound guidance. GYIDE offers a unique value proposition by providing in-office procedures, faster procedure time, quicker recovery, and, importantly, preserving the uterus. This ensures the best for all stakeholders.
"Receiving CDSCO clearance is a testament to Nesa Medtech's quest for developing high-quality and world-class solutions. The journey to realizing the clearance has been incredible, and the team's perseverance made it possible, said Sreekar Kothamachu, CEO & founder of Nesa Medtech."
GYIDE's approval is expected to have a significant impact on the treatment of uterine fibroids, as it offers a micro-invasive solution with better outcomes and increased patient satisfaction compared to other minimally invasive options.
Looking ahead, Nesa Medtech, with approval from CDSCO, would conduct performance studies at medical centers of excellence. This would enable the solution to be one step closer to offering GYIDE as a paradigm of treatment for women suffering from uterine fibroids.
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