Singapore-based medtech company, Privi Medical has received FDA clearance for its InstaliefTM Hemorrhoids Treatment device. The disposable device features an advanced “instant cold compression technology” to treat hemorrhoids.
Hemorrhoids or piles is a condition caused by swollen veins in the anal canal. It is a very common problem which is quite painful but is usually not serious. Veins can swell inside the anal canal to form internal hemorrhoids, or they can swell near the opening of the anus to form external hemorrhoids. Occasionally they become symptomatic with the most common symptoms being bleeding, pain and discomfort in the anal canal that affects sufferers’ ability to lead a normal life.
Symptomatic hemorrhoids are highly prevalent and recurrent. It is a huge unmet clinical need, with an estimated 300 million people suffering from this problem globally. The National Institute of Health estimates that 3 in 4 adults will suffer from hemorrhoids at some point in their lives.
The current treatment options such as drug-based ointments and suppositories have limited effectiveness. Furthermore, the active ingredients in these products, such as corticosteroids and epinephrine can potentially cause long-term side effects.
InstaliefTM is the only drug-free device that provides hassle-free, instant cold relief without the dangers of drug side-effects. The added benefits of being disposable further enables a clean and comfortable experience for users in the privacy of their own homes. The InstaliefTM product is cleared for adult use.
“We are excited to bring InstaliefTM, a safe, hygienic and drug-free solution to the home hemorrhoid treatment market that we believe fulfills a huge unmet clinical need for millions of sufferers,” Prusothman S. Raja, CEO, Privi Medical.
“We chose to go with FDA clearance first (instead of CE Mark, which is more common as the first regulatory path) because we did a thorough analysis of the regulatory requirements and timeline. While FDA is more difficult, we felt that in the current regulatory climate we could get the clearance faster there. We are glad to be proven right. Having said that, our CE Mark regulatory work is in very good progress.”
Privi Medical Pte Ltd is an innovation-driven medial technology company spun out of the Stanford Byers Center for Biodesign and the Singapore-Stanford Biodesign programs, and has received support from Exploit Technologies (ETPL), the commercialization arm of the Agency for Science Technology & Research (A*STAR).
Reflecting on their journey so far, the co-founders Benjamin Tee , Dr Rena Dharmawan and Prusothman S. Raja say, “Medtech product development is difficult but the potential impact of the product in people’s lives makes the challenge worthwhile. Always keep the patients as the focus of your work and any difficulty will be easier to overcome. Medtech is a long journey so it’s important that you have a good team that is able to work together. We’ve been privileged that Privi has very good company founders and employees.”