- Tristel received three regulatory approvals for its different categories of product.
- In the US, the company got approval for surface disinfectant from Environmental Protection Agency.
- The regulatory approvals will allow the company to sell its products and would contribute significantly to revenue growth.
Infection prevention and contamination control products maker, Tristel Plc (LON: TSTL) has bagged three significant approvals for its different categories of products in international markets.
The company is in research and development of disinfectant products for medical instruments cleaning, surface cleaning of hospitals, pharma companies, laboratory and preventive infection products for animal healthcare.
Approval by the US Environmental Protection Agency (EPA)
In the US, the company got approval for surface disinfectant from Environmental Protection Agency (EPA). The submission for product approval was made in October 2020 after completing three state registration of the product. It is a third approval for the form-based Jet product that led to the product’s efficacy claims to include mycobacteria.
The company expects to complete nationwide registration of products by June 2022 and has appointed Parker Laboratories as a manufacturing partner for Jet product. In the US market, the company plans to sell the products from FY23 by using parkers’ existing nationwide network of distribution on a non-exclusive license basis. Before the US product launch in FY23, the company is looking to add other distribution channels as well.
Approval by Health Canada for the disinfectant to clean ophthalmic instruments
Tristel Duo OPH received approval as a class 2 medical device from Health Canada, a department working under the Government of Canada and responsible for national health policy. The product is included in Canada’s Medical Device License listing. Duo OPH is a disinfectant used to clean different types of ophthalmic instruments like ultrasound devices and lenses that are used to examine the outer layer of the eyes.
According to the company, Duo OPH is the best high-level disinfectant used for different ophthalmic devices sold in over 15 countries, with the expected FY21 sales revenue to be £650,000.
For product sales in the Canadian market, the company is currently having a discussion with a potential distribution partner. US-based Parker Laboratories will manufacture Duo OPH product for the Canadian market.
Approval by the South Korea Ministry of Food and Drug Safety
The company received approval from the Korean Ministry of Food and Drug Safety for Sporicidal Wipe. The wipes are widely used in clinics to clean small endoscopic devices used to examine ear, nose and throat.
Duo ULT a hand-held dispenser has been approved as a proficient cleanser for ultrasound devices which uses the company’s powerful chlorine dioxide solution as a foam to the exterior of a medical device. It is widely used across Europe, the Middle East. In South Korea, Tristel’s plans to sell products through its existing distributor HP&C Ltd. The company expects both Duo ULT and Duo OPH combined sales to exceed £4.3 million in FY21.
After the announcement, Tristel’s stock was trading at GBX 625 at 11:23 AM GMT+1 with a market cap of £ 294 million. In the last 1-year, the stock has given 44% returns to its shareholders.