Strict regulations block commercial launch of bloodless syringe in Korea

2022.01.21 13:57:50 | 2022.01.21 13:58:19

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An innovative bloodless syringe needle developed three years ago in South Korea is barred from going to market in the face of regulatory barriers despite its high demand for the prevention of secondary infections among healthcare professionals.

Scientists criticize the country’s current regulations on the innovative medical device designation for fast-track marketing review are too strict to encourage innovations.

Innotherapy, a Korean bio-inspired technology company, developed a needle coated with a hemostatic substance and filed for its designation as an innovative medical device to the Ministry of Food and Drug Safety last June. The application was referred to the Ministry of Health and Welfare, but the top health regulator said the bloodless needle does not meet the innovative medical device criteria, adding it is difficult to decide in terms of safety although its innovativeness is recognized.

In response, Innotherapy said it is working on supplemental documents to beef up safety data and re-submit its application this year.

The needle was first developed by KAIST scientist Lee Hae-shin and in recognition of his invention Lee received the scientist award of the month from the government in October 2018. The needle is coated with a hemostatic substance and an adhesive substance similar to what mussels use to cling to rocks against crashing waves.

A patch-type product using the same substance was already approved for its commercial use with approval from the Ministry of Food and Drug Safety in 2015 and from the U.S. Food and Drug Administration in 2016.

A bloodless syringe can protect healthcare professionals from secondary infections that are mediated by the patient`s blood, such as AIDS, Ebola, and hepatitis. This syringe can also be used for injection treatment for patients with weak hemostasis due to hemophilia or diabetes.

It is difficult to understand that a patch product with the same substance has already been commercialized, but the application for this needle product is not accepted for safety reasons, Lee said.

By Lee Sae-bom, Jung Hee-young and Minu Kim

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