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Schelin Catheter® approved in Hainan, China
Kurs & Likviditet
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
ProstaLund today announces that Schelin Catheter® has been approved for sale in the province of Hainan in China.
Hainan is a province in southern China, with regulatory rules for medical devices that differ from the rest of China, and where the European CE marking/documentation is usually sufficient for products to be approved for sale. With the help of the Chinese distributor, ProstaLund's Schelin Catheter® has now been approved for sale in the province. The population of Hainan is about 10 million.
With Schelin Catheter®, the prostate can be effectively locally anesthetized in a simple and sterile way. Schelin Catheter® has been used as standard for many years before thermotherapy treatment with ProstaLund's own method CoreTherm®. In 2022, there were world premieres for the use of Schelin Catheter® in conjunction with a variety of prostate surgeries such as water vapor therapy, green laser surgery and others.
Schelin Catheter® means that most prostate surgeries can be moved from resource-intensive operating theaters to ambulatory settings and thus contribute to major savings in terms of healthcare resources, hospital beds and money. At the same time, the patient does not need to be general anesthetized and can thus go home immediately after treatment.
Last year, the company received approval for a so-called utility patent for Schelin Catheter® in China. The Chinese distributor has, together with ProstaLund, started the process for national registration for China, which is expected to take about 18-24 months to get in place.
"It is great pleasure for us to have this provincial registration in place. China is a country where national registration is demanding both in time and money. The registration obtained is only valid within the province of Hainan, but it is a very important step into the Chinese market where over 1,000,000 active treatments for benign prostatic hyperplasia are carried out annually. Today there is no competing product to our Schelin Catheter®. It is completely unique and the only product that can be used to give local prostate anesthesia in a sterile way directly into the prostate. " says CEO Johan Wennerholm in a comment.