Innovators behind new biopsy needle admitted to SmiLe Incubator

A Swedish company has been admitted to the SmiLe Incubator to help bring its surgical needle to market. 

Urologist Andreas Forsvall experienced frustration that some patients developed infection after prostate biopsy, which inspired him to design a completely new and safer biopsy needle. 

When there is a suspicion of cancer, tissue samples – biopsies – are taken from the prostate using a special type of surgical needle that has essentially remained unchanged in design over the past 50 years.

Even though 3-4% of patients who undergo prostate biopsy develop a post-procedure infection severe enough to require hospitalisation, the same type of needle has remained in continuous use. Prostate cancer is the second most common malignancy among men worldwide and about four million biopsy procedures are carried out annually, which indicates just how broad a problem this is.

The infection that can afflict these patients can lead to sepsis. Until now, most such cases could be cured using antibiotics, but growing widespread antibiotic resistance, a major global threat to our health, highlights the importance of developing better medical equipment.

Saga Surgical’s needle, the Forsvall Needle, was designed by Andreas Forsvall, a urologist at Helsingborg Hospital, as well as co-founder and CEO of Saga Surgical. This innovative needle results in fewer infections by minimising the risk that bacteria will enter the body. Tests on the Saga Surgical needle show that it reduces bacterial transmission by a striking 96% compared with currently used standard needles. Patient studies also show that it takes equivalent biopsy specimens and is well tolerated.

The company has patents in Europe, as well as in Japan, a pioneer in the use of this type of needle. Saga Surgical has made good progress in product development and has a contract with a manufacturer that can produce larger series. They now want to advance their commercial business development, which is why they applied to the SmiLe incubator program.

Anna Lindström, business development manager and co-founder, said: “A medical procedure to determine whether prostate cancer is present should not have to put the patient’s life at risk, which is actually the situation in today’s world since antibiotics cannot be relied upon to cure such an infection. Now we would like to take our innovation to the next level and are extremely pleased to have been accepted by SmiLe, where we will have access to their expertise and a well-established partner to support us in business development and commercialisation.”

Ebba Fåhraeus, CEO of SmiLe Incubator, added: “Trailblazing innovations have helped healthcare services to continually improve over time. Saga Surgical’s needle will make a big difference for the healthcare system and at the individual level, for a great number of patients. An additional benefit will be decreased use of antibiotics, which is enormously important in helping to curtail runaway antibiotics resistance. Andreas Forsvall first presented this innovation to me many years ago and it is a true pleasure that his company is now ready to join SmiLe. We look forward to supporting the company in its continued development.”