Nanosellulose Hydrogel Halts Urinary Incontinence

Over half of the world's women experience urinary incontinence at some point in their lives. The aging population will only increase the prevalence of this condition in the future. Urinary incontinence has long been treated using plastic mesh materials to support the urethra. However, plastic meshes have caused problems and pain for patients, leading to their prohibition in countries like the UK.

"The idea for a new approach originated from a project at Aalto University back in 2019. In February 2020, the development project received funding from Business Finland, enabling the research team to conduct valuable basic research in the laboratory, develop 3D models, and various configurations. Lignum Medical Oy was founded in the autumn of 2023 to commercialize the new treatment method," says one of the company's founders, Professor and Specialist in Obstetrics and Gynecology, Tomi Mikkola. The other founders and shareholders of the company are Eija Raussi-Lehto, a midwifery-trained healthcare educator, Anu Meerwaldt specialized in commercializing health technology, and Mikko Lehto, an expert in contract law and attorney.

The Instrumentarium Science Foundation has granted Lignum Medical Oy a €50,000 SILMU grant to further develop the treatment based on nanocellulose hydrogel.

Replacing Plastic with Natural Material

The current "gold standard" for urinary incontinence treatment relies on an implant based on plastic meshes. However, due to its many problems, it is gradually being phased out, necessitating a new treatment method, according to Mikkola. Nanocellulose hydrogel is a birch-based natural material. Instead of a plastic mesh, the urethra is supported by an injectable gel cushion. According to Mikkola, a somewhat similar product already exists, but nanocellulose is a superior material and environmentally sustainable.

"The market potential for SUI treatments is significant and growing at around 8% annually. Currently, the global market for plastic mesh support tapes is worth over €1.3 billion. Market growth is partly due to the aging of the population, as the condition is common among women aged 40-70. Additionally, the condition has previously been needlessly stigmatized, but now women are actively seeking treatment. Plastic has proven to be a problematic material that we aim to move away from, so we and Lignum Medical are moving at just the right time," reflects Mikkola.

The company aims to enter the market with a patented Lignum Medical medical device within about five years.

Strong Regulation Associated with Implants

Basic research related to the treatment and testing on animals has already been conducted. In 2024, the plan is to move on to clinical trials involving human patients. When the treatment involves installing an external implant inside the human body, regulations and standards related to medical devices are crucial. Approval of the treatment requires documentation from an external and independent expert regarding the safety and usability of the product.

"The SILMU funding from the Science Foundation comes to us at the right time, as it enables us to start the product's regulatory process. We already have several interested and preliminarily committed follow-up funders, for whom advancing the product's regulatory strategy is of paramount importance. Our goal is to obtain both FDA approval in the US and CE certification in Europe by the end of 2028," continues Mikkola.

First Funding Paves the Way for the Future

Over the years, the research project has received funding from various sources, including Business Finland. However, the SILMU grant from the Science Foundation is the first major funding the fledgling company has secured for itself. The transfer of intellectual property rights from the project initiated at Aalto University to Lignum Medical is currently underway, which is vital for the company's future and subsequent funding.

"I believe that the SILMU grant we've received now is a good sign for all interested investors. Getting the first funding is always the most difficult, but the funding from the Science Foundation shows the experts' belief in us and our idea. We aim to carry out the initiated seed funding round during the spring of 2024."

Text: Kai Tarkka
Picture: Tomi Mikkola