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Malin Nilsson, Inossia - Better Fracture Treatment for Osteoporotic Bone | LSI Europe '24

Inossia® provides vertebral augmentation solutions that have been adapted to the mechanical properties of brittle osteoporotic bone.
Speakers
Malin Nilsson
Malin Nilsson
CEO, Inossia

Malin Nilsson 00:02
When I was a kid, we had an old lady in my village. Her name was Inga. She walked around in the village with her back like a hook.

Malin Nilsson 00:14
Everyone called her Crooked Inga. What I didn't know then, that I know now, is that she suffered from multiple osteoporotic fractures in her back. And she is not alone. 33% of all women and 20% of all men over the age of 50 will suffer an osteoporotic fracture during their lifetime. That is one out of three of you ladies and one out of five of you guys, one out of three and one out of five; that is 1.4 million fractures every year. And that is not all. We also have the disc. The disc also starts to collapse with age, and it impinges the nerve, and you get chronic and severe back pain. With 400 million diagnosed, this is a real problem, and it gets worse with age. 80% of all patients over the age of 80 suffer from it, but there is a treatment today. You can inject bone cement to prevent collapse. But this bone cement that is used is rock hard. It's like throwing a stone in a pile of eggs, so you get more vertebral bodies breaking. My name is Malin, and this is the reason why I founded Inossia. Let me introduce a new solution, a revolutionary solution called the Inossia Cement Softener. It's a magic ingredient, an addition that you can add to any bone cement in the world, and it will give the bone cement a new characteristic of being soft and elastic. This elasticity also opens up new indications, like use in discs. We have several patents granted already, and we can produce 10,000 units a week. This is how it works. So the patients come in for surgery. When she lays on the table, the surgeon will mix the ordinary bone cement together with our softener and directly inject it into the vertebral body, where it immediately adapts to the patient's own bone, and she can go home the same day with no new fractures, reduced pain, increased mobility, and increased quality of life. And the hospitals, what can they offer? They can offer a successful surgery. Well, I guess that the surgeon would like to have a successful surgery in her hands, and it's easy, safe to use, and the patients are not coming back, which is the most important part, and it gives this treatment a very cost-efficient background. We have a simple business model, where on one hand, we have a partner solution, where we put the Inossia Cement Softener into a cement manufacturing package, and we get a 50% cut from each product. On the other hand, for the disc application, where there are no established bone cement manufacturers, we will produce our own material and our own product and sell it for 2,500 euros each. That would give us much higher margins. With 1.4 million fractures, this opportunity is tremendous. It's a big market valued at $1.1 billion, and we are targeting the three largest areas: the US, Europe, and Asia. We have already two commercial agreements with partners, and they cover these three areas. And that will give us a projected forecast of 1.8% of the market in 2029, and then we have the disc with 400 million diagnosed. This is a true blue ocean market opportunity, and only 1% get surgery today; that's a huge opportunity. And with huge opportunity, of course, you will have other players. There is a silicon-based bone cement, which is sticky, super expensive, and difficult to use. And then there are all the other conventional bone cement manufacturers. Do you know what? I see them all as our potential customers since we can add our Inossia Cement Softener to all of them. I met Cecilia Persson in a cadaver lab in Leeds. At that time, I worked for Bone Support, and I had co-invented the product there and brought it from idea to sales of 16 million. But at that time, Cecilia's expertise in binary mechanics and the test set that I needed was not found in Sweden, so she later became a professor at Uppsala University and built her own biomaterials department there. Her expertise and her outstanding science are a very good match with my background from the marketing and sales area. So we complement each other really well, and we also have this shared passion for osteoporosis. We have handpicked our team with people with more than 20 years of experience from both smaller and larger companies. We have also managed to attract fantastic advisors from the Noma network and also the former CEO of Vexim, which was sold to Stryker, and we are working with influential key opinion leaders, both in the US and in Europe. Cecile and I decided to bootstrap the company from the start, and we were lucky enough to get a lot of soft money to finance all of the preclinical evaluation we needed. Then in 2020, we received an eHealth grant, and with that, we could also start to attract investors. So we had a business angel round, a seed round, and with that, we started our clinical trial, and we also did a lot of other things. We got our first product to use, we had our first customer, we did the pre-submission with the FDA, we did our first prototype for the disc product, and we got the first order of 700 units. Last year, we won the EIC Accelerator, which only 3% get. So we are very, very happy about that. It's 2.3 million euros undiluted and 5 million euros in equity. And with that, we finance our biggest milestone so far, which is a multicenter study, a randomized controlled trial with 196 patients. They are all enrolled, and we expect the readout in February next year. The goal is to show fewer new fractures with our Inossia Cement Softener compared to control cement. So the surgeons love it. They even call it a game changer. So we have done a lot of things, and now we are ready to run even faster. We seek 6 to 8 million euros in a Series A round, where 1/3 is already guaranteed by the European Investment Bank. And for that money, we will expand our team, we will perform and complete the clinical trial on the disc, and we will launch our first product already next year for spinal fractures. That will give us a projected forecast of 650,000 euros in sales in 2026, and then in 2027, we will get approval for the disc application in both FDA and CE. And then that's where the ramp-up really starts because the disc product will double each year, and we project to have two-thirds of the total sales in 2031 based on the disc product and reach 88 million euros. So imagine a world without Crooked Inga. Imagine a world with no back pain. Imagine active and happy aging for all of us. Thank you. Applause.

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