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Sweden’s Inossia Completes SEK 88M Financing Round for Its Bone Cement Softener, with Half Tied to FDA Clearance

HealthTech Funding: Sweden's Inossia Completes SEK 88M Financing Round for Its Bone Cement Softener, with Half Tied to FDA Clearance

Stockholm-based medical device company Inossia has completed an oversubscribed financing round totalling SEK 88 million. About SEK 44 million (roughly €4M / $4.5M) is paid in now, and the rest is due once the company’s product is cleared by the US FDA.

The Round

The round combined a rights issue for existing shareholders with a directed share issue to a select group of investors. The directed issue was mainly subscribed by Cradle Growth and the EIC Fund. The financing is structured in two tranches: about 50% of the capital is paid on completion, and the remaining amount is invested upon FDA clearance in the United States. After the round, Inossia has 61 shareholders. Aurelia Partners acted as financial advisor.

Malin Nilsson, CEO of Inossia, said: “I am extremely pleased that we have successfully completed this financing round. It enables us to continue executing our current strategy, complete our studies, and advance our expansion plans. At the same time, we can begin the next phase of the company’s development, focusing on commercialization and international growth. The fact that we are able to attract investors at this stage who both understand the product’s potential and are willing to invest is, in my view, a strong validation of the work we have accomplished so far.”

The Product

Inossia has received FDA Breakthrough Device Designation for the Inossia® Cement Softener and intends to submit its application for FDA clearance within the next 12 months.

The softener is mixed into an FDA-approved PMMA (polymethyl methacrylate) bone cement. It is designed to adapt the stiffness of the cement to match natural bone more closely, lowering the risk of future vertebral fractures.

The Problem

According to the company, about 8.6 million vertebral fractures occur worldwide each year, including 1.4 million in the US, and around 300,000 of them are treated with bone cement. With current treatment, up to 40% of patients suffer new vertebral fractures. Inossia says no existing option includes a softening agent comparable to its product.

About Inossia

Inossia develops medical device solutions focused on active ageing, better treatment and lower healthcare costs for patients with back pain. It invented a softener for bone cement to better treat spinal fractures in osteoporotic patients.

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