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Surgify Safety Burr

Periodic Reporting for period 1 - SSB (Surgify Safety Burr)

Reporting period: 2019-08-01 to 2020-01-31

Surgify’s mission is to make bone surgery safer around the globe. Our product - Surgify Safety Burr (SSB) enables surgeons to cut bone safely, accurately and fast without compromising the safety of important soft structures. The core innovation is in the mechanisms of a disposable cutting tip of a surgical drill. SSB automatically covers the cutting edges of the small drill tip when it comes into contact with soft tissue.

Surgify has successfully tested the technology in preclinical setups with for example human and animal cadavers. Based on non-clinical trials by surgeons, Surgify estimates that SSB can realistically reduce the risk of soft tissue injuries with 80% - 91%. Academic research shows that patients without dural tears have 42% - 97% less complications. World-famous neurosurgeon, Professor Juha Hernesniemi has stated: “Breakthrough!”

The first target applications (est. potential €680M) are skull, spine and ear procedures, which account for 34% of the bone cutting disposable attachment market (€2.0B). In the future, Surgify can expand to other fields of surgery as well as robotic surgery applications.

Surgify has multiple ongoing pilots and signed letters of intent worth €355k / year. In September 2017, Surgify’s CEO received the prestigious MIT Technology Review Innovators Under 35 Europe award. In December 2018, Surgify was named as one of the 24 winners of the European Venture Contest, arranged by TechTour.

The SME Phase 1 funding was critical for Surgify. It was used to further develop a focused, detailed and achievable commercial and operational business plan that adds necessary expertise and scales the sales and revenue delivery to deliver the financial goals. With this funding, we have found commercial manufacturing partners, completed a detailed market analysis and prepared a commercial plan with financial forecasts to raise SME Phase 2 and/or VC funding for commercial product launch in 2020.
We have successfully completed our Phase 1 feasibility study providing us with the necessary input for the next steps of Surgify. During the feasibility study we conducted a thorough analysis of 4 main topics covering Surgify’s future development:

1. Technical feasibility study helped us find commercial manufacturing partners for commercial production of Surgify Safety Burrs at scale.
2. Market feasibility study provided us with a deep insight into the market potential, competitors, willingness of hospitals to pay for Surgify Safety Burr, relevant sales channels and preferred paths for geographical expansion.
3. Legal, regulatory and IPR feasibility study helped us identify potential regulatory constraints and develop a clear IP protection strategy for future product variants.
4. Financial feasibility study helped us refine current financial projections and forecasts based on actual manufacturing costs at scale and improved estimations of sales volumes. The task included identifying capital requirements for commercial launch.

As a result, we are ready for the final steps in product development crucial for introducing Surgify Safety Burr to the market.
The scope of the project was a feasibility study. The project focused on evaluating the technical, market, legal, regulatory, IPR and financial feasibility of Surgify Safety Burr technology. Most of the progress was made in improving the understanding of the company and developing a roadmap for Surgify Safety Burr technology. During the same time Surgify Safety Burr proceeded also in R&D even though no progress in terms of R&D was made as part of the project. Surgify has great potential and we expect an economic impact for the company and safer surgeries for everybody.
Surgeon using a drill