If you have a healthtec solution that is going to require regulatory approval, then you will be 'pre-revenue' for quite some time. This creates a challenge when it comes to early-stage valuation. Considering you can't market or sell a healthtec solution until approved or cleared by the regulatory agency (i.e., FDA), then typical valuation methods used in other industries aren't always the best approach to take.

The main drivers for healthtec startup valuation are IP, targeted patient population and data.

1. IP - most healthtec startups exit through acquisition by one of the big healthtec/medtech companies. The more solid your IP, the higher valuation. You need to have a different, unique, innovative solution to the healthcare problem that you are trying to solve.

2. Target patient population - this will define your available market. A solution that has the potential to affect more patients will drive a higher valuation. Keep in mind, larger patient populations (i.e., cancer, heart disease, diabetes) draw more competition ... which leads to the importance of item 1 (IP). However, the most important valuation driver in healthtec is ... data.

3. Data - without data to back up your claims for a clinical benefit behind your healthtec approach, you have very little value. Data in the medical field drives everything - regulatory approval, clinical adoption, company valuation. It's a data-driven industry. So, the quicker you can get data and the closer your data is to representing actual use, the higher your valuation. For example, animal data is more valuable than bench (in vitro) data. First-in-human (FIH) data is more valuable than animal data. Later stage (i.e. Phase II) clinical data is more valuable than FIH data. For this reason, most potential acquirers in the healthtec space won't be interested until you have human data.

So, keep protecting your IP, define your target population and continue to collect data to justify your approach.