2020, a year that no one was expecting!

2020 was the year that no one was expecting! The new COVID-19 virus hit many countries across the globe hard, and defending against the virus created great economic hardships. The outbreak and resultant lockdowns cast a heavy toll on SMEs. It was estimated that affected by the problems, around 30 percent of SMEs in Europe feared they would have to cancel all activities of growth projects, and some even permanently closed at the time of lock-downs.

At Amber Implants, like many other start-ups, we were influenced by the circumstances and we had to find new strategies that work for us, our employees, and our partners. We had to reevaluate our goals and make new priorities, and adapt our business plan.

Nonetheless, as the CEO and co-founder of Amber Implants, I am delighted to share that at the end of the year with the help of our dedicated and hardworking team, we had a very positive and productive year! A year which indeed no one was expecting! I am glad to share the following news that happened in Amber Implants in 2020:

1. The VCFix implant and surgical toolset design are finalized.

2. Manufacturing route of the device is explicit and validated.

3. ISO 13485 compliant QMS is set in our company.

4. We started working with two of the best regulatory advisors in Europe and the US leading our FDA and CE applications.

5. We have submitted our first FDA pre-submission.

6. All the preclinical tests are designed and planned based on class III medical devices regulations.

7. The clinical trial design is designed and planned for late 2021 until 2023. The study includes three phases (pilot, pivotal, and post-market) and is submitted to the FDA.

8. We have filed new patents, and our trademark VCFix is registered.

9. We have received multiple nondilutive funds and grants (MIT south Holland R&D, European research associate H2020, COL, AIL, etc.).

And... I will post two of our most significant (and my favorite) achievements of 2020 in separate posts.

During passed holiday season, I could not stop thinking about those who helped us to build a prosperous business and have been with us throughout the past year. Thank you for your support, may this new year be a full of great accomplishments for all. 

Banafsheh Sajadi