Paxman Coolers is an innovative British-based family business that, since 1997, has been helping improve the lives of cancer patients who are undergoing chemotherapy throughout the world.
We produce a scalp cooling device that helps prevent hair loss – a distressing side effect of chemotherapy. The Paxman family’s experience in cooling technology for the drinks industry, combined with a family member’s diagnosis with cancer and subsequent traumatic hair loss during chemotherapy, were the inspiration for the development of the product.
Our major barrier to the US is the regulatory pathway. We are an innovative SME with a European approved class IIa medical device and we are required to carry out a full Premarket Approval (PMA) for Food and Drug Administration (FDA) approval. This suggests our device is a high-risk device; however, it has been approved on the European market in excess of 10 years with over 2000 installations. We have had to invest in a multi-centre randomised study with five years post surveillance. This is a huge and costly barrier for an SME like us.
Our hope is that the future trade agreement TTIP and its proposed actions should enable a more efficient and focused use of the resources of the regulators, and reduce unnecessary duplications (including with respect to clinical trials).