Clinical Support for Health Entrepreneurial Success

Q: Florance, an impedance spectroscopy monitor, and its associated catheter Athena are your core products. How have these fared in the Mexican market?

A: For both of these developments we have been working closely with the National Institute of Cardiology (INC), focusing on promoting the benefits of these technologies for cardiac surgery. The research is focused on proving whether or not our technology can predict complications during a cardiac procedure. Predicting the outcome of the patient during surgery is the main priority for a doctor. With an early prediction, they can conduct the surgery with more certainty and at a lower cost. For instance, a patient with few complications in the ICU can cost US$3,000 a day versus a patient with complications, who can face costs up to US$10,000 per day. So far, we have had very positive and encouraging results. While COVID-19 did stop some progress on clinical trials, we saw the potential of Athena to work on COVID-19 cases to predict complications, as well. Overall, our device helps to assess the ICU process of a patient and the nature of the SARS-CoV-2 virus allows our device to work in such procedures, as well.

Doctors are very enthusiastic about our work in clinical trials with INC. Having professional backup is very useful when looking for investment. With the COVID-19 pandemic, investment has been more reserved and having clinical certainty allows us to keep going.

Q: You have mentioned that the company wants to grow in the UK market. How do you usually approach foreign markets?

A: We usually engage with partners in the territories we want to tackle. We had a partner in the US who would help us to target foreign markets and we are now looking for another expert in medical devices regulation to dabble in new regions. While we do have an idea of how those markets and their regulations operate, having local knowledge is fundamental to ensure a proper understanding of the processes.

Q: How much trust do investors have in health developments after the COVID-19 pandemic?

A: I do not perceive an immediate change in the medical devices sector, contrary to what is happening in the pharmaceutical sector. Medical devices are complex because returns are very slow and this process is unlikely to change very quickly with the pandemic. We saw how many entrepreneurial ventilator projects thrived last year but they all remained in the prototype phase, with no real product escalation. I do not really see local investors dabbling in slow returns. In fact, I have seen investors being more careful because they now have to prioritize their investments. They seem to be even more cautious regarding where they put their money, especially when it comes to an entrepreneurial health project, which requires clinical support and many regulatory processes. Regardless of this panorama, investment is a necessary and positive for innovative health projects.

Q: How did Alandra face the regulatory changes in Mexico in 2020?

A: COFEPRIS is saturated with COVID-19 developments, which has slowed down approval processes. Before the pandemic, wait times were around three to six months and now it is no less than a year. It has been a challenge to navigate this new reality and the constant changes within the commission. However, we always make sure to comply with every requirement to face the least amount of trouble.

We are targeting the Western European market but the regulatory landscape there has gone through some changes. One of the most important is the new medical devices regulation, which was scheduled for May 2020 but got delayed because of the pandemic. The impact on the industry was significant as many manufacturers expected this change in regulation and worked on their developments based on that. They now have to wait for about one year to have their products subjected to new rules.

Q: Roundtable: How can technology become a standard tool for care provision rather than just another option?

A: I think technology will gradually become imbedded in regular practices. While the escalation of digitalization in healthcare has been widely touted, doctors are still using traditional practices to treat COVID-19 patients. Technology has been thriving on the outside, normally to manage regular patient flows or needs, but to treat COVID-19 cases doctors have been sticking to regular practices. I do not see a major shift in technology integration for at least a couple of years.

Q: What are Alandra Medical’s expansion plans?

A: We are raising more funds to begin a clinical study of Florance and Athena in the US and China. We want to enter these markets in the future as we have identified potential patients there, mainly because of the size of the market. We are selective in our trials to make sure we really expose the value of the technology. This is where we are primarily focusing our efforts. Once a clinical trial is finished, we need to provide enough clinical and economical evidence to prove the value of our development.

We are very happy with the current results from our two main developments because these have helped us get over the financial stress we experienced during the pandemic. Our investors have seen the value of our work and this has allowed us to come out of the pandemic with a complete staff and new projects at the door.

Alandra Medical is a venture capital-funded medical technology company created by acquiring intellectual property assets and bringing in a team of highly trained physicians and professionals in medical technology, biomedical engineering, design and clinical trials.