Zennea Technologies had a clear solution for a real problem. A new, comfortable wearable medical device without bulky machines, wires or hoses promised to help people reduce chronic snoring and mild obstructive sleep apnea. It included a connectible app to help users get better sleep.
But the company faced a challenge as it worked to bring the device into the hands of those who could benefit from it – coordinating and conducting the clinical trials necessary to test for efficacy and gain market approvals. This is a challenge many companies face as they work through the development of new medical interventions or treatments.
Fortunately, Zennea was involved with the Creative Destruction Lab (CDL) in Vancouver, where they connected with IMPACT, an accelerator program connected to the University of Calgary that helps medical tech start-ups conduct clinical trials and complete the regulatory filings necessary to bring new medical products to market.
The IMPACT Clinical Trial Accelerator Program has a unique mission – to help new ventures and startups with great ideas like Zennea commercialize their health-related inventions. In the two years since IMPACT was founded the group has engaged with over 90 companies in Canada, the US, Europe and Asia, and has helped 8 organizations turn their inventions into market-ready products.
Great ideas should not face tremendous hurdles, so the IMPACT team provides expert guidance at key stages of development to help address what are typically the most challenging aspects of bringing a new health intervention to market – the coordination and execution of clinical trials and the securing of regulatory approvals.
According to Dr. Derek Exner, Founder and Executive Director of IMPACT:
“We provide a one-stop shop that starts with linking companies with expert clinical faculty to provide guidance through all the various steps required to get their product to market.”
For Zennea, IMPACT was the perfect partner to advance their development efforts. Zennea was ready to start their clinical trial but needed assistance finding a principal investigator and operationalizing their study. To help address their challenges, the IMPACT team connected with a sleep specialist at the Foothills Hospital (as a principal investigator) and started setting up the study within the University of Calgary Foothills Campus.
From there, IMPACT provided extensive ethics and regulatory support to help launch the study, and coordinated all start-up activities with the research site and principal investigator. Not only did they help Zennea achieve the sample size needed, they also helped coordinate and manage all aspects of their clinical trial, saving the company time and investment.
The trial started and was running until the COVID-19 pandemic caused a closure of all medical centres in Alberta. IMPACT quickly pivoted and found an out-of-province private clinic that was able to come on as an additional site in the interim, ensuring the study continued to generate the data Zennea required. Once the Foothills Hospital reopened the trial was able to resume recruitment at its original location. In fact, once resumed, the trial was one of the only studies being conducted in a hospital in Western Canada at the time.
Not only was the study a success, it proved to be truly beneficial for Zennea. The company is now about start their 2nd clinical trial – for FDA approval – later this year.
For IMPACT, helping companies like Zennea is a benefit in its own. By providing a full spectrum of services – ranging from regulatory support, trial management and coordination and even commercialization guidance – the team plays a critical role in helping life sciences start-ups bring their inventions into the hands of consumers.
“Going through the many phases required to conduct a clinical trial is challenging, especially for new life sciences start-ups” says Michelle Nelson, Venture Navigator at IMPACT. “Oftentimes companies have a great idea and product, but don’t have the specific experience required to secure the regulatory approvals needed to start and conduct a clinical trial. We fill that gap – and are proud to do so.”
Learn more about IMPACT by visiting their website.