- ResApp Health (RAP) was down more than 59 per cent this morning after being denied a U.S Food and Drug Administration approval for its respiratory health smartphone app
- The FDA said it will need additional information to show how the benefits of the app outweigh the risks
- CEO Tony Keating is disappointed by the FDA’s decision, especially after already receiving European and Australian approvals
- ResApp says it’s now back to the drawing board, where it will meet with the FDA and possibly resubmit a U.S. application in the future
- The company has also updated the market on its collaboration with multinational pharmaceutical company Sanofi
- At this time, Sanofi has chosen not to work with ResApp to develop a consumer health-focused product
- ResApp is down 58.8 per cent on the market this morning, selling shares for 7 cents apiece
ResApp Health (RAP) was down more than 59 per cent this morning after being declined for a U.S Food and Drug Administration (FDA) for its respiratory health smartphone app.
The U.S FDA disapproved the application based on ResApp’s application, citing the need for additional information to demonstrate how the benefits of the app outweigh its risks.
ResApp is developing smartphone applications for the diagnosis and management of respiratory disease. It’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional hardware.
CEO Tony Keating is disappointed by the FDA’s decision, especially after already receiving European (CE Mark) and Australian (TGA) approvals.
“Following positive discussions during the review process last year with the FDA and submitting a detailed response to the FDA’s request for additional information in December, we were anticipating either approval of the De Novo or further dialogue as the next steps in the process,” he said.
ResApp will be working closely with the FDA and Experien Group to plan its next steps in achieving the approval.
“In parallel, we will also continue to focus our commercialisation efforts in Europe and Asia-Pacific, where we have the appropriate regulatory approvals and a growing list of commercial opportunities,” Tony added.
The company has also updated the market on its direct-to-consumer product being developed under the Startup Creasphere program.
In this program, ResApp collaborated with pharmaceutical company, Sanofi on building a consumer health-focused product using ResApps respiratory disease diagnostic algorithms.
However, Sanofi has not taken the offer to enter this program.
“We are excited about the possibilities of bringing our clinical-grade algorithms to a smartphone application for at-home consumer use, and we continue to advance the product with a number of interested parties,” Tony told the market.
ResApp is down 58.8 per cent on the market this morning, selling shares for 7 cents apiece at 11:15 am AEDT.