Source –Better Therapeutics
On 10 July, Digital health company Better Therapeutics received FDA approval for its lead digital therapeutic (DTx), AspyreRx, for type II diabetes. The company now needs to convert this approval into a sustainable business.
In March, Better Therapeutics was forced to lay off a third of its workforce and cut costs in order to conserve cash. This was due to the long wait for FDA approval for AspyreRx, which is a cognitive behavioral therapy (CBT) designed to help patients with type II diabetes manage their blood sugar levels through better diet and exercise habits.
The approval of AspyreRx is a major step forward for Better Therapeutics, but the company still faces challenges. The digital health sector is still struggling to gain traction, due to a lack of defined routes to adoption and reimbursement of new products.
Despite these challenges, Better Therapeutics is optimistic about the future. The company plans to launch AspyreRx in the fourth quarter of this year and is also developing other DTx products for hypertension, high blood cholesterol, and non-alcoholic fatty liver disease (NAFLD).
“AspyreRx is a game-changer as we now have an evidence-based intervention to help clinicians and people living with type 2 diabetes address the underlying factors that contribute to disease progression and achieve treatment outcomes beyond glucose management alone. The cornerstone of modern diabetes care is helping to improve self-efficacy and AspyreRx now provides a prescription tool for physicians that seamlessly integrates with existing disease management programs to help patients make and sustain meaningful changes to improve their overall health.”
– David Kerr MBChB, DM, FRCP, FRCPE, Director of Digital Health at the Diabetes Technology Society
“This regulatory milestone signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioral causes of disease for the 37 million patients living with T2D in the U.S. This De Novo authorization also provides a foundation for potential future growth opportunities. Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our PDT platform to multiple related conditions in the future.”
– Frank Karbe, Chief Executive Officer at Better Therapeutics
Shares in Better Therapeutics were up nearly 50% in pre-market trading today, but the stock is still well below its peak of $10 when it went public in 2021.
The approval of AspyreRx is a significant achievement for Better Therapeutics, but the company still has a long way to go before it becomes a sustainable business. The digital health sector is still in its early stages, but there is potential for significant growth in the years to come.
