THE ABCs OF PDTs

Prescription digital therapeutics (PDTs) operate at the intersection of biology and technology—delivering evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical disorder or disease.1 PDTs incorporate advanced technology best practices for design, clinical evaluation, usability, and data security, and are developed under the same rigorous conditions as pharmaceuticals—complete with clinical trials, FDA clearance, and are available only with a physician’s prescription.1

UNLIMITED POTENTIAL

Today, PDTs are being developed for an astounding range of conditions, from schizophrenia and multiple sclerosis to chronic insomnia.2 The first such therapy was approved in 2018 and since then the annual investment in the space has more than doubled.3 During the opening three quarters of investment in 2021, more funding was raised than in the entirety of 2020, according to Rock Health—equating to $21.3 billion of venture funding provided to companies working on digital therapeutics, compared with $14.7 billion during the entirety of 2020.3

PDTs could be a vital part of future treatment models across a range of diseases with unmet medical needs, working alongside prescription medicines to better address the full burden of disease—and in some cases even offering solutions where none currently exist.2,3

Regulora, our first FDA-authorized PDT, will put the power to heal into the hands of millions of IBS sufferers.