Amid the ongoing digitization of healthcare, digital therapeutics have gained popularity, with providers and payers increasingly offering these software-based therapies to patients. According to the Digital Therapeutics Alliance, digital therapeutics are health softwares that are intended to treat or alleviate disease, disorder, condition, or injury by generating and delivering evidence-based medical intervention that has demonstrable positive patient impact. The alliance also noted that the interventions are provided independently or alongside medications, devices, and other therapies.
The digital therapeutics market is experiencing a surge, according to a recent report from Grand View Research. The market was valued at $5.09 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 26.6 percent from 2023 to 2030.
Digital therapeutics typically fall into three categories depending on their primary purpose: to treat a disease, to manage a condition, or to improve a health function. Perhaps the most common solution is health related mobile apps that are user-friendly and customizable. As of 2021, there were more than 350,000 health-related apps available on top app stores worldwide, with more than 90,000 new ones in the works, an average of more than 250 apps per day.
This rapid introduction of apps, alongside a consumer wearables market building new abilities to detect digital biomarkers of health and remotely monitor patients, marks a pivotal shift in healthcare. Historically, wearables have been synonymous with fitness trackers, primarily designed to monitor basic health metrics such as heart rate and steps. However, technological advancements have expanded their functionality, transforming them into sophisticated biometric tools capable of capturing real-time physiological data and offering unprecedented insights into an individual’s health.
One such success in the digital therapeutics and wearable ecosystem is the all-female founded h2o Therapeutics (h2o). Based in Ankara, Turkey, h2o has developed a platform that integrates artificial intelligence, augmented reality, and wearable technology to mitigate the impact of Parkinson’s Disease (PD). In November 2022, the U.S. Food and Drug Administration granted h2o a 510 (k) clearance for their Parky app, a remote monitoring tool for continuous objective assessment of PD motor symptoms such as tremors and dyskinesia, commonly associated exam findings of this neurological disorder. Operating off the power of Apple’s movement disorder API, as well as the watch’s inertial sensors, Parky leverages longitudinal, remote monitoring of motor symptoms for precise treatment decisions, using real-time symptom profile reports from the clinically validated MM4PD algorithm also developed by Apple Inc..
The Parkinson’s Foundation estimates that 10 million people worldwide live with PD. This number is expected to rise to 1.2 million by 2030. Parkinson’s is the second-most common neurodegenerative disease after Alzheimer’s disease. As a progressive neurodegenerative disorder, PD can be treated in the early stages using dopaminergic medications, however, approximately 40% of patients develop fluctuations of response to drugs like levodopa and dyskinesia after 4-6 years of treatment, and 70% after long-term treatment of 9 years or longer. Intended for clinically diagnosed idiopathic patients who are tremor and dyskinesia symptom-dominant, Parky provides clinicians with as many as 288 data points daily when the watch is worn continuously. Such remote monitoring detailing steps taken and medication compliance as an indication of patient mobility and treatment efficacy. When evaluated along with non-motor symptoms, patient insights, and in-clinic visit findings, Parky processes continuous human data and provides insights that can guide therapeutic decisions that bridge the gap between episodic medical interventions and a 360-degree level of patient management.
Yagmur Selin Gulmus, the founder of h2o Therapeutics, is the driving force behind these innovations. With a rich professional background, including significant roles at Gen Pharmaceuticals and Kironna Digital Health Solutions, Gulmus brings a blend of expertise and vision. Using daily health monitoring and personalized treatment plans she is driven by a belief that quantifiable tracking can lead to improved medication adjustments and decreased morbidity.
If it is true that novel treatment ideas like digital therapeutics will aid in extending quality of life and life expectancy, then the other two wearable devices from h2o Therapeutics hold significant promise for medical interventions. Among these innovations are Foggy, an app designed for symptomatic treatments of certain neurodegenerative diseases, and Covie, an app developed for the early detection of Covid-19. In addition to these advancements, the company is making strides in clinical research. This is evidenced by the launch of its Phase I/II trial for ProTcellTM, targeting adults with blood cancers. The primary objective of this study is to evaluate the safety and efficacy of the agent in accelerating immune reconstitution following allogeneic hematopoietic stem cell transplantation in patients diagnosed with hematological malignancies.
The rapid advancements in digital therapeutics also introduce challenges. Data privacy remains a significant concern, given the sensitivity of health-related information. Regulatory landscapes for digital therapeutic tools, still in their formative stages, present hurdles that also must be addressed. Ensuring widespread adoption among healthcare providers and patients is crucial for the successful integration of these tools into mainstream healthcare.
Under Gulmus’s visionary leadership, h2o Therapeutics exemplifies the merger of wearable biometrics and digital therapeutics. As healthcare evolves, Gulmus and her team will lead the charge, promising an era of personalized disease management tailored to individual needs.