NEW YORK – Digital medicine platform Rx.Health, a spinoff of Mount Sinai Health System and a provider of RxUniverse, has raised $1.8 million in seed funding. The funding will be used to diversify Rx.Health’s client base and support its Bulk Prescription digital therapeutics and patient engagement tool, which allows health care teams to prescribe digital therapeutics and patient-centered care plans to entire cohorts of patients through a single click. The feature will be initially launched for the treatment and monitoring of various chronic diseases, including respiratory, cardiovascular and gastroenterological illnesses. Patients who do not have their symptoms under control can simultaneously receive immediate access to education, digital therapeutics, or remote monitoring via smartphone or email. Incoming patient data is then integrated into electronic health records and care management dashboards. “We’ve seen a tremendous increase in the demand for our services and the landscape of potential clients has broadened,” said Andy Pfau, COO of Rx.Health, in a statement. “By integrating multiple evidence-based solutions under one digital medicine platform, we‘re making digital transformation simple and affordable,” noted Rx.Health COO Andy Pfau. Rx.Health curates digital solutions that are clinically proven to improve patient health, lowering the cost for health systems as they transition to value-based care. RxUniverse is the first enterprise-level, app-prescribing platform that provides an efficient prescription mechanism built into a health system’s EHR, becoming part of an evolving, bundled care plan that provides real-time feedback to providers. The platform gained recognition over the last year after scoring in the 96th percentile on the System Usability Score based on the results of RxUniverse’s eight-week pilot study and facilitated a 40% reduction in readmissions for patients of chronic heart failure. RxUniverse is live in several U.S. health systems, with additional implementations currently underway. “Rx.Health is expanding the model for patient care by extending care outside of the clinical setting and allowing health care systems to harness the power of digital health,” said Erik Lium, executive vice president of Mount Sinai Innovation Partners, in a statement. “Rx.Health is a prime example of the innovative, patient-first discoveries valued by the Mount Sinai Health System and I look forward to seeing its expansion as a leader in digital medicine.”
WASHINGTON – The U.S. Food and Drug Administration has granted Breakthrough Device designation to Dthera Sciences’ digital therapeutic to treat patients with Alzheimer’s disease. The therapeutic, DTHR-ALZ, is intended to be a prescription digital therapeutic that will use artificial intelligence to automatically optimize Reminiscence Therapy based on various forms of biofeedback from the patient. Reminiscence Therapy is an evidence-based psychosocial intervention that has been shown in clinical trials to improve symptoms of the disorder, but the therapy’s adoption has been limited because of the investment of caregiver time and resources, according to the Alzheimer’s Association. DTHR-ALZ will seek to provide Reminiscence Therapy with more frequency, consistency and personalization, while requiring minimal investment of time and resources. “While we feel this ground-breaking recognition validates Dthera’s mission to positively impact the lives of those affected by the disease, it also represents a meaningful advance for the entire digital therapeutic sector,” said Edward Cox, CEO of Dthera Sciences, a digital therpeutics company focused on seniors and those with neurological diseases. Cox said that if approved, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer’s disease. DTHR-ALZ is not yet available for commercial use in the U.S.
CAMBRIDGE, Mass. & NEW YORK – Click Therapeutics, a provider of digital therapeutics solutions, has raised $17 million in financing in a round led by Sanfoi Ventures. Click plans to use the financing to continue advancing its platform and pipeline of prescription digital therapeutics to treat a wide range of diseases. “We’ve evaluated many companies in this space, and we believe Click Therapeutics’ mobile patient engagement platform positions the company to be a leader in the field of prescription digital therapeutics,” said Bernard Davitian, senior vice president and managing director of Sanofi Ventures, in a statement. Davitian has joined Click’s board in conjunction with the financing. “Click’s platform enables the company to target multiple indications efficiently and effectively, and we have invested with the intent of partnering across a variety of therapeutic areas.” In addition to Clickotine, Click’s commercial product for smoking cessation, the company is developing prescription digital therapeutics to treat depression, insomnia, acute coronary syndrome and chronic pain. The company will seek clearance from the U.S. Food and Drug Administration for these programs as class II medical devices with disease-specific treatment claims to be prescribed by physicians and reimbursed by payers. Click expanded its collaboration last year with Magellan Health to seek FDA clearance for indication-specific prescription digital therapies, leveraging the suite of intellectual property and data from Magellan’s existing software, as well as their coverage and reimbursement experience. “The addition of Sanofi as a strategic investor, and the closing of this financing, represent major steps forward for Click and for the field of software as prescription medical treatments,” said David Benshoof Klein, co-founder and CEO of Click Therapeutics, in a statement. “By connecting patients with cognitive and neurobehavioral interventions, our platform will bring clinically-validated digital therapeutic solutions into mainstream health care.”
PORTLAND, Maine – MedRhythms, a digital therapeutics company that is using sensors, artificial intelligence and music to develop products that help people with neurologic injuries and diseases recover walking functions, recently raised an oversubscribed Series A round of financing. The company intended to raise $4 million but raised $5.3 million due to substantial interest, and closed on $5 million, said Brian Harris, CEO and co-founder of MedRhythms, in a statement. This funding will enable the company to develop and launch a digital therapeutics platform that focuses on building evidence-based prescription products for people with neurologic injuries and diseases to improve and measure walking. While the first product on the platform focuses on the post-stroke population, the pipeline includes products for Parkinson’s disease, multiple sclerosis, aging-in-place and traumatic brain injury. Harris said MedRhythms now plans to hire software, product and commercial professionals. “Developing digital therapeutics based on music requires the right mix of talent on the team, including experts in music, biotech, health care and technology,” he said. Additionally, MedRhythms has added Peter Werth to its board as lead investor, as well as Ray Pawlicki and Bill McKee. “MedRhythms has excellent growth prospects with a pipeline of therapeutic and diagnostic products in large, growing markets and is building the right team to execute,” said Werth, chairman and president of Chemwerth and leader of the investment round, in a statement. “We found MedRhythms’ strategy and business plan to build digital therapeutics for walking a compelling investment opportunity.” Harris said the company plans to eventually develop different algorithms as personalized therapeutics to address issues caused by neurologic injuries and diseases.
LAUSANNE, Switzerland and HELSINKI, Finland – Digital health company Kaiku Health, which provides intelligent patient monitoring software for health care providers across Europe, has raised $5.4 million. The company will use the funding to advance its international expansion and to further develop its line of digital therapeutics; it plans to conduct several clinical trials this year to validate the digital therapeutics. “We have seen the significant positive impact our patient monitoring platform can have on people’s health,” said Lauri Sippola, co-founder and CEO of Kaiku Health, in a statement. “This funding allows us to provide our platform to a growing number of health care providers and patients internationally.” The Kaiku Health platform is currently used in routine care by over 30 clinics in Switzerland, Germany, Italy, Sweden and Finland.
BOSTON and SAN FRANCISCO – PEAR Therapeutics is working with Novartis to develop prescription digital therapeutics for people with multiple sclerosis and schizophrenia.
The collaboration brings together Novartis’ expertise in neurological disorders, clinical development and commercialization with PEAR’s experience in prescription digital therapeutic design and implementation.
Digital therapeutics uses digital technologies to treat a medical or psychological condition.
“Novartis shares our vision for prescription digital therapeutics that work alongside drugs to deliver superior patient outcomes,” said Dr. Corey McCann, president and CEO of PEAR Therapeutics, in a statement. “We believe this collaboration further supports the clinical viability of prescription digital therapeutics as an emerging treatment modality and we are poised to execute on that opportunity.”
The two companies will pursue approval for PEAR’s existing THRIVE digital therapeutic and will work together to develop a new therapeutic application to alleviate disease burden in patients with MS, which they will then seek to validate in clinical studies.
PEAR’s prescription digital therapeutics are clinically-validated, FDA-regulated software applications that deliver
evidence-based interventions to patients through mobile applications. Once cleared, they may be prescribed alongside drug therapies and have the potential to be developed to treat a range of diseases.
“With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need, used both alone and in combination with systemic agents,” said Dr. Jay Bradner, president of the Novartis Institutes for BioMedical Research, in a statement.
As part of the collaboration, Novartis also invested in PEAR’s Series B financing.
SALERNO, Italy – While relatively new in home health care, digital therapeutics have the potential to disrupt the industry and save billions of dollars, experts say.
A recent report by Grand View Research estimates the digital therapeutics industry will be worth more than $9 billion by 2025.
“It’s a great trend that has transformational power,” said Roberto Ascione, CEO of health care consultants Healthware International, on a recent edition of the Digital Health Today podcast. “It’s a fascinating innovation.”
Digital therapeutics are a category of mobile apps, wearable devices and telehealth platforms that provide remote monitoring and help patients modify their behavior to treat specific diseases and conditions like heart disease, diabetes and COPD.
In 2016, the U.S. Department of Health and Human Services announced that it would reimburse digital therapeutic programs like those from Omada Health, Canary Health and Blue Mesa Health as part of a Centers for Disease Control-approved Diabetes Prevention Program, a lifestyle modification program clinically proven to be more effective than drug alternatives.
The Grand View report concluded that although the burden of chronic diseases is huge and requires effective management, digital therapeutics offer a wide range of services that propel users to embrace healthy habits and efficiently track and manage their conditions.
“Digital therapeutics is envisaged to become a significant market segment in the coming years,” the report’s authors wrote.
Ascione said digital therapeutics was a strong theme at the recent Frontiers health care innovation conference, an event he chairs and co-hosts each year.
“We could really see where pharma and health device companies can play a big role in helping digital therapeutics to scale,” he said. “They have the access and global distribution capabilities.”
Since digital therapeutics can be delivered at a low cost, and because they are being proven to help prevent disease progression, the technologies have the potential to save insurers billions of dollars, Ascione said.
“We’re still at the beginning, but we’re starting to see bigger things in that space,” he said.
DARMSTADT, Germany and NEW YORK – Digital therapeutics company Blue Mesa Health is partnering with Merck KGaA to pilot diabetes prevention programs in territories outside of the United States. “We have seen such great success helping people across America prevent or significantly delay the onset of Type 2 diabetes,” said Curtis Duggan, CEO of Blue Mesa Health, in a statement. “We are looking forward to helping more people outside of the United States manage their risk for Type 2 diabetes.” Blue Mesa Health developed two chronic disease prevention programs based on the Center for Disease Control’s Diabetes Prevention Program called Transform, a year-long lifestyle change program that integrates remote health coaching from dieticians, a peer support group and the integration of smartphone app technology with connected bathroom scales and activity trackers. “At Merck we are continuously striving to improve the lives of patients with diabetes, and we believe expanding our current pharmacological portfolio into an integrated disease management offering will have a tremendous impact on treatment outcomes,” said Daniel Ruggiero, head of diabetes strategy at Merck KGaA, in a statement.
ARLINGTON, Va., and BOSTON – The Personal Connected Health Alliance and the Digital Therapeutics Alliance have joined forces to further establish the field of digital therapeutics.
The partnership will combine the infrastructure, reach and resources of PCHAlliance and the expertise, thought leadership and focus of DTA.
“Digital therapeutics is an emerging trend, based on the idea that technology can improve an individual’s health as much as a drug can, as well as increase the efficacy of drug therapies,” said Patty Mechael, executive vice president of the PCHAlliance, in a statement. “We are pleased to partner with the Digital Therapeutics Alliance to combine our resources to advance the field, galvanize key stakeholders, focus on developing standards of quality, and work toward improving health outcomes through this newly developing sub-domain of personal connected health.”
The term “digital therapeutics” refers to digital technology or software to treat a medical condition, used alone and in combination with conventional drug therapies. Digital therapeutics include mobile apps, wearable sensors, health monitoring devices or software that can change an individual’s behavior to achieve positive clinical outcomes and better control the cost of care.
The PCHAlliance has also launched a new Digital Therapeutics Task Force, which will draw on DTA’s subject matter expertise to focus on an initial set of high priority projects for both organizations. The task force will be open to PCHAlliance member companies, as well as allied associations and non-corporate thought leaders by invitation only.
“Digital therapeutics companies are developing clinically validated tools that are improving value and lowering costs,” said Pierre Leurent, CEO of Voluntis, a PCHAlliance member organization, a founding member of the DTA and the task force’s chairman. “The field is evolving, so there is a need for digital therapeutics companies to come together, to clearly delineate the market, define the benefits and secure regulatory, reimbursement, provider and policy support.”