Spark Biomedical, Inc.

Pharmaceutical company Tolmar has partnered with direct-to-consumer telehealth company UpScriptHealth to provide telehealth consultations for Jatenzo, an oral testosterone-replacement therapy (TRT) for adult men. Tolmar, which acquired Jatenzo in 2022, is positioning the TRT treatment as suited for patients who lack testosterone or have low testosterone levels due to hypogonadism or other medical conditions. The treatment protocol for patients seeking testosterone, including Jatenzo, includes a series of lab tests to determine whether testosterone is the correct treatment for the patient. Peter Ax, founder and CEO of UpScriptHealth, told MobiHealthNews that the streamlined digital experience lets patients connect with licensed providers to receive treatment and ongoing care management from home. "By making the entire process more accessible and convenient, we expect better adherence rates for patients receiving testosterone replacement therapy," he explained. He said the collaboration with Tolmar was representative of a broader shift in how treatments for complex conditions can reach more patients. "Patients increasingly expect healthcare to fit their lifestyle, not the other way around," Ax said. "There's growing recognition that telehealth can provide more consistent monitoring and support than traditional models." THE LARGER TREND UpScriptHealth has launched more than 50 partnerships with pharma and has been expanding into rare diseases and complex care models, including on-site diagnostic testing for esophageal cancer, infusion care and the coordination of care with Alternative Sites of Care. The company works in a complicated regulatory environment, having to comply with fifty state laws and various federal laws regarding the delivery of care, patient safety and privacy, steering and other areas of regulation. "Compliance is fundamental to everything we do at UpScriptHealth," Ax said. "We have prioritized adherence since its inception and helped shape many of the regulations now guiding the industry." He explained that patient safety and data privacy are paramount and that focusing on compliance is critical in building trust with patients and partners. "UpScriptHealth’s clinicians are not incentivized to write prescriptions or to encourage the use of a specific therapy," he said. The company also offers treatments for hair loss and erectile dysfunction, and Ax noted that men who historically avoided seeking treatment due to stigma or inconvenience are now actively engaging with their health through UpScriptHealth’s platform. "Our goal is to make UpScriptHealth the comprehensive digital home for men's health, where patients can access the full spectrum of care they need with the convenience they expect," Ax said. In July, Axena Health and UpScriptHealth partnered to offer women online consultations with UpScriptHealth providers. This allows them to receive prescriptions for Axena’s Leva Pelvic Health System. The company has teamed up with medical device companies, including Spark Biomedical, to provide telehealth for its FDA-cleared opioid-withdrawal wearable, and Lucid Diagnostics, to expand access to esophageal pre-cancer testing, while it also enables telehealth consultations for Spark Biomedical's Sparrow Ascent wearable.

There are all kinds of specialist services provided by telemedicine – telepsychiatry, teleradiology, tele-ICU, just to name a few. But there's a unique telemedicine service that has been growing that merits attention: medical device prescriptions via virtual care. UpScriptHealth specializes in this form of healthcare delivery. Recently, Axena Health – a medical device company focused on female pelvic health – launched telehealth services with UpScriptHealth to connect women with prescribing clinicians who can evaluate their incontinence symptoms and, if appropriate, prescribe the Leva System. With the U.S. experiencing a growing shortage of OB-GYNs, the new telehealth service will allow women to access effective first-line treatment quickly and easily. UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms. And it works with Lucid Diagnostics to increase access to esophageal precancer testing via telehealth. We interviewed UpScriptHealth founder and CEO Peter Ax to discuss his direct-to-consumer telehealth company, what it is about medical devices that lend themselves to telemedicine, how the whole process works for getting a medical device prescription via telehealth, how a telehealth company and a medical device manufacturer work together, and what lessons he has learned about delivering telehealth. Q. Your direct-to-consumer telehealth company specializes in medical device prescriptions. What is it about medical devices that lend themselves to telemedicine? A. Medical devices are uniquely suited for telemedicine because they enable remote monitoring and management, which is a significant advantage for healthcare providers and patients alike. By using connected medical devices, healthcare providers can track patients' conditions in real time, collecting vital health data continuously or at scheduled intervals without the need for in-person visits. This capability is especially valuable for managing chronic conditions like diabetes, where consistent monitoring and timely interventions are crucial for effective management and treatment adherence. The convenience and accessibility of telemedicine are transformative for patients . Through telehealth, patients can access medical device prescriptions and follow-up care from the comfort of their own homes. This is particularly beneficial for those living in remote or underserved areas, where healthcare facilities may be sparse and travel can be burdensome. Telemedicine also caters to individuals with mobility issues or those who require frequent monitoring, eliminating the need for many trips to a healthcare provider's office and reducing the associated time and cost burdens. Additionally, telemedicine streamlines the process of obtaining medical devices, significantly enhancing efficiency. Traditional methods often involve multiple in-person appointments, from initial consultations to follow-up visits for device fitting and usage instructions. Telemedicine simplifies this process by enabling virtual consultations, during which healthcare providers can assess patients, prescribe appropriate devices and provide detailed usage instructions – all in one session. This not only saves time for both patients and providers but also accelerates the initiation of treatment. Telehealth platforms also can provide educational resources for the medical device being used, including comprehensive virtual training sessions, instructional videos and real-time support. These resources ensure that patients understand how to use their devices correctly and effectively, which is critical for achieving desired health outcomes. For example, in our collaboration with Axena Health, we ensure patients prescribed the Leva Pelvic Health System receive thorough guidance on its use. This includes virtual consultations where healthcare providers explain how to use the system correctly, supported by real-time feedback directly from the device. In addition to patient education, telehealth platforms facilitate ongoing patient engagement and support. Healthcare providers can monitor patients' progress remotely, offer timely advice and make necessary adjustments to treatment plans based on the data collected by the medical devices. This continuous interaction encourages high levels of patient engagement, adherence to treatment regimens and overall satisfaction with the care received. Ultimately, the integration of medical devices with telemedicine transforms healthcare delivery by making it more accessible, efficient and patient-centric. This combination harnesses the power of technology to bridge gaps in healthcare access, particularly for those who need it the most, and ensures that patients receive high-quality care tailored to their individual needs. Q. Please explain how the whole process works for getting a medical device prescription via telehealth. A. The process of obtaining a medical device prescription via telehealth typically begins with the patient visiting the brand website where they may see a "button" asking them if they would like to connect with a telehealth provider. If the patient clicks on that button, they will be ported to a telehealth platform where they complete a brief questionnaire detailing their medical history and symptoms. This is followed by an online consultation with a licensed healthcare provider who reviews the questionnaire, discusses symptoms and determines if the medical device is appropriate for the patient's condition. If deemed suitable, the healthcare provider writes a prescription and explains how to use the device. The prescribed device is then shipped to the patient's home, accompanied by instructional materials, virtual training and ongoing support to ensure proper usage. Finally, the patient may have follow-up virtual consultations to monitor progress, make necessary adjustments to the treatment plan and ensure the device is working effectively. Q. You work with Axena Health and its female pelvic health medical device, Spark Biomedical and its opioid withdrawal symptoms relief medical device, and Lucid Diagnostics and its esophageal precancer testing. Please talk a bit about how a telehealth company and a medical device manufacturer work together. A. A telehealth company and a medical device manufacturer can collaborate by integrating the manufacturer's products into a telehealth platform, allowing patients to access and obtain prescriptions for these devices through virtual consultations with practitioners specifically trained on the medical device. The telehealth company provides educational resources and training to patients, ensuring they understand how to use the medical devices correctly through virtual training sessions, instructional videos and real-time support. The medical devices may collect and transmit health data to the telehealth platform, enabling healthcare providers to monitor patients' conditions remotely and make informed decisions about their treatment. Both the telehealth company and the medical device manufacturer ensure compliance with regulatory requirements, such as FDA approvals and HIPAA regulations, to protect patient safety and privacy. For example, UpScriptHealth has worked with Axena Health to provide patients with access to the Leva Pelvic Health System through a seamless telehealth experience. Axena Health has integrated UpScriptHealth's telehealth platform directly on their website, allowing women to easily obtain prescriptions and support for the Leva System. In addition, through a partnership with Spark Biomedical, UpScriptHealth's platform is increasing access to Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms. UpScriptHealth also has a partnership with Lucid Diagnostics to power telehealth consultations for the EsoGuard Esophageal DNA test, a commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate risk through early detection of esophageal precancer. As a result, more than 4,000 firefighters have now undergone esophageal precancer testing using telehealth protocols. Q. What lessons have you learned about delivering telehealth? A. First, effective patient engagement is crucial. Providing comprehensive educational resources, user-friendly platforms and responsive support helps patients feel confident and informed about their treatment. Second, adhering to regulatory requirements, such as FDA approvals and HIPAA regulations, is critical for maintaining patient safety and trust. Ongoing efforts to stay compliant are necessary to protect patient information and ensure the efficacy and safety of the treatments we offer. Finally, gathering continuous feedback from patients and healthcare providers helps us identify areas for improvement and drives innovation in our telehealth services . This feedback loop is vital for making continuous improvements and delivering high-quality care. Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.

COLUMBUS, Ohio--( BUSINESS WIRE )--Battelle, the world’s largest independent, non-profit R&D company, and Spark Biomedical, Inc., a Dallas-based pioneer in wearable neurostimulation technologies are collaborating on the development of a non-invasive device to tackle the harmful effects of Acute Stress Reactions (ASR). The partnership is part of a $1.15 million Phase II grant awarded to Spark Biomedical, Inc. The device, Sparrow® Hawk, uses Transcutaneous Auricular Neurostimulation (tAN®) to prevent or mitigate ASRs in combat settings. In harsh or stressful environments, ASRs impair cognitive function, jeopardizing mission success and potentially endangering the health and safety of military personnel. Long-term exposure to ASRs can lead to post-traumatic stress disorder (PTSD) and a higher risk of suicide. Current treatment methods for the military are limited as providing prompt access to trained personnel is not always possible in combat or frontline settings. Sparrow Hawk’s low-profile, wearable form factor allows for use in far-forward settings. In Phase I of the collaboration, Battelle conducted interviews with combat medics to help develop critical benchmarks and performance parameters for a wearable device. During Phase II, Battelle’s medical device development team will leverage their experience in advanced materials, data science, and engineering to partner with Spark on the development of a functional Sparrow Hawk device for use in clinical trials. The clinical trials will evaluate the efficacy of the device in restoring cognitive performance in a clinical environment designed to simulate the stress of the battlefield. “We’re excited to begin this important work with Spark that has the potential to do so much good for so many people,” said Michael Darrow, a senior biomedical engineer for Battelle’s Medical Device Solutions group which specifically focuses on neuromodulation. “Once our engineers have developed a functioning device, we can then test it in a clinical setting at Battelle to evaluate its performance in a clinical model of carefully constructed laboratory stress.” “Our strong partnership with Battelle has allowed us to further advance Spark’s wearable neurostimulation device, Sparrow Hawk, and ultimately expand our clinical indications to military and civilian Acute Stress Reaction,” said Dr. Navid Khodaparast, Chief Science Officer at Spark Biomedical. “Following this project, we intend to launch a larger clinical trial examining the effects of tAN therapy in those suffering from trauma-induced ASR.” About Battelle Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org . About Spark Biomedical Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company’s mission is to eliminate opioid use disorder by working to address the full lifecycle, including withdrawal management, opioid-sparing, relapse prevention, and PTSD/trauma abatement.