Band Biomed's hypertension device wins the FDA's breakthrough name
The band Biomed's hypertension treatment is the latest medical device to receive the FDA's breakthrough name. The device is a ventricular ventricular septum modulation therapy, which means it actively reduces blood pressure using pacing algorithms.
By awarding the band’s products as the status of the breakthrough device, the FDA has incorporated it into the Rapid Track Program – the goal is that uncontrolled hypertensive patients are expected to obtain new treatments soon.
David Hochman, the band’s founder and CEO, noted that millions of people around the world work hard to control their blood pressure, especially older people and those who already suffer from cardiovascular disease.
“One of the biggest challenges is to adhere to daily medications, but even if patients follow prescribed medications, many people still fail to reach their target blood pressure. Uncontrolled hypertension remains a major risk factor for death worldwide, significantly increasing the likelihood of heart disease, stroke and heart failure,” he said.
The band’s equipment attempts to meet this unmet need by providing blood pressure that is continuously reduced immediately without the need to add other daily medications to the patient’s routine.
This device is a firmware enhancement added to standard implantable pulse generators such as pacemakers. Hochman explains that the firmware programes pacemakers between short and longer intervals between heartbeats, a mode that lowers blood pressure.
“Short intervals reduce cardiac pretension and reduce blood pressure immediately. Intermittently longer AV intervals regulate autonomic nervous system responses (pressure receptor reflexes) and reduce afterload to maintain a decrease in blood pressure,” he said.
Orchestra is currently working with medical device giant Medtronic for clinical trials on its devices, and despite the use of blood pressure control drugs, it is recruiting patients with uncontrolled hypertension.
The company has established a strategic partnership with Medtronic to develop and commercialize its products – the agreement provides that if the device’s instructions expand increasingly to help patients who do not need a pacemaker, Medtronic will receive the first opportunity to reach a global commercialization deal with the band.
Currently, the Orchestra is the only company that is publicly known to be developing house interval modulation therapy. But of course, there are other treatments and therapies doctors are prescribing to help patients with uncontrolled hypertension, including sibling surgery.
This procedure (also known as renal nerves) is a minimally invasive treatment that uses radio frequency energy to destroy hyperactive nerves near the kidneys, thereby reducing hypertension.
Hochman noted that the band’s equipment and programs such as Symplicity are designed to help lower blood pressure, but they are performed in different ways.
“We believe that effective management of hypertension will require a flexible, comprehensive treatment toolkit that allows physicians to tailor treatment to each patient’s unique needs. That’s why we are working closely with Medtronic’s collaborators to help the continuity of device-based hypertension to establish continuity of device-based hypertension management. Ultimately, we view Avim Therapy and Symplicities as clinical technologies to expand the clinical scope to expand the scope.
Founded in 2018, the band is based in New Hope, Pennsylvania, with other operations in New York City and Fort Lauderdale in Europe.
Photo: Magician, Getty Images
