By GREGORY ZELLER //
The world’s leading cause of maternal deaths is the target of new clinical trials for a trailblazing bioelectronic medical device.
The Neural Tourniquet, an electronic nerve-stimulation technology licensed to Sanguistat Inc. by the Feinstein Institute for Medical Research, is seeing action against postpartum hemorrhage in new clinical trials underway at Feinstein, the research arm of the Northwell Health system.
Sanguistat, a 2016 clinical-stage medical device spinoff founded by Feinstein Vice President Christopher Czura and Feinstein researcher Jared Huston, is partnering on the trial with The Global Good Fund, a collaboration of Bill Gates and Washington State-based Intellectual Ventures, a VC fund with an inventive bent.
The trials will measure the efficacy of the Neural Tourniquet in treating blood loss associated with postpartum hemorrhage, which most often involves the dangerous loss of 1,000 milliliters of blood or more within 24 hours of childbirth – but can occur up to six weeks after delivery.
The “tourniquet,” developed by the Feinstein Institute in partnership with Ohio health-innovation kingpin Battelle, electronically stimulates nerves to staunch blood loss. Officially described by Sanguistat as “peripheral surface electrode-mediated neurostimulation of the vagus nerve,” the bioelectronic device – in a nutshell – delivers tiny electrical zaps that make the body do stuff.
Based on the science of bioelectronics pioneer and Feinstein Institute President and CEO Kevin Tracey, the technology has performed well in numerous clinical settings.
Not only have Tracey’s techniques proved effective in blood pressure and rheumatoid arthritis studies – with similar applications currently treating epilepsy, depression and migraine headaches – but short electrical stimulations of the spleen have dramatically reduced blood loss in surgical patients.
Tracey is not involved with Sanguistat, though he did note that postpartum hemorrhage – the leading cause of death during pregnancy, according to the National Institutes of Health, with up to 86,000 global fatalities per year – is the ideal target for the bioelectronic medicine.
“It kills close to 80,000 women in Africa and Asia, and around 6,000 in the United States each year,” Tracey said. “Lab tests show that vagus nerve stimulation in mothers suffering from postpartum hemorrhage may reduce life-threatening bleeding.”
Developing regions of Africa and Asia are certainly on The Global Good Fund’s radar. The fund will monitor the new clinical trials and “advise” on the Neural Tourniquet’s “potential introduction” into developing regions, according to a statement from the Feinstein Institute.
While “all postpartum hemorrhage deaths are tragic,” they are “all-too-common in low-income countries” where proper obstetric care is scarce, according to David Bell, Global Good’s director of global health technologies.
“When these mothers die, the tragedy also impacts their children’s health and education, and perpetuates the cycle of poverty,” Bell said. “If this technology proves successful, the partnership with the Feinstein Institute and Sanguistat could mean the difference between life and death for mothers around the world who suffer from postpartum hemorrhage.”
That’s absolutely the goal, noted Sanguistat President and CEO Ronald Burch, who said his company’s flagship product “could represent a major breakthrough in treating bleeding” – and not only in controlled clinical settings.
While “delighted” to partner with The Global Good Fund on the effort to “make this much-needed therapy available for developing regions,” Burch – who boasts 25 years of experience in various aspects of discovery research, drug development, regulatory affairs and new product assessment – referenced a wide range of potential Neural Tourniquet applications that could be reinforced by a positive postpartum hemorrhage performance.
“If successful, it would have tremendously positive implications,” Burch said. “Not only for women giving birth, but also for soldiers wounded in battle, for patients in emergency rooms and for patients with chronic bleeding diseases.”