HEalth tech

Houston medical device company heads to clinical trials following recent $2.8 million raise

Saranas Inc. is testing its technology that can detect and track internal bleeding complications. Getty Images

A Houston-based medical device startup is on a twofold mission to reduce healthcare costs and improve the safety of complex medical procedures involving blood vessels.

Saranas Inc. currently is testing its Early Bird Bleed Monitoring System, which is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, president and CEO of Saranas. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

Dr. Mehdi Razavi, a cardiologist with the Texas Heart Institute at Houston's Texas Medical Center, invented the device. It's being tested by the institute and other medical facilities in the U.S. As many as 100 patients will participate in the clinical trial, which is expected to last several months.

If all goes well, the U.S. Food and Drug Administration will approve Early Bird in 2019, Syed says. Then, the device would be made widely available to medical facilities across the country.

In May, Saranas said it received $2.8 million in funding from investors to enable testing of Early Bird. In all, the startup has collected $12 million from investors. A month after the funding announcement, Saranas was one of 50 startups chosen for the MedTech Innovator program, which nurtures medical technology companies.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals get audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be halted or prevented.

"There is a risk of bleeding that occurs when some of these coronary interventions are performed through the femoral artery, which is in the upper thigh," Syed says.

In a release, Texas Heart Institute cardiologist Dr. Joggy George says internal bleeding "remains the Achilles' heel" of advances in noninvasive endovascular procedures.

Syed says there's an underappreciation for how often bleeding occurs during nonsurgical procedures that provide access to a patient's blood vessels. Each year, doctors perform these procedures on more than 20 million patients in the U.S.; of those, about 1 million experience severe complications from bleeding. Those complications can lead to longer, more expensive hospital stays along with a higher risk of death.

Initially, Saranas is targeting high-risk endovascular procedures done with large sheaths, rather than endovascular procedures performed with sheaths of all sizes, Syed says.

Syed took the helm of Saranas in February 2017. He's spent nearly 20 years in the medical device industry, including four years at Bellaire-based OrthoAccel Technologies Inc.

For the time being, Syed is one of just a handful of employees at Saranas, which was founded in 2013 and has benefited from its affiliation with the Texas Medical Center Innovation Institute. Syed expects to grow the Saranas team in 2019 once the Early Bird gains clearance from the FDA.

During his tenure in the medical device sector, Syed has been "keenly interested" in bringing impactful innovations to the market, such as the Early Bird device.

"It is especially important to me that such innovation not only improves health outcomes but also aims to drive down healthcare costs," he says. "We are in a healthcare environment where if you don't have a health economic benefit coupled with a clinical outcome, it is very challenging to get adoption of new technology."

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Houston-based imaware, which has an at-home COVID-19 testing process, is working with Texas A&M University on researching how the virus affects the human body. Getty Images

An ongoing medical phenomenon is determining how COVID-19 affects people differently — especially in terms of severity. A new partnership between a Houston-based digital health platform and Texas A&M University is looking into differences in individual risk factors for the virus.

Imaware, which launched its at-home coronavirus testing kit in April, is using its data and information collected from the testing process for this new study on how the virus affects patients differently.

"As patient advocates, we want to aid in the search to understand more about why some patients are more vulnerable than others to the deadly complications of COVID-19," says Jani Tuomi, co-founder of imaware, in a press release. "Our current sample collection process is an efficient way to provide longitudinal prospectively driven data for research and to our knowledge, is the only such approach that is collecting, assessing, and biobanking specimens in real time."

Imaware uses a third-party lab to conduct the tests at patients' homes following the Center for Disease Control's guidelines and protocol. During the test, the medical professional takes additional swabs for the study. The test is then conducted by Austin-based Wheel, a telemedicine group.

Should the patient receive positive COVID-19 results, they are contacted by a representative of Wheel with further instructions. They are also called by a member of a team led by Dr. Rebecca Fischer, an infectious disease expert and epidemiologist and laboratory scientist at the Texas A&M University School of Public Health, to grant permission to be a part of the study.

Once a part of the study, the patient remains in contact with Fischer's team, which tracks the spread and conditions of the virus in the patient. One thing the researchers are looking for is the patients' responses to virus complications caused by an overabundance of cytokines, according to the press release. Cytokines are proteins in the body that fight viruses and infections, and, if not working properly, they can "trigger an over-exuberant inflammatory response" that can cause potentially deadly issues with lung and organ failure or worse, per the release.

"We believe strongly in supporting this research, as findings from the field can be implemented to improve clinical processes-- helping even more patients," says Wheel's executive medical director, Dr. Rafid Fadul.

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