Houston medical device startup names new CEO

now at the helm

Houston-based Saranas has tapped a new leader amidst push to commercialize bleed detection technology. Photo via LinkedIn

Houston-based medical device company Saranas has tapped a veteran of the healthcare industry as its new CEO.

Mike MacKinnon most recently was president and partner at Madison Ventures +, a private equity firm based in Greenwood Village, Colorado. The firm invests in companies in healthcare, real estate, finance, and other sectors.

Before joining Madison Ventures +, MacKinnon was CEO of Zidan Medical, a startup focused on treatment of airway lesions in patients with early stage lung cancer. He served in that role from 2019 to 2023.

Earlier, he was CEO of ROX Medical, a medical device company specializing in minimally invasive vascular therapy for patients with uncontrolled high blood pressure. He held that role from 2018 to 2019. He previously worked at Philips North America, Volcano, AtheroMed, Hansen Medical, Access Closure, and FoxHollow Technologies.

In a news release, Dan Wolterman, chairman of Saranas’ board and former president and CEO of Memorial Hermann Health System, calls MacKinnon “an accomplished executive with an impressive record of bringing disruptive technology to market, guiding strategy, and driving significant growth.”

Now president and CEO of Nashua, New Hampshire-based medical device company Conformal Medical, James Reinstein was president and CEO of Saranas from 2020 to 2022. Prior to Reinstein, Zaffer Syed held that position from 2017 to 2020. He's still an adviser for the company and recently announced his role as entrepreneur in residence at the Texas Medical Center.

Saranas is working on commercializing its Early Bird Bleed Monitoring System, touted as the first and only system FDA-approved bleeding detection system for procedures involving blood vessels. It is designed to detect bleeds early, enabling physicians to reduce medical risks and potentially avoid costly medical problems.

“Bleeding remains a common issue during and after endovascular procedures and can result in life-threatening complications,” says MacKinnon.

Since being founded in 2013, Saranas has treated over 1,200 patients with its device and has received $29.2 million in funding, according to Crunchbase. This includes a $12.8 million Series B round that Saranas got in 2021 from Chicago-based Baird Capital and Austin-based S3 Ventures.

The Early Bird device was developed at Houston’s Texas Heart Institute. The FDA approved the device in 2019.

James Reinstein joins the Houston Innovators Podcast to discuss what's next for growing medical device company, Saranas. Photo courtesy

Health tech executive leads Houston startup into its next generation following $12.8M series B

houston innovators podcast episode 103

When James Reinstein took the helm of Houston-based Saranas in March 2020, he was tasked with taking the medical device company through its series B funding round and into larger clinical trials. Navigating these tasks during a global pandemic wasn't part of the plan.

"There was just so much uncertainty," Reinstein says on this week's episode of the Houston Innovators Podcast. "All of the funds didn't know which end was up, what hospitals would be doing, what procedures were going to begin again."

Saranas received FDA approval and began its clinical trials for its Early Bird Bleed Monitoring System in 2019. The device is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels. Around 20 percent of patients suffer a bleeding complication during endovascular procedures.

Reinstein explains that the way health tech funding trended over the past 18 months greatly affected Saranas. The device fell outside the parameters of what investors were looking for during this pandemic time. However, Reinstein explains, the Early Bird worked and had FDA approval — that made all the difference.

"We are very confident that the product does work and it can have a significant impact for hospitals and patients," Reinstein says. "Eventually, the term sheets came in."

Saranas announced in July that it closed a $12.8 million series B investment led by Wisconsin-based Baird Capital, the venture capital and global private equity arm of Baird, a global company with a location in Houston. Austin-based S3 Ventures also supported the round.

The funds will propel Saranas into its next phase, which includes growing its team, larger trials, and a next-generation product.

Reinstein has had decades in health care innovation all over the world, with a large chunk of his career at Boston Scientific. He's seen Houston's innovation ecosystem evolve.

"I do think that there's a great potential for Houston to really develop the industry," Reinstein says. "There's just two areas that need to get fortified. One is the funding and getting the funds directed to Houston companies — with the idea that the company stays in Houston. ... The other side of the coin is really finding the talent to come in and run the companies, take on leadership positions."

Reinstein shares more details on what's next for Saranas, as well as his advice for med tech entrepreneurs and observations on Houston's innovation ecosystem on the show. Listen to the full interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

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 receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"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, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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Rice lands $15M U.S. Army award to launch next-gen wireless research center

defense funding

The U.S. Army Research Office has awarded Rice University $15 million to establish a new center for next-generation sensing and communications.

The five-year research center—dubbed the Center for Large Aperture Secure Sensing, Imaging and Communications (CLASSIC)—will unite researchers from universities and national laboratories to develop advanced antenna technologies for future wireless systems. Edward Knightly, the Sheafor-Lindsay Professor of Electrical and Computer Engineering at Rice, will lead the center that “combines expertise in wireless networking, antennas, radar, artificial intelligence, circuits and physics to address growing demands on wireless systems,” according to Rice.

“The challenges we’re tackling require advances that span physics, hardware, communications and computing," Knightly said in a news release. “By combining those strengths in a single center, we can accelerate the development and demonstration of technologies that would not be possible through individual efforts alone.”

Joining Knightly will be Ashutosh Sabharwal of Rice, Sensen Li of the University of Texas at Austin, Hou-Tong Chen of Los Alamos National Laboratory, Danijela Cabric of UCLA, Josep M. Jornet and Tommaso Melodia of Northeastern University, Daniel M. Mittleman of Brown University, and Willie Padilla of Duke University.

Industry partners include Booz Allen Hamilton, Intel, Keysight, Lockheed Martin, MITRE, Northrop Grumman, Qualcomm and Raytheon.

CLASSIC researchers will investigate how large-scale antenna arrays (ELSAAs) can expand the capabilities of wireless systems where technology is limited.

ELSAAs use thousands of coordinated antenna elements to direct radio waves. Researchers aim to develop ways to use the technology to help maintain steady communication when signals are blocked or disrupted and to detect and generate detailed images of concealed objects.

Along with ELSAAs, the center will work to develop sensing techniques for threat detection, study wireless jamming and build resilient high-speed wireless networks. Researchers will ultimately validate the technology in labs and via drone-based field trials.

CLASSIC will also work on developing an AI-driven modeling framework that will simulate complex electromagnetic environments in real time.

“This award demonstrates Rice’s leadership in tackling complex national research challenges through collaboration across disciplines and institutions,” David Sholl, executive vice president for research at Rice, added in the release.

UH scores $18M NIH grant for chronic disease research

research funding

The University of Houston has received a coveted $18.8 million grant from the National Institutes of Health to launch a program to address the root causes of chronic disease.

Only 22 institutions nationwide receive this NIH award, and the 5-year process aligns with the newly established UH Health’s mission to expand healthcare innovations in Texas and beyond. The initiative will be housed in the UH Population Health department.

"This generous funding allows us to directly confront the root causes of chronic illness that place a heavy burden on so many families," Dr. Jonathan McCullers, vice president for health affairs at UH, said in a news release. "With the recent launch of UH Health, we have an unprecedented opportunity to translate scientific discovery into healthier outcomes for our communities by bringing together experts from across the university to improve health where it matters most.”

Through the program, UH researchers from different areas of expertise will work together to address the challenges of chronic illness by looking at biological, social and behavioral factors.

According to the university, chronic diseases like heart disease, diabetes, strokes and others are the leading cause of illness, disability and death in the U.S. They account for 90 percent of the nation’s $5.3 trillion in annual healthcare spending.

Bettina Beech, chief of population health and translational science at UH, serves as principal investigator for the program.

“Chronic disease management largely happens during the 8,700 hours each year that people are not visiting their healthcare provider,” Beech added in the news release. “While healthcare is indispensable, it only accounts for 20 percent of how health is created — genetics accounts for another 10 percent, and the other 70 percent is determined by behavior, social conditions and environment.”

With the funds from the grant, UH will also be able to expand research infrastructure, add to community partnerships, support complementary research, and invest in early-career investigators, according to the news release. UH also aims to develop solutions that could help ease the economic burden of chronic disease.