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.

Saranas has enrolled its first patient in its clinical trials. Photo courtesy of Saranas

Houston med device company secures first patient for clinical trial

health care tech

The first patient has been enrolled in a nationwide clinical trial that will evaluate the safety of Houston-based Saranas’ device for early detection of bleeding during minimally invasive heart procedures.

The initial patient was enrolled earlier this month at Morristown Medical Center in Morristown, New Jersey. The trial will eventually enroll up to 265 patients across the U.S.

Saranas’ Early Bird Bleed Monitoring System aids the detection of bleeding during high-risk percutaneous coronary intervention (PCI) procedures using mechanical circulatory support (MCS). In the clinical trial, the MCS will be the Impella heart pump.

PCI refers to minimally invasive procedures for opening clogged coronary arteries. MCS boosts heart function when the organ can’t perform at its best. The trial will test the ability of the Early Bird Bleed Monitoring System to detect serious or potentially fatal bleeding.

“As the field of minimally invasive, catheter-based procedures continues to advance, patient safety is paramount,” Dr. Babar Basir, director of acute mechanical circulatory support at Detroit’s Henry Ford Health System and co-principal investigator of SAFE-MCS, says in a news release. “This study will collect comprehensive procedural data in patients undergoing PCI with MCS.”

The data then will be reviewed to determine how real-time monitoring of bleeding can improve a patient’s health, Basir says.

Dr. Philippe Généreux, co-director of the Structural Heart Program at Morristown Medical Center, is the other co-principal investigator for the clinical trial.

“SAFE-MCS is the first prospective trial focused exclusively on the impact of integrating bleed monitoring in large-bore access for high-risk protected PCI patients,” says James Reinstein, president and CEO of Saranas, a medical device startup.

About one-fifth of patients will experience bleeding complications during “large bore” blood vessel procedures such as percutaneous MCS, transcatheter aortic valve replacement, and endovascular aneurysm repair. The estimated cost of one bleeding complication during these large-bore procedures is $18,000, adding up to an annual cost of $729 million for health care providers.

The Early Bird Bleed Monitoring System is the first and only device approved by the U.S. Food and Drug Administration (FDA) for real-time monitoring of bleeding problems during endovascular procedures for repair of blood vessels.

Saranas’ collaborators in the clinical trial are Proxima Clinical Research, a Houston-based contract research organization, and South Korea’s CardioVascular Research Foundation. The Early Bird study is expected to be completed by January 2023.

Since being founded in 2013, Saranas has collected $31.5 million in funding. This includes a $12.8 million Series B round that Saranas received this summer 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.

This week's roundup of Houston innovators includes Amy Chronis of Deloitte, James Reinstein of Saranas, and Tatiana Fofanova of Koda Health. Courtesy photos

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from energy to health tech — recently making headlines in Houston innovation.


Amy Chronis, Houston managing partner of Deloitte LLP

The Houston location is one of six Greenhouses in the U.S. and one of 40 around the world. Photo courtesy Deloitte/AlexandersPortraits.com

Co-located with the company's downtown Houston headquarters, the 14,000-square-foot Deloitte Greenhouse is intended to help executives plant and foster new ways of thinking, working, and experimenting in the energy industry.

Amy Chronis, Houston managing partner, at Deloitte LLP, says that as the energy capital of the world, Houston is an ideal location for one of six Greenhouses in the U.S. and one of 40 around the world.

"The oil and gas industry is at a crossroads where business transformation is no longer an option," says Chronis. "We are providing a controlled, safe environment for companies to experiment and test various workforce, technology and market scenarios to help them right-size and future-proof their businesses in this rapidly changing landscape." Click here to read more.

James Reinstein, president and CEO of Saranas

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

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. Click here to read more.

Tatiana Fofanova, co-founder and CEO of Koda Health

Koda Health, Houston, uses AI to help guide difficult conversations in health care, starting with end-of-life care planning. Image via LinkedIn

Founded by Tatiana Fofanova, Dr. Desh Mohan, and Katelin Cherry, Koda Health uses AI to help patients create advance medical care directives and documents—such as a living will—through an easy to use web-based interface.

The app then autogenerates legal and medical documents, which patients can notarize or electronically witness the forms through the app or on their own.

According to Fofanova, who earned her PhD in in Molecular Medicine at Baylor College of Medicine in Houston and now acts as the company's CEO, what historically has been a time consuming and expensive process, through Koda Health, takes an average of 17 minutes and is completely free of charge to the end user.

"We hope to reduce any outstanding barriers to access that might exist," Fofanova says. "It is very frequently the oldest and the poorest that are the highest utilizers of health care that don't have access to these solutions." Click here to read more.

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.


This week's roundup of Houston innovators includes Will Womble of Umbrage, Katie Mehnert of ALLY Energy, and James Reinstein of Saranas. Courtesy photos

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from energy to health care — recently making headlines in Houston innovation.

Will Womble, CEO of Umbrage

Startup founder on how Houston has evolved as a software hub — and why there's no better place to be

Will Womble joins this week's episode of the Houston Innovators Podcast. Photo courtesy

Will Womble describes his company, Umbrage, as fiercely loyal to Houston. The business, which publicly launched earlier this year, supports companies large and small with their software design, development, and more. Womble says he saw a void in Houston for this type of company, and he's attempting to fill it.

"What makes us different is speed to market — we're all onshore. We're all Houston-based, with the exception of five of our 40 employees," Womble says. "Houston was our focus and mission."

Womble has seen Houston evolve as an innovation ecosystem over the years, and now the game has changed. Click here to read more.

Katie Mehnert, founder and CEO of ALLY Energy

Katie Mehnert's company, ALLY Energy, has made an acquisition. Photo via Katie Mehnert

ALLY Energy announced it has acquired Clean Energy Social, a jobs and networking community for the clean energy industry. The deal expands ALLY's platform into the solar, wind, power, oil and gas, power and utilities, biofuels, hydrogen, geothermal, carbon capture, and other sectors that make up the energy transition.

"It's time to tackle the enormous challenge of the energy transition by connecting companies and candidates to resources so we can reduce the time and capital it takes to recruit and reskill," says Katie Mehnert, founder and CEO of ALLY Energy, in a news release. "We can speed up decarbonization by centralizing resources into one digital experience. This acquisition is a much-needed human capital investment to advance net-zero goals." Click here to read more.

James Reinstein, president and CEO of Saranas

Saranas closed its series B round this week. Photo via Saranas.com

Saranas Inc. announced 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 company will use the funds to continue its clinical trials, per a news release.

"We are pleased to announce this round of funding led by Baird Capital," says Saranas President and CEO James Reinstein in the release. "It underscores the importance of real-time monitoring of bleeding complications and our opportunity to accelerate the commercialization of Early Bird. We look forward to expanding our clinical evidence through prospective clinical trials and launching next generation products, including Bird on a Wire, to address a much broader range of endovascular procedures." Click here to read more.

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Texas voters OK $3 billion for new dementia research institute

state funding

Texas voters on Nov. 4 overwhelmingly approved a ballot measure that provides $3 billion in state funding over a 10-year span for the newly established Dementia Prevention and Research Institute of Texas (DPRIT).

Thanks to the passage of Proposition 14, Texas now boasts the country’s largest state-funded initiative dedicated to dementia research and prevention, according to the Alzheimer’s Association. Up to $300 million in grants will be awarded during the 10-year funding period.

“This is a transformative moment for Texas and for the fight against Alzheimer’s and all other dementia,” said Joanne Pike, president and CEO of the Alzheimer’s Association. “Texans have chosen to invest in hope, innovation, and solutions for the millions of families affected by these devastating diseases. With the passage of Proposition 14, Texas is now poised to lead the nation in dementia research and prevention.”

The association says DPRIT will drive scientific breakthroughs, attract top-notch dementia researchers to Texas, and generate thousands of jobs statewide.

An estimated 460,000 Texans are living with dementia, the association says, and more than one million caregivers support them.

DPRIT is modeled after the Cancer Prevention and Research Institute of Texas (CPRIT). Since 2008, the state agency has awarded nearly $4 billion in grants to research organizations for cancer-related academic research, prevention programs, and product development.

An analysis by the McKinsey Health Institute found that investing in brain health initiatives like DPRIT could boost Texas’ GDP by $260 billion. Much of that GDP bump could benefit the Houston area, which is home to dementia-focused organizations such as UTHealth Houston Neurosciences, Baylor College of Medicine’s Center for Alzheimer’s and Neurodegenerative Diseases, the University of Texas Medical Branch at Galveston’s Collaborative Alzheimer’s Disease and Memory Disorders Program, and the Houston Methodist Research Institute’s John M. O’Quinn Foundation Neurodegenerative Disorders Laboratory.

The Greater Houston Partnership says DPRIT holds the potential “to elevate Texas — particularly Houston — as a hub for brain health research.”

State Sen. Joan Huffman, a Houston Republican, is one of DPRIT’s champions. She sponsored legislation this year to create the institute and ask Texas voters to approve the $3 billion in funding.

“By establishing the Dementia Prevention and Research Institute of Texas, we are positioning our state to lead the charge against one of the most devastating health challenges of our time,” Huffman said in May. “With $3 billion in funding over the next decade, we will drive critical research, develop new strategies for prevention and treatment, and support our health care community.”

Get your tickets to the 2025 Houston Innovation Awards today

Ticket Time

We're just one week away from the 2025 Houston Innovation Awards, and it's time to secure your seat for the annual event.

Join us on Nov. 13 at Greentown Labs for an intimate evening of networking and celebrating Houston's extensive innovation community. We'll honor the trailblazers and visionaries who are shaping the future of our city, and you'll connect with like-minded individuals, industry leaders, investors, and entrepreneurs.

From burgeoning startups to fast-growing scaleups, we'll celebrate outstanding nominees across 10 prestigious categories and unveil this year's winners during our live awards ceremony. Be in the room to see who is named 2025 Startup of the Year, 2025 Mentor of the Year, and more.

Individual tickets are available for $45 and include complimentary light bites, drinks, and non-reserved seating. A limited number of Founder Tickets are available for startup founders at a special discounted price of $35.

Bringing a group? Corporate 10-packs include light bites and drinks, as well as a full row of reserved seating for 10 guests, complete with company branding.

The event is just a week away, so secure your seats today. Then, get to know the finalists in each category via our editorial spotlights.

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The Houston Innovation Awards program is sponsored by Houston City College Northwest, Houston Powder Coaters, FLIGHT by Yuengling, and more to be announced soon. For sponsorship opportunities, please contact sales@innovationmap.com.

Houston Innovation Awards to honor Wade Pinder as 2025 Trailblazer

And the award goes to...

On Nov. 13, we'll gather for the 2025 Houston Innovation Awards to celebrate the best and brightest in Houston innovation right now. And, as is tradition with the annual program, we'll honor one longstanding Houston innovator with the Trailblazer Award.

The award was established to recognize an individual who has left a profound impact on Houston's business and innovation ecosystem and is dedicated to continuing to support Houston and its entrepreneurs. The recipient is selected by our esteemed panel of judges from a pool of internal and external recommendations.

The 2025 Trailblazer Award recipient is Wade Pinder of Product Houston. A familiar face to those active in Houston's innovation sector, Pinder identifies as an "Ecosystem Wayseeker" and is the founder of Product Houston.

Pinder, a former product manager at Blinds.com, arrived in Houston in 2008 and has been deeply engaged in Houston’s startup and innovation scene since 2012. Over the years, he has supported hundreds of founders, product leaders, and community builders across the Houston area.

In 2023, he was honored as Mentor of the Year in the Houston Innovation Awards. Today, he fosters collaboration, clarity, and connection through his work at Product Houston, and he helps innovators find their place in the local sector via his monthly "Houston Ecosystem Mapping" sessions.

Read below for Pinder's insightful takes on the Houston innovation scene and what it means to blaze a new trail. Then, join us as we celebrate Pinder and all of our nominees and winners at the 2025 Houston Innovation Awards on Nov. 13 at Greentown Labs. Tickets are available now.

InnovationMap: Describe the growth of the Houston innovation ecosystem from your arrival in 2008 to now.

Wade Pinder: When I first arrived in Houston in 2008, the innovation ecosystem was more fragmented than it is today. Connecting with other innovators often meant attending a lot of hit-or-miss events. Over the years, it’s been incredible to see the network take shape and grow into a true community. I’ve had the privilege of being involved with several coworking spaces and accelerator programs along the way, and it’s been especially exciting to see Station Houston evolve into what is now the Ion District. What makes the Ion unique is how it blends openness and opportunity… ideas spill into and out of the space, and anyone can walk in, participate in programming, and find themselves in proximity to people who might help them take the next steps.

Additionally, the expansion of spaces like Texas Medical Center Innovation, Helix Park, The Cannon, and many others, have broadened Houston’s innovation landscape in powerful ways.

Today, when someone new moves to Houston and wants to plug into the startup and innovation scene, it’s much easier for them to find their way than when I moved here in 2008. I think that’s something Houston can really be proud of.

IM: As someone who engages with the broader Houston innovation community on a regular basis, what are the shared characteristics and traits that you see among its members?

WP: One of the things that makes Houston’s innovation community unique is how deeply it’s rooted in industry. So many of the innovators I meet come from within Houston’s major sectors, and they’ve seen firsthand where opportunities lie, which gives their innovation a certain practicality. They’re developing solutions that solve real, often complex, business and industry problems, not chasing trends or trying to create the next flashy consumer app.

What I admire most is that this community is growing in its understanding of the value of collaboration. They work with the systems and expertise that already exist, and find better ways to make them work together. Another shared trait I see across Houston’s innovators is a deep sense of curiosity and a drive to question the status quo while looking for better ways to build, improve, and solve.

IM: You’ve said, "Houston has Houston problems, and Houston needs Houston solutions." How do you see this taking shape in the innovation sector right now?

WP: When I first started getting connected to Houston’s startup and innovation scene in 2012, I noticed folks had a tendency to look at other cities and ask, "How can we do what they did?" Back then, we saw phrases like "Silicon Bayou" pop up, and while that enthusiasm was hopeful, it often discounted the things that make Houston unique. Over time, I’ve come to believe that the better question is: "What are we already great at, and how can we innovate from there?" The flip side of that question is to reflect on the things that hold us back as an ecosystem… identifying the friction points and finding practical ways to smooth them out.

From my time wandering around our ecosystem, I’ve come to understand Houston is great at infrastructure at scale, solving life-and-death challenges in the global spotlight, and "boldly going where no one’s gone before." These three things, in my opinion, capture the essence of Houston does best: We do hard things here.

What excites me today is that we’re applying innovation to those core strengths in ways that feel authentically Houston. One area I’m especially excited about is the emergence of the “New Space Economy,” captured beautifully in Wogbe Ofori’s thought piece “The Astropreneur’s Startup Journey Map.” It's a great example of how the next wave of space-related innovation might connect to Houston’s long-standing strengths in manufacturing, logistics, and problem-solving at scale.

Another challenge Houston faces is what I call a "proximity problem." Even when events are only a few miles apart, traffic can make it difficult for people to stay connected across the city. That’s why I’m so encouraged by the rise of what I think of as "intent-based gatherings" around the city: events designed with purpose, where people know they’ll find real connection and value once they arrive.

IM: Finally, what does being a "Trailblazer" mean to you?
WP: To me, trailblazing in the Houston innovation ecosystem means being willing to wander through the many different corners of the community and look for value in places we often overlook. It’s about showing up at events, community meetings, and pitch competitions — not just to participate, but to notice how each of these "nodes" in the ecosystem connects and adds value to the others.

Sometimes the trailblazer only walks a trail once: as they are discovering it. If you can help others see a newfound trail’s purpose and potential, it becomes a path others can follow more easily in the future. That’s the real work of a trailblazer: mapping connections, framing their value, and helping people recognize how those pathways strengthen the ecosystem as a whole.

In a broader sense, trailblazing is about seeing things not just as they are, but as they could be. Then taking the steps, however small, that make that vision real.

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The Houston Innovation Awards program is sponsored by Houston City College Northwest, Houston Powder Coaters, FLIGHT by Yuengling, and more to be announced soon. For sponsorship opportunities, please contact sales@innovationmap.com.

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