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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Mark Cuban calls AI ‘the greater democratizer’ for young entrepreneurs

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Texas billionaire Mark Cuban—whose investment portfolio includes Houston-based Holliball, a startup that makes and sells large inflatable holiday ornaments—believes AI is leveling the playing field for budding low-income entrepreneurs.

At the recent Clover x Shark Tank Summit in Las Vegas, the Shark Tank alum called AI “the greater democratizer.”

Cuban told Axios that free and low-cost AI tools enable disadvantaged teenagers to compete with seasoned professionals.

“Right now, if you’re a 14- to 18-year-old and you’re in not-so-good circumstances, you have access to the best professors and the best consultants,” Cuban said. “It allows people who otherwise would not have access to any resources to have access to the best resources in real time. You can compete with anybody.”

While Cuban believes AI is “the great democratizer” for low-income young people, low-income workers still face hurdles in navigating the AI landscape, according to Public Works Partners, an urban planning and consulting firm. The firm says access to AI among low-income workers may be limited due to cost, insufficient digital literacy and infrastructure gaps.

“Without adequate resources and training, these workers may struggle to adapt to AI-driven workplaces or access the educational opportunities necessary to acquire new skills,” Public Works Partners said.

Texas 2036, a public policy organization focused on the state’s future, reported in January AI jobs in Texas are projected to grow 27 percent over the next decade. The number 2036 refers to the year when Texas will celebrate its bicentennial.

As for the current state of AI, Cuban said he doesn’t think the economy is witnessing an AI bubble comparable to the dot-com bubble, which lasted from 1998 to 2000.

“The difference is, the improvement in technology basically slowed to a trickle,” Cuban said of the dot-com era. “We’re nowhere near the improvement in technology slowing to a trickle in AI.”

Houston's top innovators and startups for 2025 and more news to know

Trending news

Editor's note: We're looking back at the top Houston innovation news for the first half of October 2025, including the big reveal of our 2025 Houston Innovation Awards finalists. Here are the five most-read InnovationMap stories from Oct. 1-15, 2025:

1. Announcing the 2025 Houston Innovation Awards finalists

Meet the finalists for the Houston Innovation Awards, taking place Nov. 13. Graphic via Gow Media

InnovationMap is proud to reveal the finalists for the 2025 Houston Innovation Awards. Taking place on November 13 at Greentown Labs, the fifth annual Houston Innovation Awards will honor the best of Houston's innovation ecosystem, including startups, entrepreneurs, mentors, and more. This year's finalists were determined by our esteemed panel of judges, comprised of past award winners and InnovationMap editorial leadership. Continue reading.

2. 5 minority-founded Houston startups shine as Innovation Awards finalists

These five minority-founded businesses stood out to the judges for the 2025 Houston Innovation Awards. Photo via marsmaterials.tech

Houston is one of the most diverse cities in the nation, and that trend carries over into its innovation and startup ecosystem. As part of the 2025 Houston Innovation Awards, our Minority-founded Businesses category will honor an innovative Houston startup founded or co-founded by BIPOC or LGBTQ+ representation. Five minority-founded businesses have been named finalists for the 2025 award. The finalists range from a wearable health tech device company to a clean chemical manufacturing business to a startup with a lunar mission. Continue reading.

3. 2 UH projects named finalists for $50M fund to shape future of Gulf Coast

One project involves the innovative recycling of wind turbines into seawall and coastal habitats. Courtesy rendering

Two University of Houston science projects have been selected as finalists for the Gulf Futures Challenge, which will award a total of $50 million to develop ideas that help benefit the Gulf Coast. Sponsored by the National Academies of Science, Engineering and Medicine’s Gulf Coast Research Program and Lever for Change, the competition is designed to spark innovation around problems in the Gulf Coast, such as rising sea levels, pollution, energy security, and community resiliency. The two UH projects beat out 162 entries from organizations based in Alabama, Florida, Louisiana, Mississippi, and Texas. Continue reading.

4. 3 Houston-area companies appear on Fortune’s inaugural AI ranking

Spring-based ExxonMobil ranks within the top 10 on the new Fortune AIQ 50 ranking. Photo via Getty Images.

Three companies based in the Houston area appear on Fortune’s inaugural list of the top adopters of AI among Fortune 500 companies. The Fortune AIQ 50 ranking is based on ServiceNow’s Enterprise AI Maturity Index, an annual measurement of how prepared organizations are to adopt and scale AI. To evaluate how Fortune 500 companies are rolling out AI and how much they value AI investments, Fortune teamed up with Enterprise Technology Research. The results went into computing an AIQ score for each company. Continue reading.

5. 10+ can't-miss Houston business and innovation events for October

From the fourth annual Tejano Tech Summit to the first-ever Ion Family Tech Festival, here's what not to miss this month. Image courtesy the Ion

Houston's October calendar is packed with informative and impactful events—plus a few fun ones, too. From the fourth annual Tejano Tech Summit to the first-ever Ion Family Tech Festival, here's what not to miss and how to register.Continue reading.

CPRIT hires MD Anderson official as chief cancer prevention officer

new hire

The Austin-based Cancer Prevention and Research Institute of Texas, which provides funding for cancer research across the state, has hired Ruth Rechis as its chief prevention officer. She comes to CPRIT from Houston’s University of Texas MD Anderson Cancer Center, where she led the Cancer Prevention and Control Platform.

Before joining MD Anderson, Rechis was a member of the executive leadership team at the Livestrong Foundation, an Austin-based nonprofit that supports people affected by cancer.

“Ruth has widespread connections throughout the cancer prevention community, both in Texas and across the nation,” CPRIT CEO Kristen Doyle said in a news release. “She is a long-term passionate supporter of CPRIT, and she is very familiar with our process, programs, and commitment to transparency. Ruth is a terrific addition to the team here at CPRIT.”

Rechis said that by collaborating with researchers, policymakers, public health leaders and community partners, CPRIT “can continue to drive forward proven prevention strategies that improve health outcomes, lower long-term costs, and create healthier futures for all.”

At MD Anderson, Rechis and her team worked with more than 100 organizations in Texas to bolster cancer prevention initiatives at clinics and community-based organizations.

Rechis is a longtime survivor of Hodgkin lymphoma, a type of cancer that affects the lymph nodes, which are part of a person’s immune system.
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