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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Axiom Space wins NASA contract for fifth private mission, lands $350M in financing

ready for takeoff

Editor's note: This story has been updated to include information about Axiom's recent funding.

Axiom Space, a Houston-based space infrastructure company that’s developing the first commercial space station, has forged a deal with NASA to carry out the fifth civilian-staffed mission to the International Space Station.

Axiom Mission 5 is scheduled to launch in January 2027, at the earliest, from NASA’s Kennedy Space Center in Florida. The crew of non-government astronauts is expected to spend up to 14 days docked at the International Space Station (ISS). Various science and research activities will take place during the mission.

The crew for the upcoming mission hasn’t been announced. Previous Axiom missions were commanded by retired NASA astronauts Michael López-Alegría, the company’s chief astronaut, and Peggy Whitson, the company’s vice president of human spaceflight.

“All four previous [Axiom] missions have expanded the global community of space explorers, diversifying scientific investigations in microgravity, and providing significant insight that is benefiting the development of our next-generation space station, Axiom Station,” Jonathan Cirtain, president and CEO of Axiom, said in a news release.

As part of Axiom’s new contract with NASA, Voyager Technologies will provide payload services for Axiom’s fifth mission. Voyager, a defense, national security, and space technology company, recently announced a four-year, $24.5 million contract with NASA’s Johnson Space Center in Houston to provide mission management services for the ISS.

Axiom also announced today, Feb. 12, that it has secured $350 million in a financing round led by Type One Ventures and Qatar Investment Authority.

The company shared in a news release that the funding will support the continued development of its commercial space station, known as Axiom Station, and the production of its Axiom Extravehicular Mobility Unit (AxEMU) under its NASA spacesuit contract.

NASA awarded Axiom a contract in January 2020 to create Axiom Station. The project is currently underway.

"Axiom Space isn’t just building hardware, it’s building the backbone of humanity’s next era in orbit," Tarek Waked, Founding General Partner at Type One Ventures, said in a news release. "Their rare combination of execution, government trust, and global partnerships positions them as the clear successor-architect for life after the ISS. This is how the United States continues to lead in space.”

Houston edtech company closes oversubscribed $3M seed round

fresh funding

Houston-based edtech company TrueLeap Inc. closed an oversubscribed seed round last month.

The $3.3 million round was led by Joe Swinbank Family Limited Partnership, a venture capital firm based in Houston. Gamper Ventures, another Houston firm, also participated with additional strategic partners.

TrueLeap reports that the funding will support the large-scale rollout of its "edge AI, integrated learning systems and last-mile broadband across underserved communities."

“The last mile is where most digital transformation efforts break down,” Sandip Bordoloi, CEO and president of TrueLeap, said in a news release. “TrueLeap was built to operate where bandwidth is limited, power is unreliable, and institutions need real systems—not pilots. This round allows us to scale infrastructure that actually works on the ground.”

True Leap works to address the digital divide in education through its AI-powered education, workforce systems and digital services that are designed for underserved and low-connectivity communities.

The company has created infrastructure in Africa, India and rural America. Just this week, it announced an agreement with the City of Kinshasa in the Democratic Republic of Congo to deploy a digital twin platform for its public education system that will allow provincial leaders to manage enrollment, staffing, infrastructure and performance with live data.

“What sets TrueLeap apart is their infrastructure mindset,” Joe Swinbank, General Partner at Joe Swinbank Family Limited Partnership, added in the news release. “They are building the physical and digital rails that allow entire ecosystems to function. The convergence of edge compute, connectivity, and services makes this a compelling global infrastructure opportunity.”

TrueLeap was founded by Bordoloi and Sunny Zhang and developed out of Born Global Ventures, a Houston venture studio focused on advancing immigrant-founded technology. It closed an oversubscribed pre-seed in 2024.

Texas space co. takes giant step toward lunar excavator deployment

Out of this world

Lunar exploration and development are currently hampered by the fact that the moon is largely devoid of necessary infrastructure, like spaceports. Such amenities need to be constructed remotely by autonomous vehicles, and making effective devices that can survive the harsh lunar surface long enough to complete construction projects is daunting.

Enter San Antonio-based Astroport Space Technologies. Founded in San Antonio in 2020, the company has become a major part of building plans beyond Earth, via its prototype excavator, and in early February, it completed an important field test of its new lunar excavator.

The new excavator is designed to function with California-based Astrolab's Flexible Logistics and Exploration (FLEX) rover, a highly modular vehicle that will perform a variety of functions on the surface of the moon.

In a recent demo, the Astroport prototype excavator successfully integrated with FLEX and proceeded to dig in a simulated lunar surface. The excavator collected an average of 207 lbs (94kg) of regolith (lunar surface dust) in just 3.5 minutes. It will need that speed to move the estimated 3,723 tons (3,378 tonnes) of regolith needed for a lunar spaceport.

After the successful test, both Astroport and Astrolab expressed confidence that the excavator was ready for deployment. "Leading with this successful excavator demo proves that our technology is no longer theoretical—it is operational," said Sam Ximenes, CEO of Astroport.

"This is the first of many implements in development that will turn Astrolab's FLEX rover into the 'Swiss Army Knife' of lunar construction. To meet the infrastructure needs of the emerging lunar economy, we must build the 'Port' before the 'Ship' arrives. By leveraging the FLEX platform, we are providing the Space Force, NASA, and commercial partners with a 'Shovel-Ready' construction capability to secure the lunar high ground."

"We are excited to provide the mobility backbone for Astroport's groundbreaking construction technology," said Jaret Matthews, CEO of Astrolab, in a release. "Astrolab is dedicated to establishing a viable lunar ecosystem. By combining our FLEX rover's versatility with Astroport's civil engineering expertise, we are delivering the essential capabilities required for a sustainable lunar economy."

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This article originally appeared on CultureMap.com.

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