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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European spacecraft developer expands to Houston with U.S. business, new lab

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European aerospace manufacturer The Exploration Company has established its first U.S. entity and named Space City as its headquarters.

The company announced earlier this month that it has launched TEC Federal to support U.S. government customers and agencies, and to scale The Exploration Company's engineering operations in the country.

Mark Kirasich serves as president of TEC Federal. Kirasich most recently served as the senior director of human spaceflight at Blue Origin after a nearly 40-year career at NASA.

The Exploration Company is developing the reusable Nyx space vehicle. Nyx is designed to take off from any heavy launcher in the world. It will then dock at space stations, retrieve up to 3,000 kilograms of cargo, splash down and return the cargo to Earth. The company aims to make Nyx fully reusable for up to 10 missions, making it a more affordable and sustainable option for aerospace missions.

The Exploration Company completed a successful drop test of the spacecraft in May in the Mojave Desert. The company says Nyx is slated to perform its first flight demonstration in 2028.

In addition to launching the Houston business, The Exploration Company also opened its new Rapid Innovation Lab near Houston's NASA Johnson Space Center on Space Park Drive.

The Exploration Company opened its Rapid Innovation Lab earlier this month. Photo via LinkedIn

The Rapid Innovation Lab features a full-scale mockup of the future Nyx crew capsule as well as ongoing development and testing of the Nyx cargo capsule, according to the company.

The Exploration Company says the new lab will allow its engineers, designers, and operators to prototype and test crew interfaces. It will also support partnerships with NASA personnel and astronauts.

“Houston gives us direct access to the people and expertise that have built and operated human spaceflight systems for decades. We’re excited to invest and expand around that— engineers, operators, and astronauts working together and moving quickly towards building a crew capsule.” Hélène Huby, founder and CEO of The Exploration Company, said in a blog post.

According to The Houston Chronicle, The Exploration Company has about 30 employees in the Houston area.

The company was founded in 2021 by Huby, a French rocket scientist, and has raised more than $350 million in venture capital. It operates out of Germany, France, Luxembourg, Spain and Italy, with offices in the U.S. and the United Arab Emirates. It is also developing a reusable, high-thrust rocket engine known as Storm.

Exciting XSpace expansion plans + more top Houston innovation headlines

Trending Topics

Editor's note: The top Houston innovation headlines for the first half of July include XSpace's expansion and KBR's C-suite hires. Here is a recap of the five most-read InnovationMap stories published July 1-15, 2026:

1. XSpace plans $250M industrial condo expansion with RAFA Racing Club

nullXSpace plans $250M industrial condo expansion with RAFA Racing Club

Houston-based XSpace Group has teamed up with two other Houston companies, RAFA Racing Club and Maximo Capital, to develop five industrial condo projects that pair flex space and high-end car storage space with a members-only clubhouse for motorsports enthusiasts. The five projects will be built in the Dallas-Fort Worth; Miami-Boca Raton; Charlotte-Mooresville, North Carolina; Phoenix-Scottsdale; and Los Angeles markets. Continue reading.

2. KBR names C-suite duo to lead $5.3B government services spinoff

In advance of the spinoff of its Mission Technology Solutions unit, Houston-based KBR has made two C-suite hires for the new business. Michael LaRouche is coming aboard as president and CEO of the spinoff, currently called SpinCo, on Sept. 26. Nicholas Veasey joined as executive vice president and chief financial officer on July 1. Continue reading.

3. Experts: Houston's VC ecosystem has set the foundation — now we need scale

Fervo Energy went public earlier this summer. The Houston geothermal company priced its IPO at $27 per share, raised $1.89 billion, and opened the next morning at a market capitalization north of $10 billion. By most measures, it is the largest venture-backed cleantech IPO in history and an unambiguous win for Houston. It’s also a useful moment to look at where Houston's venture ecosystem stands and where it can go. The highlight: Houston's venture ecosystem has real foundations and, with increased company formation activity, can grow into the scale our city's ambitions deserve. Continue reading.

4. $12M pharmaceutical manufacturing facility to be built in Sugar Land

A nearly $12 million drug manufacturing facility is coming to Sugar Land. City leaders in Sugar Land recently approved a $1.3 million performance-based incentive for DeliverIt Group, a Sugar Land-based provider of specialty pharmacy, infusion therapy and clinical care services, for the development of the 60,000-square-foot facility. Continue reading.

5. Walmart expands drone delivery service to 8 new Houston-area stores

More Walmart delivery drones are now buzzing around Houston-area skies. In January, Walmart launched its drone delivery service in partnership with Wing at five locations in the Houston area. The retail giant just added eight more stores to its Houston-area drone delivery network. Wing says the expansion makes drone delivery available to more than 1 million residents of the Houston area. Continue reading.

UH lands $4M NIH grant to study early signs of autoimmune disease

NIH funding

The University of Houston recently received a $4 million National Institutes of Health grant to support a 10-year longitudinal study to identify the earliest biological markers of autoimmune disease.

Led by Chandra Mohan, the Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering, the study aims to examine what causes Systemic Autoimmune Rheumatic Diseases (SARDs) and to identify targets for future treatments. The study will be carried out in collaboration with Dr. Karen Costenbader at Harvard Medical School, Boston.

SARDs include conditions like rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome and systemic sclerosis—all are considered chronic diseases currently without a cure. Autoimmune diseases affect over 30 million people globally, according to UH.

SARDs occur when the body’s immune system attacks healthy, non-threatening tissues and organs. According to UH, in these diseases, the body often attacks nuclear antigens, creating anti-nuclear autoantibodies, which can be early detection signs for SARDs in more than 50 percent of patients, Mohan says.

Researchers will study blood samples and environmental exposure over the 10 years to better understand anti-nuclear autoantibodies.

“Collectively, these studies will help identify the genetic, environmental and cellular factors that are operative at the two steps of SARD development, namely the emergence of anti-nuclear autoantibodies and disease onset,” Mohan said in a news release. “ More importantly, these studies will highlight functional molecular pathways and mechanisms that may be operative at each step."

Mohan predicts that looking at SARDs’ shared characteristics, rather than each disease individually, could help identify more treatment methods.

“Individual SARDs have been examined in silos without an attempt to discern shared underlying features at the molecular level,” he added in the release. “Current understanding of the initial (and likely shared) origins of SARDs is only rudimentary but urgently needed to develop means for prevention and treatment.”

Earlier this year, UH also received an $11 million NIH grant to conduct a first-of-its-kind study of early language development in children ages 18 to 24 months. Read more here.

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