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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Italian aerospace company sets up first U.S. office at Houston Spaceport

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Como, Italy-based aerospace company Involve Space recently made the Houston Spaceport the site of its first U.S. office.

Involve Space develops high-altitude balloon platforms for Earth observation, scientific research and hardware testing. The balloons carry instruments into the stratosphere (a layer of the upper atmosphere) to collect images and data, conduct experiments and test technology.

The company plans to launch its first commercial missions from Houston by the end of this year, according to a news release.

“Houston is the global center of aerospace, and our presence at Houston Spaceport strengthens our international growth trajectory,” Jonathan Polotto, founder and CEO of Involve Space, said in the release.

Founded in 2021, Involve Space incorporates aerospace hardware, AI and geospatial tools into its offerings. Its proprietary CLEAR platform uses conversational AI to help customers interpret data and support decision-making.

Located at Ellington Airport, the Houston Spaceport provides a base for Involve Space’s North American operations, including business development and partnerships with aerospace companies and researchers.

Other tenants at the Houston Spaceport include NASA, Axiom Space, Venus Aerospace and Intuitive Machines.

Involve Space’s relationship with the Houston Spaceport began in January 2025, when it conducted its first U.S. pilot launch. During the five-hour mission, the balloon reached an altitude of about 85,000 feet and traveled about 250 miles across Texas.

One of Involve Space’s first U.S. customers is Houston-based Rhodium Scientific, a space biotech company. Polotto and Rhodium Scientific founder and CEO Olivia Gamez Holzhaus signed a deal to conduct biotech experiments aboard Involve Space’s stratospheric balloon platforms before planned missions to orbit.

“The presence of innovative platforms like those developed by Involve strengthens the Spaceport’s role as a site for testing, validating, and deploying advanced technologies between aeronautics and space,” Jim Szczesniak, director of aviation for Houston Airports, added in the release.

UH lands $3M grant to expand opioid overdose training

Overdose Response

The University of Houston has received a $3 million federal grant to expand its potentially life-saving overdose response training program.

The grant will support the Houston Health Department’s FRONTLINES program that trains first responders in Harris and Fort Bend counties to recognize opioid overdoses and administer the drug naloxone, which can counter the effects of an opioid overdose. The four-year grant comes from the Substance Abuse and Mental Health Services Administration within the Department of Health and Human Services, and it builds on eight years of work at UH, according to a release from the university.

As part of the expansion, UH medical, social work and psychology students will now also be able to take part in FRONTLINES’ overdose-response training. Some of the students will also be selected to help train community members, ultimately passing along the life-saving skills throughout Houston.

FRONTLINES is a collaboration with the City of Houston, the Fertitta College of Medicine, Baylor College of Medicine and the Houston Recovery Center. It was co-founded by Dr. James Bray, chair of the Department of Behavioral and Social Sciences at the University of Houston’s Tilman J. Fertitta Family College of Medicine, in 2018.

“When someone experiencing an opioid overdose is reached in time, naloxone can save their life,” Bray said in a news release. “We’ve seen the impact this training can have in Houston, and now we have an opportunity to extend that reach across Harris and Fort Bend counties, putting lifesaving knowledge and tools into the hands of more first responders.”

In 2024, around 450 residents of Harris County died from opioid overdoses, according to a Texas Department of State Health Services report. The report found that fentanyl was involved in about three-quarters of the deaths.

In 2025, UH also received a $2.6 million gift from the estate of Dr. William A. Gibson to expand its opioid research and develop a vaccine to help block fentanyl's effectiveness in entering the brain. The vaccine research is part of the Michael C. Gibson Addiction Research Program led by UH professor of psychology Therese Kosten and founding member of the UH Drug Discovery Institute Colin Haile. Read more about the grant and the vaccine’s development here.

Texas public libraries drive billions in economic impact, report finds

Beyond the Stacks

A new statewide study examining the economic impacts of public libraries has revealed they have generated over $3.8 billion in value to local communities — a return of $4.74 for every $1 invested.

The report, "Beyond the Stacks: Measuring the Economic and Community Value of Texas Public Libraries" was conducted by third-party consultancy JBK Economics Group in partnership with the Texas Library Association. About 300 of the total 513 public libraries in Texas participated in a survey for the report.

A major finding from the survey revealed that public libraries create billions in economic value for the communities they serve at a fraction of what it costs to pay employee wages and benefits, operating expenditures, and capital expenditures. About 11,200 jobs were directly and indirectly supported by public libraries, the report found.

The report found its $4.74 to $1 ratio by adding up the total value of the services provided by these institutions (an estimated $2.48 billion), and comparing it to total expenditures ($808.6 million).

"Public libraries had about the same economic footprint as the Texas motion picture and sound recording industry ($2.9 billion in Gross Domestic Product in 2024) or the Texas paper manufacturing industry ($4.0 billion in Gross Domestic Product in 2024)," the report said.

Many Houstonians are already familiar with Houston Public Library's expansive catalog and programming, but there are many more services the library provides that might fly under the radar. A few examples include access to subscription-based research databases and news outlets, and the Library of Things, a collection of cookware and bake ware, musical instruments, craft kits, and other tools or activity materials that are available for cardholders to borrow. Individual branches also provide free Wi-Fi, computer access, and meeting spaces.

Houston-area residents also have access to services at several other local libraries depending on their address, such as the Harris County Public Library, Montgomery County Memorial Library System, or Fort Bend County Libraries, just to name a few.

These are additional services and partnerships that Texas public libraries commonly provide, per the survey results:

  • 93 percent provide voter registration and/or serve as voting locations
  • 84 percent provide partnerships with local social services agencies
  • 82 percent provide job application assistance
  • 68 percent facilitate applications for government benefits
  • 38 percent provide on-site social services
  • 30 percent provide telehealth rooms and/or resources
"Public libraries are practical, welcoming and rooted in the communities they serve — they are unmistakably Texan," said Texas Library Association executive director Shirley Robinson in a press release. "This study puts a dollar value on the opportunities libraries create every day. Whether someone visits a library to apply for a job, access the internet, learn a new skill or simply find a new favorite book, those services create real value for Texans and their communities."

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This article first appeared on CultureMap.com.

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