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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New report shows surge in startup activity in Houston and across Texas

by the numbers

Houston and the rest of Texas are experiencing a boom in the creation of startups.

One barometer of growth in startup activity: The Houston metro area saw a 92 percent rise from 2024 to 2025 in the number of account applications submitted to Bluevine, a banking platform for small businesses.

New data from Bluevine also shows healthy year-over-year growth in account applications submitted by entrepreneurs in Texas’ three other major metros:

  • 242 percent growth in the San Antonio area
  • 153 percent growth in the Austin area
  • 28 percent growth in Dallas-Fort Worth

Further evidence of Texas’ uptick in business creation comes from a new state-by-state analysis of U.S. Census Bureau data by digital mailbox provider iPostal1.

From 2019 to 2024, the number of new business applications jumped 60 percent in Texas, according to the iPostal1 analysis. Wyoming tops the list, with a five-year growth rate of 216 percent.

“The U.S. has no shortage of ambition, but opportunity isn’t spread evenly,” says Jeff Milgram, founder and CEO of iPostal1. “In states like New York, Florida, and Texas, entrepreneurship is booming — people are starting businesses, taking risks, and finding opportunity.”

“Other states are still catching up,” Milgram adds. “Sometimes it’s access to funding, sometimes local policy, or just the confidence that new ventures will be supported.”

Women own many of the new businesses sprouting in Texas, according to a new analysis of 2024-25 data from the U.S. Small Business Administration. The analysis, done by SimpleTiger, a marketing agency for software-as-a-service (SaaS), shows Texas ranks eighth for the highest concentration of women entrepreneurs (109 per 1,000 female residents) among all states. That rate is three percent higher than the national average.

“Women entrepreneurs are no longer a side story in small business growth; they’re a leading indicator of where local economies are expanding next,” SimplyTiger says. “When women-owned business density is high, it usually signals stronger access to customers, networks, and startup pathways that make it easier to launch and keep going.”

In a December news release, Gov. Greg Abbott highlights Texas’ nation-leading job gains over the past 12 months, driven by employers small and large.

“From innovative startups to Fortune 500 corporations, job-creating businesses invest with confidence in Texas,” Abbott says. “With our strong and growing workforce, we will continue to expand career and technical training programs for better jobs and bigger paycheck opportunities for more Texans.”

Houston poised to add 30,900 new jobs in 2026, forecast says

jobs forecast

Buoyed by the growing health care sector, the Houston metro area will add 30,900 jobs in 2026, according to a new forecast from the Greater Houston Partnership.

The report predicts the Houston area’s health care sector will tack on 14,000 jobs next year, which would make it the No. 1 industry for local job growth. The 14,000 health care jobs would represent 45 percent of the projected 30,900 new jobs. In the job-creation column, the health care industry is followed by:

  • Construction: addition of 6,100 jobs in 2026
  • Public education: Addition of 5,800 jobs
  • Public administration: Addition of 5,000 jobs

At the opposite end of the regional workforce, the administrative support services sector is expected to lose 7,500 jobs in 2026, preceded by:

  • Manufacturing: Loss of 3,400 jobs
  • Oil-and-gas extraction: Loss of 3,200 jobs
  • Retail: Loss of 1,800 jobs

“While current employment growth has moderated, the outlook remains robust and Houston’s broader economic foundation remains strong,” GHP president and CEO Steve Kean said in the report.

“Global companies are choosing to invest in Houston — Eli Lilly, Foxconn, Inventec, and others — because they believe in our workforce and our long-term trajectory,” Kean added. “These commitments reinforce that Houston is a place where companies can scale and where our economy continues to demonstrate its resilience as a major engine for growth and opportunity. These commitments and current prospects we are working on give us confidence in the future growth of our economy.”

The Greater Houston Partnership says that while the 30,900-job forecast falls short of the region’s recent average of roughly 50,000 new jobs per year, it’s “broadly in line with the muted national outlook” for employment gains anticipated in 2026.

“Even so, Houston’s young, skilled workforce and strong pipeline of major new projects should help offset energy sector pressures and keep regional growth on pace with the nation,” the report adds.

The report says that even though the health care sector faces rising insurance costs, which might cause some people to delay or skip medical appointments, and federal changes in Medicare and Medicaid, strong demographic trends in the region will ensure health care remains “a key pillar of Houston’s economy.”

As for the local oil-and-gas extraction industry, the report says fluctuations and uncertainty in the global oil-and-gas market will weigh on the Houston sector in 2026. Furthermore, oil-and-gas layoffs partly “reflect a longer-term trend as companies in the sector move toward greater efficiency using fewer workers to produce similar volumes,” according to the report.

Construction underway on first-of-its-kind 3D-printed community in Houston

Building a Sustainable Future

Houston is putting itself front-and-center to help make sustainable, affordable housing a reality for 80 homeowners in an innovative scalable housing community. Developer Cole Klein Builders has partnered with HiveASMBLD to pioneer what’s touted as the world’s first large-scale, one-of-a-kind, affordable housing development using 3D printing technology — merging robotics, design, and sustainability.

Located across from Sterling Aviation High School, near Hobby Airport, Zuri Gardens will offer 80 two-bedroom, two-bathroom homes of approximately 1,360 square feet, situated in a park-like setting that includes walking trails and a community green space.

Homes in Zuri Gardens will hit the market in early summer of 2026. Final pricing has yet to be determined, but Cole Klein Builders expects it to be in the mid-to-high 200s.

Interestingly, none of the homes will offer garages or driveways, which the developer says will provide a cost savings of $25,000-$40,000 per home. Instead of parking for individual units, 140 parking spaces will be provided.

Each two-story home is comprised of a ground floor printed by HiveASMBLD, using a proprietary low-carbon cement alternative by Eco Material Technologies that promises to enhance strength and reduce CO2 emissions. The hybrid homes will have a second floor built using engineered wood building products by LP Building Solutions. Overall, the homes are designed to be flood, fire, and possibly even tornado-proof.

The "Zuri" in Zuri Gardens is the Swahili word for “beautiful,” a choice that is fitting considering that the parks department will be introducing a five acre park to the project — with 3D-printed pavilions and benches — plus, a three-acre farm is located right across the street. The Garver Heights area is classified as a food desert, which means that access to fresh food is limited. Residents will have access to the farm’s fresh produce, plus opportunities to participate in gardening and nutrition workshops.

zuri gardens 3d-printed housing community First large-scale affordable housing project of 3D-printed homes rises in Houston Zuri Gardens is getting closer to completion. Courtesy rendering

Cole Klein Builders created Zuri Gardens in partnership with the Houston Housing Community Development Department, who provided infrastructure reimbursements for the roads, sewer lines, and water lines. In return, CKB agreed to push the purchase prices for the homes as low as possible.

Zuri Gardens also received $1.8 million dollars from the Uptown Tourism Bond, 34 percent of which must be used with minority-owned small businesses. Qualified buyers must fit a certain area of median income according to HUD guidelines, and homes must be owner-occupied at all times. Zuri Gardens already has an 800-person waitlist.

“They’re trying to bridge that gap to make sure there is a community for the homebuyers who need it — educators, law enforcement, civil workers, etc.,” Cole Klein Builders’ co-principal Vanessa Cole says. “You have to go through a certification process with the housing department to make sure that your income is in alignment for this community. It has been great, and everyone has been really receptive.”

Cole has also brought insurance underwriters to visit the site and to help drive premiums below regular rates for Houston homeowners, as claim risks for one of the 3D homes are extremely low.

Tim Lankau, principal at HiveASMBLD, notes that the 3D hybrid design allows for a more traditional appearance, while having the benefits of a concrete structure: “That’s where the floodwaters would go, that’s where you can hide when there’s a tornado, and that’s where termites would eat. So you get the advantages of it while having a traditionally-framed second floor.”

It’s important to note that Zuri Gardens is not located in a flood prone area, nor did it flood during Hurricane Harvey — being flood-proof is merely a perk of a cement house. The concrete that Eco Material Technologies developed is impervious. The walls are printed into hollow forms, which house rebar, plumbing, and accessible conduits for things like electrical lines and smart house features. Those walls are then filled with a foamcrete product that expands to form a “monolithic concrete wall.”

David McNitt, of Eco Material Technologies, explains that his proprietary concrete is made of PCV, and contains zero Portland cement. Instead, McNitt’s cement is made from coal ash and is 99 percent green (there are a few chemicals added to the ash). Regardless, it’s made from 100 percent waste products.

“This is a product that has really been landfilled before,” says McNitt. “It’s coal ash, and it’ll set within 8-10 minutes. It’s all monolithic, and one continuous pour — it’s literally all one piece.”

Eco Material Technologies’ concrete product is impressively durable. A traditional cinderblock wall will crush at around 800 psi, while this material crushes at about 8,000 psi.

“It’s ten times stronger than a cinderblock wall that can withstand hurricanes,” claims McNitt. “I don’t think you’d even notice a hurricane. It’ll be really quiet inside, too — so you won’t get interrupted during your hurricane party. It’s way over-engineered, it really is.”

The second story is built using weatherproof and eco-friendly products by LP Building Solutions. Their treated, engineered wood products come with a 50 year warranty, and their radiant barrier roof decking product blocks 97% of UV rays, and keeps attic temperatures 30° cooler than traditional building materials. These materials, combined with the concrete first floor, will keep heating and cooling costs low — something the folks at HiveASMBLD refer to as “thermal mass performance.”

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This article originally appeared on CultureMap.com.