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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Texas is the 4th hardest working state in America, report finds

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It's no secret that Texans are hardworking people. To align with the Labor Day holiday, a new WalletHub study asserts that the Lone Star State is one of the five most hardworking states in America for 2025.

The report ranked Texas the fourth most hardworking state this year, indicating that its residents are working harder than ever after the state fell into seventh place in 2024. Texas previously ranked No. 4 in 2019 and 2020, slipped into No. 5 in 2021 and 2022, then continued falling into sixth place in 2023. But now the state is making its way back to the top of the list.

WalletHub's analysts compared all 50 states based on "direct" and "indirect" work factors. The six "direct" work factors included each state's average workweek hours, employment rates, the share of households where no adults work, the share of workers leaving vacation time unused, and other data. The four "indirect" work factors consisted of workers' average commute times, the share of workers with multiple jobs, the annual volunteer hours per resident, and the average leisure time spent per day.

North Dakota landed on top as the most hardworking state in America for 2025 for another year in a row, earning a score of 66.17 points out of a possible 100. For comparison, Texas ranked No. 4 with 57.06 points. Alaska (No. 2), South Dakota (No. 3), and Hawaii (No. 5) round out the top five hardest working states.

Across the study's two main categories, Texas ranked No. 5 in the "direct" work factors ranking, and earned a respectable No. 18 rank for its "indirect" work factors.

Broken down further, Texans have the second-longest average workweek hours in America, and they have the 12th best average commute times. Texans have the 6th lowest amount of average leisure time spent per day, the report also found.

According to the study's findings, many Americans nationwide won't take the chance to not work as hard when presented with the opportunity. A 2024 Sorbet PTO report found 33 percent of Americans' paid time off was left unused in 2023.

"While leaving vacation time on the table may seem strange to some people, there are plenty of reasons why workers choose to do so," the report's author wrote. "Some fear that if they take time off they will look less dedicated to the job than other employees, risking a layoff. Others worry about falling behind on their work or are concerned that the normal workflow will not be able to function without them."

The top 10 hardest working states are:

  • No. 1 – North Dakota
  • No. 2 – Alaska
  • No. 3 – South Dakota
  • No. 4 – Texas
  • No. 5 – Hawaii
  • No. 6 – Virginia
  • No. 7 – New Hampshire
  • No. 8 – Wyoming
  • No. 9 – Maryland
  • No. 10 – Nebraska
---

This story originally appeared on CultureMap.com.

Houston co. makes waves in brain health and more innovation news to know

Trending Topics

Editor's note: The top innovation news for the second of half of August includes the Inc. 5000, a big contract from NASA, a new energy accelerator's launch, and innovative brain health treatment. Here are the five most-read InnovationMap stories from August 15-31:

1. How a Houston company is fighting anxiety, insomnia & Alzheimer’s through waveforms

Nexalin develops non-invasive devices that help reset networks in the brain associated with symptoms of anxiety and insomnia. Photo via Getty Images.

A Houston-based company is taking a medicine-free approach to target brain neurologically associated with mental illness. Nexalin Technology’s patented, FDA-cleared frequency-based waveform targets key centers of the midbrain to support the normalization of neurochemicals through a process known as Transcranial Alternating Current Stimulation (tACS). Delivered via a non-invasive device, the treatment gently stimulates the hypothalamus and midbrain, helping to “reset networks associated with symptoms” of anxiety and insomnia. Early clinical evidence suggests this approach can promote healthier brain function and improved sleep. Continue reading.

2. Houston innovation hub announces first cohort for energy-focused accelerator

Alabama-based Accelerate Wind is a member of the COPILOT cohort. Courtesy photo

Energytech Nexus, a Houston-based hub for energy startups, has named its inaugural cohort of 14 companies for the new COPILOT accelerator. The eight-month COPILOT program offers mentorship, training and networking for startups. Program participants will be tasked with developing pilot projects for their innovations. Two Houston startups are members of the first COPILOT class. Continue reading.

3. Houston foundation doles out $700K for Texas chemical research

The Welch Foundation has awarded funding through two of its newest grant programs. Photo via Getty Images.

Houston-based The Welch Foundation has issued $700,000 in additional funding to support chemical research through two of its newest grant programs. The foundation has named the recipients of its Welch eXperimental (WelchX) Collaboration Retreat and Pilot Grants and the Welch Postdoctoral Fellows of the Life Sciences Research Foundation Grants. The WelchX grants were awarded to teams of two Texas researchers who presented "innovative and collaborative ideas" addressing challenges in the clean energy space, according to the foundation. Continue reading.

4. Houston tech company secures $450M NASA contract

Barrios Technology has secured a two-year contract with NASA. Photo via Getty Images.

NASA’s Johnson Space Center awarded Houston-based aerospace technology and engineering services company Barrios Technology the Mission Technical Integration Contract (MTIC). The two-year contract is worth $450 million and will begin Oct. 1, 2025. Barrios will provide technical and management support to some of NASA’s human spaceflight programs, which include the Orion and Gateway programs, the International Space Station (ISS) and possibly more human spaceflight initiatives. Continue reading.

5. Fast-growing Houston tech firm leads dozens of local companies on Inc. 5000

Houston-based Action1 landed at No. 29 nationally and No. 1 in the software category in this year's Inc. 5000 ranking. Photo via Getty Images.

Dozens of Houston-area businesses appear in this year’s Inc. 5000 ranking of the 5,000 fastest-growing private companies in the U.S., with a security software provider capturing the region’s No. 1 spot on the list. Landing at No. 29 nationally and No. 1 in the software category, the top-ranked Houston-area private company is Houston-based Action1. The company recorded median revenue growth of 7,188 percent from 2021 to 2024, according to the Inc. 5000. It’s the first appearance on the Inc. 5000 list for Action1, founded in 2018. Continue reading.

Houston femtech co. debuts new lactation and wellness pods

mom pod

Houston-based femtech company Work&, previously known as Work&Mother, has introduced new products in recent months aimed at supporting working mothers and the overall health of all employees.

The company's new Lactation Pod and Hybrid Pod serve as dual-use lactation and wellness spaces to meet employer demand, the company shared in a news release. The compact pods offer flexible design options that can serve permanent offices and nearly all commercial spaces.

They feature a fully compliant lactation station while also offering wellness functionalities that can support meditation, mental health, telehealth and prayer. In line with Work&'s other spaces, the pods utilize the Work& scheduling platform, which prioritizes lactation bookings to help employers comply with the PUMP Act.

“This isn’t about perks,” Jules Lairson, Work& co-founder and COO, said in the release. “It’s about meeting people where they are—with dignity and intentional design. That includes the mother returning to work, the employee managing anxiety, and everyone in between.”

According to the company, several Fortune 500 companies are already using the pods, and Work& has plans to grow the products' reach.

Earlier this year, Work& introduced its first employee wellness space at MetroNational’s Memorial City Plazas, representing Work&'s shift to offer an array of holistic health and wellness solutions for landlords and tenants.

The company, founded in 2017 by Lairson and CEO Abbey Donnell, was initially focused on outfitting commercial buildings with lactation accommodations for working parents. While Work& still offers these services through its Work&Mother branch, the addition of its Work&Wellbeing arm allowed the company to also address the broader wellness needs of all employees.

The company rebranded as Work& earlier this year.

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