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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Houston team develops low-cost device to treat infants with life-threatening birth defect

infant innovation

A team of engineers and pediatric surgeons led by Rice University’s Rice360 Institute for Global Health Technologies has developed a cost-effective treatment for infants born with gastroschisis, a congenital condition in which intestines and other organs are developed outside of the body.

The condition can be life-threatening in economically disadvantaged regions without access to equipment.

The Rice-developed device, known as SimpleSilo, is “simple, low-cost and locally manufacturable,” according to the university. It consists of a saline bag, oxygen tubing and a commercially available heat sealer, while mimicking the function of commercial silo bags, which are used in high-income countries to protect exposed organs and gently return them into the abdominal cavity gradually.

Generally, a single-use bag can cost between $200 and $300. The alternatives that exist lack structure and require surgical sewing. This is where the SimpleSilo comes in.

“We focused on keeping the design as simple and functional as possible, while still being affordable,” Vanshika Jhonsa said in a news release. “Our hope is that health care providers around the world can adapt the SimpleSilo to their local supplies and specific needs.”

The study was published in the Journal of Pediatric Surgery, and Jhonsa, its first author, also won the 2023 American Pediatric Surgical Association Innovation Award for the project. She is a recent Rice alumna and is currently a medical student at UTHealth Houston.

Bindi Naik-Mathuria, a pediatric surgeon at UTMB Health, served as the corresponding author of the study. Rice undergraduates Shreya Jindal and Shriya Shah, along with Mary Seifu Tirfie, a current Rice360 Global Health Fellow, also worked on the project.

In laboratory tests, the device demonstrated a fluid leakage rate of just 0.02 milliliters per hour, which is comparable to commercial silo bags, and it withstood repeated disinfection while maintaining its structure. In a simulated in vitro test using cow intestines and a mock abdominal wall, SimpleSilo achieved a 50 percent reduction of the intestines into the simulated cavity over three days, also matching the performance of commercial silo bags. The team plans to conduct a formal clinical trial in East Africa.

“Gastroschisis has one of the biggest survival gaps from high-resource settings to low-resource settings, but it doesn’t have to be this way,” Meaghan Bond, lecturer and senior design engineer at Rice360, added in the news release. “We believe the SimpleSilo can help close the survival gap by making treatment accessible and affordable, even in resource-limited settings.”

Texas among 5 hardest working states and more innovation news to know

Trending News

Editor's note: As we look back at the top Houston innovation news for the first half of September, reports show that Texas is one of the hardest working states, while local startup activity has slowed down. Plus, exciting medical innovation advancements. Here are the most-read InnovationMap stories from September 1-14.

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

Texas is home to some of the hardest workers. Photo via Getty Images

It's no secret that Texans are hardworking people. To align with the recent 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. Continue reading.

2. UH receives $1M grant to advance research on rare pediatric disorder

The Cynthia and George Mitchell Foundation has granted $1.1M to the University of Houston to support research on Usher Syndrome. Photo courtesy University of Houston.

The University of Houston has received a two-year, $1.1 million gift from the Cynthia and George Mitchell Foundation to advance research on a rare genetic disorder that can lead to both deafness and blindness in children, known as Usher Syndrome. The current grant will support the research of UH biomedical engineering professors Muna Naash and Muayyad Al-Ubaidi, who work in the Laboratory for Retinal Molecular and Cellular Biology and Gene Therapy in the Cullen College of Engineering. Continue reading.

3. Houston's surge in new startups cools since pandemic peak, study shows

Startup applications in Houston have dipped since their 2021 peak, even as national entrepreneurship hits record highs, according to a new report from The Kaplan Group. Photo via Getty Images.

Startup activity in the Houston metro area has dipped since its pandemic peak, according to a new study. Dating back to 2005, the volume of applications to form new businesses in the Houston area hit its highest level in 2021 (151,804). Since then, though, the application volume has fallen, according to the study, conducted by business debt collection agency The Kaplan Group. Continue reading.

4. TMC lands $3M grant to launch cancer device accelerator

Recent funding from CPRIT will help launch the new Accelerator for Cancer Medical Devices. Photo via TMC

A new business accelerator at Houston’s Texas Medical Center has received a nearly $3 million grant from the Cancer Prevention and Research Institute of Texas. The CPRIT grant, awarded to the Texas Medical Center Foundation, will help launch the Accelerator for Cancer Medical Devices. The accelerator will support emerging innovators in developing prototypes for cancer-related medical devices and advancing them from prototype to clinical trials. Continue reading.

5. 10 Houston billionaires make Forbes' list of richest Americans in 2025

Pictured: Nancy and Richard Kinder, the richest Houstonian, according to the Forbes 400. Photo by Michelle Watson/Catchlight Group

America's wealthiest billionaires are $1.2 trillion richer in 2025, bringing their collective worth to a staggering $6.6 trillion. And Houston's own Richard Kinder has become the richest billionaire in the city, according to the new Forbes 400. The Kinder Morgan chairman is the 11th richest Texas resident and ranks as the 108th richest American. Kinder also dethroned Tilman Fertitta to claim the title as the wealthiest Houstonian. The annual Forbes 400 list is a definitive ranking of the wealthiest Americans, using interviews, financial data, and documentation provided by billionaires and their companies. Continue reading.

Oxy's $1.3B Texas carbon capture facility on track to​ launch this year

gearing up

Houston-based Occidental Petroleum is gearing up to start removing CO2 from the atmosphere at its $1.3 billion direct air capture (DAC) project in the Midland-Odessa area.

Vicki Hollub, president and CEO of Occidental, said during the company’s recent second-quarter earnings call that the Stratos project — being developed by carbon capture and sequestration subsidiary 1PointFive — is on track to begin capturing CO2 later this year.

“We are immensely proud of the achievements to date and the exceptional record of safety performance as we advance towards commercial startup,” Hollub said of Stratos.

Carbon dioxide captured by Stratos will be stored underground or be used for enhanced oil recovery.

Oxy says Stratos is the world’s largest DAC facility. It’s designed to pull 500,000 metric tons of carbon dioxide from the air and either store it underground or use it for enhanced oil recovery. Enhanced oil recovery extracts oil from unproductive reservoirs.

Most of the carbon credits that’ll be generated by Stratos through 2030 have already been sold to organizations such as Airbus, AT&T, All Nippon Airways, Amazon, the Houston Astros, the Houston Texans, JPMorgan, Microsoft, Palo Alto Networks and TD Bank.

The infrastructure business of investment manager BlackRock has pumped $550 million into Stratos through a joint venture with 1PointFive.

As it gears up to kick off operations at Stratos, Occidental is also in talks with XRG, the energy investment arm of the United Arab Emirates-owned Abu Dhabi National Oil Co., to form a joint venture for the development of a DAC facility in South Texas. Occidental has been awarded up to $650 million from the U.S. Department of Energy to build the South Texas DAC hub.

The South Texas project, to be located on the storied King Ranch, will be close to industrial facilities and energy infrastructure along the Gulf Coast. Initially, the roughly 165-square-mile site is expected to capture 500,000 metric tons of carbon dioxide per year, with the potential to store up to 3 billion metric tons of CO2 per year.

“We believe that carbon capture and DAC, in particular, will be instrumental in shaping the future energy landscape,” Hollub said.

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

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