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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3 Houston innovators who made headlines in May 2025

Innovators to Know

Editor's note: Houston innovators are making waves this month with revolutionary VC funding, big steps towards humanoid robotics, and software that is impacting the agriculture sector. Here are three Houston innovators to know right now.

Zach Ellis, founder and partner of South Loop Ventures

Zach Ellis. Photo via LinkedIn

Zach Ellis Jr., founder and general partner of South Loop Ventures, says the firm wants to address the "billion-dollar blind spot" of inequitable distribution of venture capital to underrepresented founders of color. The Houston-based firm recently closed its debut fund for more than $21 million. Learn more.

Ty Audronis, CEO and founder of Tempest Droneworx

Ty Audronis, CEO and founder of Tempest Droneworx

Ty Audronis, center. Photo via LinkedIn.

Ty Audronis and his company, Tempest Droneworx, made a splash at SXSW Interactive 2025, winning the Best Speed Pitch award at the annual festival. The company is known for it flagship product, Harbinger, a software solution that agnostically gathers data at virtually any scale and presents that data in easy-to-understand visualizations using a video game engine. Audronis says his company won based on its merits and the impact it’s making and will make on the world, beginning with agriculture. Learn more.

Nicolaus Radford, CEO of Persona AI

Nicolaus Radford, founder and CEO of Nauticus RoboticsNicolaus Radford. Image via LinkedIn

Houston-based Persona AI and CEO Nicolaus Radford continue to make steps toward deploying a rugged humanoid robot, and with that comes the expansion of its operations at Houston's Ion. Radford and company will establish a state-of-the-art development center in the prominent corner suite on the first floor of the building, with the expansion slated to begin in June. “We chose the Ion because it’s more than just a building — it’s a thriving innovation ecosystem,” Radford says. Learn more.

Pharmaceutical giant plans $5.9B Houston facility and more news to know

Trending News

Editor's note: It's time to look back at the top Houston innovation news from the second half of May 2025. From exciting VC raises to major manufacturing facilities in the works, here are the most-read InnovationMap stories from May 16-30.

1. Pharmaceutical giant looks to bring $5.9 billion facility to Houston

Eli Lilly is looking to build an active pharmaceutical ingredient manufacturing facility at Generation Park. Rendering courtesy of McCord

Pharmaceutical company Eli Lilly and Company is looking to build a $5.9 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, according to a recent filing with the state of Texas.

The proposal states that the project plans to employ 604 full-time direct employees at the site upon ramp-up completion. Construction is projected to begin in 2026, with a completion target of 2030 and commercial operations beginning in 2031. Continue reading.

2. Houston VC firm closes $21M fund for underrepresented founders

Zach Ellis, founder and general partner of South Loop Ventures, which recently closed its debut fund. Photo via LinkedIn

Houston-based South Loop Ventures recently closed its debut fund for more than $21 million, led by investments from Rice Management Company and Chevron Technology Ventures.

The funds will go toward teams with at least one underrepresented founder of color working in the energy, health, space, sports and fintech sectors. Additional investments came from The Great Commission Foundation of the Episcopal Diocese of Texas, Texas CapitalBank and others organizations. Continue reading.

3. Houston-founded startup raises $1.2M and moves headquarters to Detroit

ChurchSpace, founded in Houston by Day Edwards and Emmanuel Brown, is moving to Detroit. Photo courtesy ChurchSpace.

Houston-founded ChurchSpace, known as the Airbnb for churches, has formed an official partnership with the City of Detroit and will relocate its headquarters.

The announcements come as the company successfully closed a $1.2 million oversubscribed funding round. The round was led by California-based Black Ops Ventures, with participation from Michigan Rise and Dug Song of Minor Capital, who is also the founder of the Song Foundation, another Michigan-based organization. Continue reading.

4. Houston aerospace co. soars with first U.S. test flight of hypersonic engine

Venus Aerospace successfully completed the flight test of its hypersonic engine, the first of an American-developed engine of its kind. Photo courtesy Venus Aerospace

Houston-based Venus Aerospace successfully completed the first U.S. flight test of its proprietary engine at a demonstration at Spaceport America in New Mexico.

Venus’ next-generation rotating detonation rocket engine (RDRE) is supported by a $155,908 federal Small Business Innovation Research (SBIR) grant from NASA and aims to enable vehicles to travel four to six times the speed of sound from a conventional runway. The recent flight test was the first of an American-developed engine of its kind. Continue reading.

5. Houston regenerative medicine company expands lab for future trials

FibroBiologics has opened a new 10,000-square-foot Houston lab to scale up research efforts and pave the way for in-house manufacturing. Photo via Fibrobiologics.com

A Houston regenerative medicine company has unveiled new laboratory space with the goal of expanding its pioneering science.

FibroBiologics uses fibroblasts, the body’s most common type of cell, rather than stem cells, to help grow new cells. With its new space, the publicly traded company, which has more than 240 patents issued or pending, will be even better equipped to power forward with its research. Continue reading.

Houston university to launch artificial intelligence major, one of first in nation

BS in AI

Rice University announced this month that it plans to introduce a Bachelor of Science in AI in the fall 2025 semester.

The new degree program will be part of the university's department of computer science in the George R. Brown School of Engineering and Computing and is one of only a few like it in the country. It aims to focus on "responsible and interdisciplinary approaches to AI," according to a news release from the university.

“We are in a moment of rapid transformation driven by AI, and Rice is committed to preparing students not just to participate in that future but to shape it responsibly,” Amy Dittmar, the Howard R. Hughes Provost and executive vice president for academic affairs, said in the release. “This new major builds on our strengths in computing and education and is a vital part of our broader vision to lead in ethical AI and deliver real-world solutions across health, sustainability and resilient communities.”

John Greiner, an assistant teaching professor of computer science in Rice's online Master of Computer Science program, will serve as the new program's director. Vicente Ordóñez-Román, an associate professor of computer science, was also instrumental in developing and approving the new major.

Until now, Rice students could study AI through elective courses and an advanced degree. The new bachelor's degree program opens up deeper learning opportunities to undergrads by blending traditional engineering and math requirements with other courses on ethics and philosophy as they relate to AI.

“With the major, we’re really setting out a curriculum that makes sense as a whole,” Greiner said in the release. “We are not simply taking a collection of courses that have been created already and putting a new wrapper around them. We’re actually creating a brand new curriculum. Most of the required courses are brand new courses designed for this major.”

Students in the program will also benefit from resources through Rice’s growing AI ecosystem, like the Ken Kennedy Institute, which focuses on AI solutions and ethical AI. The university also opened its new AI-focused "innovation factory," Rice Nexus, earlier this year.

“We have been building expertise in artificial intelligence,” Ordóñez-Román added in the release. “There are people working here on natural language processing, information retrieval systems for machine learning, more theoretical machine learning, quantum machine learning. We have a lot of expertise in these areas, and I think we’re trying to leverage that strength we’re building.”

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