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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6 Houstonians named to prestigious national group of inventors

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Six Houston scientists and innovation leaders have been named to the National Academy of Inventors’ newest class of fellows. The award is the highest professional distinction awarded to academic inventors by the NAI.

The 2025 class is made up of 169 fellows who hold more than 5,300 U.S. patents, according to the organization. The group hails from 127 institutions across 40 U.S. states.

The Houston-based inventors are leading fields from AI to chemistry to cancer research.

“NAI Fellows are a driving force within the innovation ecosystem, and their contributions across scientific disciplines are shaping the future of our world,” Paul R. Sanberg, president of the National Academy of Inventors, said in a news release. “We are thrilled to welcome this year’s class of Fellows to the Academy. They are truly an impressive cohort, and we look forward to honoring them at our 15th Annual Conference in Los Angeles next year.”

The 2025 list of Houston-based fellows includes:

  • Vineet Gupta, Vice President for Innovation, Technology Development and Transfer at the University of Texas Medical Branch
  • Eva Harth, chemistry professor at the University of Houston
  • Dr. Raghu Kalluri, Professor and Chairman of the Department of Cancer Biology at The University of Texas MD Anderson Cancer Center
  • Sanjoy Paul, Executive Director of Rice Nexus and AI Houston and Associate Vice President for Technology Development at Rice University
  • Dr. Jochen Reiser, President of the University of Texas Medical Branch and CEO of UTMB Health System
  • Todd Rosengart, Professor and Chair of the Department of Surgery at Baylor College of Medicine

"It is a great honor to be named a Fellow of the NAI. It is deeply gratifying to know that the work my students and I do — the daily push, often in small steps — is seen and recognized," Harth added in a news release from UH.

The 2025 fellows will be honored and presented with their medals by a senior official of the United States Patent and Trademark Office at the NAI Annual Conference this summer in Los Angeles.

Innovative Houston research leads our top health tech news of 2025

year in review

Editor's note: As 2025 comes to a close, we're looking back at the stories that defined Houston innovation this year. The Bayou City continued to grow as a health tech hub, bringing in a multibillion-dollar pharmaceutical development, playing home based to startups developing innovative treatment options and attracting leading researchers and professionals to the city. Here are the 10 most-read Houston health tech stories of the year:

Houston Nobel Prize nominee earns latest award for public health research

Dr. Peter Hotez with Dr. Maria Elena Bottazzi. Photo courtesy of TMC

Houston vaccine scientist Dr. Peter Hotez is no stranger to impressive laurels. In 2022, he was nominated for a Nobel Peace Prize for his low-cost COVID vaccine.

His first big win of 2025 was this year’s Hill Prize, awarded by the Texas Academy of Medicine, Engineering, Science and Technology (TAMEST). Hotez and his team were selected to receive $500,000 from Lyda Hill Philanthropies to help fund The Texas Virosphere Project, which aims to create a predictive disease atlas relating to climate disasters. Rice University researchers are collaborating with Hotez and his team on a project that combines climate science and metagenomics to access 3,000 insect genomes. The goal is to aid health departments in controlling disease and informing policy. Continue reading.

U.S. News ranks Houston hospital No. 1 in Texas for 14th year in a row

Houston Methodist is once again the top hospital in Texas. Photo via Houston Methodist

U.S. News & World Report's 2025 rankings of the best hospitals in Texas prove that Houston is in good hands.

The esteemed Houston Methodist Hospital was rated the No. 1 best hospital in Texas for the 14th consecutive year, and the No. 1 hospital in the metro area. Eleven more Houston-area hospitals earned spots among the statewide top 35. Continue reading.

Eli Lilly to build $6.5B pharmaceutical factory at Generation Park

Eli Lilly is expected to bring a $6.5 billion manufacturing facility to Houston by 2030. Rendering courtesy Greater Houston Partnership.

Pharmaceutical giant Eli Lilly and Co. plans to build a $6.5 billion manufacturing plant at Houston’s Generation Park. More than 300 locations in the U.S. competed for the factory.

The Houston site will be the first major pharmaceutical manufacturing plant in Texas, according to the Greater Houston Partnership. Lilly said it plans to hire 615 full-time workers for the 236-acre plant, including engineers, scientists and lab technicians. The company will collaborate with local colleges and universities to help build its talent pipeline. Continue reading.

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.

Houston-based Nexalin Technology is taking a medicine-free approach to target brain neurologically associated with mental illness. The company's patented, FDA-cleared frequency-based waveform targets key centers of the midbrain. 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.

Nexalin’s proprietary neurostimulation device moved forward with a clinical trial that evaluated its treatment of anxiety disorders and chronic insomnia in Brazil this year and enrolled the first patients in its clinical trial at the University of California, San Diego. Continue reading.

Houston doctor aims to revolutionize hearing aid industry with tiny implant

Houston Methodist's Dr. Ron Moses has created NanoEar, which he calls “the world’s smallest hearing aid.” Photo via Getty Images.

“What is the future of hearing aids?” That’s the question that led to a potential revolution.

Dr. Ron Moses, an ENT specialist and surgeon at Houston Methodist, is the creator of NanoEar, which he calls “the world’s smallest hearing aid.” NanoEar is an implantable device that combines the invisibility of a micro-sized tympanostomy tube with more power—and a superior hearing experience—than the best behind-the-ear hearing aid. Continue reading.

Houston scores $120M in new cancer research and prevention grants

The Cancer Prevention and Research Institute of Texas doled out 73 more grants to health care systems and companies in the state in November. Carter Smith/Courtesy of MD Anderson

The Cancer Prevention and Research Institute of Texas granted more than $120 million to Houston organizations and companies as part of 73 new awards issued statewide this fall. The funds are part of nearly $154 million approved by the CPRIT's governing board, bringing the organization's total investment in cancer prevention and research to more than $4 billion since its inception. A portion of the funding will go toward recruiting leading cancer researchers to Houston. Continue reading.

Digital Health Institute's new exec director aims to lead innovation and commercialization efforts

Pothik Chatterjee was named executive director of Rice University's and Houston Methodist's Digital Health Institute, effective May 1. Photo courtesy Rice University.

The Digital Health Institute, a joint venture between Rice University and Houston Methodist, appointed Pothik Chatterjee to the role of executive director this summer. Chatterjee’s role is to help grow the collaboration between the institutions, but the Digital Health Institute already boasts more than 20 active projects, each of which pairs Rice faculty and Houston Methodist clinicians. Once the research is in place, it’s up to Chatterjee to find commercial opportunities within the research portfolio. Those include everything from hospital-grade medical imaging wearables to the creation of digital twins for patients to help better treat them. Continue reading.

Innovation Labs @ TMC set to launch for early-stage life science startups

Innovation Labs @ TMC will open next year at the TMC Innovation Factory. Photo courtesy JLABS.

The Texas Medical Center announced its plans to launch its new Innovation Labs @ TMC in January 2026 to better support life science startups working within the innovation hub. The 34,000-square-foot space, located in the TMC Innovation Factory at 2450 Holcombe Blvd., will feature labs and life science offices and will be managed by TMC. The expansion will allow TMC to "open its doors to a wider range of life science visionaries." Continue reading.

6 Houston health tech startups making major advancements right now

Tatiana Fofanova and Dr. Desh Mohan, founders of Koda Health. Photo courtesy Koda Health.

The Health Tech Business category in our 2025 Houston Innovation Awards honored innovative startups within the health and medical technology sectors. Six forward-thinking businesses were named finalists for the 2025 award, ranging from an end-of-life care company to others developing devices and systems for heart monitoring, sleep apnea, hearing loss and more. Continue reading or see who won here.

Houston students develop cost-effective glove to treat Parkinson's symptoms

Rice University students Emmie Casey and Tomi Kuye used smartphone motors to develop a vibrotactile glove. Photo by Gustavo Raskosky/ Courtesy Rice University.

Two Rice undergraduate engineering students have developed a non-invasive vibrotactile glove that aims to alleviate the symptoms of Parkinson’s disease through therapeutic vibrations. Emmie Casey and Tomi Kuye developed the project with support from the Oshman Engineering Design Kitchen (OEDK). The team based the design on research from the Peter Tass Lab at Stanford University, which explored how randomized vibratory stimuli delivered to the fingertips could help rewire misfiring neurons in the brain—a key component of Parkinson’s disease. Continue reading.