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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Health tech startup launches Houston study improve stroke patients recovery

now enrolling

A Houston-born company is enrolling patients in a study to test the efficacy of nerve stimulation to improve outcomes for stroke survivors.

Dr. Kirt Gill and Joe Upchurch founded NeuraStasis in 2021 as part of the TMC Biodesign fellowship program.

“The idea for the company manifested during that year because both Joe and I had experiences with stroke survivors in our own lives,” Gill tells InnovationMap. It began for Gill when his former college roommate had a stroke in his twenties.

“It’s a very unpredictable, sudden disease with ramifications not just for my best friend but for everyone in his life. I saw what it did to his family and caregivers and it's one of those things that doesn't have as many solutions for people to continue recovery and to prevent damage and that's an area that I wanted to focus myself on in my career,” Gill explains.

Gill and Upchurch arrived at the trigeminal and vagus nerves as a potential key to helping stroke patients. Gill says that there is a growing amount of academic literature that talks about the efficacy of stimulating those nerves. The co-founders met Dr. Sean Savitz, the director of the UTHealth Institute for Stroke and Cerebrovascular Diseases, during their fellowship. He is now their principal investigator for their clinical feasibility study, located at his facility.

The treatment is targeted for patients who have suffered an ischemic stroke, meaning that it’s caused by a blockage of blood flow to the brain.

“Rehabilitation after a stroke is intended to help the brain develop new networks to compensate for permanently damaged areas,” Gill says. “But the recovery process typically slows to essentially a standstill or plateau by three to six months after that stroke. The result is that the majority of stroke survivors, around 7.6 million in the US alone, live with a form of disability that prevents complete independence afterwards.”

NeuraStasis’ technology is intended to help patients who are past that window. They accomplish that with a non-invasive brain-stimulation device that targets the trigeminal and vagus nerves.

“Think of it kind of like a wearable headset that enables stimulation to be delivered, paired to survivors going through rehabilitation action. So the goal here is to help reinforce and rewire networks as they're performing specific tasks that they're looking to improve upon,” Gill explains.

The study, which hopes to enroll around 25 subjects, is intended to help people with residual arm and hand deficits six months or more after their ischemic stroke. The patients enrolled will receive nerve stimulation three times a week for six weeks. It’s in this window that Gill says he hopes to see meaningful improvement in patients’ upper extremity deficits.

Though NeuraStasis currently boasts just its two co-founders as full-time employees, the company is seeing healthy growth. It was selected for a $1.1 million award from the National Institutes of Health through its Blueprint MedTech program. The award was funded by the National Institute of Neurological Disorders and Stroke. The funding furthers NeuraStasis’ work for two years, and supports product development for work on acute stroke and for another product that will aid in emergency situations.

Gill says that he believes “Houston has been tailor-made for medical healthcare-focused innovation.”

NeuraStasis, he continues, has benefited greatly from its advisors and mentors from throughout the TMC, as well as the engineering talent from Rice, University of Houston and Texas A&M. And the entrepreneur says that he hopes that Houston will benefit as much from NeuraStasis’ technology as the company has from its hometown.

“I know that there are people within the community that could benefit from our device,” he says.

Texas Space Commission launches, Houston execs named to leadership

future of space

Governor Greg Abbott announced the Texas Space Commission, naming its inaugural board of directors and Texas Aerospace Research and Space Economy Consortium Executive Committee.

The announcement came at NASA's Johnson Space Center, and the governor was joined by Speaker Dade Phelan, Representative Greg Bonnen, Representative Dennis Paul, NASA's Johnson Space Center Director Vanessa Wyche, and various aerospace industry leaders.

According to a news release, the Texas Space Commission will aim to strengthen commercial, civil, and military aerospace activity by promoting innovation in space exploration and commercial aerospace opportunities, which will include the integration of space, aeronautics, and aviation industries as part of the Texas economy.

The Commission will be governed by a nine-member board of directors. The board will also administer the legislatively created Space Exploration and Aeronautics Research Fund to provide grants to eligible entities.

“Texas is home to trailblazers and innovators, and we have a rich history of traversing the final frontier: space,” Lieutenant Governor Dan Patrick says in a news release. “Texas is and will continue to be the epicenter for the space industry across the globe, and I have total confidence that my appointees to the Texas Space Commission Board of Directors and the Texas Aerospace Research and Space Economy Consortium Executive Committee will ensure the Texas space industry remains an international powerhouse for cutting-edge space innovation.”

TARSEC will independently identify research opportunities that will assist the state’s position in aeronautics research and development, astronautics, space commercialization, and space flight infrastructure. It also plans to fuel the integration of space, aeronautics, astronautics, and aviation industries into the Texas economy. TARSEC will be governed by an executive committee and will be composed of representatives of each higher education institution in the state.

“Since its very inception, NASA’s Johnson Space Center has been home to manned spaceflight, propelling Texas as the national leader in the U.S. space program,” Abbott says during the announcement. “It was at Rice University where President John F. Kennedy announced that the U.S. would put a man on the moon—not because it was easy, but because it was hard.

"Now, with the Texas Space Commission, our great state will have a group that is responsible for dreaming and achieving the next generation of human exploration in space," he continues. "Texas is the launchpad for Mars, innovating the technology that will colonize humanity’s first new planet. As we look into the future of space, one thing is clear: those who reach for the stars do so from the great state of Texas. I look forward to working with the Texas Space Commission, and I thank the Texas Legislature for partnering with industry and higher education institutions to secure the future of Texas' robust space industry."

The Houston-area board of directors appointees included:

  • Gwen Griffin, chief executive officer of the Griffin Communications Group
  • John Shannon, vice president of Exploration Systems at the Boeing Company
  • Sarah "Sassie" Duggleby, co-founder and CEO of Venus Aerospace
  • Kirk Shireman, vice president of Lunar Exploration Campaigns at Lockheed Martin
  • Dr. Nancy Currie-Gregg, director of the Texas A&M Space Institute

Additionally, a few Houstonians were named to the TARSEC committee, including:

  • Stephanie Murphy, CEO and executive chairman of Aegis Aerospace
  • Matt Ondler, president and former chief technology officer at Axiom Space
  • Jack “2fish” Fischer, vice president of production and operations at Intuitive Machines
  • Brian Freedman, president of the Bay Area Houston Economic Partnership and vice chairman of Wellby Financial
  • David Alexander, professor of physics and astronomy and director of the Rice Space Institute at Rice University

To see the full list of appointed board and committee members, along with their extended bios, click here.