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-based lunar mission's rocky landing and what it means for America's return to the moon

houston, we have a problem

A private U.S. lunar lander tipped over at touchdown and ended up on its side near the moon’s south pole, hampering communications, company officials said Friday.

Intuitive Machines initially believed its six-footed lander, Odysseus, was upright after Thursday's touchdown. But CEO Steve Altemus said Friday the craft “caught a foot in the surface," falling onto its side and, quite possibly, leaning against a rock. He said it was coming in too fast and may have snapped a leg.

“So far, we have quite a bit of operational capability even though we’re tipped over," he told reporters.

But some antennas were pointed toward the surface, limiting flight controllers' ability to get data down, Altemus said. The antennas were stationed high on the 14-foot (4.3-meter) lander to facilitate communications at the hilly, cratered and shadowed south polar region.

Odysseus — the first U.S. lander in more than 50 years — is thought to be within a few miles (kilometers) of its intended landing site near the Malapert A crater, less than 200 miles (300 kilometers) from the south pole. NASA, the main customer, wanted to get as close as possible to the pole to scout out the area before astronauts show up later this decade.

NASA's Lunar Reconnaissance Orbiter will attempt to pinpoint the lander's location, as it flies overhead this weekend.

With Thursday’s touchdown, Intuitive Machines became the first private business to pull off a moon landing, a feat previously achieved by only five countries. Japan was the latest country to score a landing, but its lander also ended up on its side last month.

Odysseus' mission was sponsored in large part by NASA, whose experiments were on board. NASA paid $118 million for the delivery under a program meant to jump-start the lunar economy.

One of the NASA experiments was pressed into service when the lander's navigation system did not kick in. Intuitive Machines caught the problem in advance when it tried to use its lasers to improve the lander's orbit. Otherwise, flight controllers would not have discovered the failure until it was too late, just five minutes before touchdown.

“Serendipity is absolutely the right word,” mission director Tim Crain said.

It turns out that a switch was not flipped before flight, preventing the system's activation in space.

Launched last week from Florida, Odysseus took an extra lap around the moon Thursday to allow time for the last-minute switch to NASA's laser system, which saved the day, officials noted.

Another experiment, a cube with four cameras, was supposed to pop off 30 seconds before touchdown to capture pictures of Odysseus’ landing. But Embry-Riddle Aeronautical University’s EagleCam was deliberately powered off during the final descent because of the navigation switch and stayed attached to the lander.

Embry-Riddle's Troy Henderson said his team will try to release EagleCam in the coming days, so it can photograph the lander from roughly 26 feet (8 meters) away.

"Getting that final picture of the lander on the surface is still an incredibly important task for us,” Henderson told The Associated Press.

Intuitive Machines anticipates just another week of operations on the moon for the solar-powered lander — nine or 10 days at most — before lunar nightfall hits.

The company was the second business to aim for the moon under NASA's commercial lunar services program. Last month, Pittsburgh's Astrobotic Technology gave it a shot, but a fuel leak on the lander cut the mission short and the craft ended up crashing back to Earth.

Until Thursday, the U.S. had not landed on the moon since Apollo 17's Gene Cernan and Harrison Schmitt closed out NASA's famed moon-landing program in December 1972. NASA's new effort to return astronauts to the moon is named Artemis after Apollo's mythological twin sister. The first Artemis crew landing is planned for 2026 at the earliest.

3 female Houston innovators to know this week

who's who

Editor's note: Welcome to another Monday edition of Innovators to Know. Today I'm introducing you to three Houstonians to read up about — three individuals behind recent innovation and startup news stories in Houston as reported by InnovationMap. Learn more about them and their recent news below by clicking on each article.

Emma Konet, co-founder and CTO of Tierra Climate

Emma Konet, co-founder and CTO of Tierra Climate, joins the Houston Innovators Podcast. Photo via LinkedIn

If the energy transition is going to be successful, the energy storage space needs to be equipped to support both the increased volume of energy needed and new energies. And Emma Konet and her software company, Tierra Climate, are targeting one part of the equation: the market.

"To me, it's very clear that we need to build a lot of energy storage in order to transition the grid," Konet says on the Houston Innovators Podcast. "The problems that I saw were really on the market side of things." Read more.

Cindy Taff, CEO of Sage Geosystems

Houston-based Sage Geosystems announced the first close of $17 million round led by Chesapeake Energy Corp. Photo courtesy of Sage

A Houston geothermal startup has announced the close of its series A round of funding.

Houston-based Sage Geosystems announced the first close of $17 million round led by Chesapeake Energy Corp. The proceeds aim to fund its first commercial geopressured geothermal system facility, which will be built in Texas in Q4 of 2024. According to the company, the facility will be the first of its kind.

“The first close of our Series A funding and our commercial facility are significant milestones in our mission to make geopressured geothermal system technologies a reality,” Cindy Taff, CEO of Sage Geosystems, says. Read more.

Clemmie Martin, chief of staff at The Cannon

With seven locations across the Houston area, The Cannon's digital technology allows its members a streamlined connection. Photo courtesy of The Cannon

After collaborating over the years, The Cannon has acquired a Houston startup's digital platform technology to become a "physical-digital hybrid" community.

Village Insights, a Houston startup, worked with The Cannon to create and launch its digital community platform Cannon Connect. Now, The Cannon has officially acquired the business. The terms of the deal were not disclosed.

“The integration of a world-class onsite member experience and Cannon Connect’s superior virtual resource network creates a seamless, streamlined environment for member organizations,” Clemmie Martin, The Cannon’s newly appointed chief of staff, says in the release. “Cannon Connect and this acquisition have paved new pathways to access and success for all.” Read more.

Texas organization grants $68.5M to Houston institutions for recruitment, research

Three prominent institutions in Houston will be able to snag a trio of high-profile cancer researchers thanks to $12 million in new funding from the Cancer Prevention and Research Institute of Texas.

The biggest recruitment award — $6 million — went to the University of Texas MD Anderson Center to lure researcher Xiling Shen away from the Terasaki Institute for Biomedical Innovation in Los Angeles.

Shen is chief scientific officer at the nonprofit Terasaki Institute. His lab there studies precision medicine, including treatments for cancer, from a “systems biology perspective.”

He also is co-founder and former CEO of Xilis, a Durham, North Carolina-based oncology therapy startup that raised $70 million in series A funding in 2021. Before joining the institute in 2021, the Stanford University graduate was an associate professor at Duke University in Durham.

Shen and Xilis aren’t strangers to MD Anderson.

In 2023, MD Anderson said it planned to use Xilis’ propriety MicroOrganoSphere (MOS) technology for development of novel cancer therapies.

“Our research suggests the MOS platform has the potential to offer new capabilities and to improve the efficiency of developing innovative drugs and cell therapies over current … models, which we hope will bring medicines to patients more quickly,” Shen said in an MD Anderson news release.

Here are the two other Cancer Prevention and Research Institute of Texas (CPRIT) awards that will bring noted cancer researchers to Houston:

  • $4 million to attract David Sarlah to Rice University from the University of Illinois, where he is an associate professor of chemistry. Sarlah’s work includes applying the principles of chemistry to creation of new cancer therapies.
  • $2 million to lure Vishnu Dileep to the Baylor College of Medicine from the Massachusetts Institute of Technology (MIT), where he is a postdoctoral fellow. His work includes the study of cancer genomes.

CPRIT also handed out more than $56.5 million in grants and awards to seven institutions in the Houston area. Here’s the rundown:

  • MD Anderson Cancer Center — Nearly $25.6 million
  • Baylor College of Medicine — Nearly $11.5 million
  • University of Texas Health Science Center at Houston — More than $6 million
  • Rice University — $4 million
  • University of Texas Medical Branch at Galveston — More than $3.5 million
  • Methodist Hospital Research Institute — More than $3.3 million
  • University of Houston — $1.4 million

Dr. Pavan Reddy, a CPRIT scholar who is a professor at the Baylor College of Medicine and director of its Dan L Duncan Comprehensive Cancer Care Center, says the CPRIT funding “will help our investigators take chances and explore bold ideas to make innovative discoveries.”

The Houston-area funding was part of nearly $99 million in grants and awards that CPRIT recently approved.