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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Meet the innovator who's leveraging big tech to advance Houston's ecosystem equitably

HOUSTON INNOVATORS PODCAST EPISODE 188

At a glance, Rob Schapiro's resume might not make the most sense. A trained geologist with decades of experience in the energy sector, Schapiro made the move to Microsoft three years ago.

"I saw this disconnect between technology companies and energy companies — they didn't really speak the same language," he says on this week's episode of the Houston Innovators Podcast. "I thought I could help potentially solve this problem and work between the two as a sort of translator."

Now, as Microsoft’s Energy Acceleration Program director and site leader for the company’s Houston office, which is located in the Ion, Schapiro is deeply embedded in Houston's innovation ecosystem and is dedicated to helping advance Houston's role energy transition in a sustainable and equitable way.

Inspired by the murder of George Floyd, Schapiro says he sought out opportunities in his personal life to expand his contribution to the community as an ally, and he became a big brother in Big Brothers Big Sisters. Microsoft, too, is active in supporting the community through partnering with local organizations, including SUPERGirls SHINE Foundation, the G-Unity Foundation Inc., and more.

"This has been one of the most rewarding aspects of my job, that I've had the ability to leverage the might of Microsoft and my own privilege to have an impact on real people," Schapiro says. "Microsoft's mission is to empower every person and every organization on the planet to achieve more, and when you think about how you do that, it's really daunting. We realized that in order to do that, it's going to require a workforce that looks really different than it does today."

Microsoft knows too well the changing workforce, both from a diversity perspective and when it comes to artificial intelligence and other new technology. In its recent Work Trend Index report, the company found that, rather than being afraid of AI replacing jobs, the majority of the workforce is interested in applying AI to mundane tasks.

Schapiro shares more about his view of how AI will affect the workforce, plus what all the energy industry needs to focus on amid the energy transition, on the podcast. He also weighs in on how Houston's innovation ecosystem has evolved and where he hopes it's going. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.

Greentown Houston announces plans for wet lab, calls for feedback from members

seeing green

Greentown Houston has announced it's building a new wet lab facility — but first, they need some help from the community.

Greentown Labs, which is dual located at their headquarters in Somerville, Massachusetts, and in the Ion District in Houston, has announced that they are building out a wet lab in their Midtown space.

"We have heard from several startups as well as corporate partners in the ecosystem that are looking for wet lab space," says Lara Cottingham, vice president of strategy, policy, and climate impact at Greentown Labs. "Greentown has experience running wet labs from our location in Somerville. We're excited to be able to offer wet lab space to climatetech startups as an additional amenity to the Ion District.

Although Greentown's Boston-area location has wet lab space, Cottingham says the organization is not interested in copying and pasting that same facility. Greentown wants to provide the tools that the Houston ecosystem needs, and that requires getting feedback from its current and potential members.

"We want to announce to the community that this is something we're going to build — but we still need a lot of feedback and input from startups so we can learn what exactly they need or want to see from the wet lab," Cottingham tells InnovationMap. "No two wet labs are the same."

Right now, there aren't any details available about timeline or specifics of the new facility. Greentown is prioritizing getting feedback from its members and having conversations with potential sponsors and corporate partners.

"Corporate partners are a big part of the ecosystem and the community at Greentown. They can be so many things to our startups — mentors, customers, investors," Cottingham says. "And in this space, they can help us sponsor and financially support the wet lab. We're still fundraising — we have some partners that have committed to funding, but we're still looking for more funding."

In addition to monetary contribution, Cottingham says they are looking for other options as well, from partnerships with equipment providers, hazardous materials management, and more.

Startups that need wet lab space are encouraged to fill out the online form, which will be open through the summer, and potential corporate partners can express their interest online as well.

Greentown Houston opened its doors in 2021 and has since grown to house more than 75 energy and climatetech startups, as well as several accelerators, thanks to support from dozens of corporate partners.

Recently acquired Houston hospitality tech company continues to expand following fresh funding

tech growth

Houston-based HungerRush, which is a point-of-sale system that includes payment-processing, digital ordering, customer engagement, and delivery management, continues to spread its impact to businesses big and small.

A New York private equity firm, Corsair Capital, saw the potential for the cloud-based POS software and purchased a majority stake in HungerRush last summer. In 2022, HungerRush was on target to reach $100 million in recurring revenue according to The Deal.

HungerRush aims to serve an industry that according to the tech company, 80 percent think technology is the way to go to assist restaurants with labor shortages and other barriers. HungerRush acquired artificial intelligence text ordering app OrderAI, ordering and marketing company 9Fold LLC and Menufy.com over the past two years to grow its reach.

In the first quarter, the company introduced a comprehensive all-in-one POS system bundle designed to meet the needs of independent operators (IOs), with the overall goal of providing a tech stack to transform the experiences of both restaurant staff and customers. Their partnership with Menufy, which helps IOs drive both growth and profitability through an online website and mobile app ordering experience and currently serves over 15,000 restaurants across the US market, has helped to deliver the transformed IO experience to pizza restaurants and our offerings have quickly expanded to serve Vietnamese and Mexican restaurants as well.

One of the businesses seeing the benefits of platforms like HungerRush is Little Pop’s Pizzeria, which is a Naperville, Illinois-based pizza spot that uses the HungerRush to communicate to help the small business keep up with the large demands of the Chicagoland suburbs.The platform’s help has led to substantial business growth.

“Thanks to having 5,000 loyalty program customers stored in HungerRush, we were able to quickly communicate the new curbside pickup and no contact delivery options,” says HungerRush user Mike Nelson of Little Pop’s Pizzeria. “Getting the word out through email and Facebook has increased our business by 75 percent.”

HungerRush continues to flourish in a crowded marketspace, which Chief Revenue Officer Olivier Thierry attributes to the platform’s accessibility to the audience and variety of features.

“While speaking to small business restaurant owners, we continued to hear the unique challenges they faced around having to navigate multiple delivery app interfaces, labor scheduling solutions, and other tools – resulting in many ending the month under their goal quotas, “ Thierry says. “Our tech tools arm our IOs to be able to manage omnichannel ordering, inventory, loyalty programs, and labor scheduling - but most importantly, support them where they need it the most to be successful in today’s digital world.”
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