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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State-of-the-art innovation hub opens in Houston Energy Corridor

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French multinational company Schneider Electric has opened a new 10,500-square-foot, state-of-the-art Energy Innovation Center in Houston.

The new facility is located in Houston’s Energy Corridor and is designed to “foster increased collaboration and technological advancements across the entire value chain,” according to a news release from the company. The new Houston location joins Schneider's existing innovation hubs in Paris, Singapore and Bangalore.

The venue will serve as a training center for process control engineers, production superintendents, manufacturing managers, technical leads and plant operations personnel. It can simulate various real-world scenarios in refineries, combined-cycle power plants, ethylene plants, recovery boilers and chemical reactors.

It includes an interactive control room and artificial Intelligence applications that “highlight the future of industrial automation,” according to the release.

"Digitalization is significantly enhancing the global competitiveness of the U.S. through continuous innovation and increased investment into next-generation technology," Aamir Paul, Schneider Electric's President of North America Operations, said in the release.

Texas has over 4,100 Schneider Electric employees, the most among U.S. states, and has facilities in El Paso, the Dallas-Fort Worth metroplex and other areas.

"This flagship facility in the Energy Capital of the World underscores our commitment to driving the future of software-defined automation for our customers in Houston and beyond,” Paul added in the release. “With this announcement, we are excited to continue supporting the nation's ambitions around competitive, efficient and cost-effective manufacturing."

Schneider Electric says the new Houston facility is part of its expansion plans in the U.S. The company plans to invest over $700 million in its U.S. operations through 2027, which also includes an expansion at its El Paso campus.

The company also announced plans to invest in solar and battery storage systems developed, built, and operated by Houston-based ENGIE North America last year. Read more here.

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This story first appeared on our sister site, EnergyCapitalHTX.com.

9 can't-miss Houston business and innovation events for April

where to be

Two new conferences will launch while another longtime business competition celebrates its 25th anniversary this month in Houston. Plus, there are networking opportunities, family tech events and more.

Here are the Houston business and innovation events you can't miss in April and how to register. Please note: this article might be updated to add more events.

​Ion Block Party: Art Crawl

Network and socialize with other tech enthusiasts and business-minded individuals while taking in the new gallery at Community Artists’ Collective and experiencing the immersive dome at Omnispace360. See work by Joel Zika, who will showcase his digital sculptures through augmented reality screens, and other public art around the Ion while also enjoying food and drink.

This event is Thursday, April 3, from 4-7 p.m. at the Ion. Click here to register.

​CLA Presents: Raising Capital over Happy Hour

Gain a better understanding of the capital-raising process and various funding opportunities at this educational happy hour. Keith Davidson, the market leader for CLA in Dallas and former CFO of ICS, will present.

This event is Thursday, April 10, from 4-6 p.m. at The Cannon. Click here to register.

Rice Business Plan Competition 

The Rice Alliance for Technology and Entrepreneurship will host the 25th annual Rice Business Plan Competition this month. Forty-two student-led teams from around the world, including one team from Rice, will present their plans before more than 300 angel, venture capital, and corporate investors to compete for more than $1 million in prizes.

This event is April 10-12. Stream the Elevator Pitch Competition and Final Round here.

RSVF Annual Conference

The Rice Student Venture Fund will host its first-ever Annual Conference to celebrate the university's entrepreneurial spirit and the rising generation of student-led innovation. The conference will include live startup demos, an RSVF fund update, a keynote fireside chat, a builder-investor panel and networking. RSVF welcomes students, alumni, investors, faculty and staff, and innovators and community members of the broader tech scene.

This event is Monday, April 14, from 4-8 p.m. at the Ion. Click here to register.

​TEX-E Conference

TEX-E will host its inaugural conference this month under the theme "Energy & Entrepreneurship: Navigating the Future of Climate Tech." The half-day conference will feature a keynote from Artemis Energy Partners CEO Bobby Tudor as well as panels with other energy and tech leaders from NRG, Microsoft, GE Vernova and TEB Tech.

This event is Tuesday, April 15, from 1-4:30 p.m. at the Ion. Click here to register.

Houston Methodist Leadership Speaker Series 

Hear from Dr. Jonathan Rogg, Chief Quality Officer and Vice President of Operations at Houston Methodist Hospital and a a practicing emergency medicine physician, at the latest Houston Methodist Leadership Speaker Series. Rogg will present "Leadership from the Bedside to the Boardroom."

This event is on Wednesday, April 23, from 4:45-6 p.m. at the Ion. Click here to register.

Ion Family STEAM Day– Let's Build a Tripwire Alarm

STEAM on Demand will host a hands-on, family-friendly engineering lesson for young ones on the Ion Forum Stairs. Kids will learn to create and test their own working alarm system. The event is geared toward those ages 7 to 14.

This event is Sunday, April 26, from 10 a.m. to noon at the Ion. Click here to register.

 Greentown Houston Fourth Anniversary Transition On Tap

Climatetech incubator Greentown Labs will celebrate its fourth anniversary with a special edition of its signature networking event, Transition On Tap. Entrepreneurs, investors, students, and friends of climatetech are invited to attend.

This event is Tuesday, April 29, from 5:30-7:30 p.m. at Greentown Labs. Click here to register.

Integrate Space Technology Into Your Small Biz

The SBA Houston District Office and the UH Technology Bridge will host a collaborative event designed to help small businesses leverage space technology for prototype development. Attendees will also hear from industry experts on resources and gain access free technical engineering assistance to help accelerate their businesses.

This event is Wednesday, April 30, from 9:30-11:30 a.m. at UH Technology Bridge Innovation Center. Click here to reserve your spot.

Texas university's innovative 'WaterHub' will dramatically reduce usage by 40%

Sustainable Move

A major advancement in sustainability is coming to one Texas university. A new UT WaterHub at the University of Texas at Austin will be the largest facility of its kind in the U.S. and will transform how the university manages its water resources.

It's designed to work with natural processes instead of against them for water savings of an estimated 40 percent. It's slated for completion in late 2027.

The university has had an active water recovery program since the 1980s. Still, water is becoming an increasing concern in Austin. According to Texas Living Waters, a coalition of conservation groups, Texas loses enough water annually to fill Lady Bird Lake roughly 89 times over.

As Austin continues to expand and face water shortages, the region's water supply faces increased pressure. The UT WaterHub plans to address this challenge by recycling water for campus energy operations, helping preserve water resources for both the university and local communities.

The 9,600-square-foot water treatment facility will use an innovative filtration approach. To reduce reliance on expensive machinery and chemicals, the system uses plants to naturally filter water and gravity to pull it in the direction it needs to go. Used water will be gathered from a new collection point near the Darrell K Royal Texas Memorial Stadium and transported to the WaterHub, located in the heart of the engineering district. The facility's design includes a greenhouse viewable to the public, serving as an interactive learning space.

Beyond water conservation, the facility is designed to protect the university against extreme weather events like winter storms. This new initiative will create a reliable backup water supply while decreasing university water usage, and will even reduce wastewater sent to the city by up to 70 percent.

H2O Innovation, UT’s collaborator in this project, specializes in water solutions, helping organizations manage their water efficiently.

"By combining cutting-edge technology with our innovative financing approach, we’re making it easier for organizations to adopt sustainable water practices that benefit both their bottom line and the environment, paving a step forward in water positivity,” said H2O Innovation president and CEO Frédéric Dugré in a press release.

The university expects significant cost savings with this project, since it won't have to spend as much on buying water from the city or paying fees to dispose of used water. Over the next several years, this could add up to millions of dollars.

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A version of this story originally appeared on our sister site, CultureMap Austin.

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