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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CultureMap Emails are Awesome

2024's 5 most-read startup feature stories

year in review

Editor's note: As the year comes to a close, InnovationMap is looking back at the year's top stories in Houston innovation. This past year, InnovationMap featured profiles on dozens of these Houston startups — from health tech to startups fostering community. Here are five Houston startup features that stood out to readers this year — be sure to click through to read the full story.

Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

A Houston company with a promising immuno-oncology is one step closer to delivering its cancer-fighting drug to patients who need it. Photo via Getty Images

A Houston immuno-oncology company has recently made major headway with the FDA, including both a fast track and an orphan drug designation. It will soon start a phase 2 trial of its promising cancer fighting innovation.

Diakonos Oncology was born in 2016, the brainchild of Baylor researchers already hard at work in the realm of dendritic cell vaccines. Drs. Will Decker, Matt Halpert, and Vanaja Konduri partnered with Dan Faust, a Houston businessman and pharmacist, to bring their treatment to the public, says COO Jay Hartenbach.

The name Diakonos means “deacon or servant in Greek,” he explains. “A lot of companies end up focusing on treating a specific disease or cancer and what you end up having is a significant amount of potential but with a lot of tradeoffs and downsides. And so our goal is we need to eliminate the cancer but we can't harm or dramatically malign the patient in doing so.” Continue reading.

Houston founder taps into AI tech to create game-changing healthy eating platform

A Better Meal — a new app from a Houston founder — gives you all the tools you need to make healthier food choices. Photo via abettermeal.com

After many years of living to eat, a large swath of American society is now facilitating a seismic shift to the healthier alternative, eating to live.

But here’s the rub: eating healthy is confusing, time consuming and, unfortunately, oftentimes pricey.

So, anyone that can come in and cut through the healthy eating machine can carve out a necessary niche in the marketplace.

Enter Houstonian Mark Semmelbeck, founder and CEO of A Better Meal, a platform created to help busy families plan healthy meals easier and to make gradual improvements to their health and well-being.

“My vision is to use rapidly expanding AI technology together with the knowledge and wisdom of an active community to take the stress out of meal planning and improving nutrition,” says Semmelbeck, a seasoned oil and gas executive with over 30 years of experience in founding companies. “While developing the technology for the app, my daughter gave me two beautiful grandkids who both have significant food allergies. Combine that with the fact I now have five cardiac stents and the significance of eating well while paying attention to the details has only grown in importance.” Continue reading.

Hardtech startup moves into Houston area with new Conroe facility, eyes tests in space

FluxWorks, a hardtech startup, opened its new home-base in Conroe, Texas. Photo courtesy FluxWorks

FluxWorks, a hardtech startup, recently opened its new base of operations in Workhub Developments’ Conroe location.

Founded in College Station by CEO Bryton Praslicka, FluxWorks specializes in making contactless magnetic gears for use in extreme conditions. At 9,000 square feet, the new Conroe facility is a result of discussions with Governor Greg Abbott's office and the Greater Houston Partnership, who introduced the company’s leadership to the Conroe Economic Development Council, encouraging their move, Praslicka tells InnovationMap.

“The pieces of the puzzle were all there, and with the support of the local, state, and federal government, we were thrilled to move to Conroe,” Paslicka says. Continue reading.

Houston startup secures IBM partnership for AI-backed consumer tech

IBM and Boxes recently partnered to integrate the IBM watsonx Assistant into Boxes devices, providing a way for consumer packaged brands to find out more than ever about what its customers like and want. Photo courtesy of Boxes

With the help of a new conversational artificial intelligence platform, a Houston startup is ready to let brands get up close and personal with consumers while minimizing waste.

IBM and Boxes recently partnered to integrate the IBM watsonx Assistant into Boxes devices, providing a way for consumer packaged brands to find out more than ever about what its customers like and want.

The Boxes device, about the size of a 40-inch television screen, dispenses products to consumers in a modern and sustainable spin on the old-fashioned large vending machine.

CEO Fernando Machin Gojdycz learned that business from his entrepreneur father, Carlos Daniel Machin, while growing up in Uruguay.

“That’s where my passion comes from — him,” Gojdycz says of his father. In 2016, Gojdycz founded Boxes in Uruguay with some engineer friends. Continue reading.

Houston founder aims to help find your purpose, make strategic connections over a cup of coffee

Cup of Joey has expanded across Houston to help make valuable connections to Houston entrepreneurs. Photo courtesy of Cup of Joey

What is your purpose in life? One Houstonian is asking that question of his fellow entrepreneurs all across town.

Joey Sanchez founded Cup of Joey, a weekly meetup opportunity for innovators, business leaders, and the whole Houston community. The events are a place not only to share a cup of coffee but also their very own mission in life.

It all started in 2021 at the Houston Tech Rodeo, an initiative from Houston Exponential, where Sanchez worked as a director of corporate engagement. Texas had just opened social distancing in public events since the beginning of the COVID-19 pandemic, and Sanchez was finding ways to reconnect the Houston community.

‘We thought what better way than over a cup of coffee?” Since then, Sanchez has connected thousands of people based on purpose every Friday for the past three and a half years. Continue reading.

3 clean energy innovators make Forbes list of top young energy professionals

under 30

A handful of Houstonians have been named to the Forbes 30 Under 30 Energy and Green Tech list for 2025.

Kip Daujotas is an investment associate at Aramco Ventures, a $7.5 billion venture capital arm of the world's largest energy company. Houston is the Americas headquarters for Saudi Aramco. Since its inception in 2012, Aramco Ventures has invested in more than 100 tech startups. Daujotas joined the team over two years ago after studying for an MBA at Yale University. He led Aramco’s first direct air capture (DAC) investment — in Los Alamos, New Mexico-based Spiritus.

Also representing the corporate side of the industry, Wenting Gao immigrated from Beijing to obtain an economics degree from Harvard University, then got a job at consulting giant McKinsey, where she recently became the firm’s youngest partner. Gao works on bringing sustainability strategies to energy and materials companies as well as investors. Her areas of expertise include battery materials, waste, biofuels, and low-carbon products.

Last but not least, Houston entrepreneur Rawand Rasheed is co-founder and CEO of Houston-based Helix Earth. He co-founded the startup after earning a doctoral degree from Rice University and co-inventing Helix’s core technology while at NASA, first as a graduate research fellow and then as an engineer. The core technology, a space capsule air filtration system, has been applied to retrofitting HVAC systems for commercial buildings.

Each year, Forbes 30 Under 30 recognizes 600 honorees in 20 categories. The 2025 honorees were selected from more than 10,000 nominees by Forbes staff and a panel of independent judges based on factors such as funding, revenue, social impact, scale, inventiveness, and potential.

Specifically, the Energy & Green Tech category recognizes young entrepreneurs driving innovation that’s aimed at creating a cleaner, greener future.

“Gen Z is one of the fastest-growing groups of entrepreneurs and creators, who are reshaping the way the world conducts business, and our Under 30 class of 2025 proves that you can never begin your career journey too early,” says Alexandra York, editor of Forbes Under 30. “With the expansion across AI, technology, social media, and other industries, the honorees on this year’s list are pushing the boundaries and building their brands beyond traditional scopes.”

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This article originally ran on EnergyCapital.

Houston expert: How leaders can manage divisive topics in the workplace to maintain a unified culture

guest column

Social issues to economic pressures and personal challenges are all stressors businesses must face and navigate. When employees face these obstacles, they can impact their performance. Amid it all, business leaders must adopt proactive strategies to maintain morale, professionalism and productivity.

People bring divisive topics into the workplace. Everyone has a different opinion on today’s news and current events, which can excite some and alienate others. Below are key strategies that employers can implement to manage potential conflicts and foster a positive work environment.

Create clear policies

Tempering controversial topics and cultural discussions is done with clear policies that outline acceptable behaviors. These policies should cover physical and virtual workspaces, specifying topics and content that are appropriate for work. What may seem like neutral items, like photos or trinkets seen on a video call, can sometimes stir controversy if they carry controversial associations.

Policies need to clearly state what is considered controversial cultural discussions and what is acceptable to address in the office or post on social media. Exceptions may be needed for discussions protected under the National Labor Relations Act, such as employees discussing wages. Removing vagueness helps set clear expectations and avoid misunderstandings.

It’s critical for leadership to follow the policies they developed. By their own actions, leadership can show the importance of staying neutral and professional at work. This sets a standard others can follow, resulting in a more focused and cohesive workplace. Conversely, if leaders openly discuss hot topics, employees may feel encouraged to do the same, creating undue tension among team members.

Remember clients and customers

Clients and customers likely have different opinions than your business leaders. Avoiding divisive topics and discussions helps bolster good working relationships with clients and customers who most certainly have a wide range of cultural views.

Everyone within the company, from the top down, should focus on the company's core mission. This laser focus will help maintain client relationships.

Strengthen mission and values

Most things today can become politicized, so it can be beneficial to take a close look at the company’s mission statement and values. It’s important to ensure these statements continue to reflect the company’s commitment to positive contributions for the broader community, clients, and employees. No matter the size of the company, the mission and values should provide a unifying purpose that can help buffer the workplace from tensions.

In today’s complex cultural landscape, it is important to create a culture of respect, neutrality, and complete focus on the company’s mission.

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Jill Chapman is a director of early talent programs with Insperity, a leading provider of human resources and business performance solutions.