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 Fervo Energy bumps up IPO target to $1.82 billion

IPO update

Houston-based geothermal power company Fervo Energy is now eyeing an IPO that would raise $1.75 billion to $1.82 billion, up from the previous target of $1.33 billion.

In paperwork filed Monday, May 11 with the U.S. Securities and Exchange Commission, Fervo says it plans to sell 70 million shares of Class A common stock at $25 to $26 per share.

In addition, Fervo expects to grant underwriters 30-day options to buy up to 8.33 million additional shares of Class A common stock. This could raise nearly $200 million.

When it announced the IPO on May 4, Fervo aimed to sell 55.56 million shares at $21 to $24 per share, which would have raised $1.17 billion to $1.33 billion. The initial valuation target was $6.5 billion.

A date for the IPO hasn’t been scheduled. Fervo’s stock will be listed on Nasdaq under the ticker symbol FRVO.

Fervo, founded in 2017, has attracted about $1.5 billion in funding from investors such as Bill Gates-founded Breakthrough Energy Ventures, Google, Mitsubishi Heavy Industries, Devon Energy (which is moving its headquarters to Houston), Tesla co-founder JB Straubel, CalSTRS, Liberty Mutual Investments, AllianceBernstein, JPMorgan, Bank of America and Sumitomo Mitsui Trust Bank.

Fervo’s marquee project is Cape Station in Beaver County, Utah, the world’s largest EGS (enhanced geothermal system) project. The first phase will deliver 100 megawatts of baseload clean power, with the second phase adding another 400 megawatts. The site can accommodate 2 gigawatts of geothermal energy. Fervo holds more than 595,000 leased acres for potential expansion.

Cape Station has secured power purchase agreements for the entire 500-megawatt capacity. Customers include Houston-based Shell Energy North America and Southern California Edison.

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

Texas university's new flight academy opens at Houston Spaceport

cleared for takeoff

The vehicles may not have “student driver” stickers on them, but Texas Southern University has moved a dozen planes into its new training facility at the Houston Spaceport, opening the way for student flyers to use the facility.

TSU previously reached a deal with Houston Airports and the City of Houston in 2023 to house its prospective Flight Academy at Ellington Field. At the time, TSU had a small fleet of nine planes for student use, but a $5.5 million investment from the city greatly expanded the space available.

The Flight Academy includes a 20,000-square-foot hangar that serves as a TSU satellite campus. The school now has a fleet of 12 Cirrus SR20 aircraft that were acquired last year through state and alumni funding. An additional 4,500 square feet is used as classroom and office space. An 8,000-gallon fuel tank will support flight training operations.

TSU first launched its Aviation Science Management program in 1986 and added a professional pilot program in 2016. The school is now part of the United Airlines pipeline program and has also forged relationships with Delta and Southwest.

“I want to commend Texas Southern University and Houston Airports for their leadership and partnership in advancing aviation education right here in our city,” Houston City Councilwoman Dr. Carolyn Evans-Shabazz in a press release.

“It connects our students to high-paying, high-demand careers in aviation and aerospace. This is how we grow a city in the right way—by investing in workforce development, aligning education with industry and making sure our residents are prepared to lead in the industries of tomorrow. Houston is already a global leader in aerospace and projects like this strengthen that position even further, especially here at Ellington, where innovation and opportunity continue to take flight.”

The City of Houston signed an agreement to continue funding the academy for five years.

Amazon launches ultrafast, 30-minute delivery service across Houston

Amazon Now

More than 20 years after it redefined fast shipping, Amazon is preparing to raise the bar on consumer expectations again by offering to fulfill customers' most urgent product needs in Houston and other parts of the world in a half-hour or less for an extra fee.

The company, which revolutionized online shopping in 2005 with two-day deliveries for Prime members, is rapidly opening small order-processing hubs in dozens of U.S. and foreign cities to cater to shoppers who can't or don't want to wait for cough medicine to relieve flu symptoms or tomatoes for tonight's dinner salad.

The ultrafast service, called Amazon Now, first launched in India last June. Amazon says 30-minute deliveries now are also available in urban areas of the United States, Brazil, Mexico, Japan, the United Arab Emirates, the United Kingdom.

The mini-warehouses devoted to Amazon Now are about the size of a CVS drugstore. They stock about 3,500 products for expedited delivery, including beer, diapers, pet food, meat, nonprescription medications, playing cards and cellphone charging cables.

“We know that customers love speed and always have,” Beryl Tomay, Amazon’s head of transportation, told The Associated Press on Monday. “What we see customers doing, when we offer faster speeds, are they purchase more from Amazon. And Amazon becomes more top of mind for that or other types of items as well.”

In the U.S., the company first tested Amazon Now in Seattle, the home of its headquarters, and in Philadelphia. Most residents of the Dallas-Fort Worth area and Atlanta now have access as well. The service is also live in Dallas-Fort Worth, Denver, Minneapolis, Phoenix, Oklahoma City, Orlando, and dozens of other cities, Amazon said, with New York City and others expected by year-end.

The service charges for Amazon Now start at $3.99 for Prime members, who pay an annual fee of $139, and $13.99 for non-members. A $1.99 small basket fee applies to orders under $15, Amazon said.

The company's bet on a need for speed also comes as some consumers are rebelling against rushed deliveries as they weigh the potential impact on the environment and the workers tasked with preparing orders at a rapid rate.

Amazon’s approach
A relentless focus on speed helped Amazon build a logistics and e-commerce empire. After it made two days the new delivery time normal, Amazon moved into one-day and same-day deliveries for its Prime members. This spring, the company began making 90,000 products available in one hour or three hours at an extra cost.

The scaled down and sped up microhubs that are designed to handle 30-minute orders represent another step in Amazon's pursuit.

Only a handful of people prepare orders from aisles of shelves in the 5,000- to 10,000-square-foot facilities, unlike the sprawling fulfillment centers storing millions of items where Amazon employs a mix of human workers and robotics to pick and pack orders.

Amazon tailors the product inventory to each location and uses artificial intelligence and other technology to analyze what customers buy, as well as when and how often. The most popular U.S. purchases so far include soap, toothpaste, mouthwash, toilet plungers, bananas, limes and wireless earbuds, Amazon said.

The competition
Amazon’s attempt to up the instant gratification ante provides direct competition to on-demand food delivery platforms like Instacart, Uber Eats, DoorDash and Grubhub, which don't have the scale of the e-commerce titan, according to independent retail analyst Bruce Winder.

“What Amazon brings is their prowess in supply chain,” Winder said.

These smaller companies said they don't see Amazon as a threat, though, citing the hundreds of thousands of items they are able to deliver to users' doorsteps by partnering with various merchants and restaurants.

“DoorDash has a mission to empower grocers and retailers and augment their existing footprint, not to replace them,” DoorDash spokesperson Ali Musa said in an emailed statement. “We win only when they win, which is how we can offer over half a million grocery and retail items in under an hour across the country.”

Amazon also is in a race with Walmart to become the retailer that reliably gets orders to online shoppers in under an hour.

For an additional $10 on top of standard delivery charges, shoppers can place Walmart Express Delivery orders from among more than 100,000 products that are guaranteed to arrive in an hour. Many customers, however, are receiving the items under 30 minutes, Walmart CEO John Furner told analysts in February.

Domino's cautionary tale
Companies have promised deliveries in 30 minutes or less before, but the landscape also is littered with failed attempts to break the speed barrier.

The COVID-19 pandemic produced a flurry of companies that promised 10- to 15-minute grocery deliveries from microwarehouses in dense neighborhoods, according to Sucharita Kodali, an analyst at market research firm Forrester Research.

But soaring operating costs, low customer loyalty and the drying up of investor money ultimately caused most to fail before the pandemic was over, analysts said.

Domino’s in 1984 pushed a guarantee that customers would receive their pizzas for free if they weren't delivered in under a half-hour. The company amended the “30 minutes or it’s free” policy after two years, providing only a $3 discount for late deliveries.

The promotion helped Domino’s win market share, but it ended up tarnishing the company's reputation. It dropped the guarantee in December 1993 after a string of crashes and lawsuits involving drivers racing to meet the deadline.

Brad Jashinsky, a retail analyst at information technology research and consulting firm Gartner, said he thinks Amazon should take the pizza chain's experience as a cautionary tale.

“You get in trouble when you start overpromising something like that,” he said.

Amazon won't be making any time guarantees and instead plans to keep customers who chose the 30-minute delivery option updated on the progress of their orders, Tomay said.

“There's no rushing either in our building workers or the gig workers,” she said.

Taking it slow
Kodali thinks Amazon will need a lot of people placing orders around the same time from the same or adjacent apartment buildings for the 30-minute service to be cost-effective.

Consumers may appreciate rapid receipt of products like toilet paper and batteries, but retailers and logistics experts said they also see some online shoppers, especially members of Generation Z, choosing no-rush shipping for products they don't need in a hurry.

Amazon for several years has invited customers to skip one- or two-day delivery and to receive their orders on the same day in as few parcels as possible. Consolidating orders into fewer packages by electing to have them delivered at the same time cuts down on boxes, shipping envelopes and fuel use, analysts said.

“The millennials who came to age in an era that was on fast delivery came to expect it de facto, whereas ... Gen Z is more accepting of a slower speed than previous generations before them,” said Darby Meegan, a general manager at Flexport, a supply chain and logistics company that fulfills orders for thousands of online merchants.

Still, Amazon executives have cited positive early results for Amazon Now in India, where they said Prime members tripled their requests for 30-minute deliveries once they started using the service.

Amazon Now also is attracting more repeat American customers, Tomay said.

“It’s in early days and time will tell,” she said. “I think that it will be interesting to see how it evolves.”