Houston med device company secures first patient for clinical trial

health care tech

Saranas has enrolled its first patient in its clinical trials. Photo courtesy of Saranas

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 cleantech company sees shining success with gold hydrogen

bling, bling

Houston-based cleantech startup Cemvita Factory is kicking things into high gear with its Gold Hydrogen product.

After successfully completing a pilot test of Gold Hydrogen in the oil-rich Permian Basin of West Texas, Cemvita has raised an undisclosed amount of funding through its new Gold H2 LLC spin-out. The lead investors are Georgia-based equipment manufacturer Chart Industries and 8090 Industries, an investment consortium with offices in New York City and Los Angeles.

Gold Hydrogen provides carbon-neutral hydrogen obtained from depleted oil and gas wells. This is achieved through bioengineering subsurface microbes in the wells to consume carbon and generate clean hydrogen.

Cemvita says it set up Gold H2 to commercialize the business via licensing, joint ventures, and outright ownership of hydrogen assets.

“We have incredible conviction in next-generation clean hydrogen production methods that leverage the vast and sprawling existing infrastructure and know-how of the oil and gas industry,” Rayyan Islam, co-founder and general partner of 8090 Industries, says in a news release.

Traditional methods of producing hydrogen without greenhouse gas emissions include electrolysis powered by renewable sources like wind, solar or water, according to Cemvita. However, production of green hydrogen through normal avenues eats up a lot of energy and money, the startup says.

By contrast, Cemvita relies on depleted oil and gas wells to cheaply produce carbon-free hydrogen.

“The commercialization and economics of the hydrogen economy will require technologies that produce the hydrogen molecule at a meaningful scale with no carbon emissions. Gold H2 is leading the charge … ,” says Jill Evanko, president and CEO of Chart Industries.

Investors in Cemvita include Oxy Low Carbon Ventures, an investment arm of Houston-based Occidental Petroleum, as well as BHP Group, Mitsubishi, and United Airlines Ventures.

Oxy Low Carbon Ventures and United Airlines Ventures are financing Cemvita’s work on sustainable jet fuel. United Airlines operates a hub at George Bush Intercontinental Airport Houston.

Founded by brother-and-sister team Moji and Tara Karimi in 2017, Cemvita uses synthetic biology to turn carbon dioxide into chemicals and alternative fuels.

Houston named best city in Texas and No. 11 in U.S. in prestigious report

best in tx

At least according to one new report, Houston is not only the Energy Capital of the World but also the livability capital of Texas.

A new study from Best Cities, powered by Resonance Consultancy, puts Houston at No. 11 among the best cities in the U.S. That’s the top showing among the six Texas cities included in the ranking. Houston appeared at No. 17 on last year’s list.

“Educated, diverse and hard-working, Houston is America’s stealthy powerhouse on the rise,” Best Cities proclaims.

Best Cities notes that while Austin grabs much of the best-city attention, “the promise of the Lone Star State drawing Californians and New Yorkers is quietly being fulfilled in Houston.” The website points out that the Houston metro area has gained nearly 300,000 residents in the past year, thanks to both domestic and international migration.

Here are some of the individual rankings that contribute to Houston’s 11th-place finish:

  • No. 4 for restaurants
  • No. 7 for culture
  • No. 8 for foreign-born population

“Houston is a diverse and vibrant metro where individuals can start a family, grow their business, attend world-class institutions and universities, or be immersed in the 145 languages that are spoken by our residents,” Houston Mayor Sylvester Turner says in a news release. “The quality of life we have in Houston is second to none, and the data we receive from placements such as … Best Cities further reaffirm the strength and resiliency that has come to define this great city of ours.”

A few spots behind Houston on the Best Cities list are No. 14 Dallas and No. 15 Austin.

What lifts Dallas to the No. 14 spot? These are some of the factors cited by Best Cities:

  • Location of more than 10,000 corporate headquarters
  • Strong showing (No. 2) in the airport connectivity category
  • Kudos for the soon-to-be-expanded Kay Bailey Hutchinson Convention Center Dallas
  • Home of the country’s sixth largest LGBTQ+ community
  • Presence of the 28-block, 68-acre Dallas Arts District

Austin comes in at No. 15, one notch behind Dallas.

Best Cities praises Austin as “a place that’s incredibly livable. Talk to any entrepreneur leaving Silicon Valley or Seattle and chances are they’ve considered Austin.”

The website points to a number of Austin’s assets, such as:

  • Growing presence of Fortune 500 headquarters
  • Comparatively low unemployment rate
  • Location of the University of Texas’ flagship campus
  • Status as the Live Music Capital of the World
  • Home of the annual SXSW gathering

Two other Texas cities make the Best Cities list: No. 34 San Antonio and No. 94 McAllen.

Best Cities bases its list of the best U.S. cities on Resonance Consultancy’s combination of statistical performance plus qualitative evaluations by locals and visitors. Those figures are grouped into six main categories. This year’s ranking features 100 U.S. cities. To come up with the ranking, Resonance Consultancy assessed all U.S. metro areas with at least 500,000 residents.

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This article originally ran on CultureMap.

How a Houston med device startup pivoted to impact global health and diagnostics

HOUSTON INNOVATORS PODCAST EPISODE 153

In the span of a couple years, a Houston startup went from innovating a way for patients with degenerative eye diseases to see better to creating a portable and affordable breath-based diagnostics tool worthy of a prestigious grant from the Bill and Melinda Gates foundation.

Steradian Technologies, founded in 2018, set out to create human super-sight via proprietary optics. In early 2020, the company was getting ready to start testing the device and fundraising. Then, the pandemic hit, knocking the company completely off course.

Co-founder and CEO of the company, Asma Mirza, says on this week's Houston Innovators Podcast that the Steradian co-founders discussed how their optic technology could detect diseases. Something just clicked, and the RUMI device was born.

"We are from Houston, Texas, which is one of the most diverse and accessible cities in the country, and we were having trouble with basic diagnostic accessibility. It was taking too long, it was complicated, and people were getting sick and didn't know if they were positive or negative," Mirza says on the show. "That's when we pivoted the company and decided we were going to pivot the company and use optics to detect diseases in breath."

Fast forward two years and the company has been recognized by the Bill and Melinda Gates Foundation with a grant to sport the development of the tool — which costs about the same price as a latte to make. The impact for global health is huge, Mirza says, allowing for people to test their breath for diseases from their own homes in the same time it takes to take your temperature.

"You blow into a cartrige and we're able to take the air from your breath into a liquid sample," Mirza says, explaining how the device uses photons to produce quick results. "It's wild that we still don't have something like that yet."

She shares more details about the grant and the future applications for the technology — as well as the role Houston and local organizations have had on the company — on the podcast. Listen to the interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


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