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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4 Houston health tech startups advancing medical innovation

meet the finalists

Houston has been driving medical innovation for decades. And thanks to leading hospitals, cutting-edge research and breakthrough technologies, the region’s healthcare ecosystem continues to improve how patients are diagnosed, treated and cared for.

The Health Tech Business category in our 2025 Houston Innovation Awards will honor an innovative startup within the health and medical technology sectors.

Four forward-thinking businesses have been named finalists for the 2026 award. This year's finalists, selected by our esteemed panel of judges, range from a startup developing miniaturized medical technologies for space to a company using AI to help develop cancer treatment plans.

Read more about these businesses, their innovative founders, and how they're shaping the future of health care below.. The 2026 winners will be announced on InnovationMap.com in mid-November.

Bairitone Health

Bairitone Health is bringing anatomy imaging for sleep apnea to the home environment. The company's platform maps users' anatomy during natural sleep using a facial patch to determine the root cause of airway obstruction. It then offers effective therapies for each patient.

The company was founded in 2022 in the Texas Medical Center's Biodesign program by CEO Meagan Pitcher, CTO Onur Kilic and chief medical officer Britt Cross. It was a member of Activate Houston's inaugural cohort and has participated in numerous accelerators and incubators. The company raised an oversubscribed seed round for $2.4 million earlier this year and received Breakthrough Device Designation from the Food and Drug Administration in April.

InformAI Inc.

InformAI Inc. develops fit-to-purpose AI solutions for the clinical setting. Its RadOncAI product recently received FDA 510(k) clearance. The product uses AI to create a first-pass radiation therapy dose plan for complex head and neck cancers in an effort to eliminate bottlenecks in radiation planning and ultimately cancer treatment. The company has also developed AI products for sinus disease detection and 3D organ reconstruction.

CEO Jim Havelka founded the company in 2017. It is participating in the Mayo Clinic Accelerate Platform. It has raised about $4 million in seed funding and has received numerous non-dilutive grants from the National Science Foundation, the National Institutes of Health and the Cancer Prevention and Research Institute of Texas. The company shared in its application that it plans to launch a Series A fundraising round and submit an FDA 510K application for its organ reconstruction product, Voluquant, by the end of 2026.

Prana Surgical

Prana Surgical is developing a minimally invasive surgical platform for small, hard-to-reach lung nodules that may be cancerous. The company's Prana System cleared U.S. Food and Drug Administration (FDA) approval earlier this year.

Prana Surgical was originally founded as Prana Thoracic in 2022. It has participated in numerous accelerators, including the Texas Medical Center Innovation Accelerator in 2023 and the IGNITE Health accelerator in 2022. It raised $6 million in Series A funding rounds in 2023 and 2024 , with a Series B currently ongoing. The company said in its application that it is currently moving into the next stage of clinical validation and revenue generation in the U.S., in addition to preparing its manufacturing and commercial infrastructure for broader use.

Skybound MedTech

Skybound MedTech develops technologies that aim to address the health risks of long-duration spaceflight. Its compact, miniaturized medical technologies can deliver complex therapies without a physician.

CEO Matthew Kuhn, who previously founded Taurus Vascular, founded Skybound last year. The company emerged from stealth in January after raising a $1.25 million Series A round. It plans to advance its lead dual-use platform into critical preclinical validation in November, the company shared in its application. It is currently raising a $25 million Series A round and is pursuing federal research partnerships with DARPA and ARPA-H.

Generation Park lands new facility to scale xeno-organ production

Organ innovation

Maryland-based United Therapeutics Corp. has opened a new 77,448-square-foot facility to manufacture xeno-organs in Northeast Houston’s growing biotech hub, Generation Park.

The new Houston location is United Therapeutics’ third Designated Pathogen-Free (DPF) site, named for transplant pioneers Dr. Bartley P. Griffith and Dr. Robert A. Montgomery. The company says the new facility will enable it to scale commercial production of its xeno-organs once they receive regulatory approval.

An existing DPF facility in Virginia is supporting clinical trials for the xeno-organs, and a third site in Minnesota will also focus on commercialization with the Houston site, according to the company.

Xeno-organs are organs taken from a non-human animal source and transplanted, implanted or infused into a human recipient.

Currently, United Therapeutics is advancing clinical trials to support a Biologics License Application with the U.S. Food and Drug Administration for its investigational-stage xenotransplantation, UKidney, UThymoKidney and UHeart products. The products all involve working with the genes from humans and pigs.

In 2025, Chron.com reported the company was working to construct an estimated $96 million facility to breed genetically engineered animals. Head of investor relations at United Therapeutics Dewey Steadman told the Houston Business Journal in 2025 that the pigs’ DNA will be edited. In November 2024, a 53-year-old woman in Alabama received a transplanted kidney from UKidney that had 10 gene edits. She had the transplant removed in April 2025, after her body rejected it.

The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility requires a “strictly controlled, biosecure barrier environment, including air filtration, filtered water, filtered feed supplies, and state-of-the-art decontamination entryways,” according to the company. Being pathogen-free means it includes calibrated air and water conduits to support the transplantability of xenograft products and to prevent contamination. For energy considerations, the building also features solar arrays.

“With our third xenograft production facility now open and clinical trials underway, United Therapeutics is moving closer to its goal of providing transplantable organs to the people who need them,” Martine Rothblatt, chairperson and CEO of United Therapeutics, said in a news release. “It is fitting that this facility is named for Dr. Griffith and Dr. Montgomery, whose first-in-human surgeries turned xenotransplantation from a theoretical possibility into a clinical reality.”

The facility, which wrapped construction in August, is located at 11848 Common Dock Dr. in Generation Park, which will house manufacturing sites for pharmaceutical heavyweights Bristol Myers Squibb and Eli Lilly. Last fall, Eli Lilly tapped Generation Park for its $6.5 billion manufacturing plant, and Bristol Myers Squibb made a $2.3 billion investment in August to bring its state-of-the-art site to the master-planned commercial district.

Elon Musk's SpaceX reports profit as AI and satellite businesses booms

Booming Business

SpaceX reported a bigger quarterly profit than expected on Tuesday, October 20, as its satellite communications and artificial intelligence businesses boomed.

The company, run by Elon Musk, posted a profit for the three months through September 2026 of $4.4 billion, or 35 cents per share, reversing a year-ago loss and easily topping Wall Street's expectations. Revenue soared to $14.6 billion, up 161%.

On a conference call with analysts, Musk suggested a merger with his electric car company Tesla might be in the works, something that has been rumored for months. He said both companies formed “special committees” of independent directors to discuss the issue, though he played down the chances of an imminent deal.

“Some people out there assume that a SpaceX and Tesla merger is a certainty,” he said. “I think that would be overstating it.”

The AI business became SpaceX's largest by revenue in the third quarter, although the Starlink satellite service remains the biggest profit generator.

“They beat across all metrics and the Starlink business looks to be accelerating,” said Dan Ives, an analyst at Yorkville Ives. “This is just what (Wall) Street wanted.”

The stock rose 7.5% in after-hours trading.

Musk also told analysts that for next month's launch of its Starship rocket, SpaceX will attempt to grab both the booster and ship with mechanical arms upon return to base, a key step toward demonstrating it can reuse the massive spacecraft.

“The only way that we can extend consciousness beyond Earth on a sustained basis is with a fully reusable orbital launch vehicle,” Musk said, calling the attempt, if successful, “a massive technology milestone.”

SpaceX hopes to get Starship on a regular launch pattern in preparation for NASA's upcoming lunar missions.

The company already has huge contracts with the federal government, and House Democrats have called for investigations into those contracts and Musk’s work with the Department of Government Efficiency. Musk has spent $276 million since July in support of Republican candidates.

In a filing for its initial public offering in June, SpaceX warned that a change in control of Congress could have a “material and adverse impact on our growth and competitive position.”

Musk recently drew criticism from politicians in Washington after speeds for a military version of SpaceX's satellite communications service were slowed for Ukraine following President Donald Trump's deal to get more diesel oil from Russia amid a push to end the war. The Wall Street Journal reported Tuesday that it was Musk who ordered the slowdown, impeding Ukraine’s use of drones along the front. SpaceX did not immediately respond to an Associated Press request for comment on the Journal story.

Both Trump and Musk have denied responsibility for the slowdown.

As midterm elections near, Musk on Monday promised to give one share of SpaceX to “every kid in America” next year, though he provided no details on how the distribution would be carried out. With communities nationwide protesting the construction of large data centers and concerns about AI safety, AI companies are trying to build goodwill. Anthropic pledged to commit 5% of its shares to a new “public benefit” fund.

SpaceX shares have been under pressure over concerns that the company was spending too much on major projects to compete with rivals such as Anthropic. The company said capital expenditures totaled $19.6 billion last quarter, nearly triple the figure from a year earlier, and it forecast spending would grow to $35 billion to $40 billion in the current quarter.

Shares of SpaceX closed Tuesday at $147.79, down from a peak near $201 after its IPO, which made Musk the world’s first trillionaire at the time. But the share prices for SpaceX and Tesla have since dropped, reducing his net worth to $925 billion, according to Forbes magazine.

Tesla reports third-quarter financial results Wednesday. Last week, Tesla unveiled a new Roadster sports car that in some versions may include thrusters allowing it to briefly fly using SpaceX technology — though experts say anything usable for drivers is a long shot.

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