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.

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.


The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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Shipley Donuts launches AI-powered ordering assistant

fresh tech

Popular Houston-born doughnut chain Shipley Donuts has added a first-of-its-kind AI-powered assistant to its online ordering platform.

The new assistant can create personalized order recommendations based on individual or group preferences, according to a news release from the company. Unlike standard chatbox features, the new assistant makes custom recommendations based on multiple customer factors, including budgetary habits, individual flavor preferences and order size.

"We're not just adding AI for the sake of innovation — we're solving real customer pain points by making ordering more intuitive, personalized and efficient," Kerry Leo, Shipley Vice President of Technology, said in the release.

The system also works for larger events, as it can make individual orders and catering recommendations for corporate events and meetings by suggesting quantities and assortments based on group size, event type and budget.

According to Shipley, nearly 1 in 4 guests have completed orders with the new AI technology since it launched on its website.

“The integration of the AI ordering assistant into our refreshed website represents a significant leap forward in how restaurant brands can leverage technology to enhance the customer experience,” Leo added in the release.

Houston company wins AHA competition for pediatric heart valve design

winner, winner

Houston-based PolyVascular, which develops minimally invasive solutions for children with congenital heart disease, was named the overall winner of the American Heart Association’s annual Health Tech Competition earlier this month.

The company was founded in 2014 by Dr. Henri Justino and Daniel Harrington and was part of TMCi's 2017 medical device cohort. It is developing the first polymer-based transcatheter pulmonary valve designed specifically for young children, allowing for precise sizing and redilation as the child grows while also avoiding degradation. PolyVascular has completed preclinical studies and is working toward regulatory submissions, an early feasibility study and its first-in-human clinical trial thanks to a recent SBIR grant from the National Heart, Lung, and Blood Institute.

With the new AHA honor, PolyVascular will be invited to join the association’s Center for Health Technology & Innovation Innovators’ Network, which connects entrepreneurs, providers and researchers to share and advance innovation in cardiovascular and brain health.

“This is a tremendous honor for PolyVascular—we’re especially proud to bring hope to families and children living with congenital heart defects,” Justino said in a news release. “Our technology—a minimally invasive valve that can be expanded over time to grow with the child—has the potential to dramatically reduce the need for repeated open-heart surgeries.”

The Health Tech Competition is a live forum for health care innovators to present their digital solutions for treating or preventing cardiovascular diseases and stroke.

Finalists from around the world addressed heart failure, hypertension, congenital heart defects and other issues that exist in cardiovascular, brain and metabolic health. Solutions were evaluated on the criteria of validity, scientific rigor and impact.

The judges included Texas-based Dr. Eric D. Peterson, professor of medicine in the division of cardiology at UT Southwestern Medical Center, and Dr. Asif Ali, clinical associate professor of cardiovascular medicine at the University of Texas Medical School in Houston and director at Cena Research Institute.

According to the American Heart Association, nearly half of U.S. adults live with some form of cardiovascular disease or stroke.

“The American Heart Association plays a pivotal role in advancing innovative care pathways, and we’re excited that our solution aligns with its guidelines and mission,” Justino said in a news release. “It’s time these life-changing technologies reach the youngest patients, just as they already do for adults.”

EO Houston is where ambitious founders go to scale smarter

Don't Go It Alone

Scaling a business from early traction into true growth is one of the most exciting — and punishing — chapters of entrepreneurship. Houston founders know this better than most. Our city is built on ambition: fast-moving industries, talent from around the world, and opportunities that expand as large as the Texas sky.

But as many entrepreneurs eventually learn, scaling isn’t simply “more of what worked.” It requires new systems, new thinking, and often, a new version of the founder. Even the most capable founders eventually face decisions, pressures, and turning points that only other entrepreneurs can truly understand.

Entrepreneurs’ Organization, a global peer-to-peer network of more than 18,000 business owners across 220 chapters in 75+ countries, exists for exactly this stage. One of the largest chapters in the organization, EO Houston brings that global community to life locally, offering founders the connection, learning, and accountability needed to grow sustainably and to grow up as leaders.

A community where founders learn at the highest level
The real value of EO emerges in the lived experiences of other entrepreneurs. When Houston-area founders talk about the moments growth nearly broke their companies, a universal theme appears: you can’t do it alone.

EO Houston member Robert De Los Santos of Sky High Party Rentals learned this the hard way when rapid post-COVID growth made expansion feel limitless — until it wasn’t.

“After COVID, we doubled every year and assumed inventory was the limit. In 2023 we overbought, only to realize demand had peaked. That taught us a hard truth: growth in one city has ceilings. Expanding into Austin and Dallas — the Texas Triangle — gave us new markets to put our inventory to work while we figured out how to penetrate Houston better. The challenge shifted from a strategy of ‘buy more units for demand’ to learning how to tackle the challenges of ‘leading across cities.’”

Founders often enter EO exhausted from trying to maintain control as things grow more complex. Many discover, like Jarred King of Summit Firms, that scaling requires the difficult shift from doing everything to building the team that can.

“We grew quickly because of my network, relationships, and hustle… but I was doing all the work,” King says. “I realized at that point you have to delegate — not just busy work, but important decisions to your key team, as well as set up really effective SOPs.”

“The uncomfortable truth is that you are no longer the best person for most jobs in your company," agrees Darren Randle of Houston Tents & Events. "Your inability to delegate or hire people smarter than you in key leadership and management level roles will become the single biggest drag on the entire business. You have to accept that your original 'hustle' is now a scalability risk."

Making hard decisions, such as walking away from customers or contracts, can feel like less of a sting when you know others have also been faced with tough choices. Aaron Gillaspie of West U's My Salon Suite recalls, “You can’t be everything to everyone, it’s ok to say no, and just understand some customers aren’t the right fit. It’s a two way street and both must win.”

Perspective is perhaps the most important reality check that members find at EO.

“Bigger volume will not make problems go away — you just got to get used to walking the tightrope," says Roger Pombrol of Emerald Standard. "Develop a system for good balance and do not freak out. Scared is no way to live your life. It’s ok if you fall. Your family will still love you. Money is just money. Love is love. The world tries to make you conflate them, but don’t."

Actionable insights from entrepreneurs who’ve already scaled
Conversations like these are happening every month inside EO Forum Meeting. Each EO chapter is divided into several small Forums. These confidential, committed group of 7–10 entrepreneurs who meet to share the real five percent of what they’re experiencing. It’s not advice, but experience — shared candidly, respectfully, and with the kind of vulnerability that leads to breakthroughs.

What makes Forum so impactful is the honesty it draws out. Entrepreneurs are often surrounded by employees, partners, and even family members who rely on them for answers, but seldom do they have a group where vulnerability is not only welcomed, but expected.

Learning experiences that match your ambition
EO supports that growth far beyond peer groups. Through the organization’s global partnerships with institutions like Harvard, Oxford, and INSEAD, Houston members gain access to executive-level learning experiences designed specifically for entrepreneurs.

These programs help founders step out of the day-to-day and think strategically about competitive advantage, innovation, and organizational leadership. Paired with ongoing learning through EO Jumpstart, Nano Learning, and its global library of member-created content, founders stay informed, challenged, and ahead of emerging trends.

And through global communities — ranging from EO Women and EO Under 35 to industry-specific groups — Houston members tap into expertise that spans continents and sectors. Whether someone is navigating M&A, exploring international expansion, or integrating new technologies, the right perspectives are always within reach.

What truly distinguishes EO Houston, however, is its culture. Houston’s entrepreneurial landscape is uniquely diverse and resilient, filled with founders who are hungry to build, innovate, and elevate the city’s business community. EO Houston amplifies that spirit, creating relationships that are as supportive as they are strategic. Many members describe the chapter not simply as a network, but as a catalyst for becoming better leaders, better thinkers, and — just as importantly — better human beings.

Your next level starts here
For entrepreneurs who are ready to scale—beyond their first million, beyond their current comfort zone, and toward a future that requires sharper leadership and stronger community—EO Houston offers an unmatched platform. It is a place where ambitious founders grow faster, think bigger, and gain the confidence to take bold next steps.

If you’re ready to elevate your business and your leadership alongside people who understand the journey, EO Houston is ready to welcome you. Your next level starts with the peers who can help you reach it. Learn more and become a member here.

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