Houston medical device company launches is product in the U.S. and hires new exec

Early bird gets the worm

Houston-based Saranas' technology is now being premiered in the United States. Courtesy of Saranas

A Houston company is changing the game when it comes to early bleed detection, and now the company can provide its life-saving service to the United States.

Saranas Inc., which received FDA approval for its Early Bird Bleed Monitoring System in March, announced that it is launching its device in the US. at the Transcatheter Cardiovascular Therapeutics Conference next week in San Francisco. 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.

"As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time," says Saranas president and CEO, Zaffer Syed, in a news release. "With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures."

Around 20 percent of patience suffer a bleeding complication during endovascular procedures, like transcatheter aortic valve replacement, endovascular aneurysm repair, and percutaneous hemodynamic support, and, according to a report in the Journal of the American Medical Association, these complications result in higher mortality, longer hospital stays, and higher medical bills.

In other exciting news for the company, Saranas hired Tom Lucas as vice president of sales and marketing. He has 28 years of experience in medical sales, and he is tasked with business development, marketing, sales, and more for the company.

"Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.," Syed says in the release. "His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence."

Saranas began its clinical trials last year after raising $2.8 million. The company revealed the results of those trials earlier this year, leading to the FDA approval.

"Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure," says Saranas Chief Medical Officer Dr. Philippe Généreux in the release. "Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient."
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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2 Houston universities top list for best graduate, undergraduate entrepreneurship programs

Best of the rest

In Houston, a little bit of friendly competition between two universities goes a long way, but each gets a win according to a recent ranking.

The University of Houston's Cyvia and Melvyn Wolff Center for Entrepreneurship within the C. T. Bauer College of Business claimed the top spot on the 2020 Princeton Review's top 15 programs for undergraduate entrepreneurship studies. Meanwhile, Rice University's Jones Graduate School of Business claimed the top spot on the graduate schools list.

Both schools have appeared on the list before, but it's the first time either has topped their categories.

"Entrepreneurship and the creation of new businesses and industries are critical to Houston and Texas' future prosperity and quality of life," says Rice Business Dean Peter Rodriguez, in a news release. "Today's ranking and our decades-long leadership in entrepreneurship education and outreach is a testament to our visionary and world-class faculty, the enormous success of the Rice Business Plan Competition and of our commitment to our students and the community we serve."

The Rice program, which in 1978, has appeared on the top-10 list for 11 years in a row, and it's the fourth time for the program to make it into the top three. According to the Princeton Review release, Rice grads have started 537 companies that went on to raise over $7 billion in funding.

A UH news release also calls out the fact that UH has seen more than 1,200 alumni-founded businesses, which have amassed over $268 million in funding over the past decade. UH's program, which began in 1991, has appeared in the top 10 list since 2007, and rose from the No. 2 position last year.

"The Wolff Center is the catalyst, but entrepreneurship goes beyond that to the entire Bauer College, including RED Labs, social entrepreneurship, energy, health care, arts and sports entrepreneurship, among many other programs," says Bauer Dean Paul Pavlou. "We're an entrepreneurial university, and innovation and the startup ecosystem we want to promote for the city of Houston starts with the Wolff Center and Bauer."

The ranking considered more than 300 schools with entrepreneurship studies programs and factored in over 40 data points. Some of the factors considered include: the percentage of students enrolled in entrepreneurship courses, mentorship programs, the number of startups founded and investments received by alumni, and the cash prizes at university-backed business plan competitions. The rankings will be published in the December issue of Entrepreneur magazine.

Sustaining a culture of innovation is key to driving the energy industry, says this Houston expert

Guest column

The prevailing economic environment has made innovation essential to gaining a competitive edge in the oil and gas industry.

Global economic shifts and the unstable oil market have been considerable factors inhibiting the advancement of innovation in the oil and gas sector. Oil prices have not significantly increased in the past four to five years, while investors and Wall Street hold corporate executives accountable for capital discipline.

In light of these trends, corporate culture and innovation are key factors that hold the potential to drive novelty in the next upcycle. To bring value to shareholders, the oil and gas industry needs to nurture an environment that fosters a radically innovative culture to create new product lines and markets, unique ecosystems, product content, and processes.

Culture from the top down

Organizational culture is one of the essential dynamics that drive innovation. Employee behavior helps influence and promote the acceptance of innovation as a fundamental corporate value. Organizations are therefore admonished to concentrate on fostering an innovative culture that allows the growth of new ideas.

This culture needs to be created by deliberate action on the part of leaders of industry or by indirect measures such as composition and institutional policy directions. A model of innovative culture which translates into cultural transformation emerges as a result of this deliberate action and institutional policy directions.

Various studies over the years have examined innovative culture models focused on cultural characteristics or factors. A comprehensive, innovative culture model that incorporates cultural traits and their determinants is reviewed in this contemplative piece.

Execution  culture vs. innovative culture

In her book, "The Culture Map: Breaking Through the Invisible Boundaries of Global Business," Erin Meyer explains that "ambidextrous culture" is the concurrent search of flexibility and alignment at a business unit/sector which is linked to several organizational outcomes including improved performance and innovation.

This ambidextrous culture can be divided into two broad categories: Execution culture and innovative culture. Execution culture is a working environment that is more process- and task-driven to get things done. The oil and gas industry has typically favored the execution culture, where there is a central decision-maker at the head of the table. Research and recommendations on pertinent matters are typically presented to decision-makers who sit through a PowerPoint presentation. Subsequently, a decision is made based on the facts presented via PowerPoint presentation.

One critical demerit of this setup is that it usually leans towards low-risk conservative judgment. The executive lifestyle has worked in the past in the oil and gas industry due to the high fixed cost, and the "failure is unacceptable" approach in the industry.

With new technologies such as 3D printing, predictive analytics, machine learning, and deep learning, one can test some ideas or thoughts through rapid prototyping in a lab setting to test their hypothesis. Therefore, this type of culture as a sole approach to decision-making in the industry may need to be reconsidered.

Meanwhile, innovative culture is a work environment where leaders encourage and nurture unorthodox thinking in approaching problem solutions and applications. If the energy industry leaned more toward this style of culture, it would help foster innovation and accelerate the innovation landscape in the industry.

Innovative culture is a more design-oriented approach that generates a large pool of options and also incorporates a visual thinking framework. It enhances a creative mode for the audience, and everybody in the company ends up being a decision-maker. This type of culture fosters open innovation, eliminates the fear of expression, and pushes for more collaboration and creativity in the ecosystem.

According to a recent survey done by Accenture Strategy, 76 percent of leaders say they regularly empower employees to be innovative, while only 42 percent of employees agree. This shows an apparent disparity in more than the perceptions of employers versus employees and the belief that innovative culture is not promoted by middle management. This barrier can be broken down by instituting and enforcing an innovative culture.

Staying agile in a transforming world

The world has changed, and it will continue to transform. Various factors are disrupting traditional methods of business management across the globe, and organizational behavior is being impacted significantly. For an organization to be competitive globally, it requires innovation and creativity.

The rate at which businesses are facing competition requires agility. Employees are pressured to give their best and to come up with new ideas at a level even beyond some of history's greatest minds. For many, uncertainty and insecurity abounds. The fear of being made redundant and a resulting lack of trust prevents creativity among employees.

Trust, productive gameplay, and fun — critical components of an innovative culture — can spark creativity and increase global competitiveness. Due to the recent downturn, most teams are burdened with the same amount of work, which was meant for double or tripled their workforce and are still expected to perform at their peak capability. They need the right conducive environment to function.

Implementing action

While the energy industry should avoid trying to copy innovative practices from technology companies, oil and gas companies should review possible case studies that can be incorporated in fostering an acceptable culture for millennials to be attracted to the industry.

Presentation is important

Take a look at your marketing materials, for instance. Skip the stereotypical image of the macho oil guy on a rig operating the brake handle and showcase how the industry is adapting open innovation across sectors such as using predictive analytics and rapid prototyping to help design a safe working environment. Showcasing the conducive culture we experience in oil and gas, which challenges us to think outside the box and solve the world's energy problems will be an excellent way to create opportunities internally in companies and also attract and retain talent from different backgrounds and industries to help solve the world's energy problems.

Consider flexible work initiatives

To help establish and foster an innovative culture in oil and gas, the industry needs to embrace virtual and remote working environments, retraining and refresher courses to keep employees' skills relevant to solving problems, leaders setting a positive example on work-life balance and cutting down or avoiding long-distance travel via virtual meetings. Others essential pointers to consider are, giving employees the freedom to be themselves at work, leadership or management having a positive attitude towards failure, allowing remote work on days on which employees have personal commitments, networking events with company leaders scheduled during office hours, having an open channel for the report of sexual discrimination/harassment incident(s) to the company, among others.


I'd like to close with a quote from another influential book, "The Innovator's Dilemma," by Harvard Professor Clay Christensen. He writes, "When an organization's capabilities reside primarily in its people, changing to address new problems is relatively simple. However, when the capabilities have come to live in processes and values and especially when they have become embedded in culture, change has become extraordinarily complicated."

Establishing a uniquely innovative culture within the energy industry will be a great foundation going forward, for spurring progress in the oil and gas sector.

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Nii A. Nunoo is senior associate and management consultant within Strategy and Energy Core Operations at KPMG.

This Houston virtual health care platform makes it easier to get answers

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As hard as he tried, Brigham Buhler couldn't achieve the weight-loss and fitness goals he'd set in his mid-20s. Plus, he constantly felt tired and stressed out. On top of that, Brigham's entire immediate family has diabetes, and he was exhibiting the warning signs.

Buhler's nutritionist recommended he get his hormones checked. It wound up taking three months to get an initial appointment with a urologist, who then recommended a comprehensive blood test.

The blood work revealed that he did, indeed, have a hormone deficiency. Subsequent hormone treatment, in addition to taking vitamins and supplements to combat various risk factors, got Buhler's endocrine system back on track.

Born out of that frustrating situation and spurred by his more than 15 years in the medical-device industry, Buhler launched Houston-based Ways2Well in 2018. Propelled by a virtual health care platform, the company envisions a better way to treat patients by challenging the traditional health care model.

"While most virtual health care providers focus on sick care — treating patients experiencing symptoms that indicate sickness — Ways2Well is focused on preventative health care," says Buhler, a graduate of the University of Houston.

Through his own patient journey, Brigham Buhler saw a need for Ways2Well to exist. Photo via ways2well.com

Here's how Ways2Well works.

A patient visits the company's website to schedule a blood analysis at a Houston-area location of Quest Diagnostics. (Each year, Quest Diagnostics serves one-third of American adults and half of U.S. physicians and hospitals.)

Before the lab work, the patient discusses health concerns and wellness goals through a virtual appointment with a Ways2Well nurse practitioner.

Once the blood analysis is done, the nurse practitioner reviews the test results during a virtual appointment. The practitioner pinpoints underlying causes of chronic symptoms and potential risks for major conditions like heart disease, cancer, and diabetes. Those three ailments are the main drivers of the $3.5 trillion in annual health care costs racked up in the U.S. Ways2Well strives to reverse the symptoms of these and other chronic illnesses.

Finally, the nurse practitioner shares lifestyle or dietary changes that can reduce the likelihood of developing chronic diseases.

"Our online platform allows you to manage your health care journey from the convenience of your home or office, as long as you have access to a computer or phone and internet," Ways2Well says on its website.

Ways2Well charges nothing for a patient's initial 15-minute consultation. The blood analysis costs $299; Buhler says it goes well beyond what primary care doctors normally offer. The review of the blood analysis costs $120. Follow-up appointments cost $60 each. Neither Ways2Well nor ReviveRx accepts health insurance. However, an insurer might reimburse some out-of-pocket expenses.

The Ways2Well clinical team can prescribe medication, hormone therapy, prescription-grade vitamins and supplements, and other remedies through Ways2Well's partner pharmacy, ReviveRX. Ways2Well and ReviveRx occupy offices in the same building.

Typically, health care providers and pharmacies don't collaborate that closely on patient care. "Ways2Well is bridging that gap to offer better treatment to our patients," Buhler says.

Although ReviveRx is a full-service pharmacy, it doesn't operate like retail pharmacies such as Walgreens and CVS. Rather, patients are referred directly to ReviveRx by Ways2Well or Houston health care providers.

Today, Ways2Well focuses on the Houston market. But Buhler says the 12-employee, self-funded startup aims to expand to other Texas markets, such as Austin, Dallas-Fort Worth, and San Antonio.

"Because Ways2Well is a virtual health care provider that offers appointments via video conferences and leverages the Quest Diagnostics network for blood analysis, Ways2Well can treat patients from anywhere in Texas," he says. "Ultimately, the goal is to make Ways2Well available nationwide, with a team of clinical experts across the U.S."

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