Houston-based health tech startup is revolutionizing patient selection for clinical trials

working smarter

Sieve Health is an AI cloud-based SaaS platform designed to automate and accelerate matching patients with clinical trials. Photo via Getty Images

On many occasions in her early career, Dr. Arti Bhosale, co-founder and CEO of Sieve Health, found herself frustrated with having to manually sift through thousands of digital files.

The documents, each containing the medical records of a patient seeking advanced treatment through a clinical trial, were always there to review — and there were always more to read.

Despite the tediousness of prescreening, which could take years, the idea of missing a patient and not giving them the opportunity to go through a potentially life-altering trial is what kept her going. The one she didn’t read could have slipped through the cracks and potentially not given someone care they needed.

“Those stories have stayed with me,” she says. “That’s why we developed Sieve.”

When standard health care is not an option, advances in medical treatment could be offered through clinical trials. But matching patients to those trials is one of the longest standing problems in the health care industry. Now with the use of new technology as of 2018, the solution to the bottleneck may be a new automated approach.

“Across the globe, more than 30 percent of clinical trials shut down as a result of not enrolling enough patients,” says Bhosale. “The remaining 80 percent never end up reaching their target enrollment and are shut down by the FDA.”

In 2020, Bhosale and her team developed Sieve Health, an AI cloud-based SaaS platform designed to automate and accelerate matching patients with clinical trials and increase access to clinical trials.

Sieve’s main goal is to reduce the administrative burden involved in matching enrollments, which in turn will accelerate the trial execution. They provide the matching for physicians, study sponsors and research sites to enhance operations for faster enrollment of the trials.

The technology mimics but automates the traditional enrollment process — reading medical notes and reviewing in the same way a human would.

“I would have loved to use something like this when I was on the front lines,” Bhosale says, who worked in clinical research for over 12 years. “Can you imagine going through 10,000 records manually? Some of the bigger hospitals have upwards of 100,000 records and you still have to manually review those charts to make sure that the patient is eligible for the trial. That process is called prescreening. It is painful.”

Because physicians wear many hats and have many clinical efforts on their plates, research tends to fall to the bottom of the to-do list. Finding 10-20 patients can take the research team on average 15-20 months to find those people — five of which end up unenrolling, she says.

“We have designed the platform so that the magic can happen in the background, and it allows the physician and research team to get a jumpstart,” she says.” They don’t have to worry about reviewing 10,000 records — they know what their efforts are going to be and will ensure that the entire database has been scanned.”

With Sieve, the team was able to help some commercial pilot programs have a curated data pool for their trials – cutting the administrative burden and time spent searching to less than a week.

Sieve is in early-stage start up mode and the commercial platform has been rolled out. Currently, the team is conducting commercial projects with different research sites and hospitals.

“Our focus now is seeing how many providers we can connect into this,” she says. “There’s a bigger pool out there who want to participate in research but don’t know where to start. That’s where Sieve is stepping in and enabling them to do this — partnering with those and other groups in the ecosystem to bring trials to wherever the physicians and the patients are.”

Arti Bhosale is the co-founder and CEO of Sieve Health. Photo courtesy of Sieve
Houston-based Pulmotect announced a grant from the U.S. Department of Defense that will fund two COVID-19 drug trials. Photo via Getty Images

Houston biotech receives up to $6M federal grant for COVID-19 treatment

DOD delivered

The Pentagon is putting its financial power behind two COVID-19 clinical trials led by Houston-based biotech company Pulmotect Inc.

The U.S. Department of Defense is pumping as much as $6 million into the pair of Phase 2 trials, which involve a total of 300 U.S. participants, according to a January 27 news release from Pulmotect. When it's inhaled, Pulmotect's drug, PUL-042, stimulates the lungs' immune system to fight bacteria, viruses, or fungi that cause respiratory illnesses.

Pulmotect joins a number of Houston organizations that have tapped into Department of Defense funding for research into COVID-19 therapies.

In January, for instance, researchers at the University of Texas Health Science Center at Houston (UTHealth) collected $5.1 million from the department to evaluate whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients.

"It's wonderful that we have COVID-19 vaccinations available now, but they won't directly help patients who are already sick in the hospital or who will become sick in the future," Dr. Holger Eltzschig, chairman of Department of Anesthesiology at UTHealth's McGovern Medical School, says in a news release.

Also in January, Houston-based clinical research organization Pharm-Olam LLC sealed a $36.3 million deal with the Department of Defense to conduct a clinical trial of an antibody treatment for inflammatory problems associated with COVID-19.

So far, Pulmotect's PUL-042 has shown promise in battling the coronaviruses that trigger MERS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome). The current trials related to the coronavirus that causes COVID-19 are evaluating PUL-042's effect on prevention of infections and reducing the severity of the disease.

Pulmotect initially designed PUL-042 to treat and prevent respiratory complications in cancer patients. But once the coronavirus pandemic set in, the company pivoted to testing the effectiveness of its drug in combatting the virus that causes COVID-19. Last May, the U.S. Food and Drug Administration (FDA) approved Pulmotect's COVID-19 trials.

Pulmotect says PUL-042 someday could be a therapy that's deployed during pandemics, epidemics, and bioterrorism attacks.

Invented at Houston's MD Anderson Cancer Center and at Texas A&M University, PUL-042 has earned patents in 10 countries. The National Institutes of Health, the Cancer Prevention and Research Institute of Texas, and other organizations have supported R&D for PUL-042.

Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector. In September 2019, the company brought aboard Dr. Colin Broom as CEO. He previously was CEO of an Irish biopharmaceutical company.

Thus far, Pulmotect has garnered about $18 million in equity and about $20 million in other funding.

Before the pandemic, Pulmotect was evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus.

COPD, which affects 30 million Americans, is the No. 3 cause of death in the U.S., according to the COPD Foundation. Pulmotect says 40 percent of COPD-related costs could be avoided by heading off complications and hospitalizations, which usually result from COPD problems caused by a bacterial or viral infection. In this context, the drug is meant to treat cancer patients undergoing chemotherapy whose weakened immune systems make them susceptible to pneumonia.
Pulmotect is headed to clinical trials to verify how its drug fights against COVID-19. Getty Images

Houston biotech company gets green light from FDA to test coronavirus-fighting drug

clinical trials bound

Houston biotech company Pulmotect Inc. has embarked on two clinical drug trials that could create weapons for the battle against the novel coronavirus.

Pulmotect gained permission from the U.S. Food and Drug Administration to test its inhaled drug, PUL-042, as a way to prevent coronavirus infections and to slow the early progression of COVID-19, the potentially fatal disease caused by the novel coronavirus. Pulmotect developed PUL-042 to activate the lungs' front-line defense against respiratory infections, and now it's being enlisted in the race to devise coronavirus treatments and cures.

"We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," Dr. Colin Broom, CEO of Pulmotect, says in a May 7 release. "Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of [the coronavirus] and future emerging pathogens, and protecting vulnerable populations."

Unlike a vaccine, which typically takes 10 to 15 years to bring to the market, PUL-042 promises much faster deployment as scientists and health care workers wage war against COVID-19.

Each of the two clinical trials, both in the second phase, is being conducted at 10 sites across the U.S., including locations in Houston. In all, 20 sites are participating. Money for the trials came from the company's recently completed $12 million round of series B funding.

Pulmotect's partner in the trials is Covington, Kentucky-based CTI Clinical Trial and Consulting Services Inc. PARI Respiratory Equipment Inc., whose North American headquarters is in Midlothian, Virginia, is supplying medical equipment known as nebulizers to administer Pulmotect's inhaled drug.

"Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy," Broom says in a May 5 release.

"In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a 10-day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042."

Previous experiments conducted by Pulmotect indicate PUL-042 effectively protects mice against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are caused by coronaviruses that differ from the COVID-19 virus. Researchers performed those tests at the University of Texas Medical Branch at Galveston.

PUL-042 initially was developed to fight respiratory problems in cancer patients undergoing chemotherapy, which weakens the immune system. But the drug offers the potential to prevent or treat an array of respiratory infections caused by viruses, bacteria, or fungi.

"We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face," Broom says.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are susceptible to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's PUL-042, which holds patents in 10 countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which fosters early stage companies in the life sciences sector.
Saranas Inc. is testing its technology that can detect and track internal bleeding complications. Getty Images

Houston medical device company heads to clinical trials following recent $2.8 million raise

HEalth tech

A Houston-based medical device startup is on a twofold mission to reduce healthcare costs and improve the safety of complex medical procedures involving blood vessels.

Saranas Inc. currently is testing its Early Bird Bleed Monitoring System, which is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"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, president and CEO of Saranas. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

Dr. Mehdi Razavi, a cardiologist with the Texas Heart Institute at Houston's Texas Medical Center, invented the device. It's being tested by the institute and other medical facilities in the U.S. As many as 100 patients will participate in the clinical trial, which is expected to last several months.

If all goes well, the U.S. Food and Drug Administration will approve Early Bird in 2019, Syed says. Then, the device would be made widely available to medical facilities across the country.

In May, Saranas said it received $2.8 million in funding from investors to enable testing of Early Bird. In all, the startup has collected $12 million from investors. A month after the funding announcement, Saranas was one of 50 startups chosen for the MedTech Innovator program, which nurtures medical technology companies.

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 get audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be halted or prevented.

"There is a risk of bleeding that occurs when some of these coronary interventions are performed through the femoral artery, which is in the upper thigh," Syed says.

In a release, Texas Heart Institute cardiologist Dr. Joggy George says internal bleeding "remains the Achilles' heel" of advances in noninvasive endovascular procedures.

Syed says there's an underappreciation for how often bleeding occurs during nonsurgical procedures that provide access to a patient's blood vessels. Each year, doctors perform these procedures on more than 20 million patients in the U.S.; of those, about 1 million experience severe complications from bleeding. Those complications can lead to longer, more expensive hospital stays along with a higher risk of death.

Initially, Saranas is targeting high-risk endovascular procedures done with large sheaths, rather than endovascular procedures performed with sheaths of all sizes, Syed says.

Syed took the helm of Saranas in February 2017. He's spent nearly 20 years in the medical device industry, including four years at Bellaire-based OrthoAccel Technologies Inc.

For the time being, Syed is one of just a handful of employees at Saranas, which was founded in 2013 and has benefited from its affiliation with the Texas Medical Center Innovation Institute. Syed expects to grow the Saranas team in 2019 once the Early Bird gains clearance from the FDA.

During his tenure in the medical device sector, Syed has been "keenly interested" in bringing impactful innovations to the market, such as the Early Bird device.

"It is especially important to me that such innovation not only improves health outcomes but also aims to drive down healthcare costs," he says. "We are in a healthcare environment where if you don't have a health economic benefit coupled with a clinical outcome, it is very challenging to get adoption of new technology."
Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

4 tips for pay negotiation amid inflation from this Houston expert

guest column

With the consumer price index rising 9.1 percent since last year, many Americans are evaluating new employment opportunities with better pay. However, employees would be wise to consider the risks of accepting a new position in the face of inflation and a possible recession, which could leave employers unable to sustain higher wages and generous benefits.

As a safer option in the longterm, employees may wish to ask for a raise from their current management, yet many do not know how to start the conversation. By understanding best practices for negotiations, employees can improve their chances of obtaining a pay raise without undermining relationships.

Understand the risks of job-hopping

Conventional wisdom suggests that job hopping can result in higher salary increases than an annual raise. During the pandemic, many employees took advantage of labor market shortages to secure new positions for higher pay. However, job hopping presents risks, particularly in an uncertain economic environment. Companies may institute “last in, first out” layoffs, leaving recent hires unemployed.

Even in strong economic conditions, job-hoppers face uncertain outcomes. When employees leave a company, they may leave behind teammates, mentors, client partnerships and friendships years in the making. These relationships can redevelop in a new organization, but employees may find themselves in an unfamiliar setting, facing unrealistic expectations or unexpected challenges that were not clear during the interview process.

Prepare ahead of time

Before approaching management with a request for a raise, employees should understand their own financial needs and how much additional compensation would improve their finances. If inflation has caused financial strain, employees should gather recent data on inflation, including the consumer price index, to share with management. The more information employees can offer about changing economic conditions, the more management will understand and accept their position.

Focus on the positive

Employees should begin a conversation about salary with praise for the organization and a reiteration of their commitment to the team. By beginning on a positive note, employees set the tone for a mutually productive conversation. Although employees may view salary negotiations as adversarial across the table, productive negotiations are a conversation with both employee and employer on the same team.

Likewise, while employees may worry about looking greedy, employees should not let that fear prevent them from opening the conversation. Employers also understand that employees work to meet their financial needs. While employers may face budget constraints or other considerations in salary allocation, strong management also recognizes the importance of nurturing growth among employees, both in compensation and job responsibilities.

Nonetheless, employees should focus the discussion on broader economic conditions like inflation, not on their personal budget items. By acknowledging the economic environment outside of the employer’s control, employees can then respectfully request their salary be adjusted for inflation.

Employees with a record of strong results can also gather data or performance reviews to demonstrate their contributions to the team beyond the expectations of their role. In doing so, employees can frame a salary increase as a celebratory recognition of the mutually successful partnership between employee and employer and an investment in the relationship.

Be flexible if negotiations stall

If employers decline to adjust an employee’s salary for inflation, employees should not give up on negotiating additional compensation or benefits. Rather than a pay raise, employees can ask for reimbursement for gas mileage or additional remote days to cut down on their commutes. If management declines a pay raise based on timing, employees can acknowledge that management may face budgetary constraints, remaining flexible but firm. For instance, a compromise may involve revisiting the discussion in three to six months.

As employees face record-breaking inflation, it remains critical to consider the risks of departing one role for another. By implementing best practices in salary negotiations, employees can secure a salary increase that matches inflation, avoid the uncertainty of job-hopping and invest in the future at their current company.

------

Jill Chapman is a senior performance consultant with Insperity, a leading provider of human resources and business performance solutions.

Houston small biz tech platform launches entrepreneur-focused credit card

hello credit

When you're a small business owner, every service you sign up for or institution you open an account at should be a helpful partner on your business journey. At least, that's how Hello Alice sees it.

The Houston company has partnered up with Mastercard and First National Bank of Omaha to provide small business owners a suite of financial services with their line of credit. The Hello Alice Small Business Mastercard will offer users expert business advice, business insights, cashback, and a rewards program that gives entrepreneurs points for completing business-advancing activities on the Hello Alice platform.

“We designed the Hello Alice Small Business Mastercard to meet the needs of small business owners where they are, breaking longstanding barriers to mentorship, access to credit, and overall financial health for those who have traditionally been denied access,” says Elizabeth Gore and Carolyn Rodz, co-founders of Hello Alice, in a statement.

“In times of economic boom and bust, access to capital remains the leading challenge for all small business owners, and particularly for New Majority owners, which is why we continue to focus our efforts on expanding the capital continuum beyond our existing grants and loans programs,” the duo continued.

Offered as a traditional credit card, the Hello Alice Small Business Mastercard provides users with credit-building opportunities. Business owners with a limited or poor credit history also have the opportunity to a secured version of the credit card that still provides full benefits from the program.

“Small businesses are the backbone of our communities, yet too often face significant obstacles in securing the resources they deserve, particularly if the owners come from underserved communities,” says Linda Kirkpatrick, president for North America at Mastercard, in the release. “The launch of the Hello Alice Small Business Mastercard is an important step in our mission to build a more inclusive digital economy by providing small businesses with the financial tools and capital they need to thrive, while also advancing our half-billion-dollar commitment to help close the racial wealth and opportunity gap for Black communities.”

This initiative is the latest announcement from Hello Alice’s Equitable Access to Capital program, which is focused on increasing access to the capital — as well as financial products, tools, and education — small businesses need to grow sustainably and power the national economy. By 2025, according to Hello Alice, approximately $70 million in grants could fund credit enhancements for approximately 30,000 business owners, unlocking up to $1 billion in credit access.

“FNBO has been committed to helping small businesses succeed for 165 years, and we are proud to partner with Hello Alice and Mastercard in this vital initiative to elevate all small businesses,” says Jerry J. O’Flanagan, executive vice president of Partner Customer Segment at First National Bank of Omaha.


The new credit card will provide credit and financial advice, support, and education to small business owners. Image via helloalice.com

Houston Methodist to open health innovation center in the Ion

coming soon

The Houston Methodist healthcare system has teamed up with the Ion innovation hub to open a health care innovation center.

The 1,200-square-foot tech hub is expected to open later this year. It initially will be geared toward activities like entrepreneurial programming, networking, mentoring, and pitching.

The space will be modeled after Houston Methodist’s Center for Innovation Technology Hub, which opened in 2020. In fact, the new hub will be a smaller “twin” of the existing hub, according to a news release.

Jan Odegard, executive director of the Ion, says the collaboration with Houston Methodist “will advance the Ion’s ability to support entrepreneurs and innovators that are already at the Ion as we embark on a new focus in health care innovation.”

Amid the rise of artificial intelligence and other tech advancements, along with the health care sector’s continuing drive to cut costs, one forecast indicates the value of the global market for digital health care will jump from $216.4 billion in 2022 to $441 billion by 2026. That would represent an increase of 104 percent.

Houston Methodist is the Ion’s first health care partner. The Ion already has partnerships in the aerospace and energy sectors.

“We are advancing the evolution of the hospital’s role in health care through digital transformation,” said Michelle Stansbury, vice president of innovation and IT applications at Houston Methodist. “Having a footprint at the Ion will not only provide the Ion’s network and Houston community with a window into what we are doing for patients, consumers and providers, but also gives The Ion community and rising innovators an opportunity to bring its own ingenuity and ideas to life with ours.”

Houston Methodist operates eight hospitals in the Houston area.

The 266,000-square-foot Ion anchors a 16-acre innovation district in Midtown. Rice Management Co. developed the district on behalf of Rice University.

“By enhancing opportunities for our network of academics, businesses, entrepreneurs, and innovators to collaborate across the Ion District and globally, we’re creating a more resilient future economy for our region,” says Bryson Grover, investment manager of real estate at Rice Management.

The space will be modeled after Houston Methodist’s Center for Innovation Technology Hub, which opened in 2020. Natalie Harms/InnovationMap

View All Listings