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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Houston femtech co. debuts new lactation and wellness pods

mom pod

Houston-based femtech company Work&, previously known as Work&Mother, has introduced new products in recent months aimed at supporting working mothers and the overall health of all employees.

The company's new Lactation Pod and Hybrid Pod serve as dual-use lactation and wellness spaces to meet employer demand, the company shared in a news release. The compact pods offer flexible design options that can serve permanent offices and nearly all commercial spaces.

They feature a fully compliant lactation station while also offering wellness functionalities that can support meditation, mental health, telehealth and prayer. In line with Work&'s other spaces, the pods utilize the Work& scheduling platform, which prioritizes lactation bookings to help employers comply with the PUMP Act.

“This isn’t about perks,” Jules Lairson, Work& co-founder and COO, said in the release. “It’s about meeting people where they are—with dignity and intentional design. That includes the mother returning to work, the employee managing anxiety, and everyone in between.”

According to the company, several Fortune 500 companies are already using the pods, and Work& has plans to grow the products' reach.

Earlier this year, Work& introduced its first employee wellness space at MetroNational’s Memorial City Plazas, representing Work&'s shift to offer an array of holistic health and wellness solutions for landlords and tenants.

The company, founded in 2017 by Lairson and CEO Abbey Donnell, was initially focused on outfitting commercial buildings with lactation accommodations for working parents. While Work& still offers these services through its Work&Mother branch, the addition of its Work&Wellbeing arm allowed the company to also address the broader wellness needs of all employees.

The company rebranded as Work& earlier this year.

Rice biotech studio secures investment from Modi Ventures, adds founder to board

fresh funding

RBL LLC, which supports commercialization for ventures formed at the Rice University Biotech Launch Pad, has secured an investment from Houston-based Modi Ventures.

Additionally, RBL announced that it has named Sahir Ali, founder and general partner of Modi Ventures, to its board of directors.

Modi Ventures invests in biotech companies that are working to advance diagnostics, engineered therapeutics and AI-driven drug discovery. The firm has $134 million under management after closing an oversubscribed round this summer.

RBL launched in 2024 and is based out of Houston’s Texas Medical Center Helix Park. William McKeon, president and CEO of the TMC, previously called the launch of RBL a “critical step forward” for Houston’s life sciences ecosystem.

“RBL is dedicated to building companies focused on pioneering and intelligent bioelectronic therapeutics,” Ali said in a LinkedIn post. “This partnership strengthens the Houston biotech ecosystem and accelerates the transition of groundbreaking lab discoveries into impactful therapies.”

Ali will join board members like managing partner Paul Wotton, Rice bioengineering professor Omid Veiseh, scientist and partner at KdT Ventures Rima Chakrabarti, Rice alum John Jaggers, CEO of Arbor Biotechnologies Devyn Smith, and veteran executive in the life sciences sector James Watson.

Ali has led transformative work and built companies across AI, cloud computing and precision medicine. Ali also serves on the board of directors of the Drug Information Association, which helps to collaborate in drug, device and diagnostics developments.

“This investment by Modi Ventures will be instrumental to RBL’s growth as it reinforces confidence in our venture creation model and accelerates our ability to develop successful biotech startups,” Wotton said in the announcement. "Sahir’s addition to the board will also amplify this collaboration with Modi. His strategic counsel and deep understanding of field-defining technologies will be invaluable as we continue to grow and deliver on our mission.”