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."

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Houston biopharma company launches equity crowdfunding campaign

money moves

A clinical-stage company headquartered in Houston has opened an online funding campaign.

FibroBiologics, which is developing fibroblast cell-based therapeutics for chronic diseases, launched a campaign with equity crowdfunding platform StartEngine. The platform lets anyone — regardless of their net worth or income level — to invest in securities issued by startups.

The funding, according to a press release, will be used to support ongoing operations of Fibrobiologics and advance its clinical programs in multiple sclerosis, degenerative disc disease, wound care, extension of life, and cancer.

"We're excited to partner with StartEngine on this campaign. StartEngine has over 600,000 investors as part of their community and has raised over half a billion dollars for its clients," says FibroBiologics' Founder and CEO Pete O'Heeron, in the release.

"This is an exciting time at FibroBiologics as we continue progressing our clinical pipeline and developing innovative therapies to treat chronic diseases," he continues. "This new funding will fuel our growth in the lab and bring us one step closer to commercialization."

The campaign, launched this week, already has over 100 investors, at the time of publication, and has raised nearly $2 million, according to the page. The minimum investment is set at around $500, and the company's indicated valuation is $252.57 million.

In 2021, FibroBiologics announced its intention of going public. Last year, O'Heeron told InnovationMap on the Houston Innovators Podcast of the company's growth plans as well as the specifics of the technology.

Only two types of cells — stem cells and fibroblasts — can be used in cell therapy for a regenerative treatment, which is when specialists take healthy cells from a patient and inject them into a part of the body that needs it the most. As O'Heeron explains in the podcast, fibroblasts can do it more effectively and cheaper than stem cells.

"(Fibroblasts) can essentially do everything a stem cell can do, only they can do it better," says O'Heeron. "We've done tests in the lab and we've seen them outperform stem cells by a low of 50 percent to a high of about 220 percent on different disease paths."


Texas ranks as a top state for female entrepreneurs

women in business

Texas dropped three spots in Merchant Maverick’s annual ranking of the top 10 states for women-led startups.

The Lone Star State landed at No. 5 thanks in part to its robust venture capital environment for women entrepreneurs. Last year, Texas ranked second, up from its No. 6 showing in 2021.

Merchant Maverick, a product comparison site for small businesses, says Texas “boasts the strongest venture capital scene” for women entrepreneurs outside California and the Northeast. The state ranked fourth in that category, with $6.5 billion invested in the past five years.

Other factors favoring Texas include:

  • Women solely lead 22 percent of all employees working for a business in Texas (No. 4).
  • Texas lacks a state income tax (tied for No. 1).

However, Texas didn’t fare well in terms of the unemployment rate (No. 36) and the rate of business ownership by women (No. 29). Other Texas data includes:

  • Average income for women business owners, $52,059 (No. 19).
  • Early startup survival rate, 81.9 percent (No. 18).

Appearing ahead of Texas in the 2023 ranking are No. 1 Colorado, No. 2 Washington, No. 3 California, and No. 4 Arizona.

Another recent ranking, this one from NorthOne, an online bank catering to small businesses, puts Texas at No. 7 among the 10 best states for women entrepreneurs.

NorthOne says Texas provides “a ton of opportunities” for woman entrepreneurs. For instance, it notches one of the highest numbers of women-owned businesses in the country at 1.4 million, 2.1 percent of which have at least 500 employees.

In this study, Texas is preceded by Colorado at No. 1, Nevada at No. 2, Virginia at No. 3, Maryland at No. 4, Florida at No. 5, and New Mexico at No. 6. The rankings are based on eight metrics, including the percentage of woman-owned businesses and the percentage of women-owned businesses with at least 500 employees.