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."

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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 space company lands latest NASA deal to advance lunar logistics

To The Moon

Houston-based space exploration, infrastructure, and services company Intuitive Machines has secured about $2.5 million from NASA to study challenges related to carrying cargo on the company’s lunar lander and hauling cargo on the moon. The lander will be used for NASA’s Artemis missions to the moon and eventually to Mars.

“Intuitive Machines has been methodically working on executing lunar delivery, data transmission, and infrastructure service missions, making us uniquely positioned to provide strategies and concepts that may shape lunar logistics and mobility solutions for the Artemis generation,” Intuitive Machines CEO Steve Altemus says in a news release.

“We look forward to bringing our proven expertise together to deliver innovative solutions that establish capabilities on the [moon] and place deeper exploration within reach.”

Intuitive Machines will soon launch its lunar lander on a SpaceX Falcon 9 rocket to deliver NASA technology and science projects, along with commercial payloads, to the moon’s Mons Mouton plateau. Lift-off will happen at NASA’s Kennedy Space Center in Florida within a launch window that starts in late February. It’ll be the lander’s second trip to the moon.

In September, Intuitive Machines landed a deal with NASA that could be worth more than $4.8 billion.

Under the contract, Intuitive Machines will supply communication and navigation services for missions in the “near space” region, which extends from the earth’s surface to beyond the moon.

The five-year deal includes an option to add five years to the contract. The initial round of NASA funding runs through September 2029.

Play it back: Houston home tech startup begins 2025 with fresh funding

HOUSTON INNOVATORS PODCAST EPISODE 272

One of the dozen or so Houston startups kicking of the new year with fresh funding is SmartAC.com, a company that's designed a platform that enables contractors in the HVAC and plumbing industries to monitor, manage, and optimize their maintenance memberships through advanced sensors, AI-driven diagnostics, and proactive alerts.

Last month, the SmartAC.com raised a follow-on round with support from local investor Mercury to continue growth and expansion of the product, which has evolved on many ways since the company launched in 2020, emerging from stealth with $10 million raised in a series A. In a May 2023 interview for the Houston Innovators Podcast, Founder and CEO Josh Teekell explained how he embraced the power of a pivot.

The company's sensors can monitor all aspects of air conditioning units and report back any issues, meaning homeowners have quicker and less costly repairs. While SmartAC.com started with providing the service and tech to homeowners directly, Teekell says he's had a greater interest in working with plumbers and HVAC companies who then deploy the technology to their customers.

"It became quite evident that homeowners don't care about air conditioning really at all until their system breaks," Teekell says on the show. "The technology is really built around giving those contractors as another way to gain a customer relationship and keep it."

Revisit the podcast episode below where Teekell talks about SmartAC.com's last raise.

SmartAC.com's previous round in 2023 — a $22 million series B — was used grow its team that goes out to deploy the technology and train the contractors on the platform.

"We've been very fortunate to get some of the biggest names in Houston on our cap table," Teekell says in the May 2023 conversation. "Since we're raising a bunch of money locally, everyone understands what a pain air conditioning can be."

Houston biotech company tests hard-to-fight cancer therapeutics

fighting cancer

A Houston-based, female-founded biotech company has developed a treatment that could prove to be an effective therapy for a rare blood cancer.

Cellenkos Therapeutics has completed promising Phase 1b testing of its Treg cell therapy, CK0804, in the fight against myelofibrosis. According to a news release from the Cellenkos team, the use of its cord-blood-derived therapeutics could signal a paradigm shift for the treatment of this hard-to-fight cancer.

Cellenkos was founded by MD Anderson Cancer Center physician and professor Simrit Parmar. Her research at the hospital displayed the ability of a unique subset of T cells’ capability to home in on a patient’s bone marrow, restoring immune balance, and potentially halting disease progression.

Myelofibrosis has long been treated primarily with JAK (Janus Kinase) inhibitors, medications that help to block inflammatory enzymes. They work by suppressing the immune response to the blood cancer, but don’t slow the progression of the malady. And they’re not effective for every patient.

“There is a significant need for new therapeutic options for patients living with myelofibrosis who have suboptimal responses to approved JAK inhibitors,” Parmar says. “We are greatly encouraged by the safety profile and early signs of efficacy observed in this patient cohort and look forward to continuing our evaluation of the clinical potential of CK0804 in our planned expansion cohort.”

The expansion cohort is currently enrolling patients with myelofibrosis. What exactly are sufferers dealing with? Myelofibrosis is a chronic disease that causes bone marrow to form scar tissue. This makes it difficult for the body to produce normal blood cells, leaving patients with fatigue, spleen enlargement and night sweats.

Myelofibrosis is rare, with just 16,000 to 18,500 people affected in the United States. But for patients who don’t respond well to JAKs, the prognosis could mean a shorter span than the six-year median survival rate outlined for the disease by Cleveland Clinic.

Helping myelofibrosis patients to thrive isn’t the only goal for Cellenkos right now.

The company seeks to aid people with rare conditions, particularly inflammatory and autoimmune disorders, with the use of CK0804, but also other candidates including one known as CK0801. The latter drug has shown promising efficacy in aplastic anemia, including transfusion independence in treated patients.

The company closed its $15 million series A round led by BVCF Management, based in Shanghai, in 2021. Read more here.

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