HEalth tech

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

Saranas Inc. is testing its technology that can detect and track internal bleeding complications. Getty Images

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."

Houston-based Moleculin has three different oncology technologies currently in trials. Getty Images

Immunotherapy and personalized medicine get all the headlines lately, but in the fight against cancer, a natural compound created by bees could beat them in winning one battle.

In 2007, chairman and CEO Walter Klemp founded Moleculin Biotech Inc. as a private company. The former CPA had found success in life sciences with a company that sold devices for the treatment of acne. That introduction into the field of medical technology pushed him toward more profound issues than spotty skin.

"Coincidentally, the inventor of that technology had a brother who was a neuro-oncologist at MD Anderson," Klemp recalls.

The since-deceased Dr. Charles Conrad slowly lured Klemp into what he calls the "cancer ecosphere" of MD Anderson. In 2016, the company went public. And it looks like sooner rather than later, it could make major inroads against some of the toughest cancers to beat.

Klemp observed that while Houston has the world's largest medical center, "the tragic irony" is that other cities have far more biotech money ready to be invested.

"The Third Coast is really starved for capital," he says. "What drew me into this was I was one of the few entrepreneurs that lived here that knew the ropes in terms of tapping into East and West Coast capital structures and could make that connection for them."

The company has three core technologies currently being tested with some success, but the most promising is called WP1066, named for researcher Waldemar Priebe, "a rock star" in his native Poland, according to Klemp, who works at MD Anderson. Though Priebe came to the U.S. in the 1980s, he is still an adjunct professor at the University of Warsaw and conducts some of his trials in Poland because it's easier to get grant money there.

WP1066 uses propolis, a compound of beeswax, sap and saliva that bees produce to seal small areas of their hives, as a base. The molecular compound that Priebe discovered affects STAT3 (signal transducer and activator of transcription), a transcription factor that encourages tumor development. In short, the active compound in WP1066 both downregulates the STAT3, a long-time Holy Grail in the cancer research world, and directly attacking the tumor, but also quieting T Cells, which allows the body's own immune system to fight the cancer itself. Essentially, it works both as chemotherapy and immunotherapy.

WP1066 is demonstrating drug-like properties in trials at MD Anderson on glioblastoma, the aggressive brain cancer that recently took the life of the hospital's former president, John Mendelsohn, as well as John McCain and Beau Biden. It is also being tested against pancreatic cancer, one of the most virulent killers cancer doctors combat.

Priebe also created Annamycin, named for his oldest daughter, a first-line chemotherapy drug that fights Acute Myeloid Leukemia without the cardiotoxicity that can damage patients' hearts even as they beat their cancer.

WP1122 uses yet another mechanism to fight cancer.

"Most people don't know that morphine is essentially a modified version of heroin," Klemp explains.

The difference between the poppy-based drugs? Heroin can cross the blood-brain barrier. It's described as the dicetyl ester of morphine. WP1122 is the dicetyl ester of 2DG (2-Deoxyglucose), a glycolysis inhibitor, which works by overfilling tumor cells with fake glucose so that they can't consume the real glucose that makes them grow.

"The theory is, we could feed you so full of junk food that eventually you'd starve to death," Klemp elucidates. It can cross the blood-brain barrier and is metabolized slowly, meaning that it can be made into a drug in a way that 2DG cannot.

What's impressive about Moleculin is its diversity of drugs. Most companies have one drug that gets all or most of the attention. Moleculin has strong hopes for all three currently in trials.

"It's essentially multiple shots on the goal," says executive vice president and CFO Jonathan Foster.

Moleculin has 13 total employees, five of whom are based in Houston. An office in the Memorial Park area serves as a landing pad for employees and collaborators from around the world to get their work done when in Space City. The virtual office set-up works for the company because experts can stay in their home cities to get their work done. And that work is on its way to saving scores of lives.