The next TMCx cohort begins August 5. Courtesy of TMC

The Texas Medical Center's startup accelerator, TMCx, has added 19 companies from all around the world to join its medical device family.

The TMC Innovation Institute team narrowed down 140 applications to 40 for the second round of the process, which includes face-to-face interviews, according to a release. After those, 18 companies were selected to join the TMCx09 class, which focuses on medical devices. The last cohort, which specialized in digital health, concluded on June 6.

Out of the 18 companies, five are from Houston. Four other startups hail from other corners of the United States, while 10 international companies also made the cohort. The program commences on August 5, and will run for four months before concluding in a demo day event in November.

Here are the medical device startup companies joining the TMCx09 cohort.

See update at the bottom of this story.

Vascular devices

  • Neurescue (Copenhagen, Denmark) — Neurescue has developed a computer-aided aortic occlusion catheter to help save the lives of patients in the emergency care setting.
  • Venari Medical (Galway, Ireland) — Venari Medical is developing BioVena — a medical device that treats varicose veins and venous leg ulcers with a minimally invasive approach intended to reduce pain.
  • Obsidio (Solana Beach, California) — Obsidio is developing a universal gel embolic material to shrink lesions or to treat internal bleeds, aneurysms and vascular malformations.

Novel therapies

  • PATH EX (Houston) — PATH EX is developing an extracorporeal blood cleansing device designed to selectively remove pathogens, including multi-drug resistant bacteria, and endotoxins from circulating blood to diagnose and treat sepsis.
  • Innosphere (Hafia, Israel) — Innosphere is a medical device company developing brain stimulation solutions for treating cognitive disorders, with a focus on ADHD.

Rehab

  • AbiliTech (St. Paul, Minnesota) — AbiliTech is restoring independence to patients with upper limb neuromuscular conditions by offering a wearable assistive device that allows the user to perform independent activities of daily living.
  • Komodo OpenLab (Toronto, Ontario, Canada) — Komodo OpenLab has developed Tecla, an assistive device giving individuals with physical disabilities the ability to communicate, control, and connect with the world.

Surgery

  • CNX Medical (Houston) — CNX Medical is developing a transcutaneous neurostimulator that is placed in the ear and helps reduce inflammation after abdominal surgery, with a focus on post-operative ileus.
  • CorInnova (Houston) — CorInnova has developed a soft robotic non-blood contacting biventricular cardiac assist device for the treatment of heart failure that would eliminate the many adverse events associated with current technologies.
  • Ictero Medical (Houston) — Ictero Medical is developing a minimally invasive ablation solution to treat high-risk patients with gallstone disease and offer patients the benefits of surgery without the risk. The company was among the big winners at the Texas A&M New Ventures Competition.

Diagnostics

  • Artidis (Basel, Switzerland) — InArtidis has developed a nanomechanical biomarker technology using precise tissue measurement in combination with data analytics to personalize cancer diagnosis.
  • Inveox (Munich, Germany) — Inveox automates the pre-analytical process in cancer diagnosis to improve patient safety and lab efficiency.
  • Cambridge Respiratory Innovations Ltd. (Cambridge, United Kingdom) — CRiL has developed, N-Tidal, a device that analyzes CO2 end-tidal breathing to improve respiration monitoring.

Toward home health

  • Kegg (San Francisco) — Kegg is on a mission to simplify every woman's journey towards taking charge of her fertility with a user-friendly monitoring device.
  • TestCard (London) — TestCard is a flat pack urine test kit that functions in combination with a mobile phone application, turning a phone's camera into a clinical grade scanner.
  • Patch'd (New South Wales, Australia, and San Francisco) — Patch'd uses deep learning and wearable devices to predict the onset of sepsis in the at-home patient.

Transplant

  • Volumetric (Houston) — Volumetric's 3D bioprinting platform creates materials with living cells with applications in biomaterials, cancer research, and eventually human organ replacements. The company's technology started out of Rice University.
  • Tevosol (Edmonton, Alberta, Canada) — Tevasol is developing organ transplant transportation solutions. Their portable warm perfusion machines will help surgeons transplant more organs today and solve organ shortage tomorrow.

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Diagnostic Photonics withdrew from the program after the article published.

Houston-based Galen Data is growing its clientbase and just formed two new partnerships with medical device companies. Photo via galendata.com

Houston health care data company grows with new medical device partnerships

Digitizing health

Educated as an engineer, Chris DuPont has stepped outside his professional comfort zone to generate funding for his Houston-based startup, Galen Data Inc. DuPont's pool of technical contacts in Houston is "wide and deep," he says, but his pool of financial contacts had been shallow.

Overcoming obstacles in Houston's business waters, DuPont has raised two rounds of angel funding — he declines to say how much — that have enabled Galen Data to develop and market its cloud-based platform for connecting medical devices to the internet, including pacemakers and glucose monitors. DuPont is the startup's co-founder and CEO. Galen Data's platform meets compliance standards set by the U.S. Food and Drug Administration (FDA), the Health Insurance Portability and Accountability Act of 1996 (HIPPA), cybersecurity organizations, and others.

Galen Data's patent-pending technology lets medical device manufacturers tailor the cloud-based software to their unique needs. DuPont says his company's software is geared toward medical devices that are outside, not inside, hospitals and other healthcare facilities. He declines to divulge how many customers the startup has.

Among the startup's customers is San Clemente, California-based Fresca Medical Inc., developer of a device designed to treat sleep apnea.

DuPont says his company's software allows Fresca to perform such tasks as proactively diagnosing problems with the battery in a sleep apnea device or collecting patient data to back up insurance claims. The software even can monitor trends among various medical devices, he says. Galen Data also is helping Fresca develop its mobile app for patients.

Another customer is Friendswood-based Spark Biomedical Inc., developer of a smartphone-connected device, called a neurostimulator, that eases the symptoms of withdrawal from highly addictive opioids.

Hatched within Houston-based Tietronix Software Inc., DuPont's previous employer, Galen Data launched in 2016 but didn't roll out its first product until 2018.

Galen Data's emergence comes as the market for internet-connected mobile health apps keeps growing. One forecast envisions the global space for mobile health exceeding $94 billion by 2023.

"We want to be at the forefront of that technology curve," DuPont says. "We might be six months early, we might be a year early, but it's starting to happen."

Galen Data vies for customers in a largely untapped market, since the majority of medical devices still aren't connected to the internet, according to DuPont. As a whole, medical device makers have been reluctant to delve into connectivity, given the compliance headaches, DuPont says. That's where Galen Data steps in. It's the startup's job, he says, to ensure its tech platform adheres to myriad compliance regulations.

DuPont says a medical device manufacturer easily could spend $250,000 to $500,000 to create its own compliant, connected tech platform similar to Galen Data's offering — and that doesn't include ongoing operational expenses. Galen Data's platform delivers the same benefits at a fraction of that cost, he says.

The startup strives to accomplish its mission with minimal staffing. Between full-timers (including the three co-founders) and contractors, Galen Data employs fewer than 10 people, DuPont says. As needed, Galen Data taps the software development talent at Tietronix, which owns a minority stake in the startup, according to DuPont.

"I'm very, very capital-efficient with our cash," he says. "I don't like layoffs. We'll never have planned layoffs."

If Galen Data continues to achieve its financial goals (it's not profitable yet), DuPont says, the company's workforce could total 20 to 30 within three years. He foresees opening satellite offices in Austin (a tech hub) and Boston (a life sciences hub) at some point.

As for additional products, DuPont wants to eventually build on Galen Data's existing platform by paving the way for data to be securely transferred from medical devices to electronic medical records.

Anchored in Houston, Galen Data hopes to be a player in what DuPont calls "the next biotech corridor of the United States," encompassing not just Houston but Galveston, Austin, Dallas, and San Antonio.

For Galen Data to thrive in that environment, though, it must conquer what DuPont classifies as his biggest hurdle: raising money from investors in a region rooted in the oil and gas industry. In the first quarter of 2019, Houston startups collected less than 6 percent of the venture capital reported throughout Texas — far below what startups in Austin and Dallas reaped during the same period.

Ramping up investment in Galen Data will require educating local investors about the promising potential of the medical device sector, DuPont says. Meanwhile, he's begun hunting for funding outside Texas.

"It's challenging for a startup to raise money in Houston," says DuPont, who praises local entrepreneurs for their support of Galen Data. "We've done it, but it's been hard."

"If Galen is super successful, hopefully we can invest in other early stage companies," DuPont adds. "That's part of the vision."

Galen Concept Video www.youtube.com

Houston-based Saranas has received de novo distinction from the FDA for its bleed monitoring technology. Courtesy of Saranas

Houston medical device company gains FDA approval

EarlyBird got the worm

When it comes to early bleeding detection, Houston-based Saranas, which closed $2.8 million in funding last year, is ahead of the game with its Early Bird Bleed Monitoring System. The Food and Drug Administration has recognized the medical device company and granted it De Novo distinction.

"Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications," says Saranas president and CEO, Zaffer Syed in a release. "As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures."

The Early Bird technology is designed to detect bleeding from vessel injury caused by a surgery, for instance. One in five patients experienced a bleed complication in over 17,000 large-bore transcatheter procedures, according to the release which cites the National Inpatient Sample Database.

"Bleeding remains an Achilles' heel of advancing minimally-invasive, catheter-based procedures," says Dr. Dimitrios Karmpaliotis, director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center, in the release. "The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time."

In May, Saranas received $2.8 million in funding $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.

Currently in the piloting stage, Saranas plans to commercially launch the Early Bird Bleed Monitoring System in select markets across the United States. Currently, the company hasn't disclosed a timeline for that roll out.

The De Novo distinction's purposes is to review new technologies and mitigate risk as they prepare to enter the market. In December, the FDA proposed new procedures and criteria for the De Novo classification process.

"The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," says FDA Commissioner Scott Gottlieb, in a release. "At the same time, the FDA is modernizing its 510(k) pathway, which is used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market. The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances. Our goal is to make the De Novo pathway significantly more efficient and transparent by clarifying the requirements for submission and our processes for review."

As medicine and technology both advance, these Houston startups are at the forefront of the industry. Getty Images

5 Houston medical device companies changing the industry

The future is now

With the Texas Medical Center at the heart of Houston, health advancement opportunities are endless. Medical breakthroughs are happening across town, but as technology advances, the industry is seeing more and more startups popping up to take new tech tools and applying them to traditional medical devices and procedures.

These five Houston startups are developing the future of the industry — one device at a time.

Portable Therapeutix

For years, Squid Compression has helped ease the pain of patients in doctor's offices. Now, anyone can get the treatment on the go. Photo via squidgo.com

The country is currently in an opiod crisis, and one solution is making pain-relieving devices more accessible to patients. That's what Houston-based startup Portable Therapeutix LLC is trying to do with its drug-free solution to pain called Squid Go. The portable device is designed to ease the pain and swelling of sore joints and muscles using cold therapy and compression therapy. It's a follow-up to the company's Squid Compression, a pain management device launched in 2013 for patients at rehabilitation centers, hospitals, doctor's offices, and the like.

To reap the benefits of Squid Go, a consumer uses the device for just 15 minutes. Squid Go — which combines a cold gel pack with proprietary compression technology — features special air pockets that inflate and deflate, gently massaging the body part needing treatment. That massaging boosts circulation and reduces swelling.

"Increased circulation brings more nutrient- and oxygen-rich blood to the area, promoting recovery," says Sam Stolbun, co-founder of Portable Therapeutix. "Meanwhile, [the] gentle compression also drives the pain-relieving cold from the gel pack deeper into the tissues to alleviate soreness and discomfort." Read more about Squid Go here.

Zibrio

Balancing is important throughout your life, and Zibrio has the tools and tips for you to use to stay centered. Pexels

From NASA to your bathroom floor — Katharine Forth has found a new way to track balance. With her company, Zibrio, people can have the everyday ability to figure out how balanced they are.

"The machines typically used for balance measurement can be as large as a telephone booth, so we invented a new way to measure postural control using a much smaller mechanism that fit inside a moon boot," Forth says.

Zibrio is a health company that aims to be the gold standard of measuring balance. The Zibrio scale calculates users' weight like a typical scale and rates their balance on scale of 1 to 10.

The scale gathers data from your weight, your postural control, your muscles and other factors to calculate the rating. Andrea Case-Rogers, chief experience officer at Zibrio, describes a perfect rating of 10 as elusive for most, or "Simone Biles on a good day." Read more about Zibrio here.

Saranas Inc.

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 in clinical trials for its Early Bird Bleed Monitoring System, which is designed to detect and track bleeding complications related to endovascular procedures. 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.

"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. Read more about Saranas and the Early Bird here.

EllieGrid

Courtesy of EllieGrid

Talking the right vitamins and medications at the right times shouldn't seem like more trouble than it's worth. Houston-based EllieGrid is a smart pill box that is easy to organize and stylish to use on the go. Plus, with a growing volume of users, the company is able to use its customer data to track medication compliance.

"What's really neat about EllieGrid is that we are starting to learn users' habits as days go by, so that we can trigger alarms at optimal times," says co-founder and CEO Abe Matamoros at The Cannon's female entrepreneurs pitch night.

For co-founder, Regina Vatterott, the company is about reinventing traditional medical devices that can be clunky or inefficient for daily use.

"We want to do more and more with medical devices because we think that people are always people before they are patients," Vatterott says. Read more about EllieGrid here — as well as more about the founder here.

Intelligent Implants

Intelligent Implant's co-founder, Juan Pardo, told the crowd at Demo Day that his company's device allows for 50 percent faster bone growth in patients. Photo by Cody Duty/TMC

Chronic lower back pain can result in a need for spinal fusion surgery — and 40 percent of those surgeries fail, says Juan Pardo, co-founder of Intelligent Implants, which has an office in Houston. Pardo and his team have come up with an implant that tracks post-op healing and introduces electronic stimulation wirelessly.

The device is the same size and shape as the spacer that surgeons currently use, but contains a technology that can deliver electronic stimulation therapy and monitor progress without needing batteries. The doctor is able to adjust treatment remotely, and the device can heal the patient 50 percent faster than the standard care.

Intelligent Implants was announced as the first in-residence company at the Center for Device Innovation by Johnson and Johnson and also launched its large animal studies. The company has a goal to raise $1.6 million, and has already secured $900,000 — $250,000 of which came from the new TMC Venture Fund. Read more about Intelligent Implants and the other Texas companies in its TMC cohort here.

From a locally sourced meal service company to stem cell research and a balance measuring device, this week's innovators are ones to know in the health industry. Courtesy photos

3 Houston health-focused innovators to know this week

Who's who

More and more Americans are focusing on their health, from eating right to experimenting with new treatments or devices. These three Houston innovators are riding the coattails of this health-focused movement with their startups. With advances in technology and the movement only growing faster and faster, you'd better keep your eye on these Houston innovators.

Marla Murphy, founder of The Blonde Pantry

Courtesy of The Blonde Pantry

Marla Murphy didn't feel like she was doing enough to promote health and wellness with her platform, The Blonde Pantry. So, she expanded it to incorporate locally sourced produce and easy-to-make recipes she gets ready every weekend to deliver to her members by Monday.

"It's not about selling meals and moving on, I want this to be a lifestyle company that is really founded and has deep roots in Houston," says Murphy in a InnovationMap story.

Murphy tells InnovationMap that in the next year she hopes to expand into the retail space and find a bigger commercial kitchen to function as their own. She also hopes to partner with companies outside of food and continue to nourish lives in someway.

David Eller, chairman, co-founder and CEO of Celltex

Courtesy of Celltex

Stem cell treatment is personal to David Eller, chairman, co-founder and CEO of Celltex. Eller had the treatment in hopes of resolving pain from a college football injury.

"I would go to work and put four to six Advil in my pocket," Eller says in an InnovationMap story about Celltex's technology. Within months, he stopped needing those pills.

Houston-based Celltex tracks its progress with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

Katharine Forth, founder and CEO of Zibrio

Courtesy of Zibrio

Katharine Forth has used a technology she developed with her colleague at NASA to measure balance in astronauts to create a device that any terrestrial human can now use from the comfort of their own homes.

"The machines typically used for balance measurement can be as large as a telephone booth, so we invented a new way to measure postural control using a much smaller mechanism that fit inside a moon boot," Forth says in an InnovationMap article about Zibrio, The Balance Company. Zibrio, The Balance Company.

Zibrio is now a finalist for the 2019 SXSW Pitch in the health and wearables category and will take its balance technology to the stage in March.

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Houston SaaS startup closes $12M series A funding round with support from local VC

money moves

A Houston startup with a software-as-a-service platform for the energy transition has announced it closed a funding round with participation from a local venture capital.

Molecule closed its $12 million series A, and Houston-based Mercury Fund was among the company's investors. The company has a cloud-based energy trading and risk management solution for the energy industry and supports power, natural gas, crude/refined products, chemicals, agricultural commodities, softs, metals, cryptocurrencies, and more.

"We led the seed round of Molecule upon their formation and are excited to participate in their series A," says Blair Garrou, co-founder and managing director of Mercury, in a news release. "Molecule's success in the ETRM/CTRM industry, especially in relation to electricity and renewables, positions them as the company to beat for the energy transition in the 2020s."

The company will use its new funds to further build out its product as well as introduce offerings to manage renewables credits, according to the release.

"In 2020, we realized that electricity — the growth commodity of the 2020s — represented over half of Molecule's customer base, and we decided to double down," says Sameer Soleja, founder and CEO of Molecule, in the release. "We were also rated the No. 1 SaaS ETRM/CTRM vendor. With this fundraise, we have the fuel to become No. 1 SaaS platform for power and renewables, and then the market leader overall.

"Molecule is ready to power the energy transition," Soleja continues.

Molecule's last round of funding closed in November 2014. The $1.1 million seed round was supported by Mercury Fund and the Houston Angel Network.

Houston-based afterlife planning startup launches new app

there's an app for that

The passing of a loved one is followed with grief — and paperwork. A Houston company that's simplifying the process of afterlife planning and decision making is making things even easier with a new smartphone app.

The Postage, a digital platform meant to ease with affair planning, recently launched a mobile app to make the service more accessible following a particularly deadly year. The United States recorded 3.2 million fatalities — the most deaths in its history, largely due to the coronavirus pandemic.

After losing three family members back-to-back, Emily Cisek dealt first hand with the difficulty of wrapping up a loved one's life. She saw how afterlife planning interrupted her family's grieving and caused deep frustration. Soon, she began to envision a solution to help people have a plan and walk through the process of losing someone.

The Postage, which launched in September, provides a platform for people to plan their affairs and leave behind wishes for loved ones. The website includes document storage and organization, password management, funeral and last wishes planning, and the option to create afterlife messages to posthumously share with loved ones.

"Right now, as it stands ahead of this app, end-of-life planning is really challenging. It's this daunting thing you have to sit down and do at your computer," says Cisek. Not only is it "daunting," but it's time-consuming. According to The Postage, families can expect to spend nearly 500 hours on completing end-of-life details if there is no planning done in advance.

With more than 74 percent of The Postage's web traffic coming from mobile users, an app was a natural progression. In fact, Entrepreneur reports the average person will spend nine years on their mobile device. Cisek wanted to meet users where they are at with a user-friendly app that includes the same features as the desktop website.

"What we wanted to do [with the app] is make it so easy to plan your life and the end of your life using one click — as easy as it was for posting and commenting on social media," explains Cisek. "People are so used to reflecting on those behaviors and clicking one button to add a picture ... we wanted to make it that simple," she continued.

Cisek and her team focused on providing a "seamless experience" within the app, which took approximately four months to build, which mirrors the desktop platform.

Though The Postage's website had mobile functionality, the app includes the ability to record and upload content. Whether snapping a picture of their insurance policy or recording a video to share with loved ones, The Postage app allows users to capture photos and videos directly within the app.

After snapping a picture, "the next step inherently is sharing it with your loved ones," says Cisek. Photos, family recipes and videos can easily be shared securely with loved ones who accept your invitation to The Postage so "that legacy continues on," she says.

Since The Postage's fall launch, the company has grown a steady base of paid subscribers with plans to expand.

"We're really starting to change the way people plan for the future," says Cisek.