Thermocuff has several patents and expects FDA approval at the end of the year. Image via thermocuff.com

A great idea can strike anytime — and for Sam Sabbahi, his concept cooked up six years ago while defrosting a chicken for his son’s dinner.

Sabbahi, a physical therapist by trade, knew there had to be a better way to heat and cool common joint injuries — elevating the traditional way of using ice or heat packs.

“In the field, we were always getting people coming in trying to get us to purchase different medical devices and we wondered, ‘who knows what we need better than we do?’” he says. “A patient asked me ‘what a cold pack does’ and I was thinking in my head that a cold pack just cools the skin to three millimeters depth.”

Sabbahi then developed and invented a portable convection-based heating and cooling system device that could be used for joint injury rehabilitation – the device, dubbed Thermocuff, works much in the way that an air fryer circulates the air to get an even temperature.

“It just clicked for me like a light. You know what people say,” he says. “I just got the idea and thought ‘let’s just try this out and see if it would work.”

The device uses air that goes over top of the thermoelectric unit and cycles in a closed loop system. After some proof concept testing, Sabbahi determined that Thermocuff could cool a joint more than twice as quick as the traditional water circulating system that’s currently available on the market now.

The attached tablet connects through Bluetooth to the unit, which allows the patient to increase or decrease the temperature and adjust for heating or cooling.

“You're trying to get the range of motion back,” he says. “We are addressing pain and range of motion now – trying to reduce the swelling inside of a joint to help in function.”

Because the disposable cuff kind of looks like a Chinese finger trap, Sabbahi says it’s not something that you could just make a mold of and then mass produce.

Fast forward to today, Sabbahi and his team of eight have acquired four patents in the U.S., Canada, China and Japan and are waiting on Europe and Mexico.

The team is working toward FDA approval at the end of the year. Thermocuff also has received a grant from the U.S. military. The device is part of the Southwest Pediatric Medical Device Consortium and received grants for production and research from the Medical Technology Enterprise Consortium, which helps startups in the medical field source grants.

The team is targeting business to business, physical therapy clinics, universities, and sports training associations with the hope to move into the consumer market in the coming years.

“We all have ideas is the hardest part, is trying to figure out how to turn your idea into actual product,” he says. “It's fun, actually — kind of like a big puzzle. You know, you're trying to get all, find all the pieces and put them together.”

Stroke patients have a new hope for arm rehabilitation thanks to a team from UH. Photo courtesy of UH

Robotic device created at the University of Houston helps stroke patients to rehabilitate

next-gen recovery

Almost 800,000 people in the United States suffer from a stroke annually — and the affliction affects each patient differently. One University of Houston researcher has created a device that greatly improves the lives of patients whose stroke affected motor skills.

UH engineering professor Jose Luis Contreras-Vidal developed a next-generation robotic arm that can be controlled by the user's brainwaves. The portable device uses a brain-computer interface (BCI) developed by Contreras-Vidal. Stroke patient Oswald Reedus, 66, is the first person to use a device of this kind.

Reedus lost the use of his left arm following a stroke that also caused aphasia, or difficulty speaking. While he's been able to recover his ability to speak clearly, the new exoskeleton will help rehabilitate his arm.

When strapped into the noninvasive device, the user's brain activity is translated into motor commands to power upper-limb robotics. As patients like Reedus use the device, more data is collected to improve the experience.

“If I can pass along anything to help a stroke person’s life, I will do it. For me it’s my purpose in life now,” says Reedus in a news release from UH. His mother and younger brother both died of strokes, and Reedus is set on helping the device that can help other stroke patients recover.

Contreras-Vidal, a Hugh Roy and Lillie Cranz Cullen distinguished professor, has led his device from ideation to in-home use, like with Reedus, as well as clinical trials at TIRR Memorial Hermann. The project is funded in part from an $813,999 grant from the National Science Foundation’s newly created Division of Translational Impacts.

"Our project addresses a pressing need for accessible, safe, and effective stroke rehabilitation devices for in-clinic and at-home use for sustainable long-term therapy, a global market size expected to currently be $31 billion," Contreras-Vidal says in the release. "Unfortunately, current devices fail to engage the patients, are hard to match to their needs and capabilities, are costly to use and maintain, or are limited to clinical settings."

Dr. Gerard E. Francisco, chief medical officer and director of the Neuro Recovery Research Center at TIRR Memorial Hermann, is leading the clinical trials for the device. He's also chair and professor in the Department of Physical Medicine and Rehabilitation at McGovern Medical School at UTHealth Houston. He explains that TIRR's partnership with engineering schools such as the Cullen College of Engineering at UH and others around the nation is strategic.

“This is truly exciting because what we know now is there are so many ways we can induce neuroplasticity or how we can boost recovery,” says Francisco in the release. “That collaboration is going to give birth to many of these groundbreaking technologies and innovations we can offer our patients.”

Both parts of the device — a part that attaches to the patient's head and a part affixed to their arm — are noninvasive. Photo courtesy of UH

Houston-based CorInnova is gearing up to pitch at a prestigious event. Photo via CorInnova.com

Houston health tech company tapped for prestigious pediatric medical device competition

ready to pitch

Houston-based medtech company CorInnova is gearing up for what could be a big payday.

CorInnova is among five medtech companies that have been invited to present pitches in October for the National Capital Consortium for Pediatric Device Innovation’s “Make Your Medical Device Pitch for Kids!” competition.

CorInnova and the four other finalists now have access to a four-month pediatric accelerator program led by MedTech Innovator and will vie for a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA). The pitch event is part of the 10th annual Symposium on Pediatric Device Innovation.

“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap,” says Kolaeh Eskandanian, president and chief innovation officer at Children’s National Hospital and principal investigator for the pediatric device consortium.

CorInnova has developed a minimally invasive device for the treatment of congestive heart failure. Specifically, CorInnova’s soft, flexible device can be inserted through a 1-inch incision to increase the amount of blood pumping in the heart by 50 percent.

The device’s primary benefit is that there’s no contact with blood, thus minimizing complications when the device is being used. Blood contact during a heart procedure can increase the risk of health problems such as stroke and kidney disfunction.

“The device is collapsible, allowing it to be delivered and secured to the heart in a minimally invasive manner. The device conforms to the heart’s surface, and gently compresses the heart to increase cardiac output using an external pneumatic driver that operates in synchrony with the heartbeat,” CorInnova explains on its website.

In the U.S., around 40,000 babies are born each year with congenital heart defects. About one-fourth of these newborns have critical defects, often prompting the need for surgery or other procedures.

Since being founded in 2004, CorInnova has raised at least $6.3 million, according to Crunchbase. This includes a $6.1 million investment from Wellcome Trust, a London-based charitable foundation that focuses on biomedical research.

Aside from the MedTech Innovator accelerator, CorInnova has participated in the TMC Accelerator’s fall 2019 accelerator program for medical device makers and the fall 2018 gBETA Medtech accelerator program.

The four other finalists in the medtech pitch competition are:

  • La Palma, California-based Innovation Lab, whose mechanical elbow brace stabilizes tremors in some pediatric patients with cerebral palsy.
  • Biddeford, Maine-based Prapela, whose vibrating pad helps treat apnea in newborns.
  • Richmond, Virginia-based Tympanogen, whose nonsurgical procedure takes the place of surgery for eardrum repair.
  • Xpan of Concord, Ontario, Canada, whose universal trocar (a surgical instrument) improves safety, access, and flexibility during various procedures.
BiVACOR named Thomas Vassiliades as CEO effective immediately. Photo courtesy of BiVACOR

Former Medtronic exec takes the helm of Houston med device startup

mover and shaker

A Houston-based preclinical artificial heart device company has a new head honcho as it grows its team and further develops its technology.

BiVACOR named Thomas Vassiliades as CEO effective immediately. He replaces the company's founder, Daniel Timms, in the position. BiVACOR is on track to head toward human clinical trials and commercialization, and Vassiliades is tasked with leading the way.

“BiVACOR led an extensive CEO search, and Tom was the clear choice given his experience, background, leadership style, and exceptional track record,” says Timms in a news release. “Tom has the skillset and credibility to guide BiVACOR through its next chapter of transformation and advancement as we undertake the next stage of clinical activities leading up to First in Human early feasibility studies.”

Vassiliades has over 30 years of experience within the medical device industry as well as cardiothoracic surgery. He was most recently the general manager of the surgery and heart failure business at Abiomed and held several leadership roles at Medtronic. Dr. Vassiliades received his MD from the University of North Carolina, and his MBA was achieved with distinction at Emory University.

“I am excited and honored to join the BiVACOR team, working closely with Daniel and the entire team as we look forward to bringing this life-changing technology to the market,” says Dr. Vassiliades in the release. “Throughout my career, I’ve been guided by the goal of bringing innovative cardiovascular therapies to the market to improve patient care and outcomes – providing solutions for those that don’t have one. BiVACOR is uniquely well-positioned to provide long-term therapy for patients with severe biventricular heart failure.”

Timms will take over BiVACOR's technical team working on the Total Artificial Heart system as CTO. The device, billed as the first long-term therapy for patients with severe heart failure, is an implantable artificial heart based on rotary blood-pump technology. Similar in size to an adult fist, it is small enough to be implanted in many women and some children yet capable of delivering enough cardiac power to a man who's exercising. Unlike the two-chamber human heart, BiVACOR's device features a single chamber.

The medical device company, which has operations in Houston and Australia, recently announced the addition of eight new employees doubling their team. The growth comes following its series B raise last year.

“It is a testament to the great progress the team has made and to the importance of the unmet clinical need addressed by the Total artificial Heart technology," Timms says on the appointment of Vassiliades. "We look forward to Tom’s leadership as BiVACOR navigates the path to commercialization.”

Proxima Clinical Research has its New Year's resolution and is ready to start working hands on with health tech startups. Graphic via proximacro.com

Houston organization plans to launch health tech accelerator in 2022

ready to grow

A contract research organization based in Houston has announced its new accelerator program aimed at helping startups quickly grow their health tech businesses.

Proxima Clinical Research released details of M1 MedTech, which expects to launch early next year. The CRO has raised funds to launch and invest in members of the inaugural cohort.

“Our goal is to move these companies substantially forward in a short amount of time,” says Kevin Coker, CEO of Proxima, in a news release. “Proxima is in a unique position to leverage our experienced team of regulatory, quality, and clinical experts. We won’t be working at arm’s length from these companies. We will be a big part of what they do every day.”

The program will focus on a small group of companies and the Proxima team will provide hands-on support, including instruction, workshops, and one-on-one mentoring.

“This will be a unique experience for all parties involved, as Proxima is also a young, yet established, company that is now creating a program to assist companies at an earlier stage,” says Larry Lawson, co-founder of Proxima, in the release. “Our experience in the CRO realm and ability to provide coaching in clinical, regulatory, quality, and go-to-market strategies will only strengthen M1 MedTech’s ability to support the success of emerging companies and provide more life-saving technology to the public.”

Kevin Coker and Larry Lawson co-founded Proxima in 2017. Photos courtesy

The accelerator will target Class II and III medical devices for its initial cohort. In the future, Proxima plans to expand to include an even more extensive incubator focused solely on Class III devices, according to the release.

“M1 will be a place where startups can go to receive concrete resources to further their development. The participant success is our sole focus, and the ultimate goal is to have a substantial impact on the ideation-to-market process for Class II and Class III medical devices,” says Isabella Schmitt, director of regulatory affairs at Proxima and a principal at M1, in the release. “Proxima’s specific expertise alongside our M1 partners will provide resources for all key areas of a medical device entrepreneur’s journey to market and beyond.”

The M1 MedTech applications will open online in the spring.

“We don’t view M1 as competitive to other accelerators, rather we believe it will offer a different experience. Our team will strive to create a personalized program where companies have a dedicated touch point throughout the process,” says Sean Bittner, director of programs at M1 MedTech, in the release. “We will also provide specific, tailored connections and resources vetted by our team through professional partnerships, not just a general list of industry contacts.”

James Reinstein joins the Houston Innovators Podcast to discuss what's next for growing medical device company, Saranas. Photo courtesy

Health tech executive leads Houston startup into its next generation following $12.8M series B

houston innovators podcast episode 103

When James Reinstein took the helm of Houston-based Saranas in March 2020, he was tasked with taking the medical device company through its series B funding round and into larger clinical trials. Navigating these tasks during a global pandemic wasn't part of the plan.

"There was just so much uncertainty," Reinstein says on this week's episode of the Houston Innovators Podcast. "All of the funds didn't know which end was up, what hospitals would be doing, what procedures were going to begin again."

Saranas received FDA approval and began its clinical trials for its Early Bird Bleed Monitoring System in 2019. 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. Around 20 percent of patients suffer a bleeding complication during endovascular procedures.

Reinstein explains that the way health tech funding trended over the past 18 months greatly affected Saranas. The device fell outside the parameters of what investors were looking for during this pandemic time. However, Reinstein explains, the Early Bird worked and had FDA approval — that made all the difference.

"We are very confident that the product does work and it can have a significant impact for hospitals and patients," Reinstein says. "Eventually, the term sheets came in."

Saranas announced in July that it closed a $12.8 million series B investment led by Wisconsin-based Baird Capital, the venture capital and global private equity arm of Baird, a global company with a location in Houston. Austin-based S3 Ventures also supported the round.

The funds will propel Saranas into its next phase, which includes growing its team, larger trials, and a next-generation product.

Reinstein has had decades in health care innovation all over the world, with a large chunk of his career at Boston Scientific. He's seen Houston's innovation ecosystem evolve.

"I do think that there's a great potential for Houston to really develop the industry," Reinstein says. "There's just two areas that need to get fortified. One is the funding and getting the funds directed to Houston companies — with the idea that the company stays in Houston. ... The other side of the coin is really finding the talent to come in and run the companies, take on leadership positions."

Reinstein shares more details on what's next for Saranas, as well as his advice for med tech entrepreneurs and observations on Houston's innovation ecosystem on the show. Listen to the full interview below — or wherever you stream your podcasts — and subscribe for weekly episodes.


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Houston doctors recognized among top creative leaders in business

winners

This week, Fast Company announced its 14th annual list of Most Creative People in Business — and two notable Houstonians made the cut.

Dr. Peter Hotez and his fellow dean of the National School of Tropical Medicine at Baylor College of Medicine, Dr. Maria Elena Bottazzi, were named among the list for “open sourcing a COVID-19 Vaccine for the rest of the world.” The list, which recognizes individuals making a cultural impact via bold achievements in their field, is made up of influential leaders in business.

Hotez and Bottazzi are also co-directors for the Texas Children's Hospital's Center for Vaccine Development -one of the most cutting-edge vaccine development centers in the world. For the past two decades it has acquired an international reputation as a non-profit Product Development Partnership (PDP), advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. One of their most notable achievements is the development of a vaccine technology leading to CORBEVAX, a traditional, recombinant protein-based COVID-19 vaccine.

"It's an honor to be recognized not only for our team's scientific efforts to develop and test low cost-effective vaccines for global health, but also for innovation in sustainable financing that goes beyond the traditional pharma business model," says Hotez in a statement.

The technology was created and engineered by Texas Children's Center for Vaccine Development specifically to combat the worldwide problem of vaccine access and availability. Biological E Limited (BE) developed, produced and tested CORBEVAX in India where over 60 million children have been vaccinated so far.

Earlier this year, the doctors were nominated for the 2022 Nobel Peace Prize for their research and vaccine development of the vaccine. Its low cost, ease of production and distribution, safety, and acceptance make it well suited for addressing global vaccine inequity.

"We appreciate the recognition of our efforts to begin the long road to 'decolonize' the vaccine development ecosystem and make it more equitable. We hope that CORBEVAX becomes one of a pipeline of new vaccines developed against many neglected and emerging infections that adversely affect global public health," says Bottazzi in the news release from Texas Children's.

Fast Company editors and writers research candidates for the list throughout the year, scouting every business sector, including technology, medicine, engineering, marketing, entertainment, design, and social good. You can see the complete list here

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Samsung sets sights on nearly $200 billion expansion in Texas

chipping in

As it builds a $17 billion chipmaking factory in Taylor, tech giant Samsung is eyeing a long-term strategy in the Texas area that could lead to a potential investment of close to $200 billion.

Samsung’s plans, first reported by the Austin Business Journal, call for an additional $192.1 billion investment in the Austin area over several decades that would create at least 10,000 new jobs at 11 new chipmaking plants. These facilities would be at the new Taylor site and the company’s existing site in Northeast Austin.

The first of the 11 new plants wouldn’t be completed until 2034, according to the Business Journal.

“Samsung has a history already in the Austin market as an employer of choice, providing high wages, great benefits, and a great working environment. All of this will be on steroids in the not-too-distant future, creating a historic boost to the already booming Austin economy,” John Boyd Jr., a corporate site selection consultant, tells CultureMap.

Samsung’s preliminary plans were revealed in filings with the State of Texas seeking possible financial incentives for the more than $190 billion expansion. The South Korean conglomerate says the filings are part of the company’s long-range planning for U.S. chipmaking facilities.

Given that Samsung’s 11 new plants would be decades in the making, there’s no certainty at this point that any part of the potential $192.1 billion expansion will ever be built.

Last November, Samsung announced it would build a $17 billion chipmaking factory in Taylor to complete its semiconductor operations in Northeast Austin. Construction is underway, with completion set for 2024. Boyd proclaimed last year that the Taylor project will trigger an “economic tsunami” in the quiet Williamson County suburb.

The Taylor facility, which is expected to employ more than 2,000 people, ranks among the largest foreign economic development projects in U.S. history. The impact of a nearly $200 billion cluster of 11 new chipmaking plants would far eclipse the Taylor project.

The Taylor factory will produce advanced chips that power mobile and 5G capabilities, high-performance computing, and artificial intelligence.

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This article originally ran on CultureMap.