Eleven Medical Hardware Startups Backed by Texas Medical Center File for IPO

For medical device startups, there are few incubators suited to their needs. They must overcome significant regulatory hurdles to align with the business models of medical incubators or to gain favor from investors.

Currently, the world’s largest medical center is drawing attention from medical device companies. Founded in 1945 and located in Houston, the Texas Medical Center (TMC) is the largest medical complex globally, featuring a high density of clinical patient care facilities, basic science research, and translational research. The center comprises 54 nonprofit affiliated medical institutions. Additionally, the Texas Medical Center serves as the hub of the eighth-largest business district in the United States and provides the nation’s largest air ambulance service. The center has 1,360 operating rooms, offers more than 9,200 patient beds in total, performs an average of one surgery every three minutes, and sees one baby born every 20 minutes.

TMC’s Innovation Institute announced on Wednesday that 11 medical device startups will join a 15-week program at the center.

The incubator program, called TCMx, has consecutively invited startups to visit Houston over the past two years, with this year marking the first time it is specifically targeting medical device companies. “There are few high-quality incubator programs tailored for medical device startups, so we are filling a gap in the life sciences ecosystem,” said Dr. Erik M. Halvorsen, Director of TMCi (Texas Medical Center Innovation Institute), in a statement.

Furthermore, the only other medical technology incubator that comes to mind is “Zero to 510,” located in Memphis, Tennessee. The name derives from the 510(k) regulatory pathway, which the U.S. Food and Drug Administration (FDA) uses to review and clear most medical devices for market entry.

“0 to 510” adopts the Simple Agreement for Future Equity (SAFE), a model pioneered by the renowned tech incubator Y Combinator, in exchange for a $50,000 investment. TMCx does not take equity and appears not to make an investment. The Texas-based incubator requests that each selected startup send at least one founder to Houston to participate in this 15-week program, which will culminate in a “Demo Day” in November 2016.

Within the program, entrepreneurs will be introduced to stakeholders from the 56 member institutions of the Texas Medical Center, including physicians and scientists serving the community. Proximity to clinical settings is a prerequisite for any healthcare incubation program; this is particularly valuable for medical device startups, as products in this industry are typically designed for use by physicians.

Although TCMx’s focus this year is on medical devices, it will return to selecting digital health startups next year. The aim is to alternate courses between medical devices and digital health, creating an engaging and insightful platform where healthcare intersects with the rise of connected devices in the internet era. Applications for the fourth cohort of the Digital Health program will open on August 17.

So, which were the 11 medical device startups in 2016? (Listed in alphabetical order and by media announcement sequence)

Provides a device for the precise identification of the ureter during minimally invasive surgery. Each year, over one million minimally invasive procedures requiring ureteral identification are performed in the United States. The preoperative placement of ureteral stents is costly and does not prevent ureteral injury, while identifying the ureter through extensive tissue dissection is time-consuming and increases surgical risk. Allotrope eliminates the need for ureteral stent placement; this intuitive handheld device assists surgeons in rapidly and easily identifying the ureter during surgery, enabling its detection before injury occurs.

Dr. Albert Huang, Founder and CEO of Allotrope, has received training from world-class institutions such as Harvard University and possesses over a decade of industrial design experience integrating tissue engineering with surgical training. He is capable of understanding problems from the perspectives of hospitals, environments, culture, and workflows in complex spaces.

A credit card-sized inhaler has been invented for the emergency treatment of asthma patients. Bloom utilizes the clinically validated “Open Mouth Technique,” an innovative approach that enables precise doses of medication to be effectively delivered deep into the lungs, similar to traditional spacer inhalers. The “Open Mouth Technique” functions like a breath-actuated spray, requiring the user to press and inhale through an open mouth, thereby serving as a replacement for your current handheld inhaler. With Bloom, patients with asthma and chronic obstructive pulmonary disease (COPD) can say goodbye to bulky spacer devices at home, enjoying greater convenience and hygiene by simply carrying it in their wallet.

Bloom can be reused indefinitely and is compatible with any pMDI medication prescribed by your doctor, as well as all HFA inhalers. Each trigger press delivers a precise dose of medication, featuring a leak-proof seal to ensure no medication is wasted.

Bloom has undergone rigorous testing to ensure it exceeds the FDA’s stringent requirements for medical devices. “We prioritize performance, reliability, and safety,” the company emphasized. Once approved, the device will be available for pre-order.

A sensor has been invented that enables continuous blood pressure monitoring without the need for an inflatable arm cuff. Blumio started with blood pressure measurement, aiming to find better ways to monitor our vital organs. Currently, most of our understanding of blood pressure comes from data collected by upper-arm sphygmomanometers during rest. However, we know that blood pressure varies across different parts of the body during physical activity. A single device simply cannot provide us with this information.

Blumio is a highly innovative startup that is disrupting the traditional blood pressure monitor market through its novel approach. The company has developed a sensor-based, adhesive monitoring device that leverages radar technology instead of an inflatable cuff, enabling continuous blood pressure measurement. This provides users with a more convenient method to accurately measure and track their blood pressure and daily activities.

Blumio has positioned itself in a highly competitive market, yet cardiac health remains a significant topic with substantial untapped data potential. Although the technology still faces numerous challenges during its pre-commercialization phase, it is certainly worth watching for medical technology investors or medical device manufacturers.

Improved surgical tools empower surgeons with greater confidence. Briteseed originated from Northwestern University’s NUvention Medical Innovation program in 2011–2012 and, according to Inc. magazine, is ranked among the top ten startup programs in the United States. Briteseed is dedicated to fostering innovative technologies that enhance the healthcare experience.

Briteseed is a visionary company dedicated to the detection of critical tissues in minimally invasive surgery. Its team is currently developing SafeSnips, a real-time vascular detection technology that integrates biosensors into minimally invasive surgical tools, including laparoscopic instruments and mechanical cutting devices.

Briteseed’s SafeSnips technology integrates sensory capabilities into surgical instruments, which will have a profound impact on surgical techniques. In the near future, surgeons using Briteseed’s innovative surgical devices will receive real-time alerts from an alarm system as they approach blood vessels. This will assist surgeons in making strategic incisions or avoiding human tissue, thereby enhancing surgical safety.

Flexios offers a streamlined, high-efficiency solution for hand tendon repair surgery, leading to improved hand strength, dexterity, smoothness of motion, and patient satisfaction. The Flexios team includes Dr. Michael Deem; Kim Neely, Professor of Bioengineering at Rice University; an industrial design student from the University of Houston; and Forrest Roth, a surgeon based in Houston.

A handheld device has been invented to eliminate the uncertainty associated with lumbar puncture. Lumbar puncture (LP) is a technically demanding procedure; while it typically takes about 30 minutes to complete, it can sometimes require more than two hours. Repeated needle insertions and prolonged procedural duration can lead to serious complications, such as bleeding, pain, infection, or cerebrospinal fluid leakage due to dural tear.

IntuiTap simplifies the entire process through various innovative and exciting approaches. Currently, most lumbar punctures are performed by palpating bony landmarks with fingers, which can lead to imprecise procedures when certain anatomical regions in patients are indistinct or when the operator lacks sufficient skill. IntuiTap has developed a patented “palpation” system that provides a digital representation of the patient’s lumbar skeletal anatomy and recommends optimal insertion sites and angles. The system incorporates an inline pressure sensor, enabling faster and more accurate measurement of opening pressure while minimizing the risk of contamination. Furthermore, the system features a patented fluid collection system that is easier to use and reportedly less prone to contamination.

Pioneer of the Tumor Diagnostic Platform: Delivering High-Precision, Real-Time Diagnosis for Cancer Patients Without the Need for Fixed Equipment. Founded by the former Dean of the College of Engineering at the University of Wisconsin-Milwaukee, NovaScan has achieved significant growth and is dedicated to commercializing its breakthrough cancer detection technology and solutions. This technology requires no capital equipment, is not constrained by size, and provides instant results with unparalleled accuracy.

The company’s core technology is the Kohl Relaxation Frequency. Impedance has a long history in the field of cancer detection, yet it has undeniably yielded mixed results. Impedance involves complex mathematical calculations comprising real and imaginary components. Many companies have combined additional measurements with impedance to improve accuracy. In some cases, this has led to slight improvements in results, but it has also increased costs, size, and complexity, while the outcomes remain suboptimal.

NovaScan is the first and only company to identify a parameter—namely, the Cole relaxation frequency—that differs by several orders of magnitude between cancerous and non-cancerous tissues. The Cole relaxation frequency does not vary with mass and exhibits minimal overlap between malignant and benign tissues. This will provide a broadly applicable, ultra-low-cost, and highly accurate platform for cancer detection, rather than one constrained by scalability limitations.

A Urinary Catheter System That Transforms the Delivery of Liver Cancer TherapyOtricath, a closed-loop urinary catheter system, is changing the rules for delivering liver cancer treatment. The system is designed to deliver a targeted therapeutic agent directly to the tumor site and extract it after treatment, preventing its dissemination to other parts of the patient’s body. This design concentrates the drug where it is most needed while minimizing the side effects commonly associated with existing chemotherapy methods.

The Otricath team stated, “We are delighted to have been invited to participate in TMCx. The support and assistance we have received from distinguished teams here, along with the opportunity to widely share our innovative technologies with the medical community, will accelerate our development and enhance our prospects.”

Voyager Biomedical, based in College Station, Texas, is creating a better solution to optimize vascular access for dialysis patients.

Dialysis requires hundreds of venous access procedures annually. Their product, ARK, offers a “first-stick success” solution for vascular access. ARK is designed to help locate veins while preventing unnecessary needle punctures, ensuring accurate targeting with each insertion. In this process, a titanium implant that functions as an exoskeleton encases the vein, enhancing its structural integrity, thereby improving patient comfort and eliminating many common complications associated with vascular access.

The company stated, “TMCx has developed an excellent curriculum that helps Voyager clearly identify and address commercialization barriers. Through its course offerings and networking connections, TMCx has inspired Voyager to become the next success story in medical devices!”

An Effective Exoskeleton Invented for the Elderly and Individuals with Physical Impairments. WeaRobot is a startup technology company developing wearable robotic devices (exoskeletons) aimed at improving the quality of life for older adults and addressing physical impairments. Its goal is to democratize the use of exoskeletons by applying modular technologies to reduce costs and enhance versatile rehabilitation or mobility assistance processes.

Human longevity is inseparable from advanced technologies applied in medicine and lifestyle. However, as we age, our quality of life often declines due to aging. Leveraging high-tech application design and modular concepts, the robotic exoskeletons developed by WeaRobot are highly accessible and user-friendly. Ergonomics experts specializing in physical rehabilitation are among our key partners.

The modular design of the WeaRobot exoskeleton ensures that customers receive precisely what they need, whether for a single joint (such as knee, elbow, hip, or shoulder correction) or a combination thereof. Compared to competing products on the market that only offer full-body systems, WeaRobot provides a more comprehensive platform at a lower cost. Meanwhile, healthcare centers will have the opportunity to serve diverse patient populations through either full-body exoskeletons or modular components. The modular concept of robotic exoskeletons is a patented innovation of WeaRobot. This international patent, currently undergoing certification, has recently been valued at over $40 million. Over the next two decades, WeaRobot will be the sole company capable of leveraging this equipment concept.

SingleStick™, launched by WestFace Medical Devices in 2010, is an imaging adapter for pediatric vascular access that leverages optical coherence tomography (OCT). SingleStick™ comprises two components: a handheld imaging adapter (disposable component) and an OCT image processor (capital equipment component). The handheld imaging adapter can secure any hollow-bore needle and subsequently introduce an optical fiber into the needle lumen. Images captured from the needle tip are transmitted to an image processor, providing a view of the needle’s trajectory. This view is real-time and automatically advances with the needle. Traditional vascular access techniques rely on such real-time imaging for guidance during advancement.

Therefore, compared with existing imaging technologies, SingleStick™ offers multiple advantages. For example: SingleStick™ does not require changes to existing techniques (unlike ultrasound guidance, which requires a two-handed technique); SingleStick™ is compatible with standard needles and catheters; SingleStick™’s integrated imaging clearly defines anatomical targets when describing surrounding anatomy (i.e., lungs, nerves, and arteries); SingleStick™ facilitates vascular access in infants and young children, even in the presence of increased adipose tissue and microvasculature; and SingleStick™ improves efficiency and reduces procedure time in emergency situations.