TheraNova Introduces Canary Catheter

TheraNova, LLC, a medical device development company creating practical medical solutions, announces the development of a minimally invasive Canary™ Catheter sepsis detection and treatment technology.

The advanced monitoring technology in this revolutionary new catheter has the potential to save lives by providing early warning detection of impending sepsis and the prevention of fluid overload during the treatment of septic patients; both potentially fatal if diagnosis is delayed.  

In the U.S. alone there are 750,000 cases of sepsis each year, which account for 215,000 deaths annually.  Combine this with $16.7 billion spent each year to treat sepsis cases, the Canary™ Catheter not only saves lives but has the potential to save billions in healthcare costs.

The Canary™ Catheter is capable of continuously monitoring intra-abdominal pressure, relative stroke volume, core body temperature, respiratory rate, heart rate and urine output through the advent of powerful sensors. The combination of increased sensitivity with improvements in processor speed allow for rapid acquisition of large amounts of data; taking advantage of unique frequency domains to inherently separate them from a single data stream.  This non-invasive catheter utilizes the urine drainage catheter found in all ICU patients to extract valuable clinical data; eliminating the need for additional body access.

The manual acquisition and review of data combined with system integration challenges are the leading causes for diagnosis delays. These contribute to significant delays in the diagnosis of sepsis in ICU patients where every hour delay results in a 7% increase in mortality.  The Canary™ Catheter eliminates these delays by integrating all manual data acquisition into one device, allowing continuous trending of these variables and optimization of diagnosis and treatment.  Analyzing all data is a machine-learning enabled algorithm capable of reporting trends that would be very difficult, if not impossible, for the human eye to see.

“As a company, our focus is the development of medical devices that provide innovative solutions for unmet needs. We recognized a void in today’s medical device technology that represents an opportunity to save hundreds of thousands of lives,” said Dr. Daniel Burnett, president and CEO of TheraNova. “Although it wasn’t our first objective, this device also has the potential to save billions of dollars in the treatment of sepsis annually, but product adoption will be the determining factor in just how big of an impact we can make.”

The Canary™ Catheter is part of Consano Medical, the most recent spin-out from TheraNova, a medical device incubator responsible for the creation of seven spin-out companies; each focused on a wide gamut of clinical needs: BARAnova, Sequana Medical, Velomedix, EMKinetics, Channel Medsystems, Potero Medical and Consano Medical.  Consano expects FDA 510(k) clearance and subsequent launch of its Canary Catheter in late 2015.

TheraNova is currently working on several additional technologies, including a non-invasive congestive heart failure diagnostic, a more effective chest tube/wound drain, a closed loop enteral feeding system, an artificial pancreas, a device to increase bone density in patients with osteoporosis and two medical apps.

Solution for ‘Spin-Out’ Success

by Dr. Daniel Burnett, CEO, TheraNova

If I were to ask you to give me one word to define healthcare in the U.S, what would you say? I’m guessing “expensive” would be a leading response for many Americans, and they wouldn’t be wrong. Modern healthcare is costly due in part to the expensive development process for novel therapies, which historically were focused on superior care; paying little attention to cost. At TheraNova, we moved away from the traditional model by leveraging a rapid, highly capital efficient process and focusing on the development of advanced medical devices that will reduce overall healthcare costs. This resulted in a majority of our seven established spin-outs generating clinical data within a year of funding and with less than $1 million in financing. Wondering how we do it?

One of the driving forces behind the company’s success is our recognition early on, that with the traditional development model it was becoming increasingly difficult to generate return based on the amount of money companies were raising and spending. At TheraNova, we recognized it was better for everybody – founders, shareholders, investors, potential acquirers, etc. – to keep costs low and generate value as capitally efficient as possible. Sounds simple, but with the industry average for bringing a concept to market hovering around $31 million, it is definitely easier said than done.

To keep costs lean, spin-out companies typically share a facility with Theranova until they outgrow it. The companies share a wet lab, a clean room, cages, manufacturing benches, and isolation hoods allowing us to maintain complete control of the process and dramatically cut down on early development costs. By streamlining operations, needs identification, strategic staffing, intellectual property filing and diversified funding this model is tracking towards taking concepts to market for around $5 million; a fraction of the $31 million industry average. Simply put, we only take what we need rather than bloating the company with the capital required for excessive staffing and facilities. This frugality, in turn, creates outstanding value for shareholders and investors and results in a venture that can be acquired at a reasonable price while still generating excellent returns for investors.

Funding remains paramount, but as with most medical device incubators, the current financial climate has made an impact on our business model. We’re currently funded only by partners within the LLC, but we could drive greater medical device advancements and support existing companies further if we were to have a like-minded investment partner; allowing us to focus on generating more value in each of the technologies prior to spinning them out and taking in an equity investment. Based in San Francisco, we recognize that institutional investors in the Bay Area are still hard-hit and focused on the social networking boom, so we shifted focus and are finding success with SBIR grants and private equity outside of the Bay Area; particularly in San Antonio where there is a concerted effort to become one of the life science hubs of America.

Our most recent spin-out, Consano Medical, is developing a urinary catheter for use in critically ill patients and is on track to hit the market with less than $5MM invested. Pilot clinical data has demonstrated the technology’s ability to detect subtle changes in several physiological parameters: core body temperature, respiratory rate, heart rate, intra-abdominal pressure (IAP) and relative cardiac output. Taken together we expect that these changes will give an earlier signal of the onset of sepsis in the intensive care unit which should result in superior care AND dramatic cost-savings to the healthcare system. Additionally, we are working on several other potentially cost-saving technologies, including a novel chest tube, a non-invasive hypothermia therapy, an artificial pancreas, a device to increase bone density in patients with osteoporosis and two medical apps.

Healthcare as a whole is expensive and it will remain that way unless more companies focus not only on innovations that provide superior care, but do so in a cost-effective manner with an eye towards reducing the overall cost of healthcare. With this model, everybody wins – patients get superior care, the healthcare system sees reduced costs and shareholders see excellent returns.

TheraNova redefines financial model for devices from concept to market

Taking a medical device from concept to market has never been easy. Or cheap. But one medical device incubator and capital technology developer has created a business model that allows it to leverage what it calls a rapid, highly capital efficient development process.

San Francisco Mayor Edwin M. Lee visits TheraNova

This week Mayor Edwin M. Lee visited medical device incubator TheraNova for his Tuesday Tour. The incubator is currently working on their 7th spinout, and the Mayor had an opportunity to chat with the engineers on staff as well as see a couple of device demonstrations. A fascinating visit and a prime example of why…

Emerging Medical Technologies (EMT)® Innovator of the Month – March 2014

With a background as a biomedical engineer, physician, inventor, commissioned officer at the U.S. Food and Drug Administration, and venture investor, Dr. Burnett has spun out seven device companies to date through his San Francisco-based incubator, TheraNova, with technologies focused around his chosen theme of well-defined but frequently overlooked health problems with relatively ineffective current…

Incubator with six venture-backed spinouts seeks 2014 exit, unveils new sepsis spinout

theranovaTheraNova is a San Francisco-based sandbox incubator and capital technology developer for medical devices. With one exception, all the ideas for technology are internally generated, CEO Dr. Daniel Burnett said. That’s led to all its medical device companies spinning out, and, like tops, they’re still going.

In fact, Burnett said the company has just spun out its seventh startup, Consano Medical. It’s just been incorporated and has an emphasis on critical care monitoring.

“Consano is backed by angels and Theranova and is now raising a larger round from angels to develop its sepsis detection and treatment technology,” Burnett said in an e-mail.

The six venture-backed spinouts include:

  • Baronova, a startup trying for weight loss devices that are both non-surgical and non-pharma. The company closed a $27.3 million Series C round in February 2013, which was led by Boston Scientific (BSX) and Sante Ventures.
  • SequanaMedical (formerly Novashunt), a Swiss medtech company with a pump implant for patients with liver failure, allowing them to pass ascites through their urine. The company is backed by NeoMed Management, VI Partners, Biomed Invest, Capricorn Health Tech and Entrepreneurs Fund.
  • Velomedix, based in Menlo Park, Calif., uses an automated system to deliver mild therapeutic hypothermia to reduce acute myocardial infarction size in patients who have suffered heart attacks. It’s backed by Longitude Capital and Acadia Woods.
  • EMKinetics, a healthcare startup creating neuromodulation solutions for overactive bladder and migraine, is backed by Allergan.
  • Potrero Medical, a medical device company with next-generation urine monitoring tech, is venture-backed by Scientific Health Development Partners in Texas.
  • Channel MedSystems, based in the same building as TheraNova, is focused on cryoablation as a treatment for heavy menstrual bleeding. This platform technology in women’s health has a lot of buzz surrounding it. In the spring, it raised $9.7 million in a Series B round led by BSX. It’s this startup, Burnett said, that is “white hot.”

TheraNova currently incubates the following technologies:

A TheraNova-Channel Medsystems Android app that assesses menstrual bleeding (which it’s meeting about with the FDA this month; look out for an approval some time this year), a mechanical vibration treatment for osteoporosis prevention and a closed-loop blood glucose monitor infusion device (an artificial pancreas minus the glucagon).

TheraNova began essentially as an IP holding company back in 2003, dreamt up by two Mayo Clinic interns (Burnett and Dr. Shane Mangrum, now chief medical officer for the company).

“At that point you could get a company funded with a good idea and a patent or two,” Burnett said.

For Burnett, an MD who logged years as a general partner at MedVenture Associates before deciding he preferred making companies to funding them, operating this model of incubator works well.

“I’m certainly hypomanic so I could not be sitting down doing the same surgery day after day after day, so that’s what makes it perfect for me. I’m very happy doing what I’m doing right now,” Burnett said.

The founders and engineers at TheraNova come up with an idea that has clinical need and market appeal. “Then we do the testing we think necessary in order to get the company funded.” Finally, they seek out funding and build a team around the promising technologies. Those staff members are hired into TheraNova. “It almost always buds off, then most of those people go with the new entity. It’s the frustrating part for me,” he said.

Once a company’s spun out, TheraNova uses that capital to fund the medtech sitting on the back burners back at the HQ. The spinouts can pay a retainer to TheraNova for continued regular staff support. Either way, TheraNova retains its equity investment in the spinouts.

This is why Burnett is very excited about a goal he’s banking on this year: having one (or more) of the companies make a true exit. This is the CEO’s ambitious New Year’s resolution:

“To get an exit with one or more of the companies so we can better capitalize TheraNova and take more of these technologies on the back burners to the front burners. To increase our number of burners to work on more technologies at once.”

Confident of that exit, Burnett said TheraNova is looking to set up a satellite office in a city that already has some medical device infrastructure and is a direct flight from SFO. Though the company has considered both Sweden and Singapore, Burnett said the team would “dramatically prefer” a U.S. location.

Follow MedCity News on Facebook and Twitter for more updates.