08.09.11
Companies to Watch
A look at four growing medtech firms with long-term potential. These companies are positioning themselves with cutting-edge technology portfolios in growth markets.
A look at four growing medtech firms with long-term potential. These companies are positioning themselves with cutting-edge technology portfolios in growth markets.
Avantis Medical Systems Inc.
Location: Sunnyvale, Calif.
Status: Venture-backed
Leadership: Rick Randall, Chairman and CEO
Sector: Chip-on-catheter imaging devices for endoscopic applications
Online: www.avantismedical.com
Avantis Medical has a different view via its Third Eye device.
Avantis Medical Systems Inc., ofSunnyvale, Calif., has a different view on colonoscopies, available via its Third Eye Retroscope, a disposable, catheter-based camera indicated for use during a standard colonoscopy to provide an additional view of the colon for diagnostic purposes.
The U.S. Food and Drug Administration-cleared device is deployed through the instrument channel of a standard colonoscope, providing the physician with a backward view to complement the colonoscope’s forward view of the lining of the colon.
“There are numerous folds and ledges that exist inside the colon, so with a forward view as seen with traditional colonography, we only can see with great accuracy and precision the adenomas and polyps that exist on the sides of the folds that you’re looking at,” said Avantis CEO Rick Randall. He noted that studies that have taken place over the last decade indicate that there is at least a 25 percent miss rate in the general population of precancerous lesions in the colon from standard colonoscopies.
The Third Eye is advanced through the working channel of the traditional colonoscope and advances out past the tip of the colonoscope and then it turns and looks back. “On the withdrawal, you now have two images—one coming from the colonoscope, forward looking, and one coming from our Third Eye Rectoscope, looking back, and now you’re visualizing both sides of a fold simultaneously,” Randall said.
The device has been the subject of multiple studies in more than 1,000 patients, which have found a detection rate of about 23-25 percent of additional precancerous adenomas, or pre-cancerous polyps.
March of this year, data from the Third Eye Retroscope Randomized Clinical Evaluation (TERRACE) study, conducted at nine centers in the United States and Europe, showed that the device increased detection of adenomas when used during colonoscopy. The study’s authors determined that Third Eye colonoscopy detected 23.2 percent additional pre-cancerous adenomas when compared to standard colonoscopy. The 448-patient study was led by Peter Siersema, M.D., Ph.D., of the Department of Gastroenterology and Hepatology at University Medical Center, Utrecht in the Netherlands
The TERRACE study results are part of the firm’s marketing efforts as it undertakes a controlled product release that will carry through much of the remainder of this year.
“Our marketing strategy is to make physicians aware of that via the data,” Randall said. “We have five peer-reviewed journal articles now, culminating in this most recent TERRACE study publication, and we make them aware of the technology and then also expose them to folks who can tell them how easy it is to adopt this technology and show them how they can do that.”
The marketing strategy also emphasizes that the company now has a second-generation version of the Third Eye.
The company sees the overall addressable market in the United States as the 15 million colonoscopies performed each year, although the more specific target market is made up of those patients who are at higher risk for colon cancer, for precancerous adenomas—patients who perhaps had a prior positive colonoscopy or patients who are symptomatic of lower gastrointestinal distress. That patient population is roughly half the larger figure, or about a $2 billion market for the technology.
CardioMems
Location: Atlanta, Ga.
Status: Venture-backed
Leadership: Jay S. Yadav, M.D., Founder, CEO, Director
Sector: Cardiovascular/Wireless sensing and communication
Online: www.cardiomems.com
CardioMEMS focuses on easier acquisition of patient data.
As is true with all entrepreneurs, Jay Yadav can get downright evangelistic when it comes to the subject of medical innovation, specifically when it has to do with the wireless sensing technologies being developed by his Atlanta, Ga.-based company, CardioMEMS.
The company, whose implantable sensors are made using microelectromechanical systems, or MEMS for short, is focused on improving the outcomes for diseases such as heart failure via wireless, real-time acquisition of patient information that then can be used in what Yadav refers to as “proactive patient management.”
The technology had its genesis in the increased number of heart failure-related admissions that Yadav, an interventional cardiologist and neurologist, was seeing while at the Cleveland Clinic. “More and more beds were getting used by these patients,” he said. “We were doing right-heart catheterizations on these patients to gain information about their cardiac performance, and we used that information to treat them.”
Yadav wondered if there was a way to get that information noninvasively on a daily basis.
“So, I started researching that,” he said. “I was looking for a wireless technology. I didn’t want to have batteries and leads, the way we were doing things for years. I wanted a new way to do it.”
In looking for a wireless, battery-less type of technology, he found sensors that were being developed at Georgia Tech in Atlanta for use in the combustion chambers of military jet engines. “We needed a way to communicate with them and the MIT [Massachusetts Institute of Technology] Media Lab had some efficient wireless technologies,” Yadav explained. “I licensed those patents from those institutions and we started the company down here in collaboration with Georgia Tech.”
Over somewhat more than a decade of existence, CardioMEMS has further refined the technology to the tune of some 100 patents, and its Champion Sensor System is gathering a body of clinical results to support the company’s premarket approval application to the U.S. Food and Drug Administration, with the hope that approval will come yet this year.
Like many innovations in medicine, the idea is simple even if the execution is complex: Substantial improvements can be seen by keeping closer tabs on the condition of heart failure patients via regular noninvasive pulmonary artery pressure monitoring.
“What we have developed is a way to manage patients while they are at home, better medical management based on hemodynamic information that before our technology could only be obtained through a right-heart catheterization,” Yadav said. “But now we can get it every day. Using this information, the doctors can make medication changes which lead to better outcomes, and we have demonstrated this in our CHAMPION clinical trial with a 28 percent reduction in hospitalizations at six months, a 39 percent reduction at one year.”
Noting that heart failure commercialization really is the focus of the company; he acknowledges that there are “a lot of other applications available” to the platform technology. As one might expect, several of them are in the cardiovascular arena, but there are many other disease states to which it many apply as well, including neurological, liver disease, urological applications.
“Almost every area of the body has a fit,” Yadav said, adding that CardioMEMS will be looking at those opportunities as it proceeds with heart failure commercialization.
In September 2010, St. Jude Medical invested $60 million in CardioMEMS in exchange for a 19 percent equity ownership interest and an exclusive option to acquire the remaining 81 percent of CardioMEMS for an additional $375 million during a period that extends through the completion of certain commercialization milestones.
CorMedix Inc.
Location: Bridgewater, N.J.
Status: Went public in 2010
Leadership: John C. Houghton, President and CEO
Sector: Renal Care/Combination Products
Online: www.cormedix.com
Combination products spell opportunity for CorMedix.
CorMedix is focused on the treatment of cardiorenal disease by reducing cardiovascular and metabolic complications, or “treating the kidney to treat the heart.” Founded in 2006, the company is working on establishing two platform technologies.
The first is aimed at preventing the infection and clotting that can occur with the use of chronic central venous catheters (CVCs), particularly in hemodialysis. CVCs also are used regularly in patients receiving chemotherapy, chronic antibiotic therapy, total parenteral nutrition or intensive care. Infection from chronic use of CVCs is a significant source of both morbidity and mortality in hemodialysis patients.
The company is developing two products under that technology platform, designed to keep implanted chronic CVCs infection-free and fully flowing. CRMD003, or Neutrolin, is an antimicrobial/anticoagulant solution, and CRMD004 is described by the company as a “thixotropic” gel that changes from a semisolid to a free-flowing liquid under the pressure of insertion into or withdrawal from a catheter.
CorMedix’s initial indication sees the use of Neutrolin in hemodialysis, which total 12 1/2 million sessions a year in the United States alone. Central venous catheters are subject to clotting and catheter-related bloodstream infections (CRBI), which result in as many as 6,000 deaths annually. That’s a big medical issue unto itself, and when you add in the potential of addressing other CVC indications, market potential grows substantially.
According to CEO John Houghton, “There is no reason why this can’t be used in all central venous catheter applications.”
Neutrolin prevents biofilm formation on a catheter, via application of a three-part compound that includes taurolidine, an anti-microbial, and two anti-coagulants, citrate and heparin, to prevent thrombus formation and clotting. “Combining these three,” Houghton said, “you end up with the ideal solution to CRBI.”
CorMedix is about to begin a pivotal trial for Neutrolin, and its clinical timeline sees FDA approval in mid-to-late 2013. The approval process in Europe works somewhat differently for a device. With a CE mark application to be made soon, Neutrolin might see European commercialization by the end of this year.
The second platform technology prevents and/or treats cardiorenal diseases by reducing tissue-damaging oxidative stress caused by excess catalytic iron. Two related products are in development: CRMD001, or deferiprone, a proprietary formulation of the first “iron-trap” pill, licensed from Shiva Biomedical, and CRMD002, a diagnostic biomarker test for measuring levels of urinary catalytic iron.
Deferiprone is aimed at treating cardiorenal diseases by reducing tissue-damaging oxidative stress caused by excess catalytic iron – also known as “labile” or “toxic” iron. CorMedix said deferiprone is one of the most widely studied oral iron chelators, having been used in thousands of patients, both in clinical trials and post-registration for iron overload disorders. Deferiprone is in Phase II trials in the United States.
Besides its work in a substantial market, CorMedix is a rarity in the medical field, having successfully negotiated the initial public offering waters, raising $12.5 million and listing on the New York Stock Exchange AMEX in 2010.
Mauna Kea Technologies Inc.
Location: Paris, France
Status: Public company
Leadership: Sacha Loiseau, Ph.D., President, CEO, Co-Founder
Sector: Endoscopic imaging
Online: www.maunakeatech.com
Mauna Kea shows its prowess the clinic and the market.
Mauna Kea Technologies, which is developing endomicroscopic products to visualize and detect abnormalities in the gastrointestinal and pulmonary tracts, has asserted itself both clinically and financially in recent months.
The Paris, France-based company’s flagship product, Cellvizio, provides physicians and researchers high-resolution cellular views of tissue inside the body. Designed to improve patient outcomes and reduce healthcare costs, Cellvizio can be used with almost any endoscope. The product is U.S. Food and Drug Administration (FDA)-cleared and has the CE Mark for use in the gastrointestinal and pulmonary tracts.
Mauna Kea closed a much-anticipated initial public offering on the Euronext exchange on July 4, besting its projections to close at just over $70 million.
The funding will go toward sales support of the Cellvisio platform, and the company said in a news release that it also may look into some strategic acquisitions.
Mauna Kea reported the planned offering in mid-June, estimating that shares would go for between 10.65 and 13 euros. The shares sold for 13 euros apiece, and the placement was more than five times oversubscribed. The company’s take stood to reach almost $81 million (56.5 million euros) with over-allotments.
Mauna Kea, which was founded in 2000, received both the CE Mark and FDA approval in 2005 for use of its laser microscopy products in the GI tract and lungs in 2005. Clinical trials are under way to evaluate Cellvisio for use in additional indications.
New data representing the final results of the international registry study of Mauna Kea’s Cellvizio pCLE system and CholangioFlex miniprobe were presented during Digestive Disease Week (DDW) 2011 in Chicago this May, showing that direct, cellular-level visualization of the lining of the bile or pancreatic ducts “significantly improves” bilio-pancreatic cancer detection rates in patients with previously indeterminate bilio-pancreatic strictures. Sensitivity of pCLE (probe-based Confocal Laser Endomicroscopy), the ability to accurately predict disease, was 98 percent compared to 45 percent sensitivity via tissue sampling.
Adam Slivka, M.D., Ph.D., associate chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Medical Center, presented the findings from the prospective multicenter study during a plenary session of the American Society of Gastrointestinal Endoscopy at DDW.
“Our preliminary experience with pCLE in patients with indeterminate bile duct strictures is promising. We were able to detect more bile duct cancers at the index procedure compared to conventional tissue sampling methods,” said Slivka. “In our study, pCLE detected, in real time, over 90 percent of the cancers at the index procedure where standard pathology missed over half of them.”
Slivka said that second and third studies involving the technology are being organized, with one of the points of emphasis being the “fair number of false positive results we got in the first study. We need to better figure out where those false positives are.”
Sacha Loiseau, founder, president and CEO of Mauna Kea, cited the “significant unmet medical need for improved tissue characterization so patients can receive the accurate diagnosis and treatment for diseases like cholangiocarcinoma more quickly and effectively.”