Private companies make their pitches to receptive audience

By Larry Haimovitch

Medical Device Daily Contributing Writer

January 24, 2014

SAN FRANCISCO — Although this annual conference has long been and continues to be dominated by publicly-owned healthcare companies, once again this year there was an impressive roster of attractive private companies.

One of the more successful private companies in the med-tech space is AngioScore (Fremont, California), whose CEO Tom Trotter reported here that it has generated in excess of $200 million in revenue since it began its commercial operations in 2006. Its global revenue has grown impressively each year and Trotter estimated that it reached about $52 million in 2013. Moreover, Trotter proudly noted that his company is on the verge of profitable operations, as measured by EBITDA.

Its key technology is the AngioScupt "next generation" angioplasty catheter line, which participates in a global balloon angioplasty catheter market that Trotter estimated at about $2 billion. AngioSculpt is approved in all major markets globally and has consistently garnered market share wherever it is sold.

The two key components of its product are a semi-compliant balloon catheter with a high pressure capability and a proprietary laser cut nitinol scoring element (SE) with highly-polished flat edges surrounding the balloon. The SE locks into the lesion and as the balloon is inflated the SE produces a force 15 to 25 times that of a typical angioplasty catheter, At its full Inflation, the SE causes the vessel to widen much more fully. Trotter described his company's technology as "simple and elegant" and it has been the engine behind its impressive revenue growth.

AngioSculpt is sold in 65 countries around the world with AngioScore fielding a direct sales force in the U.S. It has attained over 70% market penetration of the 1500 or so cath labs in the U.S., serving in excess of 1100 accounts. Outside the U.S., AngioScore relies on key cardiovascular distributors for its sales. Approximately half its sales are generated by cardiovascular procedures with the other half occurring in the peripheral vessels.

Trotter discussed two exciting major new products that are in its pipeline, the drug coated AngioSculpt and CardioSculpt. The former is the world's first drug coated scoring balloon catheter and will be applicable for both coronary and peripheral applications. Human data from its 61-patient (5 sites outside the U.S.) PATENT-C randomized controlled clinical trial, which is comparing an uncoated AngioScuplt to a drug coated version, has produced "very gratifying results" Trotter said.

The drug coated cohort has seen a much lower rate of late lumen loss, a statistically significant reduction in major adverse events and a remarkably low rate of target lesion revascularization so far. According to Trotter, these results are very competitive with the best-in-class conventional drug-coated balloons currently being sold in Europe and bodes very well for its market acceptance. AngioScore also believes that the unique "mechanical benefits" of the AngioSculpt scoring balloon catheter compared to plain old balloon angioplasty – no slippage or "geographic miss" and a much lower rate of dissections - will prove to be a significant competitive advantage for a drug-coated AngioSculpt once it is commercially available.

CardioSculpt is the world's first scoring angioplasty balloon catheter for the treatment of structural heart disease, specifically for the treatment of valvuloplasty in patients with severe aortic stenosis and for pre-dilatation prior to TAVR. This product, which will address two large commercial opportunities, is in clinical trials offshore.

Trotter said that he hopes to launch both new products in Europe sometime in 2015.

Another intriguing medical device company, appearing for the first time at the J.P. Morgan conference was Topera (Lexington, Massachusetts). The company addresses the huge and growing atrial fibrillation (AF) market opportunity and its CEO Ed Kerslake said that his company's goal is to ". . . become the recognized global leader in pinpointing tissue sources sustaining complex arrhythmias to enable patient-tailored, targeted therapeutics."

There is little doubt that AF is an enormous opportunity with unmet clinical needs. Fairly recent data has shown that AF patients are hospitalized twice as often, have a three-fold rate of multiple hospitalizations, a four-fold rate of cardiovascular-related admissions and an eight-fold rate of multiple cardiovascular-related admissions. Moreover, total direct medical costs were estimated to be 73% higher for atrial fibrillation patients than in matched control subjects, representing a net incremental cost of $8,705 per patient per year (2008 values cited from a 2010 publication).

Topera's system features two components, a full-contact basket mapping catheter (tradenamed FIRMap) to acquire the electrical signals and a workstation (tradenamed RhythmView), which interprets the acquired catheter signals and pinpoints the target tissue to guide the therapy. Both devices are now FDA-approved and CE Marked and Topera is now beginning to commercialize its technology in these markets. It has a direct sales force in the U.S. and a blend of direct sales and distributors outside the U.S.

According to Kerslake, the key competitive advantage offered by its system is that it provides highly precise information on where the arrhythmogenic electrical activity is occurring. In turn, this information guides the electrophysiologist to a precisely targeted ablation area. By contrast, Kerslake noted that the "current systems show the catheter relative to the anatomy but not the AF source itself, resulting in a generic ablation strategy."

The inability to know precisely where the catheter ablations should be made has been the main culprit in the mediocre results seen from the current, commercially available catheter ablation technology. Kerslake estimated that success rate at about 50%. He noted that an independent evaluation of today's "standard of care" AF ablation procedure, pulmonary vein isolation, revealed that it works by "serendipitous" ablation rather than by truly identifying the arrhythmogenic tissue. This information was discussed in detail in the July 9, 2013 issue of the Journal of the American College of Cardiology in an article titled "Direct or Coincidental Elimination of Stable Rotors or Focal Sources May Explain Successful Atrial Fibrillation Ablation: On-Treatment Analysis of the CONFIRM Trial."

Kerslake said that several credible trials have now firmly established Topera's efficacy. These include the CONFIRM trial, which was reported at the Heart Rhythm Society meeting in 2011, the Precise-PAF trial (Heart Rhythm Society 2013, Late Breaking Clinical Trials) and the CONFIRM-Extended trial, which was presented at the American Heart Association (AHA; Dallas) scientific sessions in November 2013. The latter trial was presented at the AHA meeting by the lead author, John Miller, MD, an electrophysiologist at the Krannert Insitute of Cardiology (Indianapolis, Indiana).

The presentation titled "Ablation of Atrial Fibrillation Rotors and Focal Sources Improves Outcome Over Conventional Ablation Alone in Independent Laboratories: Multicenter Validation of Focal Impulse and Rotor Modulation (FIRM)" reported on 149 patients in a comparative study from 11 centers across the U.S. Importantly, 71% of these patients had documented persistent or longstanding atrial fibrillation.

Topera did not participate in the data gathering, evaluation or analysis of the data and did not provide sponsorship or support for the study by these investigators.

Commenting on the results, Miller said that "maintaining one year freedom from AF in more than 80% of patients after a single procedure is highly unusual and achieving this result in this largely persistent AF population is frankly remarkable." Miller went on to say that "These patients have historically responded poorly to therapy and are our most challenging AF patients to treat. Now, guided by Topera's 3D mapping system, we have an effective approach to help them."

While permanent AF may account for an estimated 70% of all atrial fibrillation cases, it comprises only 25%-30% of all ablation cases are because the success rate has been very low. These patients have typically been in AF for many months or years and locating and ablating the appropriate tissue is far more challenging than for the earlier stage paroxysmal (intermittent) AF patient.

The upshot of all this data is that Topera's technology has the potential to dramatically expand the estimated $3 billion global AF catheter ablation market, not only providing a significantly higher success rate for the paroxysmal patients but also for the longstanding or permanent AF patients, where the unmet clinical need and the cost of care is considerably greater.

In addition to an improved rate of catheter ablation success, Kerslake also noted that catheter ablation, the only curative option for AF today, already is cost advantaged vs. drug therapy.

"We believe, based on our analysis of the data, that catheter ablation will be . . . even more economically attractive with RhythmView guidance."

J.P. Morgan Healthcare Conference 2014

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