The January 2013 merger of two innovative cardiovascular device companies – CardioLogical Solutions and Emboline Inc. – under the name promises to provide a one-stop shop for a full range of accessory devices to improve the safety and efficacy of transcatheter aortic valve implantation (TAVI) procedures performed by either an interventional cardiologist or a thoracic surgeon. [See Deal]

The aortic valve is located between the left ventricle and the aorta of the heart. The main indication for TAVI is the narrowing of the aortic value (aortic stenosis) that prevents normal blood flow. Currently, there are roughly 30,000 TAVI procedures performed annually in the world, and the number is projected to rise to 100,000 by 2015. This translates into a potential market opportunity of around $2-$3 billion for CardioLogical Solutions and other companies targeting this fast-growing market. (See Also see "As TAVI Advances, Adjunctive Devices Multiply" - Medtech Insight, 16 December, 2011..)

David W. J. Smith, the company’s CEO, attributes the growth in large part to the US regulatory approval of the SAPIEN heart valve from Edwards Lifesciences Corp. in November 2011. “Rather than a patient having his sternum split for direct surgical intervention into the heart to replace the aortic valve, devices like this are minimally invasive,” he says. “They enter the heart through a catheter that is placed in the patient’s femoral artery, or directly through the apex of the heart through an incision made between the ribs.” Compared with the more invasive standard of care, TAVI is associated with far less patient trauma and reduced procedure expenses because the recovery time is a few days versus around 10 days. Minimally invasive heart valves also can accommodate patients with more advanced stages of cardiovascular disease because of significantly lessened trauma.

Rather than focus on the replacement valve itself, CardioLogical Solutions is pursing four accessory technologies for TAVI. The first is an access and closure device from VasoStitch. “This is actually the first family of devices that has been developed for both transfemoral [through the femoral artery] and transapical [through the chest wall] access and closure for large-bore procedures,” Smith says. “The VasoStitch technology effectively allows the cardiologist to perform the entire TAVI procedure by himself, without the need for a vascular surgeon to open up the femoral artery at the beginning and then return at the end to sew up the femoral artery.”

The second product line is the Emboline CAP (complete accessible protection), which is a novel embolic protection device to protect not only the head (for stroke prevention) but also the rest of the body from emboli, which are particles dislodged by either catheter manipulation or the valve implantation itself. These particles then enter the bloodstream and can potentially block a cerebral artery and cause a stroke, or block an artery farther downstream – such as an artery in the kidney – that could lead to impaired kidney function and/or hypertension. “There is even evidence that these clots can end up in the mesenteric artery [the arterial system that feeds the intestines],” Smith notes. “The Emboline technology provides a woven nitinol windsock-like sleeve that sits in the aortic arch to protect the body from embolic material generated by the valve implantation procedure.” The device captures any clots while enabling the valve to be delivered through the device. CardioLogical Solutions owns the only issued US patents for embolic diverting devices in the aortic arch.

The two remaining technologies are brand new. One is a novel technology to minimize the occurrence of contrast-induced nephropathy, which is damage to the kidneys resulting from the large amount of dye used to image the vessels via X-rays during many cardiology procedures. “This is an issue not only with TAVI, but also with all other catheter-based procedures that use X-rays, such as coronary angiograms,” Smith points out. The other new technology is a device that enables insertion of the large catheters (sheaths) that are used in these procedures to provide the initial access to the arteries. This new technology enables access to arteries that may otherwise be too small to accept the sheath and minimizes vessel trauma during sheath insertion. Smith expects interventional cardiologists to use all four technologies together during the same TAVI procedure.

CE mark for the VasoStitch and Emboline devices is likely in 2015, followed two years later by a probable PMA for the VasoStitch product and a 510(k) for the Emboline CAP. Approvals for the contrast-induced nephropathy prevention and atraumatic sheath insertion technologies will be farther out.

Prior to the merger of VasoStitch and Emboline, both companies sought outside financing independently: a Series A in the amount of $6 million to $8 million for VasoStitch and a Series B of $10 million to $12 million for Emboline. Both were visiting the same venture capitalists and strategic partners. In fact, it was at the suggestion of several strategic partners that the two companies joined forces. “The more we thought about it, the more sense it made,” Smith says. “These VCs tend to have larger and larger funds. Ironically, it seems to be far easier to raise $15 million than $5 million.” Streamlining the two operations also makes financial sense. “We have harmonized the clinical advisory board and expect to use the same centers for much of our clinical work, and in some cases enroll the same study patients for the VasoStitch and Emboline devices,” Smith maintains. Complete compatibility among product offerings will also be ensured, as will the broadest range of applicability and compatibility with current valve devices.

CardioLogical Solutions’ co-founder, Amir Belson, MD, is a pediatric nephrologist by training and the primary founder of both VasoStitch and Emboline. A serial entrepreneur, Belson has more than 250 issued and pending patents in a wide range of medical devices. David Smith also has extensive experience in medical devices. Besides serving as CEO of VasoStitch from December 2011 to December 2012, Smith served as the founding president and CEO of Tenaxis Medical Inc. (surgical sealant) from 2004 to November 2011. Prior to that, he was senior VP of marketing and business development for Cohesion Technologies Inc. (surgical sealant for vascular surgery), and VP of business development at Carl Zeiss Inc. (ophthalmic diagnostic instrumentation).

The third co-founder, Scott Russell, president and COO of the new company, was acting CEO of Emboline from November 2011 to January 2013. A metallurgist by training, Russell has a long history of medical device development, including serving as CEO of SeptRx Inc. (heart defect closure) from 2008 to the present, in parallel with Emboline’s early development. Previously, he co-founded and served as chief technology officer of ConfirMD LLC (a medical device testing business) from 2007 to 2008, was the founder and principal of Benchmark Nitinol Device Technologies LLC (medical device consulting) from 2006 to 2008, and director of the Advanced Device Concepts medical device incubator within Johnson & Johnson/Cordis Corp. and Nitinol Devices and Components (NDC) from 2000 to 2006.

CardioLogical Solutions has four issued and three pending patents and will not be sharing royalties/revenues with another entity. The company has yet to begin any human clinical studies of its devices. Competitors to VasoStitch’s access and closure device offer either a transfemoral approach or a transapical approach, but not both. For instance, Abbott Laboratories Inc. (Prostar, ProGlide) provides transfemoral closure that was originally configured for the stent market, so its devices close much smaller holes. “Typically, the cardiologist will need to use two or three of them to close the larger hole created by a TAVI intervention,” Smith says. On the other hand, [Entourage Medical Technologies Inc.] targets the transapical market by using a corkscrew suture approach similar to that of VasoStitch; however, “we only leave behind the suture, just as the cardiac surgeon does,” notes Smith. In addition, Entourage employs a nitinol anchor, both inside and outside the heart.

A chief competitor to the Emboline CAP is the embolic deflector system made by Embrella Cardiovascular Inc. (acquired by Edwards LifeSciences in March 2011). “This is an umbrella-like cover that is inserted through the brachiocephalic artery [supplying blood to the head, neck, and arms] and the mesh covers one to three branch vessels, depending on the patient’s anatomy,” Smith explains. “But this device is unable to protect the entire body, as does the Emboline CAP.” Claret Medical Inc. (Montage System) has a dual filter that also goes through the brachiocephalic artery, and also without complete protection.

There are no competitors for CardioLogical Solutions’ contrast-induced nephropathy prevention technology, according to Smith. “This is a very novel, new field of medicine,” he says. “The problem is recognized, but there is really no solution at this stage.” The atraumatic sheath insertion technology is also unique. “At the moment, drugs are sometimes injected to reduce vasospasm during insertion of the introducer sheath,” Smith states. “But more often, femoral access may be abandoned altogether and an alternative access route sought.”

The VasoStitch access and closure device and the Emboline CAP are both projected to begin selling in Europe in 2015. The company will likely use the sales force of a strategic partner already in the TAVI field or considering entering it. The VasoStitch device will sell for about $1,500 and the price of the Emboline CAP will be predicated on the European reimbursement for similar devices, currently $3,250.

Although Smith declines to divulge the amount of money raised to date, a Series A round from private investors closed between December 2011 and June 2012. A Series B of $16 million to $18 million, targeting venture capitalists, is underway and is expected to close in March. That funding will take the company to the CE mark. There is also the potential to ink a deal with a strategic partner during the early development stage. “All the potential partners we are in discussions with would prefer to conduct the US clinical studies themselves, because I think they recognize that they will have to live with any marketing claims from those studies,” he says.

CardioLogical Solutions, based in Los Altos, CA, also eventually plans to address the mitral valve market, which has attracted a number of start-ups, and also its share of false starts. (See Also see "Percutaneous Mitral Valve Therapy: The Next Decade" - Medtech Insight, 28 March, 2012..) Furthermore, the Emboline CAP could be used for other cardiology interventions that carry a risk of stroke, whereas the VasoStitch device is applicable for implanting any large device, such as stent grafts for thoracic and abdominal aortic aneurysm repair. (See Also see "Expanding The EVAR Toolbox: A Glimpse Into The Future" - Medtech Insight, 28 March, 2012..)

CardioLogical Solutions: Combining Forces To Deliver A Range Of TAVI Accessories

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