Companies With Innovative Technologies Compete in TCT Shark Tank

Eight startup companies with novel CV technologies competed for the TCT 2015 Innovation Award in a “Shark Tank” competition. 

The winner will be announced on Thursday morning and will give a presentation in the Main Arena at 9:30 a.m.

The eight participants were chosen from more than 60 submissions to present their advance to nine “Sharks” drawn from academia, industry and the venture capital world. Judging was based on six criteria including unmet clinical need; out-of-the-box concept; intellectual property position and viability; biological proof of concept; clear regulatory pathway; and commercialization potential.

“There is nothing more important than peer recognition” for startups with unproven but promising technologies, said Shark Tank member Juan F. Granada, MD, of the CRF Skirball Center for Innovation, Orangeburg, N.Y.

Nerve modulation for hypertension 

Dave Peterson, PhD, from Valencia Technologies, Valencia, Calif., presented a median nerve neurological modulation system for treatment of refractory hypertension. A median nerve stimulator about the size of a nickel is implanted into the forearm of a patients with uncontrolled hypertension likely caused by autonomic dysfunction.

The system works by excess sympathetic outflow inhibition by somatic afferent activation, and it was shown in a feasibility and safety trial to reduce office systolic BP at 6 months by 10.22 mm Hg.

Health care data architecture 

Hilbert Paradox, a company in Antwerp, Belgium, has developed a global, cloud-based architecture to help health care providers with storage, retrieval and data processing, while maintaining strict compliance with privacy regulations and security needs, the company’s co-founder Bart Segers said.

Possible applications include using continuous glucose monitoring data to forge therapy recommendations, interpretation of automated real-time ECG algorithms, and sequencing, assembly and storage of automated genome information.

Autonomic neural sensing guidewire

Reasons cited for the failure of the SYMPLICITY HTN-3 trial of renal denervation for resistant hypertension include the absence of procedural feedback, no sense of correct dosing and poor patient selection, said Robert S. Schwartz, MD, of the Minneapolis Heart Institute Foundation, Minneapolis, Minn. As a result, Autonomix Medical LLC developed a guidewire-based autonomic neural sensing system for the renal artery lumen that can do for renal denervation what fluoroscopy does for PCI.

The sensing system is placed on a 0.014-inch wire that can be used with any ablation system, whether radiofrequency, cryogenic, ultrasound or radiation, and “enables precise procedural guidance,” he said.

Implantable left atrial pressure monitor 

Left atrial pressure monitoring is more accurate than pulmonary artery pressure monitoring for early detection of acute decompensation in HF patients, so Vectorious has developed a miniature wireless left atrial pressure monitoring system, according to Leor Perl, MD, of Stanford Hospital and Clinics, Stanford, Calif.

In preclinical studies, the implant has achieved complete fixation and has not been associated with thrombosis or perforation at 6 months, he said.

Novel treatment for ambulatory HF

Effective treatments are lacking for HF patients with NYHA class III or IV symptoms because medical management often fails by the time the disease progresses to that point. But these patients are not yet good candidates for a left ventricular assist device or heart transplant, said Manesh R. Patel, MD, from Duke University Medical Center, Durham, N.C.

Procyrion designed the Aortix System, a heart pump deployed by a catheter that does not expose the patient to risks associated with surgery and improves hemodynamics, including cardiac function, cardiac work, renal function and renal flow capacity.

Transcatheter mitral valve replacement

Several transcatheter mitral valve replacement devices are in development, but the Accufit (Sinomed) has features that address many challenges, including residual mitral regurgitation, paravalvular leak and risk of damaging adjacent structures, according to a presentation by Patrick W. Serruys, MD, PhD, of Imperial College London and the Thoraxcenter of Erasmus Medical Center, Rotterdam, the Netherlands.

The device features a reverse leaflet design to eliminate central leakage, a sealing ring design to prevent paravalvular leak, a low ventricular profile (< 14 mm) to guard against damaging adjacent structures and controlled deployment to avoid LV outflow tract obstruction.

Pulmonary artery hypertension denervation 

Therapeutic IVUS, as developed by SoniVie, is a viable treatment for pulmonary hypertension, Alex M.K. Rothman, MD, of the University of Sheffield, Sheffield, United Kingdom, said. He added that novel treatments are vital because pulmonary arterial hypertension is associated with a 15% annual mortality rate and a 5-year survival rate of less than 50%.

The system employs pulmonary artery denervation to deliver energy to nerves to reduce elevated catecholamines and muscle sympathetic nerve activity without damaging the intima and media. A preclinical study showed that applying pulmonary artery denervation to pigs reduced acute pulmonary hypertension, he added.

Pulmonary embolism clot-removal device

An interventional clot-removal device-based system (FlowTriever System, Inari Medical) has the potential to remove most or all of a pulmonary embolism, according to Brian Cox, of Inceptus Medical LLC, Aliso Viejo, Calif. The system consists of a clot-removal device, an aspiration guide catheter and a retraction aspirator.

“The system is easy to use, provides an acute patient impact, effectively removes thrombus, restores rapid flow, improves right ventricular dysfunction, reduces or eliminates the need for thrombolytics and their potential bleeding and stroke risk and might reduce acute and long-term mortality,” Cox said.

Disclosures: 

• The presenters and members of the “Shark Tank” report relationships with multiple device and pharmaceutical companies.