Medical Device Daily Contributing Writer

HAIFA, Israel — How to accelerate collaboration, financing and success of convergent high tech-based medical devices, hybrid technologies with digital interfaces for diagnosis, treatment and patient management?

To facilitate that goal, the second Israel Innovation Summit, held here in the latter part of March, brought more than 180 Israeli breakthrough technologies from start-up to global enterprises together with leaders, developers and financiers in 10 areas where Israel plays a key role in global R&D.

"Our multi-platform approach is aimed to accelerate innovation through mind sharing, collaboration and investment," said Joseph Gilor, CEO of Olive Bay (Haifa) and founder and driving force behind the event.

Doron Birger, president and CEO, Elron Electronic Industries (Haifa) and chairman of the Israel Innovation Summit, introduced the summit, saying, "Israel's academic, industry and government run platforms for technological innovation support what is globally recognized as the most important technology hub outside of the U.S., attracting over $12 billion in venture capital, invested in Israeli technology development over the last decade, the highest percentage of GDP in the world."

One cardiology device session led by Shmuel Fuchs, of Rabin Medical Center (Petah Tikva), focused on devices developed to listen to the heart.

How to better screen for coronary artery disease (CAD) without exposure to radiation or expensive monitoring? Cardiometer (Tel Aviv) founder and CEO Ronen Arbel showed proof-of-concept in humans at risk for significant CAD with its noninvasive device using spectral analysis of pulse wave amplitude during slow-guided deep breathing, or respiratory modulation response (RMR).

He showed in a clinical trial at the Rabin Medical Center on 97 consecutive patients referred for coronary angiography, that a clearly flattened RMR consistently signaled patients with coronary stenosis greater than 50%, those sent to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Amos Katz, director of cardiology at Barzilai Medical Center (Ashkelon), who developed the concept, presented these results at last month's American College of Cardiology meeting in New Orleans.

Arbel told Medical Device Daily, "Sensitivity was 79% and specificity 87%. Now our aim is to bring this device to market."

CardoAcoustics (Haifa) is applying cutting-edge signal-processing methods to the sounds of cardiopulmonary interaction, to provide a continuous functional monitor of the health of the heart.

Inventor and company founder Nathan Intrator, of both Tel-Aviv University and Brown University (Providence, Rhode Island), said that the start-up is seeking to expand clinical trials of its prototype noninvasive continuous monitor-analyzer as an early warning system for congestive heart failure (CHF), cardiomyopathy and other cardiac malfunctions.

CardoAcoustics just entered a new private incubator housing four other young companies founded by Noam Gavriely — OHK Medical Devices, developing devices for bloodless orthopedic limb surgery; Karmel Sonix, developing continuous asthma monitoring device; ETview, developing tools for endotracheal management; and Inspure, developing a state-of-the-art gas mask.

Gavriely said, "The cost savings of preventing a single CHF event and ER admission are substantial enough to cover the expense of monitoring large numbers of patients at risk."

The Edema Guard Monitor (EGM) produced by RS Medical Monitoring (Jerusalem) changes fundamentally the treatment concept of pulmonary edema (PED) — a typical consequence of CHF, acute coronary syndrome and other heart conditions. In fact, R&D chief physician Michael Shohat told MDD, "the EGM is leading a new generation of predictive medicine and devices for PED."

The device uses internal thoracic electrical impedance (ITI) measurements to detect PED forerunners. RS discovered and demonstrated that a decrease of ITI below 10% from its initial value is predictive of PED, then showed that ITI increases after treatment for PED.

"PED, once it is detected, is already difficult to treat, so our strategy is to prevent its clinical onset," said Pavel Rabinovich, physician and inventor of EGM. He told MDD, "Just 24 to 72 hours of monitoring patients suffering from diseases that pose risk of PED allows us to predict onset of PED well before the appearance of any clinical signs, when simple medical treatment can fully prevent its development."

Nicast (Lod) develops high-performance biomimetic implantables from the inside out. The company began clinical trials earlier this year on its flagship nanofiber-based drug-eluting stent for treating coronary and peripheral vascular disease, with a $5 million investment led by Infinity Venture Fund (Tel Aviv).

The Rehabilitation and Orthopedics session, chaired by Dalia Megiddo, managing partner of InnoMed Ventures (Neve Ilan), the Israeli venture fund dedicated to medical devices, was a showcase for devices that are becoming ever more dynamic rehabilitative tools, responsive to stresses and natural growth, even than the natural skeleton.

Megiddo said, "Aging baby boomers will sharply increase the pool of patients in need of solutions for joint and spine diseases. This unique group of patients will demand better performance and longer terms implants compatible with their more mobile, quality-conscious, autonomous lifestyle. At the same time, the changing regulatory climate is focusing more attention on safety, cost efficiency and evidenceebased medicine."

She introduced Orthogon, a start-up from the Ofakim Innovative Technologies incubator (Ofakim), and its proprietary, magnetically actuated intramedulary nail (IM) that addresses the problems of non-adhesion of implants in severely fractured long bone, and limb lengthening.

The IM is activated manually with a low-power directional magnetic field, exposing the fracture to growth-stimulating forces reported to accelerate bone-healing to one-third or one-half the time of passive healing.

Similarly, for brisk limb lengthening, while completely avoiding the numerous complications from external fixture — which would also become another candidate for vestigial devices of the past.

Orthogon is seen as a displacing advance over passive intramedullary nails currently in use, and seen as the forerunner of the next generation of externally controllable orthopedic treatment devices.

Impliant (Ramat Poleg), part of Innomed's portfolio, presented two years of clinical results supporting its own paradigm shift in the treatment of moderate-to-severe spinal stenosis (with or without degenerative spondylolisthesis and facet arthrosis).

CEO Ron Sacher showed how the implantable TOPS System's advanced biomechanics allow surgeons to decompress and stabilize the impaired spinal segment without sacrificing motion, and while relieving chronic lower back pain.