Medical Device Daily Israel Correspondent

ZICHRON YA'AKOV, Israel — Microalgae cohabiting with pancreatic islet cells inside a implantable device could be the "future/now" solution for insulin-dependent Type 1 diabetes and a subgroup of Type 2 of the disease.

The device is implanted subcutaneously in a 15-minute, minimally invasive procedure that could be performed under local anesthesia in the out-patient clinic. This hybrid biotech/device, an artificial pancreas dubbed BO2, is under development by Israeli start-up Beta-O2 Technologies (Petach-Tikva), founded in 2004.

The BO2 device has not only harnessed the photosynthetic cycle, it also has captured the interest of Boston Scientific (Natick, Massachusetts) according to Globes, the Israeli version of the Financial Times. The on-line daily recently reported that Boston Sci is in advanced negotiations for an option to acquire Beta-O2 in stages.

According to the local media source, Boston Sci is buying a 10% share in Beta-O2 for $4 million, with additional investment subject to progress in product development and regulatory approval. In the end, the U.S. company could acquire full control of Beta-O2, at an amount, including royalties, said to exceed $1 billion.

The BO2 allows implanted islet of Langerhans insulin-producing beta cells to normally monitor blood glucose levels and secrete insulin according to need, as the pancreas cells are continuously oxygenated and nourished by green microalgae suspended in water droplets.

Carbon dioxide waste, that animal cells normally produce, is consumed by the microalgae which are photosynthetically stimulated by a tiny artificial light-source to continuously produce oxygen — a miniature ecosystem that replicates the interdependent role of Plant and Animal Kingdom on Earth, using water as the common medium, in a device the size of a pacemaker.

It is widely known in the diabetes community that other efforts to produce an implantable artificial pancreas capable of restoring normal glucose-stimulated insulin secretion are yet to succeed.

Although unwilling to comment on the BSC media report, Beta-O2's CEO Chanan Schneider had said earlier that "The challenge of supplying oxygen to transplanted cells has not been solved until now. The technology developed by Beta-O2 proves that a solution can be found."

The company also had stated its hope to see this artificial pancreas to market by 2011, assuming all goes well.

The B02 has undergone extensive laboratory and animal testing since the implantable chlorophyll-based oxygen generator was invented and patented (2001, 2002) by Beta-O2 cofounders Pnina Vardi and Konstantin Bloch, leading clinical and research endocrinologists from Tel-Aviv University and Rabin Medical Center (Petach Tikva), with serial entrepreneur Yossi "Yosef" Gross, and co-workers.

In 2004, the start-up completed a $2 million seed financing round led by Vitalife Life Sciences Venture Fund (Savyon, Israel), with Heznek, the Israeli government start-up fund. Pitango (Herzliya), one of Israel's top venture capital funds is a major shareholder. Beta-O2 has raised $7 million to date.

Globes stated that Boston Scientific has invested a few million dollars in the company within the last six months, prior to the current negotiations.

The biggest problem has not been obtaining the beta cells as transplants from deceased donors nor implanting them, but preventing these high-metabolism cells from dieing due to lack of oxygen and establishing an ongoing feedback-regulated loop of ambient glucose and insulin," Bloch told Medical Device Daily.

"The BO2 is based on a new model system for immuno-isolated islets in combination with light activated, photosynthetically-stimulated, oxygen production of microalgae. The illuminated algal cells are co-immobilized in a separate compartment from the insulin-secreting islets," Bloch said.

Without confirming or denying the Globes report, Professor Avi Ludomirsky, founder of Vitalife and managing partner and chairman of Beta-O2, said, "Beta-O2 is a winning combination of unique technology, tremendous market potential as well as an experienced and expert team of entrepreneurs, managers and employees having the talent and vision to create a world-class success."

Gross is an Israeli medical device icon. Since 1997, he has founded more than 20 medical device start-ups and owns more than 300 patents. These include, besides BO2, a capsule-sized device being developed by E-Pill Pharma (Caessaria) that allows oral delivery of large molecule drugs; and a transdermal drug delivery system being developed by TransPharma Medical (Lod, Israel).

"I focus on solutions to unmet medical needs that depart radically from other devices in development, such as the solution of Beta-O2 to create a dual-encapsulated microenvironment of algae and pancreatic cells," Gross has said.

Rcadia's COR analyzer FDA-cleared

Rcadia Medical Imaging (Haifa), a developer of computer-aided diagnostic software, reported receiving FDA clearance for its COR Analyzer I, used to assist in screening triage patients for coronary artery disease (CAD).

The COR Analyzer I and COR Analyzer II software packages use image processing algorithms to analyze CT Angiography (CTA) studies to provide fast, accurate identification of CAD.

"Particularly in the ER . . . the Rcadia COR Analyzer software, which works hand-in-hand with CTA images, enables highly accurate identification of coronary artery disease as the cause for chest pain," said Dr. Anna Chacko, vice chairman of the division of radiology at Boston Medical Center.

Chacko added: "CTA is being rapidly adopted to triage patients in ERs across the U.S. Rcadia's COR Analyzer II . . . streamlines patient care and prevents unnecessary delays in diagnosis and treatment."

In a recent pilot study, Rcadia COR Analyzer I and COR Analyzer II packages successfully identified coronary artery disease in 100% of patients and 99% of the analyzed blood vessels.

"The real benefit of Rcadia's software is its high negative predictive (NPV) value," according to Jeff Mendel, MD, chair of the Department of Radiology at Caritas St. Elizabeth's Hospital (Boston). Mendel added that high NPV is the key to screening because it identifies true negative tests and is highly reliable in ruling out coronary artery disease.