A Medical Device Daily

Endoart (Lausanne, Switzerland), a developer of telemetrically driven medical devices, reported that it has raised $10.5 million (CHF 13.5 million) in a Series C financing.

The company said the investment will allow it to launch its lead product, EasyBand, a remotely adjustable gastric band for severe obesity, in Europe and initiate clinical development in the U.S.

The financing was co-led by Venture Incubator and Renaissance PME, managed by Vinci Capital, with the participation of EMBL Ventures and Genevest. A number of existing investors, such as Sofinnova Partners, also participated in the round. Additionally, Diego Braguglia from Venture Incubator will join the board of Endoart.

The EasyBand device, approved for marketing in Europe in 2005, will be made available through specialized obesity centers in 2006, Endoart said. It said that clinical development, beginning this year in the U.S., is anticipated to take several years before it will be available in the U.S.

“Endoart's technology offers significantly higher comfort to patients. Remote adjustment allows precise and painless control of the device, which is key for patient compliance and success of treatment,“ said Philippe Dro, chairman and CEO of Endoart.

Endoart already markets the Flowatch-PAB in Europe for pulmonary artery banding in newborn infants. The company said its FloWatch technology allows precise control of flow through organs and vessels via activation and control of a battery-free, implanted device that can be applied in a number of indications. The company has been selling the FloWatch-PAB device in Europe since 2003 for newborn babies with severe heart malformations.

Active Implants (AIC; Memphis, Tennessee), an early intervention orthopedic implant company, reported that it has raised $10 million to date in a Series A preferred stock offering and has begun a European clinical trial of an all-polymer hip implant.

The low-wear, pliable polymer hip implant developed by AIC is an alternative to traditional, rigid metal implants used today for reconstruction of degenerated joints. The company said its hip product is implanted with minimal bone preparation, finger-touch surgical technique and flexible fixation without cement.

AIC said it is initially developing its implants for the hip and knee.

In other financing news:

• Synthetic Blood International (SBI; Costa Mesa, California), a company developing pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring, said it has received the first tranche of a bridge financing from overseas investors. The amount and terms of the financing were not disclosed.

SBI also reported that increased cerebral oxygen tension was documented following Oxycyte administration in the first three patients treated in the company's eight-patient Phase II proof-of-concept study in traumatic brain injury.

Studies indicate that about one-third of all severe head injury patients show reduced brain oxygen tension during the first six to 12 hours following injury, and this is associated with a poorer clinical outcome. Patients who die from severe brain injury have abnormally low brain oxygen levels.

Oxycyte is a perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute that is being administered in this Phase II study to increase the solubility of oxygen in the blood and thus improve oxygen delivery to the acutely injured brain following traumatic head injury.

“We are very encouraged that initial trial patients treated with Oxycyte are showing increased cerebral oxygen levels with no observed drug-related adverse effects to date,“ said Robert Nicora, SBI president and CEO. “Early results from the first three trial patients support our belief that Oxycyte may safely improve clinical outcomes in this patient population. However, while encouraging, these early results do not necessarily predict the outcome of the completed eight-patient study.“

In conjunction with its Phase II pilot study in sickle cell anemia, the company also reported that it has submitted a revised protocol to the FDA.

Subject to the availability of future funding, the company said it expects to initiate this trial in 2Q06.

• Emisphere Technologies (Tarrytown, New York) said it has filed a shelf registration statement on Form S-3 with the SEC to sell up to six million shares of common stock or warrants to purchase common stock from time to time in one or more offerings.

The company said it intends to use proceeds from the offering for general corporate purposes, including further development of its lead clinical programs.

Emisphere develops drugs in oral form for drugs that are otherwise injectable.

Tug McGraw Foundation in Napa

Establishing their headquarters in Napa is a homecoming of sorts for the Tug McGraw Foundation (Napa, California), an organization formed in memory of Phillies and Mets relief pitcher, Tug McGraw, by his son, country singer Tim McGraw, and friend and caregiver, Jennifer Brusstar. Tug was from nearby Vallejo, California.

Brusstar, the president of the foundation, said the two-year old organization has retained NewLevel Group to “help the board focus on advancing its mission of funding brain tumor research and improving the quality of life for those affected by brain tumors."

The foundation has created the "Tug McGraw Center for Quality of Life and Supportive Care Research in Neuro-Oncology" at Duke University, as well as a grant program that provides funds for brain tumor quality of life research.

CCHIT invites critiques

The public and healthcare information professionals are invited to participate in a survey assessing the progress of the Certification Commission for Healthcare Information Technology (CCHIT; Chicago) to date in developing a certification process for electronic health record (EHR) products to be used in outpatient or office-based settings. Stakeholders – from healthcare information technology professionals to product vendors to providers – are encouraged to take the survey through April 28 by visiting the web site at www.cchit.org.

The development of CCHIT's certification criteria and inspection process is carried out by over 70 volunteers from all sectors of healthcare who serve on its work groups. New members for the five work groups have been announced as part of a yearly call for participation.

"Our achievements to date reflect the dedication of our volunteers – commissioners, work group co-chairs and members – and their commitment to accelerating the adoption of robust, interoperable health IT," said Mark Leavitt, MD, PhD, CCHIT's chair. "We're approaching a major milestone, but we'll have no time to rest as we must begin immediately to update and refine our ambulatory criteria and develop our inpatient EHR benchmarks."

Late June is the target for announcing the first certified EHR products, CCHIT said.