A Medical Device Daily
Ventracor (Sydney, Australia) reported progress in its U.S. clinical trial program and revealed details of its U.S. clinical trial strategy for its VentrAssist product.
CEO Peter Crosby said Ventracor's overall objective "is to reach the end point of U.S. FDA approval to market the VentrAssist in the U.S. as soon as possible. Working closely with the FDA on several initiatives, we have received approval for both the Bridge to Transplant Trial (BTT) and Destination Therapy (DT) Trial protocols."
The DT protocol is a prospective, randomized, controlled trial with two modules, both with event-driven end points. Module A (primary) consists of 180 patients, with 2:1 randomization of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT. Module B (secondary) consists of up to 45 patients, with randomization of the VentrAssist to an LVAD approved by the FDA for DT.
The company said it believes that this trial has the potential to reduce time-to-market by up to 18 months compared to earlier DT trials. A patent on the trial design has been applied for.
The BTT trial protocol is a single-arm prospective trial to an objective performance criterion of 75% ± 10% success, defined as heart transplantation or listed for heart transplantation at 180 days. There will be an interim analysis at 98 outcomes.
Ventracor said data from patients in the feasibility trial may be pooled with data in both trials will commence following FDA approval after review of data from patients in the feasibility trial. The DT and BTT trials will be run concurrently at up to 40 centers.
The VentrAssist left ventricular assist device is an implantable blood pump designed, the company said, to improve the lives of heart failure patients and their families.
Bridgetech enterprise gets China approval
Bridgetech Holdings International (San Diego) said its wholly owned foreign enterprise, Guangzhou Bridgetech Medicines Co. Ltd. (GBML; Hong Kong), has received the Chinese government's Certificate of Approval, which means that Bridgetech can independently import, export and distribute products under its own management, thus ensuring direct access to customers and quality of service at all levels of the supply chain, unlike the conventional way of relying on third-party distributors.
The approval by the Chinese Ministry of Commerce allows GBML to operate for 30 years in China.
Michael Chermak, CEO and chairman of Bridgetech, said the approval positions GBML to build a distribution network to assure that approved drugs and devices can reach target groups in the Chinese community. "This is a major milestone in the realization of Bridgetech's mission to introduce world-class healthcare products to China," he said.
Late last year, Bridgetech established two contract research organizations (CROs), in Guangzhou and Hong Kong. The Guangzhou CRO has a license to submit applications to China State Food & Drug Administration for approval of drugs and medical devices. It also manages the regulatory component of the drugs and medical devices application process, while the Hong Kong CRO, a joint venture with the Chinese University of Hong Kong, manages the clinical trials component.
Bridgetech said it has engaged Professor Jean Hao as technical director of GBML to forge these elements together. Hao was head of Sanofi-Aventis' regulatory and corporate affairs prior to her retirement in December 2005.
Female Condom distribution expands in India
The Female Health Co. (Chicago) said that its partner in India, Hindustan Latex Ltd. (HLL), has expanded its promotion of the Female Condom to three additional cities. After earlier launching the Female Condom to consumers in the cities of Bangalore, Chennai and Kolkata, the company now has launched the product in New Delhi, Mumbai and Hyderabad. The six cities have an aggregate population of some 67 million.
HLL plans to launch in a total of 34 cities over time.
As previously announced, Female Health Co. expects a third FC2 production line, developed with HLL at Kochi, India, to be operational by the end of 2Q07. FC2 is the company's second-generation Female Condom product, which is currently being manufactured on two production lines in Malaysia.
The Female Health Co. markets the FC Female Condom, which is primarily distributed by public health organizations and donor groups in more than 90 developing countries around the world. In all, the Female Condom is available in various programs in 108 countries.
Deshpande heads up Eclipsys India
In other news out of India, Eclipsys (Boca Raton, Florida) reported that Nitin Deshpande has been named president of India operations, with responsibility for Eclipsys India's day-to-day operations.
Deshpande comes to Eclipsys from BMC Software, an enterprise management software provider, where he served as president/CEO of the company's operations in India. Deshpande grew the BMC organization from 200 to about 900 employees in three years.
Eclipsys is a provider of integrated information software, clinical content and professional services aimed at helping healthcare organizations improve clinical, financial, operational and customer-satisfaction outcomes.
New distributor arrangement for Align
Align Technology (Santa Clara, California), inventor of the Invisalign method of straightening teeth without wires or brackets, reported an agreement giving Invisalign Australia and Invisalign Hong Kong sole distribution rights for the Invisalign system in Australia and Hong Kong, respectively.
Invisalign Australia and Invisalign Hong Kong are owned and operated by Mark van Weelde, formerly Align's managing director for the Asia Pacific Region.
"This agreement will streamline regional operations and meet the needs of Asia Pacific customers in the most effective and efficient way possible," said Gil Laks, Align's vice president, international. "Partnering with Mark van Weelde provides Align with a distributor that has extensive knowledge of the Invisalign system and that can ensure Invisalign doctors in the region continue to receive great service from local representatives they've grown to know and trust."
As part of the agreement, Align entered into a stock purchase agreement with Mark van Weelde whereby he purchased 100% of the shares in Invisalign Australia and Invisalign Hong Kong.