A Medical Device Daily
HemoBioTech (Dallas) said it has engaged Paragon Biomedical (Irvine, California),a contract research organization,to provide regulatory and clinical services inIndia related to the company’s human blood substitute, HemoTech.
Paragon will submit pre-clinical data regarding HemoTech studies that were part of a European IND and clinical data related to the HemoTech human study in Zaire to the Indian regulatory agency for review. The goal is to receive permission to commence clinical studies of HemoTech in India.
A limited clinical study of HemoTech was performed in 1991 in Zaire. Results of the study were published in Surgery, Gynecology & Obstetrics the following year. In the study, nine sickle cell anemia patients were infused with amounts of HemoTech representing 25% of patients’ total blood volume.
The company said the limited clinical trial resulted in “significant” patient improvement and suggested that HemoTech can work as a physiological oxygen carrier in humans, is non-toxic, is vasodilatory and anti-inflammatory; and induces red blood cell production. Peripheral blood reticulocytes increased from 4% to 49 %.
“HemoBioTech considers India a key component of our global strategy to commercialize HemoTech,” said Arthur Bollon, PhD, chairman and CEO, citing its population of 1.1 billion people, “significant middle class and a good infrastructure for clinical studies.”
Paragon Biomedical’s India office is located at the Technopark Campus in Trivandrum. The facility is India’s only CMMI Level 4 accredited technology center and one of the two largest IT campuses in India today, Paragon said.
China clears Cynosure workstations
Cynosure (Westford, Massachusetts), manufacturer of a broad line of light-based aesthetic treatment systems, said it has received regulatory clearance to market and sell its Elite family of laser workstations in China.
“We are excited about the opportunity to market and sell our Elite, Apogee 5500 and Acclaim 7000 laser workstations in the fast-growing Chinese market,” said Cynosure President and CEO Michael Davin. “As global demand for aesthetic laser procedures continues to increase, and as Chinese consumers seek effective, high-quality treatment options, we believe our Elite family of products will provide a competitive solution for those seeking laser cosmetic treatments.”
The Elite workstation combines the Apogee 5500 system, which contains a short-wavelength 755 nm Alexandrite laser for lighter skin types, and the Acclaim 7000 system, which is equipped with a high-powered 1064 nm Nd:YAG laser for use on tan and darker skin types to permanently remove hair. In addition, the Elite can be used to treat benign epidermal pigmented lesions such as age spots, sunspots and freckles, as well as leg and facial veins.
The company established a wholly-owned subsidiary in China last December.
Artimplant gets U.S. okay
Biomaterials company Artimplant (Vastra Frolunda, Sweden) said it has received FDA clearance for marketing its Artelon STT Spacer in the U.S. The product is indicated for osteoarthritis in the STT joint.
Small Bone Innovations (New York), the licensee of Artimplant, will market the product in the U.S.
Patients with osteoarthritis in both the CMC and STT joints that previously could not be treated for thumb-base osteoarthritis with only the Artelon CMC Spacer now will be able to benefit from use of Artelon Spacers in both joints, the company said.
Artimplant President/CEO Hans Rosn said, “Artelon STT Spacer is an important complement to our currently best-selling CMC Spacer.”
Artimplant is focused on solutions to problems in orthopedic and oral surgery, developing degradable implants that regenerate body functions and improve quality of life. The company produces implants for treatment of osteoarthritis in the hands and feet, for shoulder and other soft-tissue injuries, as well as oral applications.
PDSi in Startronics marketing accord
Pinnacle Data Systems (PDSi; Columbus, Ohio) reported agreeing to a partnership with Startronics (Givatayim, Israel), a subsidiary of STG International , to jointly market and support PDSi products and services in that country.
Under the terms of the agreement, Startronics will represent and resell PDSi products in the Israeli market, as well as provide the first level of support for existing and new customers.
“Startronics’ knowledge and expertise in the distribution and support of highly complex systems and components will be an asset in helping support existing and new customers locally in Israel,” said Michael Sayre, president and CEO of PDSi. “By partnering with Startronics, PDSi is continuing to expand its capabilities to provide the highest quality support for our customers on a global scale.”
Avner Arroyo, general manager of Startronics, said, “We are looking forward to opening many doors in Israel for PDSi’s unique and flexible solutions.”
PDSi provides computer design, production, and repair services to OEMs who build computers into their products in medical equipment and other industries.
EDAP expands Stonebreaker distribution accord
EDAP TMS (Lyon, France), a developer of high-intensity focused ultrasound (HIFU) devices for treating prostate cancer and provider of ESWL devices for the treatment or urinary stones, has signed an exclusive distribution for the LMA Urology Suisse (Gland, Switzerland) StoneBreaker system in the Malaysia and Korea domestic markets.
The agreement with LMA also grants EDAP worldwide exclusive distribution of the StoneBreaker when bundled with EDAP’s existing line of products. The new agreement adds to the company’s March debut as the exclusive StoneBreaker distributor in LMA’s French territory.
The LMA Stonebreaker is a portable intra-corporeal contact lithotripter which fragments stones in the urinary tract. The hand-held system complements extracorporeal lithotripsy procedures performed with ESWL devices. The system, manufactured in Switzerland, received the CE mark in June 2006 and is validated by extensive clinical trials confirming the effectiveness of the cynetic intracorporeal lithotripsy technique, EDAP said.