Richard Walmsley, CEO of Norwood Devices, a division of medical technologies group Norwood Abbey (Melbourne, Australia), reported receiving approval from the Therapeutic Goods Administration (TGA) for its Centurion SES Epikeratome, the key component of Epi-LASIK technology, an advanced generation system for Lasik surgery.
Approval in Australia follows FDA and European CE mark approvals in 2004.
Walmsley said: "Norwood Abbey is now at the forefront of laser vision correction [LVC] in Australia and across the world. Epi-LASIK is a proven technology with nearly 3,000 patients already undergoing the procedure in the U.S. and Europe."
The Epi-LASIK treatment uses the Centurion SES system and EpiEdge disposable separator, removing the need to cut the eye and, hence, eliminating associated complications. The instrument gently separates a thin layer of living cells, called the epithelium, on the outside of the eye, along a natural cleavage plane. The clinician then moves the epithelial sheet to one side, the laser corrects the vision and the epithelial sheet is then moved back into place with minimal surgical manipulation.
"The [Lasik surgery] market potential in Australia is significant," Walmsley said. "There are close to 30 laser refractive centers across Australia, with an expected 30,000 patient procedures being undertaken in 2005. In 2003, there were in excess of 3 million LVC procedures performed worldwide using approximately 5,700 LASIK cutting devices."
He added: "Epi-LASIK combines the benefits of current laser vision correction procedures and eliminates their disadvantages – particularly the need to cut the eye."
Walmsley said that the company's Devices division forecasts revenues of AUS$14 million in 2005 and expects to be cash-flow positive and profitable on a month-by-month basis by the end of 2005.
Norwood Abbey has two divisions: Norwood Immunology and Norwood Devices.
Hemosol close $13.4 million funding
Hemosol (Toronto) on Friday reported closing the previously disclosed financing raising gross proceeds of around $13.4 million and the extension of the company's $20 million credit facility (Medical Device Daily, April 4, 2005).
Hemosol said it expects the financing proceeds, together with the extension of the credit facility, to be enough to fund company operations through the balance of 2005.
"Having secured this financing, we look forward to advancing our therapeutic protein and bio-manufacturing initiatives," said Lee Hartwell, president and CEO.
Hemosol in March reported that it had achieved a key milestone in its therapeutic protein initiative by completing the technology transfer and successfully implementing the novel Cascade technology at a 30-litre scale. Implementation of the Cascade at this magnitude has established a foundation to build toward clinical-scale production by the end of 3Q05, Hemosol said, and that once clinical scale is reached, investigational new drug (IND) applications related to the three initial lead proteins will be prepared for submission to the FDA, followed by clinical development activity and full commercial scale-up of the Cascade process, it said. It expects the first of the three IND's to be filed before the end of 2005.
Hemosol said it expects to develop a portfolio of products from Cascade that will lead "to significant revenues." Following successful completion of clinical trials, new drug applications will be filed with the FDA.
Hemosol is focused on the development of biologics, particularly blood-related proteins. It has a range of therapeutic products in development, including oxygen and protein-based therapeutics to treat certain infectious diseases, cancers and anemia.