A Medical Device Daily
Norwood Abbey (Melbourne, Australia), a drug delivery and immunology company, reported on Tuesday that it is pushing forward with a variety of restructuring efforts, including outsourcing of its device activities and an attempt to achieve greater “presence” in the U.S.
The company said it has decided to outsource “all future product research work in relation to the Devices Division to Boston.” This and other restructuring efforts, it said, will result in a savings of $1.5 million annually.
The restructuring, it said, will “involve redundancies of some Australian-based staff,” but it did not detail the number of employees considered “redundant.”
In the effort to establish a higher-profile presence in the U.S., Norwood Abbey said it would “immediately” establish a central office in Boston to “facilitate interaction with key partners, including Massachusetts Institute of Technology” (MIT; Cambridge, Massachusetts), as well as enabling “senior management to further foster relationships with investors and investment bankers in the U.S.”
This effort will come under the direction of Professor Ian Hunter of the BioInstrumentation Laboratory at MIT, it said, thus extending the company’s existing relationship with Hunter’s group.
It added: “Future product development work will be undertaken by specialized Boston-based product development firms.”
Also as part of the push for increased U.S. presence, Peter Hansen, Norwood’s executive chairman, and Jeff Bell, chief operating officer, will be relocating to the U.S., it said. Head office, management and control of Norwood Abbey will remain in Melbourne.
The company said it would continue its plan to gain further recognition in the U.S. market “at both an operational and investor level.”
It said that several of the initiatives being pursued are part of an effort to advance its listing on the Nasdaq market. It expects a listing application to be submitted some time in the third quarter, and it is awaiting Securities and Exchange Commission (SEC) approval for the submission, based upon the inclusion of a full financial year’s accounts for its EyeCare division.
The company’s U.S. subsidiary is Norwood EyeCare (Duluth, Georgia), an ophthalmic devices firm. Norwood EyeCare is the developer of the Epi-LASIK treatment, uses the Epi-keratome system and a disposable separator, removing the need to cut the eye and thus eliminating associated complications. The device gently separates a thin layer of living cells – 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.
Norwood Abbey in March completed a private placement to three U.S. institutions to raise A$5.8 million ($4.5 million) (Medical Device Daily, March 31, 2005). It said that through this transaction it was building its base of U.S. shareholders, who now own about 26% of the company. And with the same investors, it said it could receive an additional equity investment of another $6 million during the next six months.
Norwood Abbey’s technologies include laser-assisted delivery, micro-needle arrays, a needleless injection system and pressure wave technology for the transfer of both drugs and genetic material.
Use of aortic graft system successful
Cook (Bloomington, Indiana) reported that the Monash Medical Centre (Melbourne, Australia) recently admitted a 50-year-old man presenting with “crushing chest pain” and that he was then successfully treated with a new medical device combination, under development by the company, using its TX2 TAA Endovascular Graft.
The man was diagnosed with aortic dissection, a tearing of the main blood vessel of the body, suspected as the cause of the death of actor John Ritter. To repair the leaking aorta, surgeons Terry Devine, MD, and Greg Self, MD, deployed the proximal part of a Cook Zenith TX2 TAA Endovascular Graft over the torn section of the thoracic aorta.
Before treatment, blood flow to the man’s extremities was so weak that physicians feared he would lose both legs and the left kidney, even if treatment of the dissection were successful. Some reduction in blood flow remained due to compression of the abdominal aorta, as a result of trapped blood in the vessel wall resulting from the tear.
Devine resolved this by placing the Zenith Dissection Stent, developed by surgeons at St. Vincent’s Hospital (Melbourne) in conjunction with Cook, in the aorta along the length of the compressed section.
After placement of the TX2 and the dissection stent, Devine reported that blood flow was restored, the kidney had normal circulation and both legs “displayed strong pulses.” A post-procedural computed tomography scan confirmed that the Zenith device had treated the aortic dissection successfully, hospital officials said. The patient was discharged a week after the procedure.
Barry Thomas, global leader of Cook’s endovascular therapy products division that developed the Zenith TX2 Endovascular Graft and dissection stents, said. “Dr. Devine told us that in his opinion, this case demonstrated that endovascular repair of aortic dissection does work, and that he will be treating the next Type B dissection he sees using this revolutionary technique.”
Cook said it is the only company in the world “at this time exploring the possibility of using stents and endografts to repair aneurysms and dissections throughout the entire aorta.”
It bills the Zenith AAA Endovascular Graft as “the world’s best-selling endovascular system for treating abdominal aortic aneurysm.” It is approved for sale in Europe, Australia and the U.S. The Zenith TX2 Endovascular Graft is approved in Australia and Europe for treating thoracic aortic aneurysms, dissections and trauma and the STARZ-TX2 clinical trial of the device is underway in the U.S.