AOI Aoi (Regs)

 

TIDMAOI 
 
RNS Number : 8618P 
AOI Medical, Inc. 
31 March 2009 
 
Press Information 
 
AOI Medical, Inc. Treats Thirty (30) Patients in Ascendx(TM) VCF Reduction 
System Clinical Trial 
 Procedure Designed to Provide a Mechanical, Repeatable Cutting of Cancellous 
Bone and to Provide Even Distribution of Bone Cement 
 
London, UK, 31 March 2009 - AOI Medical, Inc. (the "Company" or "AOI") (AIM: 
AOI), a medical device company focusing on innovative orthopaedic medical 
devices for the spine and trauma markets, has successfully completed surgical 
procedures on thirty (30) patients in a clinical trial with Ascendx(TM) 
Vertebral Compression Fracture ("VCF") Reduction System ("Ascendx(TM)") at six 
sites across the United States. The board is pleased with the progress of the 
clinical trial and results to date; evaluation of clinical outcomes is ongoing. 
William J. Christy, CEO of AOI Medical, said: "The clinical program has gained 
momentum and we are pleased with our progress to date. The Ascendx(TM) system is 
designed to provide notable improvements in the way physicians traditionally 
treat VCFs. While all currently existing VCF procedures offer immediate pain 
relief to the patient, the Ascendx(TM) technology is specifically designed to 
provide a mechanical, repeatable cutting of cancellous bone and to deliver an 
even distribution of the bone cement." Over time, these features may potentially 
provide benefits with respect to clinical outcomes, subject to ongoing clinical 
evaluation. 
On 12 March 2008, AOI received final approval from the FDA to commence a 
clinical trial for its Ascendx(TM) technology. The single arm trial of 
Ascendx(TM) will ultimately involve sixty (60) subjects in eight centers, with 
the primary end point being acute procedural success defined as successful 
device deployment, cement delivery, and device withdrawal. The data from the 
trial will be used as clinical support for the company's 510(k) submission to 
the FDA in relation to Ascendx(TM). 
The clinical trial is expected to complete its last patient enrollment and make 
its 510(k) submission to the FDA in mid-2009. The company believes that it 
remains on target for a market launch of Ascendx(TM) in the United States 
towards the end of 2009. 
 
 
About Ascendx(TM) 
Ascendx(TM) is an investigational device which comprises a 
set of tools specifically designed for use in the treatment of painful 
pathological fractures of the vertebral body that may result from osteoporosis, 
benign lesions and/or malignant lesions such as metastatic cancers and myeloma. 
Ascendx(TM) will comprise two main instruments: a cutting device that creates a 
cavity in cancellous bone, and a reduction device that is used to restore the 
height of the fractured vertebra and which can deliver and contain the 
bio-material (bonding agent) in the cavity. The set of tools is designed to 
offer a potential enhancement over current techniques. Ascendx(TM) is an 
investigational device limited to investigational use in the ongoing IDE study 
in the United States. 
Ascendx(TM) presents an attractive market opportunity. The size of the market is 
estimated to be in the region of $700 million annually, rising to over $900 
million by 2012 (source: CRT Capital, LLC 2008). 
 
About AOI Medical, Inc. 
AOI is a medical device company focusing on the 
development and commercialisation of innovative orthopaedic medical devices for 
the spine and trauma markets.  It is progressing the development of three 
separate innovative product platforms: Ascendx(TM) VCF Reduction System, BAMF 
Trauma and Cervical Plate. Further information can be found at www.aoimedical.n 
t 
 
+------------------------------------------------+----------------------------------------+ 
|                                                |                                        | 
| Enquiries:                                     |                                        | 
|                                                |                                        | 
| AOI Medical, Inc.                              |                                        | 
+------------------------------------------------+----------------------------------------+ 
| William J. Christy, CEO                        | Tel: +1 407 770 1800                   | 
+------------------------------------------------+----------------------------------------+ 
| Angela Johnston, CFO                           |                                        | 
+------------------------------------------------+----------------------------------------+ 
|                                                |                                        | 
+------------------------------------------------+----------------------------------------+ 
| Numis Securities Limited                       | Tel: +44 (0) 20 7260 1000              | 
+------------------------------------------------+----------------------------------------+ 
| Nominated Adviser: Michael Meade / Brent Nabbs |                                        | 
+------------------------------------------------+----------------------------------------+ 
| Corporate Broking: David Poutney               |                                        | 
+------------------------------------------------+----------------------------------------+ 
|                                                |                                        | 
+------------------------------------------------+----------------------------------------+ 
| The Investor Relations Group                   |                                        | 
+------------------------------------------------+----------------------------------------+ 
| Erika Moran/Tom Caden                          | Tel: +1 212 825 3210                   | 
+------------------------------------------------+----------------------------------------+ 
| Public Relations: Susan Morgenbesser           |                                        | 
+------------------------------------------------+----------------------------------------+ 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 RESCKDKKABKDBNN 
 

Aoi (Regs) (LSE:AOI)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024

Aoi (Regs) (LSE:AOI)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024