Biomod3STM
Following the XR-Digital Imaging revolution and the opportunity to share huge quantity of digital images and medical information across hospital digital networks, the diagnostic imaging industry and the community of radiologists are seeking for solutions that can fuse and simplify that amount of available information into meaningful images. As a result, functional imaging and 3D visualization technologies are the new hot trends in the Diagnostic Imaging industry.
Opportunity: the 3D Analysis of Spinal Deformations.
Biomod3STM is a medical device allowing computer-aided 3D clinical analysis of spinal deviations, using 2D images obtained from any standard digital radiological set up. It offers the 3D visualization solution that spine orthopedic surgeons, radiologists, physical and rehabilitation physicians are looking for to leapfrog to 3D spine imaging. A simplified version (BIOMODL) offers 3D imaging capabilities for Chiropractors.
The BIOMOD platform offers a continuum of 3D imaging for the continuum of care related to spine: from pediatric detection ($400M US market), Adolescent Scoliosis and Spine Deformity centers ($100M), Sports Orthopedic centers ($133M), Physical Rehabilitation ($300M) and last (but not least) Chiropractors (+$1.1B)
|
Competitive Edge:
Biomod 3S™ is the only add-on equipment to fuse 2D digital images of the spine into a 3D model. When compared to CT scanner, it offers the same 3D resolution at no dose, in standing position. If compared to emerging diagnostic imaging equipment, it offers similar 2D-3D fusion outputs at a fraction of the cost, at no incremental footprint nor services costs, leveraging the installed base of existing Digital Imaging XR-systems. In the huge Chiropractor market, BIOMODL will compete with only one other manufacturer.
| |
 |
| Biomod3S Clinical Workflow |
|
|
|
Intellectual Property, Clinical Validation, Regulatory Position:
Biomod3STM technology, value proposition and market access plans are protected by two patents. Biomod3STM has been validated on more than 30 patients. Results have been published in peer reviewed journals, and presented in numerous scientific meetings in from 2005 to 2008. It has been proven that BIOMOD3S 3D results compare to those obtained by CT scan, which is the current standard protocol for 3D spine imaging.
Biomod3S is CE marked and already selling in Europe.
In the US, BIOMODL does not require 510k approval to enter the chiropractor market, which will be done as soon as possible. The BIOMOS3STM US regulatory roadmap is based on strong predicates to reach a simplified 510k by mid 2010.
|
 |
| Biomod3S 3D Outputs (examples) |
|
|
|
Team, Medical Advisory Board and Management team:
The design and clinical evaluation have been performed in Europe under the clinical leadership of a prestigious medical and spine surgeons Advisory Board from 2004 to 2008. Late 2008, letters of intent have been signed with prestigious US-based Spine surgeons and Spine Deformity Institutions to prepare for US-based Clinical Evaluation and further developments.
BIOMOD's leadership is technologically and operationally savvy, with a detail domain knowledge of the international Spine Deformity, Rehabilitation and Chiropractor industry.
Business Plans
BIOMOD is looking for an equity based $1.6M investment to fuel it's further business development objectives, including the commercial expansion BIOMOD in Europe, the launch of BiomodL in the US (Chiropractors) and the regionalization, clinical evaluation, and FDA 510k submission for Biomod3STM (targeting full launch late 2010).
Please contact us if you would like to receive the Executive Summary for the Biomod3S opportunity.
|
|
News:
02/03 Biomod receives Award from ANR ( French National Research Agency)
05/04 Biomod receives EUREKA award from the European Innovation Networks
09/07 Biomod receives Award from AFSSAPS, the French Drug and Medical Devices Association
04/08 Biomod receives a $70,000 grant to calibrate US Markets Opportunities from French Innovation Fund
06/08 Biomod receives Award from OSEO French Innovation Fund
09/08 Biomod Business Story is showcased in Les Echos, the #1 Business newspaper in France
10/08 Biomod establishes preliminary agreements with 3 major US Clinical Sites
|
|
