Aclarion

Address: 951 Mariners Island Blvd

City: San Mateo

State: CA

Zip: 94404

Country: US

Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), and a proprietary biomarker to optimize clinical treatments. Aclarion’s technology addresses the $134.5B U.S. low back and neck pain market. The Company is currently utilizing Artificial Intelligence (“AI”) to assist in quality control processes that flag spectroscopy data indicative of a poor MRS study. The Company is also researching the application of AI and machine learning platforms to analyze both the raw spectroscopy data and the post-processed signal to evaluate whether AI platforms can more efficiently and more effectively associate MRS data with clinical outcomes. The company has conducted its operations since early 2008 on over $3.5 million dollars of Series A Preferred financing. This was raised via private placement “Angel” investments via accredited investors, including from each of the company’s founders and a long list of world renowned thought leaders in spine surgery, pain management, and imaging/radiology. The company&s;s direction and management continue to be led by its co-founders, and via an expanded team of management and operational professionals - and other consultants - adding further significant experience and acumen in engineering, sales &a; marketing, reimbursement, and regulatory/quality/clinical affairs relevant to the company&s;s field. The company already achieved many significant development milestones for its primary first investigational product, NociscanTM, involving multiple inventions captured in intellectual property owned by the Company. The company initially sponsored a $1MM/2 year co-development program at UCSF from early 2008 to early 2010. This principally featured feasibility clinical studies to initially develop the technology for use with one initial commercially available high field MR system for robustly acquired and post-processed in vivo MRS data, and to train a diagnostic algorithm based on that MRS data which correlates highly to pain and degeneration per other standard diagnostic controls (e.g. including invasive discogram for pain). The data from this initial investigational clinical development study demonstrated high procedural success for the Nociscan MRS diagnostic platform, with extremely high diagnostic accuracy against standard controls for diagnosing discs as painful vs. non-painful, and was the subject of multiple podium presentations in various medical and scientific society venues. Nocimed&s;s more recent activities and objectives have been to advance Nociscan in next investigational development steps from the successful initial development and feasibility experience enjoyed at UC San Francisco. This has principally involved development for cross-platform use via multiple different MR system platforms from different manufacturers, and while gathering more clinical data for assessing correlations and algorithm training. The company plans to complete this development under an on-going multi-platform, multi-center study that was IRB approved in October 2011 and launched on a first platform (Siemens 3T Verio) in November 2011. While Nociscan is being developed and evaluated for compatible use with various MR systems from multiple manufacturers, the company is using the current study and conducting concurrent negotiations to evaluate which MR system(s) will be chosen for advancement for future trials, regulatory pathways, and ultimate planned commercialization in the future. Upon successful completion of this study, the company plans to freeze the platform design for a first generation planned product offering, and conduct a prospective, multi-center trial to further confirm the robustness of the uses intended for regulatory clearance of the platform. These latter activities are likely to be conducted via a multi-$ million dollar Series B Preferred financing that the company plans to conduct by mid-2011.

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+16502411741

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