PhotoSonix Medical Inc.
A medical device development company
Monday, March 9, 2015
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About

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PhotoSonix Medical Inc. is developing CLENS™ (Coincident Light Energy and Non focused ultraSound), a novel energy-based therapy which synergistically combines light and ultrasound energy to treat biofilm-based bacterial infections. Bacterial biofilms are extremely resistant to standard antibiotics because they pose a physical barrier and exist in a low metabolic state.
CLENS™ is initially being developed for the treatment of dermal infections caused by biofilms, specifically moderate to severe acne. This is a large and attractive market given:
- Conventional device therapies have limited effectiveness and many drugs carry "black box" warnings against severe side-effects.
- Approximately 8 million US patients and $2 billion in annual expenditures.
- An effective device-based treatment offers many advantages over pharmaceuticals.
- CLENS™ efficacy can be cost effectively demonstrated via small split-faced studies.
Target prescribers include dermatologists, pediatricians, and primary-care physicians. While a range of competing devices have been marketed for acne, including scrubbers, light sources, heaters and lasers these products have not achieved wide scale commercial success due to limited effectiveness, inconvenience, safety issues and/or patient discomfort.
CLENS™ therapy addresses multiple mechanisms underlying chronic acne via a proprietary combination of synergistic therapeutic energies. Ultrasound energy mechanically stimulates bacteria within the biofilm causing them to boost their metabolism and become susceptible to treatment. Light targets their chromophores creating toxic oxygen products. The combined treatment also enhances healing as ultrasound increases blood flow and tissue remodeling while light exposure reduces chronic inflammation.
The CLENS™ system consists of a small base unit, single-hand piece and single-use disposables. It will be physician prescribed for at-home use. After an initial treatment in the physician's office, a three week at-home treatment period (one treatment every other day) is anticipated with an estimated per treatment cycle cost of $800. This is comparable with other office based treatments and prescription topical agents. Proprietary coupling gels/emollients will yield additional revenue to the company and prescribing clinician.

3 Major Issues

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- We have proposed a physician prescribed, home treatment model. Will dermatologists support this approach?
- What would be a good marker of clinical safety (not electrical safety)? Appearance? Skin swab? Biopsy?
- What are the issues involved with using distributors that target the dermatology market to start sales? When do we move to our own sales force? What would be a rational sales ramp to provide investors?

Program:

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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Mark Schafer, PhD, President and COO, will deliver the Company's "Elevator" Pitch to the Group
8:20 - Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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