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HBS Business Plan Finalists – PainMD

1. YOUR PITCH.
PainMD offers a highly effective, non-invasive, non-addictive pain treatment for the 46 million patients in America suffering from debilitating chronic pain. There are many causes of chronic pain including neuropathy, back injury, and trigeminal neuralgia. Existing therapies are largely ineffective in providing pain relief; treatments that work tend to be highly addictive (such as morphine) or highly invasive (such as implantable spinal cord stimulators). PainMD offers a treatment with the efficacy of implantable spinal cord stimulators and the safety profile of over-the-counter medications.

The basis of our treatment involves TMS (Transcranial Magnetic Stimulation), a safe and proven therapy that induces a local magnetic field over the somatosensory cortex, a region of the brain involved in pain sensation. PainMD has licensed intellectual property from the Beth Israel Deaconess Medical Center that enables us to use electroencephalography (EEG) to monitor electrical activity in the brain while applying TMS. We can therefore use EEG to localize and deliver targeted pulses to the region of the brain affected in chronic pain patients. Our novel proprietary use of EEG and TMS simultaneously allows us to monitor, real-time, patient safety as well as treatment efficacy, as measured by cortical electrical activity during our treatment. Seizure is the primary risk associated with TMS, but has not occurred in any study of TMS applied to chronic pain with EEG monitoring. There are over 100 studies demonstrating the efficacy of TMS applied to chronic pain, making this an effective, demonstrated approach to providing relief to the millions of people who suffer from chronic pain.

2. IDEA: WHAT SPARKED THE IDEA FOR YOUR BUSINESS PLAN?
Inventing Breakthroughs and Commercializing Science with Professors Vicki Sato and Lee Fleming and a subsequent field study on monetizing this technology.

3. TARGET MARKET: WHO ARE YOU TARGETING? WHY?
There are 46.5 million patients in the US who suffer from chronic pain. The patients who comprise this $80 billion market could be helped by our treatment. Of this large patient population, there are 9.6 million patients (a $17B market) with chronic neuropathic pain. Of this patient population, we estimate there are 61,000 patients ($100M market) who have not responded to multiple drug treatments and are now indicated for spinal cord stimulators. These patients, eager to avoid the risks involved with implantation of spinal cord stimulators, are likely to be early trialers of our therapy.

To reach these patients, we initially plan to work with pain specialists (physiatrists, anesthesiologists, neurologists) who specialize in chronic pain and practice at specialized pain clinics. There are several hundred pain clinics in America. After reaching this audience with our technology, we plan to reach pain specialists who practice in ambulatory and hospital settings, and eventually primary care physicians who see chronic pain patients in their clinics.

4. CHALLENGES: WHAT DO YOU FORESEE AS THE BIGGEST CHALLENGE OR IMPEDIMENT IN REACHING COMMERCIAL VIABILITY/SUCCESS?
The biggest hurdle, especially in this challenging economic environment, will be in raising sufficient funds to complete the appropriate studies, including a clinical feasibility study, needed for FDA approval. We have a developed proof-of-concept used for a decade by the neurologist who is the world leader in TMS applied to chronic pain (and who is serving as our Chief Medical Officer). Initiating and completing the required studies will be a hurdle for any company in the medical device space, especially in this difficult economic climate.

5. FUNDING: IF YOUR TEAM WERE TO RECEIVE $100,000 IN FUNDING FOR YOUR BUSINESS TOMORROW, WHAT WOULD YOU DO WITH IT? WHAT IS THE MOST CRITICAL INVESTMENT YOU NEED TO MAKE IN ORDER TO GROW YOUR BUSINESS?
Our initial investment would be to fund a clinical feasibility study which is necessary to receive FDA approval for our integrated therapy.

6. TEAM:
We tried to be thoughtful in balancing the backgrounds of the members of our team. We have two clinicians in training in the joint MD/MBA program at Harvard Medical School/Harvard Business School who are both neuroscientists and have research backgrounds. We have a PhD in biomedical engineering who founded a medical device start-up and has a research background. We have several other team members with backgrounds in finance, consulting, and engineering that have been important in rounding out our skill sets. We all believe passionately in the value of this technology in improving the lives of patients.

April 21, 2009
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