Vancouver, British Columbia, Canada
http://www.pneuvation.com

PneuVation Medical is a privately held medical device company developing a range of patent-pending pneumatic products. PneuVation’s first product Trekke is an ambulatory spinal unloading belt for chronic low back pain, a $2B opportunity. Simply described, Trekke is a soft, supple air-filled belt that stretches vertically lifting and unloading upper torso weight off the lumbar, alleviating low back pain. Unique from back support products, Trekke provides active pneumatic lifting and proven spinal unloading relief, and different from back bracing products which immobilize or restrict movement, Trekke’s soft, supple air-filled design enables comfortable, longterm wear and dynamic movement together with pain relief---an ideal combination for those suffering chronic low back pain. Trekke has successfully completed development, prototype testing and is FDA and Health Canada approved for sale. In June 2008, clinical validation of Trekke will be conducted at the world-renowned Cleveland Clinic in Ohio. This will be followed by the North American commercial launch of Trekke, directly to more than 20M chronic low back pain sufferers as a consumer-friendly, no prescription required device for patient self care, the growing trend in chronic low back pain.

Chronic low back pain ranges from mild to debilitating. Despite 19M visits/yr to physicians for back pain, typically there is no definitive medical diagnosis or definitive treatment and patients are encouraged to actively seek treatment alternatives to determine what works best to relieve their back pain. Trekke is focused on 20M chronic low back pain sufferers, of which 13% report pain as 5/10 or greater. Assuming only those with significant (5/10+) chronic pain may purchase Trekke, the target market is 20Mx13%=2.6M customers/yr. Priced at $700/unit, this results in a $1.8B opportunity for Trekke, consistent with reports that "the addressable market is $2B in the US alone". PneuVation’s business model reflects direct to consumer sales through multiple distribution channels, including custom branded OEM product, sales doubling each year and a lean organization with costs contracted out, resulting in a profitable, innovative medical device company well positioned for high growth and strategic acquisition.

The competitive landscape for chronic low back pain relief is fragmented with no definitive treatment or dominant leader. Competitors most similar to Trekke that claim ambulatory spinal unloading include: Orthotrac $1,750 requires prescription (Orthofix USA) and Vertetrac $1,195 requires prescription (Meditrac, Israel). Cheaper products sold in Asia include Disk Dr. $269 (Changeui Medical, Korea); Airtrac $499-$1,032, Korea; and Spine-A-Trac $340 (Access Equipment Corp). Trekke competitive advantages include consumer-friendly with no prescription required, comfortable, dynamic movement and restored activity, easy-to-use and affordable, conveniently available in S,M,L with adjustable belt sizing, FDA/Health Canada market approvals, clinically proven spinal unloading and low back pain relief as well as PneuVation's patent-pending design.

In 2003, PneuVation filed its patent application followed by PCT filing in 2004. In 2007, the patent was published: Patent Application No. 10/564971 Title: FLUID OPERATED ACTUATORS AND PNEUMATIC UNLOADING ORTHOSES Abstract: A flexible fluid filled actuator has an elastic bladder and a guide surrounding the bladder. The guide has asymmetrical elastic properties. When the bladder is inflated the guide directs the bladder to expand preferentially in a selected direction or directions. The actuator has utility in the traction and/or unloading of portions of the body. A fluid-filled traction apparatus is disclosed which has particular advantages in spinal unloading. In January 2007 and again in February 2008, PneuVation’s patent attorneys reported that these patent applications in the United States and Europe are in good standing and are proceeding without challenge. In 2008, PneuVation began to prepare additional patent applications to capture and further protect innovations in the design of Trekke. This additional patent work will be filed in May 2008.

Management: Knowledgeable, experienced and credible: Greg Hakonson, founder/inventor handled Trekke from concept to development, supported by engineering and intellectual property expertise of Scott Phillip’s Starfish team. Cynthia Roney brings 21+ years experience in medical device commercialization including clinical, regulatory, marketing and sales as well as substantial investor experience. PneuVation's Board of Directors include seasoned business professionals, actively invested in PneuVation.