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BioRemedi

Executive Summary
Bioremedi Therapeutic Systems, Inc. (“the Company”) is the leader in infrared (IR) therapy devices. The Company’s HealthLight infrared phototherapy devices are used mainly with peripheral neuropathy, but use in a wider range of other applications is common as well. The Company is based in New York and distributes primarily through clinical outlets and select national resellers. HealthLight, the main product line, is FDA cleared and registered as a prescription-only device.

HealthLight is the best IR phototherapy product available on the market. It has the strongest energy output of any similar IR device and was designed to function as a complete system, as compared to other “individual” devices. The HealthLight manufacturing operation is an FDA-registered GMP facility and complies with all regulation and inspection requirements.

Products are wholly manufactured domestically at LED Designs in Albuquerque, New Mexico, a manufacturer of light therapy products serving a global market of private label distributors. Its products serve multiple uses, including human and equine applications. Bioremedi Therapeutic Solutions accounts for approximately 60% of LED Designs’ revenue. The Company and LED Designs are now exploring a merger/acquisition scenario that will combine for the manufacturing and sales of new, consumer-focused products with substantial revenue potential. Collectively, the companies end point price is a multiple of 16X manufacturing cost.

With a HealthLight and LED Designs merger or acquisition, the new company will be vastly more vertically integrated and combine many aspects of R&D and sales & marketing, which ultimately will reduce overhead and increase profitability. Alternatively, a joint partnership can be formed to appear as a unified entity. This closer collaboration will help speed up new product releases, such as those outlined below, directed to the over-the-counter (OTC) market. Catering to the OTC market has several benefits, most notably of which is the ability to go to market without the lengthy and very expensive FDA approval process by using the prescription devices as predicates (substantial equivalents). For medically administered treatment/device coverage, this route to FDA approval will still be pursued, as it is a necessary step to receiving Medicare reimbursement approval.

Two other IR devices are well along in the development pipeline: HairPro® for hair loss/thinning clients and Snorelight® for snoring reduction and mild to medium Obstructive Sleep Apnea (OSA). The base technology is identical to HealthLight® but the product design will be created specifically for the intended use. Infrared devices for hair re-growth are in use today as both clinical and consumer versions from various manufacturers. Regulatory approval, based on predicate devices, is a less cumbersome process. Research into a light based OSA device or protocol has uncovered nothing and we are in the process of a patent application for the protocol + device. However, the lack of a predicate snoring device could create significant burdens in the regulatory process unless the new FDA de novo program is applicable. On the upside, the competition will face the same hurdles.

Bringing a wider range of products to market through a merger, acquisition, or joint partnership will allow the Company to target multiple large and growing markets in the U.S. and internationally. Combined, the target markets will include:

• Diabetes: 24 million American suffer from diabetes, and another 12 million diagnoses are expected by 2020. The global market for diabetes products is $40 billion.

• Neuropathy: Around 30 million American suffer from the illness, which costs Medicare alone more than $3.5 billion annually.

• Hair Loss: An estimated 35 million men and 21 million women are dealing with going bald or thinning hair in the U.S., spending $3.5 billion annually.

• OSA: Snoring and OSA afflict millions of individuals (more if you consider their partners). One researcher suggested this device could displace 40% of the CPAP devices in mild to medium OSA cases.

• Clinical market:
o Chiropractors: More than 49,000 practitioners in the U.S. in 2008, will grow to 58,700 by 2018, according to the Bureau of Labor Statistics
o Physical therapists: 188,500 in 2008 – will grow to 241,700 by 2018
o Home health care providers: About 23,000 single-location companies and branches of multi-location companies in the U.S.

Much of this market is being spurred by the massive baby boomer population, which will push the number of Americans over the age of 65 to more than 70.3 million by 2030 nationwide, up from just 38.9 million in 2008. This will drive the demand in the health care industry for years to come.

Moving forward, Bioremedi Therapeutic Systems will attempt to penetrate the above markets as well as to attain enhanced FDA clearances for its pain management and other products. Any significant forward momentum in its medical device revenue beyond $6-8 million will come with a change in Bioremedi Therapeutic Systems Inc’s Indications For Use (IFU) for infrared devices as approved by the FDA for any IR device currently available. This can only come about through data gathered in a clinical trial with well-defined hardpoint outcomes.

The devices then need to be approved by Medicare for re-imbursement through a national determination process. While a Medicare determination is dependent on a change in the IFU, the devices may be marketed without a national determination as they are now. The road map for a national approval was clearly outlined in the Anodyne Therapy national determination rejection in 2006. The decision was bad news for Anodyne Therapy and anyone else relying on local Medicare determinations but great news for a company well placed to conduct such a trial. The other players in this industry are simply underpowered financially and unable to fund the above.

With a Medicare-approved device and OTC products, the Company can easily reach hundreds of thousands of patients through existing durable medical equipment suppliers (DMEs). This, however, will require a clinical trial with costs at or exceeding $1 million and will cover 18 months from inception to publication. The trial itself will only span 12 weeks of the 18 months. With Bioremedi Therapeutic Systems in a financially stronger position than competitors, and given its relationship with LED Designs, it can capitalize on this wide-open market.

1.1 Objectives
• Creating and developing HealthLight professional and OTC devices
o HealthLight Home (new OTC device)
o Avalon Effect (existing integrative medical and energy market)
o HairPro (hair re-growth, in development)
o Snorelight (anti snoring, in developemt)

1.2 Mission Statement
Developing products and services that benefit humanity by empowering people to control their own wellness and raising an awareness which produces possibilities and probabilities.

1.3 Keys to Success
• Merger and/or acquisition of LED Devices by Bioremedi Therapeutic Systems
• Attaining CE, ISO 9000, and ISO13485 certifications for LED Designs
• Installing new key personnel for expansion, including a plant manager and electronics/software engineer
• Undergoing FDA & Medicare approval processes for expanded market access

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