The device can be used during the day, at night, or both. Unlike CAPD, it is not necessary to connect to and disconnect from the Tenckhoff catheter four times a day, which should reduce the risk of peritonitis. Peritoneal dialysis patients typically lose about 8 grams of proteins and amino acids per day from the treatment. This device will return most of the patient's proteins and amino acids to the dialysate, rather than discard them. If the patient wishes, the device can be powered by plugging it into a wall socket, rather than using a battery pack. The device's functionality can include the ability to log a wide variety of data, for later use by the nephrologist, the renal care nurse, the patient, or Angel Medical. The data could be downloaded to a printer, to a laptop PC, or to a similar device via a USB port. The data could also be uploaded to an E-mail or to an internet site via a USB port.

ADVANTAGES of the PORTABLE DIALYSIS DEVICE, vs. HEMODIALYSIS

The Portable Dialysis Device has many advantages to the patient, versus hemodialysis. These include the following:

Since their fluid balance is continuously maintained, and their biotoxins (mainly urea and creatinine) are continuously cleansed (rather than building up for three days), patients should feel better, be healthier, and possibly live longer.

With the device, there is no unpleasant "wash out" after a dialysis treatment, or ever.

The device does not require any needles, or access to the patient's blood stream.

There is no risk of blood infection.

No fistula surgery is ever needed.

The patient is not tied to a renal center.

The patient can easily move, work, recreate or travel, while receiving dialysis treatment.

A large storage space is not required for heavy, cumbersome bags of dialysate.

The work load is greatly reduced for dialysis center personnel and equipment.

MANUFACTURING COSTS, PRODUCT PRICING, and MEDICARE REIMBURSEMENT

The estimated manufacturing costs are as follows:

Control Unit $460

Cassette (disposable, sterile) $52

Sorbent Cartridge (disposable, sterile) $18

Glucose Solution Cartridge (disposable, sterile) $5

The combined package can either be sold up front, for $1,500, or be leased at $100 per month. The patient will need a Cassette and a Dialysate Replacement Kit every five to seven days (to be determined). Because the monthly revenue per patient is fixed at about $2,000, the longer the time between Cassette and dialysate change outs, the greater the company's gross margin. The patient will need one Sorbent Cartridge and one Glucose Solution Cartridge per day.

As a practical matter, the maximum price that can be charged for a new dialysis method is the monthly amount that Medicare will reimburse for existing types of dialysis treatment. This is approximately $2,000 per month (about $66 per day) for direct dialysis costs, irrespective of which type of dialysis is used. Expenses such as drugs, doctor fees, hospital fees, etc. are reimbursed separately. The monthly financials for the disposables therefore tallies up as follows:

Gross Revenue: $2,000

Disposables Mfg Costs (depending on change out frequency): $713 + ($217 to $304)

Gross Margin: $983 to $1,070

49.1 to 53.5%)

There are currently about 51,000 PD patients in the U.S. Because Medicare will pay about $24,000 a year for direct dialysis costs, the potential annual market for this product is $1.22 billion. Medicare has two different payment methods. In Medicare reimbursement Method I, dialysis centers order equipment and consumables from their suppliers. The dialysis centers pay their equipment suppliers, then bill Medicare for reimbursement. In Medicare reimbursement Method II, the dialysis equipment suppliers supply equipment and consumables directly to the patients, then bill Medicare directly.

MARKETING

Professionals at a top-notch dialysis center will use several factors when deciding the best dialysis method to recommend to a patient. Home hemodialysis and both types of peritoneal dialysis require a patient who is mentally aware, physically able, self-disciplined, and who takes an interest in caring for themselves. It also helps if the patient has some mechanical aptitude, and if he lives with others. The main reasons hemodialysis dominates peritoneal dialysis is that many dialysis patients are either elderly, have mental or physical diseases or impairments in addition to kidney failure, or simply do not have the interest or discipline to learn to care for themselves in this area.

The best tool for encouraging nephrologists and dialysis nurses to make their patients aware of the Portable Dialysis Device, and to recommend it to them, is to emphasize all of the advantages it has over the other types of dialysis. Nephrologists usually favor anything that can improve their patient's health and/or comfort. Strong selling points with nephrologists include the favorable urea and creatinine clearance rates expected in the Portable Dialysis Device, the recycling of the patient's proteins and amino acids, the use of dialysate that is less irritating to the patient's peritoneal membrane, and decreased risk of abdominal fluid migration or of hernias, due to a smaller required...

Their opinions and expertise will be solicited regarding optimizing the device for use by dialysis patients. At a later stage, their opinions and expertise will be sought regarding marketing and Medicare reimbursement strategies. Marketing efforts will include lectures at various dialysis and kidney association conferences, direct mail to nephrologists and renal centers, articles in appropriate medical periodicals, and booths at medical trade shows.
COMPETITIVE OUTLOOK

Baxter Healthcare (headquartered in Deerfield, IL) currently has 90% of the U.S. peritoneal dialysis market. They derive most of their peritoneal dialysis revenue from selling bags of dialysate and from leasing APD cyclers, so any significant market penetration by Angel Medical would most likely be seen as a threat. While Baxter has a large U.S. And international sales presence, they are notoriously weak in R&D. Nearly all of their products and technologies were purchased, rather than developed internally. Baxter attempted to create a Portable Dialysis Device in 2000, but gave up after insufficient progress was made in the allotted time. Baxter is also the most likely suitor for Angel Medical, after the device has achieved some market penetration.

Fresenius (Germany), and Gambro (Sweden), dominate the dialysis market outside of the U.S. Both companies are much stronger in the field of hemodialysis than they are in peritoneal dialysis. Fresenius has more R&D capability than does Baxter, but Fresenius has not attempted to make a Portable Dialysis Device.

There are currently about 4200 dialysis centers in the U.S. The two largest operators are DaVita and Fresenius, which operate about 1400 dialysis centers each. Successfully working with them will be one of the keys to success for the Portable Dialysis Device.

POTENTIAL Business RISKS

Potential business risks include the following:

Possible partial infringement on existing dialysis patents?

Baxter, Fresenius, Gambro, DaVita, or Renal Solutions might induce some dialysis centers to not work with us.

Baxter, Fresenius, Gambro, DaVita, or Renal Solutions might induce MEI or another key supplier to not work with us.

Medicare might not pay for the product (this is a low risk).

POTENTIAL TECHNICAL RISKS

Current technical unknowns include the following:

How prevent occasionally clogging the filters?

How detect if the cartridge is not fully removing dialysate?

Will the gear damage the proteins?

Some small air or CO2 bubbles might not be removed from the dialysate.

Some spent dialysate occasionally might not cavity.

Will microbial infection be a problem?

POTENTIAL RISKS DURING USE

Potential risks while using the Portable Dialysis Device include the following:

Risk of infection.

The patient might not properly use the device.

The patient might not use the device often enough for adequate health.

PRODUCT DEVELOPMENT for an ANIMAL STUDY

Initial product development will focus on the exact chemical makeup of the Silicon Sulfate and the Silicon Oxide. Chemically and physically analyze each chemical in the cartridge, to help specify the chemicals to use in initial experiments.

COMPANY MILESTONES

The following milestones range from company startup to sale of the company:

Raise $5,433,000 from a California life science Angel investor(s)

Incorporate in Delaware

Sign a patent license agreement with Manteca State U.

Lease small office space (in or near Manteca)

Write a regulatory plan

Write a product specification for the proof-of-concept device

Write an animal study protocol, and conduct a proof-of-concept animal study

Raise $14 million from California life science venture capital firm(s)

Hire a contract control chip software engineer(s)

Recruit a local nephrologist and a dialysis nurse as consultants

Write and file patents

Write a trial protocol

Conduct an investigatory human trial

Write a trial protocol

Conduct a pivotal human clinical trial

Sign a supply exclusivity agreement with MEI

Raise $18 million from California life science venture capital firm(s)

Lease and equip a manufacturing and distribution site (in Manteca?)

Hire a full staff for production, quality, product support and sales

Purchase and validate the following computer systems: ERP, accounting, document control,…