Nanomed Devices, Inc.

Nanomed Devices, Inc. (Nanomed), incorporated in Delaware, and based in Albany, NY, is a late clinical-stage medical product company focusing on non-invasive drug delivery technology. Nanomed’s transdermal device technology is designed to safely and more effectively deliver drugs, including protein drugs that, until now, must be delivered by needle injection.

Nanomed’s proprietary device addresses a large, systemic and well-documented problem in drug delivery: more than 95% of current biotech drugs require a needle injection, which has several disadvantages.

• For patients, needle injections are painful
• For doctors and nurses, they present the risk of accidental needle sticks
• For pharmaceutical companies, needle injection does not controlled release to deal with short lifetime issues often associated with protein drugs.
• For hospitals, needles are a challenging and expensive solid-waste disposal problem

Nanomed’s founders include experienced entrepreneurs, recipients of SuZhou Entrepreneur of the Year Award in China and the Ernst and Young’s New England Entrepreneur of the Year Award in USA. Nanomed’s initial product, Functional Microneedle Array™ (FMA™), is based on the application of well advanced semiconductor technology. FMA™ contains a disposable skin patch as well as a re-usable applicator, and has been demonstrated to deliver both small and large drug molecules effectively. The first product using FMA™, LidoFast™, was successfully validated by a randomized, double-blind and placebo-controlled clinical trial in China. The company has recently reached an agreement with Harvard Medical School/Mass General Hospital to start an independent clinical trial of FMA™ in support of an FDA 510 (k) filing in the US.

Nanomed’s strategy is to focus on the multi-billion dollar pain management market first (with LidoFast™), partnering with Endo Pharmaceuticals, Sandoz and other potential partners for initial product launch. Using FMA™, Nanomed also has capability to improve FDA approved, off-patent drugs to achieve significant clinical impact (more than 10 candidates in our pipeline for reformulation study). These key candidates, offering improved therapeutic performance, are FDA approvable through 505(b)2 process. Many pharmaceutical companies, including Sandoz and Triprime have already expressed strong interest in co-development, leading to product marketing privileges.

Nanomed has been self-funded by the current founders to date, through personal investment and grants we have successfully secured. Nanomed is now seeking its first round of institutional venture capital to complete the US clinical trials and to convert potential customers showing strong interest in our products to paying ones.

Products

Nanomed has developed an easy-to-use medical device, Functional Microneedle Array™, to safely deliver a broad range of drugs for people who dislike needle injections. Our proprietary device is based on advanced fabrication technology that can reliably produce hundreds of medical-grade microneedles, each with a diameter smaller than that of a human hair. Nanomed has already received marketing approval for FMA™ in China. The company is starting a US clinical trial at Harvard Medical School/Mass General Hospital in support of an FDA filing planned for 2007-2008.

The first product we anticipate releasing using the FMA™ device is LidoFast™, based on a low-concentration FDA-approved anesthetic drug. Our clinical study showed that LidoFast™ improves pain score changes by a factor of 7 and cut down onset by 2/3, making it a promising candidate for pain management applications such as lower back pain, PHN, and invasive medical procedures. LidoFast™ would be a minor modification of Lidocaine, resulting in rapid onset delivery, with features that only require a 505 (b) 2 FDA approval process.

The preclinical study of our second product FeronSafeTM , also based on FMA™, demonstrated 100 times enhancement of bioavailability for an off-patent drug interferon, targeting a market of over $2 billion, approvable via NDA or 505 (b) 2. We anticipate a short approval cycle in overseas market for this product.

Nanomed’s first two target pharmaceutical products LidoFast™ and FeronSafe™, represent markets totaling over $5 billion in pharmaceutical sales. We also have a strong product pipeline of more than 10 FDA-approved drugs that have been tested using our proprietary technology for future growth. It provides strong evidence that FMATM can be a platform for the rapid development of new products at lower cost to assure multiple successes.

PCCI's panel will consider:

1. What is the best product positioning and pricing strategy for an aspiring, young drug delivery company?
2. What are the top three added values a life science start-up should look for from investors other than money?
3. What are the proven pathways to evolve a drug delivery company to a specialty pharma company like Alza?

Program:

6:30 - Cocktails & Dinner (Cash bar and 2-entree menu)

8:00 - Dr Bai Xu, President and CEO will present Nanomed to the Group

8:20 - A Panel will Address 3 Major Issues for Nanomed

9:00 - Open discussion: Members & Guests

PLEASE RSVP to

Peter van der Kam,

email: peter@rxpcci.com

phone: (610) 296-8086

Good Company! Good Drink! Good Food!
Good Program! Good Fun!

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BIOSOME INC.

Biosome is founded upon an innovative nanoparticle based detection technology with applications in drug discovery, medical diagnostics, and pathogen detection.

Company Description: Biosome is initially focused on providing products to evaluate the "drug-like" properties of compounds (e.g.: solubility, membrane affinity, tissue distribution, oral bioavailability) to predict whether or not potential drugs will reach their target in humans. Biosome products will greatly reduce the costs of these evaluations and vastly increase their throughput. Instead of costing up to tens of thousands of dollars for a single compound with current methods; hundreds of thousand or even millions of compounds can be evaluated in days for a few dollars or less per compound with Biosomes*.

Biosome, Inc. is a spin-out of Analytical Biological Services (ABS) Inc.. Biosomes was founded to commercialize a novel technology developed by ABS, to serve a largely unmet need in the pharmaceutical industry. Founded in 1990, ABS serves clients in every major pharmaceutical company in the U.S. and Europe. ABS is a world leader in providing custom biological products and services to drug discovery scientists. Its contacts and market presence will be invaluable in providing Biosome with diect market access.

Following the development of drug discovery products, Biosome can leverage its technology to develop products for medical diagnostics, payhogen detection, or biodefense either through in-house R&D or licensing agreements.

Products and Technology: Biosomes* are stable water soluble nanoparticles, cosisting of a polimer and other components that are added to modify its properties for various applications. Mixing compounds with various Biosomes* formulations generates fluorescent signals that are related to compund properties, such as membrane affinity, charge and water solubility. These signals can be read with standard laboratory equipment. Several measures of key properties can be easily measured for many thousands of compounds in a single day. These experimental data are then combined with computer models of compound proprties to improve the reliability of those models to predicts the suitability of the compound as a potential drug. This combined biosomes*/ in silico approach promises to greatly improve the speed and reliability of bioavailability predictions in humans, while at the same time greatly reducing the costs of these evaluations. Proof of concept data indicate that Biosomes* can be effectively and profitably commercialized within a reasonable timeframe with additional investment in product development. This technology also has applications in other areas such as cosmetics and personal hygiene products where tissue penetration is an issue. In addition, by incorporating antibodies or other biological recognition elements, it can be applied to medical diagnostics and the rapid detection of pathogens.

Biosomes* will be sold as various liquid formulations for a variety of applications, including solubility tsting, membrane affinity, tissue distribution and oral bioavailability. These formulations can be manufactured at low cost with relatively little infrasctructure. Biosomes* will be paired with molecular modeling / data analysis software. Commercial software packages that we have tested can be easily adapted to various Biosomes* applications. A long term revenue stream would come from the addition of new compounds to collections, new product development (e.g.: tumor selectivity prediction), and either formulation or software improvements to enhance the predictive value of various measures.

PCCI's panel will consider:

1. Choice of Product Development Strategy in view of available funding opportunities
2. Feasibility of additional funding through the Pharmaceutical and Biotechnology industries since the Biosomes Products may increase the success of drug approvals
3. What valuation would this technology command at its current state and who would be the most likely acquirer?

Program:

6:30 - Cocktails and Dinner
(There will be a cash bar and a special 2-entree menu)

8:00 - Charles F. Saller, Ph.D., President and & CEO will present BIOSOME to the group

8:30 - A Panel will Address 3 Major Issues for BIOSOME

9:00 - Open discussion: Members & Guests

PLEASE RSVP to

Peter van der Kam,

email: peter@rxpcci.com

phone: (610) 296-8086

Good Company! Good Drink! Good Food!
Good Program! Good Fun!

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INFRASCAN INC.

Our September 11, 2006 Meeting at the Chesterbrook Wyndham will feature Infrascan Inc., a Philadelphia based Medical Device Company

Infrascan Inc. is a medical device company that has the potential to be the world's leading provider of handheld diagnostic imaging devices based on its exclusive patent portfolio. There is a lack of effective alternatives for mobile imaging that are convenient and accessible. Infrascan Inc.'s patented Near Infrared (NIR) technology for diagnosing brain hematomas enables neurosurgeons to effectively, conveniently, and accurately detect intracranial bleeding in patients with head trauma.

Infrascan Inc.'s Infrascanner* is a handheld brain hematoma detector that caters to this unmet need. The Intrascanner* provides an affordable, highly accurate, clinically effective system to detect brain hematomas in patients with head trauma in settings where effective monitoring and triaging is necessary, and in places where access to CT scans is restricted.

PCCI's panel will consider:

Program:

6:30 - Cocktails and Dinner
(There will be a cash bar and a special 2-entree menu)

8:00 - Short Business Meeting

8:10 - Pitch to the Group - Anne-Marie Maman will deliver LumenVu's "Elevator" Pitch to the Group

8:30 - A Panel will Address 3 Major Issues for LumenVu

9:00 - Open discussion: Members & Guests

RSVP to:

Don Skerrett via

Email: don@rxpcci.com or 

phone: (610) 608-1569

Good Company! Good Drink! Good Food!
Good Program! Good Fun!

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LumenVu

LumenVu is a BioAdvance company that couples near infrared light with conventional catheter technology to offer real-time visualization systems for bedside placed catheters.

The featured presenter is Anne-Marie Maman. Ms. Maman has an AB from Princeton and an MBA from the JL Kellogg Graduate School of Management.

Background

LumenVu, Inc. is the developer of a unique technology that improves accuracy of catheter placements with significant economic and therapeutic advantages. Its products offer real-time bedside imaging of catheters as they are placed into patients – eliminating guesswork by the clinician in 'blind' placements. LumenVu's intuitive technology gives the clinician visual information that helps to locate the catheter tip in relation to surrounding anatomy. This allows for optimized catheter placement. The company's first product will be for the placement of Percutaneously Inserted Central Catheters (PICCs), with products for placing feeding tubes and central venous catheters to follow.

PCCI's panel will consider:

2) the proposed licensing strategy to enter the feeding tube market, and

3) major considerations when selecting and contracting with contract developing/manufacturing firms.

Program:

6:30 - Cocktails and Dinner
(There will be a cash bar and a special 2-entree menu)

8:00 - Short Business Meeting

8:10 - Pitch to the Group - Anne-Marie Maman will deliver LumenVu's "Elevator" Pitch to the Group

8:30 - A Panel will Address 3 Major Issues for LumenVu

9:00 - Open discussion: Members & Guests

RSVP to:

Don Skerrett via

Email: don@rxpcci.com or 

phone: (610) 608-1569

Good Company! Good Drink! Good Food!
Good Program! Good Fun!

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NanoVec, LLC

Our March 13, 2006 PCCI Meeting at the Chesterbrook Wyndham will feature NanoVec, developer of next-generation vaccines and immunotherapeutics utilizing novel nanobiomolecular delivery systems.

Products in Development

Vaccines Against Viral Infectious Diseases Influenza, Hepatitis C, HIV/AIDS
BioDefense Vaccines Marburg, Ebola, Smallpox
Cancer Immunotherapeutics Breast, Prostate, Colon

Core Technology

NanoVec's SynVec*("Synthetic Vector") platform is comprised of a biocompatible nanoparticulate delivery vehicle that encapsulates proprietary vectors, facilitates targeted in vivo delivery and stimulates either cellular or humoral immune responses to specific antigens

Proprietary vectors include:

• DNA-Vec* facilitates robust, self-amplifying gene expression and protein production
• RNA-Vec* is a non-pathogenic, non-integrating, self-amplifying vector derived from naturally occurring viruses,and is ideal for intracellular protein expression and production
• P-Vec* is a nanoscaled scaffold structure facilitating the display of antigenic peptides and proteins

Competitive Advantages

• Scalable, rapid, cost-effective synthetic production and manufacturing that does not require biologic systems
• Synthetic constructs likely to be stable at room temperature and have extended shelf-life, facilitating stockpiling
• Flexible platform technology to express a broad range of bioactive molecules, alone or in combination
• Non-integrating, non-infectious, self-amplifying RNA and/or DNA-based gene vector

2005 Achievements

• Strategic Alliance established with GE Healthcare Fast-Track Bio Defense Division
• Sponsored Research Agreement established with Fox Chase Cancer Center
• Ebola and Influenza vaccine prototypes developed
• In-Vitro validation of influenza vaccine and breast cancer immunotherapeutic
• Colaborative research and development agreements (CRADA) established with:
  - Stanford Research Institute
  - US Army Medical Research Institute (USAMRIID)
  - Brookwood Pharmaceuticals

PROGRAM:

6:30 - Cocktails and Dinner
(There will be a cash bar and a special 2-entree menu)

8:00 - Short Business Meeting

8:10 - Chad Womack, Ph.D., President and Chief Scientific Officer, and Gregory Davenport, Ph.D., Chair of NanoVec's Corporate Advisory Board will represent NanoVec and deliver its "Elevator" Pitch to the Group

8:30 - A Panel will Address 3 Major Issues for Nanovec

9:00 - Open discussion: Members & Guests

3 Major Issues for Nanovec

1. What are the anticipated advantages of NanoVec's synthetic nanoparticle vaccines in terms of manufacturing time, cost of production, number of doses to elicit a protective immune response , and storage requirements compared to current and other future vaccine technologies?

2. Synthetic nanoparticles have not been approved for use in humans as therapeutics. What are the potential benefits and risks of synthetic nanoparticle? Are there any data to support their benefits and lack of toxicity?

RSVP to:

J. Peter van der Kam via

Email: peter@rxpcci.com or 

phone: (610) 296-8086

Good Company! Good Drink! Good Food!
Good Program! Good Fun!

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CureDM, Inc.

CureDM has been established to rapidly bring new, safe, and effective therapies for diabetes mellitus (DM) to the US market. These therapies are expected to prevent, ameliorate or cure Type 1 and Type 2 diabetes and allow for discontinuation of the required daily insulin injections.

There are currently 20.8 million people in the United States with diabetes. Each day, approximately 4,110 people are diagnosed with diabetes. One out of every three Americans born in 2000 will develop diabetes in their lifetime. Direct medical and indirect expenditures attributable to diabetes in 2002 were estimated at $132 billion for the United States. Direct medical expenditures alone totaled $91.8 billion and comprised $23.2 billion for diabetes care, $24.6 billion for chronic complications attributable to diabetes, and $44.1 billion for excess prevalence of general medical conditions.

There were more than 224,000 fatalities in 2002 in the United States linked to individuals with diabetes. Diabetes is the fifth-deadliest disease in the United States. Since 1987 the death rate due to diabetes has increased by 45 percent, while the death rates due to heart disease, stroke, and cancer have declined. Yet the money spent on diabetic care each year is for palliative, rather than curative, treatments.

Type 1 Diabetes typically occurs in childhood or adolescence. The islet cells of the pancreas are destroyed by the bodys T-Cells in an auto-immune reaction, which renders the pancreas incapable of producing insulin. Type 1 patients must inject insulin to control sugar levels. If insulin therapy is not administered, the patient will die within days to weeks of hyperglycemia which results in diabetic ketoacidosis.

In contrast, Type 2 Diabetes typically occurs over the age of 30, though recent studies show an increase in

the number of patients diagnosed with Type 2 diabetes prior to the age of 30. In Type 2 diabetes, the pancreas does not produce enough insulin to meet the body's needs or the insulin is not metabolized effectively. Approximately 90% of patients diagnosed with Diabetes have Type 2. Type 2 diabetes is often treated through diet and exercise, although 70% of patients diagnosed are treated with oral medications or injected insulin.

CureDM has discovered and owns the patents on a novel therapeutic candidate for diabetes which is a distinct human peptide (chain of amino acid molecules) that research shows will accelerate the transformation of human pancreatic ductal cells into insulin producing islet cells. This process takes place normally in healthy humans, albeit at a very slow rate, in order to replace the small percentage of islet cells which die off naturally each day. CureDMs Human proIslet Peptides (HIP) is believed to stimulate the natural regeneration process to proceed at 20 times the normal rate, enabling a type 1 diabetic patient to re-establish their own insulin producing islet cells, and discontinue the use of insulin injections.

To prevent an auto-immune reaction from destroying the new islet cells, the new insulin-producing cells will be protected by one of the promising new immune agents, which have been studied in newly diagnosed type 1 diabetes. Until now, the natural islet cell regeneration process has been too slow to utilize these immune therapies in patients with preexisting diabetes. CureDMs human peptide therapy will be effective for curing both newly diagnosed patients and those patients with longstanding diabetes. It will be developed through preclinical stages into human studies before it is licensed to a major pharmaceutical company for production and commercialization.

PROGRAM:

6:30 - Cocktails and Dinner
(There will be a cash bar and a special 2-entree menu)

8:00 - Short Business Meeting

8:10 - Loraine V. Upham, CEO of CureDM,

will deliver its "Elevator" Pitch to the Group

8:30 - A Panel will Address 3 Major Issues for CureDM (see below)

9:00 - Open discussion: Members & Guests

3 Major Issues for CureDM

There are two opposing viewpoints with which the company has been confronted: Stay focused One product does not a company make

CureDM has the opportunity to license-in a delivery technology that will provide for a potential pipeline of products for metabolic disorders. HIP is headed for preclinical and has great promise for a large and lucrative partnership payoff. Is it sufficient for now or should the company build out the story of CureDM to be broader and less reliant on the success of HIP and risk defocusing its efforts?

Financial question:
What are some accepted guidelines for valuing a company such as CureDM?

Consider that its innovative product stands to virtually eliminate at least a couple of billion-dollar-a-year products such as insulin, insulin pumps and other consumables. The sales projections, even if priced like TPA, could not match the lost revenues that will be experienced by the current providers of treatments for diabetes. They are doing damage control. CureDM proposes reversal of the disease state. How does CureDM value this innovation?

Management/Logistical Question:
Given that many companies fail because they hire too fast , Management is reluctant to hire full-time personnel at this stage. However, some VC's seem to have a need for "permanent management in place". What is sufficient in terms of in-house management at this early stage?

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Monday, January 9,2006

Start the New Year Well by Attending the Next PCCI Meeting!

Location:The Wyndham Chesterbrook

(directions to The Wyndham)

"GALLEON"
PCCI MEETS GALLEON

PLEASE RSVP ASAP to Peter van der Kam, Treasurer PCCI

email: peter@rxpcci.com

Our January 9, 2006 PCCI Meeting at the Chesterbrook Wyndham will feature a Philadelphia based emerging pharmaceutical company.

Company Background:

Galleon focuses on respiratory diseases with a lead clinical drug candidate ready to start a Phase IIa proof-of-concept clinical trial in adult sleep apnea. It has an exclusive license for a patented technology platform that enables a new therapeutic area for medicines to treat breathing control problems found in diseases such as sleep apnea (18 MM), chronic obstructive pulmonary disease (10 MM), stroke (5MM), heart failure (5 MM) and other conditions (~ 2MM). Current treatment is usually a hospital or home ventilator or no treatment at all.

This represents a rare investment opportunity to:

• Establish a leadership position for a major new therapeutic class for a market with an established unmet medical need,
• Enjoy little competition and
• Use an existing drug as a template to quickly create a near-term stream of valuable products.

Galleon is raising a $ 5 MM Series A round primarily to support two Phase IIa proof-of-concept clinical trials. The studies are scheduled to begin in the first half of 2006.

Technology Platform:

A recent discovery, published in Nature, revealed the pathway in the brain that controls a critical part of the brain’s ability to control breathing. By using drugs that work through this pathway it is now possible, for the first time, to consider in appropriate patients replacing the need for ventilators with a pill. Previous attempts to use a pill for sleep apnea have demonstrated some encouraging clinical success but the drugs have been too toxic for widespread use. Galleon is using an approach that avoids the toxicity.

Unmet Medical Need:

In the United States alone 18 million people have adult sleep apnea putting it in the same frequency as diseases such as asthma and diabetes. In November 2005 there was a study published in both the New England Journal of Medicine and The Wall Street Journal , which showed that sleep apnea patients are twice as likely to experience a stroke compared to those without the disease. Currently patients must wear cumbersome masks when they sleep and the compliance rate is very poor.

Here is how the format works:

Cocktails followed by dinner (6:30 pm and 7:15 pm)
(There will be a cash bar and a special 2-entre menu)

Short business meeting (8:00 pm)

Galleon CEO James C. Mannion PH.D. will deliver its "Elevator" Pitch to the Group (8:10 pm)

Panel will Address 3 Major Issues for Galleon (8:30 pm)

Open discussion: Members and Guests (9:00 pm)

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Want to Attend?

Guests are always welcome at our monthly meetings held September through May.

For information, contact:

Don Skerrett
Email: don@rxpcci.com or
Phone: 610-608-1569

Upcoming Meetings
Meetings are usually held on the second Monday of the month and are now at The Wyndham Hotel in Chesterbrook, PA. Please contact Don Skerrett (above)

Dinner prices are $30,

Parking is free

Lifetime dues for new members $100

These days, PCCI meetings are livelier than ever, and all agree the group has a lot to offer -- both to the outside world, and to each other, so let's keep the spirit:

PCCI lives!

The Wyndham provides an excellent facility, more room and a fine menu! So Come One! Come All! Bring a Business Colleague!

Good Company! Good Drink! Good Food! Good Program! Good Fun!

THAT’S OUR PROMISE TO YOU!