rxPCCI

Monday, November 14, 2005

Location:

The Wyndham Chesterbrook

(directions to The Wyndham)

"NANOSCAN IMAGING"
PCCI MEETS NANOSCAN IMAGING

Our November 14 PCCI Meeting at the Chesterbrook Wyndham will feature a Worcester-based nanotech-pharma company.

Company Background: NANOSCAN IMAGING, LLC is a transitional corporate entity* founded in August 2005 to manage the clinical development of its proprietary NanoCrystal Colloidal Dispersion (NCD) pharmaceutical technology. The company's lead product, N1177, is a non-soluble, iodinated nanoparticle (300 nm), which is used to improve the clinical utility of computed tomography (CT). Three different indications are being sought based upon routes of administration:
.

Staging of lung cancer and other malignancies of the thorax, when administered via inhalation (N1177-inh)
Staging of breast, prostate and other cancers which metastasize through the lymphatics, when administered via subcutaneous injection (N1177-sq), and
Detection and characterization of atherosclerosis systemically, when administered as a peripheral intravenous injection (N1177-iv).

Important: Each of these indications will be pursued separately. What all three have in common is that they offer to cancer and heart disease patients and their doctors a more effective, less invasive and less costly means of diagnosing and managing disease.

A consortium of companies has previously invested more than $20 MM in developing the technology underlying N1177. Ultimately, this consortium dissolved, and NSI was able to obtain all rights and assets, including the active IND for N1177. NSI's primary purpose is to complete the remaining pre-clinical activities, conduct the necessary Phase 1 and Phase 2 clinical trials, and negotiate the sale of each of the above mentioned applications of N1177 to one or perhaps several pharmaceutical market leaders. Discussions with strategic partners have already begun. This strategy is projected to result in a liquidity event in 24 to 48 months and represents the quickest and least risky route to commercialization for all three product opportunities. Management believes that N1177 has a high probability of clinical success in Phase 1 and Phase 2 trials and will have an estimated total value exceeding $300 MM in less than four years.

It is important to keep in mind the following key factors underlying NSI's success:

NSI is developing a clinically experienced compound.
1. N1177 has already been administered to more than 70 human subjects
2. More than 80 different non-clinical (tox/path) studies have been conducted with N1177
3. Hundreds of compounds were evaluated in order to come up with the active pharmaceutical ingredient (API), drug product and delivery vehicles for N1177
NSI is developing N1177 to meet the needs of the two largest segments of the healthcare market in the US.
1. Oncology: earlier detection and more accurate staging
1. Cardiology: total body evaluation of atherosclerosis
N1177 can be used to improve the clinical utility of examinations performed with every CT, current as well as future,
1. Reimbursement is currently available and approved codes could be used on an interim basis while NSI seeks product specific codes
2. Little or no change in the way that CTs are performed
There are no approved products and no compounds in clinical development that are considered a competitive threat to N1177.
1. Strategic partnerships could be established as soon as completion of Phase 1
2. Major diagnostic pharmaceutical manufacturers are in need of new, innovative products and would be willing to pay a high premium for N1177
NSI does not plan to compete directly in the marketplace; its plan is to sell the compounds to one or more market leaders that currently command a dominate market share in contrast agents.

November's panel will look at the effectiveness of the presentation, plus 1) how to evaluate an early-stage company with a clinically experienced technology, 2) how NSI should structure partnerships with established market leaders, and 3) some of the challenges NSI is likely to face as it enters Phase 1 and Phase 2 clinical trials?

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)
The NanoScan Team will deliver NSI's "Elevator" Pitch to the Group (8:10 pm)
Panel Addresses 3 Major Issues for NanoScan Imaging (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

PCCI Member Notes

Please see the minutes from the September 2004 meeting for details about a one-time reorganization fee of $20. This fee will be collected when a member attends a dinner.

The dinner fee is $30 and includes dinner for our presenters. Parking is free. Any extra proceeds go to the Treasury. Lifetime dues for new members will remain at $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 gives us a better facility, more room and a fine menu! So Come One! Come All! Bring a Business Colleague!

RSVP to:
Peter van der Kam
Treasurer
peter@rxpcci.com
or by phone: (610) 296 8086

Directions to the Wyndham Hotel: Take 202 to the Chesterbrook exit (that's 2 exits south of the Devon Exit and Winnberie's). If you were traveling south on 202, turn right at the end of the exit ramp and you'll see The Wyndham on your right. If you were going north on 202, get off at the Chestrbrook exit and turn left at the traffic light and go back across 202. You'll see the Wyndham on your right. Proceed to the traffic light and turn right into the parking lot for the Wyndham. Their phone is: 610-647-6700.

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

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Monday, October 10, 2005

Location:

The Wyndham Chesterbrook

(directions to The Wyndham)

"Meet Calcigen"
Joint PCCI-Calcigen Meeting

Presenters:
"Calcigen Corporation"

CALCIGEN is a Therapeutics Company developing a Pipeline of Hyaluronan-based devices. The Company has two investigational products for the large, rapid growing, Osteoarthritis and Dermal wrinkle filling market segments.

The featured presenter is Harlan Hemple, CEO of Calcigen Corporation.

Company Background: Calcigen Corporation is a therapeutics company developing a pipeline of Hyaluronan-based devices for large segments of the rapidly growing $2+ billion Hyaluronan (HA) market.

Calcigen has designed

second-generation products with improved safety and efficacy profiles, which offer prolonged performance and extended repeat usage for the osteoarthritis (OA) and dermal wrinkle filler (DWF) market segments. The Company is developing strategic patnerships with market leaders for these two products.
The Company’s HyalPure? line of pharmaceutical Hyaluronan offers significant safety and efficacy enhancements. The Company’s two key investigational products, CA-5136 for osteoarthritis and CA-5178 for facial wrinkles, build upon Calcigen’s ability to modify the molecule in ways which are industry-firsts.
In the OA market, clinicians cite the need for improvements to safety, increased pain relief and inflammation management, and longer efficacy periods as key product design criteria. For DWFs, doctors seek fewer adverse events, longer residence time in the body and less clumping or migration of the filler material.
Calcigen’s second generation investigational products meet or exceed these desired criteria to deliver significant product differentiators by: eliminating contaminants such as proteins and endotoxin; eliminating the need for carcinogenic additives; eliminating inflammatory components; and increasing viscosity to improve product performance and durability.

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)
Calcigen. presents its business model to the Group (8:10 pm)
Panel Addresses 3 Major Issues for Calcigen (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

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

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Monday, September 12, 2005

Joint Meeting of the
Philadelphia LES Chapter and PCCI

Presenters:
Membrane Assay, Inc.

We are pleased to be joining the area chapters of the Licensing Executives Society (LES) for our September meeting. Held over from July, Membrane Assay, Inc. - a Ben Franklin Technology Partners (Lehigh Valley) company - will be presenting its business model to the audience with our usual panel of three industry experts providing advice on its future business strategy.

About LES: The Licensing Executives Society is composed of men and women who have an interest in the transfer of technology, or licensing of intellectual property rights -- from biopharmaceutical technical know how and patented inventions to software, copyright and trade marks.

For more information, please contact:

LES: Steven Laird, steven.laird@gmail.com, Ph: (267) 257 2262
PCCI: Don Skerret, DSkerrett@aol.com, Ph: (610) 647 3231

H. Donlon Skerrett
President, PCCI (Pharmaceutical Consulting Consortium International, Inc.)
CEO, NanoScan Imaging, LLC
Managing Partner
Corporate Development Advisors
89 Bunker Hill Court
Chesterbrook, PA 19087
T/F: 610-647-3231
Mobile: 610-608-1569

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)
Membrane Assay Inc. presents its business model to the Group (8:10 pm)
Panel Addresses 3 Major Issues for Membrane Assay (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

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

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Monday, July 11, 2005

"Membrane Assay"

Our July 11 PCCI Meeting at the Chesterbrook Wyndham will feature a BFTP Lehigh company that seeks to commercialize revolutionary new tools for drug discovery. The tools envisioned are integrated circuits which directly interact with and interrogate living cells. These are enabling tools which promise to shorten the drug discovery process.

The featured presenter is Janet Kay Robertson. Dr. Robertson has a Ph.D. in Electrical Engineering, with a minor in BioEngineering, from the University of Michigan, Ann Arbor, MI.

July's panel will look at
1)	what and how long it will take for pharma to adopt the technology
2)	how MAI should structure the sale of its disposable ICA plates, including how the purchase of disposables differ from the purchase of equipment
3)	what is the best strategy for bringing up an external manufacturing line?

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a special 3-entre menu)
Short business meeting (8:00 pm)
Janet Robertson will deliver Membrane Assay's"Elevator" Pitch to the Group(8:10 pm)
Panel Addresses 3 Major Issues for Membrane Assay (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

Company Background:
At its core, Membrane Assay (MAI) is an integrated circuit manufacturing company. MAI's first product is a disposable microwell plate used by drug discovery scientists to test the response of cells to potential new drugs. MAI's lead product is unique. Its ICA (Ion Channel Assay) incorporates an integrated circuit, yielding a microwell plate capable of stimulating cells with an electric field, mimicking the electric fields normally present in the body. The ICA can test the interaction of pharmaceuticals on critical parts of living cells called "voltage-gated ion channels." These channels play a vital role in such processes as the beating of the human heart, the contraction of muscles, and the release of hormones. By altering the function of specific ion channels with pharmaceuticals scientists hope to treat heart disease, cancer, chronic pain, migraine headaches, glaucoma, memory disorders and other diseases.

The ICA will be marketed to pharmaceutical, biotech, and contract research companies engaged in drug discovery.

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

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Monday, June 13, 2005

"IMMUNOTOPE"

Our June 13 PCCI Meeting at the Chesterbrook Wyndham will feature a Doylestown company whose proprietary technologies identify rare, naturally processed antigens present only on diseased cells that are key to the development of immunotherapeutic and diagnostic products. The featured presenters are Ramila Philip, Ph.D., and Lorraine Keller, Ph.D.

June's panel will look at
1)	which companies to partner with
2)	the quality of Immunotope's story
3)	the effectiveness of their presentation.

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a special 3-entre menu)
Short business meeting (8:00 pm)
Lorraine Keller and Ramila Philip present Immunotope's"Elevator" Pitch to the Group (8:10 pm)
The Panel Addresses 3 Major Issues for TNG (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

Company Background:
IMMUNOTOPE is developing immunotherapy products for the treatment of cancer and chronic viral diseases. These products are based on natural antigens that are presented by Major Histocompatibility Complex Class I and Class II molecules, and that elicit a strong T cell-mediated immune response to enable a patient's own immune system to attack and destroy diseased cells, leaving healthy cells unaffected. IMMUNOTOPE's proprietary immunoproteomics technologies identify antigens that are present only on diseased cells, which is critical to the development of safe and efficacious immunotherapeutic vaccines and antibody therapeutics, without the complications of autoimmunity.

Immunotope was formed in January 2003 with technology developed by its scientific founders and
intellectual property purchased from Argonex Pharmaceuticals. Immunotope's laboratories are located at
the Jefferson Center for Biotechnology Research in Doylestown, PA, a facility that also houses the
Hepatitis B Foundation and The Drexel Institute for Biotechnology and Virology Research.

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Monday, May 9, 2005

The Niemi Group, LLC.

Our May 9 PCCI Meeting at the Chesterbrook Wyndham will feature a well-thought-out new pharmaceutical service company from New York City. The featured presenter is Founder and President Peter Niemi of The Niemi Group.

May's three-person panel will look at the following three questions as they relate to penetrating the marketplace for clinical trials:
1)	(PHARMA) How can TNG gain access to decision makers at pharma and biotech to get their insights into making its recruitment offering more attractive and integrate it with their existing efforts? The Group's aim is to offer a plug and play solution with built in ROI for swift adoption and uptake. Faster sales cycles are critical to TNG's success.
2)	(RESEARCH) How can CROs best use TNG's service to supplement their own research capabilities in order to enhance value for shared clients and increase sales for everyone. As the front-line organizations for clinical research, offering a solution for their needs is expected to speed TNG's growth. A related alliance that is pivotal for TNG is centerwatch.org as well as CISCRP -- non profits engaged in recruitment awareness-raising.
3)	(REGULATORY) David Brailler is the federal healthcare informatics chief: how can TNG assist him and other regulatory bodies (FDA) with their goals of an automated healthcare information process? TNG seeks to position itself as a catalyst for change, benefiting drug makers, consumers, and regulatory. Government buy-in/endorsement of TNG's approach is expected to enhance credibility and seed sales cycles.

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a special 3-entre menu)
Short business meeting (8:00 pm)
Peter presents The Niemi Group's "Elevator" Pitch to the Group (8:10 pm)
The Panel Addresses 3 Major Issues for TNG (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

Company Background:
The Niemi Group has architected web-based software and a content delivery system to address the problem of recruiting participants for clinical trials in the pharmaceutical industry.

COMPANY PROFILE: The Niemi Group merges technology and marketing to serve the needs of the drug discovery and marketing process. TNG draws its clients from the pharmaceutical, biotechnology, and healthcare sectors. Their offering delivers special value to CROs conducting drug trials. The team is made up from a group of healthcare, marketing, and technology veterans who founded of Hyphen in 2001, a member of the Omnicom Group of companies. Central to their approach are tools that adhere to standards for integration (HL-7) and privacy (HIPAA).

Founder Peter Niemi spent 10 years at Grey Healthcare Group, where he served as Global Director of Technology, followed by four years as Senior Vice President and Chief Information Officer at Torre Lazur McCann Healthcare. These two firms are considered global pacesetters in developing advertising, marketing and technology-enabled strategies for major healthcare companies.

Join us for a most interesting evening.

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Monday, April 11, 2005

TSP Pharma, LLC.

Our April PCCI Meeting will feature a new Therapeutics and Theragnostics company from Boston, MA. The featured presenter is TSP Pharma's CEO, Paul Horan.

April's panel will look at issues surrounding the "therapeutics versus diagnostics" business model as well as key investor issues. Headlining April's panel is Morgan Lewis and Bockius Steve Goodman. The panel will look at the following three questions as they apply to TSP Pharma:
1)	Cancer therapy is conducted using a series of therapeutic approaches which can include, beam radiotherapy, chemotherapy and Targeted biologicals. Do you believe that a targeted radio-therapy, such as the one that TSP Pharma is looking to develop, provides competitive advantages or can be used synergistically with other therapeutic approaches? How do you see those approaches being used?
2)	With regard to diversification of risk and potential for success in early stage companies, is it more attractive from a financing perspective to be seen as a company focusing on a single platform technology or a company that combines that approach with in-licensing mid-stage development projects synergistic but not identical to the platform technology base?
3)	Who are some of the local venture capitalists and Angels that TSP should consider introducing itself to for its Series A financing?

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a special 2-entre menu)
Short business meeting (8:00 pm)
Paul Horan presents TSP's "Elevator" Pitch to the Group (8:10 pm)
The Panel Addresses 3 Major Issues for TSP Pharma (8:30 pm)
Open discussion: Members and Guests (9:00 pm)

Company Background:
TSP Pharma, Inc. is a biotech start-up company that has licensed a series of peptides and
Mab's that have demonstrated a strong affinity and specificity for solid tumors (colon, lung, prostate, pancreatic) and plans to develop products for therapeutic use in several solid cancers. TSP's intellectual property position will provide it with the premier methodology to successfully use peptides with liquid, targeted radiotherapy that have previously failed because of toxicities.

TSP has a rapid commercialization strategy in which it anticipates initial sales from a therapeutic/theragnostic combined product for colon cancer in 2011, to be followed by a series of Phase III and Phase IV studies to expand the indication list and evaluate its use in other cancers.

Join us for a most interesting evening.

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Monday, March 14, 2005

AthenaBio, Inc.

Our March PCCI Meeting will feature a promising new Life Sciences company from Newark, Delaware. The featured presenter is Barry Marrs, AthenaBio's founder and CEO.

March's two-person panel will look at licensing and investor issues. Lead by Linda Johnson of Mattson Jack, the panel will look at the following three questions as they apply to AthenaBio:
1)	Who is responsible for purchasing libraries in a typical big pharma company, and what kind of information about the library is needed to making a buying decision?
2)	How do you handle exclusivity arrangements for particular compounds? For example, anybody can look But after that does the exclusivity in the field go to the first to make a successful bid, and then others are notified?
3)	How urgent is it to fill the CTO position in AthenaBio? Is it unusual to launch a startup without one, even though we think we have the function covered. And how does something like this look to an outsider?

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a special 3-entre menu)
Short business meeting (8:00 pm)
Barry Marrs presents AthenaBio's"Elevator" Pitch to the Group (8:10 pm)
2-Person Panel Addresses 3 Major Issues for AthenaBio (8:30 pm)
Open discussion: members and guests (9:00 pm)

Company Background:
AthenaBio has developed a revolutionary technology for the culturing (laboratory growth) of previously non-culturable bacteria (Microbial Family Planning) that offers a completely unique source of new antibiotics, lead compounds, enzymes, and therapeutic targets.

The company also has an integrated platform for sourcing, optimizing and producing industrial enzymes designed to perform in their specified applications at 1/100th of current costs.

AthenaBio has a signed contract with DuPont for the supply of leads, which commits DuPont to purchase a minimum of 5,000 leads for a minimum of $550,000 revenue in first three years. DuPont presently provides laboratory, greenhouse and office space at no cost.

In addition, the company has also successfully completed a $1.0 million contract with Hercules, Inc. for optimization of an enzyme for paper processing.

Join us for a most interesting evening.

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Exscribe, Inc.

February 21, 2005 Meeting Summary

By Donna Lombardo, M.S.

The February PCCI Meeting featured a promising new Electronic Medical Records (EMR) company from Bethlehem, PA. The featured presenters were Tom Stine and Richard McCormick, Exscribe’s President and COO. Headlining PCCI's all-star panel for February were Web consultant, Tom Thompson, Market research specialist Martha Nelson and Joe Patterson, editor and publisher of Phorum.com. The meeting covered many areas of interest.

According to GSK data, only 82% of MDs use the internet for work-related purposes, but only 5% for prescribing, making this an area for potential growth.
Using the Internet to provide patient education is another opportunity to offer MDs.
Surgeons tend to like "gadgets" and so may be especially interested in computer-based applications.
Pharmaceutical product managers tend to invest in products that directly increase scripts, and so showed little interest in Exscribe's products as marketing tools. But, perhaps the Managed Care department may be interested.
Potentially, Excribe's products could be purchased by Pharma companies to gain access to or build relationships with key MDs, although current AMA guidelines restrict Pharma companies from offering certain types of free gifts.
Explore potential to target MD groups with specific interests in IT issues, i.e., a special interest group similar to the Flying Physicians Association (which is focused on aviation). Perhaps the AMA can help identify such groups.
Target medical practice managers who may influence MDs to purchase EMR products.
Develop EMR software for PDAs and notebook computer, to enable MDs to enter results from patient exams.
Exscribe can help Pharma companies understand how to use their products to meet
compliance guidelines.
Some MDs may be turned off by too much emphasis on IT issues and use of computer jargon.
Measure satisfaction of existing customers.
Expand to other medical specialties.
The focus on AAPI seems opportunistic, based on an existing relationship, and not part of an overall marketing strategy. Focus on the core business, EMR, vs. e-detailing and websites. There is less competition in the EMR marketplace.

Suggestions for Exscribe's website:

Clearly state the benefits to MDs
Make the "top stories" section more prominent.
Explain the relationship with Stryker and other partners on the "partners" page.
Add Exscribe's company information and website link on Stryker's website.
Update information on HL7.

Monday, February 21, 2005

Exscribe, Inc.

Our February PCCI Meeting will feature a promising new Electronic Medical Records (EMR) company from Bethlehem, PA. The featured presenters are Tom Stine and Richard McCormick, Exscribe’s President and COO.

Mr. Stine and Mr. McCormick have asked us to look at three areas of immediate interest:
1)	What marketing criteria (technology, size, vertical practice area, etc.) are most important to Pharma in deciding how/where to spend their physician-targeted, pull-through, web-marketing funds?
2)	What is the biggest unmet marketing need common to all Pharma companies?
3)	How can PCCI help Exscribe to better leverage its assets to capture a share of Pharma's web-based marketing budgets?

Headlining PCCI's all-star panel for February will be Web consultant, Tom Thompson, addressing #1. Market research specialist Martha Nelson and Joe Patterson, editor and publisher of Phorum.com, will handle questions #2 and #3.

Here is how the format works:

Cocktails and dinner (6:30 pm)
(There will be a cash bar and a 3-entre menu)
Short business meeting (8:00 pm)
Stine and McCormick Present Exscribe’s "Elevator" Pitch to the Group (8:10 pm)
Panel Addresses 3 Major Issues for Exscribe (8:30 pm)
Open discussion: members and guests (9:00 pm)

Company Background:
EMR -- Exscribe provides uniquely packaged, scalable electronic medical records software and services to Orthopedic physicians. While there are presently more than 100 EMRs widely available and actively marketed in the US, industry fragmentation has not resulted in active niche market development.

Instead, the industry model is for a general EMR with practice-specific modules. Exscribe sees this as an opportunity to differentiate its software and develop underserved niche markets, while providing specialty-specific workflow and coding documentary enhancements that lead to demonstrable revenue gains for end-user physicians.

In 2003, Exscribe reached a sales and marketing agreement with Stryker Orthopedics, in which Stryker was granted the right to private label Exscribe’s EMR product in return for providing marketing support through its 400+ sales representatives nationwide.

E-Detailing/Website Marketing -- Exscribe has an arrangement with AAPI (American Association of Physicians of Indian Origin) to develop Web sites for its estimated 10,000 members. The sites would be offered to the members at little or no cost Exscribe would then up sell its Web services to participating AAPI members; appointment scheduling, patient history, subscription processing, and patient education. In exchange for an annual fee, Exscribe would like to offer Pfizer, which has ties to AAPI, and/or other pharmaceutical companies the following:

1) Preferred ad placement on ALL AAPI Websites
2) Scheduled time and access in order to conduct new drug, and drug ed webinar/seminars to AAPI
member users
3) Exclusive pharmaceutical vendor status on all Exscribe-hosted AAPI websites

Join us for a most interesting evening.

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BACKGROUND ON SEROMETRIX
In August 2002, Serometrix took permanent assignment of two US Patents awarded to the New York State Department of Health (NYSDOH). This breakthrough technology, discovered by Dr. Gerald Mizejewski, utilizes a naturally produced human peptide to fight cancer in a safe, nontoxic, yet highly aggressive manner.

This novel drug, named the Growth Inhibitory Peptide ("GIP"), is a functional subset of a key human protein, long known to be essential to the rapid, yet controlled growth and development of human fetuses. The GIP drug has demonstrated a natural regulatory role that beneficially inhibits unhealthy growth of both fetal and tumor cells. The GIP has been further demonstrated to effectively inhibit both tumor metastasis and angiogenesis.

More than 30 years of research at the NYSDOH, the Rumbaugh-Goodwin Cancer Institute (Florida), the National Cancer Institute, SUNY Upstate Medical University and several other internationally recognized research institutions forms the intellectual property foundation for this therapeutic technology.