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Date Certain M&A of Raydiance, Inc., its Assets and Intellectual Property

Gerbsman Partners – http://gerbsmanpartners.com has been retained by Raydiance, Inc. (“Raydiance” or the “Company”), to solicit interest for the acquisition of all or substantially all of Raydiance assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “Raydiance Assets”).

The sale is being conducted with the cooperation of Raydiance.  Raydiance and its employees will be available to assist purchasers with due diligence and assist with a prompt transition.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to the Raydiance Assets has been supplied by third parties and obtained from a variety of sources. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Raydiance or Gerbsman Partners (or their respective directors, officers, staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing (the “information”), as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

The Company, Gerbsman Partners, and their respective directors, officers, staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Raydiance’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the Raydiance Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of, Gerbsman Partners or Raydiance. Without limiting the generality of the foregoing, the Company, Gerbsman Partners, and their respective directors, officers, staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Raydiance Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Raydiance’s or Gerbsman Partners’ prior consent.

SUMMARY OF HISTORICAL INFORMATION

Raydiance develops, manufactures and markets precision manufacturing solutions enabled by femtosecond laser technology. The company’s one step all-laser solutions optimize factory work flow, beyond material processing and handling, to radically improve production efficiency and quality with unmatched part-to-part consistency, higher yields and lower costs. Raydiance solutions are deployed in factories of Fortune 500 companies worldwide and readily integrate into customer manufacturing lines or R&D environments, delivering rapid prototyping and transfer to production.

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Production Machine

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Raydiance Femtosecond Laser

Raydiance originated from a DARPA-funded research project at the University of Central Florida. Initial external funding came from entrepreneur Barry Schuler (former AOL CEO), who was recruited by DARPA to commercialize the technology. In 2007, the company moved its headquarters to Petaluma, CA where it is currently occupies a 40,000 ft2 facility. In the course of the last ten years the company has raised $80M in five rounds of financing from prominent investors including DFJ, DFJ Growth and Samsung Ventures. Headcount currently totals 61 full-time employees. The management team and Board of Directors is compromised of:

Executive Management Team Board of Directors
Richard Pierce – President & CEO

Barry Schuler, Chairman, Managing Director, DFJ Growth

John H. N. Fisher, Managing Director, Draper Fisher Jurveston

Jeff Safchik – MD, Greenstreet Partners
William R. Beyer – COO/CFO
Keith Morton– Senior Vice President, Sales
Tim Flood – Vice President, Engineering
Dr. Steve P. Sapers – Vice President, Operations
Dr. Sri Srinivas – SVP, Business Development

Raydiance reported revenue in 2014 of $11m and forecasts 2015 revenue of $21M. The chart below gives a historical perspective of Raydiance bookings and billings (revenue) growth.

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The Company’s business model is product sales-based with ASPs ranging from $275,000 to over $1,000,000. The Company’s product portfolio spans three primary categories: standalone lasers (~$275,000), to laser with beam delivery rail and software (~$525,000) through full production systems (>$1,000,000).

The Xompany is recognized as a pioneer in two key aspects of laser-based micro-machining:

1) development of the world’s first highly reliable, fiber-based commercial grade femtosecond laser and;
2) a world-class applications team that combines knowledge of femtosecond laser programming with the physics of material science to produce economical solutions in automotive, medical and consumer applications.

UnknownHow Femtosecond Lasers Improve Precision Manufacturing

A femtosecond is one quadrillionth of a second. In the world of ultrafast lasers for material processing, light pulsed in the femtosecond regime (meaning pulses that are faster than 1 picosecond) deliver energy without imparting heat, this is athermal ablation.

Femtosecond laser technology enables all-laser precision manufacturing, which eliminates the need for post-processing (such as grinding, etching, sanding or polishing) and greatly reduces operating expenses while significantly improving yields. Manufacturers can simplify and optimize factory workflow to reduce cost and accelerate time-to-market for new innovations. Femtosecond all-laser processing enables utilization of both new product designs and previously difficult to economically process materials, such as metal alloys, brittle materials (Gorilla® glass or sapphire), heat sensitive polymers and other composite materials.
Target Market Opportunity, Focus and Applications

Precision micromachining markets span a wide variety of market segments where precision defines the products. This is true for semiconductors, medical devices, aerospace, automotive and many consumer devices. Also, the world of ophthalmics and precision jewelry and watches depend on very precise processing or machining. In aggregate, the annual worldwide manufacturing market is over $100B with precision micromachining making up approximately 10% of this total or just short of $10B. The opportunity is very large however success depends on focus.

Raydiance elected to focus in three micromachining segments: medical, automotive and consumer. This focus is driven by market size and the economic advantages made possible with femtosecond laser-based processing.

Raydiance has established a defensible position in each of these segments by leveraging its unique applications expertise to develop trade secrets and know-how for complete turnkey solutions for customers in each of the segments outlined below. The common theme in all of these application areas is that laser processing allows for single step machining. In other words, traditional mechanical machining or even other laser processing leaves a rough surface after drilling, milling or cutting. These rough surfaces demand multiple steps and techniques (grinding, polishing, chemical etch) to achieve desired surface quality for precision parts. Femtosecond laser processing achieves desired surface quality in a single step – a major element of the value proposition.

Medical ApplicationsUnknown Implantable medical devices including metal (nitinol) and polymer (plastic) stents [picture], heart valves, catheter guide wires and surgical needles. Intricate patterns never before achieved have advanced the efficiency of heart stents helping to prolong and save lives. Femtosecond-based laser machining take a metal or polymer tube and cut the intricate patterns in a single pass yielding substantial cost savings.

Automotive Applications: UnknownFuel injector spray nozzles depend on very precise holes that determine the efficacy of both fuel economy and emissions of all engine types, be it automotive, marine, or industrial. Femtosecond-based laser machining is advancing the state of the art by allowing for different shape holes and fashioning the entrance and exit of holes. Instead of making smaller and smaller holes the shape of the holes is now allowing manufacturers to meet government regulations more efficiently.

Consumer Applications: UnknownGorilla Glass™ cutting for smartphones and tablets is a $15B standalone business today. The precision of cut glass edges determines the strength of glass and its tendency to break: a very important quality for all mobile devices. Femtosecond-based laser machining provides single cut quality eliminating the need to polish surfaces. Further, new so-called 3D or shaped glass is very well suited to the flexibility of laser-based cutting.

Customers
Raydiance has strong customer relationship with blue-chip customers across the focus market segments that the company serves. With over 150 systems shipped or installed worldwide, the company is a worldwide leader amongst ultra short-pulse femtosecond suppliers.

In the medical segment, the Company services eight (8) of the top twenty (20) medical device manufacturers worldwide.   Customers will be disclosed upon execution of a nondisclosure agreement.

In the automotive segment, the Company serves six (6) of the top twelve (12) automotive parts suppliers or manufacturers worldwide.  The Company has recently achieved an applications breakthrough to uniquely and efficiently micromachine diesel fuel injectors holes and has pending designs wins with diesel-focused customers.

In the consumer segment, the company serves some of the largest customers including Samsung.   The applications focus is on glass cutting and display repair.

A key factor in Raydiance’s success is the Company’s end-to-end customer support throughout the sales process, providing consultative services for customer application problems and refining or optimizing the efficiency of the machining process. Installation / post-installation support is also an important customer satisfaction element since the Raydiance laser is designed for remote monitoring and diagnostics through an Ethernet connection. Many customers appreciate the preventive maintenance service that can be performed “over the wire.” Raydiance’s knowledgeable team of scientists, who come from an assortment of research disciplines, can provide knowledgeable insight and have “inventioneered” multiple industry applications.

Summary of Intellectual Property

The intellectual property of the Company consists of 33 issued patents and 20 pending patents reflecting a first-to-market position. The patent strategy is both defensive and offensive. The defensive aspect is focused on what’s inside the laser whereas the offensive aspect involves patenting the processing and application know-how that allows the Company to charge for the value that is generated by its applications engineers. The Company’s offensive strategy is designed to not only protect Raydiance’s market leading position but to support the company’s ability to charge a license fee for application knowledge contained in its software embedded in products. The Company includes a royalty free software license with products sold but reserves the right to charge a future recurring revenue stream based on the development of IP for its applications.

 Category                        Issued     Pending    Total

Total                                  33                 20              53

 

Raydiance Patent Summary

In addition to granted patents and patents pending the company has accumulated 230 patentable trade secrets and know-how that are documented in a “Records of Invention” or ROI database. The ROI’s represent the following categories.:

Ultra-short Pulsed Lasers –   178

Consumer Electronics – 24

Medical – 12

General Micro-machining – 11

Automotive –  4

Spectroscopy–  1

Total =230

Summary reasons why the assets are attractive:
1.  Large Market Opportunity – The need for precision manufacturing is growing especially given the need for smaller, lighter cheaper consumer devices. The consumer segment alone is forecast to be a $2.5B market opportunity for precision glass cutting in the next five years.
2.  World class application know-how – Raydiance built a best-in-class applications development team that distinguishes the Company from all other laser manufacturers. Applications knowledge turns standalone lasers into useful, ready-to-use tools.
3.  World class fiber-based laser design and manufacturing capability – Raydiance possesses unique knowledge in what is required to design, build and service fiber-based femtosecond lasers.

4.  Diversified Base of Customers – Raydiance laser-based systems are used in three primary market segments (medical, automotive and consumer) that represents manufacturing application diversity. This diversity also creates cross-selling opportunities between the market segments and customers.

5.  Broad, highly defensible patent portfolio – The Company employs a highly defensible IP strategy, with 33 patents awarded and 20 patents pending in areas related to applications know-how, short pulse technology and power / form factor.

Detailed reasons why Raydiance assets are attractive are:

Raydiance has transformed or pivoted from being a pure laser manufacturer to a company that now delivers the much more than “just the laser.” The Company delivers turnkey packages of ingredients that make femtosecond lasers useful tools. The analogy being that a microprocessor or CPU is a very powerful semiconductor device but unless housed in a smartphone, tablet or personal computer the capabilities remain “untapped.”

The same is true with femtosecond lasers and the programming required to unleash the capabilities for solving unique material problems or precision part fabrication. This programming coupled with the right beam delivery approach is key to the company’s application approach. Depending on the specific application, the package elements vary.

The key elements include the laser, the optics (may include a scanner) to direct the beam, the part holding capability and ultimately the software programming that transforms a standalone laser into an integrated factory floor ready production tool. Raydiance recognized early that to harness the market opportunity one needs to provide turnkey solutions (full packages for customers). Customers are willing to pay for these solutions and prefer turnkey solutions as opposed to needing to contracting/hiring/outsourcing the design and problem-solving aspect of harnessing femtosecond technology.

This unique market approach is what distinguishes Raydiance and leads to these reasons for why the assets are attractive. The timing of the release of subsequent purchase orders under a major customer supply agreement has lead to working capital constraints and the opportunity to acquire all or a portion of Raydiance’s assets to be sold. The acquisition of these assets can enable the purchaser to realize significant short and long term value from the Raydiance assets as Raydiance maintains the ability to quickly scale within the context of sufficient working capital and a stronger balance sheet.

· Large Market Opportunity – The need for precision manufacturing is growing especially given the need for smaller, lighter cheaper consumer devices. The market for laser-based solutions is a subset of the $100 billion industrial manufacturing market and comprised $8.8B in 2014. Worldwide laser sales are projected to increase 6.2% in 2015, reaching a total market size of $9.3B, of which industrial laser material processing is expected to be $2.5B(1). In addition, consumer segment alone is forecast to be a $2.5B market opportunity for precision glass cutting in the next five years.

(1): Strategies Unlimited: “The Worldwide Market for Lasers: Market Review and Forecast 2014”

· World class application know-how – Raydiance has built a best-in-class applications development team that distinguishes the company from all other laser manufacturers. Applications knowledge turns standalone lasers into useful, ready-to-use tools: a fact cherished by Raydiance customers and a primary reason for Raydiance’s market leading position. In addition to building the world’s most commercially reliable fiber-based femtosecond laser, Raydiance has assembled a team of highly skilled optics, material science and machine building expertise that is able to rapidly solve customer problems and provide them a turnkey solution to meet customer requirements.

· World class fiber-based laser design and manufacturing capability – Raydiance possesses unique knowledge in what is required to design, build and service fiber-based femtosecond lasers. The company pioneered the use of real-time computer-controlled pulse stabilization and control, and the amplification techniques to achieve efficient use of fiber for high power, ultra-short pulsed lasers.

· Diversified Base of Customers – Raydiance laser-based systems are used in three primary market segments (medical, automotive and consumer) representing manufacturing application diversity. The diversity also creates cross-selling opportunities between the market segments and customers. Customers are highly dependent on the Raydiance technology today in critical applications where there is no other economical means to produce such high-precision parts is available.

· Broad, highly defensible patent portfolio – The company owns a highly defensible IP strategy, with 33 patents awarded and 20 patents pending in areas related to application development, short pulse technology and power form factor. The company has a long standing history of discoveries and inventions that are pushing the adoption of femtosecond laser technology into a broader set of applications in each of the target market segments.

To learn more about the Company’s technology or products, click on the following links.

1. Precision Machining without Heat – a white paper on the physics of no heat machining.
2. Medical Applications Overview – learn about the economics of femtosecond processing in the medical implantable device market segment.
3. Laser Spec Sheet – an overview of the technical aspects of the key component of Raydiance solutions.
4. R-Drill Spec Sheet – learn how Raydiance packages the needed pieces together to turn a standalone laser into a useful tool.

Safari does not work with the above links

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Raydiance Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners or Raydiance, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Raydiance and Gerbsman Partners (and their respective, staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Raydiance Assets. Sealed bids must be submitted so that they are actually received by Gerbsman Partners no later than Thursday,  July 9, 2015 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at Raydiance office, located at 1450 North McDowell Blvd., Petaluma, CA 94594. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $250,000 (the refundable deposit will be held in Raydiance’s legal counsel trust account.). The winning bidder will be notified within 3 business days of the Bid Deadline. Unsuccessful bidders will have their deposits returned to them within 3 business days of notification that they are an unsuccessful bidder.

Raydiance reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all of the assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

Raydiance will require the successful bidder to close within a 7 day period. Any or all of the assets of Raydiance will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Raydiance Assets shall be the sole responsibility of the successful bidder and shall be paid Raydiance at the closing of each transaction. For additional information, please see below and/or contact:

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456- 0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

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Gerbsman Partners (http://www.gerbsmanpartners.com) has been retained by Venture Lending & Leasing VI, Inc. and Venture Lending & Leasing VII, Inc. (together “WTI” http://westerntech.com), the senior secured lender to AxioMed Spine Corp., (“AxioMed”), (http://www.axiomed.com) to solicit interest for the acquisition of all or substantially all of AxioMed’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “AxioMed Assets”). Please be advised that the AxioMed Assets are being offered for sale pursuant to Section 9-610 of the Uniform Commercial Code. Purchasers of the AxioMed Assets will receive all of AxioMed’s right, title, and interest in the purchased portion of WTI’s collateral, which consists of substantially all of AxioMed’s assets, as provided in the Uniform Commercial Code.

The sale is being conducted with the cooperation of WTI and AxioMed. AxioMed has advised WTI that it will use its best efforts to make its employees available to assist purchasers with due diligence and assist with a prompt and efficient transition at mutually convenient time.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to the AxioMed Assets has been supplied by third parties and obtained from a variety of sources. It has not been independently investigated or verified by WTI or Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by WTI or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing (the “information”), as a statement, opinion, or representation of fact. Please further note that all information provided herein relating to the operations of AxioMed’s business and its market positions relates to periods on or prior to August 31, 2014. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

WTI and Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of WTI’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the AxioMed Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of, WTI and Gerbsman Partners. Without limiting the generality of the foregoing, WTI and Gerbsman Partners, and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the AxioMed Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum is not to be supplied to any other person without Gerbsman Partners’ prior consent. The information contained herein is not subject to the Non-Disclosure Agreement, however any additional requested information will require execution of the attached NDA attached hereto as Exhibit A. Also attached is a detail sales letter, Exhibit B, AxioMed Fixed Asset List (a portion of the fixed asset list is subject to a secured lien by the Ohio Department of Development- Innovation Loan Fund), and Intellectual Property and Trademark summary.

Headquartered in Cleveland, Ohio, AxioMed is a medical device company that has developed innovative, next generation technology for restoring function in the Cervical and Lumbar Spine. The Freedom® Technology platform is a next generation elastomeric based Total Disc Replacement (TDR), which is projected to represent a multi-billion dollar market opportunity. Currently, with minimal marketing efforts the Freedom platform is on track to achieve over $1MM during the next 12 months in the EU.
To date, the Company has received investments from a number of sources totaling over $70,000,000. The Company’s equity investors are led by Thomas McNerney & Partners, Investor Growth Capital, MB Ventures and Primus.

Company Profile

Founded in 2001 AxioMed® Spine Corporation, developed Freedom with the goal of restoring spinal function to patients by adhering to the natural biomechanics of the spine. While current generation discs can provide unconstrained motion and restore disc height, they cannot replicate function, lordotic curve and viscoelastic properties native to a healthy intervertebral disc.

Shown In figures 1 and 2, Freedom Cervical Disc (FCD) and Freedom Lumbar Disc (FLD) are one-piece viscoelastic artificial discs consisting of elastomeric cores bonded to titanium alloy retaining plates. The patented designs include proprietary polymer-metal bonding and morphometric characteristics for optimized fit. Freedom’s design philosophy is to re-establish the function of the spinal segment, working in conjunction with the surrounding anatomy to mimic the biomechanics of a healthy spinal segment.
The FLD was the first elastomeric technology to complete a multi-center study in Europe and receive U.S. Investigational Device Exemption (IDE) approval for a pivotal study. The technology will benefit from a significant time-to-market advantage over competition as it has enrolled more than 400 patients in the randomized pivotal U.S. study and can achieve FDA approval in 2016/2017. As a result, FLD could be the first next generation elastomeric disc approved in the U.S. Combined with CE Mark for FCD, which was received in May 2012, AxioMed’s Freedom is the most complete TDR platform in a potential multi-billion dollar market opportunity for cervical and lumbar TDRs.
AxioMed believes its assets are attractive for a number of reasons:

As a result of concerns related to clinical efficacy and lack of compelling comparative cost effectiveness data, fusion procedures have recently faced mounting reimbursement challenges, which have led surgeons and payers to actively seek an alternative standard of care for degenerative disc disease (DDD). Freedom, along with other TDRs, are poised to take advantage of this opportunity with increasing long term efficacy results and documented economic benefits. To support market launch and favorable reimbursement, AxioMed included economic endpoints in its FDA pivotal study for FLD, including surgical time, length of hospital stay, return to work time, medication usage, quality adjusted life year measurements and cost data for the index procedure as well as any subsequent interventions.
Additional AxioMed has created significant value in:

1.  CE Mark Approval for FCD – Pre-clinical testing and clinical rationale on safety and performance made up the CE Mark Technical File submission for the FCD, an anatomically optimized design that was accepted by the EU Notified Body in conjunction with the receipt of CE Mark approval in May 2012. This pre-clinical testing will also be used for an FDA IDE submission. The FLD experience provides excellent data support and a proven regulatory pathway for an efficient IDE process for the FCD.

2.  Complete FCD European Pilot Clinical Study – AxioMed’s FCD was first implanted commercially in the EU in February 2013, in conjunction with the start of the post-market study in the EU that is collecting clinical data to support an FDA IDE application (estimated for year-end 2014).

3.  Completing FLD Pivotal Clinical Study Enrollment – The Company has completed the IDE Study enrollment with more than 400 subjects, which will place Freedom on track to receive FDA approval in 2016/2017.

4.  Pro-Actively Solicit Expanded Reimbursement for TDRs – Economic data generated from the FLD IDE study will be used to expedite national coverage for FLD as a viable standard of care for DDD. This economic data will support FLD reimbursement in advance of market launch.

5.  Establish Market Awareness of Freedom with Key Opinion Leaders in Europe – Availability of FLD in Europe since 2009 has increased awareness of AxioMed’s clinical approach to TDRs. To date, key opinion leaders in strategic markets have performed TDR procedures with Freedom and have presented positive clinical outcomes data in international spine surgeon symposia.

Impact of the Freedom Technology on the market

Current Market

Industry research and analysts estimate that the current worldwide lumbar TDR market is $350 million1. Similarly, the worldwide cervical TDR market is estimated to be $600 million[1]and analysts expect growth to exceed 25%[2]. Current estimates, however, emphasize the limitations of and challenges faced by first generation TDR technologies and thus, have not fully considered the impact that next generation technologies will have in addressing third party payer and surgeon concerns, in management’s opinion. In addition, current market estimates do not fully appreciate the concept that Freedom’s pivotal study economic data will have an influential effect on the reimbursement landscape by proving to third party payers that a new technology is available to them with as good or better clinical outcomes and significantly better economics.

Limitations of Fusion

In contrast to fusion, first generation TDRs were designed to allow motion in the diseased segment and possibly provide greater pain relief, diminished disability and earlier return to activity. Results for fusion, currently the standard of care treatment for symptomatic DDD and a market exceeding $6 billion1, have demonstrated that the procedure may increase intradiscal pressure and motion at levels adjacent to the fusion which may contribute to radiographic and symptomatic DDD at levels adjacent to fusion. As the surgical treatment of choice for DDD for many years, fusion has thus far had a consistent reimbursement history. Published data indicate, however, that only about 75% of fusion patients experience any clinical benefit.[3] Only half of the fusion patients will experience major or complete relief of pain or disability. Anticipated re-operation rates within ten years are reported to be between 10% and 25%.3 Additionally, fusion is believed to cause complications that result in the potential for increased pain and patient disability. Patient and physician dissatisfaction with fusion gave rise to the concept that removal of the symptomatic disc with maintenance of motion (as is done in total knee and hip procedures) is more likely to improve clinical results and reduce or eliminate the incidence of adjacent level disease (ALD).

Recent third party payer pushback suggests some degree of uncertainty— calling into question the efficacy of roughly 25% of the overall fusion procedures.3 Additionally, issues concerning biologics (InFuse) and capitated pricing strategies have exerted significant downward pressure on fusion implant pricing. AxioMed believes that the increased scrutiny on fusion reimbursement, recent pricing trends and physician and patient desire for an alternative treatment create a significant market opportunity for a differentiated technology such as Freedom. As an example of recent payer pushback on fusion, Blue Cross/ Blue Shield recently limited fusion procedures in certain circumstances. In addition, CMS bundled pricing on anterior cervical decompression with the associated fusion procedure, which resulted in fusion pricing being essentially equal to cervical TDR reimbursement.2

Other Drivers
A recent market study suggested that approximately 77% of cervical TDR procedures were single-level with the remainder applying to two or more levels.10 This represents a significant upside potential for FCD due to its unique anatomically optimized design, including the FCD’s viscoelastic properties similar to that of a healthy natural disc and the Freedom technology’s ability to reproduce the normal spinal function and alignment.

EU Lumbar and Cervical TDR Market Opportunity

AxioMed’s assessment of the EU market opportunity was developed under similar assumptions as those used to estimate the US opportunity. The main differences are related to the timing of Freedom’s and other technologies’ earlier availability in the EU as well as consideration for the higher adoption rates experienced by new technologies in the EU. Furthermore, medical devices in the EU are typically priced at a discount to those sold in the US. Based on this premise and current pricing data, AxioMed estimated EU average selling prices for FLD and FCD to be $4,200 and $3,200, respectively, with projected prices increasing 3% annually.
European Sales

AxioMed currently markets the Freedom Technology in Europe through a limited distribution network. The primary countries are Germany, United Kingdom and Switzerland. With minimal marketing efforts the Freedom platform is on track to achieve over $1MM over the next 12 months.
AxioMed’s Assets

AxioMed has developed differentiated next generation total disc replacement platform in Freedom. The company has created significant intellectual property and assets. These assets fall into a variety of categories, including:
· 8 US Patents, 3 US patent applications, 20 PTC applications and 3 Registered trademarks

· Complete FLD Pivotal study enrollment. The Company has enrolled more than 400 patients, which will place AxioMed on track to receive FDA approval 2016/2017.

· Technology addressing the multi-billion dollar symptomatic degenerative disc disease market.

· Expanded Reimbursement for TDRs – Economic data generated from the FLD IDE study will be used to expedite national coverage for FLD as a viable standard of care for DDD.

· Asymmetric FLD design to meet the unique morphology of the L5-S1 Disc space

· Unique and clinically relevant patient data

· Market supporting pre-clinical and clinical trials underway

· Next generation product designs

· Product cost reduction designs

· Manufacturing and design equipment

· Surgical product inventory

· Intellectual capital and expertise

The assets of AxioMed will be sold in whole or in part (collectively, the “AxioMed Assets”). The sale of these assets is being conducted with the cooperation of AxioMed. AxioMed and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, AxioMed should not be contacted directly without the prior consent of Gerbsman Partners.
Next Milestones – by 2015

AxioMed is working towards additional key milestones that will be achieved by years end. These include:
· The FCD 50 Patient Multi-center Post-Market EU clinical Study. Completion of the study enrollment provides:
o Support FCD IDE submission
o Option for clinical journal publication
o Identical sample size to the FLD multi-center European clinical study
o The prospective study, sample size and two year follow up provides significance to the data set
· FDA approved ASC’s supplement to form Clinical Events Committee (CEC). Currently conducting CEC Meetings for the FLD IDE Study. The CEC is responsible for adjudicating all Adverse Events (AE) and Serious Adverse Event’s (SAE) as it relates to the investigational device and control. This is an FDA requirement and a key item in order to begin data analysis for the PMA submission.
o The FLD Pre-clinical (biomechanical/biocompatibility studies) module is complete and AxioMed is also preparing for the manufacturing module for PMA submission.
Management

Patrick A. McBrayer
President & CEO
Mr. McBrayer joined AxioMed Spine as Chief Executive Officer in 2006 and was elected to the Board of Directors at that time. Prior to AxioMed, Mr. McBrayer was Chief Executive Officer of Xylos Corporation, a medical biomaterials company. He is also a Founder of Transave Inc. (now Insmed), a biotechnology company focused on the site specific treatment of lung disease. Prior to joining Xylos, Mr. McBrayer served as President and CEO of Exogen, Inc., a company focused on the non-invasive treatment of musculoskeletal injury and disease, which was acquired by Smith & Nephew, Inc. in 1999. Previously, Mr. McBrayer was President and CEO of Osteotech, Inc., a worldwide leader in tissue technology that was acquired by Medtronic, Inc. Mr. McBrayer began his business career with Johnson and Johnson after service as an officer in the United States Army Infantry.
James M. Kuras
COO
Mr. Kuras is co-founder of AxioMed Spine and has over 25 years of medical device development experience, his primary focus being device and market development in the orthopedic spinal area. He has development experience in the both class II and class III devices and demonstrated proficiency in developing, implementing and executing strategic business plans for the US, Europe and Pacific Rim. He previously held the position of Senior Vice President and Chief Technology Officer with the company, responsible for the development of the FLD System. He also holds a number of key patents in orthopedics. His career includes positions at such notable companies as AcroMed, Sheridan Catheter and North American Instrument Corp.
Gerald Baty
CFO
Mr. Baty joined AxioMed Spine as Chief Financial Officer in 2008 with over 20 years’ experience in finance, accounting, legal, human resources, administration and business operations. He has assisted small pharmaceutical and biotechnology companies raise funding through various vehicles, including public offerings, PIPE’s, private venture financing, debt and grants. Prior to joining AxioMed, Mr. Baty was Chief Financial Officer for Mt. Cook Pharma, a pharmaceutical development company focused in Urology.
Neal D. Defibaugh
VP Clinical and Regulatory Affairs
Mr. Defibaugh joined AxioMed Spine in 2006 and has over 20 years’ of medical device clinical and regulatory experience focused in orthopedic devices. He has clinical and regulatory experience in both class II and III devices obtaining marketing clearance / approval in the US and international markets. Mr. Defibaugh joined AxioMed Spine from Smith & Nephew, Inc., Orthopedic Division, where he most recently served as Director of Clinical Affairs.

Board of Directors

§ Ashley Friedman, Investor Growth Capital
§ Peter Kleinhenz, Chairman, CID Capital
§ James Kuras, AxioMed Spine Corporation
§ Patrick McBrayer, AxioMed Spine Corporation
§ Peter McNerney, Formerly of Thomas, McNerney & Partners, LLC
§ Larry Papasan, BioMimetic Therapeutics Inc.
§ Kathy Tune, Thomas, McNerney & Partners LLC

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the AxioMed Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of WTI, Gerbsman Partners, or AxioMed, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and WTI, AxioMed, and Gerbsman Partners (and their respective, staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the AxioMed Assets. Sealed bids must be submitted so that they are actually received by Gerbsman Partners no later than Friday, October 31, 2014 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at AxioMed’s office, located at 5350 Transportation Blvd., # 18, Garfield Heights, Ohio 44125. Please also email steve@gerbsmanpartners.com with any bid. Please bid on the fixed assets that are secured by the Ohio Department of Development- Innovation Loan Fund separately. Detail information is available in the due diligence room.

Bids should identify those assets being tendered for in a specific and identifiable way.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $250,000 (payable to Venture Lending and Leasing V, Inc.). The winning bidder will be notified within 3 business days of the Bid Deadline. Unsuccessful bidders will have their deposits returned to them within 3 business days of notification that they are an unsuccessful bidder.

WTI reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all of the assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

WTI will require the successful bidder to close within a 7 day period. Any or all of the assets of AxioMed will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the EGT Assets shall be the sole responsibility of the successful bidder and shall be paid to WTI at the closing of each transaction. For additional information, please see below and/or contact:

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

[1] Spine Technology Summit, 2010
[2] RBC Capital Markets 2Q 2011 Spine Survey, pg 19
[3] Christensen FB. Lumbar spinal fusion. Outcome in relation to surgical methods, choice of implant and postoperative rehabilitation. Acta Orthop Scand Suppl. 75 (313); pp 2-43, 2004

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Article from SFGate.

It’s suddenly a lot harder for venture capitalists and startups to raise funds, as investors fed up with low returns turn their backs on the sector.

Most industry observers agree that lots of young firms will simply not be able to raise their next round of funding, commencing a period of belt tightening, consolidation and closures. At a minimum, it seems to mark the beginning of a more level-headed investment climate in Silicon Valley, after years of insatiable lust for all things mobile and social.

But if the drop-off is too sudden and steep, this new austerity could spill over into an economy highly dependent on the tech sector. Indeed, as The Chronicle reported last week, the industry has an enormous impact, with each tech job creating 4.3 indirect jobs in the community, according to a Bay Area Council Economic Institute report.

The investors and venture capitalists I spoke to insisted that we’re not on the verge of anything like the dot-com meltdown, characterizing the shift as a minor and healthy correction, or a “rationalization.” One suggested it was little more than the usual process of separating good and bad ideas in the marketplace.

But the numbers suggest something new is afoot. In the third quarter, the amount that U.S. companies raised in venture capital dropped 32 percent from the prior year, according to Dow Jones VentureSource. Venture capital funds themselves raised 17 percent fewer dollars from the second to third quarter, even as the number of funds grew, according to a joint report from Thomson Reuters and the National Venture Capital Association.

Economic uncertainty

Some partially blame the economic uncertainty surrounding the outcome of the election and the “fiscal cliff.” But the main problem seems to be that many of the “limited partners” that fund venture capital are pulling back after years of frustration.

Ever since a brief period in the late 1990s when venture capital burned bright, the industry has been delivering consistently weak returns on the whole.

In fact, despite requiring greater risks and larger capital outlays, venture capital has been underperforming the stock market over the past decade, according to a report this year by the Ewing Marion Kauffman Foundation.

Joe Dear, chief investment officer for CalPERS, told Reuters this summer that venture capital “has been the most disappointing asset class over the past 10 years as far as returns.” The huge pension fund for California’s public employees didn’t return repeated calls from The Chronicle.

Investment horizons have steadily spread out, from five to 10 to sometimes 15 years, as exit opportunities like acquisitions and initial public offerings fail to materialize. This has sometimes forced investors to put in more money to protect their initial funds.

‘Pretty grumpy’

“The industry definitely, for the last decade, has been a tough place to be,” said Ray Rothrock of Palo Alto venture capital firm Venrock. “We’re all pretty grumpy right now.”

Some of this is due to macroeconomic conditions outside the control of venture capitalists, notably the housing and banking crises. But at least some of it has to do with poor picks and herd mentality, funding companies with few real prospects and driving up the entry price for legitimately promising companies beyond what they could pay off.

“The market overfunded the number of companies in the system,” said Hans Swildens, founder of Industry Ventures in San Francisco. “There’s a glut.”

Even the grand promise of Web 2.0 companies that lured so much recent money hasn’t generated the hoped-for returns. The ones that managed to go public were often disappointments, including Facebook, Zynga and Groupon, in some cases leaving late-stage investors underwater on their holdings.

That was a final straw for some.

Last week, Forbes dug up figures from CB Insights that highlighted a wide and growing gap between the number of companies that raised initial funding and companies securing the follow-on investments, known as a Series A, generally necessary to keep going. This year, there have been 1,747 seed or angel rounds but only 688 Series A deals, underscoring the coming crunch.

Bad businesses

Based on as scientific a survey as the PR pitches in my inbox, there’s a tremendous number of silly, redundant and poorly executed companies out there that don’t warrant additional funding. The real problem isn’t that many of these companies won’t raise more money; it’s that they raised money in the first place.

For the venture capital industry to get back on track, it needs to embrace a renewed sense of discipline – on company picks, deal terms and total spending.

But hope springs eternal in Silicon Valley.

Rothrock stresses that the industry’s trend-line averages mask very strong results and ongoing investment at top firms, as well as growing venture capital activity among corporations like Google. Companies are just being more selective and looking beyond consumer Internet opportunities.

“We’re steady as she goes in terms of funding enterprise,” he said.

Secondary opportunity

Swildens oversees a secondary fund that buys shares from limited partners and venture firms looking to liquidate part of their holdings. He sees this period as a ripe opportunity for bold investors to get into promising companies at suddenly reasonable rates.

“Ours is one of the few firms aggressively putting money into these funds,” he said.

Mark Heesen, president of National Venture Capital Association, is similarly optimistic. He says the industry could be primed for a strong comeback in 2013, as long as the broader economy strengthens.

Above all, what the industry needs are some wins – acquisitions or initial public offerings that put investors clearly in the black and start to restore some lost confidence.

“If we see these exit markets start to generate good returns, I think you’ll see limited partners look at this asset class again,” he said.

James Temple is a San Francisco Chronicle columnist. E-mail: jtemple@sfchronicle.com Twitter: @jtemple

Read more here.

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Article from GigaOm.

Zscaler a four-year-old startup that has bootstrapped its business by providing a new form of security designed for a mobile and cloud-dependent workforce, has raised $38 million in first-time financing. The round was led by Lightspeed Venture Partners and an unnamed strategic investor.

Zscaler has been fairly successful in its four years building a significant base of clients including Crutchfield Corporation, La-Z-Boy and Telefonica. The company’s software as a service is hosted in more than 100 data centers around the world and essentially protects a company’s web traffic. It does this by routing requests through Zscaler’s software. But there’s no software for users to download on their clients and there’s also no appliance for corporate IT to worry about.

As the cloud and mobility do away with the perimeter model of security where a firewall may prevent harmful traffic from getting in and corporate secrets from getting out, Zscaler is one of several new companies trying to adapt security to a world where there is no perimeter. And even if the corporate IT thought it had a perimeter, the corporation may not own it or have a say in what runs on it. A perfect example of this might be the CEO’s iPad (a aapl).

Zscaler doesn’t solve all problems, but it’s certainly ahead of the pack in thinking about security in a forward-looking way. Other companies trying to address the changes in security required by BYOD and corporate access to the cloud applications are Bromium and CloudPassage. And by waiting to take on venture capital Zscaler’s CEO Jay Chaudhry has joined a select group of established companies who are finally succumbing to the lure of VC cash. For example Qualtrics, a ten-year-old company this year raised $70 million in its first round of outside investment. Another company, Code 42, avoided VC dollars for 11 years before this year raising $52.5 million.

Read more here.

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25 People Every New Founder Should Meet In New York Tech

Alyson Shontell     | Jun. 7, 2012, 3:41 PM

Don’t be fooled by his party pictures. Ben Lerer is one of the smartest businessmen in New York tech.

New to the New York startup scene?
Don’t know a soul but in search of funding, press and good people?

Make your first 25 meetings with these well-connected people in New York.

They’re the gatekeepers to everything a founder could need.

Check out the 25 people you need to meet in New York tech.
Read more: http://www.businessinsider.com/25-people-to-meet-in-new-york-tech-2012-6#ixzz1xEt2cCru

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Re-Inventing Education for the 21st Century

The Internet is staring down the College Cartel. And the Internet will win. College costs cannot continue to rise at three times the rate of inflation, as they have for the last thirty-five years.

My friend Jack Biddle, co-founder of VC firm Novak Biddle, and an early pioneer in online education companies (Blackboard, 2Tor, Fidelis and others) puts it this way:

“Since WW II, GDP has grown at 3% per year but health care and education have and continue to grow at 7%. They are now on a path to reach 50% of GDP. For that to continue, it means that EVERYTHING else that people consume has to shrink by 4% per year. That is simply not going to happen. Herb Stein’s law says that that which is unsustainable, shall stop, and this is unsustainable.”

The Internet has brought efficiency and cost-reduction to so many industries over the last fifteen years: retailing, financial services, advertising, music, news, movies, books, and gaming. The $1 Trillion Education market is next.

Education hasn’t changed much since the days of Plato and the first Academy which he founded in 387 BC in Athens – where the wise teacher filled the brains of his students with his wisdom and knowledge. With 16 million students at 2,400 US Colleges today, that same “wise teacher” paradigm is used in hundreds of thousands of college classrooms and lecture halls each and every day.

Yet the world has changed. Today, across the Internet, more knowledge exists online about any given topic than does in the mind of any one professor at any one school. With access to the Internet, students collectively are wiser than their professors. Companies like Koofers, which helps students prepare for tests in virtual study halls, whether on the same campus taking the same course, or at completely different schools but taking the same course type (Introduction to Economics) are harnessing this collective wisdom.

Salman Khan, who started posting YouTube videos for his family, to help them better understand math being taught in school, is turning education upside down. The Khan Academy suggests that learning should be done online, and classroom time reserved for teachers to help students better understand material they have learned, but perhaps not yet mastered.

2Tor is helping brand-name universities extend their programs online, to reach students around the world. Those online students graduate with the same degrees as their counterparts who attend brick and mortar classes.

The revolution is upon us.

I see four rich veins for entrepreneurs to mine in the higher education space. A lot of wealth will be created here in the next twenty years.

First and foremost is international. The rise of the middle class in India and China alone is creating a college-eligible audience larger than the 16 million college students in the US today. Validating the credentials of these students, helping to match them with US Colleges, preparing them for college from a language or culture standpoint, and educating many of them online represents an industry perhaps as large as the entire US education market today. A new $1 Trillion market.

Second is brand extension by the top US Universities. For most, admission into college is not hard. Only 2% of US Universities are ultra-selective, accepting fewer than 25% of their applicants. These 53 out of 2,041 Universities have brands that are recognized worldwide. It might be more difficult to expand branded undergraduate offerings online, because of the breadth of the curriculum and the socialization needs of the students at that age. But brand expansion, online, for graduate programs can be a very big business. 2Tor is attacking this space dead on.

Third is what I call an “On-Campus Virtual College.” I believe that students go to college for three primary reasons. First is the social experience of college. Making friends for life, having fun, going to parties, and learning how to live and act independently from your parents. Second is to get an education and a degree that is valuable to employers in their field of choice. Third is to find a job upon graduation. Academics only comes to play in the second instance. The other two are much more pragmatic. And nothing says that the three functions can’t be split.

I foresee a day where students will go off to a campus with classrooms, teaching assistants, dorms, sports teams and cafeterias – but with no professors. Students will go to class together and watch a lecture from the best teaching professors in the world. Teaching assistants or adjunct professors will guide the students through the material. But they will learn, online, from the best teachers, unlike today, where at many schools, professors teach because they have to – and conduct research because they want to. By separating the cost of the social experience + the career planning and placement from the cost of teaching, we can fundamentally change the cost of education. This is an ideal setting for the 84% of students who attend schools that accept 50% or more of their applicants.

Fourth is transfer students. A little known secret is that 1 in 3 students transfer at some point during their college life. They graduate from a different college than they enrolled in right out of high school. This process is inefficient today and will benefit from innovations entrepreneurs will pursue. Innovations I foresee include taking the top 10% of community college students, honors candidates, putting them in an online program from a 4-year school, and preparing them to transfer to one of many 4-year schools after learning online for two years. Another idea: Creating a transfer marketplace for college students looking to upgrade the brand name on their diploma. After all, employers care about the school from which you graduated – not the one you initially went to out of high school. Top colleges would love more applicants, with a year or two of college under their belts, with a record of academic achievement from second tier schools. Helping to make that market is a big opportunity.

At New Atlantic Ventures, we are big believers in how the Internet will transform higher education. We have backed two companies in this space so far (Koofers and Wiggio,) are about to close an investment in a third company, and are looking for more!

Follow me on Twitter @jcbackus

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Outlined below are Intellectual Property and Trade Secrets assets from Cortical Pty. Ltd.  The IP and Trade Secrets were developed by Cortical, a biotechnology company that is focused on the development of inhibitors of MIF (macrophage migration inhibitory factor) for the treatment of inflammation and other diseases.

Professor Eric Morand, MD, PhD – Scientific Co-Founder and Chief Scientific Officer is the primary scientist behind the developments and will be available on a consulting basis to an acquiring company.  Eric is a Professor of Medicine at the Monash University Centre for Inflammatory Diseases at Monash MedicalCentre, Melbourne. Eric’s laboratory first identified the role of MIF in rheumatoid arthritis and SLE. He is an acknowledged expert in research on MIF research and glucocorticoid-regulated proteins, and is an author of over 100 papers in peer-reviewed journals in the area of inflammatory diseases. His academic research group has won grants from the NIH, National Health and Medical Research Council Australia, Royal Australasian College of Physicians, and Arthritis Foundation of Australia. He is also the Deputy Director, Rheumatology Unit, Monash Medical Centre, Melbourne, Australia and heads the Monash Lupus Clinic.

The objective of this correspondence is to qualify and determine any potential interest in one of your portfolio companies platforming this opportunity.  If there is interest, Gerbsman Partners will forward additional information and upon receiving a CDA will set up due diligence with Professor Morand and Cortical.

The sale process for any interested party is outlined below and Cortical will entertain Cash and Stock as potential consideration for the Intellectual Property and Trade Secrets.

Please call Steven R. Gerbsman at 415 505 4991 or email steve@gerbsmanpartners.com for additional information.

Steven R. Gerbsman
Principal
Gerbsman Partners
Phone: 415.456.0628, 703.823.1855
Fax: 415.459.2278
Cell: 415.505.4991
steve@gerbsmanpartners.com
thegerbs@pacbell.net
http://www.gerbsmanpartners.com/
BLOG of Intellectual Capital http://www.boic.wordpress.com
Skype: thegerbs

SALE OF CORTICAL PTY LTD

Gerbsman Partners (www.gerbsmanpartners.com <http://www.gerbsmanpartners.com&gt; ) has been retained by Cortical Pty. Ltd. (www.cortical.com.au <http://www.cortical.com.au&gt; ) to solicit interest for the acquisition of all, or substantially all of, Cortical’s assets.

Headquartered in Melbourne, Australia, Cortical is a discovery-phase, biotechnology company that is focused on the development of inhibitors of MIF (macrophage migration inhibitory factor) for the treatment of inflammation and other diseases.

Cortical has recently overcome a major roadblock in MIF research, resulting in a cellular assay platform that has enabled fast compound ranking, SAR and screening.  Cortical has developed a library of proprietary MIF inhibitors, including a primary scaffold currently in lead optimization.

To date, Cortical has raised more than $5 million in three rounds of venture capital financing, lead by GBS Ventures (Melbourne, Australia).  In addition, Cortical has benefited from more than $1 million in government assisted grants.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to Cortical’s Assets (as defined herein) has been supplied by Cortical.  It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact.  Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, andcompleteness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Cortical’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the Cortical Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either expressed orimplied, of any kind, nature, or type whatsoever from, or on behalf of Cortical and Gerbsman Partners. Without limiting the generality of the foregoing, Cortical and Gerbsman Partners and their respective staff, agents, and attorneys,  hereby expressly disclaim any and all implied warranties concerning the condition of the Cortical Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. Thismemorandum and the information contained herein are subject to the Confidential Disclosure Agreement attached hereto as Appendix B.

Company Profile

Cortical is a discovery-phase, Australian biotechnology company developing small-molecule inhibitors of MIF for the treatment of inflammation and other diseases.

Macrophage Migration Inhibitory Factor (MIF) is a differentiated disease target:
·     MIF is a unique pro-inflammatory protein.
·     The MIF knock-out mouse has a normal phenotype, except in disease models.
·     MIF plays a pivotal role in immune-inflammatory diseases, atherosclerosis, metabolic disease and cancer.

Cortical has recently overcome a major roadblock in MIF research, resulting in a cellular assay platform that has enabled fast compound ranking, SAR and screening.  Cortical has developed a library of proprietary MIF inhibitors, including a primary scaffold currently in lead optimization.

To date, Cortical has raised more than $5 million in three rounds of venture capital financing, lead by GBS Ventures (Melbourne, Australia).  In addition, Cortical has benefited from more than $1 million in government assisted grants.

Cortical’s program is lead by Prof Eric Morand who is both a highly respected thought leader in this field and a practicing Rheumatologist.  Dr Morand has published widely; including seminal MIF research and technical reviews: Morand et al., MIF: a new cytokine link between rheumatoid arthritis and atherosclerosis. Nature Reviews Drug Discovery 5, 399–411 (1 May 2006); see Appendix C. The technology originated at Monash University and Cortical was established to exploit its unique know-how around the inflammation target MIF.  Cortical is seeking partners with resources to fully support the MIF program, thereby maintaining its leadership position in the development of MIF-based therapies.

Cortical believes its assets are attractive for a number of reasons:

Cortical has recently overcome a major roadblock in MIF drug development, resulting in a robust cellular assay platform that has enabledCortical to advance their primary MIF inhibitor scaffold to lead optimisation.   Until recently, Cortical and other competitors in the field ranked compounds using various physical assays which were not considered a reliable predictor of in vivo activity.  Utilizing unique target know-how, Cortical has now successfully developed a robust cellular assay to enable drug development against this well validated biological target.

Cortical’s program provides the platform for MIF inhibitor development:

1.    Composition of Matter and Use claims over independent scaffolds
2.    Library of  >1000 compounds, SAR driven program
3.    Lead candidates in optimization phase
4.    Proprietary  assay methodology (TRADE SECRET) – unique in MIF space
5.    X-ray crystallography (TRADESECRET – Cortical compound-MIF co-crystals)
6.    Preclinical oral proof of concept established in several disease models
7.    Mechanistically driven clinical strategy

Impact of Technology on the Market:

Cortical’s program has targeted first-in-class oral cytokine inhibitor drugs with potential applications in inflammatory disease and cancer indications.
The inflammatory disease market is over $60 BN annually with strong recent growth expected to continue[1 – footnote) . Future growth in this sector may be driven by a new wave of targeted therapies based on orally available small molecules.
MIF is a unique cytokine-like molecule which has been validated as a therapeutic target in a wide range of inflammatory diseases (such as RA, asthma/COPD, lupus, MS, SLE colitis, atherosclerosis), metabolic diseases and cancers.

•  The inflammation market has an unmet need for oral targeted small-molecule approaches
•  Small-molecule MIF inhibition offer huge advantages to a developer:

A.  a biologically distinct target, in an uncrowded space
B.  opportunity in a wide breadth of inflammatory indications § blockbuster (e.g. RA) and niche indications (e.g. SLE)
C  oral administration – a competitive advantage compared with biologicals
D.  mechanism-based application to enable steroid sparing therapy
E.  additional roles of MIF in atherosclerosis, metabolic disease and cancer

•  Potential first-in-class line of therapeutics
§  There are no small-molecule targeted therapies currently approved in inflammation.
§  There are no known clinical-stage MIF antagonist programs worldwide.

Cortical’s Pipeline

Cortical is developing first-in-class small molecule cytokine antagonist compounds which directly target MIF.  Cortical’s novel small molecule MIF inhibitors have been discovered through a structure-based drug design approach, proprietary compound-target crystallography data, and proprietary screening assays.
Cortical molecules have good drug development characteristics such as novelty, ease of synthesis, stability, oral bioavailability, lack of off-target interactions and clean non-GLP toxicity profiles.
Cortical compounds have demonstrated preclinical proof of concept with once daily oral activity in in vivo models of rheumatoid arthritis, atheroma, endotoxic shock, delayed type hypersensitivity, and acute liver inflammation.

Pipeline

Cortical’s Intellectual Property and Trade Secret Summary

Cortical Pty Ltd has 4 active patent applications in various stages of approval, allfiled as Composition of Matter applications.  Three applications have been filed around a benzamidazole pharmacophore (Therapeutic molecules and methods 1, MIF inhibitors, and Therapeutic Small Molecules and Uses Thereof).  A fourth patent application has been filed around a bicyclic pharmacophore (Novel methods for treatment of inflammatory diseases).  This is presented in more detail in Appendix B.

In addition to patents, Cortical has developed and holds a number of trade secret data packs:

(1)  The cellular assay:
Following feedback from large pharmaceutical company partners, Cortical focused on reducing to practice a cellular assay amenable to high throughput screening, and has been successful. Other players in the field have not succeeded in solving this technical problem; literature biological assays do not reliably predict activity against the MIF target.  Physical assays such as tautomerase and biacore show binding of compounds to MIF but these have been shown to not be directly predictive of MIF in vivo activity inhibition.
Cortical has strategically elected not topatent or disclose this assay system to any parties so that this unique ability to successfully rank compounds based on in vitro cellular data remains a competitive advantage.

(2)  The crystal structures:
Cortical holds a number of high resolution proprietary compound-protein X-ray co-crystallography data-sets which demonstrate how Cortical compounds bind to MIF.  At 1.6 Å, these crystal structure data-sets further strengthen the SAR rationale.

Management

Nicole Fowler –CEO:

Nicole Fowler was appointed CEO of Cortical in October 2008.
Nicole has a BSc (Hons) from Monash University, an MBA from Melbourne Business School, with over 15 years experience in biotech. Previous roles include big pharma early discovery (SmithKline Beecham, USA), clinical trial management (Parexel, USA and ICTI, Europe) and the manufacture of generic sterile injectables and biologicals (Southern Dental Industries, Australia and Southern Cross Biotech, Australia). During the last 8 years Nicole has focused on working within young biotech companies managing the translation of academicwork into preclinical and clinical development, capital raising, and in-licensing/out-licensing of intellectual property.

Professor Eric Morand, MD, PhD – Scientific Co-Founder and Chief Scientific Officer

Eric is a Professor of Medicine at the Monash University Centre for Inflammatory Diseases at Monash MedicalCentre, Melbourne. Eric’s laboratory first identified the role of MIF in rheumatoid arthritis and SLE. He is an acknowledged expert in research on MIF research and glucocorticoid-regulated proteins, and is an author of over 100 papers in peer-reviewed journals in the area of inflammatory diseases. His academic research group has won grants from the NIH, National Health and Medical Research Council Australia, Royal Australasian College of Physicians, and Arthritis Foundation of Australia. He is also the Deputy Director, Rheumatology Unit, Monash Medical Centre, Melbourne, Australia and heads the Monash Lupus Clinic.

Board of Directors

·     Nigel Stokes, Chairman: Sydney, Australia
·     Brigitte Smith: Managing Partner, GBS Ventures – Melbourne, Australia
·     Prof Eric Morand: Founder – Melbourne Australia

The assets of Cortical will be sold in whole or in part (collectively, the ” Cortical Assets”). The sale of these assets is being conducted with the cooperation of Cortical. Cortical will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, Cortical should not be contacted directly without the prior consent of Gerbsman Partners.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity toinspect and examine the Cortical Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon anywritten or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Cortical Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Wednesday, January 18, 2012 at 5:00pm Pacific Daylight Time (the “Bid Deadline”)  to Gerbsman Partners office at 211 Laruel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com <mailto:steve@gerbsmanpartners.com> with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase.  All bids must be accompanied by a refundable deposit in the amount of $100,000 (payable to Gerbsman Partners.).  The deposit should be wired to Gerbsman Partners Trust Account.  The winning bidder will be notified within 3 business days of the Bid Deadline. The deposit will be held in trust by Gerbsman Partners.  Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

Cortical reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale.  Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder andbidders may not have the opportunity to improve their bids after submission.

Cortical will require the successful bidder to close within a 7 day period. Any or all of the assets of Cortical will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Cortical Assets shall be the sole responsibility of the successful bidder and shall be paid to Cortical at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Steve@gerbsmanpartners.com
Gerbsman Partners
(415) 456-0628

Kenneth Hardesty
Ken@gerbsmanpartners.com
Gerbsman Partners
(408) 591-7528

Philip Taub
Phil@gerbsmanpartners.com
Gerbsman Partners
(917) 650-5958

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