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.
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
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 millionand analysts expect growth to exceed 25%. 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. 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
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.
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 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.
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
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.
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 email@example.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
 Spine Technology Summit, 2010
 RBC Capital Markets 2Q 2011 Spine Survey, pg 19
 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